The broad reach of the pedicle screw litigation could put medical education on trial and stifle the free and open discussion that is a mainstay of scientific progress.
The litigation calls into question whether medical associations can provide educational forums without being liable for future claims for alleged damages resulting from injuries from the devices. One of the primary points at issue is the fact that the medical associations provided educational settings where the pedicle screw was discussed and where manufacturers exhibited the device.
Named in a number of lawsuits around the country, now consolidated in multi-district litigation in Philadelphia, are the Academy, American Association of Neurological Surgeons, North American Spine Society and the Scoliosis Research Society.
The medical associations are accused of having "promoted, sponsored and encouraged the use of spinal fixation devices utilizing pedicle screws and [have] provided exhibit space and promotional opportunities for the [manufacturers'] devices to be displayed at seminars." The Plaintiffs Legal Committee (PLC) claims this conduct was negligent, in violation of Food and Drug Administration (FDA) regulations, caused the infliction of emotional distress and was a "fraud on the marketplace." The medical associations also are accused of being involved in a "conspiracy, aiding and abetting, concert of action and enterprise."
Although the complaints against the medical associations were dismissed in August for being imprecise and inconclusive, the PLC had until Sept. 30 (later extended to Oct. 30) to file new or amended complaints. As this was written, it is anticipated the PLC will file new pleadings.
"Education is a fundamental endeavor of the Academy and many other medical associations," said William W. Tipton Jr., MD, executive vice president of the Academy. "A ruling against these medical associations would expose all medical societies to potential litigation for discussing new scientific devices and procedures.
Freedom of speech
"It would be a violation of freedom of speech and would end the scientific progress that comes from free and open discussion. Scientists and practitioners need to know about procedures, devices and drugs, whether they are experimental or in general use. They need to know how they work, the indications for use and the outcomes."
Executives of medical associations that are not named in the litigation agree. H. Dunbar Hoskins Jr., MD, executive vice president, American Academy of Ophthalmology, said, "the idea that providing information or teaching about a procedure or technique is promotional is absurd. In terms of professional education, we couldn't do anything without being liable. This would seriously impair, if not destroy, our educational process."
Paul Ebert, MD, executive director, American College of Surgeons, doubts that the court will agree with the plaintiffs that the medical associations were "promotional centers."
If there was no outside influence on the peer review of scientific papers or presentations at postgraduate courses, the associations were only providing education, Dr. Ebert said.
An adverse decision will mean "we can't do anything," Dr. Ebert said. "There will be no open and free discussion" of new scientific ideas.
The Academy, which is using outside counsel in addition to its internal legal staff to pursue the legal issues, has complied with subpoenas for more than 80,000 pages of documents.
The torrent of litigation has been consolidated for pretrial administration in the U.S. District Court for the Eastern District of Pennsylvania, Philadelphia. This multidistrict litigation process, relatively new in the legal system, allows the presiding judge, Louis C. Bechtle, to review claims and pretrial arguments and decide whether any or all claims should be heard in the districts where the cases were filed.
On April 19, 1996, Judge Bechtle expressed concern that the PLC may have pleaded the conspiracy claims too generally and told the attorneys to provide more specifics.
In August, Judge Bechtle found the pleadings of the PLC "imprecise" and dismissed the conspiracy claims against the medical associations. Judge Bechtle said the plaintiffs have not proven that the court has jurisdiction over the subject matter of the claims. He dismissed all conspiracy claims "because the claims fail to state a claim on which relief can be granted."
However, Judge Bechtle gave the PLC until Sept. 30 (later extended to Oct. 30) to refile. He explained that "the court believes it is not fair to slam the door on the plaintiff's chances for recovery simply because their lawyers did not, or could not, express their claims consistently with the pleading rules."
The medical associations had similarly argued in a motion to dismiss that the PLC complaints were vague and inadequate. They said the complaints failed to allege that what the associations did caused ultimate emotional distress to any plaintiff.
The associations also argued they cannot be held liable to plaintiffs
for injuries allegedly caused by their failure to observe FDA's
device classification of the pedicle screw (Class III, "investigational,"
"significant risk"). Judge Bechtle
ruling in March said that the FDA device status does not have to be disclosed to patients by their physicians.
The associations said that the PLC failed to state a claim of a conspiracy by the medical associations, pointing out that the complaint does not mention who were the members of the conspiracy, the nature of the agreement between the alleged conspirators and what acts were performed by each coconspirator.
The associations also said the PLC's actions are barred under the First and 14th Amendments to the Constitution.
The courts have ruled that the First Amendment specifically protects speech, even though the speaker does not generate, as an original matter, each item featured in the communication. This has protected newspaper opinion pages which present an edited compilation of speeches generated by others.
The defendant-medical associations' motion to dismiss said "the actions of the medical associations are like those of publishers in this regard. With only limited exceptions, courts hold that publishers are not liable for the content of their publications, reasoning that because publication involves speech, the First Amendment precludes liability."
Bradford W. Claxton, executive director, American Academy of Dermatology, said his association and "the entire medical community is concerned about infringement of freedom of speech. It is the whole basis of scientific dialogue."