Federal Judicial Panel Asked to Consolidate All Testosterone Lawsuits

As the number of lawsuits against manufacturers of testosterone replacement treatments continues to grow, two petitions to consolidate all testosterone cases before a single federal court have been filed with the Judicial Panel on Multidistrict Litigation.

• On March 28 a petition was filed to consolidate all AndroGel lawsuits. AndroGel is a testosterone replacement gel. If the petition is granted, all federal lawsuits against the manufacturer AbbVie claiming harms and losses caused by AndroGel would be transferred to the U.S. District Court of the Northern District of Illinois.

More than 30 AndroGel lawsuits are pending across the country, with the majority of them in Illinois’ Northern District, the petition says. Last week the Judicial Panel said it would hear oral arguments on the petition on May 29.

• On April 11, a separate petition was filed asking the panel to consolidate all lawsuits related to several testosterone treatments including AndroGel. The petition asks for all such lawsuits to be transferred to the U.S. District Court of the Eastern District of Louisiana.

The petition says that more than 50 lawsuits are pending across the country against the manufacturers of ten testosterone replacement products:

  • Gels: Androgel, Bio-T Gel, Testim
  • Topical solution: Axiron
  • Patch: AndroDerm
  • Spray: Foresta
  • Tablet: Striant
  • Injections: Delatestryl, Depo-Testosterone
  • Implant: Testopel

The panel has not yet responded to that petition.

The number of testosterone-related lawsuits has been multiplying since the Food and Drug Administration announced on Jan. 31 that it is investigating potential heart risks associated with testosterone drugs. The FDA made its announcement just two days after a research study was published which suggested that the use of testosterone replacement treatments and therapies increases the risk of heart attack, strokes and death in men over 65 and in younger men with pre-existing heart disease.

Accusations Against Manufacturers

In the various testosterone lawsuits, manufacturers are accused of:

• Failing to adequately research the risk of stroke or heart attack from testosterone therapies, especially among men with cardiovascular disease, high cholesterol, blocked arteries, diabetes, obesity and other prior heart problems.

• Marketing testosterone treatments for off-label purposes through direct-to-consumer advertising that attempts to persuade men to seek testosterone therapy even if they may not have Low T.

• Failing to warn patients of the risks of testosterone replacement treatments and therapies.

In a Pennsylvania lawsuit against the manufacturer of Testim, a testosterone gel, the petition claims that “Low T” is a “contrived and pharmaceutical industry-created and driven diagnosis” for something that is actually “a normal aspect of the natural aging process.”

Plaintiffs in that suit are Edwin and Eileen Rios, New Jersey. Edwin Rios, 67, had no history of cardiovascular problems before he began using Testim in May 2012, according to the lawsuit. In May 2013 he suffered a heart attack. Rios had previously been diagnosed with Type II diabetes.

• Plaintiff Kenneth Aurecchia filed a lawsuit in Illinois in February against AbbVie and Abbott Laboratories, the makers of AndroGel. Aurecchia suffered a heart attack after using AndroGel, although he had no previous history of heart problems, the lawsuit alleges.

Aurecchia’s petition accuses AbbVie and Abbott of “misrepresent[ing] that AndroGel is a safe and effective treatment for hypogonadism or ‘low testosterone,’ when in fact the drug causes serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.”

• John Peuler was a 61-year-old Louisiana man who died of a heart attack. His children have filed a suit against Auxilium, blaming Testim for the heart attack. According to their suit, filed in March, their father used Testim testosterone gel for about a year and had no history of heart problems before using the gel.

Ten Testosterone Treatments

Here is more information about the 10 testosterone replacement treatments and therapies which are targeted in the pending petitions for multidistrict litigation:

• AndroDerm, manufactured by Actavis, formerly Watson Pharmaceuticals. AndroDerm is a daily patch worn on the back, abdomen, thighs or arms. It was approved by the FDA in 1995.

• AndroGel, manufactured by AbbVie, formerly part of Abbott Laboratories. AndroGel is a gel applied daily to the skin of the shoulders and upper arms. IAt was approved by the FDA in 2000.

• Axiron, manufactured by Eli Lilly. Axiron is a topical solution applied to the armpits like a deodorant. It was approved by the FDA in 2010.

• Bio-T Gel, manufactured by GlaxoSmithKline. Bio-T is a daily gel approved by the FDA in 2012.

• Delatestryl, manufactured by Savient Pharmaceuticals. Delatestryl is injected into the buttock muscle every one to four weeks. It was approved by the FDA in 2003.

• Depo-Testosterone, manufactured by Pfizer. Depo-Testosterone, an injection, has been used for more than 30 years. The FDA approved a generic version in June 2013.

• Foresta, manufactured by Endo Pharmaceuticals. Forestra is a spray gel applied to the front and inner thighs daily. It was approved by the FDA in 2010.

• Striant, developed by Columbia Laboratories and purchased by Auxilium Pharmaceuticals in 2011. Striant is a tablet that releases testosterone into the mucous membranes of the mouth. It was approved by the FDA in 2003.

• Testim, manufactured by Auxilium. Testim is a gel applied to the shoulders daily. It was approved by the FDA in 2002.

• Testopel, manufactured by Slate Pharmaceuticals. Testopel is an implant placed under the skin for slow release of testosterone over a 3-6 month period. It was approved by the FDA in 2008.

For More Information

For more information, see “Testosterone Replacement Therapies, Testosterone Treatments” on this website.

If you or a loved one has received testosterone replacement treatment and have experienced harms or losses, including heart attack, stroke, infertility or death, you should learn about your legal rights. For a free consultation, contact Hasbrook & Hasbrook by telephone (866-416-4737), email (cth@hasbrooklaw.com) or use our website contact form: Contact Us.