Pedicle Screw Cases Thrown Out--at a Price
Three years and $10 million later, four medical societies have finally been exonerated in the first mass tort litigation to hit CME. But the victory incurred costs beyond legal fees.
In the mass of cases, which involved more than 2,000 civil actions and 5,000 plaintiffs, four medical societies--the North American Spine Society (NASS), the Scoliosis Research Society (SRS), the American Academy of Orthopaedic Surgeons (AAOS), and the American Association of Neurosurgeons (AAN)--were accused of putting on sales events under the guise of CME seminars as part of a conspiracy with manufacturers to promote--illegally--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 the cases to their original court- houses around the country, to be tried individually. That was when things started to turn around.
Ten cases were thrown out. Using words such as "absurd" and "incredible" to describe the plaintiffs' charges that surgeons were defrauded at CME seminars into using pedicle screws, judges dismissed the cases for lack of evidence. The plaintiffs' lawyers then "surrendered, ran up the white flag, went to the judges and threw [the rest of their own cases] out," said Shawn M. Collins, chief counsel, pedicle screw litigation, NASS, addressing the fourth plenary session at the American Medical Association's Ninth Annual Conference on CME Provider/Industry Collaboration, held in September.
One technicality remains. The plaintiffs have asked the court to revive an earlier claim that the societies conspired to violate FDA regulations, but Collins expects the court will deny that request.
Meanwhile, in an ironic twist, the FDA down-classified pedicle screws in July. They are no longer off-label. It was that classification that formed the basis for the plaintiffs' cases.
While the news is good, "this is success with an asterisk," Collins qualified. In an earlier court decision, Judge Bechtle ruled that the speech at seminars was commercial speech, not free speech, and thus not entitled to full First Amendment protection. That decision, said Collins, is still on the books and has the potential to affect medical societies.
No Recourse? The plaintiff's attorneys are "gaming the system. Period," declares Eric Muehlbauer, executive director, NASS. NASS has considered filing a lawsuit against the plaintiffs' legal committee, but such a suit would be expensive, time-consuming, and "probably not worth it," says Muehlbauer. "I would guess that every association executive who is in this position would feel like going after [the lawyers], but in the end you need to show restraint, to get back to what you're all about in the first place."
For more information on the suit, and how you can protect your society, see "Turn of the Pedicle Screw," December 1997 issue, page 37. You can find it by visiting our archives at www.meetingsnet.com, and searching for the keywords pedicle screws.
Chicago--No Longer Singing the Labor Blues? Chicago is such a great convention city for the American Academy of Family Physicians (AAFP) that even though its 1997 annual meeting cost about $500,000 more in labor costs than it would have in other destinations, the board still voted to try the Windy City again in 2007--with a caveat. "If the labor problems did not improve, we might make other plans," says Sondra Biggs, AAFP convention manager. But now that restriction is lifted. After months of negotiating, the Chicago Convention and Tourism Bureau, Chicago'sunions, and McCormick Place have reached an agreement that Biggs says "is a definite positive."
Effective January 1, 1999, the new agreement tackles the chronic labor, hotel room shortage, and cost problems that have threatened to undermine Chicago's successful meeting, convention, and trade show industry. Here are the details:
* Power Plan: Do your staff, speakers, or exhibitors really need a union electrician to connect their computer monitors? Not any longer. Convention personnel can now set up their own computers, plug in electrical equipment, and also operate their own VCRs and video cameras.
* No More Waiting: Unlike other cities, Chicago has two unions, the Decorators and the Carpenters, involved in booth construction, causing hassles for exhibitors. Now, the two unions have created a unified labor pool, so members of either union can perform the same work.
* Build It Yourself: But exhibitors don't have to wait for either union anymore. Exhibitors whose booths are 300 square feet (10 feet by 30 feet) or smaller--and 70 percent of the exhibitors booths at McCormick fit into that category--can opt to assemble their own booths. (Union personnel will still have to be called in to use power tools and ladders.)
* Dump the Double Time: Union workers will now be paid time and a half, rather than double time, for working evening and weekend hours--the times when most of Chicago's shows move in and out.
