In a week with the Supreme Court’s Bartlett preemption ruling, every other drug and device case looks like small potatoes. But we actually like small potatoes. And we love tater tots. And we love the idea from Evan Goldberg (like Seth Rogen, a very funny Canadian, and like Seth Rogen, a screenwriter of Superbad and This is the End) of making that charming Canadian concoction called poutine with the usual cheese curds and the not-so-usual tater tots. Let’s pause over that scrumptious thought for a moment.
Our tasty tater tot of a case for today’s consumption isLederman v. Howmedica Osteonics Corp., 2013 WL 3964388 (M.D. Fla. June 19, 2013). In Lederman, the plaintiff alleged injuries from the implantation of an artificial hip prosthesis. After some initial skirmishing, the only legal claim left was for negligent manufacturing. That posture makes this case a little different from most drug and device cases, where failure to warn claims tend to occupy the most prominent position. The artificial hip device in Lederman had been approved by the FDA through the Premarket Approval (“PMA”) process. As almost all of our readers know, back in 2008 the Supreme Court held in the Riegel case that state-law claims against PMA medical devices are preempted when they seek to impose requirements that are“different from, or in addition to” the “detailed federal oversight” involved in the PMA. Thus, it is not even a little bit surprising that the defendant in Lederman filed a motion to dismiss the complaint on the grounds that the Medical Device Amendments of 1976 preempted all of the plaintiff’s claims.
The plaintiff in Lederman attempted to evade Riegelpreemption in the usual manner – by cobbling together a purportedly “parallel claim” -- a claim under state law that supposedly mimics federal requirements. Here, the plaintiff alleged that the defendant violated several federal regulations relating to manufacturing. Specifically, (and in these parallel claims cases there is precious little that is specific) the plaintiff pointed to a warning letter the FDA sent to the defendant in March 2007 regarding an inspection of a manufacturing plaint in Ireland, as well as another warning letter later that year regarding an inspection of a manufacturing plant in New Jersey. The plaintiff alleged that the warning letters addressed violations of Current Good Manufacturing Practice (“CGMP”)requirements at both plants, and that the allegedly defective hip was manufactured at one of those two plants.
Putting aside awful aberrations like the Seventh Circuit’sBausch opinion, most courts insist that plaintiffs specify what the alleged parallel violation is and how it played a role in the plaintiff’s injury. The Lederman complaint failed both tests. First, the plaintiff failed to allege which “particular federal specification” or “specific PMA requirements”that the defendant violated in manufacturing the particular hip replacement at issue. Lederman, 2013 WL 3064588 at *4. A violation of CGMP is too general and doesn’t cut it. The plaintiff did allege that the device “contained dimensional mismatches” leading to“altered articulating surface geometries,” which, in turn, resulted in introduction of an unreasonable amount of wear particles into the plaintiff’s body. That is a good deal more detail than most plaintiffs alleging“parallel violations” manage to concoct. Thus, the good defense result inLederman is especially noteworthy. The problem for the plaintiff is that he was required to “allege the specific federal requirements applicable to his medical device that are identified in the warning letters, along with the violations of those requirements set forth in the warning letters.” Id. That did not happen in Lederman. Finally, the plaintiff must allege how those violations caused the claimed defect and injury. How do the violations stated in the warning letters relate to the plaintiff’s medical device and alleged injury?
The plaintiff cited the warning letters generally, but never showed that the warning letters are applicable to his claims. Neither the plaintiff nor the defendant provided the warnings letters to the court, but the court understood that it could take judicial notice of them. Id. No matter what the letters say, one wonders how warning letters issued in 2007, regarding inspections in 2006 and 2007, and referencing complaints dating back to 2005, could relate to the plaintiff’s medical device, which was implanted in 2004. Thus, one wonders why the court dismissed the case without prejudice. Perhaps the court’s allusion to “a final opportunity to plead a parallel claim based upon the warning letters, provided that Plaintiff can do so consistent with his Rule 11 obligations” reflects both charity and skepticism on the court’s part. Id.