Insys Therapeutics, Inc. Founder and Billionaire John Kapoor, Indicted For Bribing Doctors to Prescribe Fentanyl

Is this the start of indictments against senior executives at Big Pharma opioid manufacturers”

By Mark A. York (October 27, 2017)

(Mass Tort Nexus)

The founder of Insys Therapeutics, Inc., Johnathon N. Kapoor was arrested Thursday October 26, 2017 and charged with leading a massive conspiracy across the United States to pay bribes and use fraudulent sales methods in the illegal distribution of Subsys, a fentanyl spray intended for cancer patients. The Insys boardroom orchestrated an “off label” marketing campaign of “Subsys” which is a fast-acting sublingual fentanyl product, resulting in indictments against all members of the pre-2017 Insys executive board, as well as mid level managers and sales representatives across the country.

 

 

 

 

 

 

 

 

Dr. John N. Kapoor, 74, of Phoenix, Arizona, the former Chairman-CEO of Insys and still a member of its board, was indicted on federal charges of racketeering, conspiracy to commit fraud and conspiracy to violate the Anti-Kickback law. The racketeering and fraud charges carry prison sentences of up to 20 years, while the kickback charge can bring up to five years as well as millions of dollars in fines and asset forfeitures

Prosecutors allege the company paid hundreds of thousands of dollars to doctors in exchange for prescribing a sublingual spray called Subsys that contained the powerful and synthetic opioid fentanyl which is highly addictive. Three top prescribers have already been convicted of taking bribes from Insys, along with several sales and marketing representatives having entered plea deals in federal courts across the country.

In various media reports, former sales rep Patty Nixon, turned whistleblower, explained how the company lured doctors into prescribing the drug for patients who didn’t need it, known as “off-label” marketing. She stated “It was absolutely genius, it was wrong, but it was genius.”

“What I did, I was instructed to do, I was trained to do,” Nixon, who was fired by Insys after becoming adverse to the company sales activity, “she felt guilty about lying on the job” and decided to not return to work. “It was wrong, but it was genius.”

In a statement related to the Kapoor indictment, Nixon said, “I wasn’t sure this day would ever come. It is a great day for justice. A great day for the victims. Dr. Kapoor is an evil man. I give a lot of credit to all the prosecutors and all the people who worked on bringing him to justice. It’s what needs to be done.”

She said that if requested to testify against Kapoor, “I absolutely will.”

 

 

 

 

 

 

 

 

Subsys is 100 times stronger than morphine, and was approved by the FDA to treat patients with cancer who had “breakthrough” pain, that is pain which other narcotics are not addressing. This was soon seen as not the way Insys Therapeutics wanted to market Subsys and they developed a very direct and highly profitable marketing campaign that placed “profits over patients” and contributed to the current opioid crisis across the USA.  They Insys executive suite quickly ramped up a sales and marketing campaign that reached from Alabama to Alaska, two states where the Subsys sales skyrocketed, all based on the company sales efforts

The role of the sales staff was to make sure Subsys got into the hands of as many patients as possible, whether they had cancer or not, and this included using illegal and unethical methods of getting doctors to write massive numbers of Subsys prescriptions for questionable pain complaints.

Related: By Mass Tort Nexus- “THE OPIOID CRISIS IN AMERICA” – How Insys Theraputics, Inc. Sold Stock And Killed Americans At The Same Time With The Help Of Doctors

THE REIMBURSEMENT UNIT FRAUD

“My job responsibilities were to contact insurance companies on behalf of the patients and the doctors to get the medication approved and paid for by their insurance company,” along with several others.

Subsys is not cheap prescription, a 30-day supply costs anywhere from $3,000 to $30,000 and the fraudulent scheme depended upon insurance approval.That was Nixon’s job, along with the other employees in the Reimbursement Unit, who were tasked with the role of misleading insurers into believing the drug was “medically necessary.”

“I would say, ‘Hi, this is Patty. I’m calling from Dr. Smith’s office. I’m calling to request prior authorization for a medication called Subsys,” taken form the Unit’s management created insurance approval script.

The Unit staff would often pretend they were calling from the office of a cancer doctor to increase the chances of approval, as well as using specific diagnosis codes, likely to be approved, whether the patient had the condition or not.

The Reimbursement Unit role at Insys, was making sure that patients got approval for Subsys, which includes fentanyl, from insurance companies. “The unit job responsibilities were to contact insurance companies on behalf of the patients and the doctors to get the medication approved and paid for by their insurance company,” said Patty Nixon.

“We told complete bold-faced lies” as part of the part of the ongoing fraudulent Insys business model.

