It depends. Medical malpractice occurs when a doctor or other medical practitioner commits a negligent act or omission that leads to injury. Prescribing a drug for purposes authorized by the Food and Drug Administration (FDA) — even if that drug harms you and is later recalled—does not in itself constitute medical malpractice.
If you suffered injury from a recalled drug, in all likelihood you have a products liability suit against the drug manufacturer. Most such suits become class action lawsuits — some of them massive — that proceed in the federal courts.
But there are other scenarios under which a doctor who prescribed a recalled drug may face a medical malpractice lawsuit. For example, a doctor who prescribes drugs off-label — i.e., for purposes not approved by the FDA — and who continues to prescribe drugs for off-label use despite mounting evidence that such use is neither safe nor effective may be committing malpractice, especially if other doctors within his or her area of specialization no longer or never used that drug in that manner.
A doctor who prescribes too much or too little of a given medication — regardless of whether that medication is later subject to a FDA recall — puts patients at risk and may also be committing malpractice. The key to determining whether a doctor has committed malpractice by over-prescribing a medication is to look at what other doctors with similar qualifications and similar patients have done.
If your doctor stepped too far outside the bounds of established, evidence-based medicine in his prescribing practices and you suffered injury as a result, you should discuss your case with a malpractice lawyer to determine whether it makes sense for you to file a malpractice claim.
Dr. Michael M. Wilson is an attorney and a physician who earned his undergraduate degree from the Massachusetts Institute of Technology and his legal and medical degrees from Georgetown University. He has focused in the area of medical malpractice for more than three decades and secured more than $100 million in settlements and verdicts on behalf of clients throughout the country. He is admitted to practice in the District of Columbia and New York as well as the U.S. Court of Appeals for the District of Columbia and the U.S. Supreme Court. He is listed in America’s Top 100 High Stakes Litigators.