The Fifth Circuit’s decision in Bass v. Stryker allowing a parallel violation claim to survive a motion to dismiss based on allegations of violations of CGMPs earned an honorable mention in our worstdecisions for 2012.  The reason it wasn’t ranked higher is largely because the complaint in that case was fairly detailed and as we posted here provided a pretty good checklist of what a plaintiff has to have pleaded, under TwIqbal, to state an unpreempted manufacturing defect "parallel violation" claim:  

  1. The identity of the particular product that the plaintiff claims caused injury;
  2. The nature of the claimed “parallel” violation (“the FDA had previously warned             [defendant] of bioburden in excess of FDA regulations in its final rinse of the [device]”);
  3. That the violation could be causal in that it pertained to the plaintiff's device (“after [plaintiff's] surgery, [defendant] ultimately voluntarily recalled [the device], including the [device] specifically used in [plaintiff's] implant”);
  4. The nature of the plaintiff's injury;
  5. That the violation could be causal in that it bore a relation to the plaintiff's claimed injury (“the lack of bony ingrowth is a known effect of an excess of bioburden and manufacturing residuals on [the device]"); and
  6. That the alleged violation be of a sufficiently specific FDA regulation (which could include a CGMP as applied to the device by particular specifications in the approved PMA).

Bass v. Stryker, 669 F.3d 501, 510, 511-12 (5th Cir. 2010). 

For pleading standards, these aren’t too bad.  What’s even better is when their application leads to a dismissal.  Which brings us to today’s case – Williamston v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 68083 (W.D. La. May 15, 2014).  Plaintiff’s implanted cardioverter-defibrillator (“ICD”) malfunctioned causing plaintiff to receive multiple electrical shocks.  The ICD was reprogrammed (apparently successfully) and remained implanted in plaintiff.  Id. at *3.  The ICD is a Class III PMA medical device. Id.  Plaintiff’s products liability claim against the manufacturer is premised on alleged violations of several CGMPs.  Id. at *3-4. While our preference would be for a decision finding that CGMPs are too general to support a parallel violation claim, the court was constrained by the Bass ruling, so we’ll settle for a decision that this plaintiff didn’t satisfy the Bass criteria.

Using the above list, most plaintiffs don’t miss steps (1) and (4).  Plaintiff Williamston is no different.  He identified the product and alleged he was injured.  But he missed all of the remaining four points. 

Step 2:  What’s the defect?  In Bass it was the excess of bioburden.  In Williamston, the question is unanswered.  The complaint contains a list of federal regulations, “but does not articulate the existence of a specific manufacturing defect.”  Id.at *15.  Claiming that the device “deviated” from certain “specification and/or improvement standards,” hardly meets the specificity requirements in even the Fifth Circuit.  Id. at *15 n.16. The complaint did reference previous recalls of defibrillator leads manufactured by the defendant, but . . .

Step 3:  What’s the connection to the particular device? Plaintiff “concede[d] that the lead in question here was never included within a recall.”  Id. at *16. 

Step 5:  What’s the connection to the alleged injury? Although not addressed in the decision, without an alleged defect, plaintiff can’t satisfy this requirement either.  There is nothing to connect to the injury to.

Step 6:  Is there a violation of a specific FDA regulation that pertains to this device?  On this point we are indeed happy to see that courts in the Fifth Circuit aren’t reading Bass to allow parallel claims based simply on any alleged CGMP violations. Specificity and a tie to the device in question are still required:

The plaintiffs in this case have failed to set forth the specific federal violations upon which their parallel claims are predicated. As a result, the court finds that the plaintiffs have failed to successfully state a parallel claim. The simple listing of various federal regulations is insufficient to successfully plead a state law claim predicated on the violation of federal requirements.

Id. at *21-22. 

Plaintiff’s primary opposition to the motion to dismiss was that “discovery is necessary in order to determine what federal regulations the defendants have violated.”  Id. at *17.  ButTwIqbal effectively put an end to the “sort it out in discovery” approach to litigation.  To get over the hump, to go beyond the pleadings stage, and to get discovery, you have to plead something more than a general belief that because you sustained an injury the manufacturer must not have complied with FDA manufacturing specifications and processes.     

All of the above focus on the federal regulations allegedly violated, but the Williamston court also commented on the other part of the parallel – the state law cause of action:

The plaintiffs have also not been clear as to which state law causes of action correspond to, or "parallel," which specific violations of federal regulations. Mere assertions that a defendant is liable because a given product deviated from federal specifications and regulations without any more specificity are precisely the types of legal conclusions of which Rule 12(b)(6) motions are designed to dispose.

Id. at *22.  Oh right, there still needs to be a breach of a state law duty.  Let’s call that Step 7.  Plaintiff missed that one too. 

The court recognized the difficult challenge plaintiffs face in pleading parallel violation claims with sufficient specificity.  And while wary of whether plaintiff in this case could be successful, the court afforded plaintiff an opportunity to amend his complaint. But without Bass type assertions – a recall, Warning Letter, or FDA citation of a violation linked to the particular ICD and plaintiff’s alleged injury, it is unlikely Plaintiff Williamston will be able to sustain his manufacturing defect claim.