Issue: March 2012
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Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion?

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.

Expert Analysis

How Should Physicians Inform Patients of the Use of a Drug Off-Label?

Valerie A. Asher, MD

Off-Label Promotion: What Should Pharmaceutical Companies Watch Out For in 2012?

Kai Peters, JD

What Are the Top Three Considerations Attorneys Face in Medical Malpractice Litigation?

Patrick A. Malone, JD

Litigation

Alternative Dispute Resolution

Arbitration or mediation may be required by contract or statute, mandated by the court or, in some circumstances, may be the appropriate method for a negotiated resolution.


Reasons to Reach Settlement

Reasons why the attorney, physician, insurer, employer or manufacturer would want to reach settlement, and not take the off-label prescription injury action to trial.


Reasons to Go to Trial

Reasons why the attorney, physician, insurer, employer, or manufacturer would want to take the off-label prescription injury action to trial.


Jury Awards and Settlements

How much have juries awarded recently in off-label drug use injury cases?



Medical Examples

Medical: Injury from Off-Label Prescription Use

This section provides detailed medical information on off-label prescription use terminology, patient considerations and adverse reactions, and discusses the prognosis and ability to work.



Law and Medicine Resources

References

A listing of law and medical references for further information on off-label prescription use injury.


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Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion?

Table of Contents
Introduction

Expert Analysis
   Valerie A. Asher, MD
   Kai Peters, JD
   Patrick A. Malone, JD

The Perspectives: Improve Your Strategy
   Attorneys
   Physicians and Health Providers
   Insurers
   Employers and Risk Managers
   Bonus: Manufacturers

Practice the Technique: Checklists
   Attorney Checklist
   Physician Checklist
   Insurer Checklist
   Employer Checklist
   Bonus: Manufacturer Checklist

Alternative Dispute Resolution

Reasons to Reach Settlement

Reasons to Go to Trial

Jury Awards and Settlements

Medical: Injury from Off-Label Prescription Use

References