As a defense lawyer, I dream about preemption; it can bar a staggeringly wide range of claims. The plaintiffs in Gelber v. Stryker, — F.Supp.2d —-, No. 09-CIV-1322, 2010 WL 4740432 (S.D.N.Y. Sept. 14, 2010), however, do not view preemption so fondly. After Jeannette Gelber’s hip was replaced with a Stryker Trident hip, she began to have pain and noticed a squeaking sound when she walked. She was told the artificial hip was defective, and thereafter, filed suit. The defendants filed a motion to dismiss, and the plaintiff conceded the dismissal of claims based on failure to warn, improper labeling, improper or misleading marketing and/or defective design. Therefore, the only claims remaining in the defendants’ motion to dismiss were those of negligence, strict liability and breach of warranty claims based on alleged violations of the FDA’s manufacturing requirements.
And then, the defendants dropped the atom bomb: federal preemption based on the rigorous review the FDA had used in approving the Trident hip for use and distribution; in fact, as a so-called “Class III” device, the Trident hip had been subject to the “rigorous regime” of premarket approval (“PMA“) within the FDA, a process under which only 1% of devices were scrutinized in 2005:
The PMA process is lengthy-it takes over 1,200 hours to review each application-and involves the submission of volumes of comprehensive information on the device. The FDA only grants premarket approval if it finds there is a reasonable assurance of the device’s safety and effectiveness. After approval, the FDA still retains regulatory control over the device. The manufacturer is prohibited from changing “design specification, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness” without first obtaining FDA’s approval.
There is a way around federal preemption, and the plaintiffs tried it in this case: the plaintiffs claimed that the defendants violated FDA manufacturing requirements, a so-called “parallel” claim. Here’s how a parallel claim would work, in the Court’s opinion
Riegel [v. Medtronic, Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008)] specifically found that claims of strict liability, negligence and breach of implied warranty were expressly preempted. However, there is an absence of Supreme Court guidance on whether the [Medical Device Amendments of 1976] preempts state requirements of general applicability that only incidentally regulate medical devices, e.g., Uniform Commercial Code or unfair trade practice laws, since Riegel refrained from analyzing the exception provided by 21 U.S .C. § 808.1(d)(1). Riegel, 552 U.S. at 328-29 (” § 808.1(d)(1) can add nothing to our analysis but confusion…. Neither accepting nor rejecting the FDA’s distinction between general requirements that directly regulate and those that regulate only incidentally[,] the regulation fails to alter … the outcome of this case”). Post-Riegel, courts have struggled to determine whether state-law claims that only incidentally regulate medical devices are still available insofar as they are “parallel” to federal requirements. . . . This Court finds it persuasive that since the Supreme Court did not carve out a safe harbor for state laws that only incidentally regulate medical devices, the same preemption analysis applies and only those claims that are parallel to federal requirements are permissible.
(internal citations omitted). This might have been a great argument for the plaintiffs, except that the court held that they did not sufficiently plead claims “grounded in violations of federal law and/or requirements.” The pleadings didn’t provide the requisite amount of factual detail and specificity to survive the defendants’ motion to dismiss and, therefore, the remaining claims of the plaintiffs were dismissed. Pesky pleadings. However, the Court stated that “because courts have only recently articulated how a plaintiff can successfully plead a parallel claim,” the plaintiffs would be allowed to replead.