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E-Alert Case Updates

Federal Law Preempts Plaintiff’s Claim Against Generic Drug Manufacturer

Grinage v. Mylan Pharmaceuticals, Inc
No. CCB-11-1436 (D. Md., December 30, 2011)

by Colleen K. O’Brien, Associate
Semmes, Bowen & Semmes (

Plaintiff sued Mylan Pharmaceuticals, Inc. and its parent company Mylan, Inc. (collectively, “Mylan”) after her husband developed a fatal skin disease from taking Allopurinol, a Mylan manufactured-product. Allopurinol is a generic form of Zyloprim, a brand name drug approved by the FDA. Federal labeling laws require generic drugs to contain the same warnings as brand name drugs. Therefore, the warning label for Allopurinol was substantially identical to the warning label of Zyloprim. Both labels warned that skin reactions, sometimes fatal, could occur. The labels cited one study that found that 3% of patients had skin reactions, but they further noted that “with current usage, skin reactions have been observed less frequently than 1%.” Plaintiff alleged that Mylan knew or should have known that the risk of the skin diseases were greater than the 1% referenced on the label based on more recent studies. Therefore, Mylan was negligent in failing to report published articles and scientific evidence regarding same. The Complaint sounded in negligence, strict liability, fraud, and breach of implied warranty.

Mylan filed a Rule 12(b)(6) Motion to Dismiss for failure to state a claim, based on Pliva, Inc. v. Mensing, 564 U.S. ----, 131 S. Ct. 2567 (2011), which held plaintiffs’ state tort law claims were barred under the preemption doctrine. Specifically, it was impossible for the generic drug manufacturers to satisfy state products liability laws without violating FDA regulations that required generic drugs to have the same labels as their brand-name counterparts. Consequently, even if a generic manufacturer had new information about side effects, it could not change its label unless the brand-name manufacturer did so first, or unless the FDA instructed all manufacturers to do so. As a result, federal law preempted state tort law actions that would impose liability on generic manufacturers who failed to take independent action to change their labels.

The Court held that Plaintiff’s negligent warning, defective design, and breach of warranty claims failed under both Mensing (as to preemption), and Ashcroft v. Iqbal, -- U.S. --, 129 S. Ct. 1937, 1950 (2009) and Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007) (as to the failure to allege more than speculative claims). Moreover, Plaintiff’s fraud claim failed because Plaintiff failed to plead with particularity, as required under the heightened pleading standards required for such an allegation. Therefore, Hon. Catherine Blake granted the Motion to Dismiss and ordered that the case be closed.