These days, you are probably expecting a vaccine post to be about Covid.  And while we are sure we are not done with litigation in that field, for today at least we thought we would harken back to a good, old-fashioned, garden variety vaccine products liability case and some tried and true preemption.

The plaintiff in Herlth v. Merck & Co., Inc., 2022 WL 788669 (D. Conn. Mar. 15, 2022), was 15 years old in 2013 when her mother consented to plaintiff receiving the Gardasil vaccine.  Plaintiff alleges generally fine health before the first dosage, but she began experiencing dizziness, elevated heart rate, and other symptoms after her second dosage and never received the third dosage.  Id. at *1.  Plaintiff’s grouping of symptoms has been diagnosed as Postural Orthostatic Tachycardia Syndrome (POTS) and chronic fatigue syndrome (CFS).  POTS is a condition that affects the body’s ability to adjust heartrate, especially when moving from a lying to a standing position.  Id. at *2.  Before brining the current suit, plaintiff filed a petition under the Vaccine Act, 42 U.S.C. § 300aa-10 et seq. in Federal Claims court, as is required by the Act.  That claim was dismissed for “insufficient proof.”  Id.  Her current lawsuit brought claims under the Connecticut Product Liability Act (CPLA) and for common law fraud.  Subsumed under the CPLA claim were claims for failure to warn, manufacturing defect, and negligence.  All plaintiff’s claims were either preempted or failed TwIqbal.

The analysis for failure to warn involving a vaccine is the same as for a prescription drug.  The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval.  But a vaccine’s label can be changed unilaterally by the manufacturer under the “changes being effected” (CBE) regulation to reflect “newly acquired information” concerning warnings and adverse reactions, among other things.  Id. at *3.  Therefore, plaintiff’s failure to warn claim is preempted unless “she has pleaded a labeling deficiency that [defendant] cold have unilaterally changed in accordance with the requirements of the CBE regulation.”  Id.

The first part of the preemption analysis, therefore, is whether plaintiff has alleged any new information regarding the type of injury she alleges she sustained that post-dates the FDA’s approval of the vaccine in 2006 and pre-dates plaintiff’s use of the drug in 2013 – after all it is not enough for there to be new information, the alleged failure to warn must also be alleged to be a cause of plaintiff’s injury.  Id. at *4.  In examining the complaint, the court found it “replete” with allegations about potential risks of the vaccine but that “most bear no relation to [plaintiff’s] alleged injuries.”  Id.  With respect to POTS, plaintiff cited to several journal and news articles, many of which were from years after plaintiff took the vaccine.  When the court took a closer look at those from the relevant time period,

some describe no more than a theoretical relationship between Gardasil and POTS, while others consist of case reports from individual patients. Several do not specifically relate to POTS or her other injuries, and others do not appear to specifically relate to the Gardasil vaccine.

Id.  Plaintiff had not pleaded newly acquired information containing “reasonable evidence” of a causal association between the vaccine and her alleged injuries and therefore, her failure to warn claim was preempted.

Plaintiff tried to dodge this pleading deficiency by arguing that in Merck Sharp & Dohme Corp. v. Albrecht, 139 S.Ct. 1668 (2019), the Supreme Court clarified that preemption was an affirmative defense and therefore the burden is on the defendant to show the non-existence of newly acquired information.  Id. at *5.  What Albrecht actually clarified was the standard for showing “clear evidence” that the FDA would not have approved plaintiff’s proposed labeling change – part two of the preemption analysis should plaintiff establish the existence of newly acquired information in part one.  In Albrecht, part one had been conceded.  The Court made no findings regarding the pleadings requirements where part one is most definitely in dispute, like in this case.

Plaintiff’s second attempt to skirt preemption was to argue that because the Vaccine Act expressly preempts design defect claims against vaccine manufacturers, Congress “impliedly” decided not to preempt failure to warn claims.  Id.  But the court could find no basis to “infer” that when Congress made it “harder to sue a vaccine maker for design defect that it must have intended to open the floodgates to suing vaccine makers for a failure to warn.”  Id.  Conflict preemption often co-exists with express preemption.

While plaintiff tried to allege a manufacturing defect, she did not allege that the vaccine she received deviated from the standard vaccine.  Rather, plaintiff alleged that the vaccine contained ingredients or toxins that were not disclosed – but those allegations were as to the vaccine generally, not as to any flaw in the manufacturing process.  What she was really alleging was a “design defect claim dressed up as a manufacturing defect claim.”  Id.at *6.

Next, plaintiff’s complaint “lumped” together a number of “disparate theories” under the “general header of ‘negligence.’”  Id.  Most the court found dismissed by it its rulings on failure to warn, manufacturing and design defect.  What remained were claims for fraud and misrepresentation.  Plaintiff alleged both fraud to consumers via direct-to-consumer advertising and fraud to medical providers – but both failed to satisfy Rule 9’s heightened pleading requirements.

To the extent any fraud claims were based on “incomplete warnings,” they were dismissed on the same grounds as failure to warn.  As to marketing or DTC claims, plaintiffs could only identify one advertising campaign that ran before plaintiff took the vaccine.  Plaintiff claims the ads discussed the efficacy of the vaccine in preventing cervical cancer but makes contradictory allegations about whether the ads also disclosed side effects.  Id. at *8.  Regardless, plaintiff

does not allege any specific statements in the ad that were made with knowing falsity. Instead, what she describes is a perfectly ordinary advertisement, highlighting a product’s strengths while deemphasizing its weaknesses. Without more specificity, the complaint does not demonstrate with particularity or plausibility that the ad was either false or misleading.

Id.  Moreover, for fraud claims, Second Circuit law requires plaintiff “allege facts that give rise to a strong inference of fraudulent intent.”  Id. at *7.  Further, that intent cannot be based on a “general profit motive” common to all companies.  Id.  Plaintiff made only conclusory allegations about profit motive, so her fraud claims failed on this basis as well.  Id. at *8.

With respect to fraud directed to medical providers, plaintiff’s claims were even more vague.  While it mentions marketing and presentations made to doctors, the complaint “does not specifically allege how any of these marketing efforts reached [plaintiff’s] pediatrician.”  Id. at *9.  So, this claim fails for lack of a causal connection to plaintiff’s injuries.

Plaintiff also made a fraud-on-the-FDA claim which failed to meet Rule 9’s pleading requirements – but more importantly is preempted by BuckmanId.

That left plaintiff’s negligent misrepresentation claim which was “nearly indistinguishable” from her fraud claims – and therefore suffered the same fate.  Id. at *10.

Finally, plaintiff alleged a separate cause of action for common law fraud, but the court found the only claim available in Connecticut for products liability is the CPLA.  Id.