【轶闻旧事】GSK曾因为GMP问题被罚款7.5亿美元

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选自：https://www.nytimes.com/2010/10/27/business/27drug.html?module=ArrowsNav&contentCollection=Business%20Day&action=keypress&region=FixedLeft&pgtype=article

Glaxo to Pay$750 Million for Sale of Bad Products

By GARDINER HARRIS and DUFF WILSON

OCT. 26,2010

GlaxoSmithKline, the British drug giant, hasagreed to pay $750 million to settle criminal and civil complaints that thecompany for years knowingly sold contaminated baby ointment and an ineffectiveantidepressant — the latest in a growing number of whistle-blower lawsuits thatdrug makers have settled with multimillion-dollar fines.

Altogether, GlaxoSmithKlinesold 20 drugs with questionable safety that were made at a huge plant in PuertoRico that for years was rife with contamination.

Cheryl D.Eckard, the company’s quality manager, asserted in her whistle-blower suit thatshe had warned Glaxo of the problems but the company fired her instead ofaddressing them. Among the drugs affected were Paxil, anantidepressant; Bactroban, an ointment; Avandia, atroubled diabetesdrug; Coreg, aheart drug; and Tagamet, an acidreflux drug. No patients were known to havebeen sickened, although such cases would be difficult to trace.

In a risingwave, recent lawsuits have asserted that drug makers misled patients anddefrauded federal and state governments that, through Medicare and Medicaid, pay for muchof health care.

Using claimsfrom industry insiders, federal prosecutors are not only demanding record finesbut are hinting at more severe actions.

Suffering a research drought,drug makers have laid off thousands of employees. Some of those dispatched havein turn filed whistle-blower lawsuits that can lead to criminal investigations.

Justice Departmentofficials announcedthe settlement in a news conference Tuesday afternoon inBoston, saying a $150 million payment to settle criminal charges was thelargest such payment ever by a manufacturer of adulterated drugs. The outcomealso provides $600 million in civil penalties. The share to the whistle-blowerwill be $96 million, one of the highest such awards in a health care fraudcase.

When askedwhether any individual could be charged in addition to the corporation charges,Carmen M. Ortiz, the UnitedStates attorney for Massachusetts, would say onlythat the investigation was not yet complete.

GlaxoSmithKline releaseda statement saying that it regretted operatingthe Puerto Rico plant in violation of good manufacturing practices. The companysaid the problem had involved only one plant that was closed in 2009. Americanshares in the company fell 0.35 percent on Tuesday.

Tony West, theassistant attorney general in charge of the department’s civil division, saidhundreds of such lawsuits were awaiting federal review.

“We’ve openedmore investigations, we’ve recovered more taxpayer dollars lost to fraud, we’vehad more convictions, higher penalties and fines in the last two years thanwe’ve had in any other two-year period,” Mr. West said in an interview.

Whistle-blowerswho win earn a cut of the eventual fine. Ms. Eckard will collect $96 millionfrom the federal government, and she will collect additional millions fromstates.

The suits, allfiled under seal, have for years been rising in size and scope, but thecollective threat to the industry has been largely unnoticed because thegrowing mountain is obscured by a wall of judicial secrecy. Each successfulclaim begets more suits, with more being filed almost every week.

The suits arefiled under a federal law originally intended to stop Civil War hucksters fromselling rancid meat to the Union Army by paying bounties to tipsters. Thepharmaceutical industry has become the law’s most successful target because thegovernment now buys far more pills than bullets, and because fraud in healthcare is common.

Health carecases accounted for some 80 percent of the $3.1 billion recovered by theJustice Department under the false claims act last year, the Taxpayers AgainstFraud Education Fund, a nonprofit whistle-blower advocacy group in Washington,reported on Monday. Most of the money is typically returned to the programs inwhich false claims were filed, like Medicaid and Medicare.

