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Thursday, June 20, 2024 | Back issues
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Pfizer to Face Testosterone Claims After All

CHICAGO (CN) - A federal judge overturned a ruling blocking more than 2,500 patients from pursuing claims that testosterone replacement drugs made by Pfizer and others cause serious cardiovascular problems.

The U.S. Food and Drug Administration (FDA) approved the drugs for treating hypogonadism, the diminished functional activity of the gonads, including lessened production of testosterone, according to the plaintiffs in the case.

But the manufacturers - Actavis, Watson Laboratories, Pfizer, Pharmacia & Upjohn Co. and Auxilium Pharmaceuticals - marketed their drugs for a different condition, known popularly as "Low T," which they fail to alleviate, medication users claim.

Plus, the drugs - Depo-Testosterone and Testopel - have allegedly caused users to suffer serious cardiovascular problems, for which the manufacturers did not provide adequate warnings.

Since neither drug was the "pioneer," they are both "generic" and were approved via the abbreviated new drug application process based on their equivalence to a previously approved "reference-listed drug," according to court records.

The multidistrict master complaint asserted 10 primary state law claims, including strict liability based on design defect and failure to warn, negligence, breach of implied and express warranty, fraud, consumer protection, and unjust enrichment.

The plaintiffs also allege non-tort claims for wrongful death, survival, loss of consortium, and punitive damages.

U.S. District Judge Matthew Kennelly dismissed all claims and awarded the drug makers judgment on the pleadings last November, finding that all the state-law claims were preempted.

The medication users then asked the Northern Illinois Federal Court to reconsider its denial of their request for discovery and to clarify whether it intended to dismiss all their claims, including the fraud allegations.

Kennelly partially granted the motion Monday.

"Defendants' obligations under state fraud law to refrain from falsely promoting their drugs for unapproved uses do not conflict with their obligations under federal law to maintain their warning labels," Kennelly wrote. "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 under Mensing or Bartlett."

The judge later added, "Even if defendants' 'off-label' advertising and promotion would be considered 'labeling' under FDA regulations, this would not change the fact that defendants could refrain from engaging in their allegedly false promotion of their drugs for off-label uses without violating their federal duty to maintain the 'sameness' of their labeling. That is, nothing in the approved warning labels for defendants' drugs requires them to promote those drugs for unapproved off-label uses."

Medication users' claims for fraud, consumer protection, unjust enrichment, wrongful death, survival, loss of consortium, and punitive damages based on off-label promotion are not preempted to the extent that they are based on allegations of fraudulent off-label promotion, the March 7 ruling states.

But the judge refused to order additional discovery to determine whether the FDA said manufacturers of generic reference-listed drugs could change their warning labels unilaterally.

"The court might find this argument more persuasive if there were a basis to believe that the FDA had actually taken a position contrary to the one it took in its 2013 statements," Kennelly wrote. "But the reasons plaintiffs offer for this proposition amount to little more than speculation."

The plaintiffs' co-lead counsel, Ron Johnson with Schachter, Hendy & Johnson in Fort Wright, Ky., said the ruling "will give victims the right to hold pharmaceutical giants responsible for prioritizing company profits over their own safety and the safety of consumers across the country," according to a press release issued by public relations firm BerlinRosen.

Pfizer spokeswoman Neha Wadhwa said the firm is "pleased" with the ruling.

Kennelly's "most recent order only allows a narrow set of plaintiffs' claims to move forward at this time," Wadhwa said in an email. "Pfizer believes that those claims lack merit, and we will continue to vigorously defend against these lawsuits going forward."

The other drug makers did not return emailed requests for comment on Wednesday.

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