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Since the Supreme Court decided Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011), product liability litigation over childhood vaccines is rare but not extinct.  As demonstrated by today’s case — Garcia v. Sanofi Pasteur Inc., 2022 U.S. Dist. LEXIS 134330 (E.D. Cal. Jul. 28, 2022).  And while the decision does discuss preemption, this case was largely sunk by a complete failure to meet federal pleadings standards.

Plaintiff alleges that after receiving a pneumonia vaccine and a TDaP vaccine, she developed a partial tear of right rotator cuff.  Id. at *1-2.  She brought strict liability design defect, failure to test, manufacturing defect, and failure to warn claims, as well as general negligence claims against both manufacturers who both moved to dismiss.  First, the plaintiff conceded that she could not bring a design defect or a failure to test claim, so both were summarily dismissed.  Id. at *4-5, *10-11. 

The discussion of the manufacturing defect was more involved.  TwIqbal requires plaintiff to plead how the product deviated from the product’s intended design or from other identical products.  Plaintiff relied on three allegations in her complaint arguing they met the pleading requirement.  The first paragraph alleged the vaccine was defective in manufacture at the time it left the possession of the defendant.   Missing is any allegation about the condition of the vaccine at the time it was administered and, more importantly, it is only a conclusory allegation that a defect exists.  The second paragraph alleged that it was foreseeable the product would be used without inspection or testing for defects.  That too is a conclusory allegation “devoid of any factual content.”  The third allegation was that the vaccine was used in a foreseeable manner for its intended purpose.  Once again, no facts to suggest “either directly or circumstantially” that the vaccine had a manufacturing defect.  Id. at *6-9. 

Plaintiff argued that the court was setting too high a bar that could only be met by “pinpoint[ing] specifically where in the manufacturing process the alleged defect occurred.”  Id. at *9.  Plaintiff relied on an outlier case that set a much lower standard.  But even in that case the court required “a factual proposition—that the drug was not made in accordance with [the manufacturer’s] specifications.”  Id.  Plaintiff here could not even hurdle that low bar as her complaint contained no “factual allegation” only regurgitation of the elements of the claim.

To survive a TwIqbal challenge on her failure to warn claim, plaintiff was required to identify the risk that was not warned against, explain why that risk was substantial, and that the risk was known or reasonably knowable or explain how the warning was inadequate.  Id. at *11-12.  Here plaintiff tried to pull the old switcheroo—substituting a California state standard for the federal TwIqbal standard.  Plaintiff relied on a state court case describing the difference between negligent and strict liability failure to warn.  In other words, the state court decision simply stated the legal standard not a pleading standard, federal or otherwise.  In federal court, more is required that just repeating the legal standard.  Id. at *12-13.  All plaintiff alleged was that the defendant failed to warn of known dangers without even identifying what that danger was or whether it was known or reasonably knowable. 

Plaintiff tried the same argument on her negligence claims.  Citing mostly state court cases, she argued that her pleadings were sufficient because they mirrored the elements of her negligence claims.  That’s a big no-no under TwIqbal.  Without any factual allegations to even suggest defendants were negligent in their design, manufacture, or warning of the vaccines, this claim failed as well.  Id. at *14-17.

So, all of plaintiff’s claims were dismissed for insufficient pleadings, but the court still addressed the preemption argument.  The Vaccine Act established an injury compensation program for awarding damages compensation in a streamlined manner.  The trade off was that it imposed limitations on the availability of traditional tort remedies.  The Act expressly preempts design defect claims where the vaccine is accompanied by a proper warning (which is presumed if it complies with FDA requirements).  In this case plaintiff already voluntarily dismissed her design defect claims.  Defendants argued, however that the preemption should apply to her manufacturing defect claims as they are merely “re-packaged” design claims.  Id. at *20.  Since plaintiff only alleges the vaccines were defectively manufactured without alleging how they might be so, the court only could speculate as to whether the manufacturing claim was independent of the design claim.  The court was not willing to speculate and so deferred deciding this preemption issue until it could review a more detailed complaint.

Also expressly preempted by the Act are claims based on a failure to provide warnings to the claimant.  Plaintiff’s failure to warn claim was based on allegations that defendants failed to warn end users, which therefore should be preempted.   Plaintiff argued that two exceptions applied – where the manufacturer engaged in conduct that would be subject to punitive damages (intentional or wrongful conduct) or where there is clear and convincing evidence that the manufacturer did not exercise due care.  Id. at *20.  The decision discusses the “muddy waters” regarding whether those exceptions apply to failure to warn claims or just to design defect claims.  Id. at *22-23.  But regardless, because “the Complaint does not contain any non-conclusory factual allegations suggesting the absence of due care,” plaintiff did not plead any basis to apply the exceptions.  So, the court dismissed plaintiff’s failure to warn claim as preempted as well. 

Plaintiff is being given a second chance to plead her claims, which the first time around only parroted the elements of her claims.  And there is only one parrot we want more of these days, Mrs. Gambolini.