July 21, 2009

HIRSCHBECK SEEKS ACCOUNTABILITY FOR FAILED HIP REPLACEMENT

SHELTON — Mark Hirschbeck had his dream job as a Major League Baseball umpire and reached a career high with the 2001 World Series, but he says what started as routine hip replacement surgery cost him his career and has led to years of pain.

" Now, Hirschbeck is among those advocating for Congress to pass the Medical Device Safety Act.

Hirschbeck, 48, a Shelton resident for the last 12 years, grew up in Stratford. After high school, he went to school to become an umpire, and started in the minor leagues. After about eight years, he rose to the majors, where he remained for 15 years.

“Years of squatting, bending and running had taken a toll on my right hip,” Hirschbeck said. “I was having a lot of pain and needed cortisone shots.”

Hirschbeck saw a Waterbury-based physician, John Keggi, and underwent hip replacement surgery in June 2003.

“He said he’d give me the Rolls Royce in artificial hips, and I wouldn’t have to worry and could go back to umpiring,” Hirschbeck said.

About a month after his surgery, he was on a couch recovering and watching television when he heard a “pop.” The hip, a ceramic one, had shattered, according to Hirschbeck.

“Pain shot right through my side,” he said.

Hirschbeck went to the hospital, where the same doctor replaced it with the same brand of artificial hip, he said. About a month later, he developed severe pain and was diagnosed with a staph infection. He said he had a third hip replacement surgery, again with the same brand product, but infection flared up again.

Ultimately, Hirschbeck sought out a different physician, Dr. Charles Cornell of New York, who removed all the ceramic and metal from his hip and gave him antibiotics to clear the infection. Hirschbeck spent eight weeks in a hospital bed in his living room. Once he was free of infection, he received a non-ceramic hip replacement, which he has today. While he said he is much better, he still has to take pain pills, and says he can’t sit or stand for long periods.

“I can’t run anymore, I can’t play golf, I can’t do yard work, and I can’t be an umpire,” said Hirschbeck, whose brother, John, remains a big league umpire. “It is horrible. I was one of the 68 umpires in the world. I was at the peak of my career. I was devastated when I learned I couldn’t be an umpire anymore.”

When he first went in for surgery at age 42, he anticipated another 15 years of working as an ump, he said.

Hirschbeck doesn’t work now. He has four children, who range in age from 13 to 20.

Hirschbeck has a lawsuit pending in Superior Court in Bridgeport against Keggi and the manufacturer of the original hip he received, Wright Medical Technology Inc.

Attorney Eric Smith of the New Haven-based firm of Stratton Faxon, which is representing Hirschbeck, said his client “walks with a marked limp and still has pain when he sits and pain when he stands.”

In 2008, the U.S. Supreme Court ruled that manufacturers of class III medical devices that have U.S. Food and Drug Administration approval, like Hirchbeck’s artificial hip, are immune from claims challenging these products’ safety or effectiveness.

The Medical Device Safety Act, if passed, would allow injured consumers like Hirschbeck to bring product liability claims to a jury, and potentially hold medical device manufacturers accountable when their products cause injury or death, according to Smith.

Hirschbeck has gone to Washington, D.C., to lobby federal lawmakers about the Medical Device Safety Act.

“I want my day in court and to be able to tell a jury what happened,” he said. “I am going to do whatever it takes to raise awareness for this bill, from Shelton to the halls of Congress. Companies must be held accountable.”

U.S. Rep. Rosa DeLauro, D-3, said she supports the Medical Device Safety Act.

“In fact, it is stories like Mark’s that demonstrate the need for modernizing and strengthening the Food and Drug Administration’s drug and device safety responsibilities, including reforming the approval process for medical devices, increasing transparency, and enhancing post-market surveillance.”

Attorney Eugene Cooney, who represents Keggi, and attorneys with Halloran & Sage, a law firm representing Wright, did not respond to requests for comment.

In court documents, the defendants deny any wrongdoing or product problem. They claim Hirschbeck was aware of risks, and voluntarily gave his consent. They suggest that prior surgeries or underlying medical conditions could have caused or contributed to any physical pain or limitations. Another defense claim is that the plaintiff’s own negligence may have caused some or all of his claimed injuries, and that he failed to follow the advice of his physicians.

The case is slated to go to trial in September 2010.

Smith said passage of the Medical Device Safety Act will “do nothing more than help Mark get his day in court, so he can prove his case.”

“This case is tragic in so many ways,” Smith said. “He thought he was getting the best product, but he had one of the worst possible outcomes. The impact on him medically, physically and emotionally was tremendous. He lost his dream career as a Major League umpire. It was a lot of hard work to reach that level of success.”

Opponents of the Medical Device Safety Act, however, assert that it would ultimately hurt consumers and patients.

Harold Kim, senior vice president at the U.S. Chamber Institute for Legal Reform, said the organization opposes the proposed act. While Kim is aware of Hirschbeck’s situation, he said he can’t speak to his lawsuit specifically.

“Despite the title of the bill, we think enacting it would stifle innovation, would compromise the safety of American consumers, and would threaten the preeminence of the U.S. medical device industry in the world community,” Kim said.

These manufacturers must go through a rigorous process with the FDA, with experts approving devices to be sold to the public only after a litany of tests for safety, Kim said.

“The bill would allow trial lawyers to second guess the safety decisions of the FDA,” Kim said. “These devices are highly regulated because they are surgically implanted. There is always a risk.

“Manufacturers spend a lot of money to develop products, and with this legislation, could risk being sued after doing what the FDA told them to do,” Kim said. “If lawsuits can happen, manufacturers won’t want to take that risk.”

Michelle Tuccitto Sullo can be reached at mtuccitto@nhregister.com or 789-5707.