Changes in medical device information pose lawsuit risks for doctors

A Kentucky surgeon was sued after using a pain pump for an off-label purpose that allegedly injured a patient. The device manufacturer, in suing the doctor, says the physician should have read the product's latest instructions, which included a warning about using the pump with certain anesthetics. The doctor says he was unaware that the pump was not approved by the Food and Drug Administration for the way in which he used it, nor was he told of the new warning.

The case raises questions about whether doctors are responsible for seeking information about changes to medication instructions or whether device manufacturers should announce updates to physicians. The lawsuit may be the start of more doctors being blamed for medical device mishaps stemming from a lack of information by manufacturers, said Ronald E. Johnson Jr., an attorney representing the patient.

"It's kind of an honor system," he said. "The FDA does not have a bunch of officers that can run around and double-check that sales reps" are telling doctors everything they need to know. "The whole system is built around this foundation of honesty. What is most disturbing about this case is that I think it's going to make doctors question if that foundation even exists anymore."

Bruce Holladay, MD, an orthopedic surgeon at St. Elizabeth Medical Center in Edgewood, Ky., did reconstructive shoulder surgery on Lucas Frietsch in 2007. During the surgery, the doctor implanted a pain pump in Frietsch's shoulder to administer pain medication directly into his shoulder joint, according to court documents.

Frietsch later returned to Dr. Holladay complaining of shoulder pain. He was diagnosed with chondrolysis, a condition resulting in the loss or near loss of shoulder-joint cartilage. The condition can be caused by continuous administration of certain anesthetics into the shoulder joint by a pain pump.

Frietsch's family sued I-Flow Corp., the pump's manufacturer. The company knew of the risks but failed to warn doctors and patients using the pump, the lawsuit alleges. The company also did not inform physicians that some uses of the pump were not FDA-approved, the suit said.

Dr. Holladay was a defendant in Frietsch's original complaint, but he was dismissed by Johnson after he became Frietsch's attorney in the suit. Dr. Holladay was not at fault for Frietsch's injury, Johnson said.

I-Flow disagreed. The company filed a claim against Dr. Holladay as a third-party plaintiff, saying he was culpable for any injury to Frietsch by the pump. Dr. Holladay failed to follow the pump's directions, which included warnings about anesthetics and the catheter's placement, I-Flow's lawsuit states. A spokeswoman for I-Flow declined to comment. The case in ongoing in Kenton Circuit Court in Kentucky.

Relying on company reps

Doctors should not be held liable for manufacturers' mistakes, said Mary K. Molloy, Dr. Holladay's attorney. Had the doctor known about the pump's potential adverse effects, Dr. Holladay probably would not have used the product as he did, she said.

"It's our position that if there was a change [to the instructions], they didn't make sure it was in every insert, and their own reps probably didn't know about it, so they couldn't tell Dr. Holladay what it said," she said.

Similar lawsuits accusing pain pump makers of causing chondrolysis are ongoing nationwide, Johnson said. Historically, the device maker, not the doctor, was sued.

In 2009, the FDA issued a warning against using the devices with continuous infusions of local anesthetics. The agency ordered drug manufacturers to update their product labels to warn health professionals about potential serious adverse effects.

But without FDA intervention, doctors rely on sales representatives to explain changes to a medical device's instructions, Johnson said. It's unreasonable to expect a physician to re-read the instructions each time the device is used, he said.

"Doctors who put in pain pumps or sutures, they don't pull out all the instruction manuals when they arrive at the operating room and sit down and read them. They learn how to use [the device] from the sales rep and ask about any warnings they should know about," he said.

The Frietsch case probably will damage the trust between doctors and medical device manufacturers, Molloy said.

"It's a difficult position to put the health care provider in, because they're obviously trying to do the best thing for their patient, and they're being told this is the way to go" by sales reps, she said. "Generally, there's a good relationship between manufacturers and health care providers, but I think this [case] does erode the relationship somewhat."

A study in the November 2009 Pharmacoepidemiology and Drug Safety showed that many doctors are unaware which drug uses are off-label and/or lack scientific evidence.

Researchers analyzed surveys from 457 primary care physicians and psychiatrists presented with 14 drug-indication pairs that varied in FDA-approvals. Forty-one percent of respondents said that at least one pair of drugs was FDA-approved when it was not.

Lowering liability risks

Doctors are responsible for keeping current on drug and medical device information and should not depend on sales reps for the latest warnings, said Alfred F. Belcuore, a medical liability defense attorney based in Washington.

"Operating within the standard of care means keeping current with the literature. If the manufacturer or the FDA puts out notifications or warnings, it is probably not going to be a good defense to say [the doctor] never saw it," he said.

Sales reps can be useful sources, Belcuore said, but their explanations on drugs or devices should be corroborated with other sources. The Internet has made it easier for physicians to do independent research or receive email notices from agencies such as the FDA, he said.

Physicians should keep in mind that health professionals and sales reps have different goals when it comes to medical treatments, said Adriane Fugh-Berman, MD, a professor in the Dept. of Family Medicine at Georgetown University School of Medicine. Dr. Fugh-Berman, a family physician, also is director of PharmedOut, a project at the university that works to educate doctors about pharmaceutical companies' influence.

"It's in companies' financial interest to promote their products off-label, but when a lawsuit occurs, a company can then hide behind the label and leave the physician out there hanging in the wind," she said.

Although it's unrealistic to assume that doctors will know about every medication update, physicians are obligated to find proactive ways to keep current, said internist Gordon Schiff, MD, associate director of the Brigham Center for Patient Safety Research and Practice in Boston.

"I think certainly nobody would ever argue that doctors can keep up with every new development. It's an impossibility," he said. "Does that mean doctors have no responsibility to keep up to date? No, I think it's really up to us to think about system-oriented ways" for the information to be transferred.

Teamwork among doctors, nurses and patients is key to successful information transfers, he said. Health professionals should be attuned to any new changes on drugs or devices and discuss these alerts among staff. Doctors also should listen to patients' prescription concerns and look into new information they've read or heard about.

As technology advances, Dr. Schiff envisions more doctors using electronic systems in their practices to receive timely alerts about drugs and devices.

Health professionals need to take these issues "out of the finger-pointing, malpractice arena and into the arena of how can we ensure safety using as many tools as possible, so when there's a new warning or alert, or the FDA issues a 'Dear doctor' letter, it doesn't slip under the radar," he said.