Targeting Big Pharma and Their Opiate Marketing Campaigns

The Major Focus Across The USA is Now Big Pharma and Their Opiate Marketing Campaigns

Mark A. York (November 3, 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.

The state actions are now parallel to the “Motion for Consolidation in “The Opiate Prescription Litigation MDL 2804” , filed with the Joint Panel for Multidistrict Litigation. MDL 2804 is set for a Consolidation Motion Hearing before the JMPL panel in St. Louis,  MO on November 30, 2017, 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 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.

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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Chicago Asks Federal Judge For Janssen Employee Marketing Records In Opioid Lawsuit

By Mark A. York (November 3, 2017)

 

 

 

 

 

 

 

 

Chicago Is Now Three Years Into it’s Suit Against Opioid Drug Manufacturers

(Mass Tort Nexus)  In the case of City of Chicago v. Purdue Pharma LP et al., Case No. 1:14-cv-04361 U.S. District Court for the Northern District of Illinois, the City of Chicago has requested the judge order Janssen Pharmaceuticals to turn over records of 10 employees that contain information related to the city’s claims that the drug company and others marketed opioids inappropriately.

In a motion to compel Janssen to produce the documents, Chicago said that Janssen Pharmaceuticals Inc. should include the employee related documents who were responsible for its opioid marketing, as the custodians of electronically stored information that can be searched for the relevant documents. So far, Janssen has refused to offer up the records or the employees in discovery requests, with Chicago stating “the company’s reasons are baseless” in the heavily redacted filing. Their claim that the custodians are ‘duplicative’ finds no support in Janssen’s own documents,” Chicago stated in the pleadings.

SUIT CLAIMS JANSSEN MISLED DOCTORS

Chicago sued Janssen Pharmaceuticals, Purdue Pharma LP, Teva Pharmaceuticals Industries Ltd., and other opioid manufacturers in 2014, saying they misled doctors and the public about the addictive nature of opioids and pushed prescriptions despite known dangers of addiction. As a result, the city claims that it paid for thousands of medically unnecessary prescriptions for city employees.

Janssen argues that including these employees would be “duplicative,” but it’s unlikely that employees working in the same area would carry out the same tasks in a way that would make their documents the same, the city said.

“Janssen has complained of the yet unproven ‘burden’ of searching the files of additional custodians,” the city said. “Janssen offers no specifics in support of this argument.”
Janssen hasn’t declared the size or scope of the additional data in the electronic files, nor has it shared with the city any costs for searching through more employees’ information, the searches are generally standard and it’s probable all the requested data has been collected in some format, Janssen is just playing hardball in giving it up.
“It merely argues that it has collected ‘nearly a terabyte’ of data from unspecified sources and therefore refuses to collect and search anymore,” this is not a valid argument as the collection of massive amounts of data in complex litigation is standard practice and the process is very well defined in cases of this type.
“Chicago has identified more than 125 parties whose files it will search for responsive electronically stored information. Janssen has agreed to search only 17 custodians,” according to the city “In contrast, the Endo defendants have agreed to search 62 ESI custodians and the Actavis defendants have agreed to search 43 ESI custodians.”

LOCAL GOVERNMENTS IN OPIOID MDL

The city’s suit is one of a number filed by municipalities over the ongoing opioid epidemic, there is now a Motion to Consolidate the “Opiate Prescription Litigation as MDL 2804” (see OPIOID CRISIS: MDL 2804 OPIATE PRESCRIPTION LITIGATION) pending before the Joint Panel on Multidistrict Litigation, set for November 30th in St. Louis. In addition, the Cherokee Nation tribe gas filed against the drug makers, and at least one class action was filed on behalf of individuals in Arkansas, which has been placed on hold pending the outcome of the JPML motion hearing in St. Louis on November 30th.

More than 40 state attorneys general have also launched a joint investigation into at least half a dozen opiate drugmakers and distributors and many are close to moving forward in not only civil claims but looking very closely at potential criminal charges. The state AGs’ probe initially focused on OxyContin maker Purdue Pharma, now widened to include other opioid drugmakers and distributors such as Endo, Allergen, McKesson and Teva.

CRIMINAL INVESTIGATIONS

The US Department of Justice is now pursuing criminal charges against select opioid drug manufacturers in Massachusetts, where Insys Therapeutics, Inc. is under indictment. In a surprise move, the US Attorney’s office in Connecticut has opened a criminal review of Oxycontin maker, Purdue Pharma, LP, and it’s opioid drug marketing practices.

“We look forward to fully responding to this latest motion once we have the opportunity to review it with counsel,” stated Janssen, “We recognize opioid abuse is a serious public health issue that must be addressed. At the same time, we firmly believe the allegations in these lawsuits are both legally and factually unfounded

As the legal heat is turned up across the country on opioid drug manufactures, it remains to be seen how they will react to what is being termed as a repeat of the legal strategy followed in the massive and financially damaging “Tobacco Litigation.”

