Zantac (Ranitidine) Lawsuit News and Updates
The latest lawsuit and trial news for Zantac and Ranitidine.
Zantac Lawsuit Update: Zantac MDL Judge Dismisses Thousands of Cancer Lawsuits
December 7, 2022
Author: Daniel Gala
Thousands of plaintiffs alleging that they had developed cancer because of tainted Zantac and generic ranitidine saw their cases dismissed on Tuesday, December 6, when the judge overseeing multidistrict litigation (MDL) over the recalled heartburn drug granted the defendants’ motion for summary judgment.
The Zantac MDL arose out of the April 2020 recall of all ranitidine-containing drugs after the carcinogen NDMA was detected in the one-time blockbuster medication. The recall followed the United States Food and Drug Administration’s (FDA) April 1 announcement that the agency was requesting not only a recall but a complete and permanent withdrawal from the market.
Given the popularity and longevity of Zantac and, later, generic ranitidine, millions of individuals were potentially impacted. Thousands sued the drug makers, alleging that the drugs had given them or their loved one cancer and seeking to hold the defendant drug companies responsible.
By the time of the judge’s ruling, the Zantac MDL included more than 2,000 active cases, all of them dismissed in a single day by a single order.
“We are extremely surprised by this miscarriage of justice,” lawyers for the plaintiffs said in a joint statement quoted by Reuters. The plaintiff lawyers further expressed great confidence that the ruling would be overturned on appeal.
Representatives of the defendant drug companies—which included GlaxoSmithKline (GSK), Boehringer, Pfizer and Sanofi—expressed satisfaction with the judge’s ruling, though some noted that the companies still face tens of thousands of Zantac cases in state courts across the US.
In the December 6 omnibus order, US District Judge Robin Rosenberg found that the plaintiffs had failed to provide sufficient proof that Zantac caused the plaintiffs’ cancer. The determination came after Judge Rosenberg, earlier in the same order, granted the defendants’ requests to exclude essential aspects of the plaintiffs’ expert testimony.
The dismissal of thousands of Zantac lawsuits comes despite the court itself acknowledging in its order that the private testing company Valisure had discovered that, while “the FDA’s self-determined daily limit for NDMA in a drug is 96 nanograms, or ng…Valisure’s tests found NDMA in ranitidine in excess of 3,000,000 ng.”
Still, Judge Rosenberg found that the plaintiffs had not succeeded in establishing a sufficient threshold beyond which the presence of NDMA would cause a person to develop cancer. In part, the judge found that the plaintiffs and one of their experts had relied too much on the FDA acceptable daily intake (ADI) as the threshold for causation.
“Indeed, the FDA itself has cautioned against using ADI as a ‘realistic indication of the actual risk’ associated with a given drug or chemical,” Judge Rosenberg wrote. “This is, in part, because the 96 ng ADI limit represents a 1 in 100,000 cancer risk (meaning 1 in 100,000 persons could develop cancer) when exposed to 96 ng every day for a lifetime. That threshold—1 in 100,000—unquestionably falls short of the preponderance of the evidence standard required here.”
Once the court sided with defendants in dismissing key components of the plaintiffs’ case, that case fell apart, with the court noting in a footnote that the “Plaintiffs conceded on the record that the Court should grant summary judgment for the Defendants if the Court granted all of the Defendants’ Daubert motions,” referencing the 1993 Supreme Court decision that established the legal ground rules pertaining to expert witnesses.
The next step for the affected plaintiffs will be to seek having the judge’s order overturned on appeal, a prospect that—even if successful—will take months if not years.
Following the verdict, the stock prices of GSK, Sanofi, and other defendants skyrocketed, with a Barron’s headline reading, “Zantac lawsuits get tossed. GSK, Sanofi, and Haleon Stock Soars.”
Sources:
United States District Court Southern District of Florida. (6 December 2022). Omnibus Order on All Pending Daubert Motions and Defendants’ Summary Judgement Motion. Case No. 9:20-md-02924. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation.
United States Food and Drug Administration (FDA). (1 April 2022). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. FDA News Release.
Pierson, Brendan. (6 December 2022). GSK, Pfizer, Sanofi fend off thousands of U.S. lawsuits over alleged Zantac cancer link. Reuters.
Nathan-Kazis, Josh. (6 December 2022). Zantac Lawsuits Get Tossed. GSK, Sanofi, Haleon Stock Soars. Barron’s.
Zantac Lawsuit Update: 20 Zantac Lawsuits Filed in NYC Court; Over 7k Claimants Bring Suits in Delaware
October 11, 2022
Author: Daniel Gala
In addition to federal multidistrict litigation (MDL) that has centralized more than 2,000 cases, the makers of Zantac and generic ranitidine also face scores of lawsuits in state courts across the United States. Recently, a tranche of 20 such cases were filed in Manhattan civil court, with the plaintiffs alleging that the one-time blockbuster drug gave them cancer. Around the same time, more than 7,000 claimants also brought suits in Delaware state court.
The New York City lawsuits all were filed on Monday, September 12, The Patch reported. The Delaware lawsuits also were filed in mid-September, according to a news release issued by the law firm representing the plaintiffs in those cases.
Zantac and generic ranitidine were pulled from shelves in April 2020 after it was announced that ranitidine can transform chemically into NDMA, a powerful carcinogen that recently has been implicated in the recall of other drugs, including the popular blood-pressure medication valsartan.
The New York lawsuits allege that, while the FDA’s daily allowable limit for NDMA is 96 nanograms, “in a single dose of Zantac, researchers are discovering over 3 million nanograms of NDMA.” This means that an individual taking just one dose of Zantac would be exposed to 31,250 times the daily allowable limit of NDMA, and many regular Zantac users have reported taking multiple doses of the drug virtually every day for years or even decades.
Scores of state-court claims involving Zantac have been filed in other jurisdictions, as well. In August, an Illinois lawsuit set to become the first Zantac cancer case to reach trial in the US settled at the last minute for $500,000, Bloomberg reported at the time.
Given Zantac’s status as one of the world’s first blockbuster drugs, with total sales at one time eclipsing $1 billion annually, the number of cases is expected to continue to grow into the many thousands. In September, a single law firm announced that it had filed complaints in Delaware Superior Court on behalf of 7,291 different claimants who hailed from all 50 states in the US, Puerto Rice, Guam, and even France.
The Delaware lawsuits allege that the Big Pharma defendants are liable for failure to warn, manufacturing defect, negligent product design, negligent manufacturing, and negligent misrepresentation, among other claims. The more-than-7,000 Delaware plaintiffs allege that taking Zantac and/or generic ranitidine caused them to develop numerous ailments, including:
• Bladder cancer (553 cases)
• Breast cancer (1,940 cases)
• Colorectal / intestinal cancer (2,472 cases)
• Esophageal cancer (290 cases)
• Gastric / stomach cancer (200 cases)
• Liver cancer (188 cases)
• Lung cancer (119 cases)
• Pancreatic cancer (210 cases)
• Prostate cancer (1,319 cases)
Meanwhile, as of September 15, federal multidistrict litigation (MDL) over Zantac had centralized 2,047 active cases, according the Judicial Panel on Multidistrict Litigation (JPML). The federal MDL continues to make its way through pretrial proceedings in preparation for its first bellwether trial, which has been scheduled to commence in February 2023.
With the rights to the formerly highly lucrative brand name “Zantac” having changed hands several times, defendants in the Zantac lawsuits include a veritable Who’s Who of Big Pharma drugmakers: GlaxoSmithKline (GSK), Pfizer, Boehringer Ingelheim, and Sanofi.
Given the extremely large number of potential cases and the seriousness of the claims, professional estimates put potential damages in the several billions of dollars. In September, Credit Suisse predicted that the total Zantac-related liabilities for GSK alone would equal roughly $5 billion, based on an estimate of $100,000 per case and 50,000 cases. This forecast assumes that a very large number of cases will settle for significantly less than the $500,000 amount reportedly agreed to in August.
The same analysts also predict that GSK will take the brunt of the blame over Zantac.
“As the originator of Zantac and based on cumulative sales, we expect it is likely that GSK would bear a significant proportion of any liability in the event of a settlement,” said a Credit Suisse analyst, according to ProactiveInvestors.com.
If you or a loved one has been diagnosed with cancer after taking Zantac and/or generic ranitidine on a regular basis over a long period of time, contact TheLawFirm.com for a free legal consultation!
Sources:
United States Food and Drug Administration (FDA). (1 April 2020). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. Press Announcements.
Feeley, Jef. (16 August 2022). First Zantac Case Dropped Before Trial After Payouts. Bloomberg.
EIN Presswire. (20 September 2022). Baum Hedlund Files Zantac Lawsuits for Over 7,000 People in All 50 States.
United States Judicial Panel on Multidistrict Litigation (JPML). (15 September 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.
Haill, Oliver. (15 September 2022). GSK ‘sell’ rating removed by Credit Suisse as Zantac liabilities expected to be US$5bn. ProactiveInvestors.com.
Patch.com.
Zantac Lawsuit Update: Would-Be First Zantac Trial Settles for $500k
September 7, 2022
Author: Daniel Gala
On the eve of becoming the first Zantac-related lawsuit to go to trial since the drug was pulled from shelves in April 2020, an Illinois case instead reportedly has settled for $500,000, sources with knowledge of the situation told Bloomberg.
With the state-court trial slated to begin August 22, lawyers for plaintiff Joseph Bayer informed the court in mid-August that the lawsuit would be withdrawn following the payout. Bayer had alleged that his esophageal cancer had been caused by ranitidine, the active ingredient sold under the brand name Zantac.
On April 1, 2020, the US Food and Drug Administration (FDA) requested the removal of all ranitidine products from the market after it was discovered that the medication could transform chemically into a powerful carcinogen when exposed to certain conditions, such as being stored in high heat and humidity or being digested in the human stomach. The carcinogen—NDMA—is associated with several forms of cancer, including esophageal cancer, kidney cancer, and liver cancer.
In addition to numerous state-level lawsuits having been filed throughout the country, federal cases over Zantac and generic ranitidine have been centralized as multidistrict litigation (MDL) in the Southern District of Florida. As of August 15, the Zantac MDL included a total of 2,018 active lawsuits.
In the Illinois case, generic ranitidine makers Teva, Perrigo, Sun, and Dr. Reddy’s reportedly will share the cost of the half-million-dollar settlement. In other cases and in the federal MDL, Big Pharma giants such as Pfizer and GlaxoSmithKline—who at one time or another controlled the rights to brand-name Zantac—are among the named defendants.
While the first bellwether trial in the federal MDL is scheduled to begin in February 2023, the first California case presently is set to commence in October of this year.
If you or a loved one has been diagnosed with cancer after taking Zantac or generic ranitidine regularly for an extended period of time, contact TheLawFirm.com for a free legal consultation!
Source:
Feeley, Jef. (16 August 2022). First Zantac Case Dropped Before Trial After Payouts. Bloomberg.
United States Food and Drug Administration (FDA). (1 April 2020). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. FDA News Release.
United States Judicial Panel on Multidistrict Litigation. (15 August 2022). MDL Statistics Report – MDL Distribution by District.
Zantac Lawsuit Update: Parties Spar over Experts in Zantac MDL
June 29, 2022
Author: Daniel Gala
The parties in multidistrict litigation (MDL) over the blockbuster heartburn drug Zantac (ranitidine) continue to spar over expert witnesses as the MDL makes its way through the pretrial process toward its first bellwether trial.
Located at the US District Court for the Southern District of Florida, the Zantac MDL has centralized more than 2,000 federal lawsuits filed in the aftermath of the April 2020 recall of all Zantac and generic ranitidine products in the United States and numerous other countries.
The recall stemmed from the detection of a dangerous carcinogen known as NDMA in Zantac and generic ranitidine products. It later was determined that the presence of NDMA was not due to contamination but rather the chemical properties of the drug itself. Under certain conditions, it was discovered, the compounds contained in the popular heartburn drugs transform chemically into NDMA.
As the US Food and Drug Administration (FDA) stated at the time, “The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.”
Given the drugs’ popularity, widespread availability, and decades on the market, it was unfortunately no surprise when thousands of ranitidine-related lawsuits flooded the courts in the aftermath of the recall, with plaintiffs suing drugmakers, distributors, wholesalers, and retailers for allegedly manufacturing and selling a drug that gave them cancer.
In addition to the federal MDL being held in Florida, Zantac-related litigation is ongoing in several state jurisdictions. For example, in California, four bellwether trials were recently scheduled as part of judicial council coordination proceedings (JCCP) taking place in Alameda County, with the first slated for October 2022.
In the California litigation, the cancers alleged to have been caused by Zantac and/or generic ranitidine include cancers of the bladder, stomach, liver, esophagus, pancreas, breast, prostate, colon, and lung.
As of July 15, the federal Zantac MDL contained a total of 2,016 active cases.
Sources:
United States District Court Southern District of Florida. (29 July 2022). Docket. Case No. 9:20-md-02924. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation.
United States Food and Drug Administration (FDA). (29 July 2022). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. FDA News Release.
United States Judicial Panel on Multidistrict Litigation (JPML). (15 July 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.
Zantac Lawsuit Update: First Trial Set for February 2023 in Calif. Zantac Litigation
June 29, 2022
Author: Daniel Gala
The date for the first bellwether trial in California state litigation over the blockbuster heartburn drug Zantac (ranitidine) has been scheduled for February 13, 2023, pursuant to an order issued June 21.
A total of four bellwether trials were scheduled as part of the Zantac judicial council coordination proceedings (JCCP), which are being held in Alameda County superior court in Oakland, California. The second bellwether presently is slated to begin May 1, 2023, with the third set for August 7, 2023, and the fourth scheduled for October 23, 2023.
Analogous to federal multidistrict litigation (MDL), California JCCPs centralize multiple cases from different jurisdictions that share highly similar facts and legal issues. The California Zantac JCCP and the federal Zantac MDL have consolidated cases filed by individuals who allege that they developed cancer as a result of taking Zantac on a regular basis for an extended period of time.
In April 2020, the US Food and Drug Administration (FDA) requested that all Zantac and generic ranitidine products be removed from store shelves after a powerful carcinogen known as NDMA was detected in the drugs. The presence of the carcinogenic contaminant was found to be the result of chemical changes undergone by the medication itself, which were particularly prone to take place when the medication was stored for long periods of time in conditions of high heat and humidity. Additionally, the conditions found in the human stomach also were deemed to instigate this chemical transformation.
Zantac was an incredibly popular, and incredibly lucrative, medication for decades, making it tragic yet unsurprising that so many Zantac-related lawsuits have been filed. As of June 15, the federal Zantac MDL included more than 2,100 active cases. That litigation also is making its way toward its first bellwether trial.
To qualify to be a plaintiff in the California Zantac JCCP, an individual must have taken Zantac for at least one year and been diagnosed with one of the following cancers:
• Bladder cancer
• Gastric / stomach cancer
• Liver cancer
• Esophageal cancer
• Pancreatic cancer
• Breast cancer
• Prostate cancer
• Colon cancer
• Lung cancer
If you or a loved one has been diagnosed with one of the above cancers after taking Zantac for a year or more, contact TheLawFirm.com for a free legal consultation!
