Life Sciences Claim Scenarios
Even the best, most conscientious companies face claims and lawsuits. We know because we defend and represent them. Here are some claim scenarios from a variety of life sciences companies:
Sales process
Claim scenario
A patient dies three days after what should have been a five-minute surgical procedure. A medical device used during the surgery was not defective and did not malfunction. The medical device company's sales representative was in the operating room. The uninsured doctor contends the sales representative negligently advised her with respect to the medical device. The sales representative denies the allegation. The treating doctor is uninsured and judgment-proof. The hospital is a public entity subject to a $200,000 cap on damages.
Claim scenario
At an in-service training for a hospital's nursing staff, the sales representative for a fluids warming device was asked about temperature settings and use of the device for patient bathing. The salesperson misunderstood the question and responded it could work. The nurses adopted this new use until a patient was severely injured. The family and nursing staff now blame the product manufacturer for its sales rep's alleged off-label promotion.
Product failure
Claim scenario
A young patient suffers a stroke while receiving intravenous treatment. The family, and their experts, blame the infusion pump for the injury. They allege the manufacturer failed to properly warn users of the consequences of incorrectly loading the pump and inadequately trained users on proper loading of the pump. The pump manufacturer had conducted in-service training sessions on the product, but attendance was poor. The hospital is part of the state university system and is immune from all liability.
Software incompatibility
Claim scenario
Laboratory software gets installed and the lab staff trained. A pathologist then mixes up two patients' tissue slides, mistakenly putting a diagnosis in the wrong patient's record. The error was discovered and corrected minutes later. A correction was noted in the lab software system but not in the hospital's records – a different system. The patient then underwent an unnecessary surgery based upon the erroneous report. The surgeon, pathologist, hospital and software developer are all sued. State law limits total pain and suffering damages recoverable from the health care providers to a total of $250,000. There is no cap on damages applicable to the medical software provider.
Errors and omissions
Claim scenario
A customer alleges a manufacturer of computerized diagnostic and testing equipment delivers improper pre-production prototype instruments which results in financial loss. In addition, the customer alleges that the instruments do not meet their specifications.
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