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Home / Current Litigation / Nuedexta: Drug Being Pushed “Off-Label” On Elderly In Nursing Homes = $116 Million Settlement

Nuedexta: Drug Being Pushed “Off-Label” On Elderly In Nursing Homes = $116 Million Settlement

Categories: Current Litigation Tags: current litigation, nuedextaJanuary 7, 2020 by Mass Tort News Leave a Comment

Avanir Pharmaceuticals, the maker of Nuedexta, a prescription drug approved to treat a rare neurological condition is earning hundreds of millions of dollars a year  by aggressively targeting elderly nursing home residents in “off-label” use, for whom the drug may be unnecessary and now recognized as unsafe. Off-label use is when a company offers and markets a drug for reasons other than what it was initially approved for by the FDA.

The vast majority of the “off-label” related payments to nursing homes are coming straight from the federal government. Both civil and criminal actions are often intertwined in these programs. There are prime benefits by becoming known as the “go to” Qui Tam” law firm, in the ever-emerging world where billions of dollars in governments payments are made to to private industries. 

Recently, the US Department of Justice announced the settlement with Avanir for $117 million four years after whistleblowers alerted the federal government illegal marketing and payments of kickbacks to doctors for its main drug, Nuedexta — particularly in nursing homes.

US Dept. of Justice Avanir Release: https://www.justice.gov/opa/pr/pharmaceutical-company-targeting-elderly-victims-admits-paying-kickbacks-resolves-related

Qui Tam Claims Filed by Avanir Employees

The civil settlement resolves lawsuits filed by Kevin Manieri, Duane Arnold, and Mark Shipman, all former employees of Avanir, under the qui tam or whistleblower provisions of the False Claims Act, which permit private individuals, known as relators, to sue on behalf of the government for false claims and to share in any recovery.  The qui tam suits were filed in the Northern District of Ohio and the Northern District of Georgia and are captioned United States ex rel. Kevin Manieri v. Avanir Pharmaceuticals, Inc. and Deepak Raheja, Action No. 5:15-cv-611 (N.D. Ohio), and United States ex rel. Duane Arnold and Mark Shipman v. Avanir Pharmaceuticals, Inc., Action No. 1:15-cv-01250 (N.D. Ga.).  Manieri will receive $12,389,823 of the civil settlement, and Arnold and Shipman will receive $5,365,000 of the civil settlement.  In addition to the $95,972,017 being paid to resolve the United States’ civil claims, Avanir will pay an additional $7,027,983 to resolve state Medicaid claims. 

The drug, called Nuedexta, (dextromethorphan hydrobromide and quinidine sulfate), is approved to treat a disorder marked by sudden and uncontrollable laughing or crying — known as pseudobulbar affect, or PBA.This condition afflicts less than 1% of all Americans, based on a calculation using the drugmaker’s own figures,and it is most commonly associated with people who have multiple sclerosis (MS) or ALS, also known as Lou Gehrig’s disease.

Nuedexta’s financial success, however, is being propelled by a sales force focused on expanding the drug’s use among elderly patients suffering from dementia and Alzheimer’s disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company.

An example is a nursing facility patient, Lenore Greenfield was diagnosed with PBA and prescribed Nuedexta by California psychiatrist Romeo Isidro, a physician who has received hundreds of thousands of dollars in promotional payments from Avanir.

Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales with total sales of Nuedexta reaching almost $300 million that year.

NUEDEXTA OFF-LABEL” USE UNDER REVIEW

Nuedexta is being increasingly prescribed in nursing homes even though drugmaker Avanir Pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients — prompting critics to liken its use to an uncontrolled experiment. The one study the company conducted solely on patients with Alzheimer’s (a type of dementia) had 194 subjects and found that those on Nuedexta experienced falls at more than twice the rate as those on a placebo.

Avanir declined repeated requests to be interviewed for this article. In an emailed statement, the company said PBA is often “misunderstood” and that the condition can affect people with dementia and other neurological disorders, which are common among residents in long-term care facilities. A company website states PBA can afflict up to roughly 40% of dementia patients — a figure that is based on an Avanir-funded survey and was repeatedly disputed by medical experts, including some of those paid by Avanir.

Nuedexta is approved by the Food and Drug Administration (FDA) to treat anyone with PBA, including those with a variety of neurological conditions such as dementia. But geriatric physicians, dementia researchers and other medical experts told CNN that PBA is extremely rare in dementia patients; several said it affects 5% or less. And state regulators have found doctors inappropriately diagnosing nursing home residents with PBA to justify using Nuedexta to treat patients whose confusion, agitation and unruly behavior make them difficult to manage.

“There has to be a diagnosis for every drug prescribed, and that diagnosis has to be real … it cannot be simply made up by a doctor,” said Kathryn Locatell, a geriatric physician who helps the California Department of Justice investigate cases of elder abuse in nursing homes. “There is little to no medical literature to support the drug’s use in nursing home residents (with dementia) — the population apparently being targeted.”

There are now confirmed instances of dozens of cases across the country since 2013 in which state nursing home inspectors questioned the use of Nuedexta.

In a Los Angeles nursing home last year, regulators found that more than a quarter of its residents — 46 of 162 — had been placed on Nuedexta, noting that a facility psychiatrist had given a talk about the drug to employees. This psychiatrist was a paid speaker for Avanir.