CHRONIC PAIN LEADS TO DEATH

One of the patient who was prescribed Subsys was Sarah Fuller, who was prescribed the drug even though she didn’t have cancer. In her case, it was chronic neck and back pain from two car accidents. And when her doctor prescribed Subsys, an Insys sales rep was sitting in the room with them.  Within a month, Fuller’s prescription was tripled. And 14 months after she started using the drug, she was found dead on a bedroom floor.

What killed her? “Well, technically fentanyl,” Fuller’s mother said. “But a drug company who couldn’t care less about a human life. And, apparently, a doctor who didn’t either.” Sarah’s Cherry Hill, New Jersey physician, Dr. Vivienne Matalon, had her medical license suspended over the “off-label” prescribing that resulted in the death of Sarah Fuller, but denies responsibility for her death.

Sadly, Fuller is not alone, FDA reports of adverse events and possible related complications include hundreds of deaths.

Attorney Richard Hollawell who represents the Fuller’s family, is suing everyone involved in marketing and prescribing Subsys to Sarah, and said, “This is serious stuff that we’re dealing with … People need to finally be held accountable.”

Insys has denied any responsibility and insists it shouldn’t be blamed for how doctors prescribe their products. The corporation is not currently facing criminal charges and is still selling Subsys — some $240 million worth of Subsys just last year. But the company is under investigation by various states across the country regarding how the “off-label” marketing campaign came to be the company business model..

KAPOOR ADDED TO PRIOR INSYS INDICTMENTS

Dr. Kapoor will appear in federal court in Phoenix Thursday, and will have to appear in federal court in Boston, where the indictments originated, at a later date. The indictment, unsealed today in Boston, also includes additional allegations against several former Insys executives and managers who were initially indicted in December 2016.

“In the midst of a nationwide opioid epidemic that has reached crisis proportions, Mr. Kapoor and his company stand accused of bribing doctors to overprescribe a potent opioid and committing fraud on insurance companies solely for profit,” said Acting United States Attorney William D. Weinreb of Massachusetts. “Today’s arrest and charges reflect our ongoing efforts to attack the opioid crisis from all angles. We must hold the industry and its leadership accountable.”

Subsys, a fentanyl sublingual spray from Insys Therapeutics

“As alleged, these executives created a corporate culture at Insys that utilized deception and bribery as an acceptable business practice, deceiving patients, and conspiring with doctors and insurers,” said Harold H. Shaw, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division. “The allegations of selling a highly addictive opioid cancer pain drug to patients who did not have cancer, make them no better than street-level drug dealers.”

Brian Kelly, a lawyer for Kapoor, said, “My client is innocent and he intends to fight these charges vigorously.”

In response to an early 2017 investigation, Insys stated that charges against individuals discussed in the media related to “previously disclosed investigations and litigation and  Insys continues to cooperate with all relevant authorities in its ongoing investigations, including our federal investigation which began in and around December 2013.”

“We are committed to complying with laws and regulations that govern the promotion of our products and all other business practices. We continue to emphasize ethical behavior within our organization and pursue opportunities to illustrate that our company’s mission is to put patients first.”

The October 26, 2017 indictments were the first naming John Kapoor, but also include enhanced charges against the entire executive board of Insys Therapeutics, Inc. who were already facing long prison sentences and financial penalties in one of the most far reaching and aggressive US Department of Justice investigations into the root cause of the “Opioid Crisis” that is gripping all areas of the United States.

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$417 Million J&J Talcum Powder Cancer Verdict Overturned in Los Angeles Court

JOHNSON & JOHNSON SCORES A POST-TRIAL DEFENSE RULING IN CALIFORNIA STATE COURT

 

 

 

 

 

 

 

 

Last week a California state court set aside a $417 million verdict awarded in August 2017, against Johnson & Johnson in a lawsuit by a woman that claimed J&J’s talc-based product, Johnson’s Baby Powder caused her ovarian cancer after years of feminine hygiene use.

Los Angeles Superior Court Judge Maren Nelson entered a ruling  that’s a further setback facing women and family members who accuse J&J of not warning consumers about the cancer risks of its talc-based products. There are now thousands of lawsuits filed against J&J over the claims that use of talc products leads to ovarian cancer, the cases are files in both state and federal venues across the country including the federal Multidistrict Litigation in J&J Talcum Powder MDL 2738 (USDC New Jersey) as well as thousands of Missouri State court cases, (see J&J Talc Cases in Missouri State Court), where plaintiffs have successfully obtained large verdicts against J&J over the last two years. A single talc verdict won in Missouri state court, was recently overturned based on the June 2017 US Supreme Court Plavix ruling, which defined a plaintiff’s residence as the jurisdictional guide to where state court cases can be filed.

