Four medical societies are fighting to prove their innocence in the first mass tort case to hold associations liable for what they teach at seminars. It could happen to your organization.
In the worst-case scenario, [the pedicle screw case] could eliminate associations as we know them," declared William Tipton, MD, executive vice president of the American Academy of Orthopaedic Surgeons (AAOS). Speaking at the Eighth Annual Conference on CME Provider Industry Collaboration, held October 5 to 8 in Fort Lauderdale, FL, Tipton continued, "We must hear about advances and future treatments in order to make the best decisions for patients. I believe this threat, at its worst, could bankrupt our organizations and eliminate what has been the best platform for the exchange and accumulation of this information."
Imagine CME seminars, as Tipton suggests, without free and open discussion of the newest medical advances. Sound unimaginable? Think again. In a massive tort litigation case involving more than two thousand civil actions and five thousand plaintiffs, four medical societies--the North American Spine Society (NASS), the Scoliosis Research Society (SRS), the American Academy of Orthopaedic Surgeons, and the American Association of Neurosurgeons (AANS)--are accused of conspiring with manufacturers to promote--illegally-- pedicle screws, devices used in spinal surgery.
How? By putting on sales events under the guise of CME seminars, say the plaintiffs, who allege that the CME programs were no more than medical Tupperware parties designed to advertise pedicle screws. They claim CME providers defrauded attendees by concealing crucial information:at these seminars had financial relationships with the manufacturers, relationships they did not disclose to attendees, and the FDA status of pedicle screws was also not disclosed. In addition, manufacturers exhibited at the seminars, and their sales representatives solicited spine surgeons to attend the programs and also obtained the names of attendees and contacted them after the seminars. It is the first mass tort litigation case to hold associations liable for what is taught in CME.
Why Pedicle Screws? The device that has ignited this historic controversy--the pedicle screw--is a form of bone screw, used in spinal surgery. The screws hold in place plates or rods--pedicle screw fixation systems--that immobilize the spine and allow the vertebrae to fuse. They are called pedicle screws because they are implanted in the pedicles of the vertebrae. The systems are used to treat, among other conditions, fractures, degenerative arthritis, and reconstruction from tumors.
The FDA, in 1984, classified pedicle screws as Class III devices because they considered the screws to "present an unreasonable risk of illness or injury." The FDA made one exception: in 1995 it allowed promotion of pedicle screws for treatment of spondylolisthesis (displacement of one vertebra over another).
While it remains illegal to market or promote the screws for any other use, it is perfectly legal for physicians to use the systems for off-label conditions, and orthopedic surgeons continue to implant them in thousands of patients. In 1993, patients began suing in large numbers for product liability, alleging that the pedicle screws caused them ongoing severe physical harm, including injuries to the spine, emotional distress, loss of earnings, and other serious problems. Initially, the cases were directed against the pedicle screw manufacturers, companies such as Danek Medical, Inc., and Acromed, Inc. Then, in 1995, medical societies were named as defendants in lawsuits.
Mass Tort Morass "Associations were named as defendants," says Arnold Levin, co-chairman of the Plaintiffs Legal Committee (PLC), "because they aided and abetted the unlawful promotion of the device."
The societies' attorneys, on the other hand, see a money-grab. Some of the plaintiffs' attorneys are the same ones involved in tobacco and breast implant litigation, points out Shawn Collins, chief counsel, pedicle screw litigation, NASS. "The lawyers who are suing us are entrepreneurs as much or more than they are lawyers. This is part of the mass tort litigation fad in this country. What they see here is an opportunity to open up new vistas of litigation."
The societies filed a motion to dismiss the cases, but in April, U.S. District Judge Louis C. Bechtle ruled against them, deciding that most counts of the case could go forward to trial. The societies have appealed the ruling before the Federal appellate court, and a decision is expected before the end of the year.
The appellate court has several choices. It can grant the appeal and throw the case out; but sources say that's a long shot. It can send the case back to the U.S. District Court for further findings. Or it could deny the appeal--which means the hundreds of cases will go to individual courts across the country for trial, and the defendants will have to fight the cases one by one. That impending nightmare is what societies are now preparing for.
