A Take on the Radiology Community

Barbara G. Quakenbos, JD
Michael Schaff, JD

Where the Food and Drug Administration (FDA) gives pre-market approval to a medical device, should a consumer alleging harm from that device be automatically barred from asserting a state tort claim? In Riegel v Medtronic, the United States Supreme Court on February 20 definitively answered that question “yes.” The lone dissenting justice wrote a detailed opinion arguing that the lawsuit should be able to be maintained subject to a legal defense that the FDA had determined the safety of the device. In legal parlance, the Court found the state law claims preempted by federal law, specifically the Medical Device Amendments of 1976 or MDA.

The FDA’s Process as Described by the Court

The federal law that preempted the state tort claims, called the Medical Device Amendments of 1976, was adopted in the heyday of the Dalkon Shield litigation and was intended, according to the Court, to provide “a regime of detailed federal oversight.” The FDA judges risk from lowest (Class I, such as bandages and gloves) to medium (Class II, such as MRI and CT) to highest (Class III, such as replacement heart valves and pacemaker pulse generators). As one would expect, Class III devices face the most rigorous review from the FDA.

The Court was impressed by the rigor of pre-market approval for Class III devices. The FDA typically receives a multivolume application from the manufacturer, and full disclosure regarding its ingredients, components, and properties, along with the proposed labeling. The FDA is empowered to refer pre-market approval to outside experts and may request additional data from the manufacturer. According to the Court, the FDA spends an average of 1,200 hours reviewing each Class III medical device application. The FDA grants its pre-market approval if it finds “reasonable assurance” of the device’s “safety and effectiveness.” The probable benefit must outweigh the probable risks. Once it is approved, the manufacturer must report all known malfunctions, safety issues, etc.

In addition to granting approval, the FDA can deny approval or can condition approval on compliance with performance standards or impose sale and distribution restrictions. Any change in the device must be evaluated by the FDA in a supplemental pre-market approval application. The FDA can withdraw its pre-market approval if newly reported data shows that a device is unsafe or ineffective.

The Plaintiff’s Harm from a Pre-Approved Medical Device

Plaintiff Charles Riegel had a heart attack, and underwent an angioplasty procedure. His doctors inserted a balloon catheter (known as a PTCA catheter) into his coronary artery, which burst. He had emergency bypass surgery, suffered serious injury, and died several years later. The PTCA catheter received pre-market approval from the FDA in 1988 and supplemental pre-market approval in 1994. The manufacturer, Medtronic, no longer manufactures the device.

The Court seemed swayed by the fact that the catheter burst only upon its fifth inflation, which had inflated it to 10 atmospheres. The device’s label warned that it should not be inflated beyond 8 atmospheres. (The losing plaintiff argued that the force of the warning was diminished by test results showing inflation up to 13 atmospheres.)

The Court seemed convinced that the device was not defective per se, but rather only when its label warning was ignored.

The dissent contended that it is an open issue as to whether pre-market approval would effectively preempt a state law tort claim where “evidence of a medical device’s defect comes to light only after the device receives pre-market approval.”

Implications of the Decision

A consumer can still maintain a tort suit against a device manufacturer for a Class III device that received pre-market approval if they allege that the manufacturer violated the FDA regulations. A consumer can also maintain a tort suit if they can show that the state requirements under which suit is brought are “parallel” to (and not “different from or in addition to”) the federal requirements.

Because the rationale in Medtronic is so strongly dependent on the pre-market approval process, preemption should not deprive a consumer of a tort law remedy for any medical device that did not receive pre-market approval.

On a practical note, the Medtronic decision may increase pressure on the FDA to actually provide the rigorous review outlined by the Court, particularly improving its now not-very-rigorous postmarketing surveillance. The decision may put pressure on Congress to revise the preemption language in the MDA to clarify that state tort remedies may still be maintained. And finally, state legislatures may be pressured to make state tort requirements “parallel” with the MDA so that state tort remedies are not preempted.

Barbara G. Quackenbos, JD, and Michael Schaff, JD, practice in the area of health care litigation with Wilentz, Goldman & Spitzer PA, Woodbridge, NJ. For more information, contact .