There is another J&J talc related trial currently underway in front of  Judge Edward Simpson, in the same LA County Court, where there plaintiff has alleged use of J&J’s talcum powder products caused her to contract Mesothelioma. This trial started October 19th after plaintiff Tina Herford’s first trial was declared a mistrial on October 6, 2017, when Ms. Herford made a statement on the witness stand related to “talc use and ovarian cancer” causing Judge Simpson to declare a mistrial and quickly move to get the new trial started within 10 days. The J&J California state court trials and others soon to follow across the country, will keep J&J defense counsel busy for the foreseeable future, as more and more of J&J’s behind the scenes manipulation of R&D, paid research papers and suppression of adverse scientific publications is now coming to light, with all this conduct being introduced as evidence in the trials.

Judge Nelson’s ruling followed the jury’s decision in August to hit J&J with the largest verdict to date in Talc litigation, awarding California resident Eva Echeverria $70 million in compensatory damages and $347 million in punitive damages. This trial was fast-tracked due to Ms. Echeverria’s onset of stage 4 cancer and fears that she would not survive the wait for a trial set past August 2017.

Nelson reversed the jury verdict and granted J&J’s request for a new trial, ruling the August trial was underpinned by errors and insufficient evidence on both sides, culminating in excessive damages. The judge added that there also had been misconduct of the jury during the trial.

Mark Robinson, who represented the woman in her lawsuit, said he would file an appeal immediately, “We will continue to fight on behalf of all women who have been impacted by this dangerous product,” he stated.

J&J in a statement said it was pleased with the verdict, adding that it will continue to defend itself in additional trials.  J&J said declarations by two jurors after the trial showed that three members of the 12-person jury who voted against finding the company liable were improperly excluded from determining damages.

J&J also stated that  it faces lawsuits by 4,800 plaintiffs nationally asserting talc-related claims. Many of those cases are in California, where Echeverria’s case was the first to go to trial, and in the previously referenced Missouri court, where J&J has faced five trials, with very limited success.

The Missouri litigation led to four plaintiff verdicts against J&J in which juries issued verdicts totaling $307 million, with J&J only winning a defense verdict in a single trial.

But the Missouri cases do have a legal hurdle to address, the cases have largely been brought by out-of-state plaintiffs, hand now face jurisdictional questions after the US Supreme Court issued the June 19, 2017 Plavix ruling that limited where personal injury lawsuits could be filed, see U.S. Supreme Court Strikes Down California Ruling in Bristol-Myers’ Plavix Jurisdictional Case.

On October 17, 2017 , a Missouri appellate court threw out a US$72 million verdict by a jury in February 2016 to the family of a deceased Alabama woman after ruling the case should not have been tried in St. Louis, see Missouri Appeals Court Throws Out $72 Million Johnson & Johnson Talcum Powder Cancer Verdict.

Mass Tort Nexus will publish additional case updates and additional information regarding all Johnson & Johnson Talcum Powder related litigation across the country as they develop.

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Nuedexta: The Drug Being Pushed “Off-Label” On The Elderly In Nursing Homes

“PROFITS OVER PATIENTS IN THE HEALTHCARE INDUSTRY CONTINUES“

By Mark A. York (October 19, 2017)

Mass Tort Nexus

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.

 

 

 

 

 

 

 

The pill, 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 MS or ALS. 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 Nuedexta without 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.

 

 

 

 

 

 

Alex Carington’s mother, now 88, is no longer on Nuedexta and lives at a new nursing home. But Carington still questions why she was prescribed the pill in the first place.

“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 Nexus series of strategic “Off-Label” marketing by Big Pharma and other healthcare industry companies, putting profits over patients.

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Missouri Appeals Court Throws Out $72 Million Johnson & Johnson Talcum Powder Cancer Verdict

Missouri Appeals Court Throws Out $72 Million Johnson & Johnson Talcum Powder Cancer Verdict

By Mark A. York (October 17, 2017)

Mass Tort Nexus

 

 

 

 

 

 

 

 

Photo of Jacqueline Fox and her son, Marvin Salter.

   Earlier today, the Missouri Eastern District Court of Appeals threw out a $72 million state court jury verdict awarded to a woman who claimed her longtime use of Johnson & Johnson baby powder and other J&J products contributed to ovarian cancer that killed her.

The appeals court unanimously ruled that Jacqueline Fox’s lawsuit lacked jurisdiction in Missouri because of the June 2017 US Supreme Court decision, (see U.S. Supreme Court Strikes Down California Ruling in Bristol-Myers Plavix Case) that clarified where injury lawsuits can be filed based on the state where a plaintiff is a resident. The Bristol-Myers Squibb case said non-California residents could not file claims there against the New York-based maker of the blood thinner Plavix, in a ruling that established a lawsuit’s jurisdiction requiring a much clearer connection between the forum state, a corporation and a plaintiff’s claims.