At another facility in 2015, also in Southern California, an employee admitted to inspectors that a resident had been given a diagnosis of PBA to “somehow justify the use” of Nuedexta, even though its intended purpose was to control the resident’s “mood disturbances” and yelling out.

And an Ohio doctor paid by Avanir has come under government investigation for allegedly receiving kickbacks for prescribing the drug and fraudulently diagnosing patients with PBA in order to secure Medicare coverage — though the doctor has denied any wrongdoing.

The federal government foots the bill for a big portion of the money being spent on Nuedexta in the form of Medicare Part D prescription drug funding, for people 65 and over and the disabled. In 2015, the most recent year for which data is available, this Medicare program spent $138 million on Nuedexta — up more than 400% from just three years earlier.

Medicare is supposed to pay for drug uses that have been proven safe and effective for the population they are intended to treat or that have been otherwise supported by a specific collection of medical research. Nuedexta is currently only approved by the FDA for patients who have PBA. So experts say that Medicare coverage of the drug, which has been crucial to its financial success, relies on the diagnosis of this single condition. So-called “off-label” prescribing, in which doctors use the drug to treat patients who have not been diagnosed with PBA, would typically not be covered, however there is a massive trend in Big pharma the last few years to increase revenues by pushing off-label” use in most every drug in major pharmaceutical maker inventories.

The Centers for Medicare & Medicaid Services (CMS) declined to comment on the growing use of Nuedexta in nursing homes.

Thousands of the doctors prescribing Nuedexta have received money, or at least a meal, from its maker — a legal but controversial practice in the industry. Between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services, according to government data. The companies also spent $4.6 million on travel and dining costs, both for speakers and for doctors being targeted by salespeople.

Research has shown thata that nearly 50% of the Nuedexta claims filed with Medicare in 2015 came from doctors who had received money or other perks from the company (ranging from a few dollars’ worth of food or drink to hundreds of thousands of dollars in direct payments).

Pharmaceutical companies are allowed to pay a doctor to promote a drug to colleagues and other medical professionals. It is illegal, however, for doctors to prescribe the drug in exchange for kickback payments from a manufacturer.

Several of these paid advocates of Nuedexta argue that PBA manifests differently depending on the person. With dementia patients, they say, the typical crying or laughing outbursts seen in multiple sclerosis patients may be absent. Instead, symptoms may include moaning, wailing, hitting a wheelchair over and over again or repeating the same phrase. And they are adamant that the medication can be life-changing for patients, touting how safe and benign it is.

“I never hear, ‘hey doc, we put a patient on this and had really bad side effects,’” said Jason Kellogg, a geriatric psychiatrist who sees patients at nursing homes across California. Kellogg has received $612,000 in payments, meals and travel from Avanir and its parent company between 2013 and 2016, according to government data. He was a top Medicare prescriber for the drug in 2015, the most recent year for which data is available.

Kellogg, who said he was involved in early company testing of the drug for PBA, said Nuedexta is “such a blessing in psychiatry.”

“In our treatments, we don’t have many meds that are well tolerated, and I would hate if someone took that away from me,” he said.

CONCERN BY DOCTORS RAISED DURING FDA APPROVAL

During the FDA approval process, two key doctors on the committee raised concerns about Nuedexta being used for PBA in Alzheimer’s patients. They both strongly recommended that Nuedexta only be approved for PBA in patients with MSorALS. They argued that evidence it would be effective in other conditions was “weak,” that not enough was known about the safety of the drug in the elderly, and that it was unclear that PBA even existed in Alzheimer’s patients. Despite these concerns, the agency approved Nuedexta in 2010 for treating PBA in patients who have neurological conditions such as dementia.

Soon after Nuedexta hit the market in 2011, doctors, nurses and family members began filing reports of potential harm — ranging from rashes, dizziness and falls to comas and death. Nuedexta was listed as a “suspect” medication in nearly 1,000 so-called adverse event reports received by the FDA detailing side effects, drug interactions and other issues, CNN found. While the FDA uses these voluntary reports to monitor potential issues with a drug, a report does not mean that a suspected medication has been ruled the cause of the harm.

The FDA declined to comment on these adverse events or the concerns raised about Nuedexta during the approval process. But it did say that after any drug is approved, the agency continues to review safety information from a variety of sources (including adverse event data) and will take action as needed — such as updating a medication’s label, restricting its use or even taking it off the market entirely.

USC DIRECTOR WARNING

Lon Schneider, director of the University of Southern California’s California Alzheimer’s Disease Center, reviewed information from roughly 500 of the reports through a Freedom of Information Act request. Schneider, a physician specializing in geriatric and dementia care, said he was concerned about the problems stemming from potential interactions between Nuedexta and other powerful medications intended to treat problematic behaviors.

He warned that given how medicated the elderly typically are, adding just one more pill — especially one that hasn’t been extensively tested — could be dangerous.

REPORTS TO FDA BY MEDICAL PROFESSIONALS

One report filed by a nurse practitioner in 2015 detailed the rapid decline of an 86-year-old Alzheimer’s patient after Nuedexta was added to the psychotropic medications she took including Zoloft (an antidepressant), Xanax (an antianxiety drug) and Risperidone (an antipsychotic). Nuedexta had been prescribed to treat PBA and “weeping with underlying Alzheimer’s dementia.”

