Androgel Lawsuit and settlement updates
The latest news and updates regarding Androgel lawsuits and settlements.
Androgel Lawsuit Update: After Bellwether Loss, AndroGel MDL Down to Last 9 Cases
December 13, 2021
Author: Daniel Gala
Having included a total of nearly 8,000 cases, multidistrict litigation (MDL) over AbbVie’s AndroGel and other testosterone drugs is now down to its final 9 cases, court records show.
The once-massive litigation arose from allegations that AbbVie and other makers of testosterone drugs had improperly marketed their products for use my men experiencing normal, age-related declines in testosterone levels, despite the drugs not having received regulatory approval to be prescribed for that purpose. This so-called “off-label” use greatly increasing the men’s risk of serious side effects such as heart attack and stroke.
The defendants in the AndroGel MDL have included some of the biggest names in Big Pharma, including Pfizer, Eli Lilly, and Abbott, in addition to AbbVie.
After years of litigation, AbbVie—the last remaining defendant to holdout after all others had settled—reportedly reached a settlement with plaintiffs in the fall of 2018. Still, some three years later, the process of winding down the long-running MDL continues with a last few stubborn cases.
Court records show that the remaining cases name several different defendants, including AbbVie, Eli Lilly, and Actavis.
Despite it being more than three years since the vast majority of plaintiffs settled their cases, plaintiff Brad Martin took his case to trial in August, losing as the jury found for the defendant Actavis Inc. after less than one hour of deliberation. In September, Martin filed a motion for a new trial, and the parties continued to submit opposing briefs on the matter through late October. To date, the case docket does not show a court ruling on the issue.
A resident of Sauk Rapids, Minnesota, Martin and his wife LuAnn originally filed their lawsuit in 2015, suing Actavis over its testosterone drug Androderm. The Martins blamed Androderm for causing Brad’s “[m]yocardial infarction,” or heart attack, on May 25, 2013, as well as “other related medical conditions.”
Sources:
United States District Court Northern District of Illinois. (8 November 2021). Joint Status Report. Case 1:14-cv-01748. In Re: Testosterone Replacement Therapy Products Liability Litigation. MDL 1748
Elejalde-Ruiz, Alexia. (14 September 2018). AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel
United States District Court Northern District of Illinois. (Accessed 11 December 2021). Member Cases. In Re: Testosterone Replacement Therapy Products Liability Litigation. MDL No. 2545
United States District Court Northern District of Illinois. (20 October 2021). Reply to Plaintiff’s Motion for a New Trial. Case 1:15-cv-04292. In Re: Testosterone Replacement Therapy Products Liability Litigation. MDL 1748
United States District Court Northern District of Illinois. (14 May 2015). Master Short-Form Complaint for Individual Claims. Case 1:15-cv-04292. In Re: Testosterone Replacement Therapy Products Liability Litigation. MDL 1748
Androgel Lawsuit Update: AndroGel MDL Court Demands Status Report As Last Remaining Cases Stay Open
November 1, 2021
Author: Daniel Gala
With nearly 8,000 different cases having at one time or another been a part of multidistrict litigation (MDL) over AndroGel and other testosterone drugs, the litigation is now down to its last few dozen remaining cases.
However, these final cases appear to be particularly difficult to resolve, as—judging by the numbers—the wind-down effort has stalled in recent months. While the AndroGel MDL contained 92 pending cases as of mid-August, by two months later in mid-October, that number had declined by only 16, to 76 active cases.
In response, US District Judge Matthew F. Kennelly held a status hearing by telephone on October 25, ordering the parties to file by November 8 “a status report addressing the list of ostensibly open member cases,” according to court documents.
Further, the parties are required to provide the court with an update on settlement negotiations for three particular cases by November 30. The next telephonic status hearing is scheduled for January 7, 2022.
While the AndroGel MDL once was one of the largest in the country by number of active cases, those case numbers declined precipitously as a series of settlement agreements were reached between plaintiffs and the defendant drug makers. AndroGel-maker AbbVie was reportedly the last remaining defendant holdout before reaching terms in the fall of 2018, media reports at the time indicated. https://www.chicagotribune.com/business/ct-biz-abbvie-androgel-testosterone-lawsuits-settlement-0915-story.html
The AndroGel MDL centralized federal products liability lawsuits filed against AbbVie and other makers of testosterone-boosting drugs, claiming that the companies improperly marketed their medications for use by men experiencing normal, age-related declines in testosterone level, a use for which the drugs had not been approved by regulators. As a result, the individuals taking the drugs faced the risk of serious side effects, including heart attack and stroke.
The remaining cases are not limited to one or just a few defendants, who still include some of Big Pharma’s biggest names, such as Pfizer, Eli Lilly, and, of course, AbbVie.
Sources:
United States Judicial Panel on Multidistrict Litigation. (13 August 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States Judicial Panel on Multidistrict Litigation. (15 October 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States District Court Northern District of Illinois. (26 October 2021). Notification of Docket Entry. Case No. 1:14-cv-01748. In Re: Testosterone Replacement Therapy Products Liability Litigation
Elejalde-Ruiz, Alexia. (14 September 2018). AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel
United States District Court Northern District of Illinois. (Accessed 30 October 2021). Member Cases. In Re: Testosterone Replacement Therapy Products Liability Litigation. MDL No. 2545
Androgel Lawsuit Update: AndroGel MDL, with Total of Almost 8k Cases, Now Under 100
August 16, 2021
Author: Daniel Gala
Long-running multidistrict litigation (MDL) over AbbVie’s AndroGel and other testosterone drugs—which over its years in existence involved nearly 8,000 different cases—dropped below 100 pending cases as of August 13, according to the Judicial Panel on Multidistrict Litigation (JPML).
The AndroGel MDL centralized thousands of federal lawsuits filed by plaintiffs alleging that AbbVie and the other defendants illegally marketed their testosterone drugs for so-called off-label uses for which they had not received explicit authorization from regulators. Specifically, the defendant drugmakers promoted their testosterone products for use by men suffering from normal, age-related declines in testosterone levels, thereby greatly increasing those individuals’ likelihood of heart attack, stroke, and other serious side effects. Some plaintiffs were represented posthumously by their estates.
Ultimately, each of the defendants entered into master settlement agreements through which they resolved, in some instances, many thousands of cases. AbbVie, the last remaining defendant holdout, reportedly agreed to terms on a master settlement in September 2018.
Even so, it has taken nearly three years to wind down the many thousands of cases, and the AndroGel MDL still contained 92 pending cases as of August 13, per the JPML. Though small by comparison to the many thousands of cases the MDL once contained, there remains a sizeable number of cases left to be resolved. (Even now, the AndroGel MDL remains in the top one-third of active MDLs by number of cases currently pending.)
The remaining cases are not limited to a single defendant but rather name a variety of the MDL’s defendants: AbbVie, Pfizer, Eli Lilly (maker of Axiron), Actavis (maker of Androdern), Auxilium (maker of Testim), and more.
Sources:
United States Judicial Panel on Multidistrict Litigation (JPML). (13 August 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
Elejalde-Ruiz, Alexia. (14 September 2018). AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel. Chicago Tribune
United States District Court Northern District of Illinois. (Accessed 14 August 2021). Member Cases. MDL 2545. In Re: Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: Despite Thousands of Cases Having Closed, AndroGel MDL Proceeds Ahead
June 25, 2021
Author: Daniel Gala
Having included a total of nearly 8,000 cases and now down to just over 100, seven-year-old multidistrict litigation (MDL) over testosterone-replacement therapies including AbbVie’s AndroGel continues to move ahead despite its highly diminished caseload.
Originally formed in March 2014, the AndroGel MDL has centralized federal products liability lawsuits alleging that the makers of testosterone-replacement therapies illegally marketed their drugs to men suffering from normal, age-related declines in testosterone levels, thereby greatly increasing those individuals’ chances of serious health events including heart attack, stroke, and blood clots. As of June 15, the AndroGel MDL, which has included 7,884 total cases, contained just 98, according to the Judicial Panel on Multidistrict Litigation (JPML) .
The closure of the vast majority of these thousands of cases has been the result of settlement agreements entered into between large groups of plaintiffs and the defendants, which include drugmaker AbbVie as well as other makers of testosterone drugs.
In September 2018, the Chicago Tribune reported that AbbVie and the plaintiffs suing it had agreed to terms on a settlement agreement in the Chicago-based trial, and, months later, cases began closing in droves. AbbVie was reportedly the last remaining defendant to reach a settlement.
According to the Tribune, roughly 4,200 of the MDL’s cases involved AndroGel, with AbbVie as the named defendant.
Other defendants in the MDL have include the previous owners of AndroGel (Solvay Pharmaceuticals, Unimed Pharmaceuticals, and Abbott Laboratories), as well as Actavis, maker of Androdern; Endo International and its subsidiary Auxilium Pharmaceuticals, maker of Testim; and Eli Lilly, maker of Axiron.
The United States Food and Drug Administration (FDA) approved AndroGel in 2000 for use in treating a relatively rare condition known as hypogonadism, a form of severe testosterone deficiency that can be caused by illness, trauma, or genetic factors. However, plaintiffs allege that the defendants improperly marketed the drugs for so-called “off-label” uses for which they had not received FDA approval.
Hitting the airwaves with a multimillion-dollar ad campaign popularizing the term “Low-T”, the makers of testosterone therapies pitched their drugs as a quick, easy way to combat age-related symptoms like fatigue, weight gain, and low sex drive. The marketing strategy worked from a purely sales-driven standpoint, with AndroGel reaching $1.15 billion in annual sales by 2012, according to the Tribune.
In addition to the federal lawsuits contained in the MDL, approximately 200 state-court claims also were filed against AbbVie in Illinois courts. AbbVie is headquartered in Chicago.
Bellwether trials taking place prior to the settlement agreements yielded mixed results, with some juries finding entirely in favor of the defendant drugmakers, and others finding them to have acted negligently. In two cases, the juries awarded the plaintiffs nine-figures in punitive damages, but those verdicts later were overturned by the court.
The cases that remain open include plaintiffs suing a variety of the defendants, and the issues still before the court include complicated matters such as subrogation. For example, one plaintiff is embroiled in a dispute with his health insurance company over how much of the plaintiff’s settlement payout should be paid to the health plan as compensation for the nearly $100,000 in medical costs the plan covered for injuries allegedly resulting from the plaintiff’s use of testosterone drugs, court records show.
Sources:
United States Judicial Panel for Multidistrict Litigation (JPML). (15 June 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
Elejalde-Ruiz, Alexia. (14 September 2018). AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel. Chicago Tribune
United States District Court Northern District of Illinois. (18 June 2021). Paramount Insurance Company’s Response to Order to Show Cause. Case No. 1:15-cv-07612. David Huckels, et al. v. AbbVie Inc., et al
Androgel Lawsuit Update: AndroGel MDL Case Closures Continue Into March
March 13, 2020
Author: Daniel Gala
Case closures in multidistrict litigation (MDL) over testosterone drugs such as AbbVie’s AndroGel have continued into March, with twenty cases resolved in the month’s first week, according to the court’s list of member cases.
The majority of the cases to close in the month through March 6 featured AbbVie as defendant, with the AndroGel-maker accounting for 14 of the 20 cases.
Other defendants with cases resolved during the span include Eli Lilly and Company (four cases) and Endo Pharmaceuticals (two cases).
Formed in March 2014, the AndroGel MDL has centralized nearly 7,900 total cases accusing the makers of testosterone-replacement therapies of improperly marketing the drugs for so-called “off-label” uses—that is, uses for which they have not received regulatory approval.
Specifically, plaintiffs allege that defendants promoted their testosterone drugs for use by men experiencing normal, age-related declines in testosterone levels, thereby putting those men at increased risk of serious side effects including heart attack and stroke.
The recent case closures come amidst a flood of resolutions that has seen more than 800 cases closed in 2020 alone, and more than 1,600 cases resolved since they began to accelerate in late September 2019.
During fall 2018, it was widely reported that AbbVie, the last remaining defendant holdout, had agreed to a settlement, though the terms have not been disclosed publicly.
Sources:
Elejalde-Ruiz, A. (14 September 2018). AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel. Chicago Tribune
Androgel Lawsuit Update: Dozens More Cases Close In AndroGel MDL
February 27, 2020
Author: Daniel Gala
The run of recent case resolutions in multidistrict litigation (MDL) over testosterone-replacement therapies (TRTs) including AbbVie’s AndroGel continued through mid-February as more than thirty additional cases closed February 18, according to the court’s list of member cases.
The closures continued a trend that began in the fourth quarter of 2019 and has continued its momentum into 2020. Over 900 cases have been resolved since the first of the year, and over 1,400 cases have closed since November 1, 2019.
The flood of recent case resolutions followed months of apparently little movement in the MDL. For example, no cases were closed in the period between July 26 and September 13, 2019.
Since that time, however, the flurry of closures has pushed the MDL past a symbolic threshold, with more than half of the AndroGel MDL’s total cases having now been closed. Approximately 4,075 cases are now closed out of a total of roughly 7,980, according to an analysis conducted by TheLawFirm.com.
In addition to AndroGel-maker AbbVie, other named defendants to have cases resolved February 18 included Eli Lilly & Co.; Acrux, Ltd.; and Actavis, Inc. Defendant Eli Lilly (and related entities such as Lilly, USA) had the most cases closed, with 25. AbbVie was a distant second with six resolutions, followed by Acrux and Actavis, each with one case closed.