Sources:
Superior Court of California County of Alameda. (21 June 2022). Second Amended Pretrial Order No. 4 Case Scheduling, Bellwether Trial Case Selection, and Discovery Order. JCCP No. 5150
United States Food and Drug Administration (FDA). (1 April 2020). FDA requests removal of all ranitidine products (Zantac) from the market. FDA News Release
United States Judicial Panel on Multidistrict Litigation (JPML). (15 June 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District
Zantac Lawsuit Update: Judge Says Zantac MDL “Is in the Final Stages of Bellwether Trial Selection”
May 30, 2022
Author: Daniel Gala
The United States District Judge presiding over multidistrict litigation (MDL) involving the heartburn drug Zantac stated in an orderorder issued May 12 that the MDL was “in the final stages of bellwether trial selection” and that “the Court has begun the process of finalizing the claims and parties in this MDL.” Further, in another sign that the MDL continues to get nearer to its first bellwether trial, an additional order issued the same day established the schedule for motions and hearings regarding expert witnesses, which will run through the end of September.
The Zantac MDL has centralized more than 2,100 lawsuits filed by individuals alleging that they developed cancer as a result of taking brand-name Zantac or generic ranitidine, Zantac’s active ingredient. In April 2020, the US Food and Drug Administration (FDA) announced that it was requesting the removal of all Zantac and ranitidine products from the US market after a powerful carcinogen known as NDMA was detected in the drugs. While it first was suspected that NDMA was present due to contamination, it later was discovered that the compounds in Zantac and generic ranitidine transform chemically into NDMA under certain conditions, such as when exposed to high heat or humidity or, tragically, when digested by the human stomach.
Given Zantac’s status as the world’s first $1-billion-per-year blockbuster drug, the Zantac MDL has swiftly swelled to contain multiple thousands of cases. Many plaintiffs took Zantac or generic ranitidine on a near-daily basis for years or even decades believing it was a safe and effective way to treat their acid reflux. Instead, they now find themselves with cancer, which they blame on the NDMA they were exposed to via their heartburn medication.
As the first bellwether trial gets closer and closer, pretrial proceedings have grown increasingly testy, with the parties currently trading blows over the taking of depositions. In particular, the deposition of one IT employee for defendant Sanofi who has knowledge of emails that the company failed to preserve has become the subject of an extensive back and forth. Plaintiffs contend that the witness, whose name has been redacted from publicly available court documents, was ill-prepared for their deposition, which was taken in February 2022. As a remedy, plaintiffs have requested additional time for questioning the witness, identified only as “Sanofi IT Employee No. 2”. In its May 27 response to the plaintiffs request for additional questioning defendant Sanofi shot back that the plaintiffs’ request is untimely and without merit.
After defendant Sanofi filed its response, the court announced a telephone discovery hearing to be held June 1 at which the matter would be discussed.
As for the schedule moving forward, the May 12 case management order called for defendants’ written motions challenging plaintiffs’ expert witnesses to be filed by June 13, with the plaintiffs’ challenges to the defendants’ experts due July 6. Oppositions and replies will be exchanged throughout August and into September, and, finally, hearings on expert witnesses will be held September 20 and 28.
Sources:
United States District Court Southern District of Florida. (12 May 2022). Pretrial Order #78 Order Setting Deadline to Unilaterally Dismiss Individual Cases and Deadline to Amend Short Form Complaints. In Re: Zantac (Ranitidine) Products Liability Litigation. Case No. 9:20-md-02924. MDL 2924
United States District Court Southern District of Florida. (12 May 2022). Pretrial Order #77 Order Setting Daubert and Summary Judgment Briefing Schedule. In Re: Zantac (Ranitidine) Products Liability Litigation. Case No. 9:20-md-02924. MDL 2924.
United States Food and Drug Administration (FDA). (1 April 2020). FDA requests removal of all ranitidine products (Zantac) from the market. FDA News Release
United States District Court Southern District of Florida. (27 May 2022). Defendant Sanofi’s Response in Opposition to Plaintiffs’ Motion to Compel Participation in June 2, 2022 Deposition of “Sanofi IT Employee No. 2”. In Re: Zantac (Ranitidine) Products Liability Litigation. Case No. 9:20-md-02924. MDL 2924
United States District Court Southern District of Florida. (27 May 2022). Paperless Order Document 5643. In Re: Zantac (Ranitidine) Products Liability Litigation. Case No. 9:20-md-02924. MDL 2924
Zantac Lawsuit Update: Zantac MDL Reaches 2100 Cases
May 2, 2022
Author: Daniel Gala
The number of total active cases in multidistrict litigation (MDL) over the blockbuster heartburn drug Zantac (ranitidine) has reached 2,100 as of mid-April, making it the 15th largest ongoing MDL in the country.
The lawsuits stem from anApril 1, 2020 announcement by the United States Food and Drug Administration (FDA) that it was requesting the removal of all ranitidine products from the US market. The request was prompted by the discovery of a powerful carcinogen known as NDMA in Zantac and generic ranitidine. Unlike other recent instances of NDMA-related impurities being detected in pharmaceuticals, in which the carcinogen was traced back to contamination in the manufacturing process, the NDMA in ranitidine was found to be a product of the drug itself, meaning that ingredients in Zantac and generic alternatives have the potential to transform chemically into a powerful carcinogen.
“New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers,” the FDA’s April 1, 2020 news release stated. “The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
Given the popularity of Zantac and generic ranitidine and their decades on the market, this announcement had the potential to impact the lives of millions of individuals who had taken prescription or over-the-counter (OTC) ranitidine. Soon, lawsuits followed, with plaintiffs alleging that they had developed cancer after taking NDMA-tainted Zantac and/or generic ranitidine on a regular basis for an extended period of time.
Inside a Zantac MDL Lawsuit
On April 28, James H. Spurlock, a resident of Conroe, Texas, filed his short-form complaint with the Zantac MDL court at the Southern District of Florida. In his lawsuit, Spurlock says that he was diagnosed with liver cancer as well as esophageal, throat, or nasal cancer in October 2016, diagnoses he blames on taking prescription Zantac from January 2000 to December 2010.
As defendants, Spurlock names the various manufacturers of brand-name Zantac, including Pfizer, Boehringer Ingelheim, and GlaxoSmithKline. Additionally, he names retailer The Kroger Co. as defendant.
In his lawsuit, Spurlock asserts a total of twelve counts including failure to warn, design defect, manufacturing defect, general negligence, breach of implied and express warranties, unjust enrichment, and violation of the Texas Deceptive Trade Practices Consumer Protection Act.
As part of the streamlined proceedings that come with joining multidistrict litigation, the plaintiffs in each MDL develop standardized short-form and long-form complaints that make it considerably simpler for plaintiffs to file their initial lawsuits and for the court and the parties to process the high volume of cases. The short-form complaint includes standardized language with spaces for individual plaintiffs to check a box or fill in their response. While these standardized complaints work to improve efficiency and simplicity, they also can prove rigid, leaving little ability for a plaintiff to provide details unique to their individual case.
For example, under the section for “Physical Injury,” the Zantac MDL short-form complaint includes a list of different forms of cancer with a box next to each and instructions to “Check all that apply.” The forms of cancer listed include: bladder, brain, breast, colorectal, esophageal/throat/nasal, intestinal, kidney, liver, lung, ovarian, pancreatic, prostate, stomach, testicular, thyroid, uterine, or other.
The Status of the Zantac MDL
As new cases continue to join the MDL on a near-daily basis, the court and the parties have proceeded through the relatively early stages of the pretrial process. In an order issued April 21, the court reaffirmed its approval of the defendant’s leadership structure, appointing several new members to the defendants’ leadership development committee.
Due to the large number of cases—and therefore the large number of attorneys—involved in multidistrict litigation, courts have developed the convention of creating, with the parties’ advisement, leadership structures and then appointing lawyers to the various positions. While the benefits of such a system are obvious from an efficiency standpoint, it does raise certain questions about the ability of individual plaintiffs (and defendants) to exercise their right to counsel of their choice, given that a great many important decisions with potentially serious impacts on their case are made by counsel that does not represent them directly.
In the instance of the Zantac MDL, the defendants’ leadership structure includes four co-lead counsel, a generic and retailer defendants’ liaison counsel, a defendants’ steering committee, and the leadership development committee. The defendants’ steering committee acts at the direction of the co-lead counsel and assists them with their duties, while the leadership development committee is designed to give relatively less experienced attorneys an opportunity to learn via a leadership position in an MDL.
Sources:
United States Judicial Panel on Multidistrict Litigation (JPML). (15 April 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by Actions Pending
United States Food and Drug Administration (FDA). (1 April 2020). FDA requests removal of all ranitidine products (Zantac) from the market. FDA News Release
United States District Court Southern District of Florida. (28 April 2022). First Amended Short-Form Complaint. Case No. 9:20-md-02924. In Re: Zantac (Ranitidine) Products Liability Litigation. MDL No. 2924
United States District Court Southern District of Florida. (21 April 2022). Pretrial Order #76 Order on Review of Defendants’ Leadership Structure and Additional Appointments. Case No. 9:20-md-02924. In Re: Zantac (Ranitidine) Products Liability Litigation. MDL No. 2924
Zantac Lawsuit Update: Zantac MDL Judge Orders Finalization of Registry, Sets Deadline for Claimants to File Complaints
March 14, 2022
Author: Daniel Gala
In a sign that multidistrict litigation (MDL) over the blockbuster heartburn drug Zantac is entering a new phase, the presiding judge has ordered the finalization of the case registry and set a deadline by which claimants who have not yet filed a complaint must do so.
“Now, almost two years after the inception of this MDL, the time has come for the data in the Registry to be finalized,” wrote US District Judge Robin L. Rosenberg in a case management order issued February 28. “The pleadings have closed, the Plaintiffs’ Leadership has designated the specific cancers it will pursue, the parties have begun the process of preparing Daubert challenges on the issues of general causation, and the bellwether trial selection process has begun. For this MDL to proceed in an orderly fashion, both the parties and the Court need to know with some degree of certainty who the Claimants are, what claims they intend to file, and where the Claimants will file their claims.”
At the inception of the Zantac MDL, due to the large number of cases expected to be filed, the parties and the court agreed to allow some potential plaintiffs, known as claimants, to “preserve their claims without necessarily filing a case in court,” a history Judge Rosenberg recounts in her order. At the time, this arrangement benefitted all sides.
“For the Claimants, such an arrangement meant that they need not immediately pay a filing fee and prosecute their case—they could wait to do so until a later stage of litigation,” Judge Rosenberg explained. “This benefited the Defendants insofar as the Defendants had fewer filed cases to defend against and, relatedly, fewer jurisdictions in which to do so…And one important benefit for all parties—Plaintiffs, Claimants, and Defendants—was that the consolidation and preservation of the Claimants’ claims in a central registry would allow for data to be accumulated about the Plaintiffs and the Claimants: the nature of their alleged injuries and a summary of the individual characteristics of the various Plaintiffs and Claimants such as age, location, duration of product use, etc.”
Hence, the Zantac MDL registry was established as a central repository for key data relating to plaintiffs and claimants. Not only would this registry preserve the claims of claimants who had not yet filed a complaint, the data contained within it could be used to assist with the selection of bellwether cases and to inform settlement negotiations.
But, of course, such an arrangement—in which some potential cases are permitted essentially to exist in legal limbo—cannot last indefinitely, and at some point it was inevitable that the court would establish a deadline by which claimants would be forced to file a formal complaint and officially join the MDL or forego their right to do so. Pursuant to the February 28 case management order, that deadline is now June 30.
Similarly, information contained within the registry must be finalized by that date, as well. For example, for plaintiffs that have filed a complaint, the named defendants and types of cancer listed in their short-form complaint must correspond with those listed in the registry and vice versa.
Zantac—the first $1 billion per year drug—and generic ranitidine were subject to recall after the discovery that they transform chemically into the powerful carcinogen NDMA when exposed to stomach acid or stored in conditions of high heat and humidity. This revelation led thousands of individuals who had taken Zantac or generic ranitidine regularly over an extended period of time and who later were diagnosed with cancer to sue the makers, distributors, and retailers of the drugs, claiming that the defective medications were the cause of their cancer.
As of February 15, the Zantac MDL contained a total of 2,070 cases, making it the 15th largest active MDL in the country.
Sources:
United States District Court Southern District of Florida. (28 February 2022). Pretrial Order #72 Order Requiring Finalization of Registry Information and Certain Short-Form Complaints. Case 9:20-md-02924. MDL 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States Judicial Panel on Multidistrict Litigation (JPML). (15 February 2022). MDL Statistics Report—Distribution of Pending MDL Dockets by Actions Pending
Zantac Lawsuit Update: Zantac MDL Continues Discovery Process as Cases Reach 2,070
February 28, 2022
Author: Daniel Gala
As multidistrict litigation (MDL) over the blockbuster heartburn drug Zantac (ranitidine) makes its way through the complex pretrial discovery process, new cases continue to be added at an average rate of nearly two per day, court records show.
As of February 15, the Zantac MDL—which centralized federal lawsuits alleging that Zantac or generic ranitidine caused the plaintiff’s or a loved one’s cancer—reached 2,070 total cases, an increase of almost 60 cases over the previous month.
Given the popularity of Zantac and generic ranitidine, it has long been expected that the number of cases in the Zantac MDL ultimately would expand into the several thousand. Following decades as a blockbuster profit-maker, on April 1, 2020, the United States Food and Drug Administration (FDA) requested that all Zantac and generic ranitidine be pulled from store shelves after the presence of a powerful carcinogen known as NDMA was detected in samples of the drugs.
Although the NDMA initially was suspected to be the byproduct of contamination during the manufacturing process, it later was discovered that ranitidine can transform chemically into NDMA under certain conditions, including when it is stored for long periods of time—particularly in conditions of high heat and/or humidity—or when it is digested by the human body. Now, thousands of plaintiffs are claiming that they or a loved one developed cancer as a result of the NDMA in Zantac and/or generic ranitidine.
In addition to these personal injury plaintiffs, the MDL also contains a putative class action of so-called “economic loss” plaintiffs, which includes those who shelled out money—sometimes for years or even decades—on what turned out to be a defective medication that may have been doing them more harm than good.
As it adds cases, the Zantac MDL is increasingly making its way up the list of largest active MDLs in the United States, reaching number 15 as of mid-February.
If you or a loved one has been diagnosed with cancer after regularly taking Zantac or generic ranitidine over a long period of time, contact TheLawFirm.com today for a free legal consultation!
Sources:
United States Judicial Panel on Multidistrict Litigation (JPML). (15 February 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District
Judicial Panel on Multidistrict Litigation (JPML). (19 January 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States Judicial Panel on Multidistrict Litigation (JPML). (15 February 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by Actions Pending
Zantac Lawsuit Update: Zantac MDL Court Issues Multiple Discovery Rulings
January 25, 2022
Author: Daniel Gala
As multidistrict litigation (MDL) over the blockbuster heartburn drug Zantac and generic forms of ranitidine passed 2,000 total cases, the court issued several orders governing the pretrial discovery process.
Class Action Cases in the Zantac MDL
First, on January 19, US District Judge Robin L. Rosenberg entered Pretrial Order #71, which establishes the deposition protocol for the putative class actions contained within the Zantac MDL. While many plaintiffs in the Zantac MDL are individuals suing the makers, distributors, and retailers of Zantac and generic ranitidine for allegedly causing them to develop cancer, the MDL does include other classes of plaintiffs, too.
For example, the Zantac MDL includes a pending putative class action for plaintiffs alleged to have suffered economic losses due to the need for medical monitoring. Claims based on the cost of medical monitoring are permissible in certain jurisdictions when an individual has been exposed to a known hazardous substance in an amount or manner that creates a significantly increased risk of serious health consequences and when medical technology exists that would allow for early detection of the ailments and/or injuries associated with such exposure.
Similarly, the Zantac MDL also includes a pending putative class action for plaintiffs alleged to have suffered purely economic losses as a result of the defendants’ manufacture, distribution, and sale of a dangerous and defective product.
(Class action lawsuits differ from multidistrict litigation in that a class action is a single case that includes many different plaintiffs, whereas multidistrict litigation centralizes multiple cases involving highly similar facts and legal issues. Thus, it is possible for an MDL to include class actions among its cases.)
