Supreme Court rules on different standards for drug and device makers

Does a patient who's undergone implantable cardioverter-defibrillator (ICD) placement, and whose ICD's electronic components have now failed -- requiring emergent device replacement -- have the right to sue the cardiac device's maker for negligence, if he was repeatedly warned by his cardiologist of the well-known risk of post-implantation electronics failure?

Device makers have long argued 'No': every device has risks, and the FDA-CDER premarket approval process is designed to weigh risk against benefit before permitting the introduction of a new device. The Supreme Court last year substantially agreed with this view in Reigel v Medtronic by ruling that successfully obtaining premarket approval from the FDA gives medical device makers (in this case, Medtronic, a manufacturer of ICDs) a strong defense against lawsuits filed in state courts because federal regulation "pre-empts" state law here.

Today, under presumably different logic, the court ruled in Wyeth v. Levine that drug makers can be sued in state courts, even when they have obtained FDA approval.

So why the discrepancy? The Wall Street Journal Health Blog reports on the issue today:

The 8-1 ruling in the medical device case, Riegel v. Medtronic, relied heavily on the “Medical Device Amendments” signed into law in 1976.

As the court wrote in Riegel:

The MDA provides that no State ‘may establish or continue in effect with respect to a device . . . any requirement’ relating to safety or effectiveness that is different from, or in addition to, federal requirements …

That language goes to the heart of preemption, the legal question at issue in both cases: Does federal regulation override state law? In the case of devices, the court found, MDA explicitly preempts state law.

But the MDA is all about devices, while the case decided today, Wyeth v. Levine, is all about drugs. The relevant drug law is the Food, Drug, and Cosmetic Act, enacted in 1930 and amended several times in the decades since then.

Amendments added in 1962 indicated “that a provision of state law would only be invalidated upon a ‘direct and positive conflict’ with the FDCA,” Justice Stevens wrote in his majority opinion in Wyeth v. Levine.

What’s more, Stevens added, “when Congress enacted an express pre-emption provision for medical devices in 1976″ — in the MDA — “it declined to enact such a provision for prescription drugs.”

The notion of pre-emption gets to the very heart of our national experiment with federalism, and makes for a fascinating legal discussion. But it's unfortunate for most Americans that this case hinged on the issue of pre-emption, rather than addressing the broader social ramifications of an increase in state and federal drug lawsuits in our already litigation-littered society.

Something just doesn't sit well with me about our asymmetric policy for dealing with device and drug companies (largely for historic reasons related to the recency of most device legislation, and the relative strength of industry lobbying groups). We've long been doing this to our detriment, I think, in the FDA's 510K process of rapidly approving "substantially equivalent" devices.

Medical device and pharmaceutical companies face enormous legal liability and financial risk in developing the innovative therapies that physicians and patients rely upon.

So there's a few reasons why I agree with the Court's original decision in Reigel v Medtronic:

• First, mitigating the legal liability to device companies removes downward pressure on innovation;
• Second, the tort system in our country is badly broken, with punitive damages awarded by juries in many cases exceeding the pale of reason;
• Third, I'm hoping this decision will spur legislation to give FDA broader oversight and stricter controls over device development and postmarketing surveillance.

If we're answering the question of whether the companies have been negligent, and we ask -- did their actions "cause" the damages suffered, and could a "reasonable person forsee the harm" to the patient in this case? -- then I think the answer to both questions is yes.

However, drugs and devices, by virtue of their intimate relationship with our bodies, have the potential to cause immense, sometimes irreversible, harm. We can predict, and warn about the dangers of, this harm by conducting preclinical and clinical trials.

Our regulatory process should (in the ideal world) weed out those drugs or devices whose risk/benefit profile is tipped towards risk, and protect companies and physicians who adequately educate patients about that risk prior to starting treatment. Otherwise life-saving therapies would never see the light of day for fear of a class-action lawsuit.