* The Intimidation Factor: Convention and trade show organizers have complained about more than labor union costs and multiple jurisdictions: Their exhibitors and staff have reported being mistreated by union personnel. These changes should help alleviate that problem, says Paul D. Astleford, president and CEO, Chicago Convention and Tourism Bureau.
"One of the most important issues of the whole, that nobody has really talked about," Astleford says, "is that it will prevent the intimidation of exhibitors." That's because exhibitors will no longer have to work around the [union] system to get things done efficiently, he explains.
* Getting There: Transportation to McCormick Place will also be improved. By 2001, the city has plans to open a dedicated bus lane to the convention center, as well as a 3,000-car parking garage. And the center has also agreed to absorb half of the busing costs for conventions.
* Hotel Concessions: Hotels, as well as labor unions, have made concessions to keep Chicago's exhibition business healthy. They have agreed to provide large enough room blocks for the megashows, and offer more competitive room rates. On the other hand, hotels are not party--at least not yet--to the union concessions made to McCormick Place and the Navy Pier. Those negotiations may happen in the future.
Industry/Provider Relations: Drawing the Line Something as seemingly simple as who should pay attendees' greens fees on the golf course became the focus of hot debate at the American Medical Association's Ninth Annual Conference on CME Provid-er/Industry Collaboration, held September 16 to 18 at the Marriott Wardman Park Hotel in Washington, D.C.
The conference drew 299 attendees--up from last year's 200. One factor attracting attendees was the recent court ruling restricting the FDA's authority over drug and device companies. (See "Court's FDA Ruling Puts the Squeeze on CME," page 42.)
One of the most contentious issues debated at the conference was the AMA's Ethical Opinion on Gifts to Physicians. There were a lot more questions raised than answers found, but the conference provided a forum for airing frustrations and working toward clarifying key issues in provider/industry relations.
Play and Learn? Under the AMA guidelines, pharmaceutical companies should not pay more than $100 per physician for social activities or gifts at CME programs. But what can that $100 buy, ethically speaking? During the third plenary session, attendees raised the problems they have setting concise rules, and said that when they seek guidance from the AMA, they sometimes get confusing answers.
One attendee said that he had been told by the AMA that tickets to a sporting event were "inappropriate" unless the company provided a box of seats, where doctors could talk to each other. "This is ludicrous," he said. "I don't want to put my accreditation in jeopardy." Another attendee agreed, drawing audience applause when he said, "It would help to have clear, crisp rules. People want to follow guidelines."
Jessica Berg, attorney, and secretary, Council on Ethical and Judicial Affairs, AMA, attempted to clarify the guidelines, explaining that social activities are supposed to provide the opportunity for physicians to discuss the educational programs. Therefore, industry can pay for doctors to play golf, since golf is interactive--physicians talk while they play. ("They talk about golf!" exclaimed one frustrated attendee.) Broadway shows are not OK, said Berg, because people are likely just to sit and watch the show.
No matter what guidelines are in place, companies can find ways to work around them, said Glenna L. Case, PhD, director, division of education, American Academy of Neurology, Saint Paul, Minn. "We specify that they can't [host] social activities at our facility that interfere with programming. So, they hire a boat and take [physicians] out on the river."
Next year's conference will be held September 22 to 25, at the Washington, D.C. Hilton & Towers.
Win a Free Scottish Board Meeting Enter the Scottish Convention Bureau's contest and you have the chance to win a free board meeting in Aberdeen, Edinburgh, or Glasgow.
Winners will receive 15 deluxe hotel rooms for four nights and meeting space for three days. To qualify, groups must have held at least one convention in the past five years abroad or have plans to meet in Europe.
For more information, contact the Scottish Convention Bureau, c/o Mondotels, (800) 262-8244. Deadline for completed entries is December 15, 1998.
Correction In the story "Learning the Drill," September/ October 1998 issue, the Acropolis Exhibition Centre in Nice should have been described as having 170,000 square feet of space.
Help for Beginners Veteran meeting planner Ann J. Boehme has written a book about basic meeting planning techniques especially aimed at administrative assistants who have no experience in planning events or conferences. Published by the American Management Association, Planning Successful Meetings & Events covers such basics as site selection,negotiation, budgeting, and promotion.
