Whistleblower Complains of Pfizer Hiding Adverse Events

Pfizer May Be Liable for Firing Whistle-Blower


By WILLIAM DOTINGA

http://www.courthousenews.com/2012/03/02/44377.htm

SAN JOSE, Calif. (CN) - A former Pfizer executive can pursue claims that the pharmaceutical giant fired her for blowing the whistle on "dirty" data, a federal judge ruled Thursday.


Delina Ferretti, who worked for Pfizer as lead clinical protocol manager, worked with a molecule that showed promise as a cancer inhibitor in a project known as PanHER. When she noticed problems with her data, she discovered more than 200 instances of study participants using prohibited medications, as well as instances of adverse events and changes from baseline that went unreported in Pfizer's brochure and report to the Food and Drug Administration, according to her original complaint.

Pfizer "refused to do anything about the 'dirty' study results," Ferretti's suit claims.

The company allegedly reacted to her report of the trial defects by creating a hostile work environment that made Ferretti feel "vilified and disregarded." Ferretti says she was alternately "shut out" of meetings or forced to meetings necessary preparation time.

Though Pfizer let Ferretti transfer out of the PanHER program, it further subjected her to a hostile work environment, the complaint states. In March 2010, she reported her concerns about study safety, unreported adverse events and the hostile work environment to Pfizer's compliance hotline. After responding to and refuting two performance improvement plans, Ferretti learned she would be terminated in August 2010.

Ferretti filed suit the following year, but U.S. District Judge Lucy Koh severed her retaliation claim Wednesday, finding that it should have first gone to the labor commissioner.

Ferretti's wrongful termination action does not need to meet that requirement, however. "Unlike a statutory retaliation claim under [labor code], a common law wrongful termination in violation of public policy is not subject to the exhaustion requirement," Koh wrote.

Under California's labor code, an employer may not retaliate against an employee for refusing to participate in activities that violate state or federal law. Pfizer argued that Ferretti's refusal to participate in its alleged defective testing does not constitute protected activity.

Koh disagreed. "Even assuming that none of plaintiff's 'protected disclosures' exceeded the bounds of her official duties, plaintiff alleges that she not only made 'protected disclosures, but that she also refused to participate in illegal activity," the decision states.

The ruling notes Ferretti's claim that she refused to participate in PanHER because it violated five federal regulations for Investigational New Drugs (IND).

"Thus, taking all the facts in the light most favorable to plaintiff, as the court must on a motion to dismiss, it is reasonable to infer that plaintiff refused to participate in defendant's PanHER program because defendant's PanHER program violated and would continue to violate several federal IND regulations," Koh wrote.

"'Refusing to participate in an activity that would result in a ... violation or noncompliance with a ... federal rule or regulation' is explicitly protected under California Labor Code," Koh wrote, adding that the alleged activity is thus protected.

Koh also disagreed that Ferretti's activities were within the scope of her employment duties, and therefore not protected.

"A jury could construe her refusal to 'accede to an alleged practice' of not complying with and masking violations of IND regulations by requesting to be transferred out of the program 'as a position adverse to [defendant],'" Koh wrote, citing 2010 precedent.

Ferretti has also properly alleged that the company knew why she requested a transfer out of PanHER, the decision states.

"Thus, taking the facts in the light most favorable to plaintiff, plaintiff has alleged sufficient facts to draw the reasonable inference that defendant had either actual or constructive notice that plaintiff requested to be transferred because she refused to participate in illegal activity when defendant terminated her in September 2010," Koh ruled.

Ferretti's claim of wrongful termination regarding unsafe working conditions cannot proceed, however, as she did not demonstrate that she reported such conditions.

Koh also rejected Ferretti's claim of intentional infliction of emotional distress. "Indeed, besides alleging that she had 'concerns,' plaintiff has not alleged any facts to support her conclusory allegation that she suffered 'severe emotional distress,'" Koh concluded (italics in ruling).

Ferretti can seek attorneys' fees and file an amended complaint within 21 days to address the granted motions, Koh sa