Almost immediately, the woman experienced weakness and fatigue to the point that she was barely able to talk and was described as being “almost unresponsive.” The dose of Nuedexta was increased, and her symptoms worsened. The drug was discontinued about a week later, but she failed to recover. She remained unable to eat or drink and her kidneys failed — ultimately leading to her death.

“The patient seemed to be doing fine,” the nurse practitioner reported, “until she was placed on Nuedexta.”

AGGRESSIVE SALES FORCE

The combination of two generic drugs that makes up Nuedexta — a cough suppressant and heart medication — was once available from specialty pharmacists willing to combine the ingredients for less than $1 a pill, according to a US Senate report on rising prescription drug prices.

Now the FDA-approved medication costs as much as $12.60 a pill, wholesale pricing data from First Databank shows. That can add up to more than $9,000 a year, though the amount a patient actually pays depends on factors including individual insurance coverage. Medicare Part D spending on the drug averaged $3,400 per patient in 2015.

It is Avanir’s main product and biggest moneymaker. It has gained attention with the public through its television commercial featuring actor Danny Glover seesawing between laughter and tears. And it was this drug’s financial potential that attracted Japanese pharmaceutical giant Otsuka to the boutique California firm, purchasing Avanir for $3.5 billion several years ago. Otsuka declined to comment for this story.

Avanir investor documents have stated that only a small fraction — 100,000 of the 1.8 million patients suffering from moderate to severe PBA — live in long-term care facilities. Yet the company has described nursing homes as key to its growth.

On a 2013 earnings call, Rohan Palekar, a top executive who eventually became CEO but is no longer with the company, said Avanir had “just scratched the surface of its full potential” in nursing homes, according to an online transcript. He said the company aimed to get Nuedexta prescribed in far more facilities. Palekar did not respond to requests for comment.

To rack up these prescriptions, salespeople identified doctors, nurses and pharmacists who could serve as advocates for the drug, according to interviews with former Avanir employees and internal documents and emails reviewed by CNN. Salespeople then worked closely with these advocates to identify potential patients. In one case, a salesperson worked with a doctor’s office manager to pull patients’ charts, identify those who should be screened for PBA and make sure that Nuedexta brochures were inserted in their files. The sales force also coached doctors and facility employees on how to fight for Medicare coverage of the drug if it was initially refused.

Federal laws restrict the tactics pharmaceutical sales representatives can use to sell a medication. They can’t give favor or payments in exchange for a doctor prescribing the drug. They can’t have any contact with private patient records, without the patient’s consent. And they can’t promote use of a drug off-label, in a way that hasn’t been approved by the FDA.

Internal company emails have shown a culture filled with intense pressure to get the drug sold and how Avanir sales representatives were encouraged to directly target dementia and Alzheimer’s patients — a practice which is legal as long as these patients also had PBA.

In an email from several years ago, one of the company’s regional managers, Kevin Tiffany, bluntly urged his salespeople to spend “99.9 percent” of their time focused on such patients.

Devoting time to other conditions more commonly associated with PBA amounted to “diluting your chances,” wrote Tiffany, a senior sales manager in California.

“Give yourself the best chance to win,” Tiffany added.

Tiffany, who no longer works for Avanir, declined to comment through an attorney.

Other emails from managers show how the government’s crackdown on dangerous antipsychotic drugs — which were once widely used to control unruly and erratic behavior in nursing home patients — created an opportunity for Avanir.

After receiving the FDA’s most severe “black box” warning for an increased risk of death in elderly dementia patients, antipsychotics are now closely monitored by government regulators, who penalize and lower the ratings of facilities that overuse them. Internal company communications show Avanir salespeople were directed to specifically target facilities that historically used high levels of antipsychotic medications — facilities that would see Nuedexta as an attractive alternative.

Some of these tactics employed by Avanir salespeople cross into ethical gray areas, said medical ethicists and other experts who were read the emails and sales training documents or provided with details from them.

“It definitely feels like it is too much in the business of prescribing and not in the business of conveying information,” said Michael Santoro, a Santa Clara University professor and an expert in pharmaceutical industry ethics.”It feels like (the salespeople) are actually participating in the prescribing decision.”

In its statement, Avanir said that the company was committed to “an ethical culture,” uses methods “that are consistent with the law” and that its goal is “to give doctors truthful, accurate and balanced information so they can decide on the proper treatment for their patients.”

Avanir executives have long touted plans for securing FDA approval for Nuedexta’s use to treat dementia patients who don’t have PBA — setting their sights on the more widespread condition of agitation in dementia and Alzheimer’s patients, characterized by emotional and physical outbursts and restless behaviors. The company announced clinical trials for testing a version of the medication for this use in 2015, but those have not yet been completed. Without additional FDA approval for the drug’s use in those conditions, salespeople cannot promote Nuedexta for that purpose. They can only market its use for dementia patients who also have PBA.

There are currently no FDA-approved drugs for treating dementia-related agitation, and other drug makers have been penalized for marketing drugs for this use. Abbott Laboratories Inc., for instance, pleaded guilty in 2012 to illegally marketing an anticonvulsant called Depakote in nursing homes as a way to control agitated and aggressive dementia patients. But the drug had only been approved for treating seizures, bipolar disorder and migraines. The company ultimately paid a total of $1.6 billion in civil and criminal penalties.

