Chicago drug recall lawyers at Pintas & Mullins Law Firm warn the public to be wary of the off-label drug marketing practices by certain pharmaceutical manufacturers. Recently, LegalTimes reported that a Virginia federal district judge slapped $700m in fines on Abbott Labs for off-label drug marketing. This is the second biggest criminal fine for one drug alone. The fines were imposed in response to the pharmaceutical company’s guilty plea for misbranding earlier this year.
The judge ordered the healthcare company to pay the Virginia Medicaid Fraud Control Unit $500 million in criminal fines, $198.5 million in penalties, and an additional $1.5 million for promoting the Depakote drug for unapproved uses.
Depakote was marketed as a suitable treatment for schizophrenia. The drug maker also claimed that it could help manage behavioral troubles in dementia patients. However, the FDA never approved the use of the drug for these conditions.
The verdict also called for Abbott to go through a five-year probationary period. The imposed probationary period required the company’s CEO and board of directors to personally confirm that they acted in accordance with the law.
Additionally, Abbott consented to a 5-year corporate integrity agreement with the Department of Health and Human Services, which calls for increased transparency and accountability. It also requires periodic internal and independent reviews.
Abbott Labs also entered into a civil settlement agreement, agreeing to pay about $800 million to settle claims that it submitted false medical reports to government health care programs. Our drug recall lawyers note that the FDA has issued several safety alerts pertaining to Depakote, yet the dangerous drug has not been recalled. As a result, the potential for serious harm remains.
Off-label Use of Antipsychotic Drugs High among Children
Recently, the ScienceDaily reported on a national study which reveals that a considerable percentage of anti-psychotics use by children is off-label. In fact, approximately 65 percent of the children who were advised to take anti-psychotic drugs in 2007 consumed the drugs off-label.
The study revealed that in the last 10 years, strong anti-psychotic drugs were increasingly used to treat publicly enrolled children. The number of Medicaid-enrolled children aged 3 to 18 who consumer anti-psychotics increased by about 62 percent during this time.
Anti-psychotic drug use went up for all kinds of mental health issues involving children, particularly those with a diagnosed conduct disorder, or ADHD. This increase occurred despite the fact that the FDA did not give doctors the green light to use these drugs to treat such disorders in young patients. Although it may be true that more mental health illnesses are being diagnosed in children, this is not the only reason for the soar in prescriptions.
The off-label utilization of anti-psychotics is a cause for serious concern.
This is particularly because of evidence that associates the drugs with
increased potential for severe metabolic side effects, such as diabetes
or weight gain.
If a child is prescribed an off-label antibiotic, it is imperative that the physician make the child’s parents and caretakers aware of possible complications or counseling options in order to avoid unnecessary harm.
Report Off-label Marketing
If you suspect that a particular pharmaceutical manufacturer is involved in off-label drug marketing, you can report your suspicions to an experienced pharmaceutical fraud law firm, who can help to assess the validity of your allegations. Our drug recall lawyers can carry out a thorough investigation and help protect your legal rights.