Pfizer Dodges Claims Over Testosterone Drugs

CHICAGO (CN) - More than 2,500 patients cannot pursue claims Pfizer and others marketed testosterone replacement drugs that cause serious cardiovascular problems, a federal judge ruled.

The multidistrict litigation involves claims that Actavis, Watson Laboratories, Pfizer, Pharmacia & Upjohn Co., and Auxilium Pharmaceuticals promoted the use of their testosterone replacement treatments for a health issues they fail to alleviate.

Though the Food and Drug Administration approved such drugs for treating hypogonadism, the diminished functional activity of the gonads, including lessened production of testosterone, the defendants allegedly marketed their drugs for another condition, known popularly as "Low T."

The drugs, Depo-Testosterone and Testopel, do little to nothing to treat the condition, which is not a form of classical hypogonadism, the plaintiffs said.

Indeed, the plaintiffs claimed, the drugs have caused the plaintiffs to suffer serious cardiovascular problems, for which the manufacturers failed to provide adequate warnings.

While the drugs are sold under branded names, they are "generic" because neither was the pioneer drug, and therefore were approved via the abbreviated new drug application process based on their equivalence to a previously approved "reference-listed drug."

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

The defendants moved to dismiss all claims and for judgment on the pleadings, arguing that the state-law claims are preempted.

U.S. District Judge Matthew Kennelly in Chicago granted the motion Monday, tossing aside the plaintiffs' assertion that their state-law claims should stand because reference-listed drug holders can make unilateral changes to an ANDA's label, as the application is itself the drug.

"Every federal court to consider plaintiffs' argument has rejected it," Kennelly wrote.

The court brushed aside the plaintiffs' claim that a 2014 ruling by Sixth Circuit misinterpreted an FDA guidance to mean that ANDA reference-listed drug holders can never use the "changes being effected" process to make unilateral labeling changes, the ruling states.

The plaintiffs argued the FDA intended "to allow for the circumstance in which ANDA holders can make labeling changes: namely, when the ANDA holder is also the RLD holder," Kennelly wrote (emphasis in original). "As defendants argue, this is a strained reading."

The provision "provides the express circumstances under which ANDA holders can use the ["changes being effected"] process to make label changes," Kennelly added. "They can do so (1) to match the RLD labeling or (2) to respond to FDA's request to submit a labeling change. Under neither circumstance would the ANDA RLD holder be making a unilateral labeling change."

The judge also denied the plaintiffs' request for discovery.

"The court has concluded as a matter of law that federal law prohibits the ANDA defendants from unilaterally changing their drugs' warning labels," Kennelly wrote. "Additional facts about whether the ANDA defendants have attempted to make such unilateral changes would not alter that legal conclusion."

Pfizer said in a written statement that it is "pleased" with the ruling, "stands behind Depo-Testosterone as an important option for patients, and will continue to defend itself vigorously against these claims."

The drug "has been used safely and effectively for more than 60 years in the treatment of certain males with low testosterone," Pfizer added. "Depo-Testosterone's FDA-approved label has at all times provided physicians with accurate information regarding the medicine's benefits and potential risks."

The other parties did not immediately respond to a request for comment.

A federal judge in San Diego issued a similar ruling Monday, rejecting claims that Danish drugmaker Novo Nordisk failed to warn that its type 2 diabetes drugs increase the risk of pancreatic cancer.Headquartered in New York, Pfizer reported third-quarter 2015 revenues of $12.1 billion, having reportedly reaped $49.6 billion in 2014.

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