Same Actions--Different Motives The societies emphatically deny the allegations. Far from holding seminars about pedicle screws in order to promote them, says Tressa Goulding, executive director, SRS, pedicle screws were targeted by SRS because of concern about their widespread use. "Doctors were teaching themselves to do it," Goulding says. "We thought perhaps that was not the best way."
Plaintiffs accuse the societies of recruiting faculty who had a financial stake in the screws, but Goulding says it was a matter of hiring the device developers--who knew the most about the screws--to do the teaching. "It was not an effort to promote their use, she says. "It was more that we felt if surgeons were using them, they should be using them correctly."
At its annual meeting the AAOS has FDA representatives walk through the halls to make sure exhibits about unapproved devices are properly labeled, says David Lovett, deputy director, Washington, DC office, AAOS. "Our academy has always had the highest standards about disclosure," he emphasizes. Collins adds, "We have taken the depositions of hundreds of implanting surgeons. They knew the FDA status. They knew pedicle screws had inherent risks associated with them. They consciously chose to implant the pedicle screws in their patients because they thought it was the best thing to do under the circumstances. It had nothing to do with being misled at seminars. That's ridiculous."
It should also be noted that while disclosure of faculty/industry relationships and the FDA status of drugs and devices has been mandated since 1992 under the Accreditation Council for Continuing Medical Education () Standards for Commercial Support of CME, some of the seminars named in the plaintiffs' complaint were held prior to that, in the late 1980s.
Some CME providers have speculated that perhaps the associations are guilty of the nondisclosure allegations. But whether or not they are, the case will affect the entire CME world, say those involved.
"People can guess all they want," says Eric Muehlbauer, executive director, NASS. "This is mass tort litigation. It has nothing to do with actions that we may
or may not have taken. We're just part
of the scenery. The plaintiffs are after
Bad News, But Not Precedent If the appeal is granted, it will certainly be a huge victory. But the damage has been done, says Collins. The plaintiffs scored an important win when Bechtle denied the motion to dismiss. "Medical associations can be sued for holding seminars," he stresses. "As of April 1997, the decision is in the books. We're going to try to diminish the terrible effects of that decision, but we will never completely do away with it."
Tempering that view, Jonathan T. Howe, attorney with Howe & Hutton, Ltd. in Chicago, says that if the appeal is granted, "That will be the end of it." So far, Bechtle's ruling, although it can be cited in other cases, is not yet binding on any other courts. If the appeal is dismissed, then his ruling would be binding, but only within that particular circuit, Howe explains. And only if the ruling were upheld all the way up to the Supreme Court would it be binding on all federal courts.
Regardless of what happens next, one aspect of Bechtle's ruling that those involved find particularly disturbing is his decision that the court would consider the speech at the seminars to be commercial speech, not free speech. And commercial speech that is false, deceptive, or misleading is not protected by the First Amendment.
While Bechtle states that this ruling does not prevent doctors from teaching seminars on pedicle screws at CME programs, and that speech about scientific and medical issues would not be discouraged, others say the effect of his ruling is devastating.
Fearing similar litigation, associations may change their focus and teach only refinements to current medical techniques to avoid liability, says Muehlbauer. "Once you take away cutting edge discussion, you take away advancements in medicine," he underscores. "How is that good for medicine, for patients, for the country?"
Unending Implications The potential consequences reach further than medical societies and beyond education about off-label products. "I think the implications are unending," says Dennis K. Wentz, MD, director, division of CME, American Medical Association (AMA). "This will chill education. Not only CME, but graduate medical education and perhaps undergraduate education. If a teacher can be held responsible for the outcome [of a program], that forever changes the direction of education."
This summer, the AMA, along with a number of medical associations, filed an amici curiae (friends of the court) brief in support of the four societies, out of concern for the lawsuit's effect on education.
That concern has spread outside the medical association community. Two nonmedical associations, the American Council on Education and the Association of American Universities, joined the American Podiatric Medical Association and the American Association of Dental Schools in filing an amici curiae brief, which says the court's decision to rule the seminars commercial speech would not only inhibit medical associations from educating their members, but threaten the vitality of all academic speech. It also states that subjecting discourse to potential tort liability threatens to erode the very core of First Amendment protection.