 

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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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“NATIONAL PRESCRIPTION OPIATE LITIGATION MDL No. 2804”

Transfer Motion Accepted by JPML On September 29, 2017

By Mark A. York

Mass Tort Nexus (September 29, 2017)

 

 

 

 

 

 

 

The  Motion to Transfer and Consolidate MDL No. 2804, now known as “National Prescription Opiate Litigation”, was accepted by the JPML on September 29, 2017 see “JPML Motion to Consolidate Prescription Opiate Litigation as MDL 2804”, with the apparent motion hearing date being November 30, 2017 at the Joint Panel on Multidistrict Litigation hearings in St Louis, Missouri. The consolidation motion was filed by Hill, Peterson, Carper, Bee & Dietzler, based in Charleston, WV. The filing is the long expected result of the ongoing “Opioid Crisis” which has seemingly overtaken many aspects of day to day life in America, with a particular emphasis on rural America. The many small towns and counties have seen unheard of increases in overdose deaths and 911 calls for drug overdoses, which have depleted budgets and caused ever mounting levels of grief for stricken families as well as tension in government council meetings everywhere, when attempting to address the crisis.

The consolidation filing is followed in the Mass Tort Nexus briefcase, “National Prescription Opiate Litigation MDL”,as the motion directly cites the nation’s three largest wholesalers of opiod drugs, McKesson Corporation, AmerisourceBergen Corporation and Cardinal Health, Inc. as well as naming primary drug makers Purdue Pharma, Teva, Cephalon, Janssen, Endo, Actavis and Mallinckrodt as defendants in certain actions. Opiate drug makers and their executives are now firmly in the sights of not only mass tort lawyers, but facing the full force of criminal investigation by the US Department of Justice in every state, as indictments have already been handed down in several federal venues. The MDL filing contains complaints that specifically reference RICO claims in many of the 66 federal actions cited in the motion, to be transferred into the JPML venue.

The pharmaceutical industry already faces dozens of lawsuits brought by cities, counties and states — including Ohio, Missouri and Oklahoma. Some are trying to recoup the costs incurred from the surge in emergency response from spikes in opioid-related overdoses. The strategy is reminiscent of the successful litigation brought by states and municipalities three decades ago against tobacco companies.

The opioid drug industry expanded in the 1990s in response to the medical community’s push to better treat pain and chronic pain.

A primary focus is the how and why of , millions of opioid users became addicted to opioids, or heroin, after being prescribed the medication by doctors and the apparent failure of corporate executives to address the ever mounting evidence in light of the enormous profits, year in and year out.

Many doctors, in turn, said they were assured by the drugmakers that the opioids were less addictive or even not addictive, which in the civil matters will be a point of very high contention and potentially a focus of US DOJ investigators.

Some states have obtained consent decrees and financial penalties from drug makers, including Illinois, “My investigations have shown that drug companies pressure physicians into prescribing powerful, addictive drugs without regard for the law or patients’ well-being,” said Illinois Attorney General Lisa Madigan, who is also party to the new investigation.

SHOTS – HEALTH NEWS

Intent On Reversing Its Opioid Epidemic, A State Limits Prescriptions

Now, many state prosecutors say they will examine whether the industry was complicit in creating the epidemic and whether it should now be responsible for helping pay for the damage caused to many communities.

Allergan said it was “working cooperatively” with the attorneys generals on their requests for information. The other companies being investigated did not immediately issue statements, and industry lobbying group PhRMA didn’t respond to a request for comment.

The number of opioid prescriptions has declined in recent years, after federal regulators placed new limits on the drugs. That reduced the amount of opioids prescribed by 18 percent in 2015, from a peak in 2010, according to the Centers for Disease Control and Prevention.

Still, as the state attorneys general and other community leaders note, the slowdown in prescriptions has been offset by greater demand for cheaper alternatives such as heroin.

“For millions of Americans, their personal battle with opioid addiction did not start in a back alley with a tourniquet and syringe,” Schneiderman said. “They got hooked on medicine they were prescribed for pain or that they found in a medicine cabinet.”

“Governmental entities across the country are now joining together and stating “We are taking this action today because our communities and homes have been broken and families torn apart by this epidemic,” and this known danger was ignored by opioid drug makers, “This epidemic has claimed victims from all walks of life, and both the financial and emotional costs to our citizens.”

Primary allegations include “That the manufacturing companies pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction, while the distributors breached their legal duties to monitor, detect, investigate, refuse and report suspicious orders of prescription opioids:, which is applicable to all afflicted communities across the country.

