Starks v. Coloplast Corp., 2014 U.S. Dist. LEXIS 19611 (E.D. Pa. Feb. 18, 2014), brings us another favorable preemption ruling.  This is not a mass tort.  It appears to be a one-off complaint filed in Pennsylvania state court and, since Coloplast is a Minnesota company, removed to federal court where Coloplast’s preemption motion might be better received.  It was.

The product was the Titan OTR Inflatable Penile Implant.  It had been implanted in the plaintiff and failed, requiring revision surgery and resulting in the type of difficulties that often come with that.  The Titan is a Class III medical device, however, so that brought Riegel preemption into play.

And from there, it was relatively simple.  Plaintiff’s negligence, strict liability and implied warranty claims were all preempted – and rather ordinarily.  But there are two interesting notes.  First, the plaintiff tried to concoct a claim by simply regurgitating (roughly) the standard to be met to state a parallel violation claim: the company failed to satisfy “state duties equal to, or substantially identical to, federal requirements.”  Id. at *15.  Nice try, but a whole lot more is required.  The complaint must identify the actual standard that was not met and a state law that enforces the same standard.  Plaintiff did neither.  Two, while the court on a number of occasions underscored plaintiff’s failure to identify an FDA regulation or statute that the defendant failed to satisfy, id. at *15-18, we want to highlight once again that even doing so wouldn’t have been enough.  Plaintiffs do not have the authority to bring a private right of action for violating FDA regulations.  The FDCA explicitly disallows it.  Plaintiff must instead identify a state law that independently allows private plaintiffs to sue based on the conduct that resulted in those violations.  Nothing in the court’s opinion indicates that plaintiff did so.

Not all of plaintiff’s claims were preempted.  He also brought  breach of express warranty and breach of contract claims.  The court held that such claims, if properly pleaded, can survive preemption.  Id. at *18-22.  But plaintiff hadn’t pleaded facts to support the existence of an express warranty or a contract.  Plaintiff relied, for the most part, on statements made about the product in a brochure.  The brochure, however, was given to plaintiff’s doctor, not plaintiff.  Alleging the existence of an undated brochure given to a third party doesn’t state a contract or warranty claim, particularly given the lack of factual allegations surrounding an offer or acceptance of a contract or warranty. Id. at *21-22.  So the court dismissed these claims, but without prejudice.

Finally, this is another case in which the court accepted and considered publicly available FDA documents without converting the motion to dismiss into a summary judgment motion. Id. at *2-3.  This is becoming more and more common and is, we believe, proper.  Considering such documents allows the defense to inject a dose of reality into a motion that is based on a complaint that might be trying to tiptoe around it.