Medical Devices, Liability Reform, and Defensive Medicine

The House Energy and Commerce holds a hearing this morning, “Impact of Medical Device Regulation on Jobs and Patients,” to examine the state of the medical device industry and the impact of regulations on job creation and patient access.

It’s a timely topic. Working on H.R. 5, the medical liability reform bill, the House Judiciary Committee rejected an amendment (Amdt. 15) sponsored by Rep. Mike Quiqley (D-IL) to strike the “safe harbor” provisions that would preclude punitive damages in litigation against FDA-approved medical devices and drugs. We discussed the importance of that language in a post Wednesday, “Why Medical Liability Matters to Manufacturers.”

Elsewhere in the world of medical liability, a new study provides further documentation that the threat of lawsuits drives doctors to conduct unnecessary and expensive tests, driving up health care cost. From the American Academy of Orthopaedic Surgeons, “Healthcare Spending: Study Shows High Imaging Costs for Defensive Purposes“:

Nearly 35 percent of all the imaging costs ordered for 2,068 orthopaedic patient encounters in Pennsylvania were ordered for defensive purposes, according to a new study presented today at the 2011 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

For many years now, some physicians have ordered specific diagnostic procedures that are of little or no benefit to a patient, largely to protect themselves from a lawsuit. Until now, however, efforts to actually measure defensive medicine practices have been limited primarily to surveys sent to physicians. Such surveys would simply ask whether or not that individual actually practiced defensive medicine.

“This is the first study we know of that looked at the actual practice decisions of physicians regarding defensive imaging in real time — prospectively done,” says John Flynn, MD.

And here’s the agenda for the summer convention in New York City of the American Association for Justice, the trial lawyers’ lobby. You’ll see that AAJ’s members are very interested in suing doctors, drug makers and medical device manufacturers.

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