Since March 2014, the AndroGel MDL has centralized pretrial proceedings for federal lawsuits accusing AbbVie and other makers of TRTs of illegally marketing their drugs for uses for which they have not received regulatory approval. Specifically, testosterone drugs such as AndroGel have received approval from the US Food and Drug Administration (FDA) to treat a relatively rare medical condition in which men suffer from unusually low testosterone levels. However, plaintiffs allege that the companies promoted their testosterone drugs for use by men experiencing normal, age-related declines in testosterone levels, increasing those patients’ risk of serious side effects such as heart attack and stroke.
AbbVie, the last remaining defendant holdout, reportedly agreed to terms on a settlement agreement in fall 2018. The recent run of closures suggests those agreements finally are beginning to take effect. If the current pace of case closures is maintained, the MDL could see nearly all of its cases closed by the end of 2020.
Terms of the settlement agreements have not been released publicly.
The MDL is located in the Northern District of Illinois, in Chicago.
Sources:
United States District Court Northern District of Illinois. (Accessed 26 February 2020). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: As Closures Continue, More Than Half Of AndroGel MDL Cases Now Resolved
February 14, 2020
Author: Daniel Gala
With more than 200 cases having closed in the first half of February alone, case resolutions in multidistrict litigation (MDL) over testosterone-replacement therapies including AbbVie’s AndroGel have continued at a rapid pace, carrying the long-running litigation past a symbolic threshold as more than half of the MDL’s nearly 8,000 cases now are no longer active, according to the court’s list of member cases.
That more than 4,000 cases now have been resolved is a testament to the rapid movement of the past several months, with nearly 900 cases already having closed in just the first six weeks of 2020 and more than 1,400 since November 1, 2019.
The flood of case resolutions follows months of apparently little movement in the MDL despite all of the corporate defendants reportedly having agreed to settlement terms as of fall 2018. That so many cases have been resolved in such a relatively short time frame suggests those settlement agreements finally are beginning to take effect.
In addition to AndroGel-maker AbbVie, other named defendants with cases to have closed in the first two weeks of February 2020 include Endo Pharmaceuticals; Eli Lilly & Company; Fagron, Inc.; Auxilium Pharmaceuticals; and Pfizer.
The defendant drugmakers are accused of illegally marketing their testosterone drugs for so-called “off-label” uses, that is, purposes for which they had not received regulatory approval. Specifically, plaintiffs allege that the defendants targeted their drugs for use by men experiencing normal, age-related declines in testosterone levels, thereby increasing those patients’ risk of serious side effects, including heart attack and stroke.
The AndroGel MDL, based in the Northern District of Illinois, has been ongoing since March 2014.
Source:
United States District Court Northern District of Illinois. (Accessed 13 February 2020). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Settlement Update: More Than 500 AndroGel MDL Cases Close In January
January 29, 2020
Author: Daniel Gala
The recent string of case closures continues in multidistrict litigation (MDL) over testosterone-replacement therapies (TRTs) including AbbVie’s AndroGel, with more than 500 cases having closed in January alone, according to the court’s list of member cases.
The January case resolutions followed more than 400 such closures in December, meaning that nearly 1,000 cases have been resolved in those two months alone. The flood of closures follows a relative drought of case resolutions that saw zero cases close in the MDL for a period spanning from July 26 through September 13.
Since September 18, however, more than 1,200 cases have closed in the MDL that has contained nearly 7,900 total cases, suggesting that settlement agreements reportedly entered into more than a year ago are now beginning to take effect.
The more than 500 cases to close to date in January involve a variety of named defendants, including AndroGel-maker AbbVie as well as Auxilium Pharmaceuticals, Endo Pharmaceuticals, Pfizer, Abbott Laboratories, Actavis, and Eli Lilly and Company.
The defendant pharmaceutical makers stand accused of marketing their testosterone drugs to men experiencing normal, age-related declines in testosterone levels, a use for which they had not received regulatory approval. This so-called “off-label” usage of the drugs increased those men’s risk of serious health side effects, including heart attack and stroke.
The MDL, originally formed in March 2014, now appears to be winding down in earnest, with more than 15% of the total cases having closed in just the past few months.
Source:
United States District Court Northern District of Illinois. (Accessed 28 January 2020). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Settlement Update: AndroGel MDL Case Closures Continue Into 2020
January 13, 2020
Author: Daniel Gala
The run of recent case closures in mutidistrict litigation (MDL) over prescription testosterone drugs including AbbVie’s AndroGel has continued into early 2020, with more than 150 cases having been resolved in the first two weeks of the new year, according to the court’s list of member cases. The recent case closures follow more than 400 in the month of December 2019, suggesting that settlement agreements reportedly reached more than a year ago are beginning to take effect.
The AndroGel MDL, which has included nearly 8,000 total cases, centralized federal lawsuits over allegations that the makers of testosterone replacement therapies (TRTs) like AndroGel improperly marketed their prescription drugs for use by men experiencing normal, age-related declines in testosterone levels, an “off-label” use for which the drugs had not been approved by the US Food and Drug Administration (FDA). Such unapproved use of the drugs increased those patients’ risk of serious side effects including heart attack and stroke.
Originally formed in March 2014, the AndroGel MDL had been experiencing a relative lack of case resolutions despite media reports that AbbVie, the last remaining defendant holdout, had reached a settlement agreement with plaintiffs in the fall of 2018. However, over the past several months, nearly one thousand cases have closed, suggesting that the MDL has begun the process of winding down.
The nearly 150 cases to close from January 2 through January 10 involved a variety of the MDL’s defendant pharmaceutical companies, including Pfizer, Endo Pharmaceuticals, Auxilium Pharmaceuticals, and Abbot Laboratories in addition to AbbVie.
Despite the recent closures, more than half of the MDL’s total lawsuits remain active, with approximately 4,300 remaining as of January 12.
Source:
United States District Court Northern District of Illinois. (Accessed 12 January 2019). Member Cases. MDL 2545. In re: Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: 2019 Ends With More Case Resolutions In AndroGel MDL
January 3, 2020
Author: Daniel Gala
The run of recent case closures in multidistrict litigation (MDL) over testosterone-replacement therapies (TRTs) including AbbVie’s AndroGel continued through the end of 2019, with exactly 100 cases having been resolved in the final two weeks of December alone for a total of more than 400 in the month, according to the court’s list of member cases.
After months of cases closing at a relative trickle despite all defendants reportedly having reached settlement agreements in principal as of fall 2018, more than 700 of the MDL’s nearly 8,000 total cases have closed in the last three months of 2019 alone.
By way of comparison, between July 26 and September 13, no cases in the MDL were reported to have closed. Since September 18, more than 800 have been resolved.
The recent rush of closures suggests that settlement programs finally are beginning to take effect in the long-running MDL, which was formed in March 2014 to centralize federal lawsuits filed against the makers of TRTs by patients who had taken the drugs. The patient plaintiffs allege that the defendant pharmaceutical companies, including AbbVie, marketed their testosterone drugs at men experiencing normal, age-related declines in testosterone levels, a use for which the drugs had not received regulatory approval.
By taking the testosterone drugs for off-label uses, these men increased their risk of serious health consequences, including heart attack and stroke.
Of the 100 cases to have closed from December 18 through December 30, AbbVie was named defendant in the vast majority, accounting for roughly 75 of the closures itself, according to a count conducted by TheLawFirm.com. Eli Lilly and Company accounted for most of the remaining closures, with more than 20.
Auxilium Pharmaceutical, Actavis, and Pfizer each had a single case against them closed during that span, as well.
Sources:
United States District Court Northern District of Illinois. (Accessed 2 January 2020). Case Management Orders. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: Run Of AndroGel MDL Case Closures Continues With Nearly 150 Closed Over 3-Day Span
December 19, 2019
Author: Daniel Gala
The rush of recent case resolutions in multidistrict litigation (MDL) over testosterone drugs including AbbVie’s AndroGel continued into mid-December, with nearly 150 additional cases having closed from December 11 through December 13, making for more than 300 closures in the first half of the month alone, according to the court’s list of member cases.
The relative flood of case closures suggests that settlements reportedly agreed to more than a year ago are finally beginning to take effect, resulting in plaintiffs having their cases resolved by the dozens. The terms of the settlement agreements between the defendant drug makers and plaintiffs have not been disclosed publicly.
The MDL, established in March 2014 in the Northern District of Illinois, centralized federal lawsuits filed by plaintiffs who accused AbbVie and other makers of testosterone drugs of illegally marketing their testosterone-replacement therapies (TRTs) to men experiencing normal, age-related declines in testosterone levels, a use for which it had not received approval from the US Food and Drug Administration (FDA). Such off-label use increased those patients’ risk of serious side effects including heart attack and stroke.
Of the roughly 140 cases to close from December 11 through December 13, nearly 100 involved Endo Pharmaceuticals as named defendant. Other defendant pharmaceutical makers with cases to close during that span include Auxilium Pharmaceuticals, Eli Lilly and Company, AbbVie, Pfizer, and Acrux.
The December 11 through 13 case closures capped an active five-day period for the MDL, which also closed nearly 160 cases during December 9 and 10, as previously reported by TheLawFirm.com.
Despite the recent progress, the AndroGel MDL, which has included 7,881 total cases, remains far from over. Even after the 300 closures through the first half of December, more than half of the MDL’s total cases remain open, with roughly 4,700 active cases as of December 18.
Sources:
United States District Court Northern District of Illinois. (Accessed 18 December 2019). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Elejalde-Ruiz, A. (14 September 2019). AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel. Chicago Tribune
Androgel Lawsuit Update: Nearly 160 Cases Close In Latest Tranche of AndroGel MDL Resolutions
December 10, 2019
Author: Daniel Gala
Multidistrict litigation (MDL) over AbbVie’s AndroGel and other testosterone drugs continued its run of recent case resolutions with nearly 160 cases having been resolved on December 9 and 10, according to the court’s list of member cases.
The December case closures follow more than 150 such resolutions in November, showing a sustained momentum that may indicate that settlement agreements reached over one year ago are beginning to take effect in the long-running MDL, which was formed in March 2014 and has included nearly 8,000 total cases.
According to a count conducted by TheLawFirm.com, Auxilium Pharmaceutical, Inc. accounted for the largest share of the recent case closures, being the named defendant in about 70 of the 159 cases closed December 9 and 10, or roughly 44%.
Endo Pharmaceuticals, Inc. had the next largest number of cases resolved over that span with about 50 out of the 159 cases closed, for just over 30%. AbbVie, Inc., maker of AndroGel, followed with about 35 cases closed, or roughly 22%. Pfizer, Inc. also had approximately 5 cases close over the course of December 9 and 10.
The MDL, based in the Northern District of Illinois, has centralized federal products liability lawsuits alleging that the makers of testosterone-replacement therapies (TRTs) like AndroGel improperly marketed their testosterone drugs to men experiencing normal, age-related declines in testosterone levels, a use for which the drugs had not received regulatory approval.
Instead, the testosterone drugs had been approved by the United States Food and Drug Administration (FDA) for the treatment of rare conditions in which men suffer from abnormally low testosterone levels. Use of the medications by men experiencing normal declines in testosterone levels increased their risk of serious health risks, such as heart attack and stroke.
The recent uptick in case closures comes after months of cases closing at a relative trickle, despite media reports that all defendants had reached settlement agreements as of fall 2018.
However, even with the more than 300 cases that have closed in November and December, still well over half of the MDL’s 7,881 total cases remain active, with just over 3,000 having closed as of December 11, leaving more than 4,850 cases still pending resolution. This means that, even if the MDL were to maintain its new pace of approximately 150 cases closures per month, the litigation still would take nearly three years to wind down.
Sources:
United States District Court Northern District of Illinois. (Accessed 11 December 2019). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Elejalde-Ruiz, A. (14 September 2018). AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel. Chicago Tribune
Androgel Lawsuit Update: December Opens With More Case Closures In AndroGel MDL
December 7, 2019
Author: Daniel Gala
Nine more cases closed December 2 and 4 in long-running multidistrict litigation (MDL) over testosterone-replacement therapies (TRTs) such as AbbVie’s AndroGel, the latest sign that settlement agreements finalized more than a year ago are beginning to take effect.
Eight cases closed on December 4, with an additional case closing December 2, according to the court’s list of member cases. Of the nine, eight named AbbVie, Inc., the maker of AndroGel, as defendant. The remaining case involved Eli Lilly and Company.
Taking place in the Northern District of Illinois, the MDL has, since 2014, centralized federal lawsuits filed by patients who claim that AbbVie and other makers of TRTs improperly promoted their testosterone drugs for uses for which they had not been approved by the US Food and Drug Administration (FDA).
Specifically, the plaintiffs allege that the drug makers marketed their TRTs to men suffering from normal, age-related declines in testosterone levels, thereby increasing those patients’ risk of serious side effects, including heart attack and stroke.
In total, the testosterone-drug MDL has included roughly 7,900 cases, of which nearly 2,900 have closed, leaving approximately 5,000 testosterone-drug lawsuits yet to be resolved, according to a count of member cases conducted by TheLawFirm.com.
The nine recent closures follows more than 150 such resolutions over the month of November, a notable increase over previous months. The MDL registered a combined 147 case closures on November 4 and 15, with an additional four cases closing November 25.
During the fall of 2018, it was widely reported that AbbVie, the last remaining defendant holdout in the testosterone-drug MDL, had come to terms on a settlement agreement to resolve AndroGel-related claims. However, for nearly a year cases continued to close at a mere trickle before the November uptick suggested that perhaps the settlement programs were beginning to result in a greater number of case resolutions.
Terms of the settlement agreements have not been disclosed publicly.