From the extensive research by Mass Tort Nexus to date, it appears that this is just the tip of the litigation iceberg that will be brought against all levels of opiate pharmaceutical manufactures and affiliated distributors in the USA. Based on US Dept. of Justice criminal filings, the executive boardrooms are not exempt from indictments and criminal charges,  as well as the many doctors, sale and marketing professionals and others who helped facilitate the current opioid crisis, which directly results in related civil and mass tort actions against all involved.

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ACTEMRA: Why Is Genentech Ignoring Wrongful Death, Heart Attack and Stroke Injuries?

ACTEMRA: Why Is Genentech-Roche Ignoring Ever Increasing Evidence Of Wrongful Deaths, Heart Attack and Stroke Injuries?

By Mark A. York

Mass Tort Nexus (September 26, 2017)

 

 

 

 

 

 

 

 

 

 

Many newer rheumatoid arthritis drugs have strong warnings known as black box warnings, dictated by FDA guidelines, which warn of the risk of heart attack, stroke, heart failure, lung disease, and other injuries, but Actemra warnings were not issued by the drug maker when the medication was introduced.

Actemra, a rheumatoid arthritis medication by Roche-Genentech, has now been linked to increased heart attacks, stroke and lung interstitial disease among other side effects that the maker, Genentech did not warn the public about.

Blockbuster Drug

Actemra is a humanized interleukin-6 (IL-6) receptor antagonist approved for treatment of adults with moderately to severely active rheumatoid arthritis. It was approved in 2010 and has been prescribed to more than 760,000 patients. The drug was responsible for $1.7 billion in revenue for Genentech and Roche last year and considered a blockbuster.

Actemra Wrongful Death

Actemra has been found to be the cause of thousands of deaths and critical illnesses, according to recent reports, it’s now documented that hundreds of patients taking the RA drug died from cardiovascular and pulmonary complications – medical issues not usually known to be  associated with the drug. According to the investigation, Actemra did not carry warning labels about the possible side effects, unlike many competing RA drugs. Stat said it investigated more than 500,000 side effect reports for RA drugs and “found clear evidence” that the risks of the side effects, such as heart attack or stroke, “were as high or higher for Actemra patients than for patients taking some competing drugs.” The difference Stat stressed is that Actemra, unlike the other RA drugs, does not carry a warning label for those side effects.

What is Actemra?

Actemra (tocilizumab) is Genentech’s newest blockbuster rheumatoid arthritis drug introduced by parent company Roche in 2010. It is given to patients as an intravenous infusion on a monthly basis or as a subcutaneous (under the skin) injection on a weekly or bi-weekly basis.

Actemra is a monoclonal antibody drug, approved by the FDA to treat autoimmune disorders including Rheumatoid Arthritis (RA), Polyarticular Juvenile Idiopathic Arthritis (PJIA), and Systemic Juvenile Idiopathic Arthritis (SJIA) and was recently approved for the treatment of Giant Cell Arteritis (GCA).

In autoimmune disorders like RA, the immune system begins to attack and destroy the body’s own joint or other tissue. Actemra works to suppress the immune system by blocking interleukin-6, an immune messenger.

Actemra is Genentech’s Poster Drug?

Roche-Genentech touted their new rheumatoid arthritis drug as a “unique” breakthrough treatment, and it has since become a blockbuster drug, generating $1.6 billion in sales in 2016. Actemra competes with other popular and widely used rheumatoid arthritis drugs already on the market, including Enbrel, Humira, and Remicade.

Actemra Has Caused Serious Heart and Lung Injuries

 

Competitor RA drugs Enbrel, Humira and Remicade contained strong warnings about the heart risks and other serious health problems, but Actemra warnings did not indicate that patients may develop heart attacks, stroke, heart failure, lung disease, pancreatitis or other serious side effects.

Unfortunately, many doctors and patients were falsely led to believe that Actemra was safer, and Actemra may have actually caused these same, or even increased a greater risk of heart problems, lung complications, and other injuries.

Report Highlights Failure to Warn About Actemra Risks

In June 2017, the national publication STATNews.com released a detailed review of adverse event reports submitted to the FDA involving Actemra problems. The report raised a serious question about the failure to warn about the risk of cardiovascular problems, pancreatitis, lung disease and other injuries that have been experienced by users nationwide.

STAT News researchers examined thousands of serious adverse event reports filed with the FDA and found that 1,128 cardiac and respiratory deaths in Actemra patients had been reported to the FDA, along with thousands of other serious adverse events including heart attack, stroke, interstitial lung disease, gastrointestinal perforation and others.

STAT identified at least 13,500 reports of issues following an Actemra infusion or injection, which were submitted to the FDA between 2010 and 2016.