Boehme's book is available in paperback through Adams Business Media's Bookstore at (800) 396-3939.
LEARN FROM FOR-PROFITS, SAYS NEW PCMA FOUNDATION HEAD After 10 years with Marriott, Phil Mogle has moved over completely to the education side of his profession. Leaving his position with Marriott as regional vice president, national accounts, Mogle has become the first chief operating officer of the PCMA Foundation. As COO, he intends to "help associations move into the virtual future, and to be more efficient and productive in providing training and continuing education to their members."
Associations need guidance now, more than ever, Mogle says, because for-profit education providers are drawing business away from associations. Take CME, for example. While education has traditionally been provided by specialty societies and other associations, now those groups have to compete with for-profit CME providers. When threatened, one approach is to try to stop the competition. That is not a practical solution, cautions Mogle. "The reality is you are not going to stop free enterprise. It is incumbent on non-profits to become as nimble and as competent as [any other] providers."
To help associations compete, Mogle says the foundation will track best education practices among nonprofits, for-profits, the military, universities, and the government. He wants associations to have access to the "latest thought processes of the entire free enterprise system. We are not limiting ourselves to the traditional meeting and convention environment, but [will conduct a] broader scan."
The foundation will also track best practices in using technology to advance education. "Those of us who traditionally have been in the meet-and-greet, press-the-flesh meeting industry may not have always been as sophisticated as we needed to be in doing our business," he says. All that has to change if associations and suppliers are to survive in the virtual future, he asserts. As for those who worry that virtual meetings will replace face-to-face ones, he says, "When you combine virtual and traditional meetings, you end up exponentially increasing the efficiencies of both environments."
Legislative Wrap-up Music Licensing Ends on Sour Note
Hundreds of association executives wrote to their representatives urging them to support music licensing reform--but all that beating the drum didn't do the trick. The House had passed the bill back in March with a strong vote of 297 to 112. But in the final days of the fall session, House and Senate members convened a behind-the-scenes negotiation, and gutted the bill--as least as far as meeting planners are concerned.
The final version of the legislation, known as the copyright extension bill, passed the Senate without the two most important components of music licensing reform. The bill does not protect associations from vicarious liability. They can still be held responsible if an exhibitor, for example, plays music at a meeting without getting permission from music licensing organizations.
Another irritating issue for convention planners is that all disputes between music licensing organizations and associations must take place in New York. While the bill does say that disputes can now be handled locally, the provision applies only to certain proprietors. "It could be a stretch to apply [the wording] to associations," says George Constantine, legal and policy specialist, Public Policy Division, American Society of Association Executives (ASAE). It will be up to the courts to unravel that terminology tangle.
The fight is not over, says Constantine, who suggests association executives urge their representatives to take up this issue in the next session. Because the bill was pushed through so fast, "members of Congress may think they passed music licensing reform and not realize it is very different from the bill the House passed early this year," he says. Reps need to know that "[the final bill] is not satisfactory to the association community."
Liability Letdown Congress took no action on the Trade and Professional Associations Free Flow of Information Act of 1997. The bill would help protect associations from lawsuits such as the pedicle screw case, which result from education or information that they provide to members (see story page 14). The act has been introduced in the House and Senate, and ASAE, working with a coalition of associations supporting the bill, will encourage representatives to schedule committee hearings early in the 106th Congress in order to pave the way for floor action, says Constantine.
Cyber Tax Freedom If you sell items over the Internet, such as books, seminar tapes, exhibit booth space, or other meeting-related products, you could be clobbered with state and local sales taxes on Internet transactions. That is, you could have been, until Congress passed the Internet Tax Freedom Act in the final hours of the term.
The bill imposes a three-year moratorium on new local or state taxation of Internet commerce. It also calls for the government, in conjunction with consumer and business groups, to study Internet commerce and submit taxation policy recommendations to the President.
For more information on any association or meeting-related legislation, contact ASAE's public policy division at (202) 626-2703 or e-mail email@example.com.