U.S. Backs Whistleblower In Drug LawsuitMay 28, 2003 | AP
The U.S. government is supporting a whistleblower who sued Pfizer and its subsidiary Parke-Davis, saying evidence backs his claim that the drug maker illegally marketed the epilepsy drug Neurontin and offered lavish kickbacks to doctors.
U.S. Attorney Michael Sullivan has filed a "statement of interest" in Dr. David Franklin's civil lawsuit in federal court, arguing against the pharmaceutical company's motion to have the lawsuit thrown out on summary judgment.
"The evidence in this case supports a finding that Defendants engaged in a fraudulent scheme, involving many false statements to doctors and the United States Food and Drug Administration advanced by payment of illegal kickbacks," Sullivan wrote in documents filed Friday.
Pfizer merged with Warner-Lambert and its Parke-Davis division three years ago. A company spokesman said Pfizer employees do not promote drugs for non-approved uses.
"These activities allegedly took place a number of years ago, well before we merged with Warner-Lambert," spokesman Andy McCormick said. He declined to comment on Franklin's specific allegations and said Pfizer's attorneys would file a reply next week.
The case concerns "off-label" use, or prescribing drugs for ailments other than those approved by the FDA, of Neurontin.
Federal law allows doctors to prescribe drugs in any way they believe will best help patients, but forbids companies from promoting drugs for conditions that are not approved by the FDA.
Franklin, who worked for Warner-Lambert, the former parent company of Parke-Davis, claims in his lawsuit filed in 1996 that the company gave financial incentives to hundreds of doctors to prescribe Neurontin for non-approved uses.
Internal company memos outline plans for promoting the drug for bipolar disorder, social phobias, panic disorder, and neuropathic pain in journals and medical conferences, rather than seeking FDA approval.
In Friday's filing, Sullivan said Franklin had documented the company's kickback schemes for physicians who prescribe Neurontin for off-label uses, such as a 1996 meeting in Atlanta where doctors were given tickets to the Olympics, meals, and use of a spa.
He also says doctors were given a three-day trip to Palm Beach, Fla., cash payments and yacht trips, and were afterward tracked by Parke-Davis to see if the perks had an impact on their prescriptions. Another 1997 junket to Puerto Rico offered cash, meals and airfare.
"(The U.S.) has a keen interested in the development of the law in this area and in the correct application of that law in this case and similar cases pending in several courts," Sullivan wrote.
Christina Sterling, a spokeswoman for the U.S. Attorney's office, declined to comment.