Avanir Pharmaceuticals recently agreed to a settlement of over $100 million with the federal government and several state governments over allegations that the company paid kickbacks to doctors and engaged in illegal off-label marketing tactics to promote its flagship drug, Nuedexta. The company will also pay $7 million to Medicaid programs to resolve allegations that its improper marketing resulted in false claims submitted to government health programs.
Nuedexta is a prescription medication used to treat a medical condition called “pseudobulbar affect (PBA),” which is often associated with neurological conditions and injuries. such as frequent, involuntary, and uncontrollable outbursts of crying or laughing that aren’t connected to a true emotional state.
The U.S. Food and Drug Administration (FDA) approved Nuedexta for treating PBA in 2010, but a 2017 CNN investigation revealed that some doctors were prescribing it to “control” certain elderly patients in nursing homes and, worse, that many doctors were receiving kickbacks from the manufacturer for each prescription filled. Though doctors are allowed to prescribe medications “off label”—for conditions for which they are not FDA approved—it is illegal for them to receive compensation for doing so.
Chaffin Luhana is currently investigating cases in which patients took Nuedexta and then suffered serious injuries such as falls, broken bones, head injuries, or spinal injuries.
How Was Nuedexta Misused?
Avanir’s questionable marketing practices associated with Nuedexta were first reported to authorities in early 2015 when a former sales director named Kevin Manieri came forward. He reported that he’d been fired months after joining the company in 2014 after he’d opposed practices like illegal kickbacks to physicians. He filed a complaint against his former employer under the federal False Claims Act, but his lawsuit remained under seal for years while the Justice Department investigated his claims.
In October 2017, CNN reported that Avanir had been “aggressively targeting” frail and elderly nursing home residents in its efforts to market Nuedexta, and had earned millions of dollars in profits as a result. Yet the prescribing information for the medication stated clearly that it had not been extensively tested in elderly patients. One small study on Alzheimer’s patients showed that those taking the drug experienced falls more than twice as often compared as individuals taking the placebo.
Between 2012 and 2016, the number of Nuedexta prescriptions dispensed to long-term care facilities jumped by nearly 400 percent, with total sales of reaching almost $300 million that year. Medicare spending on the drug also increased from $3.9 million in 2011 to $138 million in 2015.
As we now know, some doctors were often prescribing the drug simply to control unruly behaviors in elderly patients, and sometimes falsely diagnosed the patients with PBA so they could use the medication to keep the patients calm. This was a dangerous practice, as the drug can create side effects and increases the risk of falls, which can be devastating in elderly patients.
Avanir defended the rising numbers by stating in an email that PBA was often “misunderstood,” and that it could affect people with dementia and other disorders common among nursing home residents. Yet, investigators found that it was more likely that Avanir’s aggressive sales force and team of paid doctors were behind the increase in prescriptions and profits.
In a Los Angeles nursing home, for example, 46 of 162 residents had been placed on Nuedexta. Coincidentally, a facility psychiatrist paid by Avanir had given a presentation on the drug to employees. In another facility in Southern California, an employee admitted to investigators that one of the residents had been diagnosed with PBA and prescribed Nuedexta simply to quell mood disturbances such as yelling out.
Indeed, between 2013 and 2016, Avanir and its parent company, Otsuka, “paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services,” CNN reported. The companies also paid an additional $4.6 million on travel and dining costs for speakers and doctors targeted by sales professionals. As for Medicare claims, nearly half of those involving Nuedexta came from doctors who had received money or other kickbacks from the company.
The law is tricky when it comes to these sorts of issues. While a doctor can be legally paid to promote a drug to colleagues, he or she must do so only for the FDA-approved treatment, not for off-label uses. It is against the law to prescribe a drug in exchange for kickbacks, no matter what the drug is prescribed to treat.
Avanir Pays Doctors to Promote Nuedexta for Off-Label Conditions
Between 2013 and 2016, Avanir paid nearly 500 doctors to speak or consult on Nuedexta. CNN identified 12 doctors who were later disciplined by state medical boards for offenses, including the inappropriate prescribing of dangerous and addictive drugs.
Jason Kellogg, for instance, a geriatric psychiatrist treating nursing home patients in California, received $612,000 in payments, meals, and travel from Avanir between 2013 and 2016. He maintained that his prescriptions were appropriate and helpful to patients.
Meanwhile, the FDA received over 1,000 reports of adverse events associated with the drug, including rashes, dizziness, falls, comas, and even death. One report from a nurse practitioner claimed that an 86-year-old Alzheimer’s patient had suffered rapidly declining health and death after Nuedexta was added to her other medications. CNN also identified more than 80 cases in 19 states where inspectors cited nursing homes for inappropriate use of Nuedexta.
An analysis of interviews with former Avanir employees, internal company documents, and company emails showed that Avanir salespeople worked with doctors, nurses, and pharmacists to identify patients that could be screened for PBA, encouraged them to target Alzheimer’s patients, and coached healthcare professionals on how to fight for Medicare coverage of the drug.
Government Launches Investigations Into Avanir’s Behavior
Shortly after the CNN investigation came out, Los Angeles City Attorney Mike Feuer launched an investigation into the company to find out if Avanir had broken any state or federal laws. “If there is a possibility they [patients] are being administered a medication not because it is in their best interest, but because it is in the financial interest of, say, the drug manufacturer, then it is important for us to intervene,” he said in an interview.
