By DON LONG
Cardiovascular Device Update Executive Editor
And MARK McCARTY
Cardiovascular Device Update Washington Editor

Though a U.S. Supreme Court hearing for the case of Riegel v. Medtronic took only slightly more than an hour in early December, the effects of the High Court's decision will have major, long-lasting impact on the medical device industry —and, potentially also, for litigators who handle, or won't, medical device product liability cases. Given the narrow timeframe for presentations to the Justices by the respective legal arguers of the case, the session was characterized by the sharp, rapid-fire questions for which this (sometimes) august body is 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.

Apart from a decision by the court to support Medtronic — which would maintain the current legal status quo as to FDA's powers and federal authority over those powers — the most important fact of the case is that the Court was hearing it. Some of the justices obviously feel it is important to at least consider the arguments concerning the relaxation of the federal pre-emption of state medical device liability law for pre-market approval (PMA). (At least four justices have to sign off on a case to get it onto the court's docket.) Very generally, 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.

Imagine: a new slew of liability cases

The ramifications are obvious: if the justices decide not to rule for Medtronic, the result will be to provide state courts a slew of liability cases to hear concerning devices gone bad, even though the FDA says they are safe. For the consumer, a decision giving this power to the states would raise the costs of device technology, given the added costs of greatly expanded litigation.

Those additional costs, however, would largely end up in the pockets of those litigating such cases, as well as, hopefully, consumers who have been injured by the failed devices.

The stakes for the FDA are very much higher, and FDA officials are probably somewhat concerned (read quaking in their boots) that the case has even come to this, let alone a worst-case scenario for the industry if the Court favors Riegel.

A decision providing legal sanction to state courts to find devices unsafe, thus trumping the approval protocols and decision-making of the FDA and its panelists, could cast a huge cloud over the agency — raising a variety of questions, in particular, how well it is really doing its job for patients, or how susceptible it is to fraudulent clinical claims by device makers.

Perhaps the biggest question here is this: If state courts begin to find FDA-approved products unsafe, would this open the agency itself to liability litigation of an especially embarrassing sort? If an FDA-approved device is found unsafe, the questioning of how the agency determines device safety, and its degree of liability in failing that task, could bring one more federal power, and its attached responsibility, into question (already being questioned by a group of former FDA staffers who recently issued a report, slamming the agency for everything from out-dated IT systems to, the most damaging complaint of all, weak leadership — an interesting critique coming from former leaders at the agency).

Most probable: status quo - but who knows?

Cardiovascular Device Update clearly doesn't think we will get to these scenarios, since we grant the justices enough intelligence of the chess-playing type and believe they are likely to reject Riegel as being susceptible to too many very highly unpredictable results. They may want to avoid being responsible for flooding state courts with a wave of new litigation of the extremely sticky and confusing sort — adding additional weight to their current overloads.

On the other hand, the justices could rule very narrowly so that only a specific and very small group of such cases could legitimately be heard by state courts. — for instance, if the FDA certifies the safety of a device based on false and blatantly deceptive information supplied by the device sponsors in conjunction with its investigators. (Could the investigators then be sued by both the product sponsoring company, the patient and the government?)

The permutations are mind-boggling, but that is what the court may (could) rule — that state's do have the right to find a device defective, thus allowing them to find for injured plaintiffs if the agency fails to uphold its own safety standards, or they are so constructed as to be too easily circumvented.

Ultimately, a decision for Riegal would probably be one of most benefit to patients — with the increased level of actual product safety off-setting the inevitable increases in costs to demonstrate safety (though that would be devilishly difficult to demonstrate).

No more DES-type approvals

Still another issue that this cascade of decisions would mean would be that the FDA could no longer base its decisions concerning safety on very short-term trial periods.

We would then no longer have any approvals of "breakthrough" devices such as drug-eluting stents, based on on trial timelines that only look at short-term primary endpoints (such as, in the case of DES, reducing restenosis, with the agency perhaps focusing too much on the avoidance of redos and associated costs), without considering long-term safety — meaning potential increases in adverse events and death in a population of heart disease patients implanted with these devices for some number of years.

A decision in favor of the plaintiff in this case could also have some impact on decisions made by the Centers for Medicare and Medicaid Services, the agency most concerned with the costs of healthcare technologies and treatments and whether their efficacy meets such an important need that they are worth encouraging by paying for them.

In recent years, this agency has been one of the hardest of federal grouops to convince, given the multiplication of new technologies with very large "grey areas" of benefit. And increased litigation concerning the safety of a device could result in further slowing of CMS' already laggard decision-making.

Safety — at a price

The final importance of the Supreme Court's hearing the decision — no matter which way it decides — could be to put much-needed emphasis on safety in the already fairly unsafe venue of medical care.

And safety is expensive. When the expense of getting guarantees of safety in medicine becomes onerous, there will be calls for radical reforms — not just the Band-Aid approach of tightening a lugnut here, or moving the carburetor to the trunk.

What does this mean for cardiovascular care?

It means that cardiovascular companies must continue to ratchet up their emphasis on safety — from the time a product moves out of the manufacturing plant to its sales representatives converations with doctors — making sure that doctors not provide a company's technologies based on the use of its products alone but on physician information concerning the clinical circumstances in which the technology should not be used.

Details known

The details of Riegel vs. Medtronic 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 subsequent appeals.

Representing the plaintiff before the High Court 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.

Why not drugs?

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.

The central focus

Representing Medtronic, Theodore Olson, a former U.S. solicitor general and now a partner with the law firm of Gibson, Dunn & Crutcher (Los Angeles), opened 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.

States as secondary regulators?

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 pathway. 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.