Two former Wyeth employees accused the drugmaker of making false claims to the government in connection with alleged manufacturing problems with its Prevnar vaccine. Anthony Sokol and Mark Livingston filed a whistleblower lawsuit against Wyeth in November 2006 in federal court in Virginia, according to Wyeth’s annual report (see page 62).

The lawsuit alleged false claims were made to the government from 2000 through 2005 in connection with the manufacture of Prevnar, a vaccine given to children to prevent meningitis and other infections. Prevnar had $2.4 billion in sales in 2007. A Wyeth spokesman told Dow Jones that company policy is not to comment on pending litigation.

The lawsuit had been filed under a federal law that allows whistleblowers to collect a portion of any settlement that may result from government investigations of the allegations. In this case, the Justice Department investigated the complaint and declined to intervene in November 2007, Wyeth said. The lawsuit had been sealed from public view until that point, and was unsealed after the government’s decision. The government reserved the right to intervene at a later date.

Wyeth said it cooperated with the Justice Department during its investigation. The company hasn’t been served with the lawsuit and a copy wasn’t immediately available.

Sokol and Livingston have filed separate lawsuits against Wyeth alleging they were improperly fired from the company in retaliation for raising their concerns about Prevnar.

Sokol, a Pennsylvania resident, had been a manufacturing scientist involved in the production of Prevnar between 2003 and 2005, according to his discrimination lawsuit filed in September 2007 in federal court in New York. He began notifying superiors about alleged quality and safety issues in manufacturing the vaccine, according to the suit. He said Wyeth was misrepresenting and concealing data from the Food and Drug Administration, and that the FDA should be notified. Sokol was fired in September 2005, according to his lawsuit.

Livingston worked as a training manager in a vaccine manufacturing plant in North Carolina between 2000 and 2002, according to a lawsuit filed in federal court in North Carolina in September 2003. He allegedly found Wyeth wasn’t complying with certain training procedures at the plant, which made Prevnar, according to his lawsuit. He alleged that his superiors resisted these findings, then retaliated by firing him in December 2002.

In July 2006, a federal judge found in favor of Wyeth on the “substantive claims” of Livingston’s discrimination suit; Livingston appealed.

Both discrimination lawsuits mention Wyeth’s agreement to pay $30 million to the government and enter into a consent decree with the FDA in October 2000. The agreement stemmed from the FDA’s probe of alleged violations of good manufacturing practices at Wyeth plants in Marietta, Pa., and Pearl River, N.Y. The FDA had seized certain Wyeth products earlier that year. Sokol’s suit alleges Wyeth violated the terms of the consent decree.

Wyeth has since sold off its Marietta plant. The FDA said in 2006 the Pearl River plant appeared to be operating in compliance with regulations and the consent decree, but the plant is still subject to FDA inspections under the decree.

In court documents, Wyeth denied many of the allegations made by Livingston and Sokol in their discrimination lawsuits.

Source: Dow Jones