Judge Rosenberg’s January 19 order establishes rules and guidelines governing the taking of depositions for the economic loss and medical monitoring putative class actions, for example by placing a “soft cap” on the number of depositions that “defendants as a group may take as to each putative class representative plaintiff.”
For economic loss plaintiffs, depositions are to be limited to a deposition “of each Plaintiff and two (2) additional depositions in connection with each Plaintiff.”
For medical monitoring claims, the defendants’ limit is expanded to three depositions in addition to the plaintiff.
If the defendants believe they have a legal basis for conducting additional depositions beyond the “soft cap”, they may seek permission from the court-appointed special master or from the court itself. Similarly, plaintiffs may seek to limit depositions to a number below the cap by similar means.
Other Discovery Rulings
In addition to the rulings related specifically to depositions in the MDL’s putative class actions, the court issued on January 20 an order memorializing and expanding upon several discovery rulings made at a January 19 hearing.
First, the court ruled against defendant Boehringer Ingelheim (BI)—which had objected to plaintiffs’ efforts to obtain “information regarding BI’s use of desiccants in their products”—finding the information sought “to be relevant and proportional to the needs of the case.”
Second, with regards to the defendant Sanofi, the court found that Sanofi must hand over information with regards to its corporate witness, including “a list of the employees [the corporate witness] spoke with to prepare for her deposition, as well as any notes she took memorializing the interviews.”
When a party to litigation is a corporation or similar organization, that entity will appoint a witness—often called a corporate witness or a Rule 30(b)(6) witness—to speak on behalf of the corporation or organization. Such a witness is required to be knowledgeable on subject matter related to the litigation, and, in the process of preparing for their deposition, it is common for corporate witnesses to review relevant documents and speak with relevant individuals within the organization.
As the American Bar Association puts it, “The purpose of the Rule 30(b)(6) witness is to represent the collective knowledge of the corporation. Rule 30(b)(6) designees do not testify as to their personal opinions and beliefs but rather present the corporation’s positions on the topics.”
While the plaintiffs prevailed on the first two points against BI and Sanofi, the court rejected an effort by the plaintiffs to obtain emails from additional Sanofi employees, “finding that the cost and burden of Plaintiffs’ request outweighs the likelihood that Plaintiffs will find the information they seek.”
The Zantac MDL
The Zantac MDL arose from evidence that ranitidine—the active ingredient in brand-name Zantac and generic ranitidine—can chemically transform into the powerful human carcinogen NDMA under certain circumstances, such as when stored in conditions of high heat and/or humidity. This led to the filing of thousands of lawsuits against the manufacturers, distributors, and retailers of Zantac and generic ranitidine.
As of January 19, the Zantac MDL included 2,014 active cases.
Sources:
United States District Court Southern District of Florida. (19 January 2022). Pretrial Order #71 Deposition Protocol for Depositions in Class Action Cases. Case No 9:20-md-02924. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (20 January 2022). Order Memorializing Discovery Rulings. Case No 9:20-md-02924. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
Wang, Joyce C. et al. (19 September 2019). Speak for Yourself: The 30(b)(6) Deposition. The Brief. The American Bar Association
Judicial Panel on Multidistrict Litigation (JPML). (19 January 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District
Zantac Lawsuit Update: Zantac MDL Approaches 2000 Cases With Flurry Of Year-End Transfers
January 4, 2022
Author: Daniel Gala
Multidistrict litigation (MDL) over the blockbuster heartburn drug Zantac and generic forms of ranitidine added a flurry of new cases as 2021 came to a close, with dozens of cases joining the MDL in the final days of the year, court records show.
The additional lawsuits have pushed the MDL’s total cases ever closer to 2,000, with the litigation having passed 1,800 cases in mid-December, according to figures released December 15, before the transfer of the additional cases at year’s end.
Given the popularity of Zantac and generic forms of ranitidine, observers have long anticipated that the litigation could grow to include thousands of cases. The centralized lawsuits allege that ranitidine, the active pharmaceutical ingredient (API) in Zantac, has the potential under certain conditions to transform chemically into a powerful carcinogen, causing the plaintiffs to develop cancer. These conditions include being stored for long periods of time, especially under high heat and/or humidity. The hazardous chemical transformation also can occur when ranitidine is being digested by the human body.
In September 2019, the United States Food and Drug Administration (FDA) released a statement first announcing that the human carcinogen NDMA had been detected in samples of ranitidine. Less than two weeks after the FDA’s initial announcement on September 13, drugmaker Sandoz announced on September 24 a voluntary recall of ranitidine capsules “following detection of an impurity.”
As the language of the recall announcement suggests, the early assumption was that the NDMA detected in ranitidine had been the result of contamination during the API manufacturing process, as had been the case when NDMA previously was detected in a class of blood pressure and heart failure medications that included valsartan, losartan, and irbesartan.
However, over subsequent months, as the FDA continued to release new information about the presence of NDMA in ranitidine, and it gradually began to appear that the carcinogen was not the result of contamination but rather of a chemical transformation that ranitidine was underdoing. Meanwhile, more and more makers of generic ranitidine announced recalls.
Finally, on April 1, 2020, the FDA issued a statement requesting that all ranitidine-containing medications be pulled from store shelves entirely.
“The agency [FDA] has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity,” the FDA statement read.
Now, thousands of individuals who have been diagnosed with cancer after regularly taking Zantac and/or generic ranitidine for long periods of time have sued the makers of the drugs, alleging that the defendants knew or should have known about the carcinogenic potential of the medications they were selling but instead turned a blind eye while collectively raking in billions in revenue.
As 2022 begins, the Zantac MDL continues to make its way through pretrial proceedings toward its first bellwether trial. While no trial date has yet been set, based on other established deadlines, the first trial likely will not take place until sometime in late 2022 or early 2023 at the soonest. By that time, it could include many thousands of cases.
Sources:
United States District Court Southern District of Florida. (2 January 2022). Civil Docket. Case 9:20-md-02924. In Re: Zantac (Ranitidine) Products Liability Litigation. MDL 2924
United States Judicial Panel on Multidistrict Litigation (JPML). (2 January 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States Food and Drug Administration (FDA). (13 September 2019). Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. FDA Statement
United States Food and Drug Administration (FDA). (26 September 2019). FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity. FDA News Release
United States Food and Drug Administration (FDA). (1 April 2020). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. FDA News Release
Zantac Lawsuit Update - Zantac MDL: Parties to Use Randomizer Software to Select Bellwether Cases
December 3, 2021
Author: Daniel Gala
In federal mass tort litigation over the blockbuster heartburn medication Zantac, which cases ultimately are selected for participation in bellwether trials will be determined at least in part by randomizer software made by computing giant Microsoft.
“On December 10, 2021, the parties shall use the Microsoft Randomizer to randomly select” which cases are to be included in the so-called “Initial Discovery Pool,” the court ordered in a November 19 filing that laid out in detail the deadlines and procedures relating to the selection of bellwether cases.
While the selection of an initial discovery pool represents incremental progress in the litigation, even under the best case scenario, it likely will be well more than a year before the first bellwether trial is actually held.
“The parties have represented that they will be ready to commence the first bellwether trial in the summer of 2023, if not sooner, and the Court is prepared to preside over this trial at the earliest appropriate date,” US District Judge Robin L. Rosenberg wrote in the November 19 order.
Federal Zantac lawsuits have been centralized as multidistrict litigation (MDL) in the Southern District of Florida. According to Judge Rosenberg, as of the November 19 order, “in excess of 1,800 cases have been consolidated into this MDL.”
The ever-growing number of cases stem from the discovery that ranitidine, the active ingredient in Zantac, can—under certain circumstances—transform chemically into a dangerous carcinogen known as NDMA. These circumstances include prolonged storage in conditions of high heat and/or humidity, as well as ingestion by the human body.
Used primarily as a treatment for ulcers and later heartburn, Zantac was one of the earliest “blockbuster” drugs, being one of the first pharmaceuticals ever to top $1 billion in annual sales in the United States alone, a feat it accomplished all the way back in 1988, a year in which it also was the world’s best-selling drug.
As is common in today’s drug industry, Zantac (ranitidine) has had a complicated ownership history. First developed by what is now GlaxoSmithKline, Zantac was first approved by the US Food and Drug Administration (FDA) in 1983. When Glaxo’s patent on ranitidine in the United States expired in 1997, other companies were free to begin manufacturing and selling their own generic versions, which a number of them did.
In the 2000s, the US FDA approved an over-the-counter version of Zantac to be sold by pharmaceutical giant Pfizer. Over the subsequent years, the over-the-counter Zantac brand moved from Pfizer to Johnson & Johnson to Boehringer Ingelheim Pharmaceuticals and finally to Sanofi.
This complicated history—which also includes bifurcated rights to over-the-counter Zantac and prescription Zantac, as well as many forms of generic ranitidine—make the plaintiffs’ task of proving the culpability of particular defendants all the more challenging.
On September 13, 2019, the FDA announced that the carcinogen NDMA had been detected in samples of ranitidine. However, it was not until more than a month later, on October 18, that Sanofi announced a voluntary recall of over-the-counter Zantac, citing “inconsistencies in preliminary test results” as the reason for its “precautionary” recall.
It did not take long for the first lawsuits to be filed accusing the manufacturers, distributors, and sellers of Zantac and generic ranitidine of causing the plaintiff’s cancer. Counsel for plaintiffs in the Zantac MDL have cited 10 different forms of cancer that they intend to litigate, according to the court’s November 19 order. These include bladder, breast, colorectal/intestinal, esophageal, gastric, kidney, liver, lung, pancreatic, and prostate cancer.
In order to ensure that all of these forms of cancer are represented in the initial discovery pool of cases, the court has required that the randomizer software be used to select a minimum of 25 cases from each cancer type (and 8% of cases for each cancer type for which 8% of cases is greater than 25) and that additional cases be added if the number of cases in the pool ever drops below 25 for any particular cancer type.
Once cases are selected for the initial discovery pool, those cases will begin to undergo additional pretrial discovery, starting with the plaintiffs’ providing authorizations to release certain medical records relevant to their cases. As more information is presented, these cases will be vetted more thoroughly for whether or not they meet the eligibility criteria for bellwether cases.
Sources:
United States District Court Southern District of Florida. (19 November 2021). Pretrial Order #69 Bellwether Selection. MDL No. 2924. Case 9:20-md-02924. In re: Zantac (Ranitidine) Products Liability Litigation
Thomson Reuters. How Zantac went from world’s best-selling drug to being pulled from store shelves. CBC
United States Food and Drug Administration (FDA). (13 September 2019). Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. FDA Statement
Sanofi. (18 October 2019). Sanofi to conduct precautionary voluntary recall of Zantac OTC in U.S. and Canada. PRNewswire
Zantac Lawsuit Update - Zantac MDL: Sanofi Denies Designing, Manufacturing Zantac Sold in US
November 16, 2021
Author: Daniel Gala
Pharmaceutical giant Sanofi has formally denied allegations that it designed or manufactured the one-time blockbuster heartburn medication Zantac, saying in a court filing that it outsourced production to other companies.
Sanofi is among several Big Pharma defendants in multidistrict litigation (MDL) involving allegations that Zantac, the brand name for the drug ranitidine, causes cancer. Research has demonstrated that ranitidine can transform chemically into a carcinogenic compound under certain conditions, such as when stored for long periods in conditions of high heat and/or humidity, or when digested by the human body.
The MDL has centralized more than 1,500 cases filed by plaintiffs with alleged injuries ranging from purely economic losses to cancer.
However, even if it is determined that Zantac did indeed cause the plaintiffs’ cancer, assigning blame for their injuries will be a difficult challenge. Take, for instance, the situation of Sanofi.
“Sanofi admits only that Sanofi marketed, distributed, and sold OTC Zantac in the United States from January 1, 2017 until Sanofi voluntarily withdrew Zantac from the market in October 2019 as a precautionary measure,” states Sanofi’s answer to the plaintiffs’ complaint, filed October 26. “Sanofi denies that Sanofi designed or manufactured Zantac and states that UNION QUIMICO FARMACEUTICA SA (‘Uquifa’) and Boehringer Ingelheim Promeco, S.A. de C.V. (‘BI Promeco’) and Patheon Manufacturing Services LLC (‘Patheon’) manufactured the finished drug product for all Zantac that Sanofi sold in the United States.
The denial by Sanofi highlights just one of the many complexities making it so challenging for plaintiffs to hold pharmaceutical companies accountable for defective drugs. Not only did the rights to Zantac change hands multiple times during its more than two decades on the market, but various aspects of manufacturing, distributing, and selling often were outsourced to unrelated third parties, as well.
Similarly, the complicated and oftentimes convoluted succession of interests also adds a level of complexity when it comes to assigning and allocating blame. Consider defendant Pfizer, which, in its own answer, summarized its involvement with Zantac as follows:
“Pfizer admits only that from 1993 to 1998, Warner-Lambert was part of a joint venture with Glaxo Wellcome that marketed an OTC version of Zantac; that from 1998 to 2000 Warner-Lambert held the marketing rights to OTC Zantac in North America; that Pfizer became the successor-in-interest to Warner-Lambert in 2000; and that Pfizer held the North American marketing rights to OTC Zantac from 2000 to 2006.”
Daunting as it might be to parse apart who was responsible for what aspect of Zantac production and sales at what time and where, these are precisely the sort of complex factual matters that multidistrict litigation is intended to deal with. By centralizing the pretrial proceedings for all federal cases involving this same set of facts and legal issues, MDLs help to ensure greater efficiency and uniformity of outcomes. (If untangling the web of Zantac responsibility once sounds challenging, imagine if courts across the country had to do it 1,500 separate times!)
Despite these challenges, the Zantac MDL continues to add cases as it makes its way through pretreial proceedings toward the first bellwethers.
Sources:
United States District Court Southern District of Florida. (26 October 2021). Answer and Affirmative Defenses of Defendants Sanofi US Services Inc., Sanofi-Aventis U.S. LLC, and Chattem, Inc. to Plaintiffs’ Amended Consolidated Medical Monitoring Class Action Complaint. MDL No. 2924. Case 9:20-md-02924. In re: Zantac (ranitidine) Products Liability Litigation
United States Judicial Panel on Multidistrict Litigation (JPML). (15 October 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States District Court Southern District of Florida. (26 October 2021). Answer and Affirmative Defenses of Pfizer Inc. to Plaintiffs’ Amended Consolidated Medical Monitoring Class Action Complaint. MDL No. 2924. Case 9:20-md-02924. In re: Zantac (ranitidine) Products Liability Litigation
Zantac Lawsuit Update: Zantac MDL Court Sets Date for Conference on Selection of Bellwether Cases
October 21, 2021
Author: Daniel Gala
Multidistrict litigation (MDL) over allegations that the blockbuster heartburn medication Zantac (ranitidine) causes cancer continues to move closer to its first trial, with the court scheduling a conference to discuss how the MDL’s bellwether cases will be selected.
On October 15, US District Judge Robin L. Rosenberg issued an order setting October 25 as the date when the parties and the court will meet via video teleconference to discuss the parties’ previously submitted bellwether selection plan.
In multidistrict litigation, multiple federal cases involving a highly similar set of facts are centralized for pretrial proceedings and then returned to their home districts for trial. Additionally, multidistrict litigation involves bellwether trials, which are meant not only to resolve the case at issue, but also to inform settlement talks for the remaining cases by putting the plaintiffs’ claims to the test before a real jury.
Agreeing on which plaintiffs out of an MDL’s hundreds or sometimes thousands of cases will be selected for bellwether trials can be a complicated and contentious process in itself. First, the parties must establish a bellwether pool, after which they need to agree upon which individual cases will go to trial.
