• Taking Chances2:24

Medication-related injuries often result in claims of medical malpractice. However, the fact that a patient suffers a side effect of a medication does not prove medical negligence. Even in the best of circumstances, patients may experience unique reactions that cannot be foreseen or avoided.

When these suits are defended, the recommended usage of the drug by the manufacturer will often become a factor. If the physician's treatment is consistent with the recommendations, the defense will rely upon them. If, however, usage is not recommended, the patient will introduce manufacturer recommendations as indications of substandard care. The Physician's Desk Reference will be used in the same manner.


The reliance that courts have placed upon this information has varied from state to state. New York State has ruled that information from package inserts may constitute prima fascia evidence if negligence. This means that if the manufacturer’s instructions were clear, and the physician deviated from the instructions, the doctor could be found negligent. All the plaintiff would need to prove is that the injury was caused by failure to follow the recommendations.


Most states have adopted a less stringent approach. In Massachusetts, the manufacturer's insert or the PDR is admissible in evidence. However, this evidence alone would not be sufficient to establish negligence. In the 1988 medical malpractice case of Grassis v. Retik, the Massachusetts Supreme Judicial Court held that the package insert was admissible in evidence. However, the plaintiff’s questions to the defendant that his action “violated” the Physician’s Desk Reference was found objectionable. The Court stated, “the question to Dr. Retik, using the word ‘violated’ was improper for the reason indicated by the judge; that is, it could have been understood to imply that a physician who did not follow the PDR was by that token irretrievably guilty of a break of the professional standards (Grassis v. Retik, 521 N.E.2d 411,414 (1988)).”


The Massachusetts rule is the better rule and the one followed by most jurisdictions. It recognizes that the decision to use a drug and the dose are matters of judgment for the physician, which go beyond the Physician's Desk Reference. There are a number of reasons drugs are used for purposes that the manufacturer does not specifically recommend. For example, a drug company may decide not to take the steps necessary for Food and Drug Administration  approval of an alternative use due to the overwhelming cost and time factors involved in the process. Also, the longer a drug is available, the more familiar practitioners will become with its usefulness in the treatment of a number of different ailments. Further, due to concerns about the cost of defending products liability litigation, the manufacturer may be reluctant to recommend such usages on a routine, as opposed to an individual, basis.  


The physician must be aware of the manufacturer’s information on recommendations regarding medication. However, this does not ban efficacious uses; that are not set forth in the package insert. A careful monitoring of the literature surrounding the evolution of a drug’s usefulness may serve as a guide to a physician’s use of a medication in the care and treatment of his patients. The physician must take steps to ensure that this use is justifiable and in keeping with the standard of practice of his colleagues.


A recent decision by the FDA highlights concerns raised by the off-label use of certain medications. The drug Thalidomide has been banned for decades due to serious birth defects associated with its use by pregnant women as a sedative. New research has suggested that it may be an effective treatment for leprosy. The FDA appears ready to approve its use for that purpose. There is serious concern, however, that once approved for this limited purpose, physicians may prescribe the medication for treatment of brain cancer, lupus, and auto immune diseases.


This is exactly the type of use that gives rise to legal concerns. The greater the chance of significant side effects, then the more information must be provided. The patient is the ultimate decision maker about whether to use a medication. So the patient should beinformed not only of the efficacy of the drug, but also its potential downside. The informed consent process needs to be documented and perhaps should include a printed form provided to the patient Further, there may be a greater need for the monitoring of blood levels and potential side effects.


The practice of off-label prescription of medication is a keystone to medical advancement As recent well known cases have shown, extra care must be taken to ensure that the physician and the patient are both well informed of the risks and benefits SO their collaboration can result in the best possible clinical outcome.


Off-Label Prescribing

by Attorney Frank E. Reardon

November 1997

Healthcare Law, Litigation & Public Policy   Medical Licensure & Discipline ♦ Employment Board of Registration

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