Photo of Michelle Yeary

When a decision says the Court finds much of the reasoning in Bausch, Stengel, and Hughes particularly persuasive, you don’t have to be the Amazing Kreskin to guess that we aren’t going to like the ruling.  You just need to be a regular reader of this blog.

Unfortunately, that’s precisely what Waltenburg v. St. Jude Medical, Inc., 2014 U.S. Dist. LEXIS 98369 at *35, *56 (W.D. Ken. Jul. 18, 2014) does say.  We’ll give the opinion some credit for a fairly thorough discussion of the relevant case law going both ways on preemption and TwIqbal – but it loses most of its appeal by landing at the wrong end of the spectrum.

The case involves an implantable cardioverter defibrillator (ICD). Plaintiff alleges that certain of the wires (or leads) have eroded causing the ICD to inappropriately administer electrical shocks to plaintiff.  Id. at *1-3.  The ICD is a Class III, PMA medical device. Defendant moved to dismiss the complaint based on preemption and TwIqbal.

The court examined the sufficiency of the pleadings first, framing the question as

is it sufficient to allege that the Defendants violated FDA regulations by deviating from the FDA-approved processes and procedures in the PMA or, instead, must the Plaintiffs identify the particular FDA regulations and set forth facts pointing to the particular PMA requirements that are alleged to have been violated?

Id. at *25.  We believe the latter is the appropriate standard and the court acknowledged it is one that has been adopted by many courts.   Persuaded by Bausch, however, the court employed the former.  The former sounds to us a lot like “magic words” pleading that doesn’t meet the TwIqbal “plausible on its face” requirement.  This blog is loaded with decisions that say referencing violations of FDA regulations in the abstract without identifying the particular regulation and violation isn’t enough for Rule 8 or for preemption.  Here, the court acknowledges that the complaint doesn’t identify the specific PMA requirements allegedly violated, but then concludes that “the absence of such details can hardly provide a solid basis for dismissing their claims at this stage.”  Id. at *35.  Isn’t that precisely what TwIqbal says The allegations in a complaint must rise above the speculative level.

Having decided that the complaint need not identify the specific regulations allegedly violated, the court also found that plaintiff Waltenburg’s complaint wasn’t as bad as others that had been dismissed.  From the opinion, we gather that the complaint did contain some “allegations as to how Defendants deviated from the specifications in the PMA.”  Id. at *34, *38-40.  Still doesn’t look like much meat on the bones, but it does appear to contain a bit more than we are used to seeing.

Moving on to preemption, the court’s analysis is hamstrung by its ruling that the non-specific allegations were sufficient.  One bad decision begets another.  Defendant argued that plaintiff’s strict liability and negligent manufacturing defect claims were expressly preempted because they were not parallel to the PMA requirements for the device.  Id. at *40.   The court essentially says we don’t know if the claims are parallel or not because there isn’t enough detail in the complaint, so we’ll let the claims stand.  Id. at *45-48.  And we’re right back to the purpose of TwIqbal in the first place.  If there aren’t enough well-documented and well-supported facts in the complaint to allow the court “to draw a reasonable inference that the defendant is liable,” the claim should be dismissed.  Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).   Instead, the court ruled that because it was not requiring plaintiff to allege specific violations, the court “is unable to compare the particular state and federal requirements at issue.”  Waltenburg, 2014 U.S. Dist. LEXIS 98369 at *46.  We can think of a way this could be achieved.  Dismiss the complaint and require plaintiff to re-file one that meets federal pleadings standards.  Rather, the court invites defendant to re-raise preemption at the summary judgment stage, after expensive and time-consuming discovery.

Unfortunately, Bausch wasn’t the only case this court found persuasive.  It also decided to take a page from Stengel and Hughes and allow plaintiff to assert a failure to warn claim based on failure to report adverse events to the FDA.  Id. at *52-57.  The court found that plaintiff’s failure to report claim is “based on Defendants’ failure to comply with FDA regulations” and therefore not preempted.  Id. at *56-57.  Adhering to the Stengel and Hughes misapplication of Buckman, the court also concluded that the claim was not implicitly preempted.  And, like those other courts, the Waltenburg court also glosses over defendant’s very legitimate argument that there is no state law duty to report to the FDA.

With an abundance of precedent going the other way, it is disappointing to see a court swayed by some of our least favorite decisions. While the decision leaves the door open to re-visiting these issues after discovery that’s a step back from the heightened TwIqbal pleading standards that we aren’t happy to see. Maybe one of Kreskin’s New Year’s Day predictions for 2015 will be the demise of BauschStengel, and Hughes.  We can dream.