Appellate Judge Lisa Van Amburg wrote “Specifically, Fox seeks to establish that J&J directed the production, packaging and distribution of its products through a Missouri company, Pharma Tech,”. and “J&J counters that Fox is precluded from supplementing the record at this stage and urges this court to dismiss the case outright with prejudice.”

Ms. Fox, 62, of Birmingham, AL, died in 2015, just four months before her trial was held in St. Louis Circuit Court. She was among 65 plaintiffs, of which only two were from Missouri, who joined in the lawsuit. A jury in February 2016 awarded her $10 million in actual damages and $62 million in punitive damages.

It was the first verdict in the country where a jury awarded damages over claims that talc contributed to cancer. Fox said in her pleadings that she used Johnson & Johnson products containing talcum powder for more than 25 years. The trial lasted more than three weeks and was the first of four multimillion dollar verdicts against Johnson & Johnson, which now total in excess of $300 million. However, the Supreme Court BMSQ Plavix ruling will have an impact on other Talc cases not only in St. Louis but across the country as well.

The plaintiffs who’ve also gone to trial here were from elsewhere — Alabama, California, South Dakota, Tennessee, and Virginia. All but one prevailed; and Johnson & Johnson has appealed all of the verdicts against the company.

Fox’s lead counsel James Onder, who represents plaintiffs in other pending talcum powder cases, said Tuesday he was disappointed by the decision but “optimistic that the Missouri Supreme Court will find otherwise.”

Onder noted that the U.S. Supreme Court sent the BMSQ Plavix case back to California state courts; he said he hopes the Missouri Supreme Court will review Fox’s case and do the same, and also look at rules allowing plaintiffs to join together to file claims in Missouri.

“I suspect this will all be decided by the Missouri Supreme Court,” Onder said.

The Bristol Myers ruling has delayed the sixth talcum powder trial that originally was set for June and was rescheduled for this week but was postponed again. It involves the first in-state plaintiff — Michael Blaes of Webster Groves — whose wife, Shawn M. Blaes, died of ovarian cancer at age 50. She was a competitive figure skater, coach and co-owner of a skate shop in Webster Groves.

Johnson & Johnson, a health care giant based in New Brunswick, N.J., had appealed the Fox verdict and has maintained that its products are safe. And stated that their talcum powder is made from talc, a mineral that has not been linked to causing cancer.

In the appeals court ruling the court vacated Fox’s complete lawsuit instead of sending it back to the circuit court, finding the court has no authority “rewind the case so as to supplement the pre-trial record to establish jurisdiction under the new standard.”

In a separate, concurring opinion, Appellate Judge Kurt Odenwald said that if Fox had anticipated introducing additional evidence establishing jurisdiction, by showing co-defendant Pharma Tech’s Missouri-based distributor of J&J products, were linked, then “she had full and ample opportunity to engage in discovery and present evidence to the trial court. She did not.”

 

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Jury Finds AbbVie Misrepresented Risks of AndroGel and Awards $140 Million in Second Low-T Bellwether Trial

“AbbVie, Inc. Misrepresented Risks of AndroGel and Jury Awards $140 Million in 2nd AndroGel Low-T Trial”

By Mark A. York (October 17, 2017

Mass Tort Nexus

 

 

 

 

 

 

 

 

 

 

 

AbbVie loses again, a jury in Chicago ordered AbbVie, Inc. to pay more than $140 million on October 5, 2017 to a man who claimed the company misrepresented the risks of its testosterone replacement drug AndroGel prescribed for Low-T, causing him to suffer a heart attack. This is the second major loss for AbbVie in the AndroGel related MDL 2545, (Testosterone Replacement Therapy MDL 2545 Briefcase) in front of Judge Matthew Kennelly, US District Court ND Illinois, this verdict follows the July 24, 2017 verdict of $150 million in the first trial.

The verdict, handed down in federal court in Chicago, came in a lawsuit filed by Tennessee resident Jeffrey Konrad and his wife, the suit was filed in 2015. It is the second verdict against AbbVie to come out of more than 6,000 additional lawsuits against AbbVie and other companies consolidated in the Chicago court in front of Judge Kennelly. Kennelly is a long-term judge, who’s not prone to judicial errors or permitting either side in cases to stray outside the fairly conservative courtroom standards Kennelly is known for, which also relates directly to any AbbVie appeals and post-trial maneuvering.

