NurseWeek: Lawsuits loom in wake of hip implant recall

Lawsuits loom in wake of hip implant recall
Patients with flawed prosthesis may face new surgeries

By Randy Dotinga
HealthScout Reporter
February 23, 2001


	You've read the article. Now tell us what you think. What To Do If you have a hip implant and think it might be a defective Sulzer product, contact your doctor. You may also wish to call Sulzer direct at (800) 888-4676, ext. 232. To read a letter about the implant recall from the president of Sulzer Orthopedics, visit this site. The American Academy of Orthopaedic Surgeons has published a booklet about hip replacements. Read the booklet here. (Use the menu at the upper right to go to different chapters.) You also might want to read previous HealthScout articles on hip replacement and others on joints.

(HealthScout). Two law firms are expanding their legal fight against the Swiss maker of defective prosthetic hips that may have been implanted in thousands of Americans since 1997.

More than a dozen patients and their attorneys filed a federal class-action suit in San Francisco against Sulzer Medica on Feb. 13, and today lawyers went to court in New York state to demand that the company pay to monitor people with the questionable implants.

Representatives of Sulzer Orthopedics acknowledge that their Inter-Op Acetabular hip shells––which make up part of a hip implant––are defective. Sulzer Orthopedics is part of Sulzer Medica. About 17,500 people have received the implants, with 90 percent of those in the United States.

According to Sulzer, which also has a base in Austin, Texas, an "unacceptable level" of lubricant was left on the surface of the shells when they were made. The lubricant can prevent the implants from bonding properly with the hip bone, meaning that the hip can detach from the leg.

The company said it's difficult to know how many of the hip implants will fail, although it has documented 129 cases of "loosening," all of which occurred in the first six months after an implant surgery.

The company is voluntarily recalling the implants and paying for the out-of-pocket costs of surgeries to remove the implants. Sulzer Orthopedics is also willing to discuss financial settlements for lost wages and pain and suffering, said company spokesman Jim Moore.

"We are profoundly disturbed by our own failure," he said. "It's as unacceptable to us as it is to the surgeons and the patients. We're endeavoring to do everything we can to make it right."

But patients and lawyers say the company isn't doing enough. Sulzer is not paying to monitor patients who received the implant, said San Francisco-based lead attorney Richard Heimann in a statement. His firm is taking part in the lawsuits in both California and New York.

"To date, Sulzer's response to this crisis has been grossly inadequate," Heimann said in the statement made before a press conference today in the Warwick Hotel in New York City.

In the New York suit, lawyers are demanding that Sulzer set up a fund for monitoring patients, and hand over any profits from the sales of the flawed devices.

An estimated 160,000 hip replacement surgeries are completed each year, and Sulzer manufactures about 12 percent of the implants used.

Despite advances over the last four decades, hip replacement surgery remains a serious operation, said William Tipton, MD, executive vice president of the American Academy of Orthopaedic Surgeons.

"I tell people to make sure you've tried everything else not operative––crutches, decreasing or modifying your activity, medication, anti-inflammatories––before you subject yourself to this," he said. "This is not a procedure to mess around with."

Hip problems tend to hit after the age of 50 or 55, when the surfaces of joints begin to deteriorate, he said. Those surfaces are coated with cartilage, which acts both as a buffer and a kind of lubricant. When the cartilage disappears -- due to injury, disease or other cause -- only bone is left, causing bone-against-bone friction and pain.

While aging is clearly a factor, no one knows why some older people suffer from hip pain and others don't, he said.

Implants replace part of the bone in ball-and-socket joints, allowing them to move more freely, Tipton said. But the implants wear out, often after just 10 to 15 years, he said.

If patients do find out that they have implants that are potentially defective, they should not rush to have them replaced, Tipton said. "Every time you do one of these [operations], you run the risks that are always there the first time. I wouldn't have them pull out a hip prosthesis if it's not giving them problems."

Moore, the Sulzer company spokesman, agreed. He said removal of implants is not necessary if there are no adverse symptoms. Implants that have been in place for more than six months or a year should not have problems, he said.

This is a News story from HealthScout, a service of Rx Remedy, Inc.