Drug Company Not Allowed To Hide Behind FDA--Baby Boy's Cancer Linked To Novartis Pharmaceutical's Elidel

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US District Court ruling allows parents of cancer victim to proceed in their litigation against Elidel manufacturer Novartis Pharmaceuticals. Novartis' Motion to Dismiss was denied after their argument that FDA labeling regulations prevented their notification of physicians and patients was deemed to be invalid. This landmark decision will have lasting impact on product and drug liability cases throughout the United States where the case relies upon a manufacturer's failure to notify of potential dangers.

A Federal Court in Pennsylvania preserved victims' rights and denied a drug manufacturer's request to allow it to hide behind the FDA. The court ruled that an injured person's claims against Novartis Pharmaceutical for the company's failure to warn of the dangers of its drug were not barred simply because the FDA allowed the drug to be sold.

The case, Perry v Novartis (Andrea Perry, et al. v Novartis Pharmaceutical Corp., et al., Civil Action No. 05-5350, US District Court for the Eastern District of Pennsylvania), required the Court to determine if the plaintiffs' claims that Novartis failed to warn of dangers was allowed under state law or whether the claim was blocked by FDA regulations. The Court accepted briefs from all parties and requested a brief from the FDA concerning the application of its statutes for labeling and warnings.

The Perrys' lawsuit claims Novartis knew about a link between its eczema treatment, Elidel (pimecrolimus), and cancer in babies. The Perrys' two-year-old son was prescribed Elidel and, within six months, the boy developed lymphoma.

Novartis argued the claim for the child's cancer was preempted or barred by FDA labeling requirements. Even though the FDA failed to require a warning about the link between Elidel and cancer, the Perrys' claim that since the company knew there was a link they should have warned about it.    

In the Court's decision, Judge Stewart Dalzell found, "The FDA has made clear that warnings other than labeling changes, such as letters to health care professionals, are permissible and the labeling regulations do not bar them." (See 44 Fed. Reg. 37434, 37447 (quoted supra)).

Judge Dalzell further found that, "The availability of state law tort suits provides an important backstop to the federal regulatory scheme. It is...difficult to believe that Congress would...remove all means of judicial recourse for those injured by illegal conduct."

Cory Rosenbaum of Rosenbaum Faria, LLP, a Manhattan-based law firm that represents people against pharmaceutical companies, stated, "Maybe this decision will finally stop drug companies from hiding the information they have and then hiding behind the FDA when they get caught selling drugs that hurt people. Judge Dalzell's decision should have lasting effects for many victims of bad drugs and bad medical devices."

Memorandum and Order by Judge Stewart Dalzell, October 16, 2006.

Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq.


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Cherie Yannone
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