Eli Lilly Says Distributor of Axiron Testosterone Product Can’t be Sued Over Cardiovascular Risks May 14, 2014
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SAN FRANCISCO — The manufacturer of prescription testosterone Axiron has removed a lawsuit filed against it to federal court in California, arguing that a drug distributor and co-defendant was fraudulently joined to the case because it assumed no duty to warn of alleged cardiovascular risks associated with the product.
Eli Lilly and Co. argues in its May 12 notice that none of the allegations in the lawsuit point directly to distributor McKesson Corp.’s liability for the deep vein thrombosis that afflicted plaintiff John Nagel after he used Axiron gel for more than a year.
As a result, the Indiana-based drug maker says that McKesson’s ties to California can be disregarded for the purpose of establishing jurisdiction and the case belongs in federal court, rather than the San Francisco Superior Court where it was filed on May 8. Nagel is a resident of Texas.
Neither defendant has been served yet with Nagel’s lawsuit, a circumstance that Eli Lilly says permits removal without McKesson’s consent. Both, however, are accused by Nagel of conspiring to fraudulently convey false and misleading information concerning the safety and efficacy of prescription testosterone, while at the same time initiating a campaign to create a low-testosterone disease epidemic through a calculated marketing effort that has vaulted sales of testosterone replacement therapies into the billions of dollars.
The complaint cites recent studies in medical journals linking prescription testosterone to an increased risk of a variety of cardiovascular injuries, including deep vein thrombosis, which Nagel was diagnosed with in May 2012. Nagel was 55 years old when he was prescribed Axiron and used the product for approximately one year to treat symptoms his healthcare providers attributed to low testosterone, the lawsuit says. Nagel also contends that his diagnosis was the result of the defendants’ efforts to artificially inflate the prevalence of low testosterone among the aging male population.
According to the lawsuit, Nagel’s prescribing physicians may not have prescribed Axiron had they been provided with appropriate and adequate warnings regarding the risks associated with the product.
“Defendants knowingly, purposely and deliberately failed to adequately warn Plaintiff, patients, consumers, medical providers and the public of the increased risk of serious injury associated with using Axiron, including but not limited to death, cardiovascular events, stroke, and thrombotic events,” the complaint says.
In its notice of removal to the U.S. District Court for the Northern District of California, Eli Lilly says that Nagel’s lawsuit fails to meet minimum pleading requirements to state a claim against McKesson based on its role as a distributor of Axiron. While the complaint alleges a failure to warn of the risks associated with the use of Axiron, notably absent are any specific allegations that McKesson made any specific representations or warranties to the plaintiffs or Nagel’s prescribing physicians or that they relied in any way on such representations or warranties.
“Plaintiffs cannot cure this deficiency by simply relying on allegations directed toward ‘Defendants’ alone,” the removal notice states.
Even if such claims were alleged, McKesson bears no duty to warn under California law because the learned intermediary doctrine only requires that a warning about risks associated with a prescription drug be communicated by the manufacturer to the physician, and then from the physician to the patient, Eli Lilly argues.
Additionally, any general allegations that the defendants knew of the alleged risks associated with Axiron are particularly deficient because the wholly conclusory claims are undermined and contradicted by more specific allegations surrounding Eli Lilly’s concealment and misrepresentation of the same information, the notice concludes.
“The allegations of Lilly’s purported concealment and misrepresentation of the alleged risks of Axiron belie any inference that McKesson, a wholesale distributor, had knowledge of that which was allegedly concealed,” drug maker contends.
Eli Lilly is represented by David E. Stanley, Janet H. Kwuon and Eric J. Buhr of Reed Smith in Los Angeles.
Nagel is represented by Eric H. Gibbs, Amy M. Zeman and Phyra M. McCandless of Girard Gibbs in San Francisco, Michael Danko and Kristine K. Meredith of Danko Meredith in Redwood City, Calif., and Norman E. Siegel and Todd E. Hilton of Stueve Siegel Hanson in Kansas City, Mo.
Nagel v. Eli Lilly and Co., et al., No. 14-2179 (N.D. Calif.).
Document Is Available Search www.harrismartin.com or Call (800) 496-4319 Removal Notice and Complaint Ref# TES-1406-09
Associated Law Firms Danko Meredith Girard Gibbs Reed Smith Stueve Siegel Hanson Associated Documents Removal Notice and Complaint
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