Medical Technology Insurance - Real World Claim Scenarios

Even the best, most conscientious companies face claims and lawsuits. We know because we defend and represent them. Here are some examples from a variety of medical technology companies:

Sales Process

Claim Description
A patient died 3 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 contended the sales representative negligently advised her with respect to the medical device. The sales representative denied the allegation. The treating doctor was uninsured and judgment-proof. The hospital was a public entity subject to a $200,000 cap on damages. 

Claim Description
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 Description
A young patient suffered a stroke while receiving intravenous treatment. The family, and their experts, blamed the infusion pump for the injury. They alleged 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 was part of the state university system and was immune from all liability.

Software Incompatibility

Claim Description
Laboratory software was installed and the lab staff trained. A pathologist mixed up two patients' tissue slides, and mistakenly put 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 underwent an unnecessary surgery based upon the erroneous report. The surgeon, pathologist, hospital and software developer were 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 Description
A customer alleged a manufacturer of computerized diagnostic and testing equipment delivered improper pre-production prototype instruments resulting in financial loss. In addition, the customer alleged that the instruments did not meet their specifications.

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