By Kathleen Bianco, J.D.
Complete dismissal of a patient’s products liability-related claims against the manufacturer of an allegedly defective contraceptive device based on preemption under the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetics Act (FDC Act) was not warranted, according to a Missouri Court of Appeals. Upon review of the record, the appellate panel concluded that certain claims, alleging negligence, defective manufacturing, and negligent supplying of product for use, fell within the narrow exception to MDA preemption or raised questions of fact relating to the applicability of MDA preemption (Williams v. Bayer Corp., December 5, 2017, Ardini, E.).
The patient underwent a procedure to have a permanent female contraceptive device implanted in her fallopian tubes to prevent future pregnancies. About halfway through the procedure, the patient began experiencing severe abdominal pain and asked her doctor to stop the procedure. As a result of the abandonment of the procedure, only one of the two devices was inserted. Several months after surgery, the patient continued to experience pain and discomfort, leading her to request the removal of the device. An x-ray performed in preparation for the removal of the device revealed that the device had broken apart and perforated the patient’s uterine wall. Consequently, pieces of the device were left in the patient’s body.
Bayer HealthCare LLC, Bayer Essure Inc., and Bayer HealthCare Pharmaceuticals, Inc. (collectively, Bayer) manufactured, sold, distributed, and marketed the Essure® contraceptive device. Bayer also allegedly trained physicians how to use Essure and provided equipment related to implanting the device. The patient filed suit against the manufacturer asserting 14 state common-law claims for the negligent and defective manner in which the device was manufactured, designed, tested, labeled, marketed, advertised, and sold, based on the injuries she allegedly sustained as a result of having the device implanted.
The manufacturer sought dismissal of the claims, asserting that the claims were either expressly or impliedly preempted by the MDA’s requirement for premarket approval (PMA) of Class III medical devices. A state trial court agreed with the manufacturer and dismissed all of the patient’s claims, finding them preempted under federal law. The patient filed a timely appeal, in which she argued that the trial court erred in its conclusion that all of the claims were expressly or impliedly preempted by MDA.
MDA/FDC Act Preemption. Under the MDA, Congress created an express preemption provision which prohibits state tort lawsuits against manufacturers of Food and Drug Administration (FDA)-approved devices when the lawsuit seeks to impose new requirements that are additional to or different from the requirements imposed by the FDA. However, state-based lawsuits can proceed against the manufacturers of FDA-approved devices when the claims seek to impose parallel duties that are identical or narrower than those found in the FDC Act. However, these parallel claims may be subject to implied preemption.
Claims analysis. Upon a review of the facts, the appeals court found that the patient’s claims asserting violation of the Missouri Merchandising Practices Act; fraudulent misrepresentation; negligent misrepresentation; breach of express warranties; breach of implied warranty of merchantability; strict product liability failure to warn–off-label use; failure to warn–post-premarket approval risks; and res ipsa loquitur were preempted by federal law. The court held that as a conditionally approved, Class III medical device, the manufacture and design of the device were solely under the authority of the FDA. Because the patient did not assert an independent state statutory scheme by which relief could be granted on these claims, such claims were either expressly or impliedly preempted under federal regulations.
As to the remaining claims, the court reasoned that the patient had presented sufficient evidence demonstrating that the manufacturing defect claims and various other negligence-related claims fit into the narrowly drawn exception to preemption. The manufacturing defect claims dodged preemption because they alleged that the patient’s injuries were caused by defects arising from the manufacturer’s failure to following specific guidelines imposed by the FDA. Because the alleged violations were based on federal standards, the patient’s claims did not seek to enforce requirements that were "different from, or in addition to," those approved by the FDA.
Negligence per se. The negligence per se claim also survived because it did not set forth requirements that were "different from, or in addition to," those set by the MDA. It merely alleged that the manufacturer failed to adhere to the requirements of the MDA. Thus, the court concluded that the negligence per se claim stated a valid cause of action that was not expressly or impliedly preempted by federal law.
Supplying equipment for use. Finally, the court determined that the patient’s allegation that the manufacturer had negligently supplied defective surgical equipment to be used to implant the device was not preempted because a question of fact existed regarding whether the equipment was a component part of the device that had been subject to the approval of the FDA or ancillary surgical implements to assist in the insertion of the device which were not reviewed and approved by FDA. If the equipment was part of the PMA, than preemption would apply. Consequently, dismissal on this issue was not proper at this stage of the proceedings. Thus, the judgment of the trial court was affirmed in part and reversed and remanded in part.
The case is No. WD80238.
Attorneys: Christopher W. Dysart (The Dysart Law Firm, PC) for Jessica Williams. Erika L. Maley (Sidley Austin LLP) for Bayer Corp.
Companies: Bayer Corp.
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