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Florida Court Addresses Learned Intermediary Doctrine in Failure-to-Warn Claim

A Florida federal court recently addressed a product liability claim against a medical device company and its parent company. The case arose when the plaintiff underwent surgery for her pelvic organ prolapse. Her physician implanted a polypropylene mesh designed by the defendants. After surgery, the woman experienced significant health issues that she attributed to the mesh device. Following the removal surgery, the woman and her husband filed a product liability claim against the defendants based on a failure to warn.

In response, the defendants moved for summary judgment based on the state’s learned intermediary doctrine. The doctrine imposes a duty on medical device manufacturers to warn of the product’s dangers to physicians instead of patients. In this case, the plaintiffs argue that the doctrine does not apply because the physician maintained a long-standing financial relationship with the defendants. Therefore, it was unreasonable for the defendants to expect the physician to warn patients of the device’s dangers. The plaintiffs asked the courts to create a “financial bias” exception to the state’s learned intermediary doctrine. The lower court declined to create such an exception and found in favor of the defendants. The plaintiffs appealed based on the failure-to-warn claim.

Under Florida law, plaintiffs pursuing a failure-to-warn claim must establish that the product’s warning was 1.) inadequate, 2.) the inadequacy approximately caused the victim’s injuries, and 3.) the victim suffered an injury from using the product. In cases involving a medical device, the physician acts as the “learned intermediary,” and it is their responsibility to weigh the device’s potential risks and benefits to their patients. For a plaintiff to succeed on a claim against the device manufacturer, they must prove that the doctor would not have used the product if the manufacturer included an adequate warning. Moreover, the chain may still be broken if the manufacturer provides an insufficient warning, so long as the doctor is aware and still recommends the device.

In this case, the plaintiffs argued that the defendants’ warning was inadequate; however, the treating physician combated that assertion through his testimony. According to the record, the defendant’s cited the physician’s testimony in which he stated that he believed the mesh was the “best option” and effective treatment option for the plaintiff. The plaintiffs further argued that the physician was not objective and his testimony should not be a basis for the learned intermediary doctrine. The court concluded that the defendant’s failure to warn could not have been the proximate cause of the plaintiff’s injuries. Further, they found that there is no basis for creating a “financial basis” exception.

Have You Suffered Injuries Because of a Defective Medical Device?

If you or someone you love has suffered injuries because of a defective medical device or pharmaceutical drug, contact the Florida personal injury lawyers at Friedman Rodman Frank & Estrada, P.A. The attorneys our office handle injury claims arising from Florida motor vehicle accidents, premises liability, construction accidents and other forms of negligence. Our attorneys are skilled at representing clients in complex personal injury cases and have recovered significant amounts of compensation on their behalf. Contact our office at 877-448-8585 to schedule a free initial consultation with an attorney on our team.

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