If the FDA makes a mistake....
It doesn't matter. Medical device users, such as insulin pumpers, can't sue the pump-maker. Why? The Supreme Court of the United States says so. A court ruling Wednesday sided with devicemaker Medtronic, holding that if federal regulators approved a device, a suit couldn't be filed under state laws. This case stemmed from a New Yorker who was injured after a Medtronic-made catheter burst during an angioplasty procedure 12 years ago. He needed emergency bypass surgery. As a result, he sued the company and alleged design and manufacturing defects in the catheter, as well as inadequate labeling on the device's packaging. The patient later died, but his widow continued the lawsuit on his behalf. The case probed whether manufacturers of sophisticated medical devices approved for sale by the FDA can be sued under consumer-friendly state laws, or whether they are preempted from such lawsuits. Writing for the court, Justice Antonin Scalia called the FDA's current "prem...