This article is reprinted from "The Gray Sheet" – November 12, 2007
A major case impacting the medical device industry's vulnerability to product liability suits will land in the U.S. Supreme Court next month and legal scholars predict the outcome will be a close call.
Riegel v. Medtronic will be argued in Washington, D.C., Dec. 4 following the plaintiff's appeal of a 2006 federal appeals ruling that Medtronic is not liable for injuries to a patient that resulted when one of the company's catheters burst during the course of a procedure (see chart: "1Case Background").
Medtronic's victory was in large part due to the appeals court's support of the federal pre-emption defense - that FDA's premarket approval of the device design and its labeling protects the company from lawsuits in state courts.
After ruling in 1996 (Medtronic v. Lohr) that the less arduous 510(k) clearance does not typically carry this pre-emptive power, the Supreme Court is set to decide if a PMA passes that threshold.
Lawyers hashed out the issues the court is likely to factor into its decision during a Center for American Progress panel discussion on Nov. 4.
Lohr Offers Little Assistance
One of the most obvious places to look for signs of how the court will rule on Riegel is the 1996 Medtronic v. Lohr case in which the same section (section 360(k)(a)) of the Medical Device Amendments to the Food, Drug and Cosmetic Act was analyzed.
Section 360(k)(a) bars states from establishing a requirement "which is different from, or in addition to, any requirement" established by the amendments or "which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter."
But Washington Legal Foundation Chief Counsel Richard A. Samp, who co-authored the foundation's amicus brief in favor of federal PMA pre-emption in the Riegel case, says the 4-1-4 Lohr decision does not offer a clear answer.
"Because Lohr was so badly fractured, I think it is fair to conclude that it will not provide the court with any clear guidance deciding the Riegel case," Samp said.
"Four justices said that section 360(k) virtually never should be read to pre-empt state common law suits, four justices said precisely the opposite, and Justice [Stephen G.] Breyer said that he thought that many such cases of action probably are pre-empted, just not the ones that were before the court in Lohr," he said.
Since then, Samp noted, two justices who favor 360(k) pre-emption have left the court, but if their views are shared by Justice Samuel Anthony Alito, Jr., and Chief Justice John G. Roberts, Jr. - both nominated by President George W. Bush whose administration is on record in support of PMA pre-emption - Breyer may again cast the deciding vote.
Common Law Versus Federal Statute
David C. Frederick, a partner at Kellogg, Huber, Hansen, Todd, Evans & Figel, says the justices will need to look to common law principles to guide their decision on Riegel.
"What we have in this case is another manifestation of that basic tension between common law remedies that most states recognize through judge-made-law that has evolved over 150 or so years and federal statutory principles," Frederick said. Common law should win, he contested.
In 1996, Charles Riegel underwent angioplasty to dilate his coronary artery. The physician used Medtronic's Evergreen balloon catheter. The catheter burst during the course of the procedure. Riegel survived, but with a severe disability.
The Riegels sued Medtronic in a New York district court, alleging negligence in design, manufacturing and labeling, among other claims. Medtronic argued that these claims were pre-empted by Section 521 of the Federal Food, Drug and Cosmetic Act, otherwise known as Section 360 (k), enacted in 1976 as a part of the Medical Device Amendments.
In 1996, Charles Riegel underwent angioplasty to dilate his coronary artery. The physician used Medtronic's Evergreen balloon catheter. The catheter burst during the course of the procedure. Riegel survived, but with a severe disability.
The Riegels sued Medtronic in a New York district court, alleging negligence in design, manufacturing and labeling, among other claims. Medtronic argued that these claims were pre-empted by Section 521 of the Federal Food, Drug and Cosmetic Act, otherwise known as Section 360 (k), enacted in 1976 as a part of the Medical Device Amendments.
In 2002, the district court sided with Medtronic. The Riegels appealed to the Second Circuit U.S. Court of Appeals, which affirmed the district court's decision, affirming the device's PMA approval authority to preclude the plaintiff's right to sue Medtronic over issues including device design and labeling. Riegel died in 2004 and the claims are currently being pursued by his estate and his wife, Donna Riegel.
Frederick, who successfully argued against pre-emption in other industries, explains that common law says manufacturers have a duty to use "due care," and if someone is injured because of a manufacturer's failure to use due care, that manufacturer is liable to the injured party in tort.