Sources:
United States District Court Northern District of Illinois. (Accessed 6 December 2019). Member Cases. MDL 2545. In re: Testosterone Replacement Therapy Products Liability Litigation
Elejalde-Ruiz, A. (14 September 2018). AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel. Chicago Tribune
Androgel Lawsuit Update: Four More Cases Close In AndroGel MDL
November 27, 2019
Author: Daniel Gala
The run of recent case resolutions in multidistrict litigation (MDL) over testosterone-replacement therapies such as AbbVie’s AndroGel continued on Monday, November 25, with four additional case closures, according the court’s list of member cases.
The four case closures follow a tranche of 147 cases that closed between November 4 and November 15. After months of cases closing at a relative trickle despite all defendants reportedly having agreed to settlement agreements as of fall 2018, the recent flood of resolutions suggests that the settlement programs are finally beginning to take effect.
Of the four cases to close November 25, three named Endo Pharmaceuticals, Inc. as defendant and one named Eli Lilly & Company. In the period November 4 through November 15, the vast majority of cases to close involved AbbVie.
The long-running MDL, which has been ongoing since March 2014, has centralized nearly 8,000 lawsuits filed by plaintiffs who say they were harmed by the illicit marketing schemes defendants employed to promote their testosterone drugs.
Specifically, plaintiffs allege that AbbVie and the other defendant drug makers illegally pushed their testosterone drugs for uses for which they had not been granted regulatory approval, marketing them to men experiencing normal, age-related declines in testosterone rather than the relatively rare conditions resulting in abnormally low testosterone levels for which they had been approved.
Such unapproved use of the testosterone drugs increased those men’s risk of serious side effects, including heart attack and stroke.
Despite the settlement agreements, only about 2,850 of the approximately 7,900 total cases have been resolved to date, according to a count of the court’s list of member cases conducted by TheLawFirm.com. This leaves roughly 5,000 cases still active.
The MDL is taking place in the Northern District of Illinois, based in Chicago. Terms of the settlement agreements have not been disclosed publicly.
Source:
United States District Court Northern District of Illinois. (Accessed 25 November 2019). Member Cases. MDL 2545. In re: Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Settlement Update: More Than 100 AndroGel Cases Close As AbbVie Settlement Makes Headway
November 15, 2019
Author: Daniel Gala
In a sign that a settlement agreement between pharmaceutical company AbbVie and thousands of plaintiffs suing the company over its testosterone drug AndroGel is beginning to have an impact roughly a year after it was first reported, nearly 150 cases have closed since the beginning of November in long-running multidistrict litigation (MDL) over testosterone replacement therapies (TRTs).
In all, 147 cases closed in the period from November 5 through November 14, according to the court’s list of member cases. Approximately 130 of the cases closed during that period named AndroGel-maker AbbVie Inc. as defendant.
Despite the recent resolutions, more than 5,000 active cases remain in the MDL that has been ongoing since March 2014 in the Northern District of Illinois. The MDL centralized federal lawsuits accusing AbbVie and other makers of TRTs of illegally marketing their testosterone drugs for purposes for which they had not received approval from the United States Food and Drug Administration (FDA).
Specifically, plaintiffs allege that AbbVie and other defendants marketed their testosterone drugs for use by men experiencing normal, age-related declines in testosterone levels. Such use, for which the drugs had not been approved by regulators, increased those individuals’ risk of serious side effects including heart attack and stroke.
Despite media reports in fall 2018 indicating that a settlement involving AbbVie, the last remaining defendant holdout, was imminent, prior to the recent slew of closures, cases had continued to be resolved sporadically and at a relative trickle.
The large number of case resolutions specifically involving AbbVie suggests that the company’s settlement program may be beginning to take effect, meaning the pace of case closures may be picking up in an MDL that has involved nearly 8,000 total cases, well over half of which remain active.
Other defendants to have cases resolved in the period November 5 to November 14 include Eli Lilly and Company; Auxilium Pharmaceuticals, Inc.; Pfizer, Inc.; and Unimed Pharmaceuticals.
Sources:
United States District Court Northern District of Illinois. (Accessed 15 November 2019). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Ekejalde-Ruiz, A. (14 September 2018). AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel. Chicago Tribune
Androgel Lawsuit Update: Sixteen More Cases Close In AndroGel MDL
November 3, 2019
Author: Daniel Gala
Sixteen additional cases closed October 29 in multidistrict litigation (MDL) over AbbVie’s AndroGel and other testosterone-replacement therapies (TRTs), according to the court’s list of member cases. The additional closings means that the MDL finished October with approximately 170 cases closed for the month.
Despite the uptick in case resolutions, more than 5,000 active lawsuits remain in the MDL out of a total of nearly 7,900.
Of the 16 cases closed October 29, seven involved Eli Lilly and Company as named defendant; four named AbbVie; and three named Actavis, Inc. Acrux, Ltd. and Watson Laboratories, Inc. also had one case each against them closed.
Despite all defendants reportedly having entered into settlement agreements, the AndroGel MDL has been slow to wind down, with cases closing at a relative trickle prior to the slight increase in October.
The MDL centralized federal claims that makers of testosterone-replacement therapies like AndroGel improperly marketing the drugs to men suffering from normal age-related declines in testosterone levels, a use for which the drugs had not received approval from the United States Food and Drug Administration (FDA). Such off-label uses put those men at increased risk of serious side effects, such as heart attack and stroke.
Meanwhile, in a press release submitted to US Securities and Exchange Commission (SEC), AbbVie announced revenues of $8.5 billion for the third quarter of 2019, and revealed that it would be increasing its quarterly cash dividend to shareholders from $1.07 per share to $1.18 per share beginning with the dividend payable in February 2020.
Sources:
United States District Court Northern District of Illinois. (Accessed 1 November 2019). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
AbbVie Inc. (1 November 2019). Form 8-K. Exhibit 99.1. United States Securities and Exchange Commission (SEC)
Androgel Lawsuit Update: Emails Implicate Nike CEO In AndroGel Athlete Doping Scandal
October 6, 2019
Author: Daniel Gala
With thousands of plaintiffs having sued the pharmaceutical company AbbVie over alleged improper marketing of its testosterone drug AndroGel, one aspect of the AndroGel fiasco that has gotten less attention publicly has been the use of AndroGel by top athletes in an effort to get gain an illicit edge on their competition. Now, with reports
that years-old emails directly tie Nike CEO Mark Parker to secret experiments using AndroGel on Nike-backed runners, the AndroGel-doping scandal has reached the highest levels of sports business.
The emails in question came to light during arbitration between the US Anti-Doping Agency and Alberto Salazar, former head coach of the Nike Oregon Project training group. Salazar has been under investigation for allegedly conducting doping experiments on athletes, purportedly to determine in what doses banned substances could be administered to an athlete while remaining undetectable to anti-doping tests.
The emails cover the time period 2009 to 2011 and show Nike CEO Parker having direct knowledge of and involvement with the illicit experiments, at least some of which involved AbbVie’s AndroGel.
“We have preliminary data back on our experiments with a topical male hormone called AndroGel,” read a 2009 email from endocrinologist Jeffrey Brown, who worked with Salazar on the experiments, to Parker, as quoted by the New York Times.
“[It] will be interesting to determine the minimal amount of topical male hormone required to create a positive test,” replied Nike CEO Parker.
Nike defended the email contents and the experiments themselves by saying the purpose was not to evade drug tests but to protect athletes from sabotage.
“Mark Parker had no idea that the test was outside any rules, as a medical doctor was involved,” a Nike spokesperson told the New York Times. "Furthermore, Mark’s understanding was that Alberto was attempting to prevent doping of his athletes.”
Nike claims Parker and others feared that a saboteur potentially could apply AndroGel or some other topically-applied banned substance onto an unwitting athlete, thereby resulting in a positive drug test.
“Nike did not participate in any effort to systematically dope any runners ever; the very idea makes us sick,” read an internal email to Nike employees sent after the revelation of Parker’s emails.
Despite the known risks, the use of AndroGel for off-label purposes unfortunately is nothing new. AbbVie and other makers of testosterone-replacement therapies have faced massive multidistrict litigation (MDL) centralizing thousands of lawsuits alleging that the companies improperly marketed their testosterone drugs to men suffering from normal, age-related declines in testosterone levels, thereby increasing their risk of serious side-effects such as heart attack and stroke.
Source:
Cresewll, J. (1 October 2019). Doping Scandal Includes a Direct Link to Nike’s CEO. The New York Times
Androgel Lawsuit Update: 16 Cases Close In AndroGel MDL, First Since July
September 19, 2019
Author: Daniel Gala
Sixteen additional cases closed September 13 in multidistrict litigation (MDL) over testosterone replacement therapies including AndroGel’s AbbVie, marking the MDL’s first case closures since July 26, according to the court’s list of member cases. Nine of the 16 cases named an AbbVie entity as defendant.
Despite AbbVie, the last remaining defendant holdout, having reportedly agreed to settlement terms almost exactly one year earlier, cases in the MDL have been closing at a relative trickle. Even with the 16 recent case closures, approximately 5,500 cases remain open out of a total of nearly 8,000.
Aside from AbbVie, the other defendants in the 16 cases to close September 13 included the drugmakers Actavis (5 cases) and Endo Pharmaceuticals (2) cases.
The MDL was formed in 2014 to centralize federal lawsuits alleging that AbbVie and other makers of testosterone replacement therapies improperly marketed the drugs to men suffering from normal, age-related declines in testosterone levels, thereby increasing their risk of serious side effects side as heart attack, stroke, and blood clots.
Despite the thousands of lawsuits faced by AbbVie and other makers of testosterone drugs, the multibillion testosterone-supplement industry continues its astronomical growth. According to a recent report by The New York Times, testosterone drugs and supplements were a $26 billion industry in 2015 and are expected to reach $300 billion by 2024.
Sources:
Elejalde-Ruiz, A. (14 September 2018). AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel. Chicago Tribune
United States District Court Northern District of Illinois. (Accessed 16 September 2019). Member Cases. MDL 2545. In Re: Testosterone Replacement Therapy Products Liability Litigation
Popescu, A. (28 August 2019). Is Low Testosterone Hurting Your Libido? Or Are You Just Aging? The New York Times
Androgel Lawsuit Update: As One-Year Anniversary of AbbVie AndroGel Settlement Comes And Goes, Thousands Of Cases Remain Active
September 11, 2019
Author: Daniel Gala
“U.S. drugmaker AbbVie has reached a tentative settlement in multidistrict litigation in Chicago over whether it failed to warn consumers that its testosterone replacement drug AndroGel could cause health problems including heart attacks and strokes,” Reuters reported on September 11, 2018. “The potential settlement was disclosed in a court filing on Monday [September 10, 2018] by U.S. District Judge Matthew Kennelly, who stayed the case while the two sides work on completing a settlement agreement.”
At the time, news of an AbbVie settlement was widely heralded as marking the beginning of the end of multidistrict litigation (MDL) over AndroGel and other testosterone-replacement therapies (TRTs). However, with the one-year anniversary of the announced settlement having come and gone, thousands of active cases remain in the AndroGel MDL, with cases closing at a relative trickle.
Per the MDL’s list of member cases, accessed September 11, 2019, no cases have closed since July 26, when just 19 cases closed. According to a count conducted by TheLawFirm.com, this leaves more than 5,400 out of the nearly 8,000 total cases in the MDL still active despite AbbVie reportedly having been the last remaining hold out among the pharmaceutical-company defendants.
The MDL centralized federal lawsuits filed by plaintiffs alleging that they or their loved ones suffered serious harm as a result of the improper marketing and undisclosed risks of the testosterone drugs, including the company’s deploying advertisements targeted at men suffering from normal, age-related declines in testosterone levels, a use for which the drugs had not obtained approval from the United States Food and Drug Administration (FDA) and which increased those patients’ risk of serious side effects such as heart attack and stroke.
Many plaintiffs in the MDL allege that they or a decedent did in fact suffer a serious cardiovascular event as a result of their taking AndroGel or another testosterone drug.
The federal MDL was established in early 2014 by order of the Judicial Panel on Multidistrict Litigation (JPML). Based on other, previous products liability MDLs involving medical devices or pharmaceuticals, it is not unusual for it to take years for the massive settlement programs to process all eligible claims.
The AndroGel MDL is being conducted in the United States District Court for the Northern District of Illinois with US District Judge Matthew F. Kennelly presiding.
Sources:
Aubin, D. (11 September 2018). AbbVie reaches tentative settlement in AndroGel litigation. Reuters
United States District Court Northern District of Illinois. (Accessed 11 September 2019). Member Cases. MDL 2545. In Re: Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: ‘Everyone Wants To Be The Biggest Toughest Dude’: NY Times Report Shows How AndroGel’s Marketing Plan Created Today’s Testosterone-Industry Monster
September 5, 2019
Author: Daniel Gala
Among the core claims facing Sanofi and other makers of testosterone replacement therapies (TRTs) in multidistrict litigation (MDL) taking place in the Northern District of Illinois is the allegation that the companies invested heavily in multimillion-dollar marketing schemes specifically designed to convince men suffering from natural, age-related declines in testosterone levels that they were in need of pharmaceutical intervention in order to return to their former masculinity and vigor, unnecessarily exposing themselves to an increased risk of serious side effects while the drug companies reaped the heady profits, which quickly ran into the billions of dollars.
According to research conducted by numerous expert organizations including the United States Food and Drug Administration (FDA), such drugs pose a “possible increased risk of heart attack and stroke with use.”
Worryingly, steps taken to inform the public of these risks, including the FDA’s requiring in 2015 a new warning on the labels of prescription testosterone drugs, seem to have done little to slow the testosterone industry’s staggering growth into a multibillion-dollar-per-year behemoth.
