Offense or defense? Managing the off-label use claim
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Liability for injury caused by an unapproved use of a drug or medical device may rest with the doctor, the manufacturer, or both. It’s all in the facts. Lawyers who represent plaintiffs injured by drugs or medical devices are increasingly encountering what is known as the “off-label” use claim. This is because off-label use of medical products is a common and growing practice. Doctors engage in off-label use of drugs or medical devices by prescribing or using them either in a way or for a condition that is not included in FDA-approved labeling for the products. An off-label claim may arise as a basis for suit against the physician who prescribed a drug or medical device, or it may come up as a defense on the part of the manufacturer. The recent fen-phen (fenfluramine/ phentermine) diet drug litigation is an example of off-label use on an enormous scale.(1) Many of these cases allege that doctors prescribed the drugs for a longer period of time than the approved literature described. The labeling for Pondimin (fenfluramine) permitted prescription for “a few weeks,” but some doctors allowed patients to take it for a year or more. And most doctors prescribed Pondimin in conjunction with phentermine, although the combined use of these drugs was not sanctioned by the package insert of either one. Another example of widespread off-label use involves bone (pedicle) screws. Lawyers representing plaintiffs injured by these devices have brought claims of off-label use against orthopedists who used them during back surgery.(2) Manufacturers of the screws had issued literature that recommended using them in long bones like the femur, but some orthopedists began using them in vertebral bones. Manufacturers have also used the claim defensively to avoid liability. Before discussing how plaintiff lawyers should use off-label claims offensively or respond to them when they are used defensively, let us briefly examine how the FDA, manufacturers, and patients and their doctors view the use of drugs and devices for other than approved uses. Regulatory perspective. The FDA approves new drugs and medical devices according to terms that are spelled out in labeling that accompanies the drugs or devices. The labeling takes the form of a package insert distributed with the product to doctors and pharmacists, but rarely to patients. The labeling for drugs also appears in the Physicians’ Desk Reference (PDR), which is published annually. Only FDA-approved uses are listed in the “indications” section of the package insert or PDR entry. Use of a product for diseases or conditions not listed, or in a dose or duration not specified, or for a type of patient (for example, a child rather than an adult) not mentioned is considered off-label. The FDA has made it clear that while it licenses drugs and devices,… Source : accessmylibrary.com |