The claims of a patient who alleged that he suffered injuries as a result of a defective prosthetic hip were preempted by the express-preemption provision of the Medical Device Amendments of 1976 (MDA) (Lederman v Howmedica Osteonics Corp., June 19, 2013, Moody, J). Furthermore, the patient failed to satisfy the limited exception for parallel claims, which requires the state and federal requirements to be “genuinely equivalent,” because he did not establish the necessary nexus between warning letters the FDA sent to the manufacturer in 2007, his device, and his injuries. The court dismissed the complaint without prejudice and granted the patient one more opportunity to state a claim.
Background. The patient, Paul Lederman, alleged that he was injured by a defective Stryker Trident artificial hip prosthesis that was designed, manufactured, and sold by Howmedica Osteonics Corp. He filed a one-count complaint against the manufacturer alleging negligent manufacturing. The manufacturer filed a motion to dismiss alleging that Lederman’s claim was expressly preempted by the MDA.
Preemption. The court noted that state-law claims against medical devices approved by the FDA through the premarket approval (PMA) process are preempted when they seek to impose requirements that “different from, or in addition to” the detailed federal oversight involved in PMA. An exception may apply for “parallel claims” in which the state law requirement matches the federal requirement. The patient attempted to state a parallel claim by alleging that the FDA sent the manufacturer warning letters in March and November 2007 regarding inspections of its manufacturing plants in Ireland and New Jersey. The court found, however, that the patient failed to allege the specific federal requirements applicable to his medical device that were identified in the warning letters, the violations of those requirements, and how those violations caused his injuries.
The case number is 8:13-cv-506-T-30AEP.
Attorneys: Matthew Erjavec (Matthew Erjavec, PA) for Lederman. Hildy M. Sastre (Shook, Hardy & Bacon, LLP) for Howmedica Osteonics Corp. and Stryker Orthopaedics Corp.
Companies: Howmedica Osteonics Corp.; Stryker Orthopaedics Corp.
MainStory: TopStory PreemptionNews MedicalDevicesNews FloridaNews
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