Actemra was linked to a higher-than-expected number of serious adverse event reports when compared with the more widely used drugs Humira, Remicade and Enbrel, which each have warnings about risks that users may face.

Actemra Serious Adverse Events

Actemra patients were more likely to have a lung disease event than patients taking Remicade and just as likely as those using Humira.

Actemra patients were 1.5 times more likely to experience a heart attack or stroke as those using Enbrel.

Will Actemra Be The Next MDL?

According to law firm and other third party investigations reviewing the Actemra drug for potential legal action against Roche and Genentech, the drug maker placed their desire for profits before patient safety by withholding important warnings about the risk of heart attacks, strokes, heart failure, lung disease, pancreatitis and other harmful side effects. When the catastrophic adverse events started to be known to the company, a boardroom decision was made to disregard the ever increasing adverse events, including those of patients dying after taking the drug. Where the Actemra investigations lead to will be known later in 2017, as determinations on taking legal action are made.

 

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Is Industrial Talc Litigation The Next Major Mass Tort?

Will Industrial Talc Litigation Become Another Asbestos?

 

 

 

 

 

 

 

Is Industrial Talc the next “major mass tort or MDL” to watch, now that talc litigation is  becoming more common in Mass Torts? Major verdicts against cosmetic talc defendants, including Johnson & Johnson (“J & J”), suggest that talc litigation, at a minimum, is a potential major threat to talc defendants other than J&J, extending into more general product manufacturing sectors including the “personal care product” industry, see J&J MDL 2738 Mass Tort Nexus Briefcase.  In 2016, J & J and other defendants suffered three large verdicts for exposure to its baby powder in St. Louis, Mo.: $72 million, $70 million and $55 million. All three verdicts, in a jurisdiction considered favorable to asbestos plaintiffs, included substantial punitive damages, see J&J Talc Cases In St Louis, MO State Court.

The plaintiffs in each of these cases alleged that exposure to talc contained in J&J’s baby powder caused them to contract ovarian cancer. Also in 2016, a Los Angeles jury awarded $18M to a plaintiff who sued a cosmetic talc defendant alleging exposure to cosmetic talc caused the plaintiff to contract mesothelioma.

There is a current ovarian cancer claim trial against J&J in Los Angeles Superior, Judge Maren Nelson that started July 10, 2017, see J&J Faces First CA Talc Cancer Trial in Los Angeles Court, where plaintiff Eva Echeverria claims that J&J baby powders caused her ovarian cancer, in the consolidated J&J Talc Litigation JCCP No. 4872 (Eva Echeverria v. Johnson & Johnson, Case No. BC628228).

Assuming talc litigation is not going away any time soon, several questions are raised. Are all talc claims the same? What is the relationship between talc and asbestos, if any? What defendants are at risk in the talc litigation? What are the insurance implications of talc claims, and are they alike or different from asbestos and other long-tail coverage claims?

Talc History

There are two types of talc: industrial talc which is used most frequently in rubber, plastics and ceramics; and cosmetic talc which is of a higher grade and is used in conjunction with products that involve direct human exposures such as cosmetics, pharmaceuticals and food additives.

Talc manufacturers and companies that have incorporated talc into their products have been, and continue to be, sued. Industrial talc defendants have been involved in litigation for decades. In lawsuits involving industrial talc, plaintiffs generally allege that the talc is contaminated with asbestos. The injuries alleged are mesothelioma, lung cancer and asbestosis. To date, there have been no claims against industrial talc defendants alleging that asbestos in the talc caused ovarian cancer. Industrial talc defendants have aggressively defended the cases and, although suffering some adverse verdicts, they won more cases than they have lost. However, will thousands of new industrial talc claims result in acceptance of litigation and pressure to settle as a suddenly arising “cost of doing business’, such as the view taken by pharmaceutical and medical device manufacturers who incorporate “litigation costs” into corporate filings and simply classify it as an expense of doing business?

Cosmetic talc cases fall into two distinct categories: 1) cosmetic talc alleged to cause ovarian cancer; and 2) cosmetic talc alleged to cause mesothelioma. The J & J verdicts were ovarian cancer cases. There was no claim that the talc was contaminated with asbestos.

While the J & J St. Louis verdicts received significant attention in the national media, cases alleging that asbestos-containing cosmetic talc caused an asbestos-related disease such mesothelioma have been percolating, and some recent notable verdicts have been obtained. In 2015, a Los Angeles jury awarded $13M to a woman who alleged talcum powder sold by Colgate-Palmolive was contaminated with asbestos causing her to contract mesothelioma.  These cases, if they emerge as viable litigation, could make cosmetic talc defendants targets by substituting them for insolvent asbestos defendants and anyone else who may be named, which would present an extreme and unforeseen threat to cosmetic talc defendants and affiliated industry.

