In March, the US Supreme Court ruled in Wyeth v. Levine that FDA approval and labeling of a medication does not pre-empt state law, or liability lawsuits against manufacturers in state courts by consumers claiming to have been harmed by the drug.
This created an odd juxtaposition: last year, in Riegel v. Medtronic, the Court ruled in precisely the opposite way on medical devices. It found that federal medical-device regulations do pre-empt state product liability suits, unless the manufacturer has actually violated FDA regulations in the process of getting its device approved.
The contradictory rulings are based on two different statutes: the device law specifically prohibits states from imposing their own requirements, a provision that the Court found implicitly applies to private suits as well. The federal Food, Drug, and Cosmetic Act lacks a similar stipulation.
So as it stands today, if you think you've been harmed by an FDA-approved drug, you can sue for damages. But if you think you've been harmed by an FDA-approved device, you can't. That may change, however, as Congress considers a new Medical Device Liability Bill (HR 1346/S. 540) specifically designed to undo the Court's ruling in Riegel.
TESTIMONY ON DEVICES
In early May, the House Energy and Commerce's health subcommittee held hearings on the bill, which is generally supported by consumer organizations and opposed by the medical device industry.
At the hearing, Bridget Robb, a 35-year-old from Pennsylvania, described being shocked 31 times by a faulty implantable defibrillator made by Medtronic. “Each time I was shocked, I saw my life flash before my eyes,” she said.
Medtronic had actually recalled Robb's particular defibrillator two months before — after 665 failures and five reported deaths, according to Heart Rhythm, the journal of the Heart Rhythm Society — but Robb said the company never notified her of the recall.
On stopcorporateimmunity.org, consumer organizations have collected other stories like Robb's, including that of five-year-old Avery DeGroch, whose defibrillator misfired when she was three and shocked her nine times, and 30-year-old Katie Meyer, who died from complications of surgery to remove a faulty defibrillator.
Since the Riegel decision, a number of lawsuits from similar patients have been thrown out of court. In January, Judge Richard Kyle dismissed more than 1,000 cases filed against Medtronic in US District Court in Minnesota after the failure of its Sprint Fidelis implantable cardioverter-defibrillator lead — the type implanted in Robb, DeGroch, and Meyer.
A JOURNALIST WEIGHS IN
Figure. MICHAEL KINS...Image Tools
But not all patients support the legislation. One prominent opponent is journalist Michael Kinsley, the former host of “CNN's Crossfire,” who has been battling Parkinson disease for more than a decade. In 2006, Kinsley had surgery to implant the Medtronic “Activa” deep brain stimulator, a device that has been shown to mitigate Parkinson symptoms in some patients.
“Now I walk around with wires in my head and two pacemaker type batteries in my chest. But thanks to these devices and these pills, I am walking around,” Kinsley told the House panel.
Kinsley sees the state tort law system as creating 50 separate little FDAs, with no scientists involved in the decision-making.
“We have a whole FDA approval process, which can take years and cost millions of dollars, and uses experts, to come up with a standard and say here is where we draw the line — there is a spectrum of safety and a cost-benefit analysis, a risk-benefit analysis, and at some place you draw the line,” he said in an interview with Neurology Today.
“You create this commission and assign it to draw this line as intelligently as it can, factoring in the benefits as well as the costs and risks — and then, you announce that you can forget all that and have 12 people who know nothing about all of this —13, including the judge — try to decide basically the same question all over again. It's ridiculous, the idea that a company can go through that whole FDA process and scrupulously follow FDA rules and then be told that it's negligent.”
IS FDA OVERSIGHT ENOUGH?
But even former FDA staff do not think that the federal agency is up to that challenge. In a friend-of-the-court brief filed in the Wyeth case, former FDA commissioners David A. Kessler, MD, and Donald Kennedy, PhD, joined the editors of the New England Journal of Medicine and 47 state attorneys general in arguing that “the FDA alone simply lacks the ability to serve as the sole guarantor of drug safety.”
“The FDA alone can't do it all,” agrees Daniel Larriviere, MD, JD, assistant professor of neurology at the University of Virginia and the incoming chair of the AAN Ethics, Law and Humanities Committee. “They're trying to do too many things and they're underfunded and understaffed. If you say that their review is as thorough as the discovery in a trial about the safety of a product, I think you're overstating your case.”
Even if the agency weren't overwhelmed and understaffed, pre-emption would be a bad idea, Dr. Kessler has argued. In “A Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims,” published in the Georgetown Law Journal in 2008, Dr. Kessler and Georgetown law professor David Vladeck wrote: “The FDA's statutory and regulatory tools for gathering post- approval information are relatively crude and often ineffective, especially when contrasted with its tools for information gathering prior to approval. For that reason, the tort system has historically provided important information about these newly-emerging risks to physicians, patients, and the FDA.”
“A lot of devices and a lot of drugs have side effects and long-term consequences that you can't get to in short-term trials because they're rare enough that you need a lot of numbers before you start seeing them,” said Dr. Larriviere. “State action is a way for the public to say that you've got to be really careful when you bring one of these things to market.”
But Kinsley said he fears that the proposed legislation will stifle innovations in device development like those that led to his deep brain stimulator. “Why would anyone want to get involved in it?” he asked. “I'm walking around with a Medtronic device in me and it's been terrific. The thought that they might not have made it if they had to worry that someone could sue them, on the one in a million chance that something might have gone wrong is sort of horrifying.”
‘A BALANCE OF INTERESTS’
“There's some truth to that — I think that has to be admitted up front,” said Paul Appelbaum, MD, Elizabeth K. Dollard Professor of Psychiatry, Medicine & Law and the director of the division of law, ethics, and psychiatry in the department of psychiatry at Columbia University. “But we're dealing with a balance of interests here. We as a society have an interest in promoting innovation; we also have an interest in avoiding the adverse consequences of too hasty or incautious innovation,” he said.
“To the extent that we attempt to promote one of those interests, we inevitably negatively affect the other. We're looking for an optimal balance: manufacturers must be given incentives to take care, but not to abandon their innovative projects.”
He pointed out that medical devices now stand alone, as compared with other devices as well as pharmaceuticals, in being shielded from state court lawsuit liability. “What makes these products different from any other product that consumers come into contact with in a sophisticated society?” he asked. “The device statute constitutes a real exception to our historic way of dealing with product liability. Our tort system has developed over hundreds of years to balance the interests and rights of manufacturers and consumers. It ought to be tinkered with, by creating exceptions for particular products, as little as possible.”
And if the FDA stands as the sole arbiter of medical device safety, what incentive is there for manufacturers to monitor and improve safety once a device is approved? “From a pragmatic standpoint, not everything approved by the FDA will be safe for everyone who uses it,” said Dr. Larriviere.
“Some of that information comes out after approval,” he continued. “If there's limited liability, manufacturers don't have much incentive to change anything, other than their standing in the community and shareholders getting mad. But that's why we have tort law — sometimes the market is not enough of a push in the right direction.”