Included with the judge’s October 15 order is a proposed pretrial order agreed upon by and submitted by the parties. This proposed order reveals a number of key details about the parties’ thinking regarding how the pretrial process should proceed, and about the MDL in general.
Proposed Selection Process
First, the proposed order calls for only Florida-based plaintiffs to be eligible for inclusion in the bellwether-selection process. The Zantac MDL is based in the Southern District of Florida.
“The Court intends to use Plaintiffs residing in the state of Florida…as bellwether Plaintiffs in this MDL,” the proposed order states, citing the court’s greater subpoena powers in such cases, as well as the avoidance of certain other legal complications that might arise with out-of-state plaintiffs.
Second, under the proposed order, the parties would break down the Florida-based plaintiffs by the type of cancer they allege was caused by Zantac (or generic ranitidine). Then, on November 16, the parties would use randomizer software to randomly select 6% of the plaintiffs from each of the cancer types. As proposed, the minimum number of cases in this initial pool would be no less than 25, with additional cases added as necessary.
Third, the proposed order provides some hints as to how the parties envision the pretrial schedule playing out in terms of the calendar, giving a rough indication of when the first bellwether might finally take place. For instance, the proposed order does not have the court ruling on expert witnesses—a vital and oftentimes contentious component of pretrial proceedings in highly technical litigation such as this—until “summer or fall 2022.” This suggests that the first bellwether trial would not be held until late 2022 or early 2023 at the earliest.
The “Alleged Cancers”
The proposed order also describes how the Plaintiffs’ Leadership Counsel (PLC) previously “had disclosed to the Court ten (10) alleged cancers that…they intended to pursue in this MDL: Bladder Cancer; Breast Cancer; Colorectal Cancer; Esophageal Cancer; Gastric (Stomach/Intestinal) Cancer; Kidney Cancer; Liver Cancer; Lung Cancer; Pancreatic Cancer; and Prostate Cancer.”
Further, the proposed order breaks down the number of Florida-based plaintiffs diagnosed with each form of these alleged cancers, showing that prostate cancer and breast cancer by far top the list, with colorectal, bladder, and kidney cancers behind them, in that order.
The proposed order states that on December 20, 2021, the PLC “will identify the alleged cancers they intend to continue pursuing in the MDL”, perhaps further whittling down the list of cancers.
As of October 15, the Zantac MDL contained 1,573 pending cases, landing it in the top 20 among active MDLs in the US.
Sources:
United States District Court Southern District of Florida. (15 October 2021). Order Setting Conference on Bellwether Selection Plan. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation. Case No. 9:20-md-02924-RLR
United States Judicial Panel on Multidistrict Litigation (JPML). (15 October 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by Actions Pending
Zantac Lawsuit Update: Zantac MDL: Defendants Ordered to Hand Over Product Samples
September 20, 2021
Author: Daniel Gala
Defendants Sanofi, Boehringer Ingelheim, and GlaxoSmithKline have been ordered to turn over product samples to plaintiffs as part of multidistrict litigation (MDL) over allegations that the blockbuster heartburn drug Zantac causes cancer, court documents show.
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In a September 14 order, United States Magistrate Judge Bruce Reinhart compelled the trio of Big Pharma defendants to produce samples of both the active pharmaceutical ingredient (API) and finished product. After receiving the samples, the plaintiffs then will presumably have the samples tested to help prove their claims that Zantac—the brand name for the drug ranitidine—can transform into a carcinogenic compound.
The Zantac MDL has centralized hundreds of lawsuits filed by individuals alleging that years of regular Zantac use caused them to develop cancer. In September 2019, the United States Food and Drug Administration (FDA) announced that “some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine…classified as a probable human carcinogen (a substance that could cause cancer).”
Beginning roughly two weeks later, the announcement was followed by a series of recalls involving Zantac and generic ranitidine.
The carcinogenic nitrosamine detected in Zantac and generic ranitidine was NDMA, the same contaminant recently discovered in certain batches of some other medications, including the blood-pressure medication valsartan. However, unlike in those other instances, where the NDMA was present due to contamination during the manufacturing process, the NDMA in Zantac appears to have formed from the drug itself.
Evidence indicates that, under certain conditions, ranitidine can transform chemically into NDMA. These conditions include being stored in high heat and/or humidity and, tragically, being digested by the human body.
Capitalizing on widespread indigestion resulting from an unhealthy modern diet, Zantac became the first drug ever to gross $1 billion annually. Given Zantac’s popularity, and that of the generic versions it spawned, the size of the Zantac MDL is expected to grow into the thousands of cases.
As of September 15, the Zantac MDL had a total of 828 active cases, up from 716 in mid-August.
While the court has yet to establish dates for any future bellwether trials, it has given hints as to when it expects those trials might be held, and they remain a good way off. In a pretrial order issued June 14, the court revised a number of deadlines related to pretrial discovery and expert witnesses. In that order, the court shared that “[t]he Court’s vision is that bellwether trials will be conducted within 9-12 months following Daubert hearings.”
Using the schedule laid out in the order as a guide, this would place the first bellwether trial sometime in spring or summer 2024.
If you have been diagnosed with cancer after regularly taking Zantac or generic ranitidine over an extended period of time, contact TheLawFirm.com now for a free legal consultation.
Sources:
United States District Court Southern District of Florida. (14 September 2021). Order Memorializing Discovery Rulings. Case No. 9:20-md-02924. MDL No. 2924. In Re Zantac (Ranitidine) Products Liability Litigation
United States Food and Drug Administration (FDA). (13 September 2019). Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. Press Announcements. FDA Newsroom
United States Food and Drug Administration (FDA). (Last Updated 16 April 2020). FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Drug Safety and Availability
United States Judicial Panel on Multidistrict Litigation (JPML). (15 September 2021). MDL Statistics Report — Distribution of Pending MDL Dockets by District
United States Judicial Panel on Multidistrict Litigation (JPML). (13 August 2021). MDL Statistics Report — Distribution of Pending MDL Dockets by District
United States District Court Southern District of Florida. (14 June 2021). Pretrial Order #65 Amended Second Pretrial Order Establishing Case Management Schedule. Case No. 9:20-md-02924. MDL No. 2924. In Re Zantac (Ranitidine) Products Liability Litigation
Zantac Lawsuit Update: Zantac MDL Passes 700 Cases
September 7, 2021
Author: Daniel Gala
Multidistrict litigation (MDL) over allegations that the blockbuster heartburn drug Zantac and its generic counterparts cause cancer has now passed 700 active cases and continues to grow, court records show.
Given the popularity of Zantac—the brand name for the drug ranitidine—and its generic forms, the total number of cases is expected to increase further, potentially into the many thousands.
Scientific evidence that ranitidine-based medications have the potential to take on carcinogenic qualities under certain conditions has existed for years. On September 13, 2019, the United States Food and Drug Administration (FDA) issued a statement warning that “some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity.” This “impurity” was, in fact, the powerful carcinogen NDMA.
Approximately two weeks later, FDA issued an alert that a number of ranitidine-based medications had been voluntarily recalled by their manufacturers.
NDMA is the same carcinogen behind other recent large-scale drug recalls, such as with the blood-pressure medication valsartan. However, whereas the NDMA detected in valsartan was the result of contamination due to faulty manufacturing processes, it appears that uncontaminated ranitidine has the potential to transform chemically into NDMA, either during storage (especially in high heat and/or humidity) or while being digested inside the human body.
Less than six months after FDA issued its first warning, in February 2020, the Zantac (ranitidine) MDL was created to centralize pretrial proceedings for the many thousands of federal lawsuits anticipated. At the time of its formation, the MDL contained a grand total of 15 cases from nine different districts.
“Plaintiffs in all of the actions allege that the heartburn medication Zantac—and specifically the ranitidine molecule, its active ingredient—breaks down to form an alleged carcinogen known as N-nitrosodimethylamine (NDMA),” the Judicial Panel on Multidistrict Litigation (JPML) wrote in its Transfer Order establishing the Zantac MDL.
In addition to Big Pharma giants Pfizer and Sanofi, who have reaped billions of dollars in revenue from Zantac sales, the MDL’s named defendants also include a slew of lesser-known generic drug makers, as well as large retailers such as Walmart and Target. With more and more large retailers now selling their own house-brand versions of generic medications, these companies are increasingly finding themselves accused not only of selling but also of manufacturing and/or repackaging tainted drugs, as well.
Though the Zantac MDL is still relatively early in pretrial proceedings, it has been growing quickly, adding cases at rate of more than one per day, having grown from 670 cases in mid-July to 716 as of August 13, according to the JPML.
If you have been diagnosed with cancer after regularly taking Zantac or generic ranitidine for a period of years, contact TheLawFirm.com today for a free legal consultation!
Sources:
United States Judicial Panel on Multidistrict Litigation (JPML). (13 August 2021). MDL Statistics Report — Distribution of Pending MDL Dockets by District
United States Food and Drug Administration (FDA). (13 September 2019). Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. FDA Statement
United States Food and Drug Administration (FDA). (25 September 2019). FDA Statements and Press Announcements on NDMA in Zantac (ranitidine). Drug Safety and Availability
United States Judicial Panel on Multidistrict Litigation (JPML). (6 February 2020). Transfer Order. In Re: Zantac (Ranitidine) Products Liability Litigation. MDL No. 2924
United States Judicial Panel on Multidistrict Litigation (JPML). (15 July 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
Zantac Lawsuit Update: Distributor / Retailer / Pharmacy Defendants Seek Full Dismissal of all Zantac MDL Claims
August 9, 2021
Author: Daniel Gala
When plaintiffs began filing lawsuits claiming—based on scientific evidence—that the popular heartburn medication Zantac (ranitidine) had given them cancer, the defendants were not limited to the current and past makers of the drug itself. Also included were some of the most common household names among retailers and pharmacies: Costco, Walgreens, CVS, along with many, many more.
Among other things, plaintiffs accused retailer, pharmacy, and distributor defendants of not properly storing Zantac and generic ranitidine in their care, increasing its carcinogenic properties. (When stored at high temperatures and/or in humid conditions, ranitidine transforms chemically into the highly carcinogenic compound NDMA; ranitidine also transforms into NDMA when digested in the human stomach.)
Once federal Zantac lawsuits were centralized as multidistrict litigation (MDL) in the Southern District of Florida, these distributor and retailer defendants as a group sought to have the claims against them dismissed, and they by and large have succeeded, but not quite completely. Now, with an August 6 filing, these companies—collectively valued at many billions of dollars—are asking the MDL court for a final judgment on all cases naming them as defendants.
To understand what these defendant companies are seeking, it is necessary to understand what they already have received. On June 30, the MDL court issued an order granting the retailer and pharmacy defendants’ motion to dismiss the MDL’s master complaint (as it applies to them) for failure to state a claim. Under the retailer and distributor defendants’ interpretation, this meant they were free from both the generic, global MDL claims as well as any more specific claims contained in individual lawsuits.
However, the court clarified that, while it was dismissing the generic claims against retailers as stated in the MDL’s master complaint, the court was not closing the door on the ability of individual plaintiffs to file more specific Zantac-related claims against those same defendants.
“If individual stores negligently stored ranitidine at unsafe, heated temperatures, how is that a global MDL-based issue?” the MDL court wrote(italics in original).
Put differently, while the court found that claims against distributors and retailers were not suited for litigation through the Zantac MDL, this did not mean that the court was willing to foreclose on the ability of plaintiffs to obtain relief on such claims through some other venue.
“It would only be appropriate for the Court to…enter a final order of dismissal as to the Retailer and Distributor Defendants in every individual case if the Court intended (through its prior rulings) to preclude the individual Plaintiffs from the future opportunity to bring a negligence claim against the Retailer and Distributor Defendants,” US District Judge Robin L. Rosenberg wrote in an August 6 order. “That is not what the Court intended. The Plaintiffs sought to impose global MDL liability on the Defendants without any concrete, particularized, or individualized allegation of negligence. The Court’s dismissal rejected this global theory.”
Judge Rosenberg later indicated that the appropriate venue for such individualized claims would be upon remand, or when MDL cases are sent back to their home districts for further proceedings in accordance with the MDL rulings.
However, in a subsequent filing fired off later the same day as Judge Rosenberg’s August 6 order, the retailer and distributor defendants again urged the court to enter final judgment on all claims against them—generic and specific, MDL and individual. It remains to be seen whether the court will be swayed enough by the defendants’ arguments to go back on its previously held—and clearly stated—position.
As of July 15, the Zantac MDL had 670 pending cases, according to the Judicial Panel on Multidistrict Litigation (JPML).
If you have been diagnosed with cancer after regularly taking Zantac or generic ranitidine over a long period of time, contact TheLawFirm.com today for a free legal consultation!
Sources:
United States District Court Southern District of Florida. (6 August 2021). Motion for Entry of Final Judgment in All Cases Naming Distributor, Retailer, and Pharmacy Defendants. MDL No. 2924. Case No. 9:20-md-02924-RLR. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (30 June 2021). Order Granting the Retailer and Pharmacy Defendants’ Motion to Dismiss Amended Master Personal Injury Complaint and Granting the Distributor Defendants’ Motion to Dismiss Amended Master Personal Injury Complaint. MDL No. 2924. Case No. 9:20-md-02924-RLR. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (6 August 2021). Order Denying the Plaintiffs’ Motion for Entry of Judgment Under Rule 58(a) in Dismissed Member Cases. MDL No. 2924. Case No. 9:20-md-02924-RLR. In Re: Zantac (Ranitidine) Products Liability Litigation
United States Judicial Panel on Multidistrict Litigation (JPML). (15 July 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
Zantac Lawsuit Update: Zantac MDL Survives Defendant Motions to Dismiss
July 7, 2021
Author: Daniel Gala
Plaintiffs suing makers of Zantac and generic ranitidine over allegations that the popular heartburn drug causes cancer have achieved an initial victory, surviving an attempt by numerous defendants to have the claims against them tossed out even before any trials had been held.
Over 600 cases have been filed in multidistrict litigation (MDL) centralizing federal products liability lawsuits alleging that the defendants knew or should have known that regularly taking ranitidine, better known by its brand name Zantac, over a long period of time significantly increases an individual’s cancer risk.
Based on research showing that Zantac can transform chemically into the powerful carcinogen NDMA either when digested by the human body or when stored in high heat and humidity, the MDLs hundreds of plaintiffs claim that Zantac caused their cancer or that of someone who has passed away.
The defendants not only include some of the biggest names in Big Pharma (Sanofi, Pfizer, GlaxoSmithKline) as well as lesser known makers of generic ranitidine, but also distributors and retailers. Household names such as Kroger, Walgreens, CVS, Rite Aid, and Costco all are named defendants. With a growing number of national retail chains selling their own house-brand generic versions of popular medications like Zantac, some of these retailer defendants are accused of more than just selling the defective drug.
On June 30, the Zantac MDL court issued a series of orders adjudicating a number of defendant motions to have certain of the claims against them dismissed. While overall the defendants succeeded in having some claims tossed out, the MDL will continue ahead based on the surviving claims.
As a sign that pretrial proceedings are continuing apace, the court issued on July 2 a production deadline for defendant drugmaker GlaxoSmithKline.
As of June 15, the Zantac MDL contained a total of 613 active cases, according to the Judicial Panel on Multidistrict Litigation (JPML).