Those who care for the elderly remain eager for tools to manage these behaviors, however. Some caregivers say investments in increased staffing can reduce the need for medications. But such measures are expensive and don’t always work, so some facilities opt for pharmaceutical solutions that can help make their many patients easier to treat.”Rather than taking someone off an antipsychotic” and opting to treat the patient in ways that don’t require medication, “providers search for a different ‘magic bullet,’” said Helen Kales, a geriatric psychiatrist and University of Michigan professor.

NURSING FACILITIES PUSHED “OFF-LABLE” USE

In one case, the executive director of a California assisted living facility tried to push Nuedexta on a dementia patient to address her “aggressive” behavior, according to emails reviewed by CNN. The director at the facility, Oakmont of Mariner Point in Alameda, California, told the patient’s son, Jason Laveglia, that the medication wasn’t an antipsychotic and threatened to evict his mother if she wasn’t put on the medication.

“(I)f her behavior cannot be muted through prescription means, I would have no choice but to pursue delivering a 30-day eviction notice,” Joan Riordan wrote to Laveglia last year.

Laveglia turned to the state for help, and by the time officials investigated weeks later, Riordan no longer worked at the facility. Social service officials ultimately found that her eviction attempt had violated state law. A spokesperson for the facility would not comment on the state’s findings, but said it “does not endorse or recommend Nuedexta nor any other medication” and that staff should not be involved in medical decisions.

Riordan disputed the idea that her emails served as an official eviction notice. Riordan, who is not a doctor, said that she had recommended Nuedexta after learning about the medication from a local psychiatrist and had seen it help a number of other aggressive dementia patients without the dangers and sedative effects of an antipsychotic.

“I’ve seen it just work wonders with people,” she said. “It was the only intervention I could come up with. We needed to do something not only for her own benefit, but also for the people around her.”

When asked whether her residents had PBA, Riordan told CNN she had never heard of the condition and had no knowledge of whether they had received such a diagnosis.

RED FLAGS RAISED

Across the country, the use of Nuedexta in nursing homes has prompted concerns among state regulators whose job is to ensure adherence to federal guidelines and protect residents from being given unnecessary drugs — especially those used as chemical restraints. But to date, the red flags raised by these regulators have been largely left buried in nursing home inspection reports and have drawn little public attention.

There have been more than 80 cases in 19 states since 2013 where inspectors cited nursing homes for inappropriate monitoring and use of Nuedexta — often because residents hadn’t exhibited any symptoms of PBA. Many of the cases — about 40% — were clustered in Southern California, where Avanir is based and where former employees said there has been aggressive marketing.

At the Montrose Healthcare Center near Los Angeles, three nursing home residents were given Nuedextawithout a doctor’s prescription or approval, according to one inspection report. All were cognitively impaired. One was known to call out for help, while another would cry when their family left the facility. But employees acknowledged that they had never seen the residents laugh or cry involuntarily — the hallmark indicators of PBA.

Regulators learned of these prescriptions in 2015, after a family member discovered that her relative was receiving Nuedexta without her consent. While researching the medication, she learned it could be dangerous for her family member because of other medications she took for a serious heart condition.

The doctors for all three residents denied ever prescribing Nuedexta. State investigators later discovered nursing staff had obtained the prescriptions without a doctor’s approval, which they are not authorized to do. They also found that at least two nurses at the facility had attended a sales seminar about Nuedexta, where they were given a doctor’s sample prescription for the medication. The facility said in a statement that it had addressed the concerns raised by the state inspection report and suggested that outside pressure had been at play.

“Our Center does not condone the pressuring of nurses by pharmaceutical reps and physicians to favor certain medications,” the facility said. “Should they feel pressured to administer medications they do not feel are appropriate, our nurses can and should bring it to our immediate attention so we may assist them in advocating for their patients.”

In New Jersey, St. Vincent’s Healthcare and Rehab Center was cited by regulators last year because six residents were prescribed Nuedexta even though no symptoms of PBA had been documented. A representative of the facility has now stated “we take a close look at all medications prescribed to ensure appropriate use.”

DRUG TREATMENT NOT NEEDED

One resident in the report told the facility’s psychiatrist there was a legitimate reason for their sadness: “All I really want is a companion. I am lonely.” In the case of another resident given the medication, a nurse said the resident’s crying was an expression of frustration, and that this had improved with a change in routine.

Two other residents at the facility were originally prescribed Nuedexta for “Dementia with Behaviors.”

Those diagnoses were then crossed out or rewritten — replaced with “PBA.”

THE DRUG PUSHERS

At first, Alex Carington couldn’t figure out why her 85-year-old mother, Lenore Greenfield, was on Nuedexta, a pill Carington had never heard of. A psychiatrist had prescribed the medication after visiting the elderly woman in her Los Angeles nursing home while she was sleeping, Carington said. Even when the drug appeared to do nothing to ease her mother’s sadness, confusion or emotional outbursts as she battled dementia, she said the doctor kept her on it.

 “Something about this whole thing made me think money was behind it,” Carington, who lived near her mother’s facility and visited her often, wrote at the time in an online comment on the blog of a psychiatrist who had questioned Nuedexta’s aggressive advertising.

As she began to look into her mother’s doctor, she discovered he had received more than $100,000 from Avanir in just over a year.

