Medical Devices/Federal Preemption

Brief - Does PMA approval trigger federal preemption of state lawsuits against a medical device supplier? - Haidak v. Collagen Corp., 67 F.Supp.2d 21 (D.Mass. 1999) and Weiland v. Telectronics Pacing Systems, Inc., 721 N.E.2d 1149 (Ill. 1999)

The Medical Device Amendments of 1976 (MDA) contains language that prevents the states from having different requirements for safety and labeling. Section 360k(a) of the MDA provides:

"[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." 21 U.S.C. s 360k(a) (1994).

In some cases, the courts have found that this preempts state tort law claims based on matters that are required by the FDA as part of its approval of the device. The MDA allows devices that are equivalent to already licensed devices or devices that were on the market prior to 1976 to be approved with little regulatory review under what is called the 510k process.  Since there is little review of 510k devices, and thus few FDA requirements, they do not raise preemption issues.  New device types undergo mandatory premarket approval (PMA), which is much more intrusive and results in close FDA scrutiny of the device, its manufacture, and its labeling.  (The FDA may also impose PMA review on devices that pose special risks.)  There are cases holding that the FDA sets requirements for devices receiving PMA review and thus torts suits should be preempted against these devices.

In Haidak v. Collagen Corp, the plaintiff sued the manufacturer of a cosmetic collagen injection for selling a defective product.  The manufacturer moved for summary judgment, relying on a previous appeals court decision on the same device.  In that case, the 1st circuit found that a lawsuit against the same manufacturer for the same product was preempted because it received extensive PMA review before being approved. Unfortunately for defendants in this case, the district court decided to follow the more recent Supreme Court case limiting preemption under the MDA, rather than the earlier case finding preemption.  While the cases are distinguishable because the Supreme Court case, Medtronic v. Lohr, 518 U.S. 470 (1996), dealt with a 510k device rather than a PMA device, the court found that since Medtronic v. Lohr did not specifically care out an exception for PMA devices, policy mitigates against extending preemption without specific Supreme Court approval.  The court refused defendant's request for summary judgment.

Weiland v. Telectronics Pacing Systems, Inc., involves cardiac pacemakers which received PMA review because they are Class III (dangerous) devices.  The court found that PMA review for pacemakers only approves or rejects the manufacturer's design - the FDA does not propose a design, and thus imposes no requirements on the final design of the device.  Thus, in this court's view, there is no preemption under the MDA unless the FDA actually specifics and approves the final device design.