Sources:
United States District Court Southern District of Florida. (Accessed 6 July 2021). Docket. In Re: Zantac (Ranitidine) Products Liability Litigation. MDL No. 2924. Case No. 9:20-md-02924-RLR
United States Judicial Panel on Multidistrict Litigation (JPML). (15 June 2021). MDL Statistics Report – Distribution of Pending MDLs by Actions Pending. MDL Statistics Reports
Zantac Lawsuit Update: Zantac MDL Court Issues New Pre-Trial Schedule As Total Cases Pass 600
June 17, 2021
Author: Daniel Gala
Multidistrict litigation (MDL) over the heartburn drug ranitidine, known popularly by the brand name Zantac, continues to grow at a rapid pace, with total cases passing 600 as of June 15, according to figures released by the Judicial Panel on Multidistrict Litigation (JPML) .
Meanwhile, the court issued on June 14 an order revising the pretrial schedule, as the MDL proceeds toward its first bellwether trial. Based on the pretrial deadlines established in the order, the earliest the first bellwether trial could commence would be sometime in mid-to-late 2022.
According to this revised schedule, the parties will “begin discussions regarding [the] process for selection of potential bellwether personal injury cases” on July 1, with the “process and plan” for selecting bellwether cases to be completed by October 1.
Though the June 14 order does not establish an exact date for any bellwether trials, the order states that the court “intends to issue an Order at a later date setting forth the bellwether trial schedule.”
However, the court does make clear its expectation that bellwether trials will be held within a year of the court’s ruling on expert witness motions presented by the parties. These so-called Daubert motions presently are scheduled to be due by May 9, 2022.
“The Court’s vision is that bellwether trials will be conducted within 9-12 months following Daubert rulings,” the order states.
The Zantac MDL has centralized federal products liability lawsuits alleging that the blockbuster heartburn drug Zantac (ranitidine) has the potential to transform into carcinogenic compounds either while being digested by the human body or while being stored long-term under certain conditions, especially involving high heat and humidity.
Hundreds of plaintiffs from across the country have sued the makers of Zantac and generic ranitidine claiming that years of regular use of the drug caused them to develop cancer. Additional defendants include drug distributors such as the massive AmeriSource Bergen as well as well-known retailers like Walgreens and CVS.
The pretrial process has been highly contentious, with the two sides exchanging pointed barbs as to who is to blame for the parties’ mutual failure to meet discovery deadlines previously established by the court. At an April 20 case management conference, the court had been forced to abandon its then-existing pretrial schedule due to the parties’ inability to meet its terms.
With Zantac having been known as the first ever “blockbuster” drug, being the first pharmaceutical to reach $1 billion in annual sales, the MDL is expected to grow well beyond the 600-plus cases it presently contains, potentially growing to include thousands of such claims.
If you have been diagnosed with cancer after years of regularly taking Zantac or ranitidine, contact TheLawFirm.com now for a free legal consultation!
Sources:
United States District Court Southern District of Florida. (14 June 2021). Pretrial Order #65 Amended Second Pretrial Order Establishing Case Management Schedule. In Re: Zantac (Ranitidine) Products Liability Litigation. MDL No. 2924. Case No. 9:20-md-02924-RLR
United States Judicial Panel on Multidistrict Litigation. (15 June 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District. MDL Statistics Report
Zantac Lawsuit Update: Parties Exchange Blame for Delays in Zantac MDL; Hearing on Motion to Dismiss Set For June 4
May 31, 2021
Author: Daniel Gala
The parties in multidistrict litigation (MDL) over allegations that the heartburn medication Zantac (ranitidine) causes cancer continue to engage in heated rhetoric over who is to blame for delays in the pretrial process, court documents show.
Meanwhile, a hearing on the defendants' motion to dismiss the plaintiffs' case—as well as a number of other outstanding motions—has been scheduled for June 4.
The plaintiffs in the Zantac (ranitidine) MDL include hundreds of individuals who have been diagnosed with cancer after regularly taking Zantac or generic ranitidine for an extended period of time. They claim based on scientific evidence that under certain conditions—such as when in long-term storage or being digested by the human body—ranitidine can transform chemically into the powerful carcinogen NDMA.
The defendants include some of the biggest names in Big Pharma—such as Boehringer Ingelheim, GlaxoSmithKline, Pfizer, and Sanofi—as well as lesser-known makers of generic ranitidine, distributors such as the giant Amerisource Bergen, and more that 20 retailers, including numerous household names like Amazon, Costco, CVS, Dollar Tree, and Walgreens.
In a dramatic but necessary move, at an April 20 case management conference, the court vacated all of the deadlines it had established in a previous scheduling order. The following day, the court instructed the parties to submit their proposals for a modified schedule. In a series of court filings over the month of May, while making the case for their respective calendars, counsel for plaintiffs and defendants exchanged volleys of increasingly pointed barbs seeking to assign blame as to why the parties have failed to live up to the court's previously mandated timeline.
On May 7, plaintiffs submitted their proposed schedule, arguing that the court's previous "18-month discovery timeline" had been "premised on all parties working together to conduct full, non-bifurcated discovery based on a series of events and deadlines heavily negotiated by the parties and adopted by the Court."
"Defendants have not kept their end of the bargain," plaintiffs asserted plainly.
In their May 21 response, defendants shot back, accusing plaintiffs of focusing their argument "on cataloguing complaints about past discovery issues" and arguing that "Plaintiffs' request for a nearly six-month extension appears to be an attempt to buy time."
Though defendants "believe that no extension is generally warranted", they "nevertheless remain willing to compromise," their May 21 filing states, countering plaintiffs' request for a six-month extension with an offer of a 90-day delay.
Plaintiffs roared back in a fiery reply filed May 28 , arguing that "Defendants' response completely disregards the realities of this litigation in relation to the timing, scheduling and completion of discovery, a worldwide pandemic, the significance of the Plaintiffs' case, and the need to fairly allow Plaintiffs the opportunity to prepare their expert witnesses."
Further, plaintiffs claim that "Defendants attempt to deflect from the delays they caused and take inappropriate shots at Plaintiffs, leading with an unsupportable claim that Plaintiffs are stalling because the science does not support our case. This is not only disingenuous, but a red herring meant to deflect from Defendants' well-documented non-compliance with this Court's Orders and ongoing delays."
Established in 2020 to centralize federal lawsuits alleging that the blockbuster heartburn medication ranitidine—known popularly under the brand name Zantac—gave the plaintiffs cancer, the Zantac MDL included 581 cases as of May 17, according to the Judicial Panel on Multidistrict Litigation (JPML), the body responsible for establishing and overseeing multidistrict litigation in the US.
Plaintiffs allege that the defendants—which include drugmakers, retailers, and distributors—knew or should have known that under certain conditions, Zantac (ranitidine) could change its chemical composition to form the carcinogen NDMA. These conditions include during prolonged storage, particularly in high heat and humidity, or while being digested in the human stomach.
If you have been diagnosed with cancer after regularly taking Zantac or generic ranitidine for an extended period of time, contact TheLawFirm.com today for a free legal consultation!
Sources:
United States District Court Southern District of Florida. (7 May 2021). Plaintiffs' Motion to Modify Pretrial Order No. 30 and Incorporated Memorandum of Law. In Re: Zantac (Ranitidine) Products Liability Litigation. MDL No. 2924. Case 9:20-md-02924-RLR
United States District Court Southern District of Florida. (21 May 2021). Defendants' Response to Plaintiffs' Motion to Modify Pretrial Order No. 30. In Re: Zantac (Ranitidine) Products Liability Litigation. MDL No. 2924. Case 9:20-md-02924-RLR
United States District Court Southern District of Florida. (28 May 2021). Plaintiffs' Reply in Support of Motion to Modify Pretrial Order No. 30. In Re: Zantac (Ranitidine) Products Liability Litigation. MDL No. 2924. Case 9:20-md-02924-RLR
United States Judicial Panel on Multidistrict Litigation (JPML). (17 May 2021). MDL Statistics Report - Distribution of Pending MDL Dockets by District
Zantac Lawsuit Update: Zantac MDL Defendants Urge Court to Dismiss Amended Complaint
May 25, 2021
Author: Daniel Gala
Defendants in multidistrict litigation (MDL) over the heartburn medication ranitidine, more commonly known by its brand name Zantac, are seeking to have the MDL's master complaint against them dismissed for a second time, arguing that the complaint—even as amended—amounts to an "improper shotgun pleading" and fails to state a claim.
In a motion filed March 24 and a reply brief entered May 21, the defendants argue that plaintiffs have failed to connect concrete actions by specific defendants to the alleged injuries.
"Plaintiffs seek to impose sweeping liability on more than 100 separate Defendants based on vague, generalized assertions of wrongdoing that Plaintiffs cannot plausibly tie to any individual Defendant's conduct or to Plaintiff's own alleged injuries," states the May 21 reply brief.
The MDL, based in the Southern District of Florida, has centralized lawsuits alleging that Zantac (ranitidine) can convert chemically into the known human carcinogen NDMA, either under certain storage conditions or when the drug is digested in the human body.
"[The Amended Master Complaint] fails to provide any Defendant notice of the facts supporting the claims against that Defendant, and it fails to plead non-conclusory facts sufficient to support those claims," the reply brief argues. "This court should dismiss or strike [the Amended Master Complaint] with prejudice."
Certain facts are not in dispute. In 2019, when it first was revealed publicly that ranitidine could transform into cancer-causing NDMA, manufacturers and retailers alike moved quickly to pull the product from store shelves. Subsequently, in April 2020, the United States Food and Drug Administration (FDA) banned the sale of ranitidine-containing products.
However, while defendants assert that they were not aware of the potential for ranitidine to transform into NDMA prior to 2019, plaintiffs argue that the defendants knew or should have known of the risks to patients but failed to act because they were making too much money.
"For decades, Defendants widely promoted and/or sold Zantac and/or its generic equivalent ranitidine as being safe and effective for use to combat heartburn symptoms, making it the first pharmaceutical drug to reach $1 billion in sales," the plaintiffs' Amended Master Personal Injury Complaint (AMPIC) states. "But Defendants concealed from the public a devastating secret. The secret: Zantac and its generic forms transform over time and under certain conditions into a well-known cancer-causing compound, N-Nitrosodimethylamine ('NDMA')."
Plaintiffs argue that Zantac (ranitidine) can transform into NDMA via two different mechanisms: endogenous formation (that is, formation within the human body, specifically in the stomach following ingestion) and degradation (specifically, degrading over time, particularly when exposed to heat and/or humidity). The plaintiffs contend that, among other reasons, the defendants knew or should have known about the risk due to the chemical makeup of ranitidine, which contains the ingredients necessary to make NDMA.
Defendants argue, however, that the plaintiffs have not presented sufficient evidence for the court to reach that conclusion.
"Plaintiffs must plead facts sufficient to support a reasonable inference that those component parts break down to form NDMA through degradation," the defendants argue in their reply brief.
The Defendants
The main defendants in the Zantac MDL are some of the biggest names in Big Pharma, including: Boehringer Ingelheim, GlaxoSmithKline, Pfizer, and Sanofi. Further defendants include nearly two dozen makers of generic ranitidine, as well as distributors such as Amerisource Bergen and more than 20 retailers. The retailer defendants include household names such as Amazon, Costco, CVS, Dollar Tree, and Walgreens.
"Ultimately, the law holds every corporate entity in the supply chain of ranitidine responsible for the personal injuries and death caused by such an unsafe product," asserts the plaintiffs' amended complaint.
'Shotgun Pleadings'
The so-called doctrine of "shotgun pleadings" was established by the Eleventh Circuit as a way of preventing defendants and courts from having to identify and respond to what may be valid legal arguments that are buried within overly long and convoluted complaints filed by plaintiffs. While courts have identified several factors indicative of different types of "shotgun pleadings", generally speaking, the characteristics they all share is a lack of specificity as to the facts alleged, how these facts apply to each individual defendant, and how the facts support each specific claim.
In other words, a "shotgun pleading" might be called using the kitchen-sink approach, where plaintiffs throw in whatever facts or law they think might possibly apply in the hopes that they can make something stick.
That, in essence, is what the defendants have accused the plaintiffs of doing in the Zantac MDL, citing case law holding that a complaint qualifies as a "shotgun pleading" if the complaint does not assert facts sufficient to distinguish between the conduct of different defendants.
Failure to State a Claim
Defendants also argue that plaintiffs' amended complaint should be dismissed for failure to state a claim. One of the most basic requirements of filing a lawsuit is that it must allege specific facts that, if true, would support the claims being asserted. Defendants contend that the plaintiffs' amended complaint fails on this count, as well.
"Even if the AMPIC were not a shotgun proceeding (and it is), numerous counts would nonetheless fail to state a claim," the defendants' reply brief argues, adding later, "Many of its claims are unavailable under the various state laws asserted. And even some claims that are theoretically available are not plausibly pleaded, because the AMPIC is rife with conclusory assertions and non-specific factual allegations."
Where Does the MDL Go From Here?
In order for the Zantac MDL to proceed to bellwether trials, plaintiffs first must survive defendants' efforts to have the amended master complaint dismissed or stricken. The court already has found defendants' arguments valid with regards to the plaintiffs' original master complaint, but the law provides plaintiffs with an opportunity to refile an amended complaint that purports to address the errors behind the previous complaint's dismissal.
However, defendants have argued that the amended master complaint fails to adequately remedy these issues, while plaintiffs argue that the MDL should be allowed to proceed.
Stay tuned to TheLawFirm.com for the latest developments in the Zantac MDL. If you have developed cancer after regularly taking Zantac or generic ranitidine, contact TheLawFirm.com today for a legal consultation!
Sources:
United States District Court Southern District of Florida. (24 March 2021). Defendants' Omnibus Motion to Dismiss and/or Strike Amended Master Personal Injury Complaint, and Incorporated Memorandum of Law. Case No. 9:20-md-02924. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (21 May 2021). Defendants' Reply Brief in Support of Omnibus Motion to Dismiss and/or Strike Amended Master Personal Injury Complaint. Case No. 9:20-md-02924. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (8 February 2021). Amended Master Personal Injury Complaint. Case No. 9:20-md-02924. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
Zantac Lawsuit Update: Zantac Litigation Passes 1200 Cases and Continues to Grow
May 7, 2021
Author: Daniel Gala
On February 6, 2020, when the Judicial Panel on Multidistrict Litigation (JPML) ordered federal lawsuits over the heartburn medication Zantac to be centralized in the Southern District of Florida, the litigation consisted of just 15 cases from nine different districts.
Exactly 15 months later, on May 6, 2021, the number of Zantac cases had increased by a factor of 80, to more than 1,200 member cases, according to an analysis of court documents
conducted by TheLawFirm.com. The exact number of cases as of May 6 was 1,237, with new cases being added on a near-daily basis.
What Is the Zantac Litigation About?
The Zantac multidistrict litigation (MDL) involves allegations that ranitidine—the active ingredient in Zantac and other heartburn medications—has the potential to form into the carcinogen NDMA either while in storage or while being digested in the human body.
"These actions share factual questions arising from allegations that ranitidine, the active molecule in Zantac and similar heartburn medications, can form the carcinogen NDMA, either during storage or when metabolized in the human body," the JPML wrote in its February 20 order
establishing the Zantac MDL. "Plaintiffs uniformly allege that the manufacturers, sellers, and distributors of Zantac and other ranitidine medications knew or should have known that these medications exposed consumers to NDMA, and that defendants concealed the NDMA-associated dangers posed to consumers by these products."
Who Are the Defendants?
Among the MDL's defendants are the makers of Zantac and other ranitidine-containing medications, a group that includes some of the biggest names in Big Pharma: Boehringer Ingelheim, GlaxoSmithKline, Pfizer, and Sanofi-Aventis, as well as lesser-known manufacturers of generic drugs. In addition to the drug makers, potential defendants also include distributors, retailers, and repackagers.
Who Are the Plaintiffs?
