A groundbreaking new study by Pediatrics, the official journal of the American Academy of Pediatrics, is raising new questions about the safety of medical devices in children by documenting thousands of injuries annually (download the study here). The study warrants a restoration by Congress of the right to hold implantable devicemakers accountable in a state court, a right which the Supreme Court ended in its 2008 Riegel v. Medtronic decision.
The study found that over 70,000 children and teens go to emergency rooms annually for injuries and complications from medical devices, with contact lenses responsible for one-fourth of the injuries. Quoting the Associated Press story on the report, “The most serious problems involved implanted devices such as brain shunts for kids with hydrocephalus (water on the brain); chest catheters for cancer patients receiving chemotherapy at home; and insulin pumps for diabetics. Infections and overdoses are among problems associated with these devices. Only 6 percent of patients overall had to be hospitalized.”
Of course, we should all celebrate the life-saving experiences of many young recipients of implantable devices, but devicemakers should be accountable for negligence. Sadly, in the 2008 Riegel decision, the Supreme Court gave total immunity to certain implantable (FDA’s “Class III“) medical device manufacturers who fail to adequately warn consumers about device risks. As I discussed in my June 24 on the dangers of federal preemption, a 1976 law authorized the FDA to preempt the numerous state requirements only in statutory law, but the Riegel decision turned those preemption provisions into blanket immunity from any accountability, with no checks and balances. As the Pediatrics study reported, the percentage of injuries attributable to Class III devices is small, but those injuries tend to be the most serious and expensive to treat. They include many catheters, pacemakers and artifical joints.
The Medical Device Safety Act (“MDSA”), a bipartisan bill in the House designed to address the decision (H.R.1346), is still under consideration by Congress. The Medical Device Safety Act would restore the 7th Amendment rights of injured consumers to hold negligent Class III medical device manufacturers accountable when their products cause injury and death. The one-and-a-half-page bill simply does two things:
1) It restores Congressional intent by explicitly stating that actions for damages under state law are preserved.
2) It makes the amendment retroactive to the date of enactment of the Medical Device Amendments of 1976.
It’s a “health care reform bill” that Constitutional conservatives can back. It doesn’t increase the size or power of the federal bureaucracy and it doesn’t create any federal regulatory powers over the health care industry. It not only doesn’t increase federal spending, it will reduce it by reducing the demand for Medicare, Medicaid, and VA spending to rehabilitate victims of defective devices. The MDSA doesn’t create a cause of action which didn’t exist for 30 years before Riegel. It doesn’t infringe on victims’ rights to choose their own health care provider or method. The Riegel decision was opposed by scores of state Attorneys General, who filed an amicus brief with the Supreme Court prior to the decision. The Act’s basis in states’ rights is the reason why the National Conference of State Legisators support the Act.
Medical device companies are lobbying hard with Democrats and Republicans to stop MDSA, and thus far have succeeded in stalling any committee action in either house of Congress. With the new study documenting so many potentially serious injuries of implantable devices, it’s imperative that Congress restore the 7th Amendment rights to the young victims’ families and hold devicemakers accountable when necessary and enact the MDSA.