Is Dennis Quaid Right? Reflecting on Riegel

In last week’s JAMA, distinguished legal and public health scholar Lawrence Gostin, affiliated with both Georgetown Law and Johns Hopkins, takes on the Supreme Court decision on the case of Riegel v Medtronic Inc. The case, decided in February, established that federal law preempts state law when it comes to medical devices. What this means is that, once the FDA approves of a medical device, consumers cannot use state liability laws to sue device-makers should they fall victim to device malfunctions or problems.

When the Riegel decision was first announced, I slammed it for expecting way too much of the FDA—which is under-funded, under-staffed, and often reliant on industry for financial support. In saying that federal law trumps all, the Supreme Court is giving final say in consumer safety to an agency that can barely do its job. As Gostin puts it so succinctly, “the court's confidence that the agency has the expertise, resources, and information necessary to ensure the safety of food, drugs, and medical devices is misplaced.”

I don’t want to replay the nitty gritty about how the FDA has declined in this post—you can check out previous posts for more details. But suffice to say, it’s incredibly wrong-headed to claim that the FDA is “rigorous” (as did the court) in its approval process, and that this approval is enough to preempt legal recourse on the part of patients who suffer harm thanks to a poorly designed device.

Gostin, however, doesn’t stop here. He also asks some tough questions about how the Riegel decision changes the rulesof the game when it comes to approval and accountability. Gostin asks: what if a medical device is approved by the FDA because “a corporation…deceived the agency into granting that approval”? Is it fair to allow device manufacturers to “use FDA approval as a shield against litigation” if they can scam their way into approval? Of course not—but this is exactly what can happen today. 

In fact, the Supreme Court approved just this sort of immunity back in 2001, in the case Buckman Co v Plaintiffs' Legal Committee. The court’s decision held that state law fraud-on-the-FDA claims were preempted by federal law. In other words, if the FDA approved a device—in this case, orthopedic bone screws—plaintiffs can’t use state laws to argue that the manufacturer only acquired approval through “fraudulent representations to the agency.” You can’t call device makers on scamming the FDA—as long as  the scam is successful.

Similar to Riegel, the logic here is that the FDA can take care of itself: since it has ample capacity to detect and deter fraud, there’s no need to allow state tort law into the picture. Together, Buckman and Riegel make for an insidious one-two punch: the first says that consumers can’t sue if a corporation defrauds the FDA, and the second says that consumers can’t even begin to try and detect said fraud. Why does Riegel mean less detection? Because “in a post-Riegel world,” notes Gostin, “lawsuits likely will be dismissed before plaintiffs' lawyers can use discovery to prove manufacturers deceived the FDA by providing false information or withholding relevant information.” Because it’s much more difficult to bring a suit to court after a device has FDA approval, it’s also much more difficult for legal eagles to explore the origins of FDA approval. If Buckman said that consumers can’t successfully file suit for FDA fraud, Riegel says that they’re less likely to ever get the chance to even try. 

If this seems like a big fat blank check for medical device makers, that’s because it is. Gostin asks another important question that comes to mind when one realizes how much leeway the court has given device makers: why would a company “conscientiously monitor a product's safety, disclose health hazards, and promptly recall hazardous devices from the market” if they “know they are immune from lawsuits”? 

Think about it: when you bar lawsuits, you’re not just protecting device-makers from existing accusations; you’re also eliminating the lingering threat of lawsuits in the future. Medical device manufacturers no longer have an incentive to nip problems in the bud in order to prevent lawsuits—that is, to inform and educate consumers, exercise stringent quality control, and generally engage in meaningful product oversight. Once they push a device through the FDA, they’re home free.

This is all troubling stuff, made more worrisome by the fact that the Bush Administration wants to see the same logic extend to prescription drugs. Here too, legal developments are afoot. Weeks after Riegel was announced, the Supreme Court deadlocked in a 4-4 decision in the case Warner-Lambert Co. v Kent, which tested whether federal pharmaceutical regulations preempt state law. In the case, 27 Michigan residents allege that they suffer liver damage from the anti-diabetic drug troglitazone, which was withdrawn from the market in 2000 because of liver toxicity. According to a case summary from the American Psychiatric Association, “Michigan law allows consumers to sue manufacturers on claims of fraud, namely, that the company defrauded the FDA and attained the agency's approval with deception.”

