The Medical Device Saftey Act and its Impact on Reigel v. Medtronic, Inc.
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Recently Medtronic recalled over 37,000 pacemakers due to defects in the wiring which may cause the pacemaker to short circuit. The FDA classified the recall as a Class 1 due to the reasonable probability that the pacemakers may pose serious health risks and even death.
The FDA provided that:
Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness.
There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. Of those, only about 21,000 pacemakers are affected by this recall, most of which have been implanted in patients for five years or longer.
Medtronic Inc. issued a letter to physicians alerting them to this problem on May 18. The company communicated with patients via letter on May 27.
Due to the March 2009 Supreme Court ruling in Wyeth v. Levine, pharmaceutical companies are no longer exempt from liability. However, per the 2008 Supreme Court decision in Reigel v. Medtronic, Inc., medical device manufactures have immunity when their products fail and cause injury or death. The Supreme Court held that in instances where the FDA has approved the medical devises, the manufacturer cannot be held liable if the device is defective, even in cases when the device has been recalled.
In response to this ruling, Congress introduced The Medical Device Safety Act.
The AJJ stated that:
The act has been introduced in Congress to restore the rights of injured consumers and to hold negligent medical device manufacturers accountable for the safety of their products in state tort actions.
The purpose of this act is to negate the Supreme Court’s holding in Reigel v. Medtronics and to provide some recourse to patients and families that have been injured as a result of a defective medical devise.