DiBartolo v. Abbott Laboratories
2012 WL 6681704
S.D.N.Y.2012Background
- DiBartolo, a New York attorney with a psoriasis history, used Humira (Nov 2008–May 2009) after a dermatologist prescribed 40 mg biweekly.
- Humira’s label and FDA-mandated Medication Guide disclosed risks including malignancies, infections, and monitoring requirements.
- Plaintiff alleges she was not pre-screened for non-melanoma skin cancer (NMSC) or adequately monitored for NMSC while on Humira.
- In 2009, DiBartolo was diagnosed with squamous cell carcinoma of the tongue and underwent complex tongue surgery with significant functional impairment.
- Plaintiff asserted eight causes of action: strict liability and negligence for failure to warn, design defect; misrepresentation; and breach of express and implied warranties.
- Abbott moved to dismiss under Rule 12(b)(6); the court granted in part and denied in part, allowing some warning-based claims to proceed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether IID governs the duty to warn in this case | DiBartolo argues IID may be inapplicable due to DTC advertising or physician compensation. | Abbott contends IID applies; no valid exceptions based on DTC or compensation. | IID applies; no valid DTC/compensation exceptions. |
| Whether DTC advertising or physician compensation creates an IID exception | DTC advertising and physician compensation could create an exception to IID. | No New York authority recognizes such exceptions; Restatement § 6(d) is not adopted here. | No exception; IID remains controlling. |
| Whether the complaint adequately pleads a design defect claim | Humira has an inherent defect and could be designed more safely; safer alternative design alleged implicitly. | Plaintiff fails to plead substantial harm as designed or feasibility of a safer design; no adequate alternative design pled. | Design defect claims dismissed for lack of substantial harm and feasible safer design. |
| Whether the complaint states a viable failure-to-warn claim | Abbott failed to warn especially of elevated NMSC risk for PUVA-treated patients; Remicade warning suggests higher risk should have been included. | Humira label warned of malignancies and monitoring; Remicade comparison does not prove inadequate warning for Humira. | Failure-to-warn claim survives to extent of omission of PUVA-related risk; other aspects dismissed. |
| Whether the complaint states misrepresentation or warranty claims | Abbott misled about Humira’s safety/indication; relied on advertisements and reputation to incur injury. | No privity for express warranty; misrepresentation claims fail for lack of specific false statements; implied warranty claim survives due to warning-related causation. | Strict liability misrepresentation and negligent misrepresentation dismissed; express warranty dismissed; implied warranty claim survives. |
Key Cases Cited
- Martin v. Hacker, 83 N.Y.2d 1 (N.Y. 1993) (IID governs warning to physicians; evaluate warning adequacy)
- Lindsay v. Ortho Pharm. Corp., 637 F.2d 87 (2d Cir. 1980) (physician as informed intermediary; warnings to doctors)
- Barnes v. Kerr Corp., 418 F.3d 583 (6th Cir. 2005) (warning adequacy assessed; context differs from NDUT cases)
- Fritz v. White Consol. Indus., Inc., 306 A.D.2d 896 (4th Dep’t 2003) (design defect/warranty interplay; caution on pleading sufficiency)