Now, for a report published August 28, the New York Times has taken an in-depth look at how these carefully crafted and implemented marketing strategies, some of which allegedly were in violation of state and federal laws, helped not only to create billions of dollars in demand for prescription testosterone drugs like Sanofi’s AndroGel (AndroGel formerly was marketed by Solvay Pharmaceuticals), but also played a prominent role in igniting a testosterone supplement industry that is projected to reach $300 billion by 2024, up more than ten-fold from $26 billion in 2015, the same year the FDA mandated the new testosterone-related warning, according to a study conducted by Grand View Research, which was cited in the Times report.
While thousands of cases brought against Sanofi and other makers of TRTs through the federal MDL have been settled or are participating in a settlement process, the Times report suggests that the public’s exposure to the serious health risks posed by testosterone-boosting drugs and supplements will only continue to grow in coming years. Research has shown that men suffering from natural age-related declines in testosterone levels who take testosterone drugs or supplements increase their risk of serious side effects, including heart attack and stroke.
Many of the plaintiffs involved in the AndroGel MDL claim that they suffered these and other harms as a result of taking AndroGel or other TRTs. Some tragically did not live to bring the lawsuits themselves, with the cases instead having been filed by the decedents’ estates.
Some medical experts blame the orchestrated, multimillion-dollar ad campaigns put forward by pharmaceutical and supplement companies for filling patients’ heads with incorrect notions about age-related declines in testosterone levels, ideas that sometimes are impervious even to the advice of the patient’s own doctor.
“Young guys get this idea in their head, and they’re totally uninterested in what their physician has to say about it,” Dr. Charles Welliver, a urologist at Albany Medical College, told the Times. “Everybody wants to think they’re the biggest, toughest dude. The guys reading this stuff online come in with these weird treatments where they say their testosterone has to be at 5,000, when normal is 400.”
Experts interviewed by the Times for its report specifically cite the advertising efforts of pharmaceutical companies pushing TRTs as instrumental to creating the present demand, which is only expected to grow further.
“Dr. Bradley Anawalt, an endocrinologist at the University of Washington, said the demand for low-T treatments is nothing new and was spurred by pharmaceutical companies in the early 2000s,” the Times reports. “Back then, Solvay Pharmaceuticals, which was pushing AndroGel, which does include testosterone, rebranded the male menopause term from ‘andropause’ to low T.”
“'How do you sell a Tesla or a Lexus?’ Dr. Anawalt said. ‘You put an image of a young attractive person having your hair flow as you drive a zippy little convertible at high speed.’”
Sources:
Popescu, A. (28 August 2019). Is Low Testosterone Hurting Your Libido? Or Are You Just Aging? The New York Times
United States Food and Drug Administration (FDA). (3 March 2015). FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use. Drug Safety and Availability
Androgel Lawsuit Update: New Mexico AG Sues AndroGel Maker Over Alleged False Advertising
August 26, 2019
Author: Daniel Gala
The attorney general of New Mexico has filed a lawsuit against pharmaceutical giant AbbVie, maker of the popular and controversial testosterone drug AndroGel, and three other drug makers over allegations that the companies violated New Mexico’s false advertising laws by improperly marketing the medications for use by men suffering from normal, age-related declines in testosterone levels, the The Santa Fe New Mexican reported August 19.
The 73-page complaint accuses the drug companies of engaging in “a deceptive and misleading marketing scheme designed to redefine the natural male aging process as a curable disease state,” as quoted by the Santa Fe New Mexican.
The lawsuit is just one of dozens New Mexico Attorney General Hector Balderas has filed against various corporate defendants, with the proceeds from such lawsuits accounting for a significant portion of his office’s operating budget. The money received from favorable verdicts and settlements are placed in the two-decade-old Consumer Settlement Fund, which the AG’s office relies on for funding.
While, prior to 2011, the fund did not account for a significant portion of the attorney general’s budget, in 2017, the fund provided 48% of the office’s funding, a spokesperson for the New Mexico Attorney General’s Office told the Santa Fe New Mexican.
Balderas’ office reportedly has brought in some $37.8 million in favorable verdicts and settlements during his four years as state AG, helping to replenish the Consumer Settlement Fund, the balance of which had sunk as low as $6 million in 2017 despite being as high as $30 million in 2014.
The New Mexico Department of Finance and Administration says the fund’s current balance stands at about $15 million.
While New Mexico Attorney General Balderas has criticized the state legislature’s reliance on the Consumer Settlement Fund to pay for his office’s budget, he maintains that decisions relating to the fund do not drive his decisions on whether or not to file any particular lawsuit.
“For me, it’s not a big factor,” Balderas told the Santa Fe New Mexican, referring to considerations relating to the Consumer Settlement Fund. “My most important factor is the violation of the law and whether I can prove up the claims through aggressive litigation. We’ve grown the fund, due to success. But I don’t rely on that as a factor.”
AndroGel and other testosterone replacement therapies (TRTs) also are the subject of federal multidistrict litigation (MDL) taking place in the Northern District of Illinois. The MDL has centralized thousands of federal lawsuits alleging that marketing TRTs for use by men suffering from normal age-related declines in testosterone levels exposed those patients to serious health risks, including an elevated risk of heart attack and stroke. While all of the defendant drug companies in the MDL reportedly have reached settlement agreements with plaintiffs, as of late August, more than 5,000 of the nearly 8,000 total cases remained active, according to the court’s list of member cases.
Sources:
Haywood, P. (19 August 2019). New Mexico Attorney General suing about 50 companies; here’s why. The Santa Fe New Mexican
United States District Court Northern District of Illinois. (Accessed 24 August 2019). Member Cases. MDL 2545. In re: Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: AndroGel Maker AbbVie Has Set Aside $330M For Litigation Costs, Quarterly Filing Says
August 22, 2019
Author: Daniel Gala
Pharmaceutical giant AbbVie, Inc., maker of the popular testosterone drug AndroGel, has set aside $330 million to pay for its various legal entanglements, including thousands of AndroGel products liability lawsuits, the company disclosed in its quarterly filing with the United States Securities and Exchange Commission (SEC), submitted August 5. The figure represents a slight decrease from the $350 million the company had allocated for legal costs as of December 31, 2018.
“Product liability cases were filed in which plaintiffs generally allege that AbbVie and other manufacturers of TRTs did not adequately warn about risks of certain injuries, primarily heart attacks, strokes and blood clots,” AbbVie’s Form 10-Q for the quarter ended June 30, 2019 states. “Approximately 3,900 claims against AbbVie are consolidated for pre-trial purposes in the United States District Court for the Northern District of Illinois under the MDL Rules as In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545.”
Despite all defendants in the testosterone replacement therapy (TRT) MDL reportedly having entered into settlement agreements, to date, cases have closed at a relative trickle. Over 5,000 of the nearly 8,000 total cases remain active, with no cases having closed in nearly a month, according to the court’s list of member cases, accessed August 21.
In addition to the thousands of federal claims, AbbVie says it also faces roughly 200 AndroGel products liability lawsuits filed in various state courts.
Further, AbbVie has found itself in legal trouble over alleged sham litigation aimed at protecting the AndroGel market from competition posed by generic drug makers, which has resulted in a court-ordered penalty of nearly half-a-billion dollars, which the company has appealed. (Based on its confidence in the success of this appeal, AbbVie has not set aside any funds to pay for this penalty.)
“In September 2014, the FTC [Federal Trade Commission] filed a lawsuit against AbbVie and others in the United States District Court for the Eastern District of Pennsylvania, alleging that the 2011 patent litigation with two generic companies regarding AndroGel was sham litigation and the settlements of that litigation violated federal antitrust law,” AbbVie disclosed. “In June 2018, following a bench trial, the court found for the FTC on its sham litigation claim and ordered a disgorgement remedy of $448 million, plus prejudgment interest….AbbVie is appealing the court’s liability and disgorgement rulings and, based on an assessment of the merits of that appeal, no liability has been accrued for this matter.”
That AbbVie has not allocated any funds to pay for potential penalties related to the FTC’s AndroGel action is a strong indication that the company’s $330 million set-aside for legal expenses may be on the low end of the spectrum.
Sources:
AbbVie, Inc. (Submitted 5 August 2019). Form 10-Q for the six months ended June 30, 2019. United States Securities and Exchange Commission (SEC). Commitments and Contingencies Abstract. Legal Proceedings and Contingencies
United States District Court Northern District of Illinois. (Accessed 21 August 2019). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: Over 4,000 State And Federal AndroGel Claims Remain, AbbVie Reports
August 9, 2019
Author: Daniel Gala
AbbVie Inc. continues to face more than 4,000 products liability lawsuits over its testosterone drug AndroGel, including roughly 3,900 federal and 200 state claims, according to the drug maker’s second quarter financial disclosures. The active lawsuits remain despite AndroGel’s having entered into a master settlement agreement pertaining to AndroGel claims in November 2018.
“Approximately 3,900 claims against AbbVie are consolidated for pre-trial purposes in the United States District Court for the Northern District of Illinois,” AbbVie reports in its Form 10-Q for the six months ended June 30, 2019, filed with the US Securities and Exchange Commission (SEC) on August 5. “Approximately 200 claims against AbbVie are pending in various state courts. Plaintiffs generally seek compensatory and punitive damages.”
The MDL over testosterone-replacement therapies such as AndroGel dates back to 2014, when the Judicial Panel on Multidistrict Litigation (JPML) centralized federal claims alleging pharmaceutical companies improperly marketed the drugs to men suffering from ordinary age-related declines in testosterone levels, increasing their risk of heart attack and stroke.
As of late July, approximately 5,500 active cases remained out of roughly 8,000 total in the MDL, according to the court’s list of member cases. AbbVie’s reported 3,900 federal claims would amount to roughly half of the MDL’s total cases.
When AbbVie agreed to a settlement agreement in November 2018, it was the last defendant holdout. Other Big Pharma defendants in the testosterone-replacement therapy MDL include Eli Lilly and Company, Actavis, Endo Pharmaceuticals, and Auxilium Pharmaceuticals.
In additional to the thousands of products liability claims, AbbVie also is embroiled in an AndroGel-related MDL in the Northern District of Georgia, where four antitrust lawsuits filed against the company have been centralized.
“These cases, brought by direct AndroGel purchasers, generally allege Solvay's [now Abbvie Products LLC] 2006 patent litigation settlement agreements and related agreements with three generic companies violate federal antitrust laws,” AbbVie reports. “Plaintiffs seek monetary damages and attorneys’ fees.”
These agreements also have formed the basis of a Federal Trade Commission (FTC) action against AbbVie. The lawsuit, filed September 2014 in the Eastern District of Pennsylvania, resulted in a June 2018 finding “for the FTC on its sham litigation claim” with the court ordering "a disgorgement remedy of $448 million, plus prejudgment interest,” per AbbVie.
AbbVie has appealed this decision. The company is so confident in its position that “based on an assessment of the merits of that appeal, no liability has been accrued for this matter.” In other words, AbbVie has not set aside any money to pay the nearly half-a-billion dollar penalty imposed by the District Judge on the FTC’s sham litigation claims.
Sources:
AbbVie Inc. (Filed 5 August 2019). Form 10-Q for the six months ended June 30, 2019. Notes to Financial Statements. Legal Proceedings and Contingencies
United States District Court Northern District of Illinois. (Accessed 8 August 2019). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: Nearly Three Dozen More Cases Close In AndroGel MDL
July 29, 2019
Author: Daniel Gala
In a sign that momentum is beginning to increase toward resolving long-running multidistrict litigation MDL) over testosterone-replacement drugs such as AbbVie’s popular AndroGel, 33 additional cases closed July 25 and 26, according to the court website’s list of members cases.
Of the 33 cases to close over the two-day span, only three involved AndroGel maker AbbVie as named defendant. Of the remaining cases to close July 25 and 26, thirteen involved Actavis Inc.; eight involved Endo Pharmaceuticals; five involved Auxilium Pharmaceuticals; three involved Eli Lilly and Company; and one involved Pfizer.
Despite reports that all defendants in the MDL had reached settlement agreements with plaintiffs as of fall 2018, case closures have proceeded at a relative trickle, with over 5,000 active cases remaining out of nearly 8,000 total.
The centralized lawsuits accuse AbbVie and other makers of testosterone-therapy products of improperly marketing their drugs for use by men suffering from ordinary, age-related declines in testosterone, a use for which the drugs had not received approval from the US Food and Drug Administration (FDA). Such use increased the men’s risk of serious side effects, including heart attack and stroke.
The MDL was created by transfer order of the Judicial Panel on Multidistrict Litigation (JPML) in June 2014.
Source:
United States District Court for the Northern District of Illinois. (Accessed 29 July 2019). Member Cases. MDL 2545 In re Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: Twelve More Cases Close In AndroGel MDL
July 22, 2019
Author: Daniel Gala
In the first case closures in over a month, twelve cases closed July 18 in multidistrict litigation (MDL) over testosterone-replacement therapies (TRTs) including AbbVie’s popular AndroGel medication, according to the court’s list of member cases. Despite all of the defendant pharmaceutical makers reportedly having entered into settlement agreements, case closures continue to come at a mere trickle, with thousands of active cases remaining in the five-year-old MDL.
Prior to the July 18 closings, the most recent case closures took place June 4, when seven cases closed.
Of the 12 cases to close July 18, six involved AndroGel maker AbbVie Inc. as named defendant. The remaining cases included defendants Auxilium Pharmaceuticals, Inc. (One case closed); Acavis, Inc. / Actavis, Plc. / Actavis, Pharma, Inc. (Four cases closed); and Eli Lilly and Company (One case closed).