Chicago-based AbbVie said in a statement “We are disappointed with today’s verdict and we intend to appeal,” With thousands more cases pending, AbbVie may need to look at changing legal strategy or to begin thinking settlement. The juries have stated that the company misled consumers via fraudulent misrepresentation in the “off-label” marketing campaign, which included urging men to their testosterone levels checked.

This verdict was comprised of $140 million in punitive damages, intended to deter the defendant and others from engaging in similar behavior, and $140,000 in compensatory damages, sending a message to not only AbbVie, but other Big Pharma drug makers, that consumers are now becoming aware of manipulation of prescription drug use behind the scenes via marketing campaigns including massive television advertisements.

SECOND BELLWETHER LOSS FOR ABBVIE

Konrad’s case is part of a series of bellwether trials aimed at helping plaintiffs and manufacturers of AndroGel gauge the range of damages and define a legal strategy and settlement options., losing both of the initial bellwether trials doesn’t look good for the defense, see “ANDROGEL” JURY RETURNS $150 MILLION VERDICT IN 1st TESTOSTERONE TRIAL.  That jury’s decision to award punitive damages without granting compensatory damages was unusual and both sides continue to fight over the verdict’s validity in court, but shows that the plaintiffs seem to have viable claims at trial.

Plaintiffs across the country allege AndroGel has caused heart attacks, strokes and other injuries, and the company was aware of the increase in adverse events while marketing “off-label” use. AbbVie has defended the drug and responded that its marketing of AndroGel adhered strictly to uses approved by the Food and Drug Administration and they have remained in full compliance with all FDA standards.

Konrad, 56, had been using AndroGel for two months in 2010 when he suffered a heart attack, from which he has since recovered. In court pleadings, the company contended that Konrad’s heart attack was caused by other factors, which are are not related to being prescribed AndroGel, such as obesity and high blood pressure. It also said it made no misrepresentations about AndroGel’s safety, which now two juries have disagreed with to the tune of $290 million.

ANDROGEL WAS A BLOCKBUSTER FROM FIRST RELEASE

AbbVie’s AndroGel is one of the more dominant testosterone treatments In the ever growing Low-T market, with sales of $675 million in 2016, and was declared a blockbuster drug and moved earnings and shares higher as soon as AndroGel hit the market. However, there were concerns about the drug safety as far back as 2012 and the FDA took notice not long thereafter. In 2014, the FDA convened an advisory committee to consider the adverse cardiovascular outcomes associated with testosterone replacement therapy, and the committee recommended changing the product warning labels, the FDA then required AbbVie to add a warning about cardiovascular risk to AndroGel’s label in May 2015.

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The Definitive Guide to Opioid Litigation

The Definitive Guide to the “Opioid Litigation”

If you believe your firm is not big enough to be involved in the “Opioid Litigation”, you are wrong. If you believe it is too late to get involved in the “Opioid Litigation”, you are so very wrong. The opioid lawsuits, filed mostly by government entities thus far, represent the tip of an extremely large iceberg. A vast number of entities both public and private, with potentially viable claims against opioid defendants, remain unrepresented. Recent actions by the FDA, the Surgeon General, and the DEA support potential product liability claims on behalf of individuals harmed by opioids. These mass litigations on behalf of individuals are in the inception phase. The total number of clients with claims in the “Opioid Litigation” could rival the Tobacco Litigation.

Mass Tort Nexus announces the upcoming release of “Volume 1 of the Definitive Guide to Opioid Litigation.”  A very limited number of  “pre-release”  copies will be provided to attendees of the October 18-20, Mass Torts Made Perfect Conference in Las Vegas.

To receive one of the limited “pre-release” copies at MTMP, contact Jenny Levine jenny@masstortnexus.com or (954) 520-4494.

Over the past two years, the research and technical divisions of Mass Tort Nexus have worked in conjunction with educational institutions, government entities and private organizations, to establish a comprehensive archive of documents, data and knowledge relevant to “The Opioid Litigation”.  Thus far, we have used our archive of documents as well as our databases to educate government entities, as well as private organizations that may have claims against the manufacturers, distributors and other co-conspirators that took part in causing the “Opioid Epidemic.”

Mass Tort Nexus also uses our document archive, data and our knowledge base to assist select law firms in identifying entities, both public and private, that have incurred the most significant financial damages related to opioids. After an entity client has been retained, Mass Tort Nexus then assists with establishing the direct connection between the actions of specific opioid defendants and the damages caused by those actions specific to given state, city, county or other entity.

Using “Big Data”  in the Opioid Litigation

Between 2013 and 2015,  68,177 doctors accepted a total of $46 million dollars in payments from opioid manufacturers. Using our collection of databases, Mass Tort Nexus can identify doctors in specific cities, counties and states that accepted payments from opioid Manufacturers. Mass Tort Nexus can then cross reference that data with the specific doctor’s opioid prescribing habits, as compared to the benchmark for their specialty.

