Medical Device Daily Washington Editor

WASHINGTON - The U.S. Supreme Court hearing for the case of Riegel v. Medtronic took slightly more than an hour yesterday and was filled with the sharp, rapid-fire questions for which the nation's highest judiciary body is well known. The lead attorney for the plaintiff seemed to experience more difficulty than her adversary in keeping the nine justices at bay with her replies, but it was not easy to tell which direction the court might be leaning.

Still, the court obviously is interested in the notion of relaxing the federal pre-emption of state medical device liability law for PMA devices or the court would not have taken the case. But it is also a fact that only four justices have to sign off on a case to get it onto the court's docket.

In general, the justices are being asked to rule on a state court's ability to find a device defective, and the manufacturer liable, even though the device has been FDA-approved.

The details of the case are by now well known.

In 1996, Charles Riegel underwent a balloon angioplasty with a stent placement, with Medtronic's Evergreen serving as the balloon catheter. The Evergreen's label indicated a maximum inflation rate of eight atmospheres and the device was contraindicated for patients with calcification in the affected arteries. However, the surgeon inflated the Evergreen used on Riegel to 10 atmospheres, and Riegel's arteries were demonstrably "heavily calcified," according to lower court documents.

The plaintiff lost the initial trial and a subsequent appeal.

Representing the plaintiff was Allison Zieve, an attorney with Public Citizen Litigation Group (Washington), who told the justices that the problem with state pre-emption of FDA pre-FDA regulations and the corresponding law required "no comparison to other products" for safety and efficacy. Another problem is that manufacturers are not required to redesign their products upon learning of an opportunity to improve them.

Chief Justice John Roberts asked whether the mandatory annual device reports companies must file with FDA did not basically address the question of devices with inherent design flaws.

Zieve responded: "yes and no." She said that "the responsibility and opportunity to improve the design is with the manufacturer" and that "FDA's role in this is more passive," indicating that the agency is in no position to force manufacturers to continually upgrade their devices.

Associate Justice Ruth Bader Ginsburg asked Zieve why pharmaceuticals are not the subject of pre-emption statutes.

Zieve responded that "drugs have been regulated since 1938" and that in the vacuum of laws governing medical devices, several states, including California, wrote device-specific regulations. Congress decided that "California should not be able to continue" down the road of regulating devices on its own because chaos would follow if other states followed suit.

Ginsburg also asked what might ensue should a plaintiff sue a device maker over a failure to make improvements to a device, even if the manufacturer had presented the proposed improvements to FDA but found the agency unwilling to allow the maker to change the device.

Zieve replied that "devices should be made as safe as they can" and that federal pre-emption should be disallowed to prevent legal action in such a circumstance.

Associate Justice Steven Breyer asked, "in what respect was this [Evergreen] catheter ... defective?" Zieve answered that in the first trial, "there was not a lot of discovery" that would answer this question, but that the Evergreen "should have been strong enough" to withstand the pressure put on it by the physician.

Zieve based this comment on the assertion that the label for the Evergreen "was misleading because although it lists 12 precautions," including a requirement that the catheter not be inflated to beyond eight times ambient atmospheric pressure, "a chart [regarding device testing] that shows up to 13 atmospheres" was also in the label.

Roberts replied that an automobile speedometer "shows 120 miles per hour, but that doesn't mean you should drive that fast."

Representing Medtronic (Minneapolis, Minnesota), Theodore Olson, a former U.S. solicitor general and now a partner with the law firm of Gibson, Dunn & Crutcher (Los Angeles), opened his remarks by stating that "the central focus of this case" is that "Congress wanted to balance device safety and efficacy with availability of life-saving devices."

Ginsburg resumed her earlier line of pursuit, asking Olsen, "Why is this more central to this [regulatory] scheme than to drugs?"

Olsen acknowledged that there is no statutory pre-emption for drugs, but that a regulatory function nonetheless exists and has been backed by the judicial system in several cases. As to why common-law torts should be pre-empted in addition to formal state laws, Olsen said, "if a jury comes up with those [additional] requirements, it would present the same problem" as a formal state law that overrode FDA's regulatory authority.

Associate Justice Antonin Scalia told Olson, "we've had torts for drugs, and manufacturers have not taken products off the market," and asked why devices are different.

Olson seemed to invoke the different economic dynamic behind blockbuster drugs vs. high-selling devices, replying that "if the juries can change" a device's regulatory status, the device "will by definition be less safe or less available" due to the higher economic burden imposed by such changes.

The current solicitor general, Edwin Kneedler, also spoke in a friend of the court briefing in support of continued federal pre-emption, noting that pre-emption is "clearly what Congress intended to do" when it passed the Medical Device Amendments of 1976, the law that established pre-emption.

Chris White, the general counsel for the Advanced Medical Technology Association (AdvaMed; Washington), said in a statement: "Allowing states to serve as secondary regulatory bodies would undermine the established science-based review process in place for medical devices and diagnostics and slow down patient access" and that AdvaMed members are "hopeful that the Supreme Court will re-affirm the two previous lower court rulings in this case."

One precedent of some relevance to the current case is the Medtronic v. Lohr decision of 1996, which eliminated pre-emption for devices that go to market under the 510(k) approval. However, the Supreme Court put that decision out in a 5-4 split, and the majority opinion at the time exempted PMA devices due in part to the more rigorous regulatory scrutiny for novel class III devices.

The court has six months to render a decision.

No Comments