Despite the ongoing lawsuits, which accuse the makers of TRTs like AndroGel of illegally marketing their prescription drugs to men suffering from normal age-related declines in testosterone levels, the United States Food and Drug Administration (FDA) recently has allowed a number of generic-drug makers to begin producing generic forms of AndroGel for the US market.
Testosterone-replacement therapies originally were developed to treat rare conditions involving decreased testosterone levels in men. As pharmaceutical makers began to market the drugs to men suffering from normal age-related declines in testosterone levels, TRTs grew into a multi-billion dollar per year industry. Unfortunately, the drugs posed severe risks when prescribed improperly, including increasing the chances of heart attack and stroke.
The AndroGel MDL has been ongoing in the US District Court for the Northern District of Illinois since March 2014. As of July 19, 2019, it still contained over 5,500 active cases, with nearly 7,900 total cases having been involved, according to the court list of member cases.
At the present pace, it likely will take years for the long-running litigation to wind down completely.
Source:
United States District Court for the Northern District of Illinois. (Accessed 19 July 2019). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Settlement Update: AndroGel MDL Winds Down As Court Irons Out Settlement Logistics
June 24, 2019
Author: Daniel Gala
The judge overseeing massive multidistrict litigation (MDL) over testosterone-replacement therapies such as AbbVie Inc.’s popular AndroGel medication continues to take steps aimed at winding down the long-lasting litigation, issuing two orders June 21 pertaining to the administration of the confidential settlement agreements now reached by all defendants. With AbbVie, the last defendant hold-out, having reached a settlement with plaintiffs in the fall of 2018, the execution of the confidential settlement agreements remains the last major hurdle to resolving the MDL.
Despite over six months having passed since AbbVie reportedly entered into a settlement agreement, more than 5,000 active cases remain out of a total of nearly 8,000, according to the court’s list of member cases . No new cases have been resolved since 7 claims were closed June 4, but the recent orders suggest that further resolutions may be on the horizon.
In one of the June 21 orders, US District Judge Matthew F. Kennelly, writing for the US District Court for the Northern District of Illinois, appointed a certified public accountant (CPA) to oversee the MDL’s common benefit funds, while the other established a qualified settlement fund for cases involving defendant Endo Pharmaceuticals.
The MDL, which has been ongoing since early 2014, centralized federal products liability claims that the makers of testosterone replacement therapies like AndroGel improperly marketed the drugs to men suffering from normal age-related declines in testosterone levels, thereby increasing their chances of serious health effects such as heart attack and stroke.
Terms of the settlement agreements have not been disclosed publicly.
In addition to facing thousands of lawsuits from patients and their decedents who allege serious injury as a result of taking AndroGel, AbbVie also has faced lawsuits and regulatory action from the federal government and state governments relating to its alleged improper marketing of the testosterone drug, as well as alleged anticompetitive practices against potential makers of generic AndroGel.
Sources:
US District Court for the Northern District of Illinois. (21 June 2019). Case Management Order No. 155 Appointment of Certified Public Accountant to Oversee Common Benefit Settlement Funds. MDL 2545 In Re: Testosterone Replacement Therapies Products Liability Litigation
US District Court for the Northern District of Illinois. (21 June 2019). Case Management Order No. 156 Order to Establish Endo TRT Qualified Settlement Fund. MDL 2545 In Re: Testosterone Replacement Therapies Products Liability Litigation
Androgel Lawsuit Update: New Report Exposes Details Of AndroGel Off-Label-Marketing Scheme
June 11, 2019
Author: Daniel Gala
As readers of TheLawFirm.com know, AndroGel-maker AbbVie Inc. for years has been embroiled in lawsuits over allegations that the company improperly marketed its popular testosterone replacement therapy (TRT) to men experiencing normal, age-related declines in testosterone levels.
On June 4, the publication Fatherly published an exposé revealing the shocking details behind AbbVie and other TRT makers’ explicit strategy to expand the market of products like AndroGel beyond patients suffering from a somewhat rare condition to include virtually all men over the age of 35.
As a result of this purposeful (and illegal) marketing push, thousands of men have suffered severe side effects, including heart attack and stroke, some of which proved fatal.
“One commercial for 25 Again (formerly known as Body Shapes Medical) aired in 2012 featured a be-stethoscoped doctor in a lab coat warning that men stop producing testosterone at age 35,” the Fatherly report states, describing an ad representative of the marketing-push orchestrated by the makers of testosterone drugs beginning in the early 2000s. “The good news, the doctor added, was that he could identify optimum levels and help men replenish them.”
Fatherly later explains the sham:
This would have been very exciting if the TV doctor had been telling the truth. But he wasn’t. Men gradually start to lose testosterone at age 35, but that’s not a problem and it’s not low testosterone. The treatment and the problem had been consciously uncoupled by advertisers.
Before this conscious shift in advertising strategy, testosterone-replacement therapies like AndroGel had been prescribed primarily to men suffering from hypogonadism, which affects only about one out of every 50 men and arises from a failure of the pituitary glands and/or testicles. Hypogonadism typically results from conditions like the congenital abnormalities, the mumps, or cancer.
However, as marketing campaigns pushed buzzwords like “Low-T” and “andropause”—the term coined to describe the supposed male equivalent of menopause—into the mainstream, the makers of testosterone-replacement drugs stood ready with the supposed solution to this manufactured health crisis.
As Fatherly puts it, “Low-T became a commonly treated medical disorder without becoming a common medical disorder because demand could be manufactured faster than lab workers could stuff pills and serums into hypermasculine packaging.”
The strategy worked, at least as far as sales were concerned. According to Fatherly, between 2000 and 2011, the number of testosterone prescription increased by a factor of 12, with sales growing commensurately from $324 million in 2002 to $2 billion in 2012.
However, as the number of prescriptions grew, based in large part on specific patient requests to doctors, routine patient protections fell by the wayside. For example, Fatherly reports that as many as 25% of testosterone-therapy prescriptions were given to patients without the doctor having performed a simple blood test aimed at detecting whether the drug would pose an increased risk of stroke in that individual patient. (Testosterone drugs thicken the blood, increasing risk of stroke, with certain men being at a particularly high risk.)
In a parallel trend, during the testosterone-drug boom of the 2000s, more TRT prescriptions were written by general practitioners than by specialists in men’s reproductive health like urologists or endocrinologists, which can likely be attributed at least in part to drug makers’ direct-marketing push.
The result has been that thousands of men who were improperly prescribed testosterone medication have suffered adverse health reactions, ranging from minor to fatal.
These tragic injuries have led, in turn, to thousands of lawsuits filed by patients and their families who claim to have suffered harm as a result of the improper marketing scheme aimed at convincing every male over 35 that he required testosterone supplementation. In the United States, federal testosterone-replacement therapy cases have been centralized as multidistrict litigation (MDL) in the Northern District of Illinois.
In total, the testosterone therapy MDL has included nearly 8,000 cases, over 5,000 of which remain active despite settlement agreements reportedly having been reached with all of the defendant companies, including AndroGel-maker AbbVie, which was named defendant in approximately 4,600 of the MDL’s lawsuits.
Sources:
Vinopal, L. (4 June 2019). Testosterone, Low Testosterone, and the Men’s Health Crisis That Wasn’t. Fatherly
United States District Court Northern District of Illinois. (Accessed 12 June 2019). Member Cases. MDL 2545. In Re: Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Settlement Update: Seven More Cases Close In AndroGel MDL
June 5, 2019
Author: Daniel Gala
More than six months after the last remaining defendant AbbVie Inc. reportedly reached a settlement agreement
with plaintiffs in multidistrict litigation (MDL) over testosterone replacement therapies (TRTs) such as AbbVie’s popular AndroGel, cases continue to close at a slow albeit steady pace, with seven additional cases closing June 4, according to the court’s list of member cases.
Of the seven cases to close June 4, three involved AbbVie as named defendant. Auxilium Pharmaceuticals, Inc. was defendant in two of the actions, with Eli Lilly and Company and Endo Pharmaceuticals, Inc. each closing one case each.
The seven June 4 case closings follow a tranche of 17 cases that closed May 24. Prior to the May 24 closings, nearly a month had passed since 19 cases closed April 26. Given the thousands of cases remaining in the MDL, the number of closures amounts to a mere trickle.
Despite all of the defendant companies reportedly having entered into settlement agreements as of fall 2018, nearly 5,400 cases remain active out of approximately 7,900 total cases in the MDL.
The MDL, which dates back to early 2014, centralized federal claims brought by plaintiffs alleging that AbbVie and other makers of testosterone replacement therapies (TRTs) had improperly marketed their drugs to men suffering from normal age-related declines in testosterone levels, thereby increasing those patients’ risk of heart attack and stroke.
Despite these health concerns, TRTs such as AbbVie’s AndroGel remain a multibillion-dollar-per-year industry, with several makers of generic drugs recently announcing they will begin selling their own generic forms of AndroGel on the US market.
Terms of the settlement agreements reached as part of the MDL have not been disclosed publicly.
In the MDL’s first two bellwether trials, juries ordered AbbVie to pay a combined sum of nearly $300 million over claims that AndroGel had caused the plaintiffs to suffer heart attacks. However, the judge overseeing the trial later reversed both rulings, with AbbVie then going on a three-trial winning streak prior to facing a retrial of the first bellwether, after which the jury again found for the plaintiff but awarded $3 million rather than $150 million in damages.
Sources:
United States District Court Northern District of Illinois. (Accessed 5 June 2019). Member Cases. MDL 2545 In Re: Testosterone Replacement Therapy Products Liability Litigation. Court website
Wood, L. (10 September 2018). AbbVie Strikes Tentative Deal In Testosterone MDL. Law360
Androgel Lawsuit Update: 17 More Cases Close In AndroGel MDL While Thousands Remain Active
May 30, 2019
Author: Daniel Gala
Seventeen more cases closed May 24 in multidistrict litigation (MDL) over testosterone-replacement therapies (TRTs) such as AbbVie’s AndroGel, according to the court’s list of member cases. While that makes for over 400 cases closed to date in 2019, over 5,000 cases remain open in the long-running litigation despite settlement agreements reportedly having been reached with all defendants as of last fall.
Of the 17 cases closed on May 24, eight involved AbbVie as defendant. The AndroGel maker was widely reported to have been the last remaining hold out in reaching a settlement agreement over claims that it had inappropriately marketed AndroGel to men experiencing normal, age-related declines in testosterone levels, increasing their risk of heart attack and stroke.
The remaining cases to close May 24 involved defendants Actavis, Inc. (5), Eli Lilly and Company (2), Endo Pharmaceuticals Inc. (1), and Auxilium Pharmaceuticals, Inc. (1).
In total, the MDL, which dates back to 2014, has included nearly 8,000 total cases. The MDL was created by order of the Judicial Panel on Multidistrict Litigation (JPML) in June 2014, centralizing federal cases involving similar claims in the Northern District of Illinois.
“On January 31, 2014, the U.S. Food and Drug Administration announced that it was ‘investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products,’” the JPML’s Transfer Order states. “Plaintiffs filed the actions now before us in the wake of this announcement. All actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism.”
Despite more than six months having passed since AbbVie reportedly entered into its settlement agreement, cases in the MDL continue to close at a mere trickle, leaving a backlog of nearly 5,500 active cases remaining. Prior to the May 24 cases, the last tranche of cases to close did so on April 26, when 19 cases closed, according to the court’s list of member cases.
At the present rate, it would take years for all cases in the MDL to close. The court has not issued a case management order since April 30.
Sources:
United States District Court Northern District of Illinois. (Accessed 29 May 2019). Member Cases. MDL 2545. In Re: Testosterone Replacement Therapy Products Liability Litigation. Court Website
Judicial Panel on Multidistrict Litigation (JPML). (6 June 2014). MDL 2545. In Re: Testosterone Replacement Therapy Products Liability Litigation. Court Website
Androgel Lawsuit Update: AbbVie Stock Continues Fall On AndroGel Settlement, Generic Competition
May 15, 2019
Author: Daniel Gala
As pharmaceutical giant AbbVie Inc. navigates a massive settlement agreement it entered last fall to resolve thousands of AndroGel-related claims and as the company faces increased competition from generic forms of its popular testosterone drug, large institutional investors continue to reduce their AbbVie holdings, resulting in significant, sustained losses in stock price, according to a May 14 report by the online financial news outlet EnHerald.
In the year since May 14, 2018, the price of AbbVie stock has lost some 30% and continues to trend downward, per EnHerald. Over the same span, the AbbVie stock had underperformed the rest of the S&P 500 by just under 35%. Despite the losses, as of May 14, 2019, AbbVie still possessed a market capitalization of $116.10 billion.
The continuing decline in stock price comes as a growing number of competitors are releasing their own generic forms of AndroGel, which, despite the thousands of products liability lawsuits it has generated, continues to be a key component and top performer in AbbVie’s overall drug portfolio. However, market conditions suggest that soon may change, and institutional investors have taken note.
On May 7, The Economic Times reported that the popular Dr Reddy’s brand was launching a generic version of testosterone gel for the US market, entering an already crowded field that is sure to further squeeze AbbVie’s share of the market as well as its profit margins.
Since 2014, federal products liability claims over AndroGel and other testosterone replacement therapies (TRTs) have been centralized as multidistrict litigation (MDL) in the Northern District of Illinois. The plaintiffs accuse AbbVie and other TRT manufactures of downplaying the risks associated with the drugs while improperly marketing them to men suffering from normal age-related declines in testosterone, thereby increasing their risk of serious health events such as heart attack or stroke.