The court’s 4-4 decision means that at this moment, there is no formal precedent for this type of case.   The stalemate “in effect upholds a previous decision by a federal appeals court, which ruled that the Michigan law was not preempted by federal regulations and that the suit could proceed.” But the while the Supreme Court  avoided making a decision in this case, it’s too soon to say that prescription drug preemption has been scrapped. Making the Warner-Lambert decision all the more flimsy is the fact that Chief Justice John Roberts sat it out because he owns between $15,001 and $50,000 in Pfizer stock (Pfizer is the parent company of the drug in question).

The Supreme Court will get another shot at prescription drug preemption in October, when it’s expected to hear the case Wyeth v. Levine. In this case, Wyeth Pharmaceuticals is challenging “a multimillion-dollar judgment against it awarded to a Vermont plaintiff [Levine] whose arm was amputated after she had a severe reaction to an injection of the company's drug promethazine. Wyeth argues that the FDA-approved labeling information, which warns of the possible adverse effect, preempts the state liability laws and shields the company from the suit.”

Not all of the activity around prescription drugs and preemption is in the courts, and some of it is surprisingly high-profile. Earlier this month, actor Dennis Quaid testified before Congress on the dangers of preemption. "Like many Americans, I believed that a big problem in our country was frivolous lawsuits," Quaid told Congress. "But now I know that the courts are often the only path to justice." If state liability laws are preempted, said Quaid, unwitting consumers will become “uninformed and uncompensated lab rats."

Make no mistake, Quaid’s testimony is not an indication that preemption is the newest Hollywood cause du jour. After all, Quaid has a special interest in issues of medical liability: a hospital mix-up resulted in his newborn twins receiving almost 1,000 times the normal dose of a blood thinner. But keep in mind that Quaid testified before Congress because Congress is considering the issue of preemption—in other words, this is an issue that’s on the legislative agenda as well..

Meanwhile, there is no  doubt that institutionalizing preemption is on Big Pharma’s agenda. If the Riegel decision is repeated in the context of prescription drugs, they could save a fortune.  Lawsuit settlements don’t come cheap. In 2005, the drug company Eli Lilly spent $700 million to settle 8,000 lawsuits over Zyprexa, a drug for schizophrenia that causes major weight gain in many patients. Between 1998 and 2006, Wyeth spent $15 billion to resolve lawsuits over a diet drug combination which caused severe heart problems in some patients. In November, Merck offered a $4.85 billion settlement to cover some 27,000 lawsuits over Vioxx, a drug which clinical trials have shown to increase the risk of strokes and heart attacks—but only after spending $1.2 billion in order to get to the settlement stage. Merck’s offer is by no means final, and some analysts expect the Vioxx debacle will ultimately cost the drug giant somewhere around $30 billion.

Without question,  drug companies are hoping for the same gift that the court gave device makers in February: complete immunity for FDA approved products. But Gostin points out that, from a patient and consumer perspective, preemption in the prescription drug world would be disastrous.

A decision similar to Riegel means that “patients would have no safety net in the likely event that the agency fails to detect and correct safety hazards. Given that there are “11 000 FDA-regulated drugs, with nearly 100 more approved each year” it’s “virtually impossible to monitor comprehensively the performance of all drugs on the market.” Yet patients would have little recourse if one of these poorly-monitored drugs caused them serious health problems.

It’s unclear exactly how the preemption debate will be resolved. While device makers have gotten a free pass, prescription drug companies seem to be undergoing more scrutiny, as evidenced by the court’s split decision in Warner-Lambert. But there’s reason to be worried. “In the end,” laments Gostin, the institutionalization of preemption means that “the public is caught in a catch-22. At the same time the FDA is widely perceived as ineffectual and the hazards of widely used drugs and devices are revealed, the Supreme Court is making it more difficult for patients to discover wrongdoing, even fraud, and to be fairly compensated for their avoidable injuries.”

Comments

[Barry Carol]

Niko,

I’m just curious. Have you ever heard of or can you name a single agency of government at any level – federal, state or local that does NOT claim to be under funded? It seems that no matter how much in taxes we pay, every government agency including the DOD, CMS, HUD, IRS, SEC, FTC, FDA, EPA, local schools and police departments, public universities and community colleges, etc. all need “more resources” to do their job properly.

With respect to drugs and devices specifically, how are these issues handled by other healthcare systems that we heap so much praise on like France, Germany, Switzerland and Japan? Most of these drugs are sold on the world market, yet I don’t read too much about multi-billion dollar settlements for defective drugs and devices in those countries.