Eleventh Circuit bars preemption in medical device case.

In a ruling that fills some gaps left by the U.S. Supreme Court's 1996 Medtronic, Inc. v. Lohr decision, the Eleventh Circuit has found that state products liability claims involving defectively designed medical devices are not preempted by federal law.

Reversing a district court's decision, the Eleventh Circuit found that manufacturers of medical devices that have received premarket approval from the FDA can be sued for products liability. (Goodlin v. Medtronic, Inc., No. 97-5801 (11th Cir. Feb. 18, 1999), petition for reh'g filed Mar. 11, 1999.)

The Lohr ruling held that the Medical Device Amendments of 1976 (MDA) did not preempt tort claims where the devices were "substantially equivalent" to a device that was already on the market when Congress passed the MDA. (116 S. Ct. 2240 (1996).)

The Eleventh Circuit's decision is important to plaintiff lawyers handling medical device products liability cases in that jurisdiction because it clarifies that manufacturers of devices that received premarket approval are not immune from liability for injuries caused by their products.

Allison Zieve, a Public Citizen Litigation Group attorney who argued the appeal for plaintiff Lisa Goodlin, said the decision is significant.

"I don't think this one decision is going to stop the medical device companies from raising the preemption issue in courts in other circuits, but the Eleventh Circuit decision is very significant as the first post-Lohr federal circuit court decision really to come to grips with the reasoning of Lohr and ... to find no preemption in the premarket approval context."

In 1991, Goodlin was implanted with a pacemaker, including Medtronic's 4004/M lead, the wire that transmits the heart-beat-steadying electrical impulse from the pulse generator to the heart.

According to the Eleventh Circuit opinion, the lead was approved for use in February 1989, but sometime after Goodlin received the pacemaker, an FDA inspection revealed a "significant risk" that it would fail due to degradation of the polyurethane insulating material wrapped around the lead.

The FDA and Medtronic suggested that doctors consider removing the lead in pacemaker-dependent patients. Goodlin underwent open-heart surgery to have the lead removed, although surgeons subsequently found it showed no signs of failure.

Goodlin, who depends on the pacemaker to support her life, sued Medtronic in 1997, claiming negligent design and strict products liability under Florida common law. She sought damages for costs related to the second surgery.

Medtronic argued that because the FDA approved the safety and effectiveness of the device under the premarket approval process, the MDA's preemption provision, [sections] 360k(a), barred her state law claims. The district court agreed and granted summary judgment to Medtronic.

On appeal, Medtronic argued that the Food and Drug Administration's premarket approval for the pacemaker lead constituted a federal "requirement" that preempted state "requirements" imposed by the common law.

Rejecting Medtronic's argument, Senior Circuit Judge Phyllis Kravitch wrote, "The FDA's approval is clearly specific to the device under review, but because the approval itself neither reveals nor imposes any ascertainable substantive prerequisite for approval that we could compare to a purportedly conflicting state requirement, the approval itself does not fit within [sections] 360k(a)(1)'s demand for a specific federal requirement."

Kravitch went a step further, writing that even if the premarket approval process constituted a federal requirement, "We cannot accept that Congress intended to exempt the manufacturers of medical devices from tort liability for all devices subject to the [premarket approval process] on the scant evidence presented here."