Cosmetic Talc Litigation – Ovarian Cancer

Cases alleging injury from cosmetic talc are relatively new, as best exemplified by the recent high-profile J & J verdicts. These cases did not depend on asbestos contamination, nor did they allege mesothelioma. Instead, they alleged that talc itself causes ovarian cancer. The ovarian cancer talc cases indeed represent an entirely new class of toxic product liability litigation. The approximately 14,000 ovarian cancer deaths a year, in conjunction with the widespread use of talc in everyday products such as baby powder, renders these cases a serious threat to certain defendants and their insurers.
According to the National Institute of Health, there are 22,280 new ovarian cancer diagnoses each year in the U.S. and 14,240 women die of the disease every year. This is seven times the number of annual mesothelioma diagnoses.

The American Cancer Society estimates that there are only 3,000 new mesothelioma diagnoses a year,  with mesothelioma lawsuit filings being stable and not increasing. Like any other business, plaintiffs’ firms are always looking to maintain and grow revenue. Litigation against cosmetic talc defendants alleging ovarian cancer offers a way to substantially increase their bottom line. Indeed, “do you have ovarian cancer?” and “did you use talcum powder?” ads are commonplace on television.

Because everyone can credibly claim exposure to cosmetic talc, the primary issue that will be litigated is the science underlying the causal connection between talc exposure and ovarian cancer. While plaintiffs prevailed in the St. Louis actions, Imerys Talc and J & J persuaded a New Jersey trial court in 2016 to dismiss with prejudice two ovarian cancer cases after granting their motions to bar expert testimony due to inadequate science supporting their opinions. Apparently pressing their advantage, the defendants persuaded the federal talc MDL in New Jersey to conduct a “science day” in which the litigants would attempt to generally demonstrate that cosmetic talc does or does not cause ovarian cancer. The plaintiffs’ bar quickly responded with their own proposed “science day” in California state court, presumably where they perceive a jurisdictional advantage. The “science” of whether cosmetic talc causes ovarian cancer will be the field of battle on which the sustainability of these claims will live or die.

The sustainability of ovarian cancer talc cases will depend on how the courts resolve the science questions surrounding causation. This will depend in large part on the plaintiffs’ bar’s ability to persuade courts outside jurisdictions traditionally favorable to asbestos claimants of the merit of their claims.

Cosmetic Talc Cases Alleging Asbestos-Contamination

In addition to the emergence of ovarian cancer cases, cosmetic talc defendants are also at risk of becoming responsible for mesothelioma cases alleging that their products were contaminated with asbestos. If plaintiffs can meet their burden of proving asbestos contamination in their products, the issue of product identification will largely be moot due to the ubiquitous use of talc in everyday products to which any plaintiff can presumably credibly claim exposure.

Allegations of asbestos contamination in talc have a long and disputed history. The FDA launched an investigation in 2010 based on reports that talc from South Korea and China contained asbestos. After extensive testing of various U.S. consumer products, the FDA found no asbestos contamination in the products. However, it described its results as inconclusive and only “informative” because it was unable to secure samples from all of the common talc suppliers.

The issue of whether cosmetic talc is contaminated by asbestos is disputed by the plaintiffs’ bar. The cosmetic talc defendants present an attractive target, especially given the declining pool of solvent asbestos defendants. In addition, while mesothelioma case filings have been relatively flat, the expected decline of mesothelioma claims has failed to emerge.

If mesothelioma cases do trend upward, plaintiffs’ lawyers will have additional incentive to identify new solvent defendants to satisfy the potential liabilities. Cosmetic talc defendants, generally not burdened by years of asbestos liabilities, make attractive defendants. In addition, because the traditional asbestos defendants that used and sold asbestos products have gone bankrupt, plaintiffs’ lawyers have increasingly struggled to demonstrate proximate cause against individual defendants and have been forced to make ever-more tenuous arguments that even de minimus exposures to asbestos caused their clients’ mesothelioma. The widespread use of cosmetic talc overcomes most traditional product identification, proximate cause defenses. Instead, the principal issue becomes only whether a particular product was contaminated with asbestos.
The plaintiffs’ bar will attempt to meet its burden of demonstrating asbestos contamination in cosmetic talc by arguing that traditional testing methods are not precise enough to detect it at low levels and that there is no safe level of asbestos exposure. In previous cases, plaintiffs have employed experts to challenge defendants that maintained talc samples. As these cases are being litigated in the same jurisdictions that handle most asbestos cases, these allegations will  be difficult for defendants to rebut.

