By EDMUND H. MAHONY
March 14, 2010
Medical experts will be watching closely Monday when a scientist who says she has been intermittently paralyzed by a virus designed at the Pfizer laboratory where she worked in Groton opens a much anticipated trial that could raise questions about safety practices in the dynamic field of genetic engineering.
Organizations involved in workplace safety and responsible genetic research already have seized on the federal lawsuit by molecular biologist Becky McClain as an example of what they claim is evidence that risks caused by cutting-edge genetic manipulation have outstripped more slowly evolving government regulation of laboratories.
McClain, of Deep River, suspects she was inadvertently exposed, through work by a former Pfizer colleague in 2002 or 2003, to an engineered form of the lentivirus, a virus similar to the one that can lead to acquired immune deficiency syndrome, or AIDS. Medical experts working for McClain believe the virus has affected the way her body channels potassium, leading to a condition that causes complete paralysis as many as 12 times a month.
“If a worker in a plant as sophisticated as Pfizer is becoming infected with a genetically engineered virus, then I think the potential is everywhere,” said Jeremy Gruber, president of the Council for Responsible Genetics, a public interest group created to explore the implications of genetic technologies.
“Genetically engineered viruses are commonly worked on at your average university,” Gruber said. “The public has a right to know what regulations are in place and what regulations are required to fix an industrywide issue. We need to have a conversation about this. Ms. McClain’s attempt to do that has been hampered at every turn, by the courts and by regulators.”
Pfizer disputes all of McClain’s claims and says it fired her in 2005 because she refused to come to work. The global pharmaceuticals manufacturer, with research labs in southeastern Connecticut, defends its safety practices and denies that McClain’s physical disability is related to exposure at its Groton lab. The company says she did not link her disability to workplace exposure until after she was fired.
As a molecular biologist, McClain studied cells on a molecular level, manipulating genetic codes in an effort to develop vaccines. During the period at issue in the suit, McClain worked in Pfizer’s Human Health Embryonic Stem Cells Technologies, Genomic and Proteomic Sciences and Exploratory Medicinal Sciences Group.
Hostile Exchanges
The sharp disagreement between McClain and her former employer mirrors a half-dozen or so years of hostile litigation leading to Monday’s jury trial in Hartford before U.S. District Judge Vanessa L. Bryant. McClain will argue that she was wrongfully dismissed and is entitled to unspecified damages. In the run-up, Pfizer attacked McClain’s legal claims, and she questioned the company’s corporate integrity.
On the advice of her lawyers, McClain would not discuss her suit last week. Neither would her lawyers, nor those representing Pfizer.
But McClain has claimed in her suit and in earlier public statements that she was fired after experiencing symptoms of illness and after complaining to the U.S. Occupational Safety and Health Administration about safety in her Pfizer lab.
OSHA dismissed McClain’s complaint. In a decision published after McClain’s termination, the agency criticized her for refusing to return to work in spite of “Pfizer’s substantial efforts” to address her concerns. In a speech last year to a labor safety group in California, McClain said she was told by an OSHA investigator that the federal agency’s legal authority has not kept pace with developments in sophisticated medical research.
A series of angry, pretrial exchanges developed over McClain’s efforts to compel Pfizer to give her precise information about the DNA sequencing of the engineered lentivirus she suspects infected her. Pfizer says it responded to all of McClain’s requests, in accordance with the law. Her advocates called Pfizer’s assertion preposterous and claimed the company has not produced — perhaps because it is subject to trademark — the sequencing data that could enable scientists to engineer a genetic cure.
Over the course of pretrial argument, the number and breadth of McClain’s legal claims against Pfizer have been reduced from eight to two. Last month, Bryant dismissed the most significant of the eight claims: that willful and wanton misconduct by Pfizer resulted in lax laboratory procedures. McClain claimed laxity contributed to her exposure.
McClain’s advocates point to language in Bryant’s ruling that suggests the misconduct allegation was dismissed, at least in part, because state law requires such claims to be resolved by state workers’ compensation rules. But Pfizer says Bryant’s ruling is another vindication of its assertion that no evidence exists to support McClain’s contention that she was infected by a viral exposure at Pfizer.
“We have thoroughly investigated Ms. McClain’s claims and our investigation concluded that her workplace was safe and that she was not infected by any virologic materials while she was employed by Pfizer,” company spokeswoman Elizabeth Power said.