Outraged, she finally got her mother taken off Nuedexta for good. Now, around two years later, she is in a new nursing home and Carington believes she is doing much better.

Her mother’s doctor was Romeo Isidro, a speaker for Avanir and one of the physicians paid the most by the drugmaker. Between 2013 and 2016, Isidro received more than $500,000 in payments, travel and meals from Avanir and its parent company. According to internal company documents, he was an advocate for Nuedexta as early as 2012, the year after it hit the market.

ISIDRO HAD 100 PATIENTS AT 11 FACILITIES ON NUEDEXTRA

In Avanir training documents, a California salesperson explained how he worked to get Isidro to prescribe Nuedexta. Now a senior sales manager at the company, Chris Burch wrote in 2012 that he and his colleague saw or spoke to Isidro about twice a week — regularly calling and texting him, and visiting him at both his office and nursing homes. Burch wrote that Isidro was at first skeptical about the condition of PBA, but after he successfully used Nuedexta to treat possible symptoms of it in one patient, he became more comfortable prescribing the medication. Burch then explained how he had directly targeted facilities where Isidro worked, finding employees who could serve as “advocate(s)” to help identify potential Nuedexta candidates for Isidro.

SALES MANAGEMENT CAMPAIGN

“He is now a speaker and I ask him to advocate in his facilities, corporate facilities, and (to) other psychiatrists, internists and pharmacies,” Burch, who did not respond to requests for comment, wrote in a form used by the company to track certain prescribers.

Attempts to contact Dr. Isidro directly were by phone and at his office, where investigators saw two stacks of PBA and Nuedexta pamphlets sat on a table in the waiting room. He declined to be interviewed but ultimately provided a written statement saying that he had “never prescribed medication for financial incentives” and that he prescribes Nuedexta to patients who he has properly diagnosed with PBA.

He also wrote about the first success he had seen with the drug, and how it helped him wean an elderly patient off of dangerous psychotropic medications — noting that her inappropriate crying and screaming symptoms reminded him of a visit from a Nuedexta representative who had told him about PBA. He said Avanir approached him about becoming a speaker, and that he agreed in order to share his first-hand experience with the medication — not to promote it.

“Since learning about PBA, I have become more skilled at recognizing it in my patients, which would in turn produce increased numbers of patients on Nuedexta,” he wrote. “I am not an advocate for a particular drug or pharmaceutical companies. I am an advocate for my patients and their families.”

In response to questions about Carington’s mother, he said he couldn’t comment on specific patients but that memories are not “infallible.” He urged third parties to substantiate any claims with medical records about her case. Ms. Carington has provided her mother’s records to invesitigators, which confirmed that Isidro had diagnosed her with PBA and prescribed her Nuedexta, which she remained on for months.

A PHARMACIST PUSHING OFF-LABEL USE FOR FEES

A different speaker paid by Avanir, a pharmacist in northern California, appeared to suggest during a 2012 presentation that doctors could broaden the use of Nuedexta when prescribing, according to an audio recording obtained by CNN. A person in attendance, who recorded the event, identified the pharmacist as Flora Brahmbhatt.

“I’m definitely pushing this a little bit, perhaps considered off label … but maybe it’s effective on some of the other behaviors too that we find challenging,” the pharmacist said in her presentation, which was sponsored by Avanir. “There are certain nursing home chains, specifically in Southern California, that are saying, ‘Hey, if you have somebody with dementia that has a behavior issue, try them on Nuedexta before you put them on a psychotropic (medication.)’ It’s a little aggressive, I’ll say that. But CMS isn’t making it easy for us to use antipsychotics anymore.”

She went on to discuss how a PBA diagnosis was essential for the medication to be “covered by insurance and not be off-label,” as well as how PBA’s definition of inappropriate laughing and crying could be interpreted by physicians. At one point, she told an Avanir employee in the room that they could cover their ears.

Followed by “We don’t have anybody from the FDA in here. I’m telling you … you can extrapolate that to mean any kind of socially inappropriate behavior when you’ve ruled out other causes,” she said. “If they have an episodic behavior and they have an underlying neurological condition, you can pretty much come up with a diagnosis.”

When she was contacted about the event and asked about the recorded statements, Brahmbhatt said she hadn’t given presentations about Nuedexta for many years. She said she didn’t give permission to be recorded and didn’t recall making those statements. “I don’t know if I said this stuff,” she said. “It was five years ago, at best.” She was read several of the quotes from the recording but declined to listen to it. An attorney representing Brahmbhatt has said that Brahmbhatt denies making the statements in the audio recording. This is normal operating procedure for someone who’s discovered to be promoting off-label” use, they klawyer up and wait to see if there’s an invesitigation.

Former FDA investigator Larry Stevens, who now works for the consulting firm The FDA Group, said it is a violation of federal law for a paid speaker to promote a drug for anything other than its FDA-approved use.

Yet another paid speaker, the Ohio physician accused of accepting kickbacks in exchange for prescribing Nuedexta, has been under government investigation. Internal Avanir documents show Cleveland neurologist Deepak Raheja was a top prescriber of the drug from the beginning, in 2011. Between 2013 and 2016, he received $289,000 in payments, meals and travel.