Notable Cosmetic Talc/Asbestos Contamination Verdicts

Two recent verdicts for asbestos contamination demonstrate the risk to cosmetic talc defendants. In October 2016, a Los Angeles County jury awarded $18M to Philip Depolian against Whittaker, Clark & Daniels finding it 30% responsible for his mesothelioma due to his alleged exposure to various cosmetic talc products used at his father’s barbershops that contained asbestos. The jury apportioned liability against various cosmetic talc defendants that had settled and several other cosmetic talc product defendants that sold products including Old Spice, Clubman, Kings Men and Mennen Shave Talc.

In 2015, another Los Angeles jury awarded Judith Winkel $13M against Colgate-Palmolive for mesothelioma allegedly caused by exposure to talc in its baby powder. The jury rejected Colgate and its experts’ claims that the cosmetic talc at issue was not contaminated by asbestos and that the talc in question were non-fibrous “cleavage fragments” unlikely to be inhaled or embedded in the lungs. Although details of the trial are not readily verified, at least one report indicated that evidence presented at trial showed that the talc contained 20% asbestos fibers.

These cases are particularly important because the defendants were held responsible for cosmetic talc containing asbestos and for having caused mesothelioma and not ovarian cancer as in the J & J cases. Further, both juries found that the defendants acted with malice. However, the cases were confidentially settled before the respective punitive damage phases.

Who’s Liable if Industrial Talc Litigation Explodes

While the ovarian cancer cases have dominated the headlines, the cosmetic talc asbestos contamination cases may present the bigger risk to defendants and a much greater reward to plaintiff counsel. Thousands of companies used cosmetic talc in their products over the last hundred years. The entire population could claim exposure, especially to defendants that sold personal care products that could be ingested, inhaled or exposed via air-borne contact. The risk is that the cosmetic talc defendants become the defendant of last resort when a plaintiff has no other convincing credible sources of exposure to asbestos, especially when the original product source is now a bankrupt entity.

Science of Cosmetic Talc Claims: While it may be difficult to challenge long-established trigger approaches if a talc claim involves a claim of asbestos contamination, ovarian cancer talc claims may require a new look at trigger issues because the underlying science of how talc exposure may cause ovarian cancer is different from how asbestos inhalation damages the respiratory system. Having learned from previous trigger battles in asbestos, the insurers are likely to challenge the science that the first exposure to cosmetic talc causes injury that can be associated with the development of ovarian cancer and characterized as “bodily injury” as required in their policies. They may seek out scientific opinion that ovarian cancer caused by cosmetic talc is not progressive in nature, and thus not warranting the imposition of a continuous trigger. And, generally, the insurers will likely seek to limit the spread of potentially triggered policies to as few years as possible, and as close to the manifestation of the disease as possible.

Exceptional advancements in the science of diagnosing and predicting cancer in just the last few years will provide plaintiffs, policyholders and insurers the opportunity to craft new trigger theories to their advantage and to circumvent past judicial decisions that were to their disadvantage. We have already seen the insurance industry using alleged advancements in asbestos science to attempt to limit the scope of historical “occurrence” policies. There is no insurance precedence with respect to trigger and talc ovarian cancer claims. Expect both sides to bring new experts and theories with respect to biologic and genomic issues, including molecular cancer experts opining about genetic alterations pre-existing before manifestation of a tumor. Resolution of these issues will be especially challenging because much less is known about females’ “defense systems” as opposed to airborne exposure through the lungs.

The science of ovarian cancer cosmetic talc claims is likely different from asbestos claims, but that will be a question for the experts and courts. Because plaintiffs will have an easy time in most cases demonstrating exposure to consumer products (e.g., for baby powder, theoretically from birth to present), both kinds of cosmetic talc claims generally would be linked together based on length and type of exposure.  .

Hiding Data That Showed Potential Dangers: The standard complaints utilized in the St. Louis cases allege that J&J knew about the risks of ovarian cancer as early as 1971. The complaints allege that “nearly all” of 23 known epidemiologic studies on cosmetic talc reported an associated risk with ovarian cancer, and assert alleged instances in which J&J “knowingly released false information” about the safety of talc in coordination with the Cosmetic Toiletry and Fragrance Association. Media reports suggest that, in post-trial interviews, jurors indicated that these allegations were part of the motivation for the large punitive damages award.

Question: Will industrial and cosmetic “personal care” products made with talcum powder and the emerging confirmed links to “asbestos” and “mesothelioma” become the new long term mass tort resulting in thousands of complaints against nontraditional and unsuspecting defendants? Such as the Los Angeles County, California Superior Court lawsuits where a 2015 “cosmetic talc” trial resulted in an $18 million verdict award based on “cosmetic talc exposure in a barbershop” against Old Spice, Clubman, Kings Men and Mennen Shave Talc, as well as a prior 2015 trial verdict of $13 million against Colgate-Palmolive for exposure to talc in its baby powder.

