United States District Court, S.D. New York
For Joyce Benefield, Kermot Benefield, Plaintiffs: Mark Thedore Sadaka, LEAD ATTORNEY, Potts Sadaka, L.L.C., New York, NY.
For Pfizer Inc., Wyeth Pharmaceuticals Inc., Defendants: Steven Francis Napolitano, LEAD ATTORNEY, Skadden, Arps, Slate, Meagher & Flom, L.L.P., New York, NY.
OPINION AND ORDER
J. PAUL OETKEN, United States Magistrate Judge.
In May 2012, Georgia resident Joyce Benefield sought treatment for a post-operative abdominal infection. She was prescribed Tygacil, an antibacterial drug manufactured by Pfizer and its subsidiary Wyeth Pharmaceuticals, for the infection. After she began taking the drug, Joyce says that she developed a number of conditions, including vasculitis, full-body lesions, organ and vessel damage, and hair loss. Joyce and her husband Kermot Benefield (" Plaintiffs" ) bring this action against Pfizer and Wyeth (" Defendants" ) in connection with those alleged injuries. They collectively assert claims for negligence, design defect, manufacturing defect, failure to warn, breach of express and implied warranties, fraud, unjust enrichment, and loss of consortium. They also seek punitive damages. Defendants have moved to dismiss the claims under Federal Rule of Civil Procedure 12(b)(6).
For the reasons that follow, Defendants' motion is granted in part and denied in part.
I. Factual Background
A. The Injuries
Plaintiffs were, at all relevant times, married. (Dkt. No. 1, Complaint (" Compl." ) ¶ 2.) They are residents of Douglasville, Georgia. ( Id. ¶ 1.)
On May 2, 2012, Plaintiff Joyce Benefield underwent an exploratory laparotomy. ( Id. ¶ 21.) As a result of the procedure, Joyce developed a " post-operative abdominal wound infection" and was admitted to the hospital for treatment on May 11. ( Id. ¶ 22.) She was prescribed Tygacil, an antibacterial drug, for the infection. ( Id. ¶ ¶ 13, 23.) Joyce was discharged from the hospital on May 14, 2012, but was instructed to continue receiving Tygacil infusions at home. ( Id. ¶ 24.) She did so until May 24, 2012. ( Id. ¶ 25.)
About two weeks later, Joyce began to develop a set of serious medical conditions. On June 8, Joyce " sought medical attention for abdominal pain and a rash on her lower extremities." ( Id. ¶ 26.) Soon thereafter, her rash " evolved into painful, blister-like lesions," which " spread to her stomach, arms, legs and feet" and ultimately to her entire body. ( Id. ¶ ¶ 27-28, 30.) On June 14, Joyce was diagnosed with " vasculitis syndromes of the central and peripheral nervous systems." ( Id. ¶ 31.) She alleges that " [h]er pain was a constant and [that] she was confined to a bed for a period of time." ( Id. ¶ 33.) She also experienced organ damage, vessel damage, scarring, severe nerve pain, open and draining sores, and hair loss. ( Id. ¶ 34.) All these conditions, Plaintiffs allege, resulted from Joyce's use of Tygacil. ( Id. )
Tygacil, Plaintiffs allege, is a " tetracycline-class antibacterial drug" designed, manufactured, labeled, marketed, sold, and distributed by Defendants. ( Id. ¶ 6.) It is administered intravenously. ( Id. ¶ 14.) Its active ingredient is tigecycline. ( Id. ¶ 15.) Tygacil is commonly used to treat infections, including " complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia" in individuals at least 18 years of age. ( Id. ¶ ¶ 6, 17.)
On December 15, 2004, Wyeth submitted a New Drug Application (" NDA" ) for Tygacil to the Food and Drug Administration (" FDA" ). ( Id. ¶ 12.) The FDA approved an amended version of the NDA on June 15, 2005. ( Id. ¶ 13.)
Plaintiffs allege that, in July 2010, the " Warnings and Precautions" section of Tygacil's label was updated to include the following information:
An increase in all-cause mortality has been observed across Phase 3 and 4 clinical trials in TYGACIL-treated patients versus comparator-treated patients. In all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4.0% (150/3788) of patients receiving TYGACIL and 3.0% (110/3646) of patients receiving comparator drugs. In a pooled analysis of these trials, based on a random effects model by trial weight, an adjusted risk difference of all-cause mortality was 0.6% (95% CI 0.1, 1.2) between TYGACIL and comparator-treated patients. The cause of this increase has not been established. This increase in all-cause mortality should be considered when selecting among treatment options [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].
( Id. ¶ 19.) The " Adverse Reactions" section of Tygacil's label was updated with similar information, also in July 2010. ( Id. ¶ 20.)
On September 27, 2013, a " Black Box" warning was added to Tygacil's label, stating the following: " TYGACIL should be reserved for use in situations when alternative treatments are not suitable." ( Id. ¶ 35.) A warning about Stevens-Johnson syndrome, among other information, was also added to the Adverse Reactions section of Tygacil's label. ( Id. ¶ 36.) Plaintiffs allege that Stevens-Johnson syndrome is a type of vasculitis. ( Id. ¶ 37.)
Plaintiffs allege that Tygacil caused the injuries to Joyce described above. ( Id. ¶ 34.) They contend that Defendants knew, or should have known, that Tygacil " unreasonably exposed patients to the risk of serious harm" ; that Tygacil " was not safe for its intended purposes" ; and that Tygacil would cause, and in some cases did cause, " serious medical problems" and " catastrophic injuries." ( Id. ¶ ¶ 38-39, 42-44.) Plaintiffs also allege that Tygacil " continues to be marketed to the medical community and to patients as safer and more effective as compared to other competing products" ; that Defendants have " underreported information about the propensity of [Tygacil] to cause injury and complications" ; that Defendants " failed to perform proper and adequate" testing, research, follow-up studies, and analysis of post-marketing data " in order to determine and evaluate the risks and benefits of [Tygacil]" ; that Defendants " provided incomplete and insufficient information to physicians . . . regarding the use of [Tygacil]" ; and relatedly, that Defendants failed to provide " sufficient warnings" and " instructions" to put the general public, including Joyce, " on notice of the dangers and adverse effects caused by the use of [Tygacil]." ( Id. ¶ ¶ 41, 46-50, 53, 56-57.)
II. Legal Standard
To survive a motion to dismiss under Federal Rule 12(b)(6), a complaint " must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). The standard of " facial plausibility" is met when " the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. Plausibility is distinct from probability, and " a well-pleaded complaint may proceed even if it strikes a savvy judge that actual proof of the facts alleged is improbable, and that a recovery is very remote and unlikely." Nielsen v. Rabin, 746 F.3d 58, 62 (2d Cir. 2014) (quoting Twombly, 550 U.S. at 556) (internal brackets and quotation marks omitted). At the same time, a court is " not bound to accept as true a legal conclusion couched as a factual ...