Yesterday the United States Supreme Court dealt a significant blow to the
Plaintiffs’ Bar’s ability to pursue tort claims involving medical devices
cleared by pre-market approval (“PMA”) application. In an 8 to 1 opinion
authored by Justice Scalia, the Court handed down their first opinion in a
trilogy of FDA preemption cases currently before the Court. In Riegel v.
Medtronic, Inc., No. 06-179 2008 WL 440744 (U.S.), the Court held that state
common law claims were preempted by the Medical Device Amendments of 1976. The
opinion of the court has been long awaited and may provide a glimpse into the
Court’s stance on two other significant upcoming preemption cases, Levine v.
Wyeth and Warner Lambert v. Kent.
In Riegel, plaintiffs allege that a Medtronic catheter, a Class III device
marketed under a PMA, ruptured in Charles Riegel’s coronary artery, causing
injury. The Riegels alleged that the catheter was designed, labeled and
manufactured in a manner that that violated New York common law. The issue
presented was whether the preemption clause enacted in the Medical Device
Amendments of 1976, 21 U.S.C. §360k, (“MDA”) bars state common law claims that
challenge the safety and effectiveness of a medical device given pre-market
approval by the Food and Drug Administration (“FDA”).
In its decision handed down February 20, 2008, the U. S. Supreme Court upheld
the Second Circuit, which in turn had affirmed the District Court, which held
that the plaintiffs’ claims of strict liability, breach of implied warranty and
negligence were preempted.
Under the express preemption clause of the MDA, a state may not “establish or
continue in effect with respect to a device any requirement . . . (1) which is
different from or in addition to, any requirement applicable under [federal law]
to the device and . . . (2) which relates to the safety or effectiveness of the
device or to any other matter including the requirement applicable to the device
under” relevant federal law. 21 U.S.C. § 360(k)(a).
For the first time since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the
Court examined the detailed, extensive scrutiny that FDA gives to medical
devices marketed under PMAs. The Court discussed in some detail the extensive
documentation that the agency evaluates before approving a device and the
extensive time spent on review of each application (1,200 hours on average). As
part of the PMA process, FDA is required to assess the risks and benefits of the
device and to determine that, as designed and labeled, there is a reasonable
assurance of safety and effectiveness. Significantly, the Court addressed the
fact that, once a device has received PMA, the manufacturer may not, without FDA
permission, make “changes in designs, specifications, manufacturing processes,
labeling, or any other attribute, that would affect safety or effectiveness.
§360(e)(d)(6)(A)(i).” Any change must be submitted to and approved by FDA before
it can lawfully be made.
The Court was deliberate in its effort to distinguish its opinion in Riegel from
its previous opinion in Lohr. In Lohr, the Court found that federal
manufacturing and labeling requirements applicable to most medical devices did
not preempt the common law claims of negligence and strict liability. The
distinguishing factor, according to the Court, between Riegel and Lohr was the
“device specific requirements” or PMA applicable to the Medtronic catheter in
Riegel versus the 510k “substantial equivalence” review in the Medtronic model
4011 pacemaker lead at issue in Lohr.
The Court relied heavily on 21 C.F.R. § 808.1(d), which provides that state
requirements are preempted only when FDA “has established specific counterpart
regulations or there are other specific requirements applicable to a particular
device” under federal law. The device marketed under PMA must be manufactured
under those specifications presented and approved in the PMA application The
plaintiffs’ common law claims were based upon state “requirements” that were
“different from or in addition to” federal ones related to safety and
effectiveness. The Court noted that the plaintiffs’ suit depended upon the
“continu[ing]. . .effect” of New York’s general tort duties “with respect to” the
catheter. Compare 21 C.F.R. § 801.1(d)(1), providing that MDA preemption does
not extend to “[s]tate or local requirements of general applicability [whose]
purpose . . . relates to other products in addition to devices . . . or to unfair trade
practices in which the requirements are not limited to devices.”
The Court affirmed its confidence in the FDA as the regulating body in the
best position to determine the safety and effectiveness of medical devices.
Because this case involved common-law claims, a decision in favor of the
plaintiffs would have essentially usurped FDA’s role and placed this function in
the hands of a jury. The Court noted that a jury is not in a position to conduct
a cost-benefit analysis similar to that done by the “experts” at the FDA.
Finally, the Court addressed the argument that it is difficult to believe
that Congress intended preemption clauses such as the one at issue in Riegel to
remove all judicial recourse for consumers injured by FDA approved devices. The
Court responded to this query with a resounding yes: “. . . this is exactly what
a pre-emption clause for medical devices does by its terms. The operation of a
law enacted by Congress need not be seconded by a committee report on pain of
judicial nullification.” Riegel at p.7 of slip opinion.
A similar issue -- whether the Food, Drug and Cosmetics Act (FDCA), 21 U.S.C. §§
301 et seq., including the NDA process, preempts state law claims for failure to
warn or failure to provide adequate warnings for FDA-approved prescription drug
labeling -- is currently before the Court. Levine v. Wyeth No. 2004-384. In her
dissenting opinion in Riegel rejecting preemption based on the MDA, Justice
Ginsburg may have provided a preview of how she may view the issues in Levine.
She wrote that the process for approving a new drug application is at least as
rigorous as PMA for medical devices, but courts have overwhelmingly held that
FDA approval of new drugs does not preempt state tort suits.
Plaintiffs and manufacturers alike will continue to wait with keen
anticipation for the Court to decide the remaining two cases in the FDA