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Lawsuit Filed Over Tainted Marrow

BY CHRISTOPHER WINK
FOR THE INQUIRER

A Northeast Philadelphia woman says tissue from an embattled biomedical firm gave her Hepatitis C.

In 2003, 42 year-old Darlene Krzywicki was in tremendous pain, often having to crawl to get around.

After exhausting every other method to relieve her of her back pain, the Northeast Philadelphia resident underwent lumbar spine surgery in January 2004 at Holy Redeemer Hospital in Meadowbrook, Montgomery County.

"It worked out really great," Krzywicki said. "Physically, I was able to do things I never could before.

That was when things got really bad.

Yesterday, an attorney for Krzywicki filed a lawsuit blaming the providers of the transplanted bone marrow used in her operation, contending that it caused her to contract hepatitis C.

Last November, Krzywicki got a call from her doctor, who wanted to see her in his office. The bone marrow used in her surgery was subject to a recall issued by the U.S. Food and Drug Administration.

"I don’t think I even understood exactly," Krzywicki said.

In December, on the advice of her doctor, she took a series of tests. Last month the results came in, and the mother of two learned that she had contracted the disease, which is spread by blood contact and will likely lead to chronic liver disease.

"I was a little nervous when I heard there was a recall," Krzywicki said. "But I didn’t think it would be something I would never get over."

Attorney Aaron Freiwald filed the suit yesterday in U.S. District Court in Philadelphia on behalf of Krzywicki and her husband, Robert, against Biomedical Tissue Services; its chief executive officer, Michael Mastromarino; and two distributors that ship parts to hospitals throughout the country. Mastromarino’s attorney has said his client did nothing wrong.

Holy Redeemer was not named in the suit.

This is the latest in a series of allegations questioning the ethics and legality of Mastromarino and his business.

Last October, the FDA began a recall of bone, skin and tendons supplied by Biomedical. The federal agency was investigating whether cadavers were raided of human parts illegally, and whether those parts were being properly screened for certain infectious diseases.

Last December, a lawsuit similar to Krzywicki’s was filed in Superior Court in Atlantic City, with Mastromarino, his firm, a distributor, and five tissue processors as defendants. That suit included the two companies that were named in Krzywicki’s suit, Medtronic Sofamor Danek and Regeneration Technologies.

Citing numerous violations that varied from unsanitary recovery to phony death records, the FDA ordered Biomedical to stop recovering and distributing tissue on February 3.

Officials began their investigation into Biomedical after Colorado pathologist Michael Bauer, a consultant hired by tissue-processing firms to review donor medical charts, noticed consistent errors, including incorrect phone numbers for doctors and relatives, for nearly 30 donor corpses. Every chart was authorized by Mastromarino, Bauer said.

The trial could begin in one to two years, Freiwald said.

For now, Krzywicki is worried about her family and other victims throughout the country.

With her husband and two sons in mind, Krzywicki said she just hopes other victims "have a good family behind them, too."

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