Courts Split on Federal Preemption After FDA Approval

Sixty-nine-year-old Johnnie Lawrence had a cardiac pacemaker implanted in 2001. About eight months later, he died.

The administrator of his estate brought a lawsuit against the manufacturer, Biotronik, in the Circuit Court of Cook County contending that the device was improperly constructed and designed, thereby causing Lawrence’s death.

Biotronik removed the case to federal court, claiming that because the pacemaker underwent a pre-market approval (PMA) by the Food and Drug Administration, federal law preempted Lawrence’s state law claims. Lawrence v. Biotronik, Inc., N.D.Ill., (No. 04 C 1876, decided Aug. 19, 2004).

The Medical Devices Amendments (MDA), 21 U.S.C.S. 360k (1994), were enacted in 1976 to provide for the safety and effectiveness of medical devices. The U.S. Supreme Court recognized this important purpose in Medtronic, Inc. v. Lohr, 518 U.S. 470, 474 (1996); however, whether common law state tort claims against manufacturers of medical devices are preempted by the PMA process has split jurisdictions across the country, particularly here in Illinois.

On Lawrence’s motion to remand, U.S. District Judge Samuel Der-Yeghiayan found that the plaintiff’s complaint was not necessarily federal in character and that there was room for state regulation. Given the narrow scope of preemption under the MDA because protecting the health and safety is the traditional province of the state, be remanded the case to state court.

The Lawrence case is factually similar to that of Daniel Horn of Pennsylvania, who had a heart attack in January 1998, but with a very different legal result.

Horn’s doctors determined that he required a heart transplant, but his condition worsened and it was necessary to place a heart pump in his chest to aid circulation. Three months later, he began bleeding from an area where a factory-installed suture had loosened and caused a critical component in disconnect. An air bubble formed, and Horn suffered a brain hemorrhage and died.

Horn’s widow filed a lawsuit alleging that the pump’s defective design and manufacture caused her husband’s death. The district court granted the defendant manufacturer’s motion for summary judgment on the grounds that the MDA expressly preempted state law claims. On appeal, the Third Circuit affirmed. Horn v. Thoratec Corp., 376 F.3d 163 (2004). In Horn, the court held the PMA process to be rigorous and, therefore, necessarily preemptive. Third Circuit Judge Julio Fuentes filed a dissent in Horn stating that federal preemption exists only against state requirements that are "different from, or in addition to" federal requirements. Id., at 180.

In Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir.1997), the Seventh Circuit held in accordance with the majority in Horn. The Illinois Supreme Court, however, recognizing that the Seventh Circuit exercises no appellate jurisdiction involving state law, disagreed with the Seventh Circuit’s interpretation in Mitchell. Weiland v. Telctronics Pacing Systems, Inc., 88 Ill.2d 415, 721 N.E.2d 1149 (Ill.1999), citing Medtronic, 518 U.S. at 498. In the absence of express preemption, which is required to overcome the principle of federalism on this issue, the Weiland court did not think the U.S. Supreme Court found implied preemption through the PMA process, absent a showing of a particular federal regulation of a particular device. To the contrary, congressional intent was to protect consumers, not manufacturers, and the statute should be construed accordingly.

In Weiland, a case involving breach of warranty and defective design and construction of a pacemaker, the court stated that for devices designed before the passage of the MDA, like pacemakers, the approval process signifies "only a finding that the manufacturer’s proposal to market a device has reasonably assured the FDA of the device’s safety and effectiveness." Id., at 1152, quoting Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1376 (11th Cir.1999).

Certainly preemption was not anticipated with pacemakers, a medical device whose design was by the manufacturers themselves. The MDA divides medical devices in three classes based on the level of risk the device poses to the public. Heart pacemakers are Class III devices, which means they pose the highest risk of injury to human life. Before a Class III device is allowed to enter the market for public use, the manufacturer must obtain a PMA to assure its safety and effectiveness by submitting samples of the device, an outline of the proposed labels and any other data and information the FDA requests.

But pre-market approval imposed no substantive requirement of the manufacture or designed of the pacemakers, as the Weiland court pointed out, nor did it address the appropriate standards of liability once the medical device entered the market. Whatever process a device may go through before approval, it should not insulate a manufacturer forever from lawsuits.

The FDA’s primary mission is "protecting the public health," but the government agency is not infallible. Eliminating the judicial branch’s sole by immunizing medical device and drug companies from damage suits when their products hurt and kill people certainly is not promoting that primary goal. When manufacturers act negligently in making faulty products, consumers who are hurt or killed should be allowed to recover damages.

Nor has it been proven that Congress meant to deprive those injured by negligent conduct – the very people the federal requirements are meant to protect – of all means of judicial recourse, as occurred in Horn. The U.S. Supreme Court recognized that in Medtronic.

The FDA and courts have been able to co-exist for years, with FDA approval generally signifying minimum standards have been met. States have been allowed to set additional standards. Rather than rob consumers of their ability to protect themselves from poorly made medical devices, other reasonable measures have been upheld by the courts to reduce such medical error. Stricter monitoring of physicians, stringent certification of medical malpractice claims and toughening standards for expert witnesses are some of the areas that legislatures have been examining.

The ruling in Horn is particularly disturbing in its bestowing god-like status on the FDA. The FDA could be wrong. One need look no further than Vioxx, the popular arthritis medication, which the FDA recalled in October because of an increased risk of heart attack and stroke. It has been approved for use in children as young as 2 years old. The recall called into question the agency’s safety-review process.

The plaintiffs in Horn have asked for a rehearing by the full Third Circuit. Perhaps the U.S. Supreme Court can revisit this important issue.