Neurontin
Experienced St. Louis Neurontin Attorneys
We represent Plaintiff's seeking economic damages for the defendants misrepresentation to the market place for the following off label uses for which either there was insufficient scientific evidence to support representations or omitted negative clinical trials and/or information:
i. Bipolar Disorder. Psychiatrists were told that early results from trials evaluating gabapentin in the treatment of bipolar disorder indicated a 90 percent rate when the drug was started at 900 milligrams per day and increased to 4,800 milligrams per day. No such results existed. In fact, the only type of clinical trial being conducted at the time was a pilot study that indicated that increasing the dose did not increase gabapentin's effect. The FDA-approved dosage for gabapentin in adults was and is 900 to 1,800 milligrams per day.
Any data regarding gabapentin in bipolar disorder was anecdotal and of unclear scientific value. Most of the published reports on the use of gabapentin in bipolar disorder had been written and sponsored by Parke-Davis, a fact that was hidden. Company sales personnel were trained to tell psychiatrists that there were no reports of adverse reactions with gabapentin when used in psychiatric illness. In fact, health care professionals had given such reports to Defendants, but they attempted to hide this information from physicians
ii. Pain Syndromes, Peripheral Neuropathy, and Diabetic Neuropathy. Parke-Davis sales personnel were trained and instructed to report that "leaks" from clinical trials demonstrated that gabapentin was highly effective in the treatment of a number of pain syndromes and that a 90 percent response rate in the management of pain was being reported. No such evidence existed. Sales personnel were trained to claim support for these findings as a result of inside information, despite the fact that no such information existed. The only basis for these claims was anecdotal evidence of minimal, if any, scientific value. Many of the published case reports had been created and sponsored by Parke-Davis in articles that frequently hid the company's involvement in the creation of the article. The company's payment for the creation of these case reports was also concealed.
iii. Treatment of Epilepsy alone (as monotherapy). Sales personnel were strongly encouraged to push neurologists to prescribe gabapentin as a single drug for the treatment of epilepsy, in spite of the fact that studies found it safe and effective only when used in combination with other seizure drugs. Neurologists were told that substantial evidence supported the company's claim that gabapentin was effective when used alone for seizure. In fact, at the time the court papers were filed, Defendants knew that clinical trials using gabapentin alone in seizures were inconclusive. One of Defendant's clinical trials showed that gabapentin alone was not effective. The vast majority of patients in the study taking gabapentin were unable to continue with gabapentin alone. In the same study, there was no significant difference between doses of 600, 1,200 or 2,400 milligrams. Nevertheless, Parke-Davis continued to urge doctors to use higher doses than approved by the FDA. In 1997, the FDA had in fact rejected an application for approval of gabapentin as monotherapy in the treatment of seizures.
iv. Reflex Sympathetic Dystrophy (RSD). Physicians were informed that extensive evidence demonstrated that efficacy of gabapentin in the treatment of RSD, a condition of pain and tenderness following traumatic injury to a limb. Again, the only evidence was in anecdotal reports of little or no scientific value. Sales personnel were trained to imply that case reports, most of which had been created or sponsored by the company, were actually studies.
v. Attention Deficit Disorder (ADD). Pediatricians were told that gabapentin was effective for the treatment of ADD. No hard data to support this claim existed--only occasional anecdotal evidence. Sales personnel were trained to report that large numbers of physicians had success in treating ADD with gabapentin, where no such case reports existed.
vi. Restless Leg Syndrome (RLS). This is another condition for which company medical liaisons were trained to refer to a growing body of evidence relating to the RLS, when no such scientific data existed. The only reports were anecdotal, the majority of which had been co-sponsored or created by Parke-Davis.
vii. Trigeminal Neuralgia. The company represented gabapentin as a treatment for trigeminal neuralgia, a syndrome of severe bursts of facial pain, when no scientific data supported this claim; only occasional anecdotal reports. No evidence was available that gabapentin was as effective as currently available less expensive painkillers.
viii. Post-Hepatic Neuralgia (PHN). This is a syndrome of severe pain following a herpes virus infection. Physicians were told that 75 to 80 percent of all PHN patients were successfully treated with gabapentin. Again, no clinical trial data supported such a claim.
ix. Essential Tremor Periodic Limb Movement. Defendants represented that gabapentin was effective in treating this disorder. No scientific data supported the Defendant's claim that gabapentin was effective for this disorder, just anecdotal reports of dubious scientific value.
x. Migraine. Claims that gabapentin was effective in the treatment of migraine headaches were made by sales personnel and were alleged to be based on early results from clinical trials. Pilot studies had been suggested and undertaken, but no early results existed to support these claims. The data was purely anecdotal and most case reports were either created or sponsored by Parke-Davis.
xi. Drug and Alcohol Withdrawal Seizures. It was suggested by the company that gabapentin be used in the treatment of drug and alcohol withdrawal seizures despite the lack of any evidence supporting the use of the drug for these conditions.