A string of decisions from the Eleventh Circuit continues to clarify what pharma plaintiffs must plead under Iqbal and Twombly. The latest such case is Gomez v. Pfizer, Inc., No. 09-22700-CIV, 2009 WL 4908937 (S.D. Fla. Dec. 21, 2009). The Gomez decision dismissed negligence and strict-liability claims without prejudice for failure to plausibly plead those claims with sufficient factual allegations. For negligence, a plaintiff must plead:

1. Each defendant’s individualized duty, including each defendant’s relationship to the product and any relationship between multiple defendants.
2. Each defendant’s specific breach of that duty.

For strict liability, a plaintiff must plead:

1. The specific product that is allegedly defective, including whether plaintiff used an over-the-counter or prescription version, or both.
2. Each defendant’s role in the design and manufacture of that product.
3. Whether the defect theory is for design, manufacture, and/or failure to warn.
4. Facts suggesting what was actually defective about the product under each of those theories.
Otherwise, allegations of simply "negligence" or "defect" really "amount to no more than bare legal conclusions."

Gomez follows the reasoning from Bailey v. Janssen Pharmaceutica, Inc., 288 Fed. Appx. 597 (11th Cir. 2008). In Bailey:

1. Strict-liability claims for design and manufacturing defects proceeded when plaintiff identified specific facts supporting both theories and made specific allegations of how the product was defective under those theories, including potential sources of those defects.
2. The strict-liability failure-to-warn claim was dismissed when plaintiff failed to plead how and why the warning was inadequate, including any explanation of the information available to the prescribing physician.
3. Every theory of negligence was dismissed when plaintiff failed to plead duty, breach, and causation as to each defendant, including the source of each individual defendant’s duty and breach relative to its role in the product’s development.

The next case in the string is Wolicki-Gables v. Arrow Int’l, Inc., No. 8:08-CV-151-T-17MSS, 2008 WL 2773721 (M.D. Fla. June 17, 2008). The general takeaway from Wolicki-Gables is that a plaintiff must do more than plead only "broad allegations of every theory of recovery against each separate [d]efendant." More specifically, though, the court listed several required factual allegations for strict-liability and negligence claims, including:

1. Specific identification of the product.
2. Facts supporting each theory of recovery as to each separate defendant.
3. Facts showing a definitive relationship between each defendant and the product.
4. Facts showing the relationship between the manufacturer and sales-rep defendants.

Finally, while the above reasoning applies equally well to consumer-fraud and negligent-misrepresentation claims, a recent non-Florida case applying Florida law, Hall v. Bristol-Myers Squibb Co., No. 06-5203 (FLW), 2009 U.S. Dist. LEXIS 121057 (D.N.J. Dec. 30, 2009), provides a more direct approach. Hall dismissed those claims for failing to plead causation and reliance in a plaintiff-specific fashion, i.e. that plaintiff and/or the prescribing physician saw and relied upon a deceptive statement or misrepresentation.

Overall, these cases provide strong arguments for drug and device manufacturers to narrow, if not eliminate, claims.

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Categories: Drug and Device Law

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