We say today’s case is about SIRVA (shoulder injury related to vaccine administration), but plaintiff tried her best to run from that allegation in her opposition to defendants’ motion to dismiss.  That’s because a SIRVA case runs up against not only a preemption obstacle, but also serious duty and causation barriers.  But since the court was not accepting on the fly pleadings amendments, plaintiff’s first amended complaint was dismissed, and she was offered one final opportunity to try to plead a case that could survive preemption and causation.  As we read the opinion, we don’t think that is likely.

The case is Garcia v. Sanofi Pasteur Inc., 2023 U.S. Dist. LEXIS 175717 (E.D. Cal. Sep. 29, 2023).  Plaintiff received injections in her right shoulder for both the pneumonia vaccine and the TDaP vaccine.  Two days later she returned to the clinic complaining of right shoulder pain. The pain continued and eventually, plaintiff was diagnosed with a partial tear of her rotator cuff and “frozen shoulder,” which required surgery.  Id. at *2-3.  In her complaint, plaintiff alleged that the package inserts, patient information sheets, and vaccine information sheets for each vaccine did not include warnings for chronic pain, torn rotator cuff, and frozen shoulder.  Id. at *6.  But that defendants knew or should have known of these side effects because her injuries are typical for someone suffering from SIRVA and that SIRVA claims had been filed “for years” before plaintiff received her vaccinations.  Id.   

Plaintiff’s first failure to warn claim was that defendants failed to warn her directly or the general public of these risks.  That claim is expressly preempted by the Vaccine Act.  Id. at *11 (no liability due to “manufacturer’s failure to provide direct warnings to the injured party.”  42 U.S.C. § 300-aa-22(c)).  Plaintiff tried to argue that her claims fell within a preemption exception because defendant failed to exercise due care.  The court was not sure the exception applied at all to the type of claim plaintiff was asserting but did not have to decide that issue because the complaint did “not contain any non-conclusory factual allegations suggesting the absence of due care.”  Id. at *13.  The complaint merely reiterates that defendants failed to warn and/or that the warnings were defective.  Plaintiff did not plead any facts to establish a due care exception. 

Plaintiff’s failure to warn her directly or the general public also failed under the learned intermediary doctrine.  Under California law, the only failure to warn claim is a failure to warn plaintiff’s medical provider/vaccine administrator.  Id. at *15. 

And, as to that claim, plaintiff failed to plead either a duty to warn or causation.  California does not require a manufacturer to warn of a known or obvious risk.  Id.  Because plaintiff pleaded that SIRVA was a well-known risk in the medical community, it stands to reason that defendants did not have to warn about it.  So, in opposition to the motion to dismiss, plaintiff argued she was not really suffering from SIRVA and tried to introduce facts not alleged in her complaint.  The court was only willing to look at plaintiff’s claims as “currently couched” – “that she suffered a well-known ailment associated with the improper administration of a vaccine.”  Id. at *16.  Therefore, plaintiff failed to allege that defendants had a duty to warn her medical provider.

Plaintiff also failed to plead causation—that a different warning would have changed her doctor’s prescribing decision.  Id.  Plaintiff only alleged that she would not have consented to the vaccines if she had received a different warning.  As noted above, plaintiff has no direct-to-consumer warnings claim, so her decision is irrelevant.  Moreover, plaintiff did not allege that the vaccines themselves, as opposed to their improper administration, caused her injuries.  The complaint alleges plaintiff suffers from SIRVA, which she does not dispute is the result of improper administration.  While plaintiff may actually want to claim she suffered a torn rotator cuff and “frozen shoulder,” the complaint also does not allege how those conditions are caused by the vaccines rather than their administration.  Since the court cannot go beyond the face of the pleadings, plaintiff’s claims were dismissed for failure to adequately plead causation.  Id. at *17.

Plaintiff is going to have to put a lot of distance between herself and SIRVA to plead a case against the vaccine manufacturers that has a chance of surviving preemption or TwIqbal.  She may hope the third time is the charm, but we’re betting on three and out.