Whodunit? Was the Doctor or Manufacturer Responsible for Surgical Injury?

Advances in technology in the medical field have done wonders for patients. Thousands of medical devices, for instance, have improved and saved the lives of so many people. However, negative consequences go in tandem, unfortunately, with the positive aspects of these technological wonders.

One U.S. patient was diagnosed with Chondrolysis after the risks about the medical device that caused the injury were not adequately revealed to him. The patient's family has since filed a lawsuit, which has prompted many to wonder who is responsible for the injury-the doctor or the device manufacturer?

The Facts

Lucas Frietsch needed reconstructive shoulder surgery. Performed by Kentucky Orthopedic Surgeon Bruce Holladay, M.D., Frietsch officially underwent the procedure in 2007. According to court documents, Dr. Holladay implanted a pain pump into Frietsch's shoulder to allow pain medication to flow directly into his shoulder joint and relieve his pain.

After the surgery, however, Frietsch's shoulder still hurt. Doctors determined that Frietsch's new pain was due to a loss of cartilage in his shoulder-joint. He was later diagnosed with a condition known as Chondrolysis. An investigation, however, revealed that Chondrolysis happens after certain anesthetics are administered to the problematic area via a pain pump.

Frietsch's family thereafter sued I-Flow Corp, the manufacturer of the pain pump under a legal premise called product liability.

Was the Manufacturer Really Responsible?

Under the law, a company that manufactures a product intended for public consumption has a duty to make sure the product is safe for consumer use. Additionally, the manufacturer has a continuous duty to sufficiently warn about the risks or dangers associated with the product.

Frietsch's family alleges that I-Flow failed to warn doctors about the risks of using the pain pump-even after the FDA determined its inherent danger in 2009.

However, I-Flow says that they provided warnings regarding the product's placement and that the doctor, in this instance, was responsible for failing to follow the instructions and provide warning to Frietsch. They have since filed a claim against Dr. Holladay as a third-party plaintiff in the lawsuit.

Has the Doctor Committed Medical Malpractice?

So who is responsible? Is the medical device manufacturer liable under product liability for failing to inform and update Dr. Holladay on risks about their product or is the doctor liable for medical malpractice for failing to perform his due diligence about risks associated with the device?

Some say the manufacturer is responsible and that, under the law, the company has a duty to adequately inform health professionals about the risks associated with their products and failed to do so in this case. Ronald E. Johnson Jr., attorney for the plaintiff, says, "Had the doctor known about the pump's potential adverse effects, Dr. Holladay probably would not have used the product as he did."

However, others say that this is a case for medical malpractice because in 2009, after the FDA determined that the pain pump had adverse affects, the agency ordered the drug's manufacturers to update their product labels to warn health professionals about the device's adverse affects and that doctors simply failed to read the updated warnings. They say doctors wrongfully relied on sales representatives to explain changes to a medical device's instructions instead of performing their own investigation.

However, Johnson says that, "It's unreasonable to expect a physician to re-read the instructions each time the device is used."

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

"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.

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

And, new data suggests this isn't an unusual case. In November 2009, Pharmacoepidemiology and Drug Safety published a study that revealed many doctors don't know which drugs are labeled as "off-label" and therefore suggesting that many aren't doing their homework.

It remains to be seen what the outcome will be for either Dr. Holladay or I-Flow, the device's manufacturer. However, one fact remains certain-a patient has experienced permanent damage as a result of the mishap.

The case in currently pending in Kenton Circuit Court in Kentucky.