The former lab director for a Newton company that stores newborns' umbilical cord blood claims he was fired after blowing the whistle on problems with the company's quality controls.
Peter Mecenas, the former laboratory director of New England Cord Blood Bank Inc., says he called federal and state regulators to complain about issues with the company's quality checks on Sept. 12. The next day, Mecenas says, he was fired and escorted out the door, according to a lawsuit he filed against the company on Dec. 18.
But John Rizza, president and owner of the blood bank, says he was unaware Mecenas had called regulators at the time. He said Mecenas was let go after the blood bank lost its accreditation with the American Association of Blood Banks, an industry trade group. Since replacing Mecenas, Rizza said, the organization is on track to regaining its AABB accreditation as early as this month. The AABB declined to discuss why it pulled the blood bank's accreditation in August or to say when it might be restored.
The suit, filed in Middlesex Superior Court, comes at a time when the business of storing babies' cord blood is gaining steam. Last month, PerkinElmer Inc. in Waltham completed a $300 million deal to buy ViaCell Inc. of Cambridge, largely for its cord blood banking business, called ViaCord, which generated $70 million in business last year.
Though it is still a niche business, a growing number of affluent families are paying thousands of dollars to store their newborn's cord blood in case the child needs it later in life. Umbilical stem cells are used to help treat more than 40 diseases, including blood cancers and genetic diseases, raising hope that cord blood could one day become an alternative to bone marrow transplants or other treatments for serious diseases.
PerkinElmer officials estimated that 85 percent of the market is shared by three companies, PerkinElmer's ViaCord, Cryo-Cell International, and Cord Blood Registry Inc. But there also are numerous smaller players scattered around the country, such as New England Cord Blood Bank.
In his lawsuit, Mecenas said he called the AABB, the Food and Drug Administration, and New York State licensing authorities in September to alert them about ongoing problems with the company's quality control system. In addition, he said he was concerned that the blood bank was continuing to claim it was accredited by the AABB, after it lost certification.
In the lawsuit, Mecenas said he feared he could face civil or criminal penalties because the organization wasn't in compliance with federal and state regulations. Still, the suit doesn't allege that he thought any blood was contaminated or mishandled. Rather, Mecenas was concerned the company didn't have the quality controls needed to ensure employees always followed the proper procedures for handling the blood, his attorney said.
"It's a verification issue," said Jo Ann Jorge, an attorney with Gleason & Gleason in Ashland.
Rizza downplayed the safety concerns. "There's never been a question about the actual procedures," Rizza said. The problem was "we didn't have enough documentation."
Mecenas, who was paid $90,000 a year, is seeking lost wages, money for emotional distress, and other damages. He is also suing for damage to his reputation, saying Rizza falsely blamed him for the company's loss of accreditation.
In addition to suing the cord blood bank, he is also suing Rizza and a related company, the new England Cryogenic Center Inc. Last year, Mecenas also oversaw the lab operations at the Cryogenic Center, which is run by Rizza's wife, Catherine Rizza, and also based in Newton.
Rizza called the lawsuit "frivolous." And a judge has not yet ruled whether any of the allegations have merit.
It is unclear whether any regulators are looking into Mecenas's allegations.
A spokesman for the New York Department of Health said the state hasn't received any written complaints about the company and will not investigate nonwritten allegations.
An FDA spokeswoman said she couldn't comment on whether the agency is looking into any complaints.
Todd Wallack can be reached at twallack@globe.com.
