Pfizer Inc.’s Warner-Lambert unit created a list of 13 ailments that its epilepsy medicine Neurontin could treat as part of its promotion of the drug for unapproved uses, a former employee testified.
“I was trained from day one” to market the drug illegally, David Franklin testified. Franklin, who worked as a medical liaison at the Parke-Davis division of Warner-Lambert, said he encouraged doctors to prescribe Neurontin for uses beyond those approved by the U.S. Food and Drug Administration.
“My job was to promote Neurontin and motivate doctors to experiment” on patients, he said today in federal court in Boston. After being hired as a medical liaison, “I was selling drugs,” he said. The uses promoted were from the “snake-oil list” of 13 medical conditions, said Franklin, a microbiologist.
Franklin was the first witness in the trial over claims by the family of Susan Bulger, 39, who hanged herself after taking the drug. Bulger’s family claims Pfizer promoted Neurontin for unapproved uses and failed to warn it could increase the risk of suicide until forced to do so by the government. Bulger started taking the drug in 1999.
The trial of the suit, the first of about 1,200 over Neurontin to go to trial, is expected to last three weeks.
Franklin filed a federal whistleblower complaint in 1997 alleging the company illegally marketed the drug for attention deficit disorder, pain and other unapproved uses. The suit resulted in a $430 million settlement by Warner-Lambert with the U.S. Justice Department in 2004.
Franklin, who worked at Warner Lambert for four months in 1995 before resigning over the company’s off-label marketing practices, received about $25 million as his share under the federal False Claims Act, the government said at the time.
Warner-Lambert officials used a variety of tactics to persuade doctors to prescribe Neurontin for unapproved uses, Franklin told jurors.
They provided the company’s sales force with a list of ailments that would benefit from Neurontin use, including restless leg syndrome, migraine headaches and withdrawal symptoms from drug and alcohol abuse, Franklin said. The FDA hadn’t approved the drug for any of those illnesses at the time, he added.
The U.S. Food and Drug Administration in December required all makers of epilepsy drugs, including Neurontin, to add a suicide-risk warning to their labels.
Pfizer’s lawyer pointed out the off-label marketing practices covered by the Warner-Lambert settlement with the government occurred before the New York-based drugmaker’s 1999 purchase of its rival.
Mark Lanier, a lawyer representing Bulger’s family, told jurors that Warner-Lambert executives began the off-label marketing campaign to transform Neurontin into a “blockbuster” medicine generating $1 billion in annual sales. The company estimated that selling it solely as an epilepsy drug would generate only about $50 million in sales, he added.
“The company made a conscious decision to do something illegal — marketing this drug off-label,” Lanier said today in his opening statements.
Bulger’s family, of Peabody, Massachusetts, sued Pfizer and Warner Lambert in August 2007, more than three years after Bulger’s husband and 4-year-old daughter found her body in their basement. Ronald Bulger said he gave his wife four Neurontin pills an hour before she killed herself.
Ohlemeyer noted in his opening statement that Bulger had made at least six other suicide attempts during her lifetime and had battled drug addiction and depression.
The case is Bulger v. Pfizer Inc., 1:07-CV-11426, U.S. District Court, District of Massachusetts (Boston). The suit is part of In Re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629.
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