The plaintiffs are regular, everyday people who got caught up in the multimillion-dollar marketing campaign promoting Zantac and other ranitidine-based medications as a safe and effective way to treat their heartburn. A random sampling of the hundreds of cases filed in the Zantac MDL shows that many of these plaintiffs took Zantac on a near-daily basis for years without any knowledge that they might be exposing themselves to a dangerous and potentially deadly carcinogen.
What Are the Alleged Injuries?
The standard Short-Form Complaint
submitted by all plaintiffs in the Zantac MDL includes an extensive list of cancer types alleged to have been caused by regular exposure to ranitidine and the cancer-causing compound it is capable of forming into. Each type of cancer has a box next to it, and plaintiffs are to check "all that apply". The forms of cancer listed include:
• Bladder Cancer
• Brain Cancer
• Breast Cancer
• Colorectal Cancer
• Esophogeal / Throat / Nasal Cancer
• Intestinal Cancer
• Kidney Cancer
• Liver Cancer
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Stomach Cancer
• Testicular Cancer
• Thyroid Cancer
• Uterine Cancer
When Will Trials Begin?
Mass tort actions of the scale of the Zantac MDL typically take many years to resolve, and that already slow process has only been slowed further by delays due to COVID-19. In June 2020, the court issued a case management order that called for pretrial discovery to continue through August 2022, meaning that the as-yet unscheduled first bellwether trial would take place at some date well beyond that.
On April 8, 2021, the court issued an additional order revising the previous discovery schedule by postponing a number of key deadlines. The court allowed the additional time at the defendants' request, with defense counsel having argued in large part that limits imposed by the ongoing COVID-19 pandemic had made obtaining the necessary records more difficult and time-consuming than usual.
With the continued delays, it appears that the first bellwether trial will not commence until late 2022 at the earliest.
Sources:
United States District Court Southern District of Florida. (6 May 2021). Civil Docket for Case #: 9-20-md-02924-RLR. In Re: Zantac (Ranitidine) Products Liability Litigation. Case No. 9:20-md-02924-RLR. MDL No. 2924
United States Judicial Panel on Multidistrict Litigation (JPML). (6 February 2020). Transfer Order. In Re: Zantac (Ranitidine) Products Liability Litigation. Case No. 9:20-md-02924-RLR. MDL No. 2924
United States District Court Southern District of Florida. (2 October 2020). Short-Form Complaint. In Re: Zantac (Ranitidine) Products Liability Litigation. Case No. 9:20-cv-81811-RLR. MDL No. 2924
United States District Court Southern District of Florida. (18 June 2020). Pretrial Order #30 Stipulated Discovery and Case Management Schedule. In Re: Zantac (Ranitidine) Products Liability Litigation. Case No. 9:20-md-02924-RLR. MDL No. 2924
United States District Court Southern District of Florida. (8 April 2021). Amended Pretrial Order #63 Supplemental Discovery Schedule for Brand Manufacturers. In Re: Zantac (Ranitidine) Products Liability Litigation. Case No. 9:20-md-02924-RLR. MDL No. 2924
Zantac Lawsuit Update:
February 10, 2021
Author: Ben Adams
There were four opinions issued in the Zantac MDL on December 31, 2020. The rulings generally found that manufacturers of generic Zantac and other defendants, such as retailers, wholesalers, pharmacies and re-packagers, cannot be held liable for state law claims since such claims are pre-empted by federal law.
Federal preemption is a legal defense that prevents defendants from being held liable under state law claims for failing to take steps that would have been restricted by federal law. This means that some defendants will face no liability for their role in distributing and marketing the potentially cancer causing drug. However, it is very important to note that these rulings have no impact on claims involving use of brand-name Zantac.
Judge Rosenberg also issued an Order entitled “Order Granting Brand-Name Manufacturer Defendants’ Motion To Dismiss Plaintiffs’ Innovator-Liability Claims.” Plaintiffs had attempted to argue that the brand name manufacturers should still be liable for injuries suffered by users who only received generic versions of ranitidine.
The theory of ‘innovator liability’ holds that brand name manufacturers still owe a duty to use ordinary care in researching and developing the drug, and warning about safety risks associated with the treatment, regardless of whether the injured party ends up taking the brand name or generic version of the drug. Judge Rosenberg determined such claims are only permissible under Massachusetts and California laws.
The Court issued two other rulings on the same day as well. In these Orders, additional claims were dismissed or the Court found they were improperly plead.
So what does all this mean to a person who took Zantac, was subsequently diagnosed with cancer and now either has a lawsuit or is considering filing one? That will depend on several important factors such as whether you took the brand name drug or a generic drug and where you lived when you took the drug. Although the number of dismissals and failed claims look scary, they don’t mean that all Zantac claims are no long viable. It is common for the Plaintiffs in a lawsuit to make broad allegations at first and for the case to ‘narrow’ as litigation progresses. As always, it’s important to talk to an attorney to determine if you have a case or not.
Zantac Lawsuit Update:
September 16, 2020
Author: Jeremy Fietz
On August 26, 2020, the Judge that is in charge of managing the many thousands of Zantac cancer cases in the United States continued in her effort to put systems in place to most efficiently move the cases forward. Judge Robin Rosenberg was appointed by the Judicial Counsel on Multidistrict Litigation to lead, manage, and resolve MDL 2924 (In Re. Zantac). For more information on what an MDL is how to make a claim, please see TheLawFirm.com’s FAQ.
On with the update.
In June of this year we published a “timeline” of what claimants could expect and we asked our clients to understand that these types of cases most often take years between start to finish.
In a most recent Pretrial Order #41, Judge Rosenberg recognizes the sad reality that many claimants will not survive to see the end of their case.
It is a tragically simple equation: Zantac contains and/or it becomes NDMA (n-nitrosodimethylamine) in the human body. (More information on that is here at TheLawFirm.com). NDMA is well-known to cause cancers. Cancers kill people. Many of those who have bravely come forward to bring a cancer claim against the makers of Zantac are in the midst of cancer treatment (this includes many of our clients). Some of those people will successfully go into remission. Some of them will succumb to their disease long before there is “justice” in the form of a settlement or trial of their claim. The families of these lost victims will carry on with their claim transformed from a cancer injury claim to a wrongful death claim.
Judge Rosenberg has recognized this circumstance and has issued PTO #41 in order to give those people the opportunity to be heard. It takes the form of what is called an in extremis deposition. Under ordinary circumstances the litigation as a whole is very new and the time to take depositions of typical claimants is likely years away (and in most cases a deposition will never be necessary). However, in cases where a claimant is not expected to survive past 12 months or is likely to not be able to give testimony past 6 months, the Judge has ordered that their deposition may be taken in order to preserve their testimony for the future. The Judge has also offered assistance and recognized the sensitivity and emotional difficulties surrounding giving testimony.
As we always tell our clients, pharmaceutical mass tort litigation like this takes time. The good news is, Judge Rosenberg appears to want to move it along as quickly as is possible and we expect that this litigation will not take as long as others we have been involved with.
Here is a complete copy of PreTrial Order #41 and we hope this explanation has been helpful to you.
If you or a loved one has been diagnosed with cancer after at least one year of regular use of Zantac, please call us at TheLawFirm.com. We’ll give you a free case evaluation and help you if we can. Check back frequently for more Zantac Litigation Updates.
Zantac Lawsuit Update: Zantac Census — It’s The Law! Zantac Judge Orders Claimants To Follow The Census Rules
August 21, 2020
Author: Jeremy Fietz
First, if this is your first time checking up on the status of the Zantac litigation there are a few background things you need to know:
1. The Zantac litigation has been consolidated into a Multi District Litigation by the US Federal Courts. This means that no matter what Federal Court your case is filed in, it will most likely end up transferred to the Zantac MDL for handling there (probably until your case is over although there is a small chance of your case being transferred in the future back to wherever you are from).
2. The Zantac MDL was assigned to Federal Court Judge Robin Rosenberg, in the Southern District of Florida and is known as MDL 2924. See the official Zantac MDL webpage of the Federal District Court:
3) Defective drug cases are generally assigned to an MDL system so that the cases can be managed together by one Judge (instead of by hundreds of different judges all over the country managing the cases in hundreds of different ways). If you have a case, it is still your case. Individual case. But they are managed together for efficiency and according to systems that have been proven for years to resolve these kinds of lawsuits.
4) You can check back with us here at TheLawFirm.com for updates on important rulings, orders, and when the time comes (settlement details).
Now, on with the update:
The Court has issued a new “Pretrial Order”.
This Order is in part a warning to Claimants and their lawyers that if they do not follow the Requirements of Pretrial Order #15 and #23, requiring the production of a Census Plus Form on each case, then the Claimant’s case may be dismissed. The Judge already said that but Judges generally fire a warning shot or two across the bow before they start dismissing cases for not following “the rules”. The Judge knows that dismissing peoples’ cases is a harsh penalty and so is giving everyone fair warning that his Pretrial Orders must be taken seriously.
What is the Census Plus Form you ask?
In Pretrial Order 15, Judge Rosenberg issued a questionnaire (Census Plus Form) that would be required to be completed by all Zantac claimants.
Why does everyone have to fill out the questionnaire? The questionnaire asks about each claimaint’s type of cancer, requires submission of medical records to prove the diagnosis, asks about usage of Zantac, etc.. This information gives the Court, the defense, and the Plaintiffs’ leadership counsel a good idea of general information such as how much of the lawsuits are for stomach cancer versus esophageal cancer, etc, but also provides a basis to verify that the claimants have legitimate claims that are supported by their medical records. It is possible that a more detailed Fact Sheet (longer questionnaire) may be required as they are typical in mass torts. For now, this abbreviated questionnaire gives everyone at least some basic information from which they can see how the litigation is shaping up. Ultimately this information is useful in settlement negotiations as well as the setting of what kinds of cases should go to trial first to serve as an example to everyone else.
This, and all other “Pretrial orders” must be followed by the lawyers and their clients as the cases progress. By the end it is expected that there will be hundreds of orders by Judge Rosenberg - likely leading to a resolution of the litigation as a whole and settlement of the thousands of individual cases. Many of these orders are routine administrative management-type orders. Some will affect the cases more significantly. Stay in contact with your lawyer to make sure they know how to get a hold of you as more and more “action” happens on your case.
We are at the beginning of this litigation. The defendants, including the “inventor” of Zantac, the giant French pharmaceutical company Sanofi, have declared that they will fight the case. That is always how these cases begin. There is a lot to do. Literally millions of documents will have to be reviewed to find out what the drug companies knew and when they knew it. Dozens of depositions will be taken of drug company executives to find out what they were hiding about what they knew (it happens all the time).
TheLawFirm.com is proud to be working directly with, and have its clients represented by, lawyers that were recognized by the Court to act in a leadership role in the Zantac litigation. What does this mean? In our over 20 years of representing people in pharmaceutical litigation, we have found that often the clients that are working with the lawyers in leadership are settled sooner or for more compensation than those that are not. Fair? Maybe not, but that’s the reality - so call us first.
Zantac Lawsuit Update: Defendants Try To Bar The Courthouse Doors -- Zantac Judge Sets Rules For Defendants’ Motions To Dismiss
August 20, 2020
Author: Jeremy Fietz
At the beginning of any major lawsuit, and Zantac litigation certainly qualifies as such, the Plaintiff(s) file a complaint. The defendant must file an “Answer” to that complaint. But first, according to Rule of Federal Procedure, Rule 12, a defendant may file a motion to dismiss the case, or certain claims, based upon any of the following:
(1) lack of subject-matter jurisdiction;
(2) lack of personal jurisdiction;
(3) improper venue;
(4) insufficient process;
(5) insufficient service of process;
(6) failure to state a claim upon which relief can be granted; and
(7) failure to join a party….
Defendants of course would love to get rid of a case right out of the gate so their fancy suited high-rise building defense lawyers comb over every word of the Complaint to look for any reason they can to leave injured victims alone in the dust. Most often, these motions by the defense are frivolous. You hear all the time about frivolous lawsuits. The next time you hear that ask the person about frivolous defenses – where powerful companies try to lock the Courthouse door so that injured victims don’t even get off of square one towards justice.
In any event, in the Zantac case, the defense has indicated that they want to file motions to dismiss and on July 30, 2020, Judge Rosenberg set the deadlines and the structure for the defendant’s initial motions to dismiss based upon Federal Rule 12.
On August 24, 2020, Defendants shall file a motion to dismiss based upon, among other things, their claim that people have no right to sue them (FDA preemption) and that the creator/inventor (innovator) of the drug is not responsible for injuries caused by the drug because it was manufactured and/or sold by other people since it was invented.
Both of these arguments are frankly a sad attempt to leave injured people with no recourse while the rich pharmaceutical companies move on with their billions in profits to sell another drug to the unsuspecting public. The fact is, at one point Zantac/ranitidine was the most widely prescribed drug on the plant. The drug companies made enormous profits and now they want to give none of it back despite the equally enormous evidence that their drug has been hurting, and even killing, people for decades.
Obviously, the attorneys for the victims will respond appropriately to these frivolous defense motions. The Court set the response deadline (called an Opposition) on October 1, 2020. The defense then gets the last word with a Reply to the Opposition, due on October 20, 2020. They get the last word because it is their motion and they have the burden of convincing the Court that the motion should be granted. It is likely that the hearing on these motions will not occur until the middle of winter and that the Court will rule at that time.
While throwing these cases out before they truly get underway is unlikely, remember that in addition to trying to win, the defendant drug companies wish to delay the litigation and drag it on as much as possible to wear down the victims and their lawyers. These motions are just the first step to forcing the pharmaceutical companies to answer. Even with a comprehensive Judge doing everything appropriate to move these cases along, it is expected that the litigation will be years before a resolution. The drug companies will take every legal opportunity to delay the process with motions like these.
Source:
Court Order
Zantac Lawsuit Update: Everyone’s A Winner: Zantac Judge Establishes Common Benefit Protocols
August 20, 2020
Author: Jeremy Fietz
In any personal injury case there are three things that must be proven: injury, causation, and damages.
1. Injury: Was there an injury?
2. Causation: Did the defendant’s actions (or inactions) cause the injury?
3. Damages: What damages did the injury cause?
In the sub-category of personal injury that deals with defective drug or medical device cases, the “causation” element is broken up into two distinct pieces. In order to determine whether the defendants defective drug or medical device caused a person’s injury it must first be established that the particular drug or device CAN cause that type of injury generally. Then, if that can be established then part 2 is whether the defendants drug or medical device is what caused the injury in the particular Plaintiff.
In the real world, let’s take Zantac/ranitidine. Thousands of lawsuits are being filed by cancer victims that accuse the inventors, makers, and sellers of Zantac/ranitidine of causing their cancer.
Before we can reach the conclusion that Zantac caused Bob Smith’s cancer (name made up), it must be first proven that Zantac can cause the type of cancer that Bob Smith has. Let’s say it is stomach cancer. Work needs to be done on the plaintiff’s side to establish that scientifically there is evidence that Zantac can cause stomach cancer generally. Then, and only then, can it be established that a particular person’s stomach cancer was caused by Zantac.
That general causation work done by the lawyers appointed by the Court, as well as the scientific experts they hire, helps everyone because everyone needs to establish that the drug can cause their particular cancer.
In order to save each and every plaintiff from having to hire experts to generally prove that Zantac can cause their form of cancer, that work is done on behalf of everyone. That work can cost millions of dollars and if it had to be done in every single case individually it would not be economical for anyone to bring a case. In recognition of that, the Court says “Ok, for all of the general work - whether it is to prove causation generally, or the general work combing through millions of pages of the defendant’s documents looking for the smoking guns, we are going to recognize that those costs should be spread around amongst all of the victims.” (I’m paraphrasing). The Court will eventually determine that a particular percentage of the case settlements is paid into a fund (called a Common Benefit Fund) that will reimburse the lawyers and the experts that did the work that benefited everyone generally. Usually that percentage is between 5% and 10% of the settlement.
