U.S. District Court rules that Federal law and FDA Regulation Pre-empt State Law Claims

In Beatrice Grinage v. Mylan Pharmaceuticals, Inc., Civil No. CCB 11-1436 (D.Md. Dec. 30, 2011), the U.S. District Court for the District of Maryland dismissed plaintiff's lawsuit on the basis that federal law and FDA regulations pre-empted the plaintiff's state law claims for negligence, strict products liability, fraud and breach of implied warranty under Pliva, Inc., v. Mensing, 564 U.S. -----, 131 S. Ct. 2567 (2011), and that to the extent any such claims survived, plaintiff failed to state a claim under Iqbal or Twombly.

Ms. Grinage filed suit against Mylan Pharmaceuticals on behalf of her deceased husband, Aaron Grinage, in Maryland state court. Mylan removed the matter to the US District Court on the basis of diversity jurisdiction and then moved to dismiss pursuant to Mensing.

Mr. Grinage had been prescribed Allopurinol, which was manufactured by Mylan, in January 2008 to treat gout. After taking Allopurinol for approximately one month, he was diagnosed with Steven-Johnson Syndrome, a skin disease, and then Toxic Epidermal Necrolysis, a more severe skin reaction. In March 2008, Mr. Grinage suffered multi-system organ failure and died.

Allopurinol is a generic version of Zyloprim, a brand-name drug the FDA approved in 1966. Mylan argued that Allopurinol's warning label was identical to that of Zyloprim and clearly stated that the "most frequent adverse reaction to [the drug] is skin rash" and that "[s]kin reactions can be severe and sometimes fatal." Both labels report that the skin reactions of Steven-Johnson Syndrome and Toxic Epidermal Necrolysis are "probably causally related" to the ingestion of the drug. Grinage argued that Mylan knew or should have known that the risks of Steven-Johnson Syndrome and Toxic Epidermal Necrolysis were greater than the 1 percent referenced in the label and that Mylan was negligent in failing to report published articles and other evidence to the FDA, the brand-name manufacturer, health care providers and patients, such that Mr. Grinage's consumption of the product "caused unreasonably dangerous risks" and was "not safe or fit for its intended purpose."

Relying on Mensing, the Court noted that the statutory language and regulations related to the Drug Price Competition and Patent Term Restoration Act and the FDA's interpretation of these rules "require that the warning labels of a brand-name drug and its generic copy must always be the same." Mensing, 131 S. Ct. at 2574-75. Thus, "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, pursuant to the impossibility of pre-emption doctrine, federal law pre-empts any state law tort action that creates liability for generic manufacturers who fail to take independent action to change their labels." Id., 131 S. Ct. at 2577-81.

Plaintiff argued that Mensing's holding was narrowly tailored to specific failure to warn claims and that her claims survived pre-emption. However, the Court held otherwise and stated that plaintiff's complaint was insufficient under the pleadings standards of Iqbal and Twombly to state a claim not otherwise pre-empted. The Court also acknowledged that Plaintiff's claim might not have been dismissed if the prescription had been for Zyloprim instead of the generic Allopurinol, but that in this instance that Court was constrained by precedent and the FDA's regulations, unless and until Congress amended the governing statutes.