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Lawsuits Over Testosterone Generic Drugs Survive Pre-emption for Fraudulent Off-Label Marketing

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The U.S. District Judge presiding over all testosterone drug lawsuits has affirmed a prior decision that failure to warn claims involving use of generic products are pre-empted by federal law, but will allow cases involving allegations of fraudulent off-label marketing to continue forward.

There are currently nearly 3,500 Androgel lawsuits, Axiron lawsuits, Testim lawsuits, Androderm lawsuits and complaints involving other testosterone replacement drugs, each involving similar allegations that the drug makers failed to adequately warn about the potentially increased risk of users suffering a heart attack, stroke, pulmonary embolism, deep vein thrombosis or other cardiovascular injury.

Given similar claims raised against various different drug makers, all federal litigation over the side effects of testosterone replacement drugs are centralized for pretrial proceedings before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, as part of a federal MDL, or multidistrict litigation.

In November, Judge Kennelly issued an order dismissing all failure to warn claims over testosterone generic drugs, such as Depo-Testosterone, Testopel and other equivalents on the market. The judge determined that the failure to warn claims involving generic drugs are pre-empted by federal law, which requires generic manufactures to provide the same warning label as the name-brand version.

The ruling stems from a controversial 2011 U.S. Supreme Court ruling known as Pliva v. Mensing, which has essentially provided generic drug makers with immunity from failure to warn lawsuits, after the court found that it is impossible for manufacturers to comply with FDA limitations on independent label changes and plaintiff’s claims that they should have provided stronger warnings.

Following that order, plaintiffs asked Judge Kennelly to reconsider or clarify the order, arguing that they should be entitled to discovery from the generic manufacturers about prior independent label changes before the ruling is finalized, and maintaining that they should still be permitted to pursue claims that generic drug companies engaged in illegal marketing of testosterone treatments for uses not approved by the FDA.

In a memorandum opinion and order (PDF) issued on March 7, Judge Kennelly confirmed that plaintiffs are pre-empted from pursuing generic testosterone drug failure to warn claims and denied the request for additional discovery into the issue, but said that they can continue with claims for fraudulent off-label marketing.

“Though neither the Seventh Circuit nor any other circuit court has addressed whether fraud claims against manufacturers of generic drugs based on off-label promotion are preempted under Mensing, other district courts have ruled that such fraud-based claims are viable, and the Court finds their reasoning persuasive,” the judge ruled. “Because the fraud-based claims based on off-label promotion do not make it impossible to comply with both state and federal law, those claims are not preempted…”

As a result of the order, Depo-Testoserone lawsuits, Testopel lawsuits and other generic testosterone drug lawsuits will proceed, at least with part of the claims intact.

Testosterone Drug Lawsuits

Although testosterone drugs were originally introduced as a “niche” treatment for men suffering from testosterone insufficiency caused by hypogonadism or other medical conditions, amid aggressive “off-label” marketing by drug makers, the products have ballooned into a $2 billion industry, commonly prescribed for lifestyle reasons to increase stamina, sex drive or energy among aging men.

Litigation over the testosterone heart risks has emerged since November 2013, when a study published in the Journal of the American Medical Association (JAMA) found that certain men who began taking testosterone drugs may be more likely to suffer a heart attack, stroke or sudden death.

That study was followed by additional research published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.

In January 2015, another study published in the medical journal Pharmacotherapy found that first time testosterone users may be 40% more likely to have a heart attack when compared to men who did not use the drugs.

In response to the concerns, the FDA announced a warning label update for testosterone therapy in March 2015, indicating that new information would be added about the evidence of a link between testosterone drugs and heart problems. In addition, the agency encouraged doctors not to prescribe drugs for natural drops in testosterone associated with aging.

As part of the MDL proceedings before Judge Kennelly, a small group of testosterone injury lawsuits are currently being prepared for early trial dates. Known as bellwether cases, these trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of cases.

Following a series of bellwether trials in the MDL, if testosterone drug settlements are not reached by the drug manufacturers, hundreds of individual cases may be remanded back to U.S. District Courts throughout the country for individual trial dates.

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