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Breaking News – Branded Design Defect Preemption

By Eric Alexander on October 15, 2014
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From the time that the Supreme Court handed down its decision in Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), we have been declaring that design defect claims against branded drugs should also be preempted.  See, e.g., here, here, here, and here.

We now have a decision that has done just that. Booker v. Johnson & Johnson, No. 3:12 oe 40000, slip op. (N.D. Ohio. Oct. 10, 2014). Booker is from the Ortho Evra MDL, which has produced many good partial summary judgment decisions.  In some, we have noted that design defect claims were left standing after motions for judgment on the pleadings while other claims fell to summary judgment.  Booker got a second bite at the apple with a motion for summary judgment on design defect and some other lingering claims and raised directly the issue of whether a state law (Georgia, in this case) claim for design defect for a branded drug was preempted under Bartlett.  In the first such decision we know about, it was:  “The Court, having carefully read Mutual Pharmaceutical Co., concludes that it was impossible for Defendants to comply with both its state-law obligation to alter the drug’s composition, and its federal-law duty not to do so.”  This is so good that we will ignore the grammar glitches.  There is nothing about the basic fact pattern here that should limit the logic of this ruling to a minority of drugs or states.  It also should not be terribly surprising that the decision came from this judge, who issued the first published decision excluding evidence under Buckman, Bouchard v. American Home Prods. Corp., 213 F. Supp. 2d 802, 811 (N.D. Ohio 2002), and whose former Chief Judge held design defect claims for a branded drug preempted four years before Bartlett in Longs v. Wyeth, 621 F. Supp. 2d 504, 508-09 (N.D. Ohio 2009), reversed in part sub nom. Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010).  We are happy to spread the word on Booker, hope it gets published, and hope that other courts follow its path.

Photo of Eric Alexander Eric Alexander
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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    Drug & Device Law
  • Organization:
    Drug & Device Law Blogging Team
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