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JPML Approves Proton Pump Inhibitor MDL 2757 Assigned to US District Court New Jersey, Judge Claire C. Cecchi on August 2, 2017

JPML Approves Proton Pump Inhibitor MDL 2757 Assigned to US District Court New Jersey, Judge Claire C. Cecchi on August 2, 2017

 The Judicial Panel on Multidistrict Litigation (JPML) has entered an order consolidating the Proton Pump Inhibitor (PPI) MDL 2757 (Nexium, Prevacid, et al) on August 2, 2017 see JPML Consolidation Order of August 2, 2017, assigning PPI MDL 2757 to Judge Claire C. Cecchi, US District Court of New Jersey based on the July 27, 2017 consolidation hearings at the Los Angeles Federal Courthouse. The case is In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2757, JPML, where the case filings have significantly increased since the initial JPML hearing on January 26, 2017 in Miami when U.S. District Judge Sarah Vance said at one point during the oral arguments “It just seems to me to be nightmarishly complex” as the primary defense counsel raised concern over the generic makers and related defense issues with so many co-defendants. The JPML ultimately denied the MDL 10 days later to the view that consolidation would be to cumbersome, however due to the large numbers of new suits and the refiling of a Motion to Consolidate, the July 27th Los Angeles hearings have had a different outcome.

The drugs at issue include Prilosec, Nexium, Protonix and Dexilant as well as potential the numerous generic manufacturers. The hearing order lists over 163 cases in 28 federal district courts and a decision will likely come in mid-August. Nevertheless, the judges may try to come up with ways to split up the cases into structures that might be simpler and more efficient or combine all parties. Ideas included single-product or single-defendant MDLs, separating out prescription-only users, or separating out patients who had only used products made and sold by AstraZeneca, which its attorney said is currently named in 100 cases.

 Kidney injuries

In their May 31 motion, Motion to Consolidate Re: PPI Hearing Los Angeles July 27, 2017, the moving plaintiffs seek centralization before U.S. Judge David R. Herndon of the Southern District of Illinois.

The plaintiffs allege that PPIs cause kidney injuries including acute interstitial nephritis, chronic kidney disease and end-stage renal disease. Concerns that these drugs have harmful side effects for users’ kidneys were brought to the U.S. Food and Drug Administration by consumer advocacy group Public Citizen in 2011, and the agency required warnings about risks of acute interstitial nephritis on labels in 2014, according to the patients’ MDL brief.

More recent research led to stronger findings of a connection, including a scientific study published in January 2016 that said PPI use was independently linked to a 20 to 50 percent higher risk of chronic kidney disease. Plaintiffs have also brought allegations of renal failure being caused by the drugs. To date, more than 5,000 PPI cases are under investigation by Plaintiff’s counsel, and more could be added to that number as awareness of the association between PPI use and kidney damage continues to increase. While the drug class first received FDA approval in 1989, serious side effects prompted the FDA in 2014 to require all PPIs to display a warning label that called out the connection to acute interstitial nephritis. The Plaintiff’s brief also mentions several studies that have made a correlation between PPI use and kidney damage during the past 25 years, including a 1992 study by the University of Arizona Health Sciences Center, a 2006 study conducted at the Yale School of Medicine and a 2016 study from John Hopkins published in the Journal of the American Medical Association (JAMA).

The plaintiffs note that in January, the JPML denied centralization of PPI cases, but say later significant developments “warrant a second look at consolidation.”

The defendants are AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc. and Pfizer subsidiary Wyeth.  The defendants’ responses are due June 27.

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Proof of Monsanto Collusion to Stop Release of Cancer Link to Roundup Weed Killer

“Another Example of Corporate America and Undue Influence on Official Release of Damaging Scientific Data”

Proof of Monsanto Collusion to Stop Release of Cancer Link to Roundup Weed Killer

Documents released in a lawsuit against Monsanto, see Roundup (Monsanto) MDL 2741 USDC ND California, raised new questions about the company’s efforts to influence public opinion by collusion and steering of data published by mainstream media, various authors and scientific research publications and revealed an internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world, used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most US regulators, the Federal Mass Tort Litigation against Monsanto and Roundup,  pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific data are released, the number of filed cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research, when an academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process, see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits. Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence”  see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from Forbes.com and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction, however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

 

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GSK Asks Supreme Court to Let it Wriggle Out of Jurisdiction in Paxil Birth Defect Case

paxil birth defectsGlaxoSmithKline, the maker of antidepressant Paxil that causes profound birth defects, according to plaintiffs, asked the US Supreme Court to release it from the jurisdiction of an Illinois trial court because the mothers and children are from out-of-state.

The case is GlaxoSmithKline LLC v. MM. Ex Rel Meyers, et al, Petition No. 16-1171. The Appellate Court of Illinois First District, Fifth Division, ruled the trial court had “specific personal jurisdiction” over the global company because the plaintiff’s claims “arise out of or relate to” Glaxo’s activities in Illinois.  See 61 NE3d 1026 (Aug. 26, 2016).

