We talk about a lot of motions to dismiss on this blog and being a defense blog, the overwhelming majority are successful.  Motions to dismiss being what they are – motions that examine only the pleadings and are generally brought early on in the life of a lawsuit – a fair number of the motions we bring to your attention are granted without prejudice.  In other words, courts frequently give plaintiffs another chance – a second bite at the apple.  And so many of our posts on these cases end with a caveat that the case could be resurrected or a prediction that plaintiff’s amended complaint will meet the same demise.  We also usually tell you we’ll report back with further developments.             

Well, so you know we aren’t making hollow promises, we have just such an update today.  Back in October, we told you about McClelland v. Medtronic, Inc., (M.D. Fla. Sep. 27, 2012) (see post) in which the court dismissed plaintiff’s claims -- negligence per se and failure to warn -- arising from the implantation of a pacemaker on the grounds of no private right of action to enforce the FDCA and preemption.  Relying on   In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.2010), the McClelland court granted plaintiff leave to file an amended complaint, noting that “a narrow gap exists for a plaintiff’s state law claim if it is to avoid express or implied preemption....”  Slip op. at 13.             

Last week, the court found that plaintiff’s amended allegations failed to fit in that “narrow gap.”  The claim that was previously dismissed was premised on defendant’s failure to report certain adverse events to the FDA.  Plaintiff’s amended complaint isn’t all that different:  “Plaintiff alleges that Defendant ‘fail[ed] to promptly and accurately report to the FDA incidents and problems with the [pacemaker] that occurred after the device received [PMA]’” in violation of FDA regulations.  McClelland v. Medtronic, Inc.__ F.Supp.2d __, 2013 WL 2109965, at *4 (M.D. Fla. May 16, 2013).  So, it isn’t surprising that the court this time found that to the extent plaintiff was alleging a breach of duty owed by defendant to the FDA, the claim was implied preempted pursuant to Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  McClelland, 2103 WL 2109965, *6.   The claim also failed because no private right of action exists under the FDCA.   Plaintiff cannot “recast a claim for violation of the FDCA as a state-law negligence claim” because “the United States rather than private litigants are authorized to file suit for noncompliance with the medical device provisions.”  Id. (quotation marks and citations omitted).           

But plaintiff also claimed that by alleging a duty to notify the FDA, she was actually contending that defendant breached a duty owed to plaintiff.  Plaintiff argued that

the essence of [her] claim is not that the defendant breached a duty to the FDA, but that it breached a duty to [the Decedent], who was in the foreseeable zone of risk created by [Defendant] – namely the duty to provide an adequate warning of the dangers of its product, which in this case paralleled its duty to comply with the conditions of its PMA. 

Id. at *4.   Ah, the magic word “parallel.”   For plaintiff’s state law claims to parallel federal regulations, and thereby arguably fit in that “narrow gap” of claims that are not preempted, they must not impose any requirement different from or in addition to FDA requirements.  Id. at *5.  And while there is a comprehensive set of regulations governing a manufacturer’s duty to report adverse events to the FDA, “[p]laintiff has not pointed to any statute or regulation which imposes a duty on the manufacturer to inform patients about such incidents.”  Id.  So, the court quoted from its first decision dismissing plaintiff’s claims.  We quoted it in our prior post, but like the court, we think it’s worth a second mention:

Under Plaintiff’s theory of liability, Defendant would be required to provide information to ... patients beyond those on the device’s labeling. Accordingly, the state and federal requirements are not “genuinely equivalent” because Defendant could be held liable under the state law without having violated the federal law.

Id.  For the second time, plaintiff’s claims were held to be both expressly and impliedly preempted.  And this time, the court said two tries was enough.  So unless plaintiff appeals, we can now close the book on McClelland; satisfied that the story ended as well as it began.