11 December 2010

Should FDA-approved drug labels be admissible into evidence in a medical malpractice lawsuit involving off-label uses of prescription drugs?

By Jessica Gibson, Managing Editor 

          During the past decade, there has been a significant amount of controversy surrounding the admissibility into evidence of Federal Drug Administration (FDA)approved drug labels in medical malpractice suits involving the off-label use of prescription drugs.
Before the FDA approves prescription drugs to be marketed and sold in the United States, the manufacturer must submit proposed labeling, including use in specific populations, warning, and dosages. If the FDA chooses to approve a certain drug, it does so only for the specific purpose or purposes indicated on the label. Accordingly, an off-label use is the prescribing of medication in a manner different than that approved by the FDA. Off-label uses count for a substantial portion of all drug prescriptions.

In a medical malpractice suit in which a patient has been harmed by a drug that was prescribed for an off-label use, the plaintiff-patient may attempt to argue that the off-label use violated the standard of care and that the defendant-physician was negligent in prescribing the medication. The patient will then try to introduce the drug’s label as evidence that the physician was negligent. Some believe that the FDA-approved label should not be admissible into evidence to prove negligence while others believe that the label should be admissible.

          Those who oppose the label’s admission argue that FDA-approved drug labels are not relevant evidence of the standard of care in a medical malpractice action involving off-label uses of drugs for several reasons:
(1) Doctors, not the FDA, regulate the practice of medicine. Thus, allowing the approved label into evidence would be infringing upon the physician’s judgment;
(2) The off-label use of the drug may not be included on the label because of a reason having nothing to do with the standard of care. For example, a particular use of a drug may not appear on an FDA-approved label because drug manufacturers have a limited amount of money, which they generally choose to spend on creating new drugs rather than trying to get drugs already being sold approved for new uses; and
(3) Sometimes the off-label use is actually the standard of care. Because science advances faster than regulation, some off-label uses may actually be considered state-of-the-art.

          Despite these arguments, the majority of courts that have addressed the issue of whether an FDA-approved label should be admitted as evidence of a doctor’s negligence in a case involving the off-label use of prescription drugs have held that the label should, in fact, be admissible. However, most of these courts have also held that the admissibility of the label should be predicted on the presence ofexpert testimony that further explains the standard of care. Furthermore, there are still some courts that allow the admission of FDA-approved labels as prima facie evidence of the standard of care because of the unique knowledge that drug manufacturers possess regarding the proper uses of their products.

          Juris Blog readers: what is your opinion? Do you believe a plaintiff should be able to introduce evidence that a physician used a drug in an off-label manner as evidence of standard of care? Or do you think that a plaintiff should not be allowed to admit such evidence?

 Jessica Gibson is a third-year day student and Managing Editor for Juris. Jessica received a bachelor's degree in Marketing and International Business from the University of Pittsburgh. She can be reached at gibsonj@duq.edu