As the last holdout among the defendant companies, AbbVie reportedly entered into a settlement agreement to resolve the MDL claims in fall 2018. However, despite the reported settlements, as of May 14, the court’s list of member cases indicated that over 5,000 cases still remain active in the MDL out of approximately 8,000 total cases.
Sources:
Spangler, B. (14 May 2019). As Abbvie (ABBV) Valuation Declined, Holder Cibc World Markets Trimmed Its Stake; Copeland Capital Management Decreased Nordson (NDSN) Holding as Stock Rose. EnHerald
The Economic Times. (6 May 2019). Dr Reddy’s launches generic testosterone gel in US market
United States District Court Northern District of Illinois. (Accessed 14 May 2019). Member Cases. MDL 2545 In Re Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: AndroGel Maker AbbVie Has Set Aside $345M For Legal Costs, Filing Says
May 4, 2019
Author: Daniel Gala
Pharmaceutical giant AbbVie, Inc. has set aside over a third of a billion dollars to pay for anticipated legal costs, according to the company’s quarterly report, filed with the Securities and Exchange Commission (SEC) on May 3. While the report does not disclose how much of that sum has been allocated for AndroGel products liability litigation, the filing does reference a November 2018 Master Settlement Agreement in the AndroGel multidistrict litigation (MDL).
AbbVie’s reported accrual balance for litigation was $345 million as of March 31, down a fraction from $350 million at the year’s end. While most of the legal proceedings disclosed in AbbVie’s Form 10-Q involved intellectual property matters, the report does provide an update on the AndroGel products liability litigation, including that the company faces approximately 3,900 lawsuits that have been centralized for pretrial purposes in an MDL located in the Northern District of Illinois.
However, these cases have been paused while the sides try to work out the mechanics of a settlement.
“In November 2018, AbbVie entered into a Master Settlement Agreement with the Plaintiffs’ Steering Committee in the MDL encompassing existing claims in all courts,” AbbVie’s filing states. “All proceedings in pending cases are effectively stayed during the settlement administration process.”
The plaintiffs in these cases “generally allege that AbbVie and other manufacturers of TRTs did not adequately warn about risks of certain injuries, primarily heart attacks, strokes and blood clots.”
AbbVie also reports that in February 2019 the District Court for the Northern District of Illinois granted its and its fellow defendants’ motion for summary judgment in a putative class action suit filed “on behalf of all insurance companies, health benefit providers, and other third party payers who paid for TRTs [Testosterone Replacement Therapies], including AndroGel.”
Source:
AbbVie, Inc. (Filed 3 May 2019). Form 10-Q For The Three Months Ended March 31, 2019. Commitments and Contingencies Disclosure. Legal Proceedings and Contingencies. United States Securities and Exchange Commission (SEC).
Androgel Lawsuit Update: Roughly 20 More Cases Close in AndroGel MDL
April 27, 2019
Author: Daniel Gala
With all of the pharmaceutical company defendants reportedly having reached settlement agreements with plaintiffs, multidistrict litigation (MDL) over testosterone replacement therapies (TRTs) such as AbbVie’s popular AndroGel drug continues to wind down, albeit slowly, with nearly 20 additional cases having closed on April 26, according to the court’s list of member cases.
Of the 19 cases shown to have closed Friday, April 26, AbbVie was the named defendant in eight, or roughly 40%. Auxilium Pharmaceuticals, Inc. and Endo Pharmaceuticals, Inc. each had four cases against them closed, while Eli Lilly & Company accounted for the remaining three.
Despite a steady flow of cases having been reported closed in recent weeks, thousands of active cases remain in the MDL. According to a count conducted by TheLawFirm.com, approximately 5,500 cases in the TRT MDL have yet to be resolved.
At a rate of approximately 20 cases closing per week, the MDL would take years to wind down, suggesting that larger numbers of case closures may be imminent, particularly with all defendants reportedly having reached settlement agreements after AbbVie, the last remaining holdout, reached a deal with plaintiffs last fall.
At the time, the judge overseeing the MDL stayed all proceedings so that an agreement with AbbVie and the plaintiffs suing it over AndroGel could be finalized.
The long-running litigation stems from a 2014 announcement by the United States Food and Drug Administration (FDA) stating that it was “‘investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products,’” according to the June 2014 transfer order issued by the Judicial Panel on Multidistrict Litigation (JPML), which established the MDL. “All actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs cause their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism.”
Sources:
United States District Court Northern District of Illinois. (Accessed 27 April 2019). Member Cases. MDL No. 2545. In Re Testosterone Replacement Therapy Products Liability Litigation
United States Judicial Panel on Multidistrict Litigation (JPML). (6 June 2014). Transfer Order. MDL No. 2545. In Re: Androgel Products Liability Litigation
Androgel Lawsuit Update: More AndroGel Cases Close As Judge Issues First Case Management Order In Nearly A Month
April 23, 2019
Author: Daniel Gala
As the long-running litigation slowly winds its way toward resolution, a half-dozen more cases closed April 18 in multidistrict litigation (MDL) over testosterone replacement therapies such as AbbVie’s popular AndroGel medication. Meanwhile, on April 19, the presiding judge issued the proceedings’ first case management order in nearly a month.
Of the six cases to close on Thursday, April 18, five named AbbVie Inc. as defendant, a sign that the settlement agreement AbbVie reportedly reached in September 2018 finally is resulting in the resolution of cases, albeit slowly. The settlement was revealed when U.S. District Judge Matthew Kennelly stayed the proceedings last fall so plaintiffs and AbbVie could finalize an agreement. AbbVie was the last defendant to reach a settlement in the MDL.
However, despite all defendants having settled, over six months later, thousands of open cases still remain in the MDL, which has been ongoing since June 2014. Despite over 300 cases having closed to date in 2019, about 5,500 cases remain active, according to the court’s list of member cases.
In a sign that the court does remain active despite the slowing of activity, Judge Kennelly issued April 19 the proceedings’ first case management order in nearly a month, the 150th such order of the MDL, as it approaches its five-year anniversary. Case Management Order No. 150 was an order to show cause for why a case should not be dismissed with prejudice for failure to comply with a previous order.
The thousands of cases to join the MDL all shared allegations that AndroGel and other testosterone replacement therapies had been inappropriately marketed to men suffering from normal age-related declines in testosterone levels, for whom the medications had increased the risk of heart attack and stroke.
Sources:
United States District Court Northern District of Illinois. (Last accessed 22 April 2019). Member Cases. MDL 2545. In re Testosterone Replacement Therapy Products Liability Litigation
Aubin, D. (11 September 2018). AbbVie reaches tentative settlement in AndroGel litigation. Reuters
Androgel News Update: Companies Release Generic AndroGel Even As Active Lawsuits Remain In AndroGel MDL
April 18, 2019
Author: Daniel Gala
Even as thousands of active lawsuits remain in multidistrict litigation (MDL) over testosterone replacement therapies (TRTs) including AbbVie’s popular AndroGel, at least two makers of generic pharmaceuticals have announced they are releasing in the United States their own versions of the drug, which has been accused of increasing the chance of heart attack and other cardiovascular events in aging males.
On April 11, Teva Pharmaceuticals, which “[w]ith nearly 500 generic medicines available” proclaims itself to have “the largest portfolio of FDA-approved generic products,” announced in a news release posted to its website that it was launching “a generic version of AndroGel (testosterone gel) 1.62% CIII in the U.S.”
Around the same time, generic drug maker Lupin Pharmaceuticals made a similar announcement.
“Lupin Pharmaceuticals, Inc. is proud to announce its recent product launch, Testosterone Gel 1.62%,” the company proclaimed in an update also posted to its website. “Lupin’s Testosterone gel 1.62% is the AB-rated generic equivalent of AbbVie Inc.’s AndroGel 1.62%.”
If one might be left wondering why makers of generic pharmaceuticals are so eager to enter the fray by releasing their own versions of a drug that has faced thousands of lawsuits over its alleged harms, Teva lays bare the reason in its press release.
“Testosterone Gel 1.62% CIII has annual sales of more than $911 million in the U.S., according to IQVIA data as of February 2019,” Teva stated in its announcement.
Meanwhile, despite settlement agreements reportedly having been reached with all defendants, including AndroGel-maker AbbVie, over 5,000 active lawsuits remain in the testosterone replacement therapies products liability MDL, which, in total, has involved nearly 8,000 individual cases.
Created in June 2014 by order of the Judicial Panel on Multidistrict Litigation, the AndroGel MDL centralized in the Northern District of Illinois federal claims that “plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism.”
Sources:
Teva Pharmaceuticals Industries Ltd. (11 April 2019). Teva Announces Launch of a Generic Version of AndroGel (testosterone gel) 1.62% CIII in the United States. Latest News
Lupin Pharmaceuticals, Inc. (Accessed 17 April 2019). Lupin Launches Testosterone Gel 1.62% - AB Rated to AndroGel. Genericss
Judicial Panel on Multidistrict Litigation (JPML). (6 June 2014). Transfer Order. MDL No 2545. In Re: AndroGel Products Liability Litigation
Androgel Lawsuit Settlement Update: Over A Dozen More AndroGel MDL Cases Close As Thousands Remain Active
April 18, 2019
Author: Daniel Gala
On April 16, over a dozen more cases closed in multidistrict litigation (MDL) over testosterone replacement therapies including AbbVie’s AndroGel, according to the court’s list of member cases. Most of these closed cases featured Pfizer as a defendant, with Endo Pharmaceuticals and AbbVie also closing one case each.
The 16 cases that closed April 16 join over 2,000 other cases to have closed in the MDL, which centralized federal lawsuits alleging that testosterone replacement therapies (TRTs) like AndroGel increase the risk of serious cardiovascular events, such as heart attack. Despite reports that all of the defendant pharmaceutical companies involved in the litigation have reached settlement agreements to resolve the claims against them, approximately 5,500 individual cases remain active, according to the court’s website.
Although thousands of active cases remain, the MDL has not seen trial activity for some time. The most recent AbbVie AndroGel bellwether trial, the sixth, was scheduled to start in January of 2018, according to the trial schedule posted to the court’s website.
AbbVie, the last remaining defendant holdout, was reported to have reached terms on an AndroGel settlement in the fall of 2018, when the judge overseeing the MDL ordered a stay of all proceedings so a deal could be finalized. According to Law360, the settlement agreement also covered AbbVie subsidiaries Abbott Laboratories, Solvay Pharmaceuticals Inc., and Unimed Pharmaceuticals LLC.
Terms of the settlement agreements, including any financial payouts, have not been disclosed publicly.
In the first two AndroGel bellwether trials, juries found for the plaintiffs and ordered AbbVie to pay nearly $300 million in total damages, but these verdicts later were overturned. On retrial of the first bellwether, the plaintiff again prevailed, but this time the jury awarded him only $3 million in damages rather than the previous award of $150 million. Meanwhile, AndroGel scored three other bellwether wins.
Even with the MDL having entered its final phases, with the rate at which the thousands of cases continue to close amounting to little more than a trickle, the AndroGel MDL likely will still be around for some time to come.
Sources:
United States District Court Northern District of Illinois. (Accessed 17 April 2019). Member Cases. MDL 2545. In Re Testosterone Replacement Therapy Products Liability Litigation
Wood, L. (10 September 2018). AbbVie Strikes Tentative Deal In Testosterone MDL. Law360
Androgel Lawsuit Settlement Update: Most AndroGel MDL Cases Remain Active Despite Reported Settlement
April 10, 2019
Author: Daniel Gala
More than six months after a reported settlement was reached involving AbbVie, Inc., the last remaining hold out in multidistrict litigation (MDL) over testosterone replacement therapies, the majority of cases in the MDL still had not been closed as of early April 2019, according to the court’s list of member cases.
Though cases in the MDL continue to close at a steady pace, with nearly 8,000 individual cases having been involved in the litigation, the current rate amounts to little more than a trickle. For example, court records show six cases having closed on April 4, with approximately 25 other cases closing March 29. The same records indicate that over 5,500 cases in the litigation remain active, meaning that, if the present pace persists, the MDL could take months if not years to wind down.
The massive, long-running litigation involves products liability claims over so-called testosterone replacement therapies, or TRTs, including AbbVie’s AndroGel. Other defendants in the MDL include Endo Pharmaceuticals, Actavis, Pfizer, Abbott Laboratories, Eli Lilly and Company, and Auxilium Pharmaceuticals.
Since June 2014, federal cases involving TRTs such as AndroGel have been centralized in the Northern District of Illinois. According to the Transfer Order creating the MDL, “All actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism.”
In September 2018, the judge overseeing the TRT MDL in the Northern District of Illinois stayed all trial proceedings after AbbVie informed the court that it had reached a tentative agreement with plaintiffs suing the company over its popular AndroGel medication. The stay, which appears to have remained in place since that time, was intended to allow the two sides time to continue negotiations aimed at finalizing their tentative settlement. Terms of the agreement have not been not disclosed publicly.
Sources:
United States District Court Northern District of Illinois. (Last accessed 10 April 2019). Member Cases. MDL 2545 In Re: Testosterone Replacement Therapy Products Liability Litigation
Aubin, Dena. (11 September 2018). AbbVie reaches tentative deal in AndroGel litigation. Reuters
jpml.uscourts.gov
Androgel Lawsuit Update: More Cases Settle In AndroGel MDL
March 27, 2019
Author: Daniel Gala
More than a dozen cases in multidistrict litigation (MDL) over testosterone replacement therapy products including AbbVie Inc.’s AndroGel closed on March 25, according an updated list of member cases posted by the Northern District of Illinois, home venue for the long-running complex litigation. Of the thirteen cases to close, eight named AbbVie as defendant.
