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
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
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
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
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
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.”