The Department of Justice also opened an investigation initiated by two False Claims Act complaints against Avanir. One of these was mentioned above, filed by Manieri, who claimed that Avanir was engaged in a drug kickback scheme with physicians around the U.S., paying them in exchange for their promises to prescribe Nuedexta.
Manieri also named in his lawsuit defendant Dr. Raheja, whom he claimed had participated in the scheme by knowingly soliciting and accepting kickbacks from Avanir in return for prescribing Nuedexta to his patients. An Ohio-based neurologist, Raheja was described as the “most-prolific” prescriber of the drug nationwide.
Manieri’s whistleblower lawsuit was followed by another filed jointly by Duane Arnold and Mark Shipman, two Avanir sales managers who had been in charge of promoting off-label uses of Nuedexta to nursing home doctors.
As part of the claims against the company, the government alleged:
- Avanir marketed the drug in long-term care facilities for uses other than PBA that had not been FDA-approved and were not accepted indications.
- Avanir instructed sales representatives to provide false and misleading information that PBA patients could be exhibiting a wide variety of “behaviors” such as crying without tears, moaning, or making other inarticulate sounds, when, in fact, those symptoms are commonly observed in patients who have dementia but do not have a diagnosis of PBA.
The DOJ issued a press release on September 26, 2019, stating that Avanir was charged for paying kickbacks to a physician to induce prescriptions of Nuedexta. “Kickbacks have the power to corrupt a provider’s medical judgment,” said Assistant Attorney Jody Hunt of the Department of Justice’s Civil Division. “And it is particularly concerning when a pharmaceutical company uses kickbacks to drive up sales in connection with a vulnerable population, such as elderly patients in nursing care facilities.”
The U.S. Attorney’s Office for the Northern District of Ohio also announced indictments of four individuals, including Dr. Raheja, who were involved in the kickback scheme. All four were charged with conspiracy to solicit, receive, offer, and pay health care kickbacks. Avanir is cooperating in the prosecution of these individuals.
As part of a deferred prosecution agreement, Avanir admitted to paying a doctor to induce him to increase his Neudexta prescription volume. The company paid a $7.8 million penalty related to this charge. In a separate civil resolution, the company agreed to pay nearly $96 million to resolve the False Claims Act allegations related to its marketing of Nuedexta.
This settlement resolved both of the whistleblower cases. Manieri received over $12 million of the settlement, with just over $5 million going to Arnold and Shipman. In addition to the nearly $96 million paid to resolve the federal government’s claims, Avanir also agreed to pay an additional $7 million to resolve state Medicare claims.
Types of Injuries Associated with Nuedexta
Patients who take Nuedexta may be at a higher risk for the following types of injuries:
- Broken bones
- Abrasions, cuts, contusions, and other wounds
- Head injuries
- Spinal injuries
What Is PBA?
Also called “emotional incontinence,” PBA affects the way the brain controls emotion. It typically occurs in people with neurological conditions or injuries including the following:
- Amyotrophic lateral sclerosis (ALS)
- Multiple sclerosis (MS)
- Traumatic brain injury
- Alzheimer’s disease
- Parkinson’s disease
- Brain tumors
- Grave’s disease
People who have suffered a stroke, in particular, are commonly affected by PBA. They may have no control over their moods or mood changes. Symptoms of the disease include:
- Laughing hysterically when it’s not appropriate, such as at a funeral
- Crying at inappropriate times, such as after someone tells a joke
- Outbursts occurring several times a day
- Sudden and unpredictable onsets, similar to the way a seizure acts
- An overall inability to control emotional responses
- Swift mood changes—short periods of uncontrollable crying followed by immediate calm
More than one million people are estimated to have PBA in the U.S., and it is relatively common among patients with neurological disorders. The disease can be embarrassing, humiliating, and debilitating, and often has a significant negative effect on an individual’s quality of life. It is sometimes misdiagnosed as depression or bipolar disorder, but there are characteristic features that can be recognized clinically or assessed by validated scales, which allows doctors to properly identify the condition and treat it.
What is Nuedexta?
On October 29, 2010, the FDA approved Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) for the treatment of PBA associated with certain neurological conditions, including multiple sclerosis. The drug came in oral capsule form taken once daily for the first seven days, then twice daily after that (one capsule every 12 hours).
Nuedexta contains two medications:
- Dextromethorphan hydrobromide (20 mg), which is active in the central nervous system
- Quinidine sulfate (10 mg), a metabolic inhibitor
Nuedexta is classified as a dual-action glutamate inhibitor that acts on sigma-1 and NDMA receptors in the brain, though exactly how it helps calm patients with PBA is unknown. Studies used to gain approval were performed in patients with ALS and MS, and showed that it was safe and effective for these patients. The drug was not tested or shown to be safe in other patient populations, such as those with Alzheimer’s disease and other dementias.
Possible side effects associated with Nuedexta include:
- Changes in heart rhythm
- Swelling of feet and ankles
- Urinary tract infection
- Elevated liver enzymes
Individuals who were harmed by inappropriate Nuedexta prescriptions have a right to compensation in court. If you or a loved one were prescribed Nuedexta without a true diagnosis of PBA, and later suffered a serious injury, you may be eligible to file a lawsuit to recover damages. Chaffin Luhana is now investigating these cases and invites you to call today at 888-480-1123.