The most recently closed cases join a slew of case closures in the MDL, as even AbbVie, the longest holdout among the defendant drug companies, has reportedly entered into a settlement agreement that would resolve hundreds of cases. The majority of active cases remaining in the MDL, which has been ongoing since 2014, name AbbVie as defendant.
The MDL involves claims by plaintiffs who allege they suffered harm as a result of the defendants’ improperly marketing their testosterone replacement therapies for unapproved purposes, a violation of federal law.
In two bellwether trials, juries have awarded nine-figure verdicts for the plaintiffs, only to have their findings subsequently tossed. In fall 2018, as the two bellwethers were pending retrial, AbbVie was reported to have reached a tentative settlement in the AndroGel MDL.
In July 2017, a jury awarded a man $150 million in punitive damages based on his claim of fraudulent misrepresentation against AbbVie, but a federal judge overruled the verdict based on the jury’s other findings in favor of AbbVie on negligence and strict liability claims, saying that the verdicts were “logically incompatible” with each other, according to Law360 .
Similarly, the jury in the second bellwether trial returned a verdict for the plaintiff, awarding over $140 million in punitive damages, medical expenses, and pain and suffering. But that jury’s findings also were overturned on similar grounds.
In September 2018, all remaining cases against AbbVie in the MDL, which has involved nearly 8,000 total lawsuits, were stayed when AbbVie and its subsidiaries Solvay Pharmaceuticals Inc. and Unimed Pharmaceuticals LLC filed a motion saying they had reached a tentative deal with plaintiffs. The terms of the reported settlement of not been disclosed.
Sources:
United States District Court for the Northern District of Illinois. (Last accessed 26 March 2019). Member Cases. In re Testosterone Replacement Therapy Products Liability Litigation. MDL 2545
Wood, L. (10 September 2018). AbbVie Strikes Tentative Deal In Testosterone MDL. Law360
Novak Jones, D. (5 July 2018). $140M Verdict Against AbbVie In Testosterone MDL Tossed. Law360
Androgel Lawsuit Update: As Dozens Of AndroGel Claims Settle, Thousands Remain
March 20, 2019
Author: Daniel Gala
Despite over 150 cases having been closed since March 1 in multidistrict litigation (MDL) involving AbbVie’s AndroGel and other testosterone replacement therapy (TRT) products, thousands of cases remain open, according to TheLawFirm.com’s review of member cases, conducted March 20.
Of the approximately 175 cases to have settled to date in March 2019, more than 60 have been cases naming AbbVie as defendant. AbbVie, facing thousands of lawsuits over its AndroGel medication, has long been identified as the biggest holdout among the MDL defendants, which also have included Endo Pharmaceuticals Inc., Pfizer Inc., Eli Lilly and Company, Abbott Laboratories, Inc., Auxilium Pharmaceuticals, Inc., and Actavis Inc.
Over 5,500 cases in the MDL have yet to be closed, with AbbVie appearing as the named defendant in the vast majority of the remaining cases. Nearly 8,000 total cases have been involved in the MDL.
The MDL plaintiffs have brought products liability claims involving allegations that AbbVie had engaged in so-called “off-label” marketing of its AndroGel testosterone-boosting drug, pushing doctors to subscribe the medication to men who were experiencing normal, age-related declines in their testosterone levels, increasing those patients’ risk of serious health impacts, including cardiovascular events such as a heart attack.
“Off-label” marketing involves promoting a prescription medication for uses for which it has not received Food and Drug Administration (FDA) approval, a practice that is illegal under US law.
In addition to the thousands of patient lawsuits, AbbVie also faces investor lawsuits related to the alleged illicit marketing scheme, TheLawFirm.com previously reported.
Source:
United States District Court for the Northern District of Illinois. (Last Accessed 20 March 2019). Member Cases. MDL 2545 In re Testosterone Replacement Therapy Products Liability Litigation
Androgel Lawsuit Update: Court Tosses Insurance Company Lawsuit in AndroGel MDL
March 7, 2019
Author: Daniel Gala
In a lengthy opinion and order posted to the court’s website March 5, the judge overseeing multidistrict litigation (MDL) involving so-called testosterone replacement therapy (TRT) products, including AbbVie’s AndroGel, tossed out the remaining claims brought by an insurance company alleging that it had suffered economic losses “as a result of defendants’ fraudulent marketing schemes.”
Medical Mutual of Ohio, an Ohio mutual insurance company, originally sued multiple makers of TRT drugs, claiming “it suffered economic injuries when, as a result of defendants’ fraudulent marketing schemes, it made reimbursement payments for what it alleges were medically inappropriate TRT prescriptions,” according to the court’s order.
The court previously had dismissed several other claims brought by Medical Mutual of Ohio, allowing only claims under the federal RICO Act and Ohio’s laws against negligent misrepresentation to stand. In the order entered February 14, 2019 by District Judge Matthew F. Kennelly, those remaining claims were dismissed, as well.
The court also had rejected, in July 2018, a motion by the insurance company requesting that the court “certify a putative class of third-party payors (TPPs) asserting these same claims.”
The TRT MDL presently making its way through the Eastern Division of the Northern District of Illinois, mostly involves “thousands of individual plaintiffs [who] have filed personal injury lawsuits against manufacturers, promoters, and sellers of testosterone replacement therapy (TRT) drugs.” Further, “individual plaintiffs allege that defendants’ TRT drugs caused them to suffer serious cardiovascular and venous thromboembolic injuries.”
At issue are allegations that the makers and distributors of TRT products, including AbbVie with its popular AndroGel medication, fraudulently marketing their products for off-label uses, meaning uses for which the drug had not received approval by the United States Food and Drug Administration (FDA). It is illegal under US law for companies to market their prescription drug products for uses that have not been approved by the FDA.
Specifically, plaintiffs claim that AndroGel was being pushed on patients suffering from normal, age-related declines in testosterone levels, greatly increasing those patients’ likelihood of experiencing a serious cardiovascular event, such as a heart attack.
Of the 7,878 individual cases to have been included in the MDL, over 5,700 remain open as of March 7, according to a review of member cases listed on the court’s website [https://www.ilnd.uscourts.gov/mdl-details.aspx?UGlDS1bLxpRHyfdf3l5DJQ==]. However, these cases appear to be making their way toward resolution, albeit slowly, with the court showing that nearly 50 cases have been closed in March 2019 alone.
Sources:
Case Management Order No. 146 (Memorandum Opinion and Order on Defendants’ Motion for Summary Judgment in Med Mutual of Ohio v. AbbVie Inc., No. 14 C 8857). (Entered 14 February 2019; Posted 5 March 2019). MDL No. 2545. Case No. 14 C 8857. United States District Court for the Northern District of Illinois Eastern Division
Member Cases. (Last Updated 5 March 2019). MDL No. 2545. Case No. 14 C 8857. United States District Court for the Northern District of Illinois Eastern Division
Androgel Lawsuit Update: Investor Lawsuit Accuses AbbVie of Off-Label AndroGel Marketing Scheme That Harmed Patients and Shareholders
February 28, 2019
Author: Daniel Gala
Two AbbVie Inc. investors have sued the pharmaceutical company alleging an off-label marketing scheme that potentially harmed both patients and shareholders, Law360 reported February 26.
“[I]nstead of issuing proper warnings and providing accurate information about AndroGel’s risks and benefits, AbbVie aggressively marketed the drug for off-label and fabricated uses that targeted otherwise healthy men or, even worse, men with pre-existing conditions where the threat of adverse events when taking AndroGel actually increased,” the lawsuit alleges.
Off-label marketing, which is forbidden under US Food and Drug Administration (FDA) rules, involves promoting the use of a drug for conditions for which it has not obtained FDA approval. In the case of AndroGel and other prescription testosterone supplements, the makers stand accused of encouraging doctors to prescribe the drugs for unapproved uses such as age-related fatigue and erectile dysfunction.
In the process, the plaintiffs claim, AbbVie not only caused serious injury to some takers of AndroGel, it also exposed the company to potentially hundreds of millions of dollars in financial liability, which in turn could hurt shareholders. The complaint, filed in Delaware Chancery Court on February 25, seeks the production of AbbVie’s internal records related to the marketing of AndroGel.
AbbVie continues to face thousands of active lawsuits in the United States alone filed by patients claiming they suffered harm by taking AndroGel. Since 2014, federal products liability lawsuits against the makers of so-called testosterone-replacement products have been consolidated as multidistrict litigation (MDL) in the Northern District of Illinois. The MDL has contained a total of 7,872 individual cases, approximately 5,700 of which remain open, according the court website’s list of member cases.
In November 2018, AbbVie reportedly entered into an agreement to settle the remaining lawsuits, though the terms, including the amount of financial compensation, if any, have not been disclosed publicly.
The investor lawsuit seeks access to information about this settlement agreement, which some observers suspect could feature a payout totaling in the hundreds of millions of dollars, as well as communications among AbbVie board members about marketing plans for the drug. The complaint allege that these documents may contain evidence that the company’s directors have violated their fiduciary duties to investors by engaging in the illicit off-label marketing schemes.
Sources:
Sullivan, V. (26 February 2019). AbbVie Investors Want Records On Testosterone Marketing. Law360
Member Cases. (Last accessed 27 February 2019). MDL 2545. In Re: Testosterone Replacement Therapy Products Liability Litigation. United States District Court for the Northern District of Illinois
Androgel Lawsuit Update: AndroGel Maker AbbVie Discloses $350m Litigation Loss Contingency in SEC Filing
February 28, 2019
Author: Daniel Gala
Pharmaceutical giant AbbVie Inc., maker of testosterone-replacement therapy (TRT) AndroGel, has set aside $350 million in loss contingency provisions for litigation-related expenses, the company revealed in its annual report to the United States Securities and Exchange Commission (SEC), filed February 27.
While the loss contingency provision is meant to cover all of AbbVie’s potential legal exposure, including “product liability, intellectual property, commercial, securities and other matters that arise in the normal course of business”, the $350 million figure represents perhaps the best information presently available regarding the financial terms of the confidential master settlement agreement AbbVie reportedly reached with AndroGel plaintiffs in November 2018.
At least two investors have sued AbbVie seeking information about the terms of the secret settlement agreement and an alleged off-label marketing scheme that purportedly involved the company’s promoting AndroGel for uses for which it had not obtained FDA approval. The shareholder plaintiffs claim that the alleged scheme potentially exposed the company to hundreds of millions of dollars in liability, meaning that a large percentage of the $350 million loss contingency could be earmarked for AndroGel cases.
According to AbbVie’s disclosures, it continues to face approximately 4,000 federal AndroGel products liability cases, which since 2014 have been consolidated as multidistrict litigation (MDL) in the Northern District of Illinois. AbbVie reports that it faces an additional 200 state-court lawsuits, as well.
“In November 2018, AbbVie entered into a Master Settlement Agreement with the Plaintiffs’ Steering Committee in the MDL encompassing all existing claims in all courts,” the company reported without disclosing any terms of the agreement. “All proceedings in pending cases are effectively stayed, including post-trial proceedings in cases that had been tried to verdict with appellate rights reserved.”
The $350 million loss contingency provision means that, in the company’s best estimation, it stands to pay out $350 million over its present legal liabilities. Exactly how much of that accounts for the AndroGel master settlement remains a mystery, for now.
Stay tuned to TheLawFirm.com for the latest developments in AndroGel litigation.
Sources:
Abbvie Inc. (Filed 27 February 2019). Legal Proceedings and Contingencies. Commitments and Contingencies Disclosure. Form 10-K for the 12 Months Ended Dec. 31, 2018
Androgel Lawsuit Update: Despite Reports of Tentative Settlement, Thousands of Cases Remain in AndroGel MDL
February 9, 2019
Author: Daniel Gala
Nine more cases involved in multidistrict litigation (MDL) over testosterone replacement therapy products including AbbVie’s AndroGel were closed February 6, 2019, according to the court’s list of member cases.
These cases join dozens more that have closed since the beginning of 2019, following reports last fall that a tentative agreement had been reached to settle the MDL’s remaining suits . However, despite the slew of recently closed cases, the member case list still named thousands of active cases in the long-running MDL, which dates back to 2014.
AbbVie and its subsidiary companies Abbott Laboratories, Solvay Pharmaceuticals Inc., and Unimed Pharmaceuticals LLC were the last defendants remaining when they tentatively reached a deal with plaintiffs on a confidential global settlement last fall, Law360 reported in September 2018=.
At the time, the judge overseeing the MDL ordered a pause in all cases pending against AbbVie and its subsidiaries. Terms of the tentative settlement have not been disclosed publicly.
The MDL’s bellwether trials over AndroGel have yielded mixed results. In the first two bellwether trials, juries returned verdicts for the plaintiffs, each awarding over $100 million in damages. However, both of those verdicts were later overturned with the cases subject to retrial, one of which again resulted in a verdict for the plaintiff, but this time with damages of only $3 million.
The MDL, taking place in the Northern District of Illinois, has involved over 7,800 cases against defendants including Endo Pharmaceuticals; Actavis, Inc.; Auxilium Pharmaceuticals Inc.; and Lilly USA, Inc., in addition to AbbVie and its subsidiaries.
