WHAT JOHNSON & JOHNSON DOESN’T TELL THE GENERAL PUBLIC ABOUT PENDING LITIGATION

By Mark York (November 7, 2017)

 

 

 

 

 

 

A Report by Mass Tort Nexus

Recently filed with the Securities and Exchange Commission:

 “Johnson & Johnson 2017 3rd Quarter 10-Q Statement”

 PRODUCT LIABILITY LAWSUITS AGAINST JOHNSON & JOHNSON

Johnson & Johnson and certain of its subsidiaries are involved in numerous product liability claims and lawsuits involving multiple products. Plaintiffs in these cases seek substantial compensatory and punitive damages. While the Company believes it has substantial defenses, it is not feasible to predict the ultimate outcome of litigation. To date in 2017, Johnson & Johnson has been exposed to over $1.5 billion in verdict awards related to various legal matters filed against products manufactured by the company.

Primary Products:

The most significant cases include:

Medical Devices:  DePuy ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System; the PINNACLE® Acetabular Cup Hip Implant System; Ethicon TVM and other pelvic mesh products

Pharmaceutical Products: RISPERDAL®; XARELTO®; INVOKANA.

Personal Care Products: J&J powders containing talc, primarily JOHNSON’S Baby Powder and Shower to Shower Body Powder

 The Legal Numbers:

 As of October 1, 2017, the numbers for litigation in the United States against Johnson & Johnson for claims against pharmaceutical and medical device products are:  

DePuy ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System – 2,000 claims

PINNACLE® Acetabular Cup Hip System – 9,900  claims

Transvaginal Mesh and Pelvic Mesh – 54,300 claims

RISPERDAL– 13,900 claims

XARELTO – 21, 400 claims  

J&J Baby Powder – 5,500 claims

INVOKANA – 1,100 claims

General Legal Disclaimer:

The Company has established accruals for product liability claims and lawsuits in compliance with ASC 450-20 based on currently available information, which in some cases may be limited. The Company accrues an estimate of the legal defense costs needed to defend each matter when those costs are probable and can be reasonably estimated. For certain of these matters, the Company has accrued additional amounts such as estimated costs associated with settlements, damages and other losses. To the extent adverse verdicts have been rendered against the Company, the Company does not record an accrual until a loss is determined to be probable and can be reasonably estimated. Product liability accruals can represent projected product liability for thousands of claims around the world, each in different litigation environments and with different fact patterns. Changes to the accruals may be required in the future as additional information becomes available.

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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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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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DePuy Pinnacle Hip Implant Trial Set for Today Delayed Based on Appellate Ruling of “Grave Error” By Sitting Judge

DePuy Pinnacle Hip Implant Bellwether Trial Set For September 5th Delayed After Appeals Court Cites Grave Error By Judge

 

 

 

 

 

DePuy Orthopaedics, Inc a subsidiary of Johnson & Johnson

By Mark A. York (September 5, 2017)

Federal Judge Ed Kinkeade has delayed the next DePuy Pinnacle hip implant bellwether trial that was set for today, Sept. 5, 2017 until later this month after a split federal appeals panel requested that he halt the proceedings due to a “grave error.”

In the August 31st opinion, two of three judges on a panel of the U.S. Court of Appeals for the Fifth Circuit refused to grant a petition for writ of mandamus filed by DePuy Orthopaedics Inc. to halt the trial. But two of the three also concluded that U.S. District Judge Ed Kinkeade, who is presiding over 9,300 cases alleging DePuy’s Pinnacle hip implants are defective, committed a “grave error” in allowing certain trials to take place before him, including the one scheduled this month on behalf of eight New York plaintiffs.

Opinion Outline

The opinion stated “despite finding serious error, a majority of this panel denies the writ that petitioners seek to prohibit the district court from proceeding to trial on plaintiffs’ cases,” wrote Circuit Judge Jerry Smith. “A majority requests the district court to vacate its ruling on waiver and to withdraw its order for a trial beginning September 5, 2017.”

Skadden, Arps, Slate, Meagher & Flom lead counsel for Johnson & Johnson, DePuy’s parent company, called on Judge Kinkeade to halt the trial, which is the fourth bellwether in the multidistrict litigation over the DePuy Pinnacle hip implant. This may help DePuy and J&J avoid a repeat of the last Pinnacle verdict in the prior bellwether trial where a Dallas jury awarded over $1 billion in damages, subsequently reduced by Judge Kinkeade, see DePuy Pinnacle Hip Implant Dec 2016 Trial Verdict Halved to Just $500 million in December 2016, which DePuy-J&J are appealing.

“We are pleased that the Fifth Circuit has determined that the MDL court does not have jurisdiction to conduct its planned trial of the claims of eight New York plaintiffs in a Texas courtroom,” Beisner wrote in an emailed statement after the ruling.

Plaintiff Counsel Surprised

Lead plaintiffs attorney Mark Lanier called it the “wildest opinion I’ve ever seen.”

“What this small panel has tried to do is change the law in the Fifth Circuit on a mandamus record, and that’s really frowned about,” said Lanier, of The Lanier Law Firm in Houston, who was joined in the appeal by former U.S. Solicitor General Kenneth Starr.

In addition to this month’s trial, the ruling could impact a separate case before the Fifth Circuit in which Johnson & Johnson has raised the same venue arguments in appealing a $1.04 billion verdict in the most recent Pinnacle trial. Oral argument on that appeal hasn’t yet been scheduled.

