Riegel v. Medtronic Is Bad Medicine

Pro: Preempting Lawsuits Diminishes Safety

by James Ronca, Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley

The Supreme Court’s recent decision in Riegel v. Medtronic grants medical device manufacturers immunity from lawsuits if a product has gone through the Food & Drug Administration’s pre-market approval process. The Court ruled the FDA was superior to a jury in determining the medical device manufacturer’s required safety guidelines. In doing so, the justices have allowed the sale of defective devices.

Plenty of evidence questions the FDA’s expertise. As reported recently in the New England Journal of Medicine, despite knowledge of dangerous defects of an implanted defibrillator lead—used to regulate the heartbeat—the FDA allowed these devices to remain on hospital shelves for months, until the manufacturer voluntarily recalled the product.

As a result, the defibrillator leads fractured in 665 patients, and five patients died. The products in question were approved by the FDA with no human clinical testing. This is just one example of a manufacturer repeatedly and knowingly selling potentially defective devices despite the FDA’s oversight.

Similar atrocities have occurred with prescription drugs. Historically, the FDA has allowed drugs onto the market in return for the manufacturer’s promise to do follow-up studies, regardless of evidence of serious side effects. For example, in 1993 the FDA approved the drug Traysol for use in heart operations, despite a link to kidney problems. No follow-up studies were done. In November, 2007, Traysol marketing was suspended for, among other things, the increased risk of kidney failure.

Often, effective studies never take place. The agency as a whole has failed to fulfill its obligations largely because of politics and a lack of sufficient funding and resources.

A jury trial in a civil lawsuit takes a more balanced approach to making the right decisions. Competent lawyers for both sides ask questions and present arguments. Highly credentialed experts on both sides explain the science. There are no “cozy” relationships or conflicts of interest, and the jury is independent.

The results of such trials would not subvert the FDA’s authority but rather act as an incentive for companies to provide safe products and promptly report problems. In the big picture, this is more effective for protecting the public from negligent conduct than the FDA’s regulations.

Con: Riegel Benefits the Manufacturers and the Public

by Richard Fama, Cozen O’Connor

The Riegel ruling has been hailed by many as a victory for medical device manufacturers only. Such a view ignores the benefits derived from the regulatory scheme governing FDA pre-market approval of medical devices that was established by the Medical Device Amendments of 1976 (MDA).

The medical device industry and the public enjoy a mutually beneficial relationship. The aging of our population has led to an increased demand for new high-tech medical aids. Today’s devices allow people to lead normal lives, when only a few years ago their survival would have been in doubt. Vice-President Dick Cheney’s ability to endure the rigors of public office, for example, is directly attributable to the implantable cardioverter defibrillator he received in 2001.

Device manufacturers, in turn, require profits for shareholders and to reinvest in new technologies. Subjecting device manufactures to different states’ laws—where junk science often rules—is not the means by which to further meet the needs of the public or manufacturers. State courts have failed to apply consistently the legal standards governing the admissibility of expert testimony at trial, hence we need a regulatory scheme that provides predictability to manufacturers, fosters innovation, and ensures the utmost in protection to the public. The MDA accomplishes just that.

And let’s not forget that the Riegel ruling applies only to medical devices that received “pre-market approval,” a rigorous process during which the FDA spends an average of 1,200 hours reviewing each application.

To ensure patient safety, manufacturers gather extensive clinical and preclinical data over many years at a cost of tens of millions of dollars. Once a device receives approval, the manufacturer is forbidden to make changes in the product’s design, labeling, or manufacturing process. Furthermore, manufacturers must inform the FDA of new clinical investigations and studies and incidents in which the device contributed to death or injury.

The stringent requirements of the MDA provide protection to the public while advancing innovation. The inability of a few plaintiffs to pursue state tort claims is a small price to pay for great strides in medicine.