After two federal juries delivered $140 million verdicts against their competitor, another maker of a testosterone replacement therapy drug will be headed to trial over claims its product caused heart attacks in men who took the drug to treat “off-label” conditions, spurred by what plaintiffs alleged was misleading marketing from drugmakers.

On Oct. 23, U.S. District Judge Matthew F. Kennelly refused requests from defendant Auxilium Pharmaceuticals LLC for summary judgment in its favor, saying the drugmaker’s claims its labeling for its testosterone drug, Testim, was controlled by federal regulators don’t hold up and should not forestall a trial slated to begin Nov. 6.

In the same ruling, however, Kennelly granted summary judgment to Endo Pharmaceuticals Inc., which in 2015 acquired Auxilium. In this case, the judge said Endo, as successor to Auxilium’s business, should not be held liable for its affiliate’s legal problems in this case.

Since 2014, Auxilium and Endo have been among a group of pharmaceutical companies facing untold amounts of potential damages amid a massive nationwide class action involving thousands of plaintiffs, who have claimed testosterone replacement therapy drugs caused clotting issues and heart attacks, among other health problems. Other companies named as defendants in the actions include AbbVie, Besins, Eli Lilly and GlaxoSmithKline.

The lawsuits, which were filed in various courts across the country, were consolidated in Chicago federal court under Judge Kennelly.

The drugs at issue were all approved by the U.S. Food and Drug Administration to treat testosterone deficiency. However, plaintiffs alleged the drugmakers misled doctors and the public with marketing designed to lead people to believe the drugs could also be used to treat a wide variety of other conditions, including “andropause” or “low T,” an allegedly nonexistent condition invented by the drugmakers.

To test the claims and evidence in court, the judge and litigants selected several of the cases for so-called “bellwether” trials.

Two of the bellwethers went to trial earlier this year, against AbbVie over claims related to its testosterone replacement drug, Androgel. In each of those cases, juries found AbbVie could not be held liable for the plaintiffs’ heart attacks, but still said they believed AbbVie had intentionally misrepresented and concealed Androgel’s effects when marketing the drug.

Jurors ordered AbbVie to pay the plaintiffs $140-$150 million in punitive damages over the marketing claims. AbbVie has appealed the first verdict, saying it did not believe the law allowed for such punitive damages in cases like this.

However, Auxilium could face two more bellwether trials of its own, including one slated to begin in early November. In that case, plaintiff Steve Holtsclaw alleges his use of Testim to treat testosterone deficiency produced a clotting condition, which led to a heart attack. He alleges Auxilium should be held responsible for not properly labeling their product to warn of the cardiovascular injury risk.

In response, Auxilium argued it should not be held liable for the contents of the label, which was controlled by the FDA. Auxilium noted it had proposed changing the label in 2013 to warn of “embolism and thrombosis,” but that language was rejected by the FDA, which was seeking a more specific warning.

“Auxilium views the FDA’s response to its proposal as a clear indication that the FDA would have rejected an attempt by Auxilium at that time to strengthen the Testim warning label with respect to cardiovascular risk,” Kennelly wrote.

The judge, howevers, said he did not believe the FDA’s rejection was as clear an indication as Auxilium believes.

“The FDA did not say, for example, that any warning about cardiovascular risk would be inappropriate,” Judge Kennelly wrote. “… There is no clear evidence, for example, that the FDA would have rejected a proposal from Auxilium for a more specific warning addressing cardiovascular risk as opposed to a vague and general warning about the possibility of ‘embolism and thrombosis.’”

The judge also brushed aside assertions from Auxilium that the plaintiffs could not demonstrate Holtsclaw’s doctor relied on Auxilium’s marketing when prescribing Testim.

He noted the doctor’s “frequent contacts with Testim sales representatives and (the doctor’s) admission that he relies upon Auxilium for accurate information about Testim’s risks and benefits.”

“… The Court concludes that a reasonable jury could infer (the doctor) relied on Auxilium’s representation to form his belief that Testim was safe and effective for the treatment of age-related hypogonadism,” Kennelly wrote.

Holtsclaw is represented in the action by attorneys with the firms of Herman, Herman & Katz LLC , of New Orleans; Ross Feller Casey Llp, of Philadelphia; Burg, Simpson, Eldredge, Hersh & Jardine PC, of Englewood, Colo.; Pogust Braslow & Millrood LLC, of Conshohocken, Pa.; and McCorvey Law LLC, of Lafayette, La.

Endo and Auxilium are represented by attorneys with the firm of Arnold & Porter Kaye Scholer LLP, of New York and Chicago.

 

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