Court Denies Medical Societies' Petition in Pedicle Screw Case The medical societies that are defendants in the pedicle screw case have scored their first major victory. Four of the cases have been thrown out by federal judges for lack of evidence.
The pedicle screw suit, the first mass tort litigation to hold societies liable for what they teach at seminars, is being closely watched not only by the CME community, but by the wider association community, because of its potential threat to association-sponsored education, (see "Turn of the Pedicle Screw," December issue, page 37; and "Court Denies Medical Societies' Petition in Pedicle Screw Case," January/February 1998, page 11.)
In the massive tort litigation case, which involves more than 2,000 civil actions and 5,000 plaintiffs, four medical societies--the North American Spine Society, the Scoliosis Research Society, the American Academy of Orthopaedic Surgeons, and the American Association of Neurosurgeons--are accused of putting on sales events under the guise of CME seminars as part of an illegal conspiracy with manufacturers to promote pedicle screws, devices used in spinal surgery.
After the societies lost in the last of their efforts to get the cases dismissed, U.S. District Court Judge Louis C. Bechtle remanded 53 of the cases to their original courthouses around the country, to be tried individually. That was last November.
In the months following, the societies' attorneys filed summary judgment motions in the individual courts. Those motions, explains Shawn Collins, chief counsel, pedicle screw litigation, North American Spine Society, "said that there is no evidence to support the plaintiffs' claims of a conspiracy to defraud implanting surgeons."
In depositions, those surgeons, under oath, said they were not fraud victims, but had used pedicle screws because they believed they worked and that they were the best treatment option for the patient, Collins says. "It completely devastates the fraud theory, because you have no fraud victim."
So far, the judges agree. Four cases were thrown out of U.S. District Courts: two in Mississippi, one in Virginia, and the fourth in Wisconsin.
"I am ecstatic," says Tressa Goulding, executive director, Scoliosis Research Society. "This proves what I have suspected all along, that once we get to the point where an open-minded judge would look at the actual evidence, [he] would see there is nothing."
While the other federal judges who will be examining the numerous other cases are not bound to follow the first four judges' rulings, "typically other judges will pay attention," says Collins. "[The first rulings] tend to be persuasive because the cases are so similar."
The plaintiffs can appeal the judges' rulings, adds Collins. "Frankly, we expect they will do that," he says. "We expect they will lose."
Although the news is good, and Collins is optimistic about future rulings, there are still negative ramifications from the lawsuit, cautions Robert M. Portman, Esq. Portman represents numerous medical societies, and is an attorney with Jenner & Block in Washington, D.C., the firm that acts as general counsel for the American Society of Association Executives.
In an earlier ruling, U.S. District Court Judge Louis C. Bechtle decided that the court would consider the speech at seminars to be commercial speech, not free speech. Commercial speech is not entitled to full First Amendment protection.
That decision, and the fact that the plaintiffs' case survived the earlier motions to dismiss, requiring the societies to expend "extraordinary resources, has to be an ongoing concern for medical societies," says Portman.
Academic CME Directors Challenge For-Profits' Accreditation In a confidential white paper obtained by Medical Meetings, nine members of the Society for Academic Continuing Medical Education (formerly the Society of Medical College Directors of Continuing Medical Education) in Washington, D.C., call on the Accreditation Council for CME to change its eligibility requirements. For-profit organizations, such as pharmaceutical, medical education, and communications companies, should not be eligible for accreditation, states the white paper. Instead, CME accreditation should be limited to licensed, academic medical institutions; specialty societies; and state medical societies.
The white paper is a work-in-progress, say signatories and has not been endorsed by the Society, although it will be brought up for discussion at the annual meeting in the fall. But news of it is circulating rapidly, igniting debate throughout the CME community.
Since the early 1980s, when the first for-profit CME provider was accredited by the ACCME, both for-profit and nonprofit organizations that meet the ACCME criteria have been eligible for accreditation. Currently, there are a total of 607 accredited providers, of which 27 define themselves as communications companies, and 147 as "others," a category comprising various types of organizations, including some for-profit medical education companies. Two pharmaceutical companies, Eli Lilly and Upjohn Pharmacia, are also accredited.