In addition to allegedly accepting kickbacks, Raheja is accused of fraudulently diagnosing patients with PBA in order to secure Medicare coverage for off-label use and increasing dosages of Nuedexta beyond what is recommended, according to a letter obtained by CNN. The letter, circulated by the Centers for Medicare & Medicaid Services (CMS) in January, alerted insurance providers that work with Medicare about the fraud allegations so that they could take “appropriate measures.”

Medicare officials said the agency could not comment on pending or active investigations. When contacted by CNN, Raheja denied that he had received kickbacks or been involved in any kind of Medicare fraud in his 25 years of practice. Raheja also said he no longer prescribes Nuedexta.

This is another article in the ongoing Mass Tort News series of strategic “Off-Label” marketing by Big Pharma and other healthcare industry companies, putting profits over patients.

(Certain comments within this article are re-use of previously published media materials)

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On May 27, 2022 Fu made history, becoming the first black woman ever appointed plaintiffs’ Co-Lead Counsel in a multidistrict litigation. She was appointed to the role in the massive products liability MDL, In Re: Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation, against two of the world’s largest manufacturers of infant formula, Abbott Laboratories (NYSE: ABT) and Mead Johnson. Comprised of more than 60 state and federal lawsuits filed across the U.S., the case stems from allegations against the manufacturers of infant formulas Similac (Abbott) and Enfamil (Mead) by parents of premature infants who were fed with that formula and developed the deadly neonatal condition, necrotizing enterocolitis (NEC). 
 
Fu currently represents individuals exposed to Paraquat, an herbicide thought to cause Parkinson’s disease. She also represents victims of civil rights violations, defective products, and other wrongful conduct. Before joining DiCello Levitt, Fu represented dozens of cities and counties in Alabama, Georgia, and Mississippi against opioid manufacturers and distributors. She has also recovered more than $30 million in damages for victims of catastrophic personal injury, product liability, employment discrimination, and civil sexual assault claims. 
 
Earlier this year, in February 2022, Fu announced that she along with Ben Crump co-founded Shades of Mass, an organization aimed at combatting the lack of diverse attorney leadership in lawsuits that disproportionately impact communities of color. Through collaboration, shared resources, education and networking opportunities, and pressure on our profession, Shades of Mass aims to rectify this inequity and achieve the diversity missing in mass tort and complex litigation case leadership. Learn more about Shades of Mass, its mission, its board members, and its board members here: https://www.law.com/2022/02/28/new-gr.... The organization will be hosting a conference in October 2023 in Atlanta. Visit the Shades of Mass website: http://www.shadesofmass.org/, to learn more. 
 
She is well-known for her relentless and compassionate client advocacy which is only matched by her passion to make this world a better place for the generations to come. Fu has extensive experience handling complex litigation, including pharmaceutical, medical device, environmental contamination, and civil rights matters. And she has earned quite a few accolades for her work, including Top 40 Under 40 attorneys (National Trial Lawyers), Top 10 Under 40 attorney for the State of Alabama (National Academy of Personal Injury Attorneys, Inc.), The National Trial Lawyers: Top 100, one of America’s Top 100 High Stakes Litigators®, and selected as a Top Woman Attorney (B-Metro magazine). 
 
Read more about Fu here: https://dicellolevitt.com/attorney/di.... 


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Fu Zimmermann Sound Bite Building a Legacy Through Leadership
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Richard “Rick” Meadow is the National Mass Tort Leader as well as the Director of Business Development for The Lanier Law Firm. His responsibilities include overseeing all the firm’s pharmaceutical mass tort litigation in addition to promoting, recruiting, and maintaining associated outside relationships at a national level. Rick has represented the rights of individuals who have been injured by pharmaceuticals, medical devices, asbestos, medical malpractice, defective products, construction defects, lead poisoning, and motor vehicles, as well as the negligence of premises owners and municipalities for over 30 years. He further has extensive experience in the representation of large national insurance companies as an insurance defense attorney. This experience provides a 360-degree perspective of the practice of tort law in the United States. 
Rick has developed an extensive practice in mass tort and aggregate litigation. He has been nominated and selected to a variety of leadership positions by both his peers and courts across the country. He has served in leadership positions in many cases that have resulted in nationwide settlements. 
Rick has been working with Mark Lanier for over 30 years and is an integral part of the Lanier Trial Academy Master Class. This year’s Lanier Trial Academy 6.0; https://laniertrialacademy.com/home, will take place on June 20-23, 2022 in Houston Texas. The program includes a third day and more content, including non-verbal cues, voir dire, examinations, and openings and closings. Check out the agenda here, and if you haven’t already, register here: https://myportal.force.com/LanierTrialAcademy/s/lt-event?id=a1U3m00000Ov12TEAR&site=a0d1N000006V1VMQA0#/loginReg!  
 
Read more about Rick here: https://www.lanierlawfirm.com/attorneys/richard-d-meadow/. 
 
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Rick Meadow, Everybody Knows Your Name
YouTube Video VVVuSC1KSll3UzVNWHQwMEgyUndoR3Z3LkE1SWV2anhKY0lj
Diandra “Fu” Debrosse Zimmermann is managing partner of DiCello Levitt’s Birmingham office, co-managing partner of the Washington, D.C. office, and co-chair of the firm’s Mass Tort division. Fu is also a member of the firm’s Public Client, Environmental, Personal Injury, Civil Rights, and Trial practice groups.
 
