The decision in Tsavaris v. Pfizer, Inc., 2016 U.S. Dist. LEXIS 11465 (S.D. Fla. Feb. 1, 2016) can be summed up neatly as the court telling plaintiff – I’m not going to do your work for you. From the opinion it sounds like the complaint in this case was a fairly typical throw in everything plus the kitchen sink and hope to sort it out later (36 page fact section, id. at *7). But that’s a shotgun pleading – “one in which it is virtually impossible to know which allegations of fact are intended to support which claims for relief.” Id. at *6. And that’s not allowed under TwIqbal.
Plaintiff brought claims for strict liability design defect, failure to warn, negligence, and negligent misrepresentation – and stumbled on all four counts. On design defect, plaintiff made general, conclusory statements about the drug’s risks outweighing the benefits and the product being unreasonably dangerous. Id. at *6. But when the court went looking for the facts to support those claims, plaintiff pointed to allegations scattered throughout the fact section of the complaint. Id. at *7. The court said it wasn’t its job to sift through the facts and puzzle together the grounds for plaintiff’s claim. Id.
Plaintiff’s failure to warn claim suffered the same flaw, plus a few more specific problems. Plaintiff used the shotgun approach again (citing to allegations spread out in the introductory paragraphs and pointing to allegations asserted in other causes of action but not incorporated into the failure to warn claim). Id. at *9. More importantly, the court took issue with the fact that plaintiff did not plead the actual risks warned of, whether that warning accompanied the product she received, or how the warnings should have been revised to no longer be inadequate. Id. at *8. In other words, if you are going to allege failure to warn you have to include the warning and your proposed change to the warning in the complaint. And relying on the drug’s label by attaching it to the briefing on the motion to dismiss doesn’t fix the problem. Plaintiff can’t amend her complaint in the briefing. Id. at *9.
Plaintiff’s negligence claim was premised on four theories: failure to test; failure to conduct post-marketing surveillance; failure to warn; and deceptive marketing. First, the court struck the failure to test claim as not recognized as an independent cause of action under Florida law. Id. at *10. Second, negligent failure to warn failed for the same insufficient pleading as strict liability failure to warn. Id. at *12. As for post-marketing surveillance, the court wasn’t prepared to equate that to fraud-on-the-FDA, but did engage in an impossibility preemption analysis. The court said that for plaintiff to avoid preemption of her negligence claim, she would have to allege that defendant violated a state tort duty and that defendant “could have acted in line with [its] federal obligations while lawfully discharging [its] state duty.” Id. Since plaintiff did not makes those allegations, the court dismissed the claim.
Finally, the court dismissed plaintiff’s negligent misrepresentation claim primarily because plaintiff relied on a version of the drug’s label that significantly post-dated plaintiff’s use of the product. Id. at *14. Even if you assume, for argument, that the statements in the label were inaccurate or misleading, plaintiff can’t allege, let alone prove, that either she or her physician relied on them in taking or prescribing the drug. Id. Even if plaintiff cited to temporally relevant statements, she failed to include the when, where and who that are essential to reliance, which is essential to a negligent misrepresentation claim. Id. at *15.
Based on all of these problems, the court tossed all the claims and told plaintiff to start over. But, the decision imposes fairly stringent pleading requirements – ones that will either find us back here talking about another successful motion to dismiss or will result in a complaint that is more factually dense and precise at the same time.