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Federal Law Preempts Plaintiff’s Claim Against Generic Drug Manufacturer
(December 2011) By Colleen K. O'Brien, Associate
For more information, contact Paul
Farquharson.
Grinage v. Mylan Pharmaceuticals, Inc.,
No. CCB-11-1436 (D. Md., December 30, 2011) |
View pdf
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.
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