This post is from the non-Reed Smith side of the blog only.

It has been almost two months since we’ve posted about an InFuse decision and in case you’ve forgotten, the InFuse litigation has been making a lot of great off-label use law (see most recent post with links to early posts).  And now Mississippi joins the growing number of courts that have said Class III medical device claims are preempted, regardless of whether the device was put to an off-label use.

The case is Ledet v. Medtronic, Inc., 2013 WL 6858858 (S.D. Miss. Dec. 30, 2012).  Plaintiff’s doctor chose to implant the InFuse bone graft in combination with a Cougar spacer cage instead of an LT-Cage which is the cage that was approved by the FDA for use with the InFuse bone graft.  Id. at *1.  Not surprisingly, therefore, plaintiff’s claims focus almost exclusively on off-label promotion.  It should also come as no surprise that plaintiff’s strict liability and negligent failure to warn and strict liability design defect claims were quickly and easily dismissed as expressly preempted.

  • Strict Liability Failure to Warn – preempted because claim is that defendant should have provided warnings different from or in addition to those required by the FDA.  Id. at *4.
  • Strict Liability Design Defect – preempted because claim attacks the “risk/benefit analysis that led the FDA to approve” the device.  Id.

Following the same reasoning applied to the design defect claim, the court also held plaintiff’s breach of express and implied warranty claims were expressly preempted:  “allowing a plaintiff to proceed with a breach of warranties claim based on the alleged unsafe nature of a device would conflict with the FDA’s prior approval of that device.”  Id. at *6.

As with the majority of other InFuse decisions, the Ledet court also dismissed plaintiff’s negligence claim based on alleged improper off-label promotion because “such a claim does not exists under state law in the absence of the FDCA.”  Plaintiffs cannot sue for direct violations of the FDCA, that’s the job of the federal government.  So, this claim is impliedly preempted under Buckman.

The court also dismissed as “vague and conclusory,” plaintiff’s general allegation that defendant failed to comply with federal regulations.  Id. at *5.   No “magic word” claim here.

Which brings us to negligent misrepresentation and fraud. This is the one area where some courts have differed on the question of preemption.  Some courts have held that if plaintiff claims that the defendant made fraudulent statements in marketing and promoting the device, such claims are traditional state-law claims that run parallel to the federal requirement that manufacturers’ representations “not be false or misleading.”   The Ledet court, however, found both types of claims preempted.  First, to the extent the fraud claim is based on alleged misrepresentations or omissions in the device’s warnings and labels, the claim is expressly preempted just like failure to warn.  Id. at *4.  To the extent the fraud claim is based on marketing or promoting off-label uses, “off-label use is a creature of the FDCA.”  Id. (citation and quotation marks omitted).  Therefore, “fraud claims related to off-label use arise solely out of the FDCA, not state substantive law, and are subject to implied preemption.” Id.

As to negligent misrepresentation, the court held that to allow such a claim would “establish design, manufacturing, labeling, and warning requirements different from, or in addition to, federal requirements for the Infuse Device.”  Id. at *5.  Express preemption.

Now, on a motion to dismiss, even when the court finds every claim preempted, the end result is often a dismissal without prejudice to afford plaintiff another chance to state his or her claims.  In Ledet, however, the court found another reason for dismissal that would make any attempted amendment futile.  Plaintiff’s claims were also time-barred under Mississippi law.  Plaintiff’s surgery took place in April 2007 and he filed his lawsuit in April 2013.  But plaintiff had his first revision surgery in June 2009, at which time a CT scan showed bone overgrowth at the very areas of his spine where the device was implanted. This, the court concluded, was the latest plaintiff could have discovered his injury and therefore he had three years from June 2009 to file suit.  Id. at *6-7.  So, the case was dismissed with prejudice.

We’ll start the clock until our next InFuse post.