MEDICAL DEVICES INCREASING DOCTORS' LIABILITY EXPOSURES

CHICAGO -- With the explosion in litigation related to implantable medical devices, medical professionals now face not only the risk of traditional malpractice claims but also being named "come along" parties to product liability suits.

It's essential, therefore, that doctors and device manufacturers work together in fighting those claims rather than trying to improve their own positions at the other's expense, according to a group of panelists at the annual Professional Liability Underwriting Society conference earlier this month in Chicago.

"Obviously, many of these cases, like breast implant cases, are filed totally against the manufacturer, and the doctor is left out," said Heather S. Heidelbaugh, a lawyer with the Pietragallo, Bosick & Gordon firm in Pittsburgh.

But "there is no question that the doctor and the product manufacturer must stand together in defense of these claims," she said.

In some situations, the product manufacturer gets left out of the suit altogether and the doctor is left standing alone, Ms. Heidelbaugh noted.

Under the federal Medical Device Amendments, negligence or strict liability claims against medical device manufacturers are pre-empted in some cases.

But in 1996, ruling in Medtronic Inc. vs. Lohr, the U.S. Supreme Court held that some cases involving medical device manufacturers may proceed based on the devices' routes through Food and Drug Administration approval, she explained.

Under the ruling, manufacturers of devices approved by the FDA under a provision of the law allowing devices "substantially equivalent" to those already on the market -- to avoid more rigorous FDA premarket approval -- do not enjoy pre-emption from state law claims.

For doctors, the implication is that if they are implanting devices that required full FDA premarket approval and hence enjoy pre-emption, the physician will stand alone in court in any subsequent malpractice action, said Ms. Heidelbaugh.

But in practice, she added, most implantable devices fall into the category of those not pre-empted by federal law, so manufacturers often are co-defendants with the doctors.

"It's rare when we don't see a combination of medical malpractice and product liability allegations," said Kevin M. Quinley, senior vp-risk services at MEDMARC Mutual Insurance Co. in Fairfax, Va.

But he noted there are many "friction points" between manufacturers and doctors.

Among them are caps on recoveries. "I think doctors and hospitals have been fairly successful at the state level in getting caps on recoveries," Mr. Quinley said. As a result of those caps on awards they can win from doctors and hospitals, plaintiffs may look to the deep pockets of the manufacturers, he said.

"Another factor is low liability coverage limits sometimes for medical providers," Mr. Quinley said. That situation, he said, often prompts the provider to try to deflect the suit toward the device manufacturer.

On the other side of the coin, certain manufacturer theories of defense, such as user error or poor patient selection, "get under the skin" of medical practitioners, Mr. Quinley said.

Despite sometimes using those strategies, however, the medical device manufacturers "agonize deeply" over defense strategies that can damage the relationship with the doctors, who are their customers, he said.

"What we see sometimes is it's the doctor or the hospital dragging the manufacturer into the lawsuit," Mr. Quinley said, though ultimately in any of these cases, "this friction only benefits the plaintiff."

He suggested that "the single most important thing is early communication among all the defendants," adding that they need to avoid "knee-jerk cross complaints."

The defendants also should agree to share information with each other, according to Mr. Quinley.

From a physician's perspective, Dr. Barry J. Greenberg, president and orthopedic spine surgeon with Orthopaedic Surgeons Inc. in Akron, Ohio, who himself has faced a lawsuit in connection with an implantable medical device, pointed out that the Food and Drug Administration "does not regulate the practice of medicine nor should it."

"There are objective criteria as to when surgery should be considered, and when doctors don't adhere to those, problems can result," he said.

Still, a physician adhering to those criteria and using devices viewed as the standard of care may later be named a party to a lawsuit if those implantable devices fail, Dr. Greenberg explained.

Summing up, Dr. Greenberg said, "You can't make a silk purse out of a pig's ear unless you start with a silk pig."