Sometimes repeated litigation concerning a particular product can help establish legal standards applicable to all cases, especially if many people received the product and try to bring suits. Plaintiffs try one theory after another; courts reject most of those theories; and the resultant mosaic of decisions forms a comprehensive picture of which claims are viable and which are not. Litigation involving breast implants, fen phen, and many other drugs (not to mention silica and other products beyond this blog’s scope) have set generalized standards for rejecting junk science, determining causation, weeding out fraudulent claims, and many other issues.
On a smaller scale, lawsuits about the Trident hip replacement system are helping to clarify the requirements to plead a parallel violation claim under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The latest example is Gelber v. Stryker Corp., 2010 U.S. Dist. LEXIS 97692 (S.D.N.Y. Sept. 14, 2010).
Plaintiff Jeanette Gelber and her husband claimed that her replacement hip prosthesis squeaked and hurt, so she sued. Defendants moved to dismiss because the Trident system received premarket approval from the FDA and therefore state law claims are preempted.
Plaintiffs argued that they pled parallel claims permitted under Riegel, but their complaint included no facts, only an unsupported statement that Defendants failed to act as required by federal law. The court surveyed the post-Riegel case and found that just about every case except Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009) (more of our criticism of Hofts here), required particular facts supporting a parallel violation claim. The court became the latest to stab Hofts in the heart with a Trident and followed the majority rule. The court held that “Twombly clearly requires more than a conclusory statement that Defendants violated federal code and rule.” 2010 U.S. Dist. LEXIS 97692 at *14. Because Plaintiffs’ complaint said nothing more, and because the complaint failed to provide any link between the alleged violations and the claimed injury, it failed to state a parallel claim.
The court granted plaintiffs leave to replead “because courts have only recently articulated how a plaintiff can successfully plead a parallel claim.” Id. at *18. We might quibble a bit with the court here, as there have been a ton of cases in the last two years holding that simply pleading a violation of FDA regulations is not enough and explaining exactly what Riegel and TwIqbal require. We cited about a dozen of those cases here.
Courts rarely impose Rule 11 sanctions any more, but aren’t we approaching the time when a court could at least slap a plaintiff or plaintiff’s counsel on the wrist for pursuing one of these claims in the face of established precedent? Even if the law were not clear when the plaintiff filed the complaint a couple of years ago, it is clear as can be now, when a plaintiff must decide whether to submit a brief opposing a motion to dismiss or fall on his or her sword and ask for leave to replead. No plaintiff’s lawyer who makes “an inquiry reasonable under the circumstances,” which is what Rule 11 requires, could believe that a conclusory parallel violation claim without supporting facts is “warranted by existing law.” Fed. R. Civ. P. 11(b)(2). We hope that the time when plaintiffs get a free pass for pleading parallel claims without any facts is coming to an end.