A federal judge has dismissed the state law counts in a massive lawsuit against eight manufacturers of testosterone replacement therapy drugs, agreeing with the defendants that the claims are preempted by federal law.

U.S. District Judge Matthew F. Kennelly ruled Monday in federal court in Chicago in the multi-district litigation involving more than 2,500 plaintiffs who have alleged they’ve suffered injuries from improper prescribing of the testosterone replacement drugs.

Prior to the defendants’ motion to dismiss the state claims, the plaintiffs had already voluntarily dropped all generic drug-related claims against defendants Actavis, Inc., Actavis Pharma, Inc., Actavis Laboratories UT, Inc. and Watson Laboratories, Inc., so the court’s ruling regarding generic drugs applies only to the other three defendants – Pfizer Inc., Pharmacia & Upjohn Company, LLC and Auxilium Pharmaceuticals, Inc.

According to court documents, the federal Food and Drug Administration has approved testosterone replacement therapy to treat hypogonadism, a condition marked by diminished function of the gonads. Hypogonadism can result in low or no testosterone production, but the lawsuit claims the defendants marketed their testosterone replacement drugs as treatment for a more generic condition known as “Low T,” which is not always caused by hypogonadism. The plaintiffs allege the drugs have little or no benefit to patients whose low testosterone levels are not caused by classical hypogonadism, but those patients still suffered cardiovascular side effects of which they were not properly warned.

The plaintiffs’ master complaint includes 10 state law claims, according to court documents. The claims allege design defects, failure to warn, negligence, negligent misrepresentation, breach of implied warranty, breach of express warranty, fraud, redhibition, consumer protection and unjust enrichment. The complaint also charges the defendants with wrongful death, survival and loss of consortium.

The question before the court was whether the state law claims are preempted by federal law. In their briefing, the court wrote, the parties “distilled the preemption issue down to a single question: whether federal law permits” the defendants to make unilateral changes to generic drugs’ warning labels. 

Federal law prohibits manufacturers from redesigning generic drugs or from labeling them differently than the original drug on which they are based. The only way the defendants could have avoided state law failure-to-warn or design defect claims would have been by violating federal law.

“[Defendants] argue that they could escape state law liability, under the failure-to-warn claims plaintiffs have asserted, only by strengthening their warning labels in violation of federal law or by leaving the marketplace altogether,” the court wrote in its opinion. “State law claims that place defendants in such a position are preempted.”

While they did not argue that the defendants were unable to redesign their drugs, the plaintiffs argued that the companies did have an avenue to strengthen their warning labels. Because “all of the plaintiffs’ claims ‘flow, to some extent’ from the … defendants alleged failure to provide adequate warnings,” the plaintiffs said the state law claims were not preempted.

The court agreed with the plaintiffs’ logic, but said there is no avenue to change the warning label under existing case law. Courts have previously established a generic drug manufacturer can only change its label to match an updated brand-name label or to comply with FDA instructions.

Pfizer and Pharmacia & Upjohn are represented in the action by DLA Piper, while Auxilium is represented by the firms of Morgan, Lewis & Bockius and Kaye Scholer.

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DLA Piper Morgan, Lewis and Bockius LLP

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