Defective Heart Valve Manufacturer Behind Bill To End Criminal Liability For Dangerous Products.

SACRAMENTO, Calif.--(BUSINESS WIRE)--April 24, 1996--Pfizer Inc., which reached a multi-million dollar settlement with the government for hiding information from the FDA about the dangers of its heart valve, is pushing lawmakers to gut consumer protections that make companies and managers criminally liable for concealing dangers in their products, according to a report released today by Consumers Union's West Coast Regional Office(a).

Over 80,000 patients worldwide have received Pfizer's heart valve implants; more than 360 people have died suddenly when a tiny strut in the valve failed. Pfizer has set aside $500 million in an open-ended settlement of claims against them into the future.

Charles Poochigian (R-Fresno) is carrying the bill -- AB 675 -- for Pfizer, the California Manufacturers Association, and other business interests. The measure guts California's Corporate Criminal Liability Act of 1991, which makes businesses and individual managers criminally liable when they know that a worker or a consumer is likely to be injured or killed because of a "concealed danger" in the workplace or in a product. It was enacted to deter companies that might otherwise conceal that their work practices or products are unsafe.

Consumers Union's report, "Concealed Danger: Who Is Really Behind the Bid to Kill the California Corporate Criminal Liability Act," describes the effectiveness of the law, the enormous stake businesses like Pfizer have in repealing it, and Pfizer's successful efforts to resurrect AB 675 after it had failed passage in the Assembly Public Safety Committee on May 9, 1995. On January 23, 1996, the Public Safety Committee reconsidered and approved the measure. On January 30, 1996, the full Assembly passed AB 675 on to the Senate on a vote of 41 to 38.

In 1995, while lobbying for AB 675, Pfizer spent more than $100,000 in lobbying expenses and campaign contributions, apparently to further its goals to weaken this successful product and workplace safety law. The lobbying firm of Nielsen, Merksamer, Parrinello, Mueller & Naylor earned more than $68,000 from Pfizer in 1995.

"The Corporate Criminal Liability Act is a common sense and common decency approach to protecting consumers. When managers know there's a danger that could hurt or kill someone, they should be obligated to report it," said Elisa Odabashian, Policy Analyst for Consumers Union's West Coast Regional Office, and author of the report. "There have been no instances of abuse of the law and no instances of upstanding businesses being harmed by the law.

"The law is accomplishing what it was set out to do: deter companies from putting profits over the safety of consumers and workers. This measure was signed into law by then-Gov. George Deukmejian, who was very pro-business. We urge the Legislature and Gov. Wilson to uphold the consumer protections in the law and to reject the Poochigian bill."

From 1979-1986, more than 80,000 Convexo-Concave heart valves, produced by Pfizer's Irvine, California subsidiary, Shiley Inc., were implanted in patients worldwide. In 1986, after more than 360 people died when a tiny strut in the heart valves failed, the device was taken off the market.

In 1994, Pfizer settled with federal investigators who accused the company of making false claims and withholding testing data about problems with the health valve in order to receive quick FDA approval to market it, and to keep it on the market. In 1994, Pfizer agreed to pay the Federal Justice Department $20 million in fines and federal costs to settle the case.

AB 675 is scheduled to be heard in early May in the Senate Criminal Procedure Committee. For a copy of the report, call 415/431-6747. -0-

Note (a): Consumers Union, publisher of Consumer Reports, is an independent, nonprofit testing and information gathering organizations, serving only the consumer. We are a comprehensive source of unbiased advice about products and services, personal finance, health, nutrition, and other consumer concerns. Since 1936, our mission has been to test products, inform the public, and protect consumers.

CONTACT: Consumers Union

Elisa Odabashian or Mariko Takayasu, 415/431-6747