Issue: June 2014
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Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability

Introduction

Liability for Pain Pump Injuries

Numerous pain pump adverse events have occurred, many resulting in serious injuries and deaths, according to the FDA. During the years 2005 through 2009 alone, 87 infusion pump recalls identified safety problems.

 

Liability issues for physicians and other health care providers can arise in a variety of contexts, including the surgical implantation of a pain pump or a component of a pain pump system, the administration of pain medication through the pain pump, or obtaining informed consent to the use or implantation of a pain pump.

 

Causes of action against manufacturers may be brought under theories based on strict products liability, which include actions for design defect, manufacturing defect, failure to warn, and failure to test adequately. Claims also may be based on theories of negligence.

 

Attorneys, physicians, manufacturers, insurers and others that may be affected by injuries related to the use or implantation of pain pumps must understand the liability issues, defenses, and medical aspects of these injuries.


The Perspectives: Improve Your Strategy

Attorneys:

What proof is needed to establish malpractice or negligence involving the use or implantation of a pain pump? And, what is a potential strategy for the attorney to employ?

Physicians:

How can liability for medical malpractice be avoided for an injury related to the use or implantation of a pain pump? 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 that the pain pump injury was not caused by the health provider’s actions? And, what is a potential strategy for the insurer to employ?

Employers:

Can an employer be subject to liability for an employee’s injury from a pain pump? And, what is a potential strategy for the employer to use? 

Bonus:

How can a manufacturer avoid liability for an injury related to a pain pump? What is a potential strategy for the manufacturer to use? 


Practice the Technique: Checklists

Attorneys:

Check this list of facts and circumstances tending to show a physician’s liability for malpractice or negligence for an injury resulting from the use or implantation of a pain pump.

Physicians:

A physician should review the items on this list when defending against claims of malpractice or negligence involving the use or implantation of a pain pump.

Insurers:

The insurer should check these “red flags” and inconsistencies when investigating a claim of injury related to the use of a pain pump. 

Employers:

Use this checklist to determine if the employee’s injury from the use of a pain pump is “work related” and “occurred in the course of the employment.” 

Bonus:

This litigation checklist can help the pain pump manufacturer determine if the manufacturer provided adequate and accurate information and warnings, if the pain pump was defective, and if the use of the manufacturer’s medical device was the cause of the patient’s injury.

Expert Analysis

What Is the Relationship Between Anesthesia, Pain Pumps, and Chondrolysis? 

Constance R. Chu, MD

What Company Policies and Procedures Can Help Prepare for an FDA Inspection?

Anthony C. Celeste

How Should Experts Be Retained and Utilized in Pain Pump Cases?

Heather A. Neal, JD

What Risk Management Strategies Should a Manufacturer Consider to Minimize Exposure to Products Liability Claims? 

Sara Dyson, JD

Litigation

Alternative Dispute Resolution

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


Reasons To Reach Settlement

The following are reasons why the attorney, physician, insurer, employer, or manufacturer would want to reach settlement, and not take the action to trial.


Reasons To Go To Trial

The following are reasons why the attorney, physician, insurer, employer, or manufacturer would want to take the action to trial.


Jury Awards and Settlements

How much have juries awarded and what settlements have been reached recently in cases involving injury from pain pumps?



Medical Examples

Pain Pumps

This section provides an overview of pain and detailed information on pain pumps, their intended use, and FDA regulation. It also provides information on the mechanics of how pain pumps work and potential patient injuries that can result from pain pump use. This section also discusses the patient’s ability to work while receiving drug treatment with the use of a pain pump and lists general FDA pain pump medical device classification information and recent FDA recalls and safety announcements concerning pain pumps.



Law and Medicine Resources

Law and Medicine Resources

Provided is a listing of law and medical resources for further information on pain pump litigation.


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Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability

Table of Contents
Introduction

Expert Analysis
   Constance R. Chu, MD
   Anthony C. Celeste
   Heather A. Neal, JD
   Sara Dyson, 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 Checklist

Alternative Dispute Resolution

Reasons To Reach Settlement

Reasons To Go To Trial

Jury Awards and Settlements

Pain Pumps

Law and Medicine Resources