Introduction

Liability for Off-Label Use of Prescription Medications
With over 150 million prescriptions written off-label for 160 or more common drugs physicians face potential malpractice for injury from the off-label use. In addition, the pharmaceutical manufacturer is exposed to liability for any over-promotion of the use of its drug.

BONUS: Because the liability of the pharmaceutical manufacturer is important in any litigation involving injury from prescription use, this perspective has been discussed in addition to the perspectives of the attorney, physician, insurer, and employer.

The Perspectives: Improve Your Strategy

Attorneys: What proof is needed for a patient to prove medical malpractice from off-label prescription use?
Physicians: How is liability for medical malpractice avoided for the prescription of a drug for off-label use? And, what is a potential strategy for the physician to employ?
Insurers: Can a payout under a medical malpractice liability policy be avoided by proof that the health provider was not negligent or there was no professional liability coverage for prescription of drugs off-label?
Employers: Can a hospital be subject to liability, for the off-label prescription or use of a drug causing a patient injury?
Bonus: What attempts have been made to find the pharmaceutical manufacturer liable for injury from use of its medications?
Practice the Technique: Checklists

Attorneys: A litigation checklist of facts and circumstances tending to prove medical malpractice resulting in injury from prescription of a medication off-label.
Physicians: Physicians must consider this litigation checklist when defending an alleged medical malpractice or negligence claim arising from off-label use of prescription medications.
Insurers: The insurer may use this litigation checklist to spot “red flags” and inconsistencies when investigating a claim of injury from the prescription of a drug for an off-label use.
Employers: Use this litigation checklist to determine if the employee’s injury resulting from the prescription of an drug off-label by a physician treating an injury arising from the employment also would be considered “work related,” and therefore compensable.
Bonus: A litigation checklist for the pharmaceutical manufacturer to determine if a warning was required, if it was given, if the warning was adequate, and if the use of the manufacturer’s drug was the cause of the patient’s injury.