By Karen M. Fontana

The effect of a physician’s decision to deviate from the pharmaceutical company’s dosage instructions contained in a drug’s FDA approved package insert has been a recurring issue in medical malpractice litigation with many claimants contending that any deviation from the manufacturer’s instructions constitutes malpractice. In a recent case the Louisiana Fourth Circuit has now specifically rejected that theory.

In Deroche v. C.B. Fleet Company et al., the Fourth Circuit stated:

We specifically hold that a manufacturer’s labeling and package insert standing alone is insufficient to establish the prevailing standard of care required by La. R.S. 9:2794. Similarly we find that a physician’s medical decision to deviate from a manufacturer’s labeling also does not ipso facto establish a breach of the standard of care.

No. 2013-CA-0979, (La. App. 4th Cir. 12/18/2013), 2013 WL6923718.

Thus the Fourth Circuit has now confirmed that deviation from FDA approved labeling and dosage instructions does not necessarily equate with a breach of the standard of care and does not relieve plaintiff’s duty to provide expert medical testimony to establish the prevailing standard.

The Fourth Circuit opinion is well founded. By the FDA’s own admission, the FDA has never had authority to regulate the practice of medicine. While the labeling and package inserts for drugs and devices are heavily regulated by the Food and Drug Administration, the FDA has made it clear that, with respect to its role in medical practice, the package insert is informational only. 12 FDA Drug Bulletin 4-5 (1982) (cited in 59 Fed. Reg. 59,820 59,821) (Nov. 18, 1994).

The FDA has also informed the medical community that “once a [product] has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.” The FDA went on to state that: “unapproved” or more precisely “unlabeled” uses may be appropriate and rational in certain circumstances and may, in fact, reflect approaches … that have been extensively reported in medical literature. 12 FDA Drug Bulletin 4-5 (1982) (cited in 59 Fed. Reg. 59,820 59,821) (Nov. 18, 1994)(emphasis added).

Thus the decision whether or not to use a drug or device for an off-label purpose or in a different manner than described in labeling is a matter of medical judgment which must be evaluated by the trier of fact with the benefit of expert medical testimony. Package inserts and manufacturer labeling will be evidentiary, but they should not be considered de facto evidence of standard of care.