A former employee of the GlaxoSmithKline pharmaceutical company has been charged with obstructing justice in a 2002 FDA investigation. The FDA says that Lauren Stevens, who worked for Glaxo in London, submitted false documents to the administration. If convicted, Stevens could face jail time and hefty fines. Glaxo agreed to a settlement with the FDA regarding the original case in 2004.
GlaxoSmithKline Vice President and Attorney Accused of Lying
In the original 2002 case, Stevens worked as a vice president and attorney for GlaxoSmithKline’s London office. The court required she testify regarding the company’s promotion of the anti-depressant Wellbutrin. The FDA was looking into claims that GlaxoSmithKline had been promoting the anti-depressant Wellbutrin as a weight loss medication without FDA approval.
Stevens reported in court that GlaxoSmithKline did nothing improper when promoting the drug and denied having promotional slides available. The indictment alleges that Ms. Stevens asked her legal team to draft a memorandum outlining the pros and cons of producing the slides for the FDA. The memorandum advised against producing the slides because they would be “incriminating evidence.”
Drug Company Promoted Drug Improperly
GlaxoSmithKline apparently paid several doctors to give speeches claiming Wellbutrin was safe to use for many conditions, not just depression. These doctors promoted the use of the anti-depressant as a weight loss medication among other things. Although GlaxoSmithKline has already paid for the crime of illegally promoting the drug, Ms. Stevens must face charges of making false statements and obstructing federal justice.
Possible Sentence if Convicted
Stevens could face three types of penalties. First, she could serve 20 years for obstructing an official proceeding. She could also serve 20 years for submitting false documents and for hiding other documents. Finally, she may face five years for submitting false statements.
A Trail of Deceit follows GlaxoSmithKline
Wellbutrin is just one of many medications that GlaxoSmithKline has used to put profits ahead of patients. In October of this year, GlaxoSmithKline settled a $750 million healthcare fraud case with the U.S. Justice Department. The company had been charged with selling several defective drugs emanating from a Puerto Rico plant including Paxil, Bactroban, Avandia, Coreg, and Tagamet. Poor manufacturing standards meant the drugs paid for by Medicare and state Medicaid programs were not as advertised. The company’s fraudulent behavior was so egregious that the courts handed down the largest criminal fine for any drug maker ever, $150 million.
Even when the company has manufactured the drugs correctly, it has made patient safety a secondary concern. Drugs like Accutane, Avandia, and Paxil have all been sources of defective drug lawsuits against the company.
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