Clients who understand how they have actually put more money in their pocket because of this system should appreciate that their case did not have to bear the enormous costs of those generic experts all by themselves. We have found that when clients are explained this process and that this fee assessed by the Judge was for their benefit, they accept that it was a good thing.
The Common Benefit Fund is something that is established in virtually every defective drug and medical device mass tort and works well to open the doors for people to bring cases without having to bear the enormous expense on their own.
Source:
Court Order
Zantac Lawsuit Update: What's with all the secrets?
June 9, 2020
Author: Jeremy Fietz
On June 1, 2020, coinciding with the opening of Discovery in the cases (please see last update for explanation), Judge Rosenberg issued PreTrial Order #25 and #26. These deal, in advance, with how both sides will treat the “special” documents and information that will be exchanged over the next 18 months. At least, that’s the theory. In reality, it is the defendants (the giant pharmaceutical companies) that are the ones that always claim that they shouldn’t have to turn over their records and documents or answer questions. Remember, it is the Plaintiffs’ side (our side) that has the burden of proof. In other words, we have to prove that the defendant’s drug is bad, that the defendant failed in their obligation to produce a safe product, failed in their obligation to warn the public of any dangers associated with their product etc. So it is Plaintiffs’ (our) side that is the one trying to gather the information in the Discovery phase of the case. In the case of a drug like Zantac, that has been on the market for decades, there are potentially millions of pages of records that could shed light on what the pharmaceutical companies did (or didn’t do) to test Zantac, what they knew about the instability of the Zantac molecule, what they knew or should have known about how Zantac can break down in the human body to create the cancer causing molecule NDMA (read our FAQ for more information about NDMA). In almost all drug cases, the company knew more than they told the public. In almost all drug cases, the big pharma put profits ahead of people. But the burden to uncover the truth is on the Plaintiffs’ (our) side during this 18 month discovery phase. So what does this have to do with secrets? Well the law protects companies from having to share certain information. If the company’s legal department created a document, that might be protected by the doctrines of attorney client privilege or attorney work product. Obviously, the big pharmaceutical company is not going to help us prove they are were bad, so they routinely do everything they can to pretend that documents and information fall into categories of secrets they don’t have to share.
The Judge in this case, though is making sure there is some accountability when the defense asserts “secret” protection (privilege). When the defense asserts that they should not have to produce a document, they will have to create what is called a “Privilege Log” and produce that. That document will state in more general terms what the document is so that our side can determine if we want to test or challenge the claim to privilege. In the case of a dispute, often the Judge will examine the document and decide whether the defendant is truly entitled to keep it a secret.
The other way big pharma protects itself is by claiming trade secret confidentiality. In that regard, the defendant will claim that most of its internal documents (even those not protected by privilege) are nonetheless important to the way it does business and therefore should not be shared with the world (trade secrets). So when the defendant produces the millions of pages of records it will claim “confidentiality” to most if not all of what they produce so that it doesn’t end up on the nightly news. The Plaintiffs’ (our) side has to abide by the Court’s rules in making sure that the documents do not leak to the outside world (that they are only used inside the case/litigation. The Court sets up a system to remove the confidentiality designation but in most cases very little is done in this regard because there is so much work to be done, our side is usually just happy to finally get the documents.
These tools the defense uses, are not usually enough to stop us from proving the case but they are used to by the companies to keep as much a secret as possible and to hide the truth from the American people. We, at TheLawFirm.com, would like to see reform in this area of law as we believe that the transparency of these kinds of legal proceedings would give the public a greater sense of justice being done and perhaps… perhaps even help change the nature of these drug companies for the better.
Here is a complete copy of PreTrial Orders #25 and #26 and we hope this explanation has been helpful to you.
PreTrial Order # 25 - Work Product and Privilege
PreTrial Order # 26 - Confidentiality
If you or a loved one has been diagnosed with cancer after at least one year of regular use of Zantac, please call us at TheLawFirm.com. We’ll give you a free case evaluation and help you if we can. Check back frequently for more Zantac Litigation Updates.
Zantac Lawsuit Update: Litigation Timeline
June 8, 2020
Author: Jeremy Fietz
On May 28, 2020, the Judge that is in charge of managing what will be many thousands of Zantac cancer cases in the United States continued in her effort to put systems in place to most efficiently move the cases forward. Judge Robin Rosenberg was appointed by the Judicial Counsel on Multidistrict Litigation to lead, manage, and resolve MDL 2924 (In Re. Zantac). For more information on what an MDL is how to make a claim, please see TheLawFirm.com’s FAQ. On with the update.
In PreTrial Order #24, Judge Rosenberg sets forth a general timeline of events.
Discovery opens now (June 2020) and lasts for approximately 18 months. “Discovery” is the phase of a case in which the parties are allowed to ask questions both in written form as well as live cross-examination (depositions). In addition, this phase permits the Plaintiffs to demand documents from Sanofi and other defendants so that we may learn what the drug companies knew about the cancer risk, when they knew it, and why they did not warn the public themselves. During this period
After the 18 month discovery period both sides will hone their medical and scientific arguments and research because after the period is over, the Court will hold “Daubert” hearings. A “Daubert” hearing is one in which the Defendant tries to convince the Court that there is not enough scientific evidence to establish that the drug causes cancer. The Plaintiff must prove that there is at least some legitimate evidence that shows the connection or else the Judge will end the litigation. Essentially, the Judge is like a gatekeeper – he or she does not decide who has better arguments, just whether or not there is enough science behind the case that the decision should be up to a jury.
Next will be “bellwether” trials. A “bellwether” trial is on in which a handful of cases are selected by the Court (with input from both sides) to go to trial. These are real cases involving real people and while their outcomes are not binding on the thousands of other plaintiffs still waiting for justice, they are looked upon as “instructive” or as “examples” of how juries see these cases. The trials proceed and both sides put their best case forward. If the defendant wins the bellwether cases by convincing juries that Zantac does not cause cancer then the prospects of a fair settlement will go down. On the other hand if our side wins the bellwether cases big, then the settlement values of the cases go up. Usually, there is some good and some bad and a settlement of the litigation is reached after a handful of bellwether cases are finished.
As we always tell our clients, pharmaceutical mass tort litigation like this takes time. The good news is, Judge Rosenberg appears to want to move it along as quickly as is possible and we expect that this litigation will not take as long as others we have been involved with.
Here is a complete copy of PreTrial Order #24 and we hope this explanation has been helpful to you.
If you or a loved one has been diagnosed with cancer after at least one year of regular use of Zantac, please call us at TheLawFirm.com. We’ll give you a free case evaluation and help you if we can. Check back frequently for more Zantac Litigation Updates.
Zantac Update: Scientific Information regarding zantac and cancer
May 26, 2020
Author: Jeremy Fietz
FDA Launches Zantac (TM) / Ranitidine Cancer FAQ Website and Confirms Zantac Molecule Unstable
Given the overwhelming use of ranitidine (Zantac) throughout the United States, the recall has prompted considerable concern amongst users. In response, the FDA has published an “FAQ” to deal with the most common questions people ask the FDA. You may find the Official FDA Zantac cancer FAQ.
Some of the leading scientists that have blown the whistle on Zantac theorize that the high levels of the cancer-causing NDMA chemical are a by product of the ranitidine (Zantac) molecule’s exposure to heat inside the body during the digestive process. While the FDA has not yet confirmed this theory, the official FDA position on NDMA in Zantac is revealing. The FDA has stated that:
“tests also show NDMA levels increase in some ranitidine products when the drug is exposed to higher than room temperatures. Based on these findings, FDA has determined that many currently marketed ranitidine products could expose consumers to unacceptable health risks. ”
Room temperature is considered to be around 70 degrees Fahrenheit (depending on your mood). The human body’s average temperature is 98.6 degrees Fahrenheit. In other words, the temperature that the unstable ranitidine molecule is exposed to in the human body is more than 25 degrees higher than the stable “shelf temperature” of the drug.
The FDA has recently acknowledged that it is continuing to examine the root cause of how NDMA is formed by the ranitidine drug but some scientists believe that the problem is fundamental to the ranitidine molecule itself. It is, according to them, simply an inherently unstable molecule - meaning that it easily breaks into sub compounds when the molecule is “excited”. When the ranitidine molecule breaks, its component parts can form the cancer-causing NDMA molecule. All molecules vibrate or move faster under warmer temperatures and it is believed by many that this heat related vibration is what causes the ranitidine molecule to break apart and form the dangerous NDMA molecule.
Studies are ongoing and we will update as the science becomes more clear and these working theories become more widely proven and accepted.
Zantac Lawsuit News Update: Information regarding the zantac cancer lawsuits
May 18, 2020
Author: Jeremy Fietz
First, if this is your first time checking up on the status of the Zantac litigation there are a few background things you need to know:
1) The Zantac litigation has been consolidated into a Multi District Litigation by the US Federal Courts. This means that no matter what Federal Court your case is filed in, it will most likely end up transferred to the Zantac MDL for handling there… for now.
2) The Zantac MDL was assigned to Federal Court Judge Robin Rosenberg, in the Southern District of Florida and is known as MDL 2924. Here is a link to the Zantac Official MDL Webpage of the Federal District Court:
3) Defective drug cases are generally assigned to an MDL system so that the cases can be managed together by one Judge (instead of by hundreds of different judges all over the country managing the cases in hundreds of different ways). If you have a case, it is still your case. Individual case. But they are managed together for efficiency and according to systems that have been proven for years to resolve these kinds of lawsuits.
4) You can check back with us here at TheLawFirm.com for updates on important rulings, orders, and when the time comes (settlement details).
Now, on with the update: despite a slight slow down in the legal world due to Covid19, for the most part, pharmaceutical litigation goes on and the Court process does not stop. The most recent ruling of Judge Rosenberg in the Zantac MDL was to appoint a Leadership Structure to the management of the litigation.
It is expected that this litigation may take several years (as virtually all pharmaceutical mass torts do) and there WILL be literally thousands of cases filed before all is said and done. Remember, Zantac has been one of the most widely used and prescribed pharmaceutical products in history and since its use cancer rates have gone up dramatically and have affected many thousands of individuals and families.
TheLawFirm.com is proud to be working directly with, and have its clients represented by, lawyers that were recognized by the Court to act in a leadership role in the Zantac litigation. What does this mean? In our over 20 years of representing people in pharmaceutical litigation, we have found that often the clients that are working with the lawyers in leadership are settled sooner or for more compensation than those that are not. Fair? Maybe not, but that’s the reality - so call us first.
We are at the beginning of this litigation. The defendants, including the “inventor” of Zantac, the giant French pharmaceutical company Sanofi, have declared that they will fight the case. That is always how these cases begin. There is a lot to do. Literally millions of documents will have to be reviewed to find out what the drug companies knew and when they knew it. Dozens of depositions will be taken of drug company executives to find out what they were hiding about what they knew (it happens all the time).
The Court has issued 21 “Pretrial Orders” already. These are orders that must be followed by the lawyers and their clients as the cases progress. By the end it is expected that there will be hundreds of orders by Judge Rosenberg - likely leading to a resolution of the litigation as a whole and settlement of the thousands of individual cases. Many of these orders are routine administrative management-type orders. Some will affect the cases more significantly. Stay in contact with your lawyer to make sure they know how to get a hold of you as more and more “action” happens on your case.
Zantac Lawsuit News Update: FDA requests removal of all heartburn drug Ranitidine (Zantac™) Products from the market - advises consumers to immediately stop taking
April 2, 2020
Author: Daniel Gala
On April 1, 2020, the U.S. Food and Drug administration issued an immediate request to all consumers, patients, health care professionals, pharmacies, and hospitals, to stop the sale of the heart burn medication ranitidine (Zantac™), citing the ongoing FDA investigation into its potential cancer risk.
- The FDA news release again reminded the public that it:
- “became aware of independent laboratory testing that found NDMA in ranitidine [Zantac™],”
- “NDMA is a probably human carcinogen (a substance that can cause cancer),”
- And that,
- “sustained higher levels of exposure may increase the risk of cancer in humans…”
As a result, the FDA is “sending letters to all manufacturers of rantidine requesting that they withdraw their products form the market,” and “advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have.”
The FDA cites continued investigation into the enormous public health hazard posed by ranitidine [Zantac™].
Given the enormous amount of ranitidine (Zantac™) that has been consumed in the United States in the past 30 years, this has the potential to be discovered as the greatest cancer-causing chemical exposure since asbestos.
For further information about ranitidine (Zantac™) and cancers watch and read more at TheLawFirm.com.
The FDA news release may be found here on the FDA’s website:
TheLawFirm.com is a consumer law firm helping families across America. Our team of top lawyers and paralegals has handled many of the major drug recall cases since the 1990s. Fen/phen, Rezulin, Baycol, Vioxx, we’ve handled them all. Our legal team has decades of knowledge, experience, and a track record of success. We have dedicated our careers to helping victims of the greedy pharmaceutical companies. Call us now for a free case evaluation.
Zantac Lawsuit News Update: Zantac MDL Passes 200 Cases As Court Adjusts Due To Coronavirus
March 30, 2020
Author: Daniel Gala
Despite the court having recently cancelled a key in-person conference due to social-distancing measures implemented in response to the ongoing coronavirus pandemic, multidistrict litigation (MDL) over the heartburn medication Zantac—known generically as ranitidine—continues to expand, growing to nearly 215 total cases as of March 28, according to the MDL docket. Meanwhile, despite the limits on in-person meetings, the court is looking for ways to continue pretrial proceedings, including by making use of videoconferencing.
“In light of the ongoing developments with the spread of COVID-19 (coronavirus), the Court cancels the Initial Conference and will not schedule plaintiffs’ leadership presentations for March 19, 2020,” a March 13 pretrial order signed by United States District Judge Robin L. Rosenberg said. “The Court will issue an order rescheduling the Initial Conference and leadership presentations at a time as soon as practicable that accounts for the health and safety of all participants.”
Established in February 2020, the Zantac MDL has centralized federal products liability lawsuits filed against the makers of Zantac and generic ranitidine in the wake of revelations that the drugs can break down into carcinogenic compounds when digested in the human body.
In September 2019, the United States Food and Drug Administration (FDA) announced that it had "learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.”
NMDA is the same substance found to have contaminated generic forms of the blood-pressure medication valsartan and related drugs, prompting widespread recalls of those drugs, as well. However, whereas it is believed that the NDMA found in valsartan and other angiotensin II receptor blockers (ARBs) including losartan and irbesartan is the result of problems in the manufacturing process, plaintiffs suing over Zantac argue that the ability of ranitidine to transform into NDMA and other hazardous compounds once in the human body is intrinsic to the drug itself.
Now, as the MDL court rushes to accommodate social-distancing measures while continuing to usher the litigation along, new cases continue to join despite coronavirus concerns overwhelming the national consciousness. Given the popularity of Zantac and its generic alternatives—and the decades these drugs have spent on the market—some observers anticipate that the MDL ultimately will grow to include many thousands of cases.
In an effort to ensure that social-distancing measures do not completely bring the nascent Zantac MDL to a halt before it even has gotten underway in earnest, Judge Rosenberg issued on March 20 a pretrial order updating the parties on the fluid and highly unpredictable situation.
“As the Court continues to monitor the health crisis and act in accordance with national, local and court directives and guidance, the Court is not in a position currently to give any greater specificity as to when and how the conference and interviews will occur,” the March 20 order said. “But the parties should be assured that the Court is working diligently to ensure that, at the soonest feasible time, the Court will give clear direction to the parties on these and other matters governing the case.”