The main point underscored in the white paper is that while the mission of traditional, licensed CME providers, such as medical schools, is to "educate physicians in order to enhance the public health," the mission of corporations, such as communications companies, is to generate profits. And because of that difference in mission, for-profit organizations are much more susceptible to undue influence from commercial supporters and are thus more likely to violate the ACCME's Standards for Commercial Support. (The Standards outline the appropriate relationship between CME providers and commercial supporters, and are designed to ensure that CME programs are unbiased and truly educational, rather than promotional.)
"When you are dependent upon making a profit in order to survive, no matter how hard you try, it is impossible, in my opinion--and I speak as a psychiatrist-- to either consciously or unconsciously not have a conflict of interest," asserts Donald S. Kornfeld, MD, white paper signatory, and associate dean and director of CME, Columbia University College of Physicians and Surgeons, New York City.
Needless to say, the white paper's position generates impassioned opposition from medical educators on the for-profit side. They argue that the issue is not whether an accredited organization is a for-profit or nonprofit provider, but whether it complies with the ACCME Essentials and Standards.
"Are we to accuse the ACCME of wrong judgment in determining that certain nonlicensed companies and groups do meet the Essentials and Standards, and can, therefore, provide CME?" challenged Robert F. Orsetti, president and CEO of CME Information Services, Inc., in Mt. Laurel, N.J., in a written response to the white paper that he sent to Medical Meetings. "When so sanctioned . . . nonlicensed companies are the equals of licensed providers of CME."
Countering the charge that for-profits are motivated only by the bottom line, Donald S. Nelinson, PhD, vice president, educational services, Impact Communications, Inc., in New York City, contends, "Our mission is education. [At Impact], we have a full-time physician, physician educator, pharmacologist, and public health researcher on staff. My question to the signatories: Do you have all the same kind of people involved in development of CME activities?"
The for-profits will take action, if their accreditation is threatened, says Nelinson. "We will defend our position as accredited sponsors very, very vigorously," he says, adding that a class-action lawsuit has been discussed as one of the strategies companies might take if they are stripped of their accreditation.
Offering the view of a professional who knows both camps, Joseph Green, PhD, president of the Alliance for CME, and associate dean for CME, Duke University School of Medicine, Durham, N.C., suggests that the more money a pharmaceutical company throws at a CME activity, the more difficult it can be for the provider to keep the pharmaceutical company from exerting undue influence.
Because of the large amounts of money that pharmaceutical companies are granting communications companies, he can understand why some providers are concerned about the potential for violations. However, he underscores that the answer is not to stop accrediting certain types of providers. The real issue, he says, is compliance, an issue that cuts across for-profit and nonprofit lines.
Green, who is also president of the Professional Resource Network, a CME consulting company, observes, "In my experience as a surveyor for ACCME, and a consultant to lots of organizations, there is a whole continuum of compliance. Violations occur in medical schools and hospitals as well as communications companies."
At press time, members of the Medical Education Communication Company Alliance had just met about the white paper with its recipient, Murray Kopelow, MD, executive director, ACCME. "The meeting was very valuable," says Nelinson, a MECCA member. "There was some good, candid discussion."
That kind of discussion is exactly what Kopelow is initiating by convening meetings with providers of all stripes. His initial response to the white paper, he explains, is to gather information and points of view. He clarifies that the ACCME is looking at the broad picture, not targeting for-profits.
"The most important message [in the white paper] is, are there some irreconcilable conflicts between the ACCME Standards and some kinds of providers or situations?" Although the white paper proposes strategies, "it isn't that set of strategies we are looking at," Kopelow says.
"We know the world of health care is dynamic and so should the world of CME be dynamic. We need to be an organization that can accommodate change, and look at ourselves periodically, and ask, is our system still the appropriate system?"
Those questions are being asked "with no preconceived notions," Kopelow emphasizes. "We have a good set of rules and a good set of providers."