Bryant’s ruling means the trial will move forward under McClain’s two remaining claims, both of which involve free speech protection. She says Pfizer fired her in violation of Connecticut’s whistle-blower law after she raised questions about Pfizer lab safety to OSHA. And she claims her dismissal also was in retaliation for questions she raised in discussion with Pfizer colleagues about safety practices. In addition to performing her research duties, McClain served on a lab safety committee for at least part of the nine years she was employed by Pfizer.
Medical Evidence
Pfizer has taken the position that Bryant’s ruling in March means no evidence will be admitted at the trial concerning McClain’s health or her claim that it was destroyed by bad lab procedures. McClain’s advocates, again, disagree. Because McClain is suing under a whistle-blower claim, they believe she will be allowed to present evidence about why she figuratively blew the whistle. If her health and safety are the reasons, they say, the judge could allow jurors to hear evidence in those areas.
In her suit, McClain says that Pfizer hired her in 1995 and that, in 2000, she became involved in human cellular research associated with vaccine development. She later learned, the suit says, that colleagues in her lab were working with infectious, genetically engineered viruses, including the lentivirus she suspects causes what her physician calls “acute intermittent paralysis.”
The suit describes lab events that McClain suggests could have infected her.
The first involved the possible malfunction of a “laminar hood,” a system designed to contain materials being subjected to scientific manipulation and to purify the air circulating around the materials. She said the hood began emitting a noxious odor at the same time she and several colleagues developed symptoms of illness, including nausea.
McClain said in the suit that, as a member of the lab safety committee, she reported the apparent hood malfunction. Judge Bryant said in a preliminary ruling that Pfizer took “various steps” to fix the hood and ultimately replaced it, twice.
Pfizer contends that the hood problem was resolved eight months after McClain reported it. But a long e-mail message by one of McClain’s supervisors and the OSHA review corroborate McClain’s contention that the problem persisted for a year. Before it was corrected, several people suffered from headaches, vomiting and nausea, including at least one member of the crew that cleaned the lab after work.
About two months after the hood problem was resolved, McClain says in the suit, she learned from a colleague that he was working “next to” her on “dangerous lentivirus material and embryonic stem cells.” The work was being done on an open lab bench, unprotected by a biological containment system, the suit says, even though lentivirus work should have been done only under a protective “biological hood.”
“I was shocked and appalled to find he had been using lentivirus materials on an open lab bench without biocontainment where I performed my office work (e.g. without gloves) in October 2003,” McClain wrote in a legal filing.
On another occasion, she says, she encountered an unidentified experimental set-up consisting of cell cultures on her laboratory bench, but she cannot recall whether she touched it.
Pfizer has responded that any lentivirus studied in lab areas where McClain was present was not derived from a human infectious virus and was not infectious because it lacked genes for replication.
McClain says in the suit that she repeatedly raised laboratory safety issues following the hood malfunction, despite a warning from a supervisor that doing so could jeopardize her employment. She said she began suffering from “fatigue, suspicion of multiple sclerosis, joint pain, and numbness in her face as well as sleep difficulties” and took a medical leave in February 2004. She was fired about 11 months later.
The suit contends the dismissal was retaliation for her complaints about safety. In a speech a year ago, McClain asserted that some of the safety deficiencies she has criticized are the product of poor lab design — design that is nonetheless acceptable under OSHA rules.
Pfizer contends that McClain’s dismissal was not related to her concern about safety. Rather, the company says, she was terminated for refusing to report back to work after the company made her repeated offers, including alternative employment opportunities, some in laboratories other than the one about which she had complained. Pfizer claims McClain was told in advance of her termination that she would be fired if she didn’t return to work.
Even though jurors are unlikely to hear arguments that McClain’s potassium disorder and related transient paralysis are attributable to exposure to an engineered virus, a network of laboratory safety advocates already is using the case as a rallying point. A group from San Francisco has planned a press conference outside the Hartford courthouse on Main Street at 12:15 p.m. Monday.
They say OSHA’s inability to stay abreast of developments in sophisticated, molecular research techniques — as well as law protecting the confidentiality of proprietary discoveries — has neutralized the agency’s ability to act as an effective regulator.
“This case shows a major flaw for workers in the biotech industry who have to prove where they got injured in order to receive workers’ compensation,” said Steve Zeltzer, one of the organizers.