Widely known for her passionate and relentless client advocacy, she represents individuals and public entities that have been injured by wrongful conduct, whether from defective medical devices or drugs, environmental contamination, corporate misconduct, or civil rights abuse. She is nationally recognized as a powerhouse in mass torts, class actions, products liability, discrimination, and sexual assault claims, and has recovered hundreds of millions of dollars in client damages. 
 
On May 27, 2022 Fu made history, becoming the first black woman ever appointed plaintiffs’ Co-Lead Counsel in a multidistrict litigation. She was appointed to the role in the massive products liability MDL, In Re: Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation, against two of the world’s largest manufacturers of infant formula, Abbott Laboratories (NYSE: ABT) and Mead Johnson. Comprised of more than 60 state and federal lawsuits filed across the U.S., the case stems from allegations against the manufacturers of infant formulas Similac (Abbott) and Enfamil (Mead) by parents of premature infants who were fed with that formula and developed the deadly neonatal condition, necrotizing enterocolitis (NEC). 
 
Fu currently represents individuals exposed to Paraquat, an herbicide thought to cause Parkinson’s disease. She also represents victims of civil rights violations, defective products, and other wrongful conduct. Before joining DiCello Levitt, Fu represented dozens of cities and counties in Alabama, Georgia, and Mississippi against opioid manufacturers and distributors. She has also recovered more than $30 million in damages for victims of catastrophic personal injury, product liability, employment discrimination, and civil sexual assault claims. 
 
Earlier this year, in February 2022, Fu announced that she along with Ben Crump co-founded Shades of Mass, an organization aimed at combatting the lack of diverse attorney leadership in lawsuits that disproportionately impact communities of color. Through collaboration, shared resources, education and networking opportunities, and pressure on our profession, Shades of Mass aims to rectify this inequity and achieve the diversity missing in mass tort and complex litigation case leadership. Learn more about Shades of Mass, its mission, its board members, and its board members here: https://www.law.com/2022/02/28/new-group-to-promote-attorneys-of-color-in-mass-torts/. The organization will be hosting a conference in October 2023 in Atlanta. Visit the Shades of Mass website: http://www.shadesofmass.org/, to learn more. 
 
She is well-known for her relentless and compassionate client advocacy which is only matched by her passion to make this world a better place for the generations to come. Fu has extensive experience handling complex litigation, including pharmaceutical, medical device, environmental contamination, and civil rights matters. And she has earned quite a few accolades for her work, including Top 40 Under 40 attorneys (National Trial Lawyers), Top 10 Under 40 attorney for the State of Alabama (National Academy of Personal Injury Attorneys, Inc.), The National Trial Lawyers: Top 100, one of America’s Top 100 High Stakes Litigators®, and selected as a Top Woman Attorney (B-Metro magazine). 
 
Read more about Fu here: https://dicellolevitt.com/attorney/diandra-fu-debrosse-zimmermann/. 


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Building a Legacy Through Leadership
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John Uustal and the Kelly Uustal Law Firm are a complex personal injury firm based in Fort Lauderdale FL, who are actively involved in traumatic and catastrophic injury litigation and Mass Torts as local trial counsel for certain MDL leadership firms. Also, KU is one of the premier tobacco litigation firms in the country, securing hundreds of millions of dollars in verdicts against Big Tobacco. Never afraid to face corporate bad conduct, John Uustal and the Kelly Uustal firm will take the fight directly to the corporate boardrooms.

Check out John Uustal's blog to stay up-to-date on corporate treachery: https://www.johnuustal.com/
888.522.6601
https://www.kulaw.com

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Calling Out Boardroom Misconduct in the Courts and Court of Public Opinion
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Today we're joined by Majed Nachawati, founder of the Fears Nachawati firm. Majed is well known as a prominent complex commercial litigator in the mass tort space and a leadership firm in emerging torts. Majed's firm is known for representing both individuals and governmental entities in dockets such as the opioid litigation, PFAS water contamination, and other major mass torts. Today we will be discussing three of the most relevant and prominent dockets in the legal world that impact both the plaintiff and defense bar. 

We engage in direct discussions on the Bayer/ Monsanto US Supreme Court appeal in the Hardeman Roundup verdict, originating in California State Court. Recently the US Solicitor General submitted a brief to the Supreme Court advising that the US Department of Justice and other federal agencies are not in favor of participating in the Monsanto- Hardeman appeal.

We then go into the Johnson & Johnson Talcum Powder MDL and related state court litigation where J&J is using the Texas Two-Step legal process to file bankruptcy, related to their talcum powder liabilities, which are expected to exceed $12 billion. Majed is also a member of the J&J bankruptcy creditor's committee.   

Majed also discusses his lead role in the Texas winter freeze litigation, where the Texas Utility Power Commission and the power grid tragically failed the citizens of Texas and numerous lives were lost, properties were destroyed and damaged. Fears Nachawati was in a leadership role from the outset of the Texas winter freeze litigation, when they filed the first lawsuit within one week of the freeze taking place. The claims in this docket relate to the catastrophic failure of the utility and regulatory entity within the state of Texas to properly ensure the safety of its citizens. Majed clearly states that it is his position in the Texas winter freeze, Monsanto roundup, and the Johnson and Johnson talcum powder litigation to be an assertive representative of firm clients in these dockets to hold the corporate parties accountable for the ongoing and embedded bad conduct, which is clearly evident in the media and now being shown in a court of law.

