Testosterone Off-Label Marketing Lawsuit
(LawyersAndSettlements.com) — Attorneys are seeing an increase in claims from men using low-T treatments or testosterone therapy. This increase is mainly due to aggressive direct-to-consumer advertising by the manufacturers of testosterone supplements and drugs. Doctors are prescribing testosterone treatment off-label to help men fight their natural decline in testosterone as they age and allegedly build muscle mass, strengthen bone density and improve sex drive. Off-label marketing of testosterone supplements and drugs is illegal.
Testosterone manufacturers such as AbbVie aggressively market its testosterone drug by telling men the following: "If you're bored, stressed or aging normally, you probably have Low T symptoms: grumpiness, less energy, lower libido and "falling asleep after dinner." These "symptoms"are also associated with the natural process of aging.
In 2000 the FDA told AbbVie that "claims and representation that suggest that AndroGel is indicated for men with 'age-associated' hypogonadism or 'andropause' are misleading."The agency said that AndroGel was only approved for men with hypogonadism—a condition in which the body doesn't produce enough testosterone.
In 2003 a lawsuit was filed against Solvay Pharmaceuticals Inc. (which was later bought by Abbott Laboratories) alleging False Claims Act violations, The whistleblower suit ( King et al. v. Solvay SA et al., case number 4:06-cv-02662, in the U.S. District Court for the Southern District of Texas) claims that off-label promotion resulted in millions of dollars worth of false claims submitted to government health care plans by pharmacies who filled the prescriptions of the drugs.
Further, in order to boost sales, Solvay allegedly conspired with doctors to prescribe off-label uses of the drugs and paid unlawful kickbacks to doctors who prescribed the drugs in the form of "bogus speaker and research fees, resort weekends, cash payments, or Harley-Davidson goods".
The lawsuit includes a leaked document by Solvay discussing the need to expand the testosterone market by 36.5 percent, according to a McClatchy Newspapers article. According to the article, Solvay talked about pushing the drug to primary care physicians, described as "easily influenced." A 2004 memo on AndroGel sales strategies said the sales force was putting extra emphasis on rural areas, since "rural doctors are typically very accessible, give us plenty of time to teach them the right way to diagnose and treat, and they have the patients."
A further document that was disclosed in a lawsuit against Solvay, then the maker of Androgel, discussed a need to expand the testosterone market by 36.5 percent, according to a McClatchy Newspapers article.
AbbVie, Inc., in response to the study, said that testosterone treatments are approved by the FDA, and the risks are listed. As noted above, the FDA has only approved testosterone drugs to men who have been diagnosed with low testosterone levels.
According to Abbott, AndroGel annual US sales are more than $600 million.
Testosterone therapy studies raise concerns about testosterone supplements that men should discuss with their doctors. Health professionals advise that patients should not discontinue testosterone treatment without first consulting their physician.
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