Six pairs of mothers and children from Florida, Colorado, Virginia, Michigan, Illinois and Wisconson, sued the giant pharma company in the Circuit Court of Cook County, IL. Each claims the GSK failed to warn about Paxil’s dangers if used during pregnancy, that Paxil was defectively designed, the GSK was negligent, breached warranties and negligently misrepresented and concealed the risks of Paxil.

GSK, of course, wants a very strict threshold for exercising jurisdiction — that the defendant’s activities in the forum state directly caused the plaintiff’s injury. In another case before the Supreme Court, Bristol-Myers Squibb is making a similar argument in an effort to escape jurisdiction of California state courts. See US Supreme Court to Rule on California State Jurisdiction Over Plavix Litigation.

Creating a conflict

GSK has many connections to Illinois:

  • It employs 16,232 people in the US, 217 of whom reside in Illinois.
  • It has an agent for service of process in Illinois.
  • Between 2000 and 2006, GSK had anywhere between 79 and 121 employees marketing specifically Paxil in Illinois.
  • GSK does business in and derives substantial revenue from Cook County, Illinois.
  • The company conducted clinical trials of Paxil in Illinois.

GSK argues that some of the plaintiffs saw their doctors and ingested Paxil outside of Illinois, and that the company is incorporated in Delaware with corporate headquarters in Pennsylvania and North Carolina. This, according to Glaxo, creates an “intolerable” conflict in the courts that the Supreme Court must resolve:

  • Six courts adhere to a proximate causation standard.
  • Five courts (including Illinois) have adopted a but-for causation standard.
  • Four other courts apply “an even looser standard that does not require any showing of causation.

Glaxo’s lawyers argue that a proximate causal link is required to exercise jurisdiction or else “a large company with nationwide operations is subject to jurisdiction on essentially any claim in essentially any state.” It calls this approach “universal general jurisdiction,” which it wants the high court to reject.

Catastrophic birth defects

The plaintiffs allege that there was a “significantly increased risk of congenital defects in babies whose mothers ingested” the drug. This knowledge was “scientifically knowable through appropriate research and testing.” Plaintiffs allege that the FDA requires defendant GSK “to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and [Paxil].”

Despite defendant GSK’s opportunity and duty to strengthen the drug’s warnings, it “touted [Paxil] as being safe for pregnant women” and “aggressively *** promoted” the drug with labels that inadequately cautioned patients of the associated risk factors, thus, misrepresenting the drug to the public and to the medical profession.

The complaint alleges that, had defendant GSK apprised plaintiffs’ physicians of Paxil’s risks, they would not have “prescribed or permitted” plaintiffs to use the drug. Likewise, had defendant GSK provided timely and “adequate warnings regarding the risks” of Paxil, plaintiffs would not have ingested the drug.

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Viibryd linked to Acute Pancreatitis and Sleep Paralysis

ViibrydViibryd, manufactured by Forest Laboratories was approved by the FDA in 2011 for the treatment of major depressive disorder (MDD) in adults.

  • After reviewing an FDA Letter to Forest Labs written on September 6, 2016, we believe new warnings will shortly be added to the Viibryd label related to a link between the drug and acute pancreatitis.
  • Additionally we expect to see new warnings related to sleep paralysis also added to the Viibryd label and prescribing information.

Although this drug affects serotonin, it functions slightly different from most SSRIs because it also acts as a partial antagonist of the 5­HT1A receptor.  Approved in 2011, Viibryd quickly became the third-most prescribed antidepressant by 2014, according to Mental Health Daily. Cymbalta and Prestiq being the two antidepressants prescribed more often that Viibryd.

Although sleep paralysis is a serious condition and which cause psychological harm in the most severe cases, the condition is generally not severe. Sleep paralysis is a condition in which a person is awake but can not move or speak. Generally, sleep paralysis occurs upon waking and last less than one minute.

However acute pancreatitis can lead to serious injury and even death. Pancreatitis, especially if it reoccurs, can lead to pancreatic cancer, which is almost uniformly fatal.

Added to Mass Tort Nexus Watch List

To the best of our knowledge no lawsuits have been filed related to these newly discovered conditions linked to Viibryd however, we expect that when the new warnings are added, it may lead to investigations by law firms and education campaigns directed toward  users of Viibryd. The result of these investigations and public education campaigns are likely to lead to Viibryd lawsuits being filed.

The potential Viibryd Litigation will be discussed at the November 11th -14th Four Days to Mass Tort Nexus Course in Fort Lauderdale. For Information on other topics that will be discussed by our panel at the November Course visit this link:  Panel Discussions

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