Opioids “The Trillion Dollar Epidemic”

The damages caused by the Opioid defendants to government entities, as well as private business and individuals is in excess of 1 trillion dollars by our estimates. Although we have no expectation that the defendants will pay for all of the damage they have caused, Mass Tort Nexus intends to do its part to make sure the opioid defendants do not get off easy.

Only a Fraction of Government Entities Have Filed Claims

Of the 45,789 State, City, County, Territory and reservation governments that potentially have claims against opioid manufacturers, less than one percent have filed claims to date. Of course, not all government entities were damaged equally, some cities or counties may have suffered very little financial damage. Understanding how to identify and account for damages caused by opioids to a given city or other government entity is vital for the potential entity client, as well as the lawyers that represent them.

Mass Tort Nexus Definitive Guide to the Opioid Litigation First 6 Volumes

 

Volume 1

Volume 1:  The Definitive Guide to Opioid Litigation provides the history of the defendants bad acts, statistics related to which government entities (Cities, States and Counties) suffered the most significant financial damage directly related to the opioid defendants actions. Volume 1 also critiques entity complaints to date, as well as defense strategies employed related to those complaints. (Limited Pre-Release at October MTMP)

 

Volume 2

Volume 2: The Definitive Guide to Opioid Litigation provides guidance for identifying entity clients, both government and provide sector, with significant damages  related to the actions of the opioid clients. This volume also delves into how law firms undertake retaining these entity clients.

 

Volume 3

Volume 3: The Definitive Guide to Opioid Litigation takes the massive amount of statistical data, documents and other information most important to clients and their attorneys and summarizes the information for ease of use. Mass Tort Nexus has collected well over one million pages of documents and billions of data points related to the opioid litigation for our internal use, in our efforts to assist entity clients and law firms we work with directly. Although it would be impossible to provide all of these documents and data in a single resource, we hope that volume three of the guide provides a road map for those who wish to undertake the monumental task of collecting the data and documents needed to be in the best position possible, to represent any client they retain.

Volume 4

Volume 4: The Definitive Guide to the Opioid Litigation records the criminal convictions of opioid manufacturers, employees and executives that have occurred to date and makes some predictions of what may occur in the near future. Hint, unlike the three Purdue Pharma Executives that paid a $65 million dollar fine and agreed to probation to resolve criminal charges, future charges against opioid executives are likely to result in their receiving an all orange wardrobe.

On the record, admissions stemming from the criminal cases already prosecuted in addition to those to come will be very useful in the ongoing opioid civil litigations.

Volume 5

Volume 5: The Definitive Guide to the Opioid Litigation is intended to tie all of the pieces and players together referenced in Volumes 1-4.  The Mass Tort Nexus research staff has been amazed by the connections that they have uncovered between supposedly independent organization that contributed to the development of the “echo chamber” that was used to convince doctors that opioids were safe, despite the fact that over a thousand years of history indicated otherwise.

 

Volume 6

Volume 6: The Definitive Guide to the Opioid Litigation  provides a comparison and contrast between three mass litigation’s with many similarities:

  1. The Tobacco Litigation
  2.  The BP Oil Spill Litigation
  3. The Opioid Litigation

 

 

 

 

 

 

 

 

 

 

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$89 MILLION SETTLEMENT ENDS MDL 2329 WRIGHT CONSERVE HIP IMPLANT LITIGATION

Wright Medical Takes Another Step Toward Their Complete Exit From Hip Implants

Mark A. York (October 9, 2017)

Mass Mass Tort Nexus

  

 

 

 

 

 

 

Wright Medical Technology, Inc. and plaintiffs in the Conserve metal-on-metal hip implant multidistrict litigation MDL 2329, (see Wright Medical, Inc. MDL 2329 Conserve Hip Implant Litigation briefcase) have agreed on a “comprehensive” settlement to resolve the remaining claims against the company. MDL 2329 has been ongoing in the US District Court of Georgia since 2012, and soon after the hip cases were consolidated, Wright sold it’s hip and knee implant operation to Chinese medical entity MicroPort Medical for just under $300 million.

The settlement comes may have been impacted with one plaintiff winning $11 million in the first bellwether trial in Atlanta in November 2015, and after the other cases were not dismissed, and with additional bellwether trials coming, the company chose to settle versus risking additional high dollar verdicts, and further issues with insurance carriers as to who would be liable.

