Allergan Agrees to Androderm Testosterone Lawsuit Settlement

Fact-Checked

Editors carefully fact-check all Drugwatch content for accuracy and quality.

Drugwatch has a stringent fact-checking process. It starts with our strict sourcing guidelines.

We only gather information from credible sources. This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts.

businessman signing settlement document

Court documents show that Allergan has finalized a settlement to end hundreds of testosterone lawsuits. The suits claimed the company’s Androderm testosterone replacement drug caused serious injuries. More than 500 people sued the company.

Actavis originally manufactured Androderm and is named in lawsuits over the product. Allergan acquired the company in 2015.

An Illinois federal court document dated July 26, 2018, revealed the agreement. The parties have not disclosed details of the settlement. A previous filing in June announced a tentative settlement was in the works.

The Androderm lawsuits are part of a multidistrict litigation (MDL). MDLs combine several similar lawsuits into a single action. They can move lawsuits through the legal process more efficiently. The testosterone therapy MDL includes several companies and their testosterone products.

Lawsuits claim people suffered serious testosterone therapy side effects. These include heart attack, stroke and death. The lawsuits accuse companies of marketing the drugs for off-label uses. Those are treatments the U.S. Food and Drug Administration has not approved a drug to treat.

Suffering from complications related to testosterone therapy? Get a Free Case Review

The FDA approved testosterone replacement therapy to treat hypogonadism. That’s a condition in which the body fails to produce enough hormones. Lawsuits claim companies marketed the drugs to boost men’s sex drive or normal signs of aging.

In 2015, the FDA cautioned against using testosterone products to treat low testosterone due to aging. It also required manufacturers to add label warnings related to heart attack and stroke risks.

Allergan was supposed to face a trial in the MDL on August 6. The court canceled it after the settlement announcement this week.

The case was a bellwether trial. Bellwethers can test legal arguments for both sides. They can sometimes lead people to drop lawsuits. Or they can help shape settlements.

People have filed more than 25,000 testosterone lawsuits in recent years. Almost 6,000 were pending in the Illinois MDL as of July 16, 2018.

Six AndroGel lawsuits have gone to trial. Two trials resulted in verdicts of $140 million and $150 million. The court overturned both. A second trial reduced the second verdict to $3.2 million. AbbVie won the next four bellwether trials.

Eli Lilly announced it would settle about 400 Axiron lawsuits in December 2017.

In June 2018, Endo International announced a $200 million tentative settlement. That agreement affected 1,300 Testim lawsuits. Endo subsidiary Auxilium Pharmaceuticals manufactures Testim. GlaxoSmithKline co-promoted the drug in the U.S.

  •  
  •  
  •  
Terry Turner
Written By Terry Turner Writer

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

  • American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • Original works published or cited in Washington Examiner, MedPage Today and The New York Times
  • Appeared as an expert panelist on hernia mesh lawsuits on the BBC
Edited By

14 Cited Research Articles

  1. U.S. Dist. Court, Northern District of Illinois, Eastern Division. (2018, July 26). In Re: Testosterone Replacement Therapy Products Liability Litigation, et al; Notification of Docket Entry. Retrieved from http://www.pacer.gov
  2. U.S. Judicial Panel on Multidistrict Litigation. (2018, July 16). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-July-16-2018.pdf
  3. United States District Court Northern District of Illinois Eastern Division. (2018, June 29). In Re Testosterone Replacement Therapy Products Liability Litigation. Case 1:14 cv 1748. Documents 2767. Case Management Order No. 128 (Stay of Cases Involving Claims Against Actavis Defendants). Retrieved from http://www.pacer.gov
  4. U.S. District Court for the Northern District of Illinois. (2018, April 19). Testosterone Replacement Therapy Products Liability Litigation. MDL No. 2545. Case No. 1:14cv-01748. Case Management Order 114. Retrieved from http://www.pacer.gov
  5. U.S. District Court for the Northern District of Illinois. (2018, June 13). Testosterone Replacement Therapy Products Liability Litigation. Case 1:14-cv-1085 Document # 69. Plaintiff’s Rule 59 Motion for a New Trial. Retrieved http://www.pacer.gov
  6. U.S. District Court for the Northern District of Illinois. (2018, February 6). In Re: Testosterone Replacement Therapy Products Liability Litigation. Notification of Docket Entry. Retrieved from http://www.pacer.gov
  7. U.S. District Court for the Northern District of Illinois. (2018, February 23). In Re: Testosterone Replacement Therapy Products Liability Litigation. Case Management Order 98. (Stay of Endo, Auxilium & GSK cases). Retrieved from http://www.pacer.gov
  8. U.S. District Court for the Northern District of Illinois. (2018, February 24). In Re: Testosterone Replacement Therapy Products Liability Litigation. Case Management Order 99. (Scope of new trial in Mitchell v. AbbVie.). Retrieved from http://www.pacer.gov
  9. U.S. District Court for the Northern District of Illinois. (n.d.). MDL 2545. Member Cases. Retrieved from http://www.ilnd.uscourts.gov/mdl-details.aspx?UGlDS1bLxpRHyfdf3l5DJQ==#collapse_2545_5
  10. Feeley J. et al. (2018, February 23). Endo, Glaxo to Settle Suits over Testosterone-Replacement Drugs. Retrieved https://www.bloomberg.com/news/articles/2018-02-23/endo-glaxo-to-settle-suits-over-testosterone-replacement-drugs
  11. U.S. Food and Drug Administration. (2018, February 26). 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. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm436259.htm
  12. U.S. District Court for the Northern District of Illinois. (2015, November 24). Third Amended Master Long-Form Complaint and Jury Demand. Retrieved from https://www.casewatch.org/civil/low_t/third-amended-master-complaint.pdf
  13. GSK. (2012, May 21). Auxilium Pharmaceuticals, Inc. and GlaxoSmithKline LLC enter into a co-promotion agreement for Testim in the U.S. Retrieved https://us.gsk.com/en-us/media/press-releases/2012/auxilium-pharmaceuticals-inc-and-glaxosmithkline-llc-enter-into-a-co-promotion-agreement-for-testim-in-the-us/
  14. U.S. District Court for the Northern District of Illinois. (2015, March 30). Testosterone Replacement Therapy Products Liability Litigation. MDL No. 2545. Case No. 1:14cv-01748. Master Short Form Complaint for Robert and Sherrie Rowley. Retrieved from http://www.pacer.gov
View All Sources
Call to speak with a legal expert
Who Am I Calling?

Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.

Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.

(844) 277-7079