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There have been some great duels throughout history: Plato-Aristotle, Stalin-Trotsky, Jolie-Aniston, us vs the Drug-and-Device Teenaged Daughter. It’s hard not to root for one vs the other. (We pick Aristotle, Trotsky, Aniston, and us).
Lately, we’ve said a few things about the Medtronic (8th Cir.) vs Bausch (7th Cir.) holdings on the parallel requirements exception to Riegel preemption. (Here, for example.) Medtronic applies TwIqbal and actually insists that the plaintiff plead facts and a specific federal violation. Bausch allows plaintiffs to allege general, fact less violations, on the theory that the confidentiality of company documents makes it hard for plaintiffs to be specific – at least until plaintiffs get the opportunity to take expensive, settlement-extorting discovery.
Last week, an opinion emerged from SDNY, and we think the court mostly sided with Medtronic – though not as much as we’d have liked. Gelber v. Stryker Corp., 2011 WL 1483927 (SDNY April 18, 2011) is yet another Trident hip replacement case. The plaintiff underwent the hip arthroplasty on July 21, 2004. The plaintiff started feeling pain in 2007 She had a hip revision surgery on January 26, 2009, where the Trident system was removed. Upon inspection, the surgeon saw a stripe on the ceramic head component, as well as wear on the ceramic insert.
The plaintiff filed a complaint in New York state court in 2009, it was removed to federal court, and it was dismissed on preemption grounds. But the court granted leave to amend the complaint. So the plaintiff amended. We mean, really amended. The amended complaint alleged multiple federal violations wholly absent from the original complaint. There were claims for strict liability based on defective manufacturing, negligence, breach of warranty, and loss of consortium. There were also factual allegations that the court generously construed as a claim for failure to warn.
It’s hardly surprising that the defendant again moved to dismiss on the grounds of preemption. It worked once and it looked like it should work again. The Gelber court begins by saying a lot of the right things. It quotes the Medtronic district court language about how “Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption.” It also quotes the Medtronic language that “Plaintiffs cannot simply incant the magic words ‘defendants violated FDA regulations’ in order to avoid preemption.”.
But the Gelber court also starts quoting Bausch. Uh oh. And then Gelber cites Bausch and the dissent in Medtronic about how critical information needed for specific pleading is kept confidential as a matter of federal law. Yikes. It’s as if Gelber is trying to bridge the “narrow gap” between Medtronic and Bausch.
Some of that is good and some of that is bad. The bad part is that the court preserved the manufacturing defect claim on the theory that the plaintiff had adequately alleged a violation of FDA current good manufacturing practices (CGMP) requirements – specifically, the court construed the amended complaint “liberally” to allege that the Trident system was defective because it was manufactured with “manufacturing residuals” and was therefore “adulterated”. What facts underlie such allegations? Not much. The plaintiff pointed to a 2007 warning letter and a 2008 voluntary recall at a manufacturing facility. Again, construing things “liberally,” the court concluded that the plaintiff “plausibly alleged that the excessive levels of manufacturing residue was one of the ‘several different factors’ that ultimately led to breaks in the lubrication layer and the stripe found” on the implanted system.
Look: we don’t think a CGMP violation is enough for a parallel violation. Other courts, including Medtronic, have said so, pointing how they are simply too generic. But even aside from that doctrinal point, the facts of Gelber (the stripe) should make a factual distinction – dare we say it? – plausible.
The Gelber court gets more right than it gets wrong. The court dismisses the failure to warn claims for lack of causation, lack of any applicable federal regulation, and for preemption. The court holds that Buckman preempts the plaintiff’s claim that the defendant failed to report certain clinical findings to the FDA. The plaintiff also claimed violations of CGMP requirements to identify and correct device problems, but here the court read the relevant CGMP requirements closely and found that the plaintiff’s interpretation wasn’t just liberal – it was a rewrite. Similarly, the court rejected the plaintiff’s “vague and conclusory allegations” that the defendant “failed to develop practices and procedures” to assure compliance with multiple federal regulations. That sounds like bootstrapping. It is also madness to say that private citizens can become roaming enforcers of federal regulations. The court dismissed those claims.
In effect, the Gelber court splits the difference between Bausch and Medtronic. (It also splits the difference on the warranty claims in a way that is not especially interesting or useful). So maybe what we said at the outset is wrong; not everybody feels the need to pick sides. But law, like sports, is more fun when there’s a rooting interest.