 $89 Million SEC Disclosure

On October 3, 2017 Wright disclosed the settlement in 3rd quarter SEC filings, where the company said its maximum liability will not exceed $89.75 million. The settlement is contingent on availability of new insurance proceeds from the company’s insurance carriers, expected to be $35 million.

The payouts will come in three agreed upon cash outlays, with the first for $7.9 million for certain claimants, the second for $5.1 for the oldest claims, and $76.75 million for the rest. The final payment is scheduled for September 2019.

 Plaintiff Eligibility

For patients to be eligible for settlement they must have a claim filed and pending and received and undergone the revision of the cup, the head, the liner, or some combination thereof, of one of the following metal-on-metal articulating bearing surface product configurations:

(a) A CONSERVE® acetabular cup paired with a CONSERVE® cobalt chromium femoral head;
(b) A DYNASTY® acetabular cup and metal liner paired with a CONSERVE® cobalt chromium femoral head; or
(c) A LINEAGE® acetabular cup and metal liner paired with a LINEAGE® or CONSERVE® cobalt chromium femoral head.

In the two-week bellwether trial, the jury awarded $11 million to Robyn Christiansen, a retired ski instructor implanted with the Conserve metal-on-metal hip implant made by the company. Christiansen received $1 million in compensatory damages and a whopping $10 million in punitive damages.

Prior to the settlement, there were approximately 629 claims that were eligible, and approximately 710 claims (of which 630 are non-revisions) that were ineligible, to participate in the comprehensive settlement. There were also approximately 47 claims pending in U.S. courts and approximately 65 claims pending in non-U.S. courts that will not be included under the agreement.

 Metal-on-Metal Controversy Remains

Metal-on-metal hips became controversial after foreign registries showed higher than normal failure rates, often resulting in Metallosis, a condition where metal particles are absorbed in to the body due to the interaction of the various metals and at times, body fluids. This results in a chronic inflammation and onset of a myriad of severe medical conditions, that prior to metal on metal implants, was relatively unknown outside the metal working industry. In May 2011, the FDA ordered manufacturers of the devices to conduct postmarket surveillance, to determine the true dangers of metallosis and how the condition will impact the thousands of patients who’ve received metal on metal implants, not only in the USA, but around the world.

Thousands of lawsuits were filed against the largest manufacturers by patients who alleged they were injury from the implants. The multi-district cases, in addition to Wright Medical’s, include:

  • Zimmer Holding’s Durom Hip Cup (290 filed cases)
  • DePuy Orthopaedics, Inc.’s ASR Hip Implant (8, 858 filed cases)
  • DePuy Orthopaedics, Inc.’s Pinnacle Hip Implant (5, 153 filed cases)
  • Biomet, Inc.’s M2a Magnum Hip Implant (978 filed cases)

DePuy Pinnacle MDL Trial

DePuy reached a multi-billion-dollar settlement with patients implanted with the ASR system last year in MDL 2197, see DEPUY MDL 2197 ASR HIP IMPLANT Litigation Briefcase.  DePuy Orthopaedics remains deeply involved in MDL 2244, see DePuy Orthopaedics MDL 2244 Pinnacle Hip Implant Litigation Briefcase, where there’s a current federal bellwether trial underway in Houston, TX that started September 22, 2017. The last DePuy Pinnacle trial ended in a jury verdict awarding over $1 billion to a group of five plaintiffs from California, which the judge subsequently reduced to just over $500 million.

MoM Controversy Remains

The issues related to metal-on-metal hip implants,the affiliated onset of metallosis and the numerous other adverse health conditions brought on by the use of MoM devices, does not appear to be going away anytime soon, as there are new hip implant multidistrict litigation consolidations arising every year including. Within the last few months the Stryker LFIT V40 MDL 2768 (see MDL 2768 Created in Stryker LFIT Anatomic CoCR V40 Prosthetic Hip Litigation) and the Smith & Nephew BHR & R3 MDL 2775 (see Smith & Nephew MDL 2775 “BHR & R3 HIP SYSTEM” in USDC Maryland Briefcase), mass torts have started, and re just 2 of the many ongoing hip implant legal disputes where metal-on-metal health related issues will be determined.

 

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States Across The Country Are Targeting Big Pharma and Their Opiate Marketing Campaigns

Is Big Pharma The Target of Litigation Modeled After Tobacco Litigation?  

Mark A. York,  October 6, 2017

 

 

 

 

 

 

 

(Mass Tort Nexus) A bipartisan group of states and their attorneys general have started massive joint investigations into the marketing and sales practices of drug companies that manufacture opioid painkillers. These drug makers are the largest in the country and are considered at the center of the current national addiction epidemic. This includes the executive suite and boardrooms of all opiate manufacturers, as the policy and direction for the massive growth in opiate prescriptions could not have gone unnoticed by executives at the opiate drug makers, for close to 15 years. Record earnings, bonuses and SEC filings all point to “boardroom knowledge” of ever increasing opiate focused sales efforts.