Sources:
Member Cases. In Re: Testosterone Replacement Therapy Products Liability Litigation. MDL 2545. 8 February 2019
Wood, L. (10 September 2018). AbbVie Strikes Tentative Deal In Testosterone MDL. Law360
Androgel Lawsuit Update: Setback for Plaintiffs in Androgel lawsuit
January 29, 2018
In a setback for plaintiffs seeking to hold pharmaceutical company AbbVie Inc. accountable for serious health conditions allegedly caused by its drug AndroGel, a federal jury in Illinois found the company not liable for the blood clot that developed in a man’s lung while taking the drug. The case was the third bellwether trial in Multidistrict Litigation (MDL) involving accusations that patients and doctors were inadequately warned about the potential harms of taking AngroGel, and it is the first complete-defense victory for the drug company, which was found liable on at least some of the alleged grounds in two previous trials.
The case involved plaintiff Robert Nolte, who developed a pulmonary embolism after beginning to take AndroGel at the age of 72 in an effort to boost low testosterone levels. Attorneys for Nolte alleged that the plaintiff specifically inquired about the drug to his doctor after seeing advertisements promoting AndroGel’s ability to return vitality to the lives of men Nolte’s age. Nolte’s attorneys further allege that AbbVie engaged in such a marketing campaign without adequately studying the potential health effects of AngroGel on patients Nolte’s age.
Plaintiff attorney Keith Mitnick of Morgan & Morgan PA argued before the jury that AbbVie entered this lucrative market without conducting the proper clinical trials for that specific demographic, off which it earned approximately $5.6 billion in AndroGel sales between 2000 and 2012, according to Mitni.
“They skipped that entire step,” Mitnik contended, according to Law360, referring to appropriate clinical trials for people Nolte’s age. “They preyed on an aging man’s natural desire to have his vitality back.”
In response, lawyers for the pharmaceutical company argued that the connection between Nolte’s pulmonary blood clot and his use of AndroGel was tenuous, pointing out that Nolte previously had suffered from a blood clot prior his taking AndroGel and that Nolte was not taking doctor-recommended blood thinners during the time at which he developed his subsequent blood clot.
In the end, the Illinois jury decided against the plaintiff and for the drug company in the third bellwether verdict to come down in the AndroGel MDL. In the first trial, a jury found in July 2017 that AbbVie was not liable for the plaintiff’s injuries in that case but did order the company to pay $150 million in punitive damages for making false representations about the drug in its marketing campaign (The $150 million decision was vacated in December 2017, with a retrial scheduled to begin in March 2018). The second trial concluded in October 2017 with the jury finding AbbVie liable for a heart attack suffered by a patient while taking AndroGel. In that case, the jury awarded $140 million in damages.
Despite this latest setback for plaintiffs in the AndroGel MDL bellwether trials, TheLawFirm.com believes that the outcome in this instance had more to do with the facts of the individual case than with AbbVie’s overall culpability in aggressively marketing AndroGel for uses and to a demographic for which it had not been appropriately vetted.
TheLawFirm.com will continue to monitor the latest developments in the AbbVie AndroGel MDL, so check back regularly for the most up-to-date news on this fast-changing area of litigation.
Androgel Lawsuit Update: Former FDA Chief Says AndroGel Ads Were Misleading
July 26, 2019
Former U.S. Food and Drug Administration (FDA) commissioner David Kessler told a jury in Illinois that the ads released by drugmaker AbbVie for its topical testosterone replacement drug AndroGel were misleading. The ads, Kessler said, promoted the drug for uses beyond those for which the FDA had granted it approval.
AbbVie’s ads for AndroGel promised that the drug could help in the treatment of symptoms that are a natural part of the make aging process, even though it had only been approved for the treatment of certain, specific conditions.
Kessler testified on behalf of plaintiff Jesse Mitchell, who blames AndroGel for causing the heart attack that he suffered in 2014. Mitchell says that he was misled into taking AndroGel by ads that promised that the drug could help with fatigue, depression, and a diminished libido. Mitchell also alleges that the drug’s warning label was insufficient, in that it did not mention that AndroGel could cause heart problems – a fact, he alleges, that AbbVie knew about but concealed.
The Chicago trial is the first case to be heard in a highly publicized Multi-District Litigation (MDL) trial over the health risks and corporate liabilities connected with such topical testosterone replacement drugs as AndroGel.
The trial is ongoing in Illinois federal court.
If you’ve suffered heart problems as a result of using testosterone replacement drugs like AndroGel, contact the expert attorneys at TheLawFirm.com. We can help you.
Androgel Lawsuit Update: AbbVie Ordered to Pay $150 Million for False AndroGel
July 24, 2018
A federal jury in Illinois has ruled that pharmaceutical manufacturer AbbVie must pay $150 million in punitive damages for advertisements that made false claims about its topical testosterone replacement therapy drug AndroGel.
In a trial brought by plaintiff Jesse Mitchell, who had alleged that his 2012 heart attack was caused by AndroGel, the jury found AbbVie not guilty of negligence, but guilty of fraudulent misrepresentation. Mitchell had argued that AbbVie had falsely promoted AndroGel to users for whom the drug was not medically appropriate.
The jury awarded no compensatory damages to Mitchell.
The decision is the first in a Multi-District Litigation (MDL) that collects thousands of lawsuits over the alleged heart attack and other health risks linked to AndroGel.
Several other cases in the MDL have yet to be tried.
If you think your heart attack might have been caused by AndroGel or other topical testosterone replacement therapy medications, you may be entitled to significant financial compensation. Contact the expert attorneys at TheLawFirm.com right away.
Androgel Lawsuit Update: AbbVie Claims FDA Never Requested Study of AndroGel Heart Attack Risk
July 20, 2018
In a setback for plaintiffs seeking to hold pharmaceutical company AbbVie Inc. accountable for serious health conditions allegedly caused by its drug AndroGel, a federal jury in Illinois found the company not liable for the blood clot that developed in a man’s lung while taking the drug. The case was the third bellwether trial in Multidistrict Litigation (MDL) involving accusations that patients and doctors were inadequately warned about the potential harms of taking AngroGel, and it is the first complete-defense victory for the drug company, which was found liable on at least some of the alleged grounds in two previous trials.
The case involved plaintiff Robert Nolte, who developed a pulmonary embolism after beginning to take AndroGel at the age of 72 in an effort to boost low testosterone levels. Attorneys for Nolte alleged that the plaintiff specifically inquired about the drug to his doctor after seeing advertisements promoting AndroGel’s ability to return vitality to the lives of men Nolte’s age. Nolte’s attorneys further allege that AbbVie engaged in such a marketing campaign without adequately studying the potential health effects of AngroGel on patients Nolte’s age.
Plaintiff attorney Keith Mitnick of Morgan & Morgan PA argued before the jury that AbbVie entered this lucrative market without conducting the proper clinical trials for that specific demographic, off which it earned approximately $5.6 billion in AndroGel sales between 2000 and 2012, according to Mitni.
“They skipped that entire step,” Mitnik contended, according to Law360, referring to appropriate clinical trials for people Nolte’s age. “They preyed on an aging man’s natural desire to have his vitality back.”
In response, lawyers for the pharmaceutical company argued that the connection between Nolte’s pulmonary blood clot and his use of AndroGel was tenuous, pointing out that Nolte previously had suffered from a blood clot prior his taking AndroGel and that Nolte was not taking doctor-recommended blood thinners during the time at which he developed his subsequent blood clot.
In the end, the Illinois jury decided against the plaintiff and for the drug company in the third bellwether verdict to come down in the AndroGel MDL. In the first trial, a jury found in July 2017 that AbbVie was not liable for the plaintiff’s injuries in that case but did order the company to pay $150 million in punitive damages for making false representations about the drug in its marketing campaign (The $150 million decision was vacated in December 2017, with a retrial scheduled to begin in March 2018). The second trial concluded in October 2017 with the jury finding AbbVie liable for a heart attack suffered by a patient while taking AndroGel. In that case, the jury awarded $140 million in damages.
Despite this latest setback for plaintiffs in the AndroGel MDL bellwether trials, TheLawFirm.com believes that the outcome in this instance had more to do with the facts of the individual case than with AbbVie’s overall culpability in aggressively marketing AndroGel for uses and to a demographic for which it had not been appropriately vetted.
TheLawFirm.com will continue to monitor the latest developments in the AbbVie AndroGel MDL, so check back regularly for the most up-to-date news on this fast-changing area of litigation.
Androgel Lawsuit Update: Doctor Testifies about AndroGel’s Heart Attack Risks
July 14, 2018
Northwestern University cardiologist Dr. Hossein Ardehali testified in a Chicago federal courtroom that there is enough evidence to suggest a link between testosterone replacement therapy drugs and an increased heart attack risk.
Dr. Ardehali testified as an expert witness on behalf of plaintiff Jesse Mitchell, who alleges that AndroGel, a topical testosterone replacement therapy drug manufactured by AbbVie, caused the heart attack that he suffered in 2012. Also central to Mitchell’s case are his allegations that AbbVie did not test the drug satisfactorily, and that it encouraged its use in men for whom testosterone replacement was not medically appropriate.
Mitchell’s case is the first of more than 4000 cases filed against AbbVie over AndroGel in a Multi-District Litigation (MDL) legal action.
Dr. Ardehali, in his testimony, likened the hazardous side effects of AndroGel in men to those suffered by women who had undergone estrogen therapy. Estrogen therapy has been implicated in increased risks of stroke, breast cancer, and heart disease.
The trial is ongoing in Chicago.
If you have suffered health problems as a result of dangerous or misprescribed drugs, the attorneys at TheLawFirm.com want to hear from you. Contact us for your free consultation.
Androgel Lawsuit Update: AndroGel Maker AbbVie Denies Drug’s Heart Attack Connection
July 10, 2018
In an ongoing trial in Chicago, major drugmaker AbbVie asserted that no clinical studies exist that demonstrate a direct connection between its topical testosterone replacement drug AndroGel and an increased risk of heart attacks.
The central issue in the trial is whether AbbVie has falsely and potentially injuriously downplayed or covered up health risks that are alleged to be linked with AndroGel. Those alleged risks include heart attack and pulmonary embolism.
The drug manufacturer asserted that it was not obligated to inform doctors or patients of a heart attack risk if no studies have suggested such a risk. Jesse Mitchell, the plaintiff in the case, disagrees. Mitchell used AndroGel for several years, until suffering a heart attack in 2012. Mitchell and his doctors believe that AndroGel was the cause of the heart attack. He filed suit in 2013.
AndroGel drew the attention of the U.S. Food and Drug Administration (FDA) in 2014, when several studies suggested that the potential connection between AndroGel topical testosterone therapy medication and heart attacks merited further investigation.
Legal and medical experts are watching closely the AndroGel trial, which has the potential to establish a precedent in cases involving this controversial drug.
If your health has been jeopardized by Big Pharma’s quest for profits, contact TheLawFirm.com to learn how we can help you.
Androgel Lawsuit Update: Plaintiff Tells Jury of AbbVie’s Failure to Label AndroGel
July 7, 2018
The plaintiff in a federal case in Illinois informed jurors that he nearly died after using the topical testosterone replacement drug AndroGel that had been insufficiently labeled for hazards.
Further, lawyers for plaintiff Jesse Mitchell alleged, AndroGel’s maker, AbbVie, was fully aware that its product was dangerous, but the company downplayed the product’s risks so that it could turn a larger profit.
Mitchell alleged that AbbVie ignored multiple warnings from the U.S. Food and Drug Administration (FDA) that AndroGel should be labeled to indicate that it had not been approved for the treatment of anything other than a specific set of hypogonadism conditions. AbbVie, the plaintiff alleged, promoted AndroGel as a broad-spectrum treatment, thus increasing health risks to users.
Topical testosterone replacement therapy drugs such as AndroGel have been linked to the risk of heart attacks.
Mitchell’s case is the second in a Multi-District Litigation (MDL) testosterone replacement drug case to be heard in court. The first case, heard in June 2017, ended in a mistrial.
Mitchell had been prescribed AndroGel in 2007 when tests showed that his levels of testosterone were low. After using the cream for some five years, Mitchell had a heart attack at the age of 44. In the suit, he alleges that AndroGel is to blame, in part because the product should have been labeled to indicate that it was not appropriate for use by men of his age.
AbbVie’s marketing campaign for AndroGel, the suit alleges, made no reference to patients’ age, though that factor is significant in determining the product’s efficacy.
The trial is ongoing in a Chicago courtroom.
If you believe that your health problems are the result of improperly prescribed or inadequately labeled prescription drugs such as testosterone replacement therapy medications, contact your doctor right away.
Then, contact the expert attorneys at TheLawFirm.com.
Androgel Lawsuit Update: AbbVie Faces Litigation about Testosterone-Replacement
June 7, 2018
An Illinois federal jury has begun hearing a case in which the plaintiff alleges that Androgel, a testosterone-replacement drug manufactured by pharmaceutical giant AbbVie, deliberately misled doctors and patients about the drug’s side effects.
In what is known as a “bellwether trial” in a Multi-District Litigation (MDL) case, Jeffrey Konrad’s suit claims that Androgel was responsible for the heart attack he suffered in 2010, and that AbbVie is culpable for failing to inform doctors of the drug’s potential to increase heart attack risk.
The suit alleges that AbbVie used unfair and aggressive marketing practices to convince doctors that Androgel was safe, even though the company was aware that its use posed significant health risks.
Androgel revolutionized testosterone-replacement treatment. Prior to its introduction, such drugs were administered by injection. Androgel is a topical cream.
Other cases in the MDL accuse AbbVie of concealing the fact that Androgel carries with it an increased risk of blood clots and pulmonary embolism, as well.
The verdicts in bellwether MDL trials often set legal precedents, and can play a significant role in determining the path of litigation in similar cases.
If you think you’ve been the victim of the unfair practices of Big Pharma, contact the attorneys at TheLawFirm.com. We can help you.
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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