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THE LEGISLATIVE SEASON:Matters Passed, Perished, and Pending

Medical Device & Diagnostic Industry
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An MD&DI September 1998 Column

Initiatives on managed care, biomaterials, and public access to technology stir debate.

Five years ago, the prospect that the American Medical Association would join hands with liberal Democrats and trial lawyers in support of health-care legislation would have seemed about as plausible as sustained economic growth without inflation. But times change, and politics makes strange bedfellows. In promoting a "Patients' Bill of Rights" that would include such provisions as a government-run process to appeal managed-care treatment decisions and the right of plan members to sue their HMOs, the AMA decided that malpractice attorneys and Washington bureaucrats aren't so bad after all, considering the alternative. According to AMA president Nancy W. Dickey, MD, the venerable physicians' group seeks to "put patients ahead of politics," as opposed to greedy insurers, who are maneuvering to "put profits ahead of patients."

Although the AMA-endorsed bill is stalled in Congress, two other health-care liability measures have recently come to resolution, with opposite results. The "Biomaterials Access Assurance Act of 1998" has been granted a bipartisan seal of approval and signed into law. Excepting cases of outright negligence, fraud, or breach of contract—and steering clear of the sticky question of silicone-gel breast implants—the act indemnifies suppliers of raw materials or bulk components used in implants from liability claims arising in civil court. Supporters of the legislation anticipate that its passage will encourage suppliers to enter or reenter the market. It's hoped that the act will stimulate innovation and corporate R&D funding, revive academic programs, and generally put the bad genie of a nascent "biomaterials crisis" back in the bottle.

The second initiative also sought protection from liability—but this time for users of a device. A bill was submitted in Sacramento that would have added California to a growing list of states that protect nonprofessionals from lawsuits if they use an automated defibrillator in an attempt to resuscitate a victim of a heart attack. Businesses that kept a defibrillator on the premises would also be protected. Backers of the measure included the American Heart Association and, of course, defibrillator manufacturers, whose success in designing simple, effective, portable devices has led them to the threshold of a potentially enormous market. If the concept of public-access defibrillation becomes a reality, commercial possibilities seem limitless.

The bill passed the state assembly's Health Committee by a unanimous vote but expired in the Judiciary Committee amid pressure from trial lawyers. Responding to queries about his group's efforts to sink the bill, the head of the Consumer Attorneys of California maintained, apparently with a straight face, that the lawyers' lobby had opposed the legislation because it would sanction exemptions from state training regulations. Despite the fact that the newest-generation defibrillators are extremely simple to operate, the California health code mandates four hours of instruction for anyone who contemplates restarting the heart of another citizen without being asked. Sponsors of the law might have reminded the lawyers that four hours spent pushing the same button are unlikely to go by as quickly as the billable variety.

The issues raised in the California case will doubtless be revisited as other states debate similar proposals and as advances in technology render additional devices more accessible to the general public. In the meantime, individuals and businesses are buying and using defibrillators, whether covered by an immunity statute or not. For instance, Las Vegas casinos participating in a recent pilot program managed to revive seven of ten patrons who had suffered cardiac arrest on the casino floor. In that town, those are sweet odds. Even seven/eleven sounds heartening.

Jon Katz

[email protected]


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