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Fighting Bad Conduct in America's Boardrooms
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John K. Rabiej served as the Deputy Director of the Bolch Judicial Institute for one year, and as the Director of the Duke Law Center for Judicial Studies for seven years. The Duke Law Center brings together judges, lawyers, researchers, government officials and other parties to advance the study and understanding of the judicial process and generate ideas for how it might be improved. During his time as the Director of the Duke Law Center, Mr. Rabiej studied the impact of technology on the judiciary, including analyzing his concerns that the courts are not keeping pace with the rapid advancement of technology in the culture at large. Prior to joining the Duke Law Center, Mr. Rabiej served as the Executive Director and Director of Judicial Outreach for The Sedona Conference; the Chief of the Rules Committee Support Office; and the American Law Institute. He presently sits on the Chief Justice’s Rules Advisory Commission, North Carolina (term ending December 31, 2023). In this episode of LegalCast, Mr. Rabiej discusses a legal bipartisan review of mass torts, class action, and the ever-expanding e-discovery quagmire that seems to be firmly embedded in complex litigation coming to a peak in 2022.  Will the plaintiffs and defense leadership be able to collaborate to reign in the ever-expanding high cost of litigation? Mr. Rabiej has made a career of working to bring opposing groups together to discuss common interests as a means to increase efficiencies in litigations. And, with millions of dollars at stake, why not at least start the discussions.

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Is Judicial Review On The Horizon?
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Stephen P New. of Beckley West Virginia is one of the country’s leading opioid litigators, by bringing the fight directly to Opioid Big Pharma's doorstep. Steve and the Opioid Justice Team have been defending and advocating for the rights of the neonatal abstinence syndrome afflicted infants, aka the "NAS Babies." Who are the truly innocent victims of the now decades-old opiate crisis in America.

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Leading the Fight for Opioid Addicted Infants
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George Haj is a Pulitzer-Prize winning editor who founded Haj Media in 2017. Haj Media is a strategic communications firm focusing on crisis communications, media relations, and litigation support for law firms and corporate clients. Prior to launching his own consulting firm, George spent three decades working in some of the nation’s largest news organizations. He has deep roots in the media industry and connections with reporters and editors in a range of publications across the country. George worked as executive business editor at the Miami Herald and then was a top editor at the Houston Chronicle. He also served as editorial director of ALM Media, where he directed a global newsroom of more than 100 journalists and oversaw iconic brands including The American Lawyer and National Law Journal. He can be reached at george@hajmedia.com. Find him on Twitter: https://twitter.com/georgehaj, LinkedIn: https://www.linkedin.com/in/george-haj-25ba481, and at http://www.hajmedia.com/. 

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Crisis Management & Media Training for Lawyers
YouTube Video VVVuSC1KSll3UzVNWHQwMEgyUndoR3Z3LmhvVDk2Q2MxUnpR
With four decades of experience in legal advertising with a passion for legal marketing, intake, and conversion, Harlan Schillinger has more than earned his title as the Grandfather of Legal Advertising. 

Harlan was the first in the industry to produce and market TV advertising for the legal community. In 1975, along with his partners, Harlan founded the first syndication TV production firm for high-end retailers and Lawyers, creating television commercials that aired throughout North America.

Since the late 1970s, Harlan has worked aggressively, productively, and professionally within the legal advertising space. He has said that: “Creating opportunities and increasing market share for advertising law firms is [his] #1 priority. The value of the case is everything in such a crowded market.” Harlan privately consults with lawyers who not only share his values, but who also share his vision of increasing business, being accountable, and obtaining high-value cases. His approach to intake and conversion rests on complete accountability within that area and he is known to practice what he preaches. Harlan has trademarked within the legal advertising world the two phrases that have become his backbone of philosophy: What You Don't Know, You Don't Know® and Ambassador of First Impressions™.

Since that time, Harlan has worked with more than 130 law firms in almost 100 markets throughout North America. Before joining Network Affiliates in 1985, Harlan was a founding partner and VP of Madison, Muyskens & Jones, a Connecticut-based advertising agency. In April 2016 Harlan retired from Colorado-based Network Affiliates, the nation's first and largest full-service legal advertising agency, where he was the leader of their attorney marketing efforts for over 34 years.

A few years ago, Harlan and two of his partners – Dino Colombo Esq. and Eric Coffman – developed Lead Docket, software for intake and conversion within law firms. Harlan says that Lead Docket helps law firms increase control and management of intake and conversion, allowing the firms to thrive.

Harlan is involved with a number of professional organizations, being a member of the National Trial Lawyers Executive Summit Committee as well as a Senior Editor and Writer for the National Trial Lawyers Magazine. He also has a passion for riding and building custom motorcycles, and is a proud member of the most prestigious motorcycle group in the world: Hamsters USA ® Motorcycle Group.

Learn more about Harlan at http://www.harlanschillinger.com/. 
And to check out the book he recommends – How to Win Friends & Influence People by Dale Carnegie and originally published in 1936 click here: https://www.amazon.com/How-Win-Friends-Influence-People/dp/0671027034. 

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Prep Like a Pro: Legal Networking Tips & Tricks
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