Houston Bad Drug Interaction Attorney

Drugs: Paxil, Wellbutrin, Avandia

GlaxoSmithKline holds the distinction of being forced to pay the largest health care fraud settlement in U.S. history. The criminal fine was $956,814,400 with a forfeiture of $43,185,600. $2 billion was paid to resolve civil liabilities under the False Claims Act.

The penalties are related to deceptive marketing, including off-label promotion and kickbacks, and failure to report safety data.

GSK agreed to pay based on:

• Promoting Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label and non-covered uses, in addition to paying kickbacks to physicians for prescribing those drugs.
• Giving kickbacks to physicians for prescribing Imitrex, Lotronex, Flovent, and Valtrex.
• Making false and misleading statements about Avandia’s safety.
• False reporting to the Medicaid Drug Rebate Program.

Drugs: Risperdal, Invega, Natrecor

Criminal fines and forfeiture totaled $485 million, and civil settlements amounted to $1.72 billion.

In the early 2000s, Risperdal was approved to treat schizophrenia. However, the company’s sales representatives were promoting the drug to physicians as a treatment for elderly dementia patients for anxiety, agitation, depression, hostility, and confusion. There were also allegations that Risperdal was marketed for other unapproved uses, such as prescription to children and individuals with mental disabilities.

Invega and Natrecor were also included in these lawsuits as having been illegally marketed for off-label and unapproved uses.

Drug: Depakote

Criminal fines in this action were $700 million and civil settlements were $800 million. Abbott promoted Depakote as a drug to control agitation and aggression in elderly dementia patients, and for schizophrenia. The FDA hadn’t approved the drug for either of these uses. For 8 years, the manufacturer marketed Depakote for this purpose in nursing homes, even though there wasn’t any evidence that the drug was safe and effective when used that way.

In fact, the FDA had approved Depakote for epileptic seizures, bipolar mania, and migraine treatment. The manufacturer had actually discontinued clinical trials of Depakote for dementia treatment in 1999 because of adverse events, yet they still continued to market it publicly.

Drug: Zyprexa (generic: olanzapine)

Eli Lilly promoted antipsychotic drug Zyprexa for uses outside the FDA’s approval, which resulted in criminal fines of $515 million and civil settlements of $800 million.

The FDA approved olanzapine in 1996 for treating psychotic disorders. It was later approved for treatment of manic episodes of bipolar disorder, and then for short-term treatment of schizophrenia. It was not approved for treatment of dementia or Alzheimer’s Disease.

However, Eli Lilly was marketing Zyprexa to primary care physicians even though it wasn’t a drug intended for the primary care market. As a result, physicians were prescribing it for patients of all ages for anxiety, irritability, depression, nausea, Alzheimer’s, and other issues.