Blood Plasma Trial|Under Way in San Diego


     SAN DIEGO (CN) — Jurors heard opening statements Tuesday in a retaliation case from former employees of San Diego-based Scantibodies Laboratory, who say they were fired for trying to comply with FDA guidelines on collecting blood plasma.
     Former lead plaintiffs Shannon Coates, Janette Nolasco, Grace Rivera and Brenda Taylor sued the company in 2014. They worked at Scantibodies Biologics in El Cajon, east of San Diego, which was opened to collect blood plasma for research use.
     Coates and Rivera were dismissed during a summary judgment hearing in February. Superior Court Judge Gregory Pollack found that Coates did not suffer harassment as an employee and had a new job before she complained to the Food and Drug Administration, so her termination did not constitute retaliation.
     Clarice Letizia, representing Nolasco and Taylor, kicked off her lengthy opening statement by telling the jury employers are not allowed to retaliate if employees refuse to violate FDA safety rules.
     Both women started working for Scantibodies in April 2009, Nolasco as the center’s manager and Taylor as the regulatory compliance supervisor. Both had experience with FDA regulations. Both were tasked with helping the center get up and running and taking it through the licensing process.
     In applying for an FDA biologic license, Scantibodies management “declined to follow the advice” of Nolasco and Taylor and applied for a license to collect jut one type of plasma called “source plasma,” Letizia said, though it also intended to collect “specialty plasma” from diseased donors, which is rarer and worth more money.
     Letizia said Scantibodies tried to bypass FDA rules requiring a specialty license by claiming the plasma would be used only in clinical trials run at its own clinic.
     The company told Taylor specifically not to contact the FDA about a specialty license because “it would raise unnecessary questions,” Letizia said. Selling plasma classified as “research-use only” would violate FDA rules.
     “Scantibodies had no intent of complying with FDA rules,” Letizia said.
     When the specialty plasma was sent to Scantibodies’ other location, the “research use only” labels were removed and replaced with “research or manufacturer use” labels, putting “profits over safety,” Letizia told the jury.
     “Scantibodies does not have approval to sell disease-state plasma and it’s my understanding they still don’t today,” Letizia said.
     Before a routine FDA audit, Scantibodies canceled its specialty donations, to hide them from the regulators it, Letizia said.
     Nolasco and Taylor both told FDA inspectors twice that Scantibodies were violating the rules, Letizia said, whereupon the company issued “counseling statements” and told them they “have a bad attitude” and, “You’re a worrywart.”
     Nolasco was fired. Taylor was demoted, put on probation, stripped of corporate duties, denied access to buildings and had to be escorted from place to place, the attorney said.
     The final straw for Taylor came when a source plasma sample tested positive for disease and Scantibodies was going to send the tainted plasma to the client anyway. “She could not have a hand in hurting another human being,” Letizia said.
     Taylor had a nervous breakdown and took medical leave, the attorney said.
     Nolasco and Taylor are asking for $2.3 million for retaliation and wrongful termination.
     In his opening statement, Scantibodies’ attorney Vince Verde asked the jury repeatedly to “consider both sides.”
     Verde said Scantibodies must comply with thousands of federal regulations. He that “mistakes were made on both sides,” but that Nolasco and Taylor participated in “every act they complained about” and “went along with it.”
     “Their main gripe was there was a disagreement,” Verde said.
     He said that Michael Nordstrom, Scantibodies’ former director of quality assurance, had “the ultimate responsibility” for ensuring compliance with FDA regulations, and interpreted the regulations differently than Nolasco and Taylor.
     Nordstrom believed source plasma was subjected to higher scrutiny than specialty plasma because it can be directly injected into the body, whereas specialty plasma is not injectable.
     When Scantibodies fired Nolasco, the business was on “life support,” but when business picked up, it offered Nolasco her job back, Verde said.
     Verde called Nolasco’s and Taylor’s claims “frivolous,” and said Scantibodies cooperated with the FDA inspection “just the way they should.”
     “This is a case of two employees blowing the whistle after the game is over and the referee called no foul,” Verde told the jury.
     The trial is expected to last three weeks.

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