The Food andDrug Administration and the inspector general of the Health and Human ServicesDepartment both announced recently that they would pursue charges againstexecutives personally under a strict liability provision of the law, somethingthat has not been done since 2007 when the three top executives of PurduePharma were convicted, sentenced to probation and personally fined $34 millionwhile Purdue paid $600 million.

The rule allowsexecutives to be prosecuted and barred from government sales even if they werenot aware of specific violations.

Legislationcould make such claims easier to win. Last month, the House of Representativespassed a bill that permits executives to be barred even if they have left thecompany where the fraud occurred and that permits the inspector general toprosecute parent companies for the sins of subsidiaries.

Pfizer alone hassettled four whistle-blower cases since 2002, and it paid a $2.3 billion finelast year, the largest in history. Whistle-blower cases have become so routinethat Wall Street no longer takes much notice of individual suits, while thegrowing trend remains hidden.

When GlaxoSmithKlineannounced in July that it was setting aside $2.4 billion for legal costs,including enough to pay for the investigation into its Puerto Rico problems,the announcement was greeted with a yawn.

Still, the casemay lead to a collective industry shiver because it opens a new frontier forwhistle-blower suits. Nearly all previous cases against the industry involvedillegal marketing. This is the first successful case ever to assert that a drugmaker knowingly sold contaminated products.

“This case willchange the way drug makers run their factories,” Ms. Eckard’s lawyer, NeilGetnick, said.

Some of theantidepressant Paxil CR produced at the plant was ineffective because a layerof active ingredient split from a layer of a barrier chemical duringmanufacturing, the government said, and some lots contained only the barrierchemical.

“The harm isreally in the public’s confidence in the health care industry,” Ms. Ortiz said.“When you go to a pharmacy and you buy a drug, you expect that drug is what itpurports to be and you don’t expect it to have any micro-organisms or not besterile or not have the power or have too much power.”

Ms. Eckard’srole in the case began in August 2002 when GlaxoSmithKline sent her to Cidra,south of San Juan, to lead a team of 100 quality experts to fix problems citedby an F.D.A. warning letter a month earlier.

This wasGlaxoSmithKline’s premier manufacturing facility, producing $5.5 billion ofproduct each year. But Ms. Eckard soon discovered that quality control was amess: the water system was contaminated; the air system allowed forcross-contamination between products; the warehouse was so overcrowded thatrented vans were used for storage; the plant could not ensure the sterility ofintravenous drugs for cancer; and pills ofdiffering strengths were sometimes mixed in the same bottles.

Although F.D.A.inspectors had spotted some problems, most were missed. And the companyabandoned even the limited fixes it promised to conduct, the unsealed lawsuitsays. Ms. Eckard complained repeatedly to senior managers; little was done. Sherecommended recalls of defective products; recalls were not authorized. In May2003, she was terminated as a “redundancy.”

She complainedto top company executives, but she was ignored even after warning that shewould call the F.D.A. So she called the F.D.A. and sued. The agency began acriminal investigation and used armed federal marshals in 2005 to seize nearly$2 billion worth of products, the largest such seizure in history. Unable tofix the plant, GlaxoSmithKline closed it in 2009.

A version of this article appears inprint on October 27, 2010, on Page A1 of the New York edition with theheadline: $750 MILLION FINE FOR DRUG MAKER OF TAINTED GOODS. Order Reprints| Today's Paper|Subscribe

beiwei5du

大致是：
由于FDA在检查GSK波多黎各工厂时中发现问题，被发了警告信。GSK派了Eckard女士带领了100多位质量专家解决检查中发现的问题，Eckard女士发现质量管控一塌糊涂，比如：

the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles.

Eckard女士于是频繁的向高层反映该问题，其建议召回有缺陷的产品，但是高层均没有授权，也没有采取措施。并且Eckard女士也被2003年裁员了。
最终Eckard女士举报了GSK，GSK被罚7.5亿美元，Eckard女士得到9600万美元举报奖励。
当然最终该工厂 SB Pharmco Puerto Rico Inc也被关闭了。

syhorchid

咎由自取的GSK