Because the relatively young MDL had not even selected members to permanent leadership positions before the coronavirus response made it ill-advised to conduct in-person meetings, Judge Rosenberg also authorized the MDL’s provisional leadership groups to continue their work in an effort to keep the litigation moving ahead.
“This Court is keenly aware of the delicate nature of balancing the interests in moving this case forward, while also ensuring that it has full information in making any decisions relating to the case, including but not limited to the important determination of permanent leadership,” the March 20 order said. “Until such time as permanent leadership is put in place, the Court finds that pursuant to its broad case management authority, particularly in MDL actions, it is in the best interests of the case to allow the Initial Census Team, Practices and Procedures Team and Interim Defense Leadership Team to continue their work and authorizes them to do so, while conferring with other counsel to ensure that all views are considered while progressing with the important matters at hand.”
Judge Rosenberg urged counsel to work together effectively in order to keep the MDL moving along during these unprecedented times.
“The Court depends on counsel more than ever to work together to advance the interests of the case, even when there may be differing view as to how such progress would occur,” the March 20 order said. “Due to the unavoidable need to reschedule the conference and interviews, the Court was unable to meet counsel in person, discuss an agenda and hear from leadership applicants. In lieu of that conference, the Court must now trust that counsel can act in concert with one another and consistent with what direction the Court gives through its written orders.”
New Cases Continue To Join The Zantac MDL
Despite the difficulties presented by the coronavirus response, new cases continue to join the young Zantac MDL at a rapid clip. For example, as of March 28, the plaintiff in one of the most recent cases to join the MDL had filed his complaint only on March 24, showing that new cases continue to be filed amid the ongoing pandemic.
That case is brought by plaintiff Ernest Lee, who alleged in his complaint that he “used over-the-counter brand name Zantac from the 1990’s through 2018” and that he “took it one to three times per day.”
“In 1998, Plaintiff was diagnosed with colorectal cancer,” the complaint said. “Based on prevailing scientific evidence, exposure to Zantac (and the attendant NDMA) causes colorectal cancer in humans. Plaintiff’s colorectal cancer was caused by ingestion of Zantac. Had any Defendants warned Plaintiff that Zantac could lead to exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Zantac. Plaintiff did not learn of the link between Plaintiff’s cancer and Zantac explode until 2020, when Plaintiff learned that Zantac contained high levels of NDMA.”
If you or a loved one has been diagnosed with cancer after regularly taking Zantac or generic ranitidine over a period of years, contact the experienced team of attorneys at TheLawFirm.com today for a free legal consultation with a licensed attorney!
Sources:
United States District Court Southern District of Florida. (20 March 2020). Pretrial Order #14 Order Authorizing Continuation of Work by Interim Teams. Case 9:20-md-02924-RLR. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (13 March 2020). Pretrial Order #9 Order Cancelling Initial Conference. Case 9:20-md-02924-RLR. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States Food and Drug Administration (FDA). (13 September 2019). Zantac (ranitidine): Safety information - NMDA Found in. Samples of Some Ranitidine Medicines. Medical Product Safety Information
United States District Court Southern District of Florida. (24 March 2020). Complaint. Ernest Lee v. Boehringer Ingelheim Pharmaceuticals, Inc., et al.; Case No. 9:20-cv-80486. MDL 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
Zantac Lawsuit News Update: Zantac Caused Illinois Woman’s Stomach Cancer
March 24, 2020
Author: Daniel Gala
An Illinois woman has sued the makers of the popular heartburn medication Zantac—known generically as ranitidine—alleging that years of regular use of the medication caused her to develop stomach cancer. The lawsuit joins scores of other cases brought by plaintiffs filing similar claims in the aftermath of an announcement by the United States Food and Drug Administration (FDA) revealing that the widely-used drug possesses carcinogenic properties.
The Illinois-based plaintiff alleges that she took Zantac on a near-daily basis for almost two decades before being diagnosed with stomach, or gastric, cancer in 2019, the Legal Examiner reported March 20.
Since the early 1980s, Zantac has been available in prescription and, later, over-the-counter (OTC) forms. However, in June 2019, the online pharmacy Valisure discovered that, once in the body, ranitidine breaks down into carcinogenic compounds.
Specifically, Valisure reported in a petition submitted to the FDA in September 2019 that the ranitidine molecule is by its nature unstable. As it is digested by the human body, ranitidine has the potential to break down into N-nitrosodimethylamine (NDMA), the same probable human carcinogen previously found to have contaminated certain batches of the blood-pressure medication valsartan and the related drugs losartan and irbesartan.
However, unlike contaminated valsartan, which was found to contain an unintended impurity due to flaws in the manufacturing process related to the use of solvents, Zantac (ranitidine) by its very nature has the potential to become NDMA when it is digested by humans.
Despite the FDA’s having made its announcement only as recently as September 2019, knowledge of the association between Zantac (ranitidine) and NDMA dates back years. In 2016, a study with the unsubtle title “Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine” found that taking ranitidine caused the content of NDMA in a patient’s urine to increase by a factor of 400.
“Following ranitidine intake, the urinary NDMA excreted over 24h increased 400-folds from 100 to 47 600 ng [47,600 nanograms], while total N-nitrosamines increased 5-folds,” the study’s authors summarized. More worrying still, the authors note that “NDMA excretion rates after ranitidine intake equaled or exceeded those observed previously in patients with schistosomiasis, a disease wherein N-nitrsosamines are implicated as the etiological agents for bladder cancer.”
Despite the 2016 study being the first to document the massively increased NDMA levels of individuals who have taken ranitidine, the potential for ranitidine to break down into carcinogenic nitrosamines like NDMA once inside the human body has been known to science for even longer.
As the authors of the 2016 study note, “[P]revious studies have demonstrated that amines [like Zantac, an amine-based pharmaceutical] can form N-nitrosamines when exposed to nitrite at stomach-relevant pH.”
In other words, scientists have known for years that Zantac has the potential to transform into a carcinogenic compound when exposed to conditions like those present in the human stomach, and yet the makers of Zantac and generic ranitidine did nothing to warn doctors, patients, or regulators, instead leaving it to the third-party pharmacy Valisure to alert the FDA years if not decades after the fact.
This history of inaction forms the basis of the dozens of lawsuits like the one filed recently by the woman from Illinois, which allege that the makers of Zantac and generic ranitidine knew or should have known of the serious risk posed to patients but continued to sell the highly profitable drug without warning anyway.
Anticipating a caseload that potentially could run into the thousands, the Judicial Panel on Multidistrict Litigation (JPML) has centralized federal Zantac (ranitidine) lawsuits as multidistrict litigation (MDL) in the Southern District of Florida at West Palm Beach. The number of cases in the Zantac MDL recently passed 150 and is only expected to grow from there.
Have you or a loved one been diagnosed with cancer after years of regularly taking Zantac or generic ranitidine? If so, contact the experienced team of attorneys at TheLawFirm.com today for a free legal consultation!
Sources:
United States Food and Drug Administration (FDA). (13 September 2019). Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines. Medical Product Safety Information
Zeng, T. et al. (June 2016). Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine. Carcinogenesis
Luhana, R. (20 March 2020). Illinois Women [sic] Files New Zantac Lawsuit, Claiming Link with Gastric Cancer
Zantac Lawsuit News Update: Zantac MDL Grows To More Than 150 Cases
March 15, 2020
Author: Daniel Gala
Despite being just over one month old, multidistrict litigation (MDL) over the popular heartburn drug Zantac (ranitidine) already is growing, having increased to more than 150 total cases as of March 15, according to the court’s list of member cases.
Established February 6 by order of the Judicial Panel on Multidistrict Litigation (JPML), the Zantac MDL centralized federal lawsuits filed by plaintiffs alleging that they were exposed to a probable human carcinogen present in the over-the-counter medication.
At the time of the JPML’s transfer order, the Zantac MDL contained 141 cases, meaning that about ten cases have joined the nascent litigation within roughly its first month. Given the popularity and widespread availability of Zantac over a period of decades, many observers expect the total number of cases potentially could reach into the thousands.
Based on information released by the United States Food and Drug Administration (FDA), plaintiffs in the Zantac MDL allege that, when in the human body, ranitidine forms enormous amounts of the probable human carcinogen N-nitrosodimethylamine (NDMA).
“N-Nitrosodimethylamine (‘NDMA’) is a potent carcinogen,” explains the complaint of plaintiff Michael Karpal, whose case, filed in late February, is one of the most recent to join the Zantac MDL. “It used to be a chemical byproduct of making rocket fuel in the early 1900s but, today, its only use is to induce tumors in animals as part of laboratory experiments. Its only function is to cause cancer. It has no business being in the human body.”
However, as the lawsuit continues: “Zantac (chemically known as ranitidine), the popular antacid medication used by millions of people every day, leads to the production of staggering amounts of NDMA when it is digested by the human body. The U.S. Food and Drug Administration’s (‘FDA’) allowable daily limit of NDMA is 92 ng (nanograms) and yet, in a single dose of Zantac, researchers are discovering over 3 million ng.”
Zantac MDL Lawsuit “The [FDA’s] allowable daily limit of NDMA is 92 ng (nanograms) and yet, in a singe dose of Zantac, researchers are discovering over 3 million ng.”
That plaintiff, Michael Karpal, alleges that he “took Zantac from approximately January 1, 2004 until approximately December 31, 2019 for about 15 years and, as a result, developed bladder cancer.”
His lawsuit names as defendants several prominent pharmaceutical companies including Boehringer Ingelheim, Sanofi, Chattem, Pfizer, and GlaxoSmithKline.
According to Karpal, Pfizer was the original holder of the New Drug Application (NDA) for over-the-counter (OTC) Zantac (ranitidine), controlling US rights from August 2004 to December 2006. Subsequently, Boehringer Ingelheim held the US rights to OTC Zantac from December 2006 until January 2017, at which time Sanofi took control (an arrangement which continues to date). Chattem, for its part, is a wholly-owned subsidiary of Sanofi and “distributes OTC Zantac for Sanofi.”
GlaxoSmithKline “was the original innovator of the Zantac drug and controlled the NDA for prescription Zantac between 1983 and 2009.” Importantly, “[b]y controlling the Zantac NDA it also directly controlled the labeling for all Zantac products through 2009.”
Karpal’s lawsuit alleges that “GSK’s negligence and misconduct related to Zantac as an innovator directly led to the failure to warn for other OTC versions of Zantac.”
Given the nature of the cases involved, in which the alleged injury can take years if not decades to develop, it could take some time for the Zantac MDL to grow into the many hundreds if not thousands of cases. But, given the millions of individuals who have taken Zantac on a routine basis, it is unfortunately only a matter of time before more cases arise.
If you or a loved one has been diagnosed with cancer after taking Zantac (ranitidine) regularly, contact the team of experienced attorneys at TheLawFirm.com today for a free legal consultation!
Sources:
United States District Court Southern District of Florida (West Palm Beach). Civil Docket For Case#: 9:20-md-02924-RLR. In Re: Zantac (Ranitidine) Products Liability Litigation
Judicial Panel on Multidistrict Litigation (JPML). (6 February 2020). Transfer Order. Case MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Eastern District of New York. (25 February 2020). Complaint and Demand For Jury Trial. Case 9:20-cv-80423-RLR. Michael Karpal v. Boehringer Ingelheim, et al
Zantac Lawsuit News Update: Zantac MDL Gets Underway In Fla., First Conference Set For March 20
March 13, 2020
Author: Daniel Gala
Multidistrict litigation (MDL) over allegations that the popular heartburn medication ranitidine—sold for years under the brand name Zantac—possesses carcinogenic qualities has taken its first steps in the Southern District of Florida, with the court appointing liaison counsel for both plaintiffs and the defense, while also scheduling the MDL’s first conference for March 20.
Established February 6 by order of the Judicial Panel on Multidistrict Litigation (JPML), the Zantac MDL centralized roughly 140 federal lawsuits filed against the makers of Zantac and generic ranitidine alleging that the ranitidine molecule develops into a probable carcinogen once inside the human body.
United States District Judge Robin L. Rosenberg, presiding over the MDL in the Southern District of Florida, has wasted little time getting the litigation underway, filing the MDL’s first pretrial order on February 14.
In addition to scheduling the MDL’s first conference for March 20, the wide-ranging, 36-page order also covers a host of other topics aimed at getting the litigation moving. For instance, it required that plaintiffs and the defense each submit by March 6 a position statement “indicating their preliminary understanding of the facts involved in the litigation and the critical factual and legal issues”; clarifies methods for proper service among the parties; establishes a standard format for pleadings in the MDL; and instructs the clerk of the court on how to handle the influx of anticipated transferee cases.
The Zantac MDL’s first pretrial order also contained an instruction to all parties not to destroy any evidence that may potentially be relevant to the litigation.
“All parties and their counsel are directed to preserve evidence that may be relevant to this action,” Judge Rosenberg ordered. “The duty extends to documents, data, and tangible things in possession, custody, and control of the parties to this action.”
In subsequent orders, Judge Rosenberg on February 28 appointed a liaison counsel for plaintiffs and on March 9 named defendants’ liaison counsel.
The allegations behind the Zantac MDL arise from a September 2019 announcement by the US Food and Drug Administration (FDA) regarding the presence of a probable carcinogen in the popular heartburn medication, sold generically as ranitidine.
"FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels,” the FDA’s September 13 statement warned. “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the results from laboratory tests.”
A month later, on October 18, Zantac-maker Sanofi announced that, as “a precautionary measure” it was recalling “all Zantac OTC (over-the-counter) in the United States” including “Zantac 150, Zantac 150 Cool Mint, and Zantac 75.”
NDMA is the same probable human carcinogen previously found to have contaminated certain lots of the generic blood-pressure medication valsartan and related drugs, leading years-long recalls that are still ongoing. However, in the case of valsartan, regulators believe they have traced the presence of NDMA back to a change in manufacturing practices having to do with the use of solvents, while evidence shows that the ranitidine molecule in Zantac transforms into NDMA once it has entered the human body.
As one Zantac lawsuit described, “[U]nlike the NDMA present in valsartan, the NDMA associated with this common drug [Zantac] is not an impurity caused by faulty manufacturing processes. Rather, the NDMA is inherent in the drug itself.”
Plaintiffs further allege that the makers of Zantac (ranitidine) have been aware of this fact for decades but, rather than alerting regulators, doctors, and patients, they instead chose to conceal the information in order to protect their cash cow.
Given the popularity of Zantac and generic ranitidine and the many years for which they were available on the market, the Zantac MDL is expected to grow significantly, potentially into the many thousands of cases.
If you or a loved one has developed cancer after years of regularly taking Zantac or generic ranitidine, contact the attorneys at TheLawFirm.com today for a free legal consultation!
Sources:
Judicial Panel on Multidistrict Litigation (JPML). (Filed 6 February 2020). Transfer Order. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (Entered 14 February 2020). Pretrial Order #1 Setting Initial Conference. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (Entered 28 February 2020). Pretrial Order #5 Order Appointing Plaintiffs’ Liaison Counsel. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (Entered 9 March 2020). Pretrial Order #7 Order Appointing Defendants’ Liaison Counsel. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States Food and Drug Administration (FDA). (13 September 2019). Zantac (ranitidine): Safety Information – NDMA Found in Samples of Some Ranitidine Medicines. Medical Product Safety Information
Sanofi. (22 October 2019). Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S. Company Announcement. United States Food and Drug Administration (FDA). Recalls, Market Withdrawals, & Safety Alerts
United States District Court For The District Of New Jersey. (Filed 25 October 2019). Complaint. George Cravens, et al. v. Boehringer Ingelheim Pharmaceuticals, Inc., et al. Case 3:19-cv-19368
Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article.
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