Not the First Tort Case Are those involved in the pedicle screw case overstating the effect? Perhaps. "It is potentially a huge threat to association-sponsored education," agrees Jerald Jacobs, attorney with Jenner & Block in Washington, DC; and general counsel for the American Society of Association Executives (ASAE). "It is far too early to predict the result, or whether it will be adverse to the associations involved, let alone whether it will establish a damaging precedent for all associations."
While the pedicle screw litigation is, apparently, the first mass tort case claiming injury from association-sponsored education, Jacobs also points out that there have been other tort cases against associations, and most have failed. The National Spa and Pool Institute was sued, with plaintiffs alleging that the association was responsible for injuries suffered by people using pools because the association published information on building swimming pools. Two of the three cases were won by the group, says Jacobs.
But in the third case, where a man died from injuries sustained after diving into his pool, the Alabama Supreme Court ruled in 1990 that the group had opened itself to potential liability because it disseminated standards for pool construction to its members. However, that decision, says Jacobs, is considered an aberration. Ultimately the Institute was found not liable for the man's death; but, according to the Legal Times, the Institute spent hundreds of thousands of dollars proving its standards were sufficient to prevent injury--costs like those being incurred by the pedicle screw defendants. (See "Why You Need to Protect Your Association," page 38.)
Losing the War Even before the courts decide on the merits of the plaintiffs' allegations, the case has begun to have the chilling effect on CME that Tipton warned of in his speech. The SRS is now conducting seminars on new technologies (all kinds, not just pedicle screws) offshore. "We're always trying to present the newest thing, and let people get out on the floor and discuss it," says Goulding. "We feel like perhaps we don't want to do that in the U.S."
Is going overseas any protection? "They try to circumvent the law by flying American doctors to other places," says plaintiffs' attorney Levin. "Which you can't do. It's the same cause of action." While American courts can sanction actions taken by American organizations overseas, it may not be practical for the plaintiffs to further expand their claims, says Robert E. Nord, attorney with Hinshaw & Culbertson in Chicago, and former SRS counsel. "It does strike me the more extravagant the reach of the plaintiffs' theories, the less plausible they are to a jury or a reviewing court," he adds.
The chilling effect on speech at meetings has reached to societies that are not involved in the suit. One representative of a specialty society, who asked not to be identified, said that because of the pedicle screw lawsuits, his organization was taking extra efforts to ensure that no off-label techniques were part of his programs. Some offerings were cut back. Some of the cuts were perhaps not necessary--but, he stressed, societies have to be cautious in these times.
While Collins says cancellation of courses is an overreaction, he adds that it doesn't surprise him. "Right at that moment--when people stop teaching about new medical developments--we have lost the battle and are well on our way to losing the war," he says. "I'm saddened to hear that's what is going on. This is our legal system making a large mistake, in my judgment."
Fighting Back As they wait for the outcome of their appeal and prepare for the eventuality of trial, the societies are fighting back on other fronts. The American Association of Neurosurgeons, with support letters from the other three associations, filed a citizen's petition with the FDA, asking the agency to make a decision on reclassification of the pedicle screw, a ruling that has been pending since 1995. "I want to be explicit," Tipton says, "We're not asking for a decision in our favor--just a decision."
One thing the societies won't do is settle. "We could take the easy way out and write a check," says Collins. "But there is something far greater at stake--the integrity of our organization and our ability to fulfill our mission, which is education of our members."
No matter what happens, associations have been forced to face their vulnerability as targets in mass tort litigation, and confront the possibility of losing CME as a forum for open discussion of medical advances. That experience has been deeply distressing to the participants. "It's made me a whole lot more wary of people's motives," reflects Muehlbauer. "I'm probably the first executive director of a medical society who has intimate knowledge of the litigation process. I hope nobody else needs to know."
Why You Need to Protect Your Association Scrupulously following ACCME guidelines does not completely protect your organization from litigation. A case can move forward to trial regardless of guilt or innocence. U.S. District Judge Louis C. Bechtle, for example, in denying the defendants' motion to dismiss, was not ruling on the merits of the plaintiffs' case, only on whether the plaintiffs presented their complaint properly. Judges are not really predisposed to dismiss cases on a motion, notes Jonathan T. Howe, attorney with Howe & Hutton, Ltd. in Chicago.