The claim by manufacturers that liability suits cannot be brought against them in state courts because FDA approved their product, and the product has therefore lived up to FDA obligations, "greatly overstates what the FDA in fact does in this particular area."
"The premarket approval in our assessment of it really provides a limited screening that's inadequate and it's not really intended to replace the normal tort remedies that traditionally are permitted to persons who are injured by defective products," Frederick stated. "The tort system provides remedies and incentives that are necessary to protect the public."
For example, FDA cannot subpoena information, he said. The agency does not have the authority to conduct independent tests and it cannot compare the safety and efficacy of the device for premarket approval with a product that is already on the market.
In addition, Frederick pointed out that the Medical Device Amendments provision does not provide for compensation to patients injured by medical devices nor does it spell out how to hold manufacturers accountable if they fail to live up to FDA obligations, even by selling just one faulty product.
Samp, on the other hand, asserted that Congress did, in fact, intend to pre-empt any actions by states that might undermine FDA regulations, "even if those state actions took the form of lawsuits."
Further Samp argued that a ruling in favor of pre-emption does not remove a patient's option to sue.
"No one argues that all of the Riegel's causes of action are pre-empted, just the ones that conflict with FDA's requirements that Medtronic design and label its product in accordance with precise FDA specifications," Samp said.
He pointed out that the lower court allowed the Riegels to proceed on their claim that the catheter was negligently manufactured and that Medtronic breached an express warranty (2"The Gray Sheet" July 2, 2007, p. 3). The Riegels were unable to prove that the catheter implanted into Charles Riegel was in fact manufactured negligently.
Samp said that the Riegels are also free to seek recovery from their physician, "who the evidence showed in this case used the Medtronic catheter in a manner [the manufacturer] had strictly warned against. The evidence is pretty clear that the catheter burst because it was inflated far more than the specifications said it ought to be inflated."
Congressional Intent In Question
Georgetown University Law Center Professor David C. Vladeck argues that there is nothing in the Medical Device Amendments to suggest that Congress intended to wipe out state tort claims. Rather, the provision was intended to pre-empt any pre-existing state requirements that are different from what FDA will propose going forward.
Vladeck points to part b of section 360(k), which offers states the option to apply to FDA to keep their stricter device requirements, as evidence of his claim.
"The word used in both provisions [parts a and b] is 'requirement,' which in my view drives home the fact that Congress when it used the word 'requirement,' it had nothing to do with state tort law," Vladeck said. "It had everything to do with trying to mesh together pre-existing regulatory systems."
However, Catherine M. Sharkey, a law professor with New York University said the issue from the Supreme Court's perch is more complicated. The court, she said, "wears the tort as two hats."
"In one hat, the court views torts as having to do with remedy and compensation," Sharkey said. "In the other hand, tort is regulation and damages. Common law damages regulate exactly as federal requirements do."
It is unclear which view of torts the court will take in this case, she noted.
If the justices cannot reach a determination one way or another based on the pre-emption language in the Medical Device Amendments, there is substantial case law that exists supporting a "presumption against pre-emption," which urges the court to tip the balance against pre-emption, Sharkey said.
However, Vladeck said that the court is "seriously divided" on the presumption against prevention analysis, and that its pre-emption decisions have come out about 50/50.
He added that the solicitor general's brief in support of pre-emption stated that this approach does not apply in Riegel v. Medtronic, though it does not clearly explain why.
"I'd be very surprised if the court just said the presumption against pre-emption [provision] applies and we need a clear statement rule here, because I don't think they have a majority who believes that," Vladeck said.
Following The Agency's Lead?
Another resource justices might rely on in their deliberations is FDA.
The agency went on record in 2004 in favor of PMA pre-emption over state lawsuits when it submitted an amicus curiae brief supporting Thoratec in a liability suit that was ultimately found in the companies favor by a federal appeals court (3"The Gray Sheet" Jan. 1, 2005, p. 4).
The position was supported more recently by the solicitor general's brief, representing the official position of the U.S. government.
Sharkey said that in pre-emption cases the Supreme Court almost always rules in favor of the opinion of the federal agency involved.
According to Sharkey, the only exception is the high court's ruling against the Environmental Protection Agency's stated preference in Bates et al. v. Dow Agrosciences by finding in favor of the plaintiffs' right to sue in state court, she said.
But the Supreme Court has never expressly voiced a policy on following agency views, Sharkey acknowledged.
"I think these things should actually be determined on a case-by-case manner based on empirical fact," she said.
- Ingrid Mezo
