The Wall Street Journal reported today that Medtronic, Inc., the medical supplies giant that has been the center of much controversy lately, is in trouble again - this time for a drug it produces for aid in spine-repair surgeries. According to the article, major side effects (and some deaths) have been reported in cases where the drug was used “off label,” or in ways not outlined on the drug’s label.
Some may remember that Medtronic was named as a defendant last year in the Supreme Court case Riegel v. Medtronic. The case was brought against the company because of faulty equipment, like pacemakers and defibrillators that caused serious health problems in patients. In a highly-publicized decision, the Court sided with Medtronic, claiming that the public does not have the right to sue a company under state law for products that have already been approved by the FDA, even if those products have side-effects not foreseen by the agency.
In response to this decision, a bill has been introduced in Congress called the Medical Device Safety Act of 2008. The bill would provide a legislative fix to the Court’s unfortunate disregard for public safety by requiring that both FDA regulation and state tort law are utilized in order to ensure the safety of medical devices.
This fall, the Court will hear another case regarding preemption, Wyeth v. Levine. In that case, pharmaceuticals giant Wyeth, is attempting to use the same reasoning from last year’s Medtronic decision to absolve itself of responsibility in the amputation of patient, Diana Levine’s arm following the misadministration of their drug Phenergan. If the Court continues to side with these companies, it will effectively leave victims of corporate malpractice without recourse.