Opiate Rx MDL 2804 Parallels State Claims

The state actions are now parallel to the September 25, 2017 filing of a “Motion for Consolidation in “The Opiate Prescription Litigation MDL 2804”, with the Joint Panel for Multidistrict Litigation. MDL 2804, where numerous Midwest counties in Ohio, Kentucky and West Virginia as well as the city of Birmingham, Alabama joined together to file suit against the 3 largest distributors of opiates in the country, McKesson Corp., Cardinal Health and AmerisourceBergen Corporation. Also named in the suit are the primary Big Pharma opiate manufacturers including Purdue Pharma, J&J’s Janssen Pharmaceuticals, Endo, Teva and others as additional defendants.

Attorney Generals from Massachusetts, Tennessee, Texas, Illinois, New Jersey, Missouri and Pennsylvania have launched full investigations, following the lead of Ohio Attorney General Mike DeWine, who sued five drug manufacturers for misrepresenting the risks of opioids. Other states are also beginning the review of opioid manufacturers and will decide if they are joining the others in filing legal claims.

“We are looking into the role of marketing and how related corporate business practices might have played into increasing prescriptions and use of these powerful and addictive drugs,” District of Columbia Attorney General Karl Racine, a Democrat, said in a statement.

Its currently unclear exactly how many states are involved in the probe, though officials said a majority of attorneys general are part of the coalition. Among those leading the probe is Tennessee Attorney General Herbert Slatery, a Republican.

Officials did not specify which companies were under investigation, but suffice it to say, any company that made and marketed opioids products over the last 10 years will be scrutinized.

Opioid drugs, including prescription painkillers and heroin, killed more than 33,000 people in the United States in 2015, more than any year on record, according to the U.S. Centers for Disease Control and Prevention.

Separate lawsuits by attorneys general in Ohio, Tennessee, New Jersey and Mississippi, are pursuing opioid-related cases as of September 2017, with many more following suit very soon. They are have targeting Purdue Pharma LP, Johnson & Johnson(JNJ.N), Endo International Plc(ENDP.O), Teva Pharmaceutical Industries Ltd (TEVA.TA) and Allergan Plc(AGN.N) as well as leaving the door open to add additional defendants, based on the information revealed in the ongoing multi-state investigations.

New Jersey Files Against Insys Therapeutics

New Jersey recently filed suit against Insys Therapeutics, Inc over marketing scheme for its Fentanyl product known as “Subsys”, and the massive off-label marketing campaign for uses other than FDA approved “cancer pain” treatments. The entire executive board of Insys was indicted in December 2016, along with many of its sales staff and numerous doctors across the country, with at least to physicians being sentenced to 20 years in prison by the US District Court in Alabama. See Insys Therapeutics, Inc Executives Indicted Over Fentanyl Sales Campaign.

Teva in a statement said on Thursday it is “committed to the appropriate promotion and use of opioids.” Representatives for the other companies did not immediately respond to requests for comment.

The companies have denied wrongdoing, saying the U.S. Food and Drug Administration approved their products as safe and effective and saying that they carried warning labels that disclosed their risks. The specific allegation focus more on “off label” and doctor targeting and marketing practices that repeatedly encouraged over-writing of opiate prescriptions for patients with minimal pain issues.

Ohio Filed First

In announcing his office’s lawsuit in May 2017, Ohio Attorney General DeWine said the drug companies helped unleash the crisis by spending millions of dollars marketing and promoting such drugs as Purdue’s OxyContin, without consideration of the long term effects of the related addiction, which Purdue was absolutely aware of throughout the years of profits that now total billions of dollars.

The lawsuit said the drug companies disseminated misleading statements about the risks and benefits of opioids as part of a marketing scheme aimed at persuading doctors and patients that drugs should be used for chronic rather than short-term pain.  Pain centers and medical practices across the country started writing an ever increasing number of high dose opioid prescriptions for what would be considered low to mid-level pain treatment.

Similar lawsuits have been filed by local governments, including those in several California counties, as well as the cities of Chicago, Illinois and Dayton, Ohio, three Tennessee district attorneys, and nine New York counties have also filed individual suits.

It is unknown at this time, if all of the legal actions filed by governmental entities across the country will be consolidated into MDL 2804, which may be the most effective way to manage the soon to be massive number of legal claims against Big Pharma and their long term opiate profit centers. Municipalities across the country seeking to recoup the enormous financial losses brought on by the opioid crisis.

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