Brief Fact Summary. Patient brings common law claims against manufacturer of faulty medical device which was FDA pre-approved.
Synopsis of Rule of Law. Â State requirements are preempted under the MDA only to the extent that they are â€œdifferent from, or in addition toâ€ requirements imposed by federal law.
In general, a device is assigned to Class III if it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury.View Full Point of Law
Issue. Whether the preemption clause in the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA) bars common law claims challenging the safety and effectiveness of a medical device given premarket approved by the FDA?
Held. Yes, such claims are preempted.
Discussion. Justice Scalia] To close a gap in regulatory oversight, Congress passed the MDA which swept back state obligations and imposed a regime of detailed oversight with respect to new medical devices. Section 360k(a) of the MDA contains a preemption provision that provides â€œno State may establishâ€¦any requirement which is different from, or in addition to, any requirement applicable under [the MDA] to the device, and which relates to the safety and effectiveness of the deviceâ€¦â€ The Court also notes the rigorous process of FDA premarket approval.
Given that the MDA expressly preempts only state requirements â€œdifferent from, or in addition to, any requirement applicable to the deviceâ€, the issue is whether the Federal Government established requirements applicable to Defendant’s catheter, and if so, whether Plaintiff’s common law claims (strict liability, breach of implied warranty, negligence in design and warnings of the device) are based on NY requirements which are different from or in addition to the federal requirements.
Citing to Medtronic, Inc. v. Lohr, where no preemption was found for a claim against a device which had not received premarket approval (it was grandfathered in under the MDA), the Court notes that federal manufacturing and labeling requirements â€œapplicable across the board to almost all medical devicesâ€ did not preempt common law claims (i.e. such requirements were not specific to the device, but reflected entirely â€œgeneric concerns about device regulation generallyâ€).
Premarket approval imposes specific requirements, as the FDA may grant premarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness. Therefore, the Court found that the premarket approval process imposes federal â€œrequirementsâ€ on the devices so approved within the meaning of the statute. Citing to Lohr, the Court finds that a State’s â€œrequirementsâ€ include its common law duties, as it would make no sense if a State tort law could require higher safety but less effectiveness than a FDA model. In addition, a federal legislative (or even state) scheme is preferable to a common-law process applied by a jury, as such jury will only recognize costs of a more dangerous design and not be concerned with the benefits of happy patients it never sees in court.
Plaintiff attempts to argue that its common law claims are not requirements maintained with respect to devices. The provision says â€œany requirementâ€ however, and nothing in the provision suggests that the preemption state requirement must apply only to the relevant device, or only to medical devices and not to all products and all actions in general.
The MDA does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations because such duties â€œparallelâ€ and do not add to federal requirements.