Just being named as defendants exacts a tremendous toll. Without being anywhere near a trial date, the case has cost the American Academy of Orthopaedic Surgeons (AAOS) $1.5 million, and that figure keeps increasing, says William Tipton, MD, executive vice president. While most of that loss has been reimbursed by insurance, the AAOS is still waiting for reimbursement for half a million dollars. And, the AAOS had to hire legal counsel to seek payments from its insurer, at a cost of an additional $100,000.
That's just the AAOS. Legal costs for each society are running about $150,000 per month, estimates Shawn Collins, chief counsel, pedicle screw litigation, North American Spine Society (NASS). Each society has hired its own defense team. NASS also had to hire counsel to seek insurance payments, and those fees, says Eric Muehlbauer, NASS executive director, will never be reimbursed.
"Innocent until proven guilty--that's at the trial," says Muehlbauer, with new-found cynicism. "There's a whole lot of expenses in the meantime."
The financial toll is only one way associations are being hurt. "I can't even imagine how many hours I've spent giving out information," says Tressa Goulding, executive director, Scoliosis Research Society (SRS). "My office looks like a storeroom. We have sent something like 1,800 pages of documents to the PLC [Plaintiffs' Legal Committee] in response to its call for depositions."
Be Proactive Here are some measures you can take to protect yourself against litigation: Be Aware: The most important thing is to be informed about the pedicle screw litigation and its potential consequences. "I am constantly surprised by the number of high-profile people who are not aware of this," says Collins.
Educate Faculty about the importance of disclosure. "I worry that faculty believe people in the audience know what is off-label use and can use their own judgments about what is credible and what isn't," says one specialty society member, who asked not be identified. "They see the need to disclose as just another ACCME requirement, as opposed to understanding the potential implications if they fail to disclose."
Exhibit Areas: When exhibitors display anything that Muehlbauer considers higher-risk technology, he now asks them to give NASS not just a certificate of insurance, but to name the society as an additional insured. "If we get sued down the road for allowing someone to display at our meeting, we have an additional policy to help us fight litigation," he explains. NASS has also formed a committee to ensure that exhibitors have the proper signage about their products' FDA status. "It's just really making sure exhibitors know we're going to be a helper to the FDA in trying to enforce" [those requirements], says Muehlbauer.
Insurance--Hidden Battle: Fighting to get legal costs reimbursed by insurance companies has been a hidden battle, says Muehlbauer. Some policies, for example, have exclusions for personal injury, which is one of the allegations made by plaintiffs. In that scenario, you have to fight a battle with the insurance company over what event triggers the coverage. Examine your policy and get advice about whether you have the right kinds of coverage, and enough coverage.
"If concerns about liability are going to keep associations from communicating with their members, that's a real problem," says Jim Clarke, vice president of government affairs with the American Society of Association Executives (ASAE). His office has been closely monitoring the progress of the Trade and Professional Association Free Flow of Information Act, a bill that would give associations some weapons with which to fight liability claims. The bill would provide associations with qualified immunity from liability for disseminating information, unless the information was fraudulent. It also includes procedures that would enable associations to file motions to strike any legal claims that are considered immune under the bill's definitions.
Recently, ASAE's public policy committee voted unanimously to support the bill, and at press time, its recommendation was going before ASAE's board of directors. If the board votes in favor of the committee's recommendation, then a course of action will be decided.
Supporters acknowledge that getting the bills passed will be a long, tough fight. Bill H.R. 1542, the House of Representatives version, sponsored by Congressman Sonny Bono (R-CA, 44th District), has been referred to the House Committee on the Judiciary, and S-1135, the Senate's version, sponsored by Senator Mitch McConnell (R-KY), is before the Senate Committee on the Judiciary. No action has been scheduled on either bill. On a positive note, David Lovett, deputy director, Washington, DC office, American Academy of Orthopaedic Surgeons (AAOS), says, "I think the exciting thing is you've got a few members of Congress aware [of the situation]. At least it's on the radar screen."