January 29, 2009 – Off-Label Promotion of Medical Devices and its Effect on Potential Product Liability (IMDMC)

Off-Label Promotion of Medical Devices and its Effect on Potential Product Liability

January 29, 2009

Lunch-n-Learn  Agenda

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Presentation Outline

I. FDA does not prohibit off-label use of medical devices:

A. FDA controls the marketing and labeling of medical devices, it does not attempt to interfere with the practice of medicine.

B. Physicians are free to use medical devices for off-label purposes.

C. Courts have found that manufacturers have no duty to control a physician’s practice of prescribing their product.  See Labzda v. Purdue Pharma, L.P., 292 F. Supp.2d 1346 (S.D. Fla. 2003).

D. “Intended Uses” under 21 CFR § 801.4; a device manufacturer’s duty to warn.

II. Off-Label Promotion and its Relation to General Products Liability 

A. Manufacturers are liable for harm caused by a product sold “in a defective condition unreasonably dangerous to any user or consumer.”  Indiana Code § 34-20-2-1.

B. A product is considered defective if the seller fails to give reasonable warnings of dangers associated with the product.  Indiana Code § 34-20-4-2.

C. A manufacturer does not have to spell out all conditions for which a drug or device is not indicated (Robak v. Abbott Laboratories, 797 F. Supp. 475 (D. Md. 1992)), but a manufacturer is not relieved from issuing warnings related to dangers associated with off-label use of the device, if it knows of such risks.  (Anderson v. Sandoz Pharmaceutical Corporation, 77 F Supp.2d 804, 807 (S.D. TX 1999)).

D. Learned Intermediary Doctrine.  See Ortho Pharmaceutical Corporation v. Chapman 338 N.E.2d 541 (Ind. Ct. App. 1979).

III. Direct to Consumer Marketing and its Effect on Potential Product Liability

 A. Relationship to Learned Intermediary Doctrine

 B.  Effect on Failure to Warn Claims

 C.  Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007) (undermining justifications for learned intermediary doctrine).

IV.     Potential Rise of Off-Label Promotion Claims due to Preemption Standard of Riegel v. Medtronic

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