Medical Device Daily Washington Editor

Liability has been a sore spot for providers and makers of drugs and devices for several decades, but Common Good (New York), a bipartisan legal reform group, is working to sign up six hospitals to host a pilot project that will give special health courts a crack at resolving the current impasse on medical tort reform.

A number of prominent voices of all political stripes in the healthcare establishment have lent their cachet to the effort, including Senate majority leader Bill Frist (R-Tennessee) and the Progressive Policy Institute (Washington), a liberal think tank presided over by Will Marshall III. Common Good has teamed up with the Harvard School of Public Health (Boston) to structure the courts with financial assistance provided courtesy of The Robert Wood Johnson Foundation (Princeton, New Jersey).

These special health courts would focus solely on healthcare matters with full-time judges who have or will receive training on some of the sector issues of the day. The judges would rely on testimony by purportedly neutral experts, and the first few decisions may set important precedents.

Special health courts would also avoid the controversy of compensations – that they seem to benefit lawyers as much as, or more than, plaintiffs.

The list of participating hospitals includes Johns Hopkins Medicine (Baltimore), Emory Healthcare (Atlanta), and Duke University School of Medicine (Durham, North Carolina).

Common Good's board of directors also boasts a wide, bipartisan membership. It includes former senators Howard Baker (R-Tennessee), Bill Bradley (D-New Jersey) and Alan Simpson (R-Wyoming). Former attorney general Griffin Bell, who served during the Carter administration, and former House speaker Newt Gingrich (R-Georgia), now with the Center for Health Transformation (Washington), are also on the board.

Philip Howard, who chairs the board of Common Good, said that these courts could “restore reliability for patients and doctors alike” and may resolve what he described as “erratic” medical justice that infests healthcare “with a debilitating distrust.”

The effort has garnered attention from the incumbents on Capitol Hill as well. A pair of senators from the American West, Max Baucus (D-Montana) and Michael Enzi (R-Wyoming), have inked a bill to boost funding for the special courts. Known colloquially as the Fair and Reliable Medical Justice Act (S. 1337), this bill was introduced to the Senate Committee on Health, Education, Labor, and Pensions last August and would cap legal fees at 20% of the total award. The threshold for liability would be reduced to proof of failure/error without discernment of the exact point of origin of the error.

The bill has generated opposition from the American Trial Lawyers Association (Washington) and the American Bar Association (Chicago) as well as from Senator Edward Kennedy (D-Massachusetts). Kennedy argues that the bill would deprive litigants of a “genuine choice” in dealing with malpractice and product liability.

Small device maker workshop set for July

FDA and the Advanced Medical Technology Association 's (AdvaMed; Washington) Medical Technology Learning Institute are teaming up to present a two-day public workshop July 12-13 “for start-up and small device manufacturers and their suppliers,” with perspectives offered by the agency and experienced members of industry.

The workshop will take place at the Marriott Fremont Hotel, in Fremont, California, and will include a networking reception the evening of the first day. The workshop will cover a variety of elements of the quality systems regulations, including inspections, design controls, production and process controls, and corrective and preventive action. Other topics include reimbursement, contact information for those seeking assistance at the agency, and the AdvaMed code of ethics.

FDA said it does not intend to provide transcripts for this event.

To register, contact Krystine McGrath at kmcgrath@advamed.org, or phone 202-434-7237.