Driving On Both Sides Of The Road: Supreme Court Hears Bartlett Oral Argument
The Supreme Court heard oral argument yesterday in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The Supreme Court will determine what most thought seemed already decided by PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011): whether design defect claims against generic drug manufacturers are preempted by federal law, and whether manufacturers can be held liable when their only other option is to withdraw from the market.
BARTLETT'S HISTORY
The plaintiff, Karen Bartlett, was prescribed generic sulindac for shoulder pain and developed Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), which left her permanently injured and disfigured. Bartlett, 678 F.3d at 34. By the time of trial, the only remaining claim for the jury to decide was whether sulindac was defectively designed. Id. The jury found in Bartlett's favor and awarded her $21.06 million in compensatory damages. Id.
On appeal to the First Circuit, Mutual argued that design defect claims against generic companies are preempted by federal requirements that generic drugs be the "same" as brand-name drugs in all material respects. Id. at 37. Mutual pointed to Mensing and its holding that the "sameness" provisions make it impossible for generic manufacturers to comply with federal labeling requirements and stricter state law requirements arising from failure to warn claims. Id. But the First Circuit did not accept Mutual's argument, affirming the jury verdict because Mutual "certainly can choose not to make the drug at all . . . ." Id. The First Circuit's decision marked a departure from the string of cases previously rejecting such a duty to recall. See, e.g., Lance v. Wyeth, 4 A.3d 160 (Pa. Super. Ct. 2010); Moore v. Mylan, Inc., 840 F. Supp. 2d 1337, 1352 n.14 (N.D. Ga. 2012); Coney v. Mylan Pharms., Inc., No. 6:11-cv-35, 2012 WL 170143, at *5 (S.D. Ga. Jan. 19, 2012); In re Fosamax Prods. Liab. Litig. (No. II), MDL 2243, 2011 WL 5903623, at *6 n.5 (D.N.J. Nov. 21, 2011).
In December 2012, the Supreme Court granted Mutual's certiorari petition. The Solicitor General of the United States filed an amicus brief representing the FDA, arguing that "duty to recall" claims should be rejected regardless of whether the drug in question is generic or branded because evaluation of the overall risks and benefits of a drug go to the core purpose of the FDA, and the FDA should be the final arbiter of whether a drug stays on the market. The Solicitor General also requested time to argue on behalf of the FDA as amicus curiae.
ORAL ARGUMENT
During the one-hour oral argument, the justices actively questioned all counsel involved. The Court probed deeply on two main points: first, whether design defect claims can be independent, rather than based on failure to warn; and second, why this case...
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