PJC Blog

Dan Meyer - Senior Associate

Yesterday the Supreme Court heard arguments in a case involving a woman who was given a pharmaceutical treatment that resulted in a significant adverse event. While I spend less time thinking about drugs than medical devices, the case, its coverage in the media and a discussion at the most recent Dartmouth Device Development Symposium (3D) got me thinking about another Supreme Court case decided earlier in the year, Riegel v. Medtronic, which has significant implications for innovation in the device industry.

The essence of the Riegel decision was that a company cannot be sued in state court for harm caused by a medical device provided that it was approved under a PMA process and was manufactured and marketed under FDA guidelines. In other words, the Court held that challenges to the safety and efficacy of such devices are "preempted." The decision was 8-1 (on a court not terribly well known for 8-1 decisions). So why would someone concerned with the prospects for medical device innovation still be thinking about this case? As it turns out, members of congress are apparently drafting legislation that would preempt preemption—and limit medical device innovation.

A few things about the case and preemption issues:

PMA vs. 510(k). Most medical devices are either approved under a PMA process or are given 510(k) “clearance” to be marketed. The PMA requirements are usually far more onerous than the 510(k) process because PMA devices generally present higher risks to the patient. Approved PMA devices are typically required to complete a variety of tests, culminating in randomized clinical trials that are typically large and expensive. Before approving a PMA device, the FDA assembles a group of clinical experts to review the data and make recommendations to the FDA. When approved, devices are given an intended use, which is specified in the device labeling.

Off-label use. The case involved a procedure in which an angioplasty catheter burst. The catheter was being used “off-label,” which is to say that it had not been approved for this type of procedure. The physician made a decision that this off-label use of the balloon was in the best interest of the patient even though the company had not studied its use (or sought approval) in these lesions.

Preemption. When the Medical Device Amendments of 1976 were written, a provision was explicitly included that provided FDA preemption for products approved under a PMA process. That essentially means that parties cannot sue in state court for injury caused by a device by saying that the device is not safe if the FDA has determined that the device meets a reasonable level of safety relative to its intended use. It is explicit preemption because it was actually written into the law.

This explicit preemption covers a relatively small number of medical products in our system: only medical devices approved under a PMA process and only PMA devices being manufactured and sold in compliance with FDA regulation. The case did not address devices cleared for marketing under a 510(k) process (the vast majority of medical devices), devices not in compliance with FDA requirements, or devices in development / in use under an IDE (this last point is a whole other issue). And in no way did it address pharmaceuticals.

Drastically changing the rules on explicit preemption (as apparently being considered by some in Congress) has a number of implications for medical device innovation. The highly technical data-intensive and often clinically nuanced information now reviewed and analyzed by the FDA and highly-specialized review committees would be reviewed by state regulatory bodies, courts, and juries lacking specific expertise. Medical device manufacturers would face the prospect of extreme and expensive liability determined by unspecialized factfinders.

The increased risk that states and courts would focus on a single event (instead of a body of evidence) would render a portion of PMA devices unfundable in early stages of development. PMA devices are difficult enough to fund at early stages. This increased potential cost to early stage companies and tort exposure to companies that acquire them could tip the scales against medical device innovation…and against the patients who would benefit from new treatments.

(Note: Preemption does not stop a patient from seeking remedy from a doctor or hospital for an error. Although medical malpractice cases are commonly cited as a corollary to medical device product liability cases, there is an important distinction: malpractice cases typically deal with single patient cases, and are generally focused on the clinical care decisions that are made in individual instances. Preemption and product liability deals with the approval, safety, efficacy and labeling of a device. These are fundamental differences.)