After hip replacements, a lawsuit

Implant company paid Penn surgeon consulting fees.

June 30, 2008|By Josh Goldstein, Inquirer Staff Writer

This story appeared in the Inquirer on June 30, 2008.

Last of two parts.

Fed up with the constant pain in her hips, Katrina McKenzie took her surgeon's advice and had them replaced with experimental implants.

The 31-year-old from Galloway, N.J., who agreed to participate in a clinical study, knew there was a risk that her new hips could fail.

Story continues below.

But she didn't know that the manufacturer financing the study, Smith & Nephew, was also paying her surgeon tens of thousands of dollars a year as a consultant.

In recent years, such payments to doctors from medical implant manufacturers and drug companies have become increasingly controversial.

Some leading orthopedic surgeons receive six- and seven-figure payments annually, in the form of royalties, consulting deals and speaking fees from the makers of artificial hips and knees.

These arrangements - and the eye-opening amounts - have prompted federal investigations and debate in Congress, which is considering legislation to force companies to disclose the payments.

McKenzie filed suit against the University of Pennsylvania Health System and her surgeon, Jonathan Garino, contending that he botched her surgery and that the consulting fees affected his decisions.

Garino and Penn responded, in court filings, that McKenzie received good care and that the payments had no effect on her treatment.

"On the merits of the medicine, we are going to vigorously defend this case," said Susan E. Phillips, spokeswoman for the Penn health system.

After the birth of her first child, the hip pain that began during McKenzie's pregnancy grew worse. In July 2002, she went to see Garino.

Her X-rays showed that bone in both hips had collapsed, according to court records. Garino recommended replacing both joints with a new type of implant made by Smith & Nephew.

At the time, the artificial hip was used in Europe, but not here. Garino was part of a clinical study aimed at winning approval for the new implant from the U.S. Food and Drug Administration.

It eventually was approved, he said.

In a deposition, Garino testified that he expected the ceramic-on-ceramic implants he recommended for McKenzie would "last longer than metal on plastic by a significant time frame."

That was particularly important for someone like McKenzie, who was about half the age of a typical hip-implant patient.

He also said that if McKenzie had voiced any reservations about participating in the study, he would have used an FDA-approved model.

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