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Are medical device makers considered health care providers?


One purpose of both medical malpractice and products liability law is to compensate individuals who have been harmed. Another, however, is to create an environment in which medical practitioners are encouraged to maintain a certain standard of care and device manufacturers have incentive to make safe products. The legal procedure used in reaching these goals, however may differ in medical malpractice and products liability suits.

One example of this is the requirement for expert reports. Under the Texas Medical Liability Act, suits for medical malpractice must be accompanied in most instances by a report by an expert regarding the standard of care and how it was breached in the case. This is because defendants in medical malpractice cases are held to a different standard of care than defendants in run-of-the-mill negligence cases. In most products liability cases, however, such an expert report is not required. But, what about products meant for medical use?

In a case decided late last year, a Texas Appeals Court took up this issue. In the case, a plaintiff alleged that a doctor had used a certain medical device known as an Eclipse Sphere in a way that was off-label and experimental, and that he had not properly obtained the informed consent of the patient. The suit named both the doctor and the medical device manufacturer, because of alleged solicitation on the part of the manufacturer for the off-label use and failure to provide required warnings about such use.

The manufacturer filed a motion to dismiss the suit based upon the fact that it had not been served with the required expert report. The device maker argued that as it was a licensed in Texas to provide health care, it was covered by the TMLA. The court, however, felt differently. The basic ruling was that there was no evidence showing that the manufacturer was involved in the provision of health services to this patient, and the use of the device itself was insufficient to make it a health care provider under the circumstances.

While this case is unusual, it illustrates the complexity and difficulty of prosecuting successful civil liability suits against defective medical device manufactures. People who have suffered serious injury because of medical malpractice or defective medical equipment should not lose hope however. They can consult with an experienced Texas attorney who can explain the applicable laws and help them build a solid case.

Source: Above The Law, "Texas Appellate Court: Medical device manufacturer not "health care provider" under Texas Medical Liability Act," John W. Scanlan, J.D., Accessed March 10, 2016

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