Zantac (Ranitidine) Lawsuit News and Updates

The latest lawsuit and trial news for Zantac and Ranitidine.

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.

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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