Issue: April 2012
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Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory

Introduction

Liability for Off-Label Use of Medical Devices

Since 2009, over $2.4 billion has been awarded for federal health care fraud in False Claims Act actions, including actions for the illegal marketing of medical devices not approved by the FDA.

Medical device manufacturers and physicians face significant liability for the off-label use of medical devices, potentially facing claims of malpractice, overpromotion, products liability, fraud, and more. This is dangerous territory that must be navigated with precise care.


BONUS: Because the liability of a device manufacturer is important in litigation involving injury from the off-label use of a medical device, 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 to prove medical malpractice from off-label use of a medical device?

Physicians:

How can liability for medical malpractice be avoided for the off-label use of a medical device?

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 off-label use of a medical device?

Employers:

Can a hospital be subject to liability for a physician’s off-label use of a medical device causing a patient injury?

Bonus:

What attempts have been made to find medical device manufacturers liable for injury from the off-label use of their devices?


Practice the Technique: Checklists

Attorneys:

Counsel must develop a list of facts and circumstances, specific to the client’s fact situation, which demonstrates proof of an act causing an injury from the off-label use of a medical device.

Physicians:

Physicians must consider this litigation checklist when defending an alleged medical malpractice or negligence claim arising from off-label use of medical devices.

Insurers:

The insurer may use this litigation checklist to spot “red flags” and inconsistencies when investigating a claim of injury from an off-label use of a medical device.

Employers:

A checklist for employers to determine if an off-label device use injury is "work-related."

Bonus:

A litigation checklist for the medical device 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 device was the cause of the patient’s injury.

Expert Analysis

What Obstacles and Ethical Dilemmas Do Whistleblowers Face When Protecting the Public Interest?

Terry Morehead Dworkin, JD

Should Prosecutors and the FDA Try to Prevent Off-Label Speech?

Robert Klepinski, JD

How Can Manufacturers Avoid Off-Label Promotion of Medical Devices?

Kai Peters, 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 medical device use 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 medical device injury action to trial.


Jury Awards and Settlements

How much have juries awarded recently in cases involving the off-label use of a medical device resulting in injury?



Medical Examples

Medical: Injury from Off-Label Medical Device Use

This section provides detailed medical information on off-label medical device use terminology, patient considerations and device use complications, 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 use of medical devices.


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Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory

Table of Contents
Introduction

Expert Analysis
   Terry Morehead Dworkin, JD
   Robert Klepinski, JD
   Kai Peters, JD

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

Practice the Technique: Checklists
   Attorney Checklist
   Physician Checklist
   Insurer Checklist
   Employers and Risk Managers Checklist
   Bonus Checklist

Alternative Dispute Resolution

Reasons to Reach Settlement

Reasons to Go to Trial

Jury Awards and Settlements

Medical: Injury from Off-Label Medical Device Use

References