What are the Limits on Medical Product Liability Cases Under Federal Law?

FACTS: On May 10, 1996, the plaintiff underwent a percutaneous transluminal coronary angioplasty, intended to dilate his right coronary artery, which had been found to be “diffusely diseased” and “heavily calcified.” The physician used an Evergreen balloon catheter, which is specifically contraindicated for patients who have “diffuse or calcified stenoses.” During the procedure, the physician first attempted to remove the calcium deposits in plaintiff’s artery with a Rotoblator device, and then unsuccessfully inserted several different balloon catheters. The physician ultimately inserted the Evergreen balloon catheter into the patient’s artery and inflated the device several times, up to a pressure of ten atmospheres. The device label for the Evergreen balloon catheter specifies that it should not be inflated beyond the “rated burst pressure” of eight atmospheres. On the final inflation, the balloon catheter burst, and the plaintiff began to rapidly deteriorate. He developed a complete heart block, lost consciousness, was intubated and placed on advanced life support, and was rushed to the operating room for emergency coronary bypass surgery. The plaintiff survived, but according to his complaint suffered “severe and permanent personal injuries and disabilities.” The patient filed suit against the manufacturer, alleging strict liability; breach of implied warranty; and negligent design, testing, inspection, distribution, labeling, marketing, sale, and manufacture. The Evergreen balloon catheter entered the market pursuant to the Food and Drug Administration’s (FDA) premarket approval process in the mid-1990s. The warning and contraindications for use of the catheter were clearly noted on the product information label.



QUESTIONS



1. What is the FDA premarket approval process?



2. How does the FDA’s premarket approval process affect lawsuits that allege injuries caused by defective medical devices?



3. What does a plaintiff have to prove to win a case against the manufacturer of a premarket-approved medical device?



After reading this case study answer the questions in a written 1 page paper using APA format, including title page and references. Include at least 2 scholarly sources. Save your assignment as first initial last name and date submitted, for example KSMITH1.20.2014. Then attach the paper to this assignment for grading.