• New Jersey Case to Watch: District Of New Jersey Recognizes Federal Preemption Of Manufacturing Defect Claims Involving So-Called "Lemons"
  • May 7, 2010 | Authors: Charlsa D. "Sandy" Broadus; Martin Magnusson
  • Law Firm: Day Pitney LLP - Hartford Office
  • Last month, in Banner v. Cyberonics, Inc., No. 08-0741 (RBK/KMW), 2010 U.S. Dist. LEXIS 9393 (D.N.J. Feb. 4, 2010), the District of New Jersey preempted plaintiffs' claims alleging a manufacturing anomaly against the manufacturer of an FDA-approved Class III medical device.

    Citing plaintiffs' assertions that Cyberonics produced a "lemon," id. at *7, the Banner court granted summary judgment in favor of Cyberonics, noting that "[t]he FDA approves the process by which a Class III device is manufactured, but it does not guarantee that every device manufactured in that process will work." Id. at 9-10. Indeed, the court explicitly acknowledged that "it is distinctly possible that the FDA-approved process introduces a margin of error wherein a properly manufactured device may nevertheless depart from its intended design." Id.

    The court cited the United States Supreme Court's seminal preemption ruling in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and also relied on Hughes v. Boston Scientific Corp., No. 2:08cv79KS-MTP, 2009 U.S. Dist. LEXIS 105835 (S.D. Miss. Nov. 12, 2009) and Wolicki-Gables v. Arrow Int'l, Inc., 641 F. Supp. 2d 1270, 1285 (M.D. Fla. 2009) in holding that "if the FDA approves a manufacturing process and the defendant-manufacturer conforms with it, a device thereby produced that nevertheless does not function as intended does not give rise to liability." Banner, 2010 U.S. Dist. LEXIS 9393, at *10 (emphasis added).