“Why this court issues an order on another court’s case, which is just an advisory opinion, is just absurd,” said Lanier. “It’s judicial activism.”

Lanier filed a petition for rehearing en banc on Friday. Later that afternoon, Kinkeade ordered the trial delayed until Sept. 18.

Final Bellwether trial

Kinkeade appeared to anticipate the Fifth Circuit’s intervention. On Aug. 25, he ordered that this month’s trial would “be the final bellwether case tried in the Dallas division of the Northern District of Texas” under which both sides have waived venue.  This was an unexpected ruling for the Pinnacle litigation, where Johnson & Johnson has appealed two other verdicts in Kinkeade’s courtroom, both involving consolidated cases that led to major awards in 2016,. Johnson & Johnson won the first verdict in 2014. But a second trial ended with a verdict of $502 million awarded to five Texas plaintiffs, while the third gave $1.04 billion verdict to six California plaintiffs.

All DePuy Hip Implant Litigation

These cases are part of the 8,707 actions consolidated before Judge Kinkeade in MDL 2244, In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, Case No. 3:11-md-02244, Northern District of Texas in Dallas.

Juries have found that DePuy and J&J have negligently designed the hip implant, failed to warn surgeons about dangerous conditions related to the implant, and concealed its risks. J&J stopped selling the devices in 2013 after the FDA issued a safety communication about artificial-hip damages.

Separately, DuPuy is facing 1,458 product liability actions consolidated before US District Judge Jeffrey J. Helmick in MDL 2197, In re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation in Toledo, Ohio.

J&J prevailed in the first Pinnacle hip case to go to trial in October 2014 after a jury rejected a Montana woman’s claims that the devices were defective and gave her metal poisoning. In March 2016, a Dallas jury ordered J&J to pay $502 million to a group of five patients who accused the company of hiding defects in the hips. A judge cut that verdict in July to about $150 million.

DePuy Claims “Lexecon” Error

DePuy and Johnson & Johnson have argued that Kinkeade lacked jurisdiction over the trials involving California and New York plaintiffs. MDL judges are assigned to oversee pretrial matters with the intention of sending cases back to their original courts for trial. But defendants often waive that right under the U.S. Supreme Court’s 1998 holding in Lexecon v. Milberg Weiss Bershad Hynes & Lerach, which allows bellwether trials to proceed before an MDL judge.

Johnson & Johnson claims it waived that right as to the first and second trials, but not the third or fourth. Plaintiffs’ attorneys have insisted that Johnson & Johnson agreed to a global waiver over all the trials.

Mass Tort Nexus will provide additional details of the ongoing trial dispute as information becomes available.

 

 

 

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Does Using Talcum Powder Cause Ovarian Cancer?

Does Johnson & Johnson talcum powder cause ovarian cancer?

(Mass Tort Nexus, August 28, 2017)  Johnson & Johnson has been ordered to pay nearly $1 billion in total damages after just 5 trials, alleging its baby powder is causing ovarian cancer, all jury verdicts have been in state courts in Missouri and California, see J&J Talc Trials St. Louis Missouri.

 

 

 

 

 

 

A Los Angeles jury said yes, and last week it ordered Johnson & Johnson (J&J) to pay $417 million to 63-year-old Eva Echeverria, She blamed her terminal illness on Johnson’s Baby Powder, which she used for decades starting at age 11. Her argument was, the company should have warned consumers about the risk, which J&J stated was not necessary and the jury chose to believe Ms. Echeverria and her trial team.

The jury award is the biggest yet against J&J, which has lost 5 of 6 trials involving claims that its baby powder and Shower to Shower powder cause ovarian cancer. The company denies there’s a connection between its products and the disease and quickly said it would appeal the Los Angeles verdict. Lawsuits involving thousands more plaintiffs are pending, see Johnson & Johnson Talc MDL 2738 Briefcase.

Medical industry and cancer research experts divide sharply on talc’s role. Some are convinced the powder is linked to an increased risk of ovarian cancer, while other  including government health experts, say the evidence is lacking.

Amanda Fader, a gynecologic oncologist at Johns Hopkins University who was not involved in the studies states “The scientific body of literature is not compelling at this time to support a strong association between talcum powder and ovarian cancer, let alone to say that any one specific case was associated with powder,” and The American Cancer Society says that studies on talcum powder and ovarian cancer “have been mixed, with some studies reporting a slightly increased risk and some reporting no increase.

Yet Fader and others aren’t ruling out that a link might someday be established. The Food and Drug Administration, which says it has found no link, is doing additional research on the topic. Although, J&J has spent millions of dollars lobbying and influencing all areas of FDA and related public oversight and commentary to prevent and type of link between cancer and talcum powder products from being abbounced, even while competitor talc products sold at Wal-Mart and Dollar Tree post warning labels declaring a possible link.

Talc, a mineral composed of magnesium, silicon, oxygen and hydrogen, is used extensively in cosmetics and personal care products. Women sometimes use talcum powder on their genital areas, sanitary napkins or diaphragms to absorb moisture and odor – contrary to the guidance of most physicians. (Asbestos, linked to lung cancer, was once an impurity in talc, but it has been banned for several decades.)  J&J is notorious for using any means possible to influence scientific data and opinion as well as manipulating research reports and public media commentary by industry experts. The recent California trial showed payments made to previously perceived impartial Science Council members, who were declaring publicly that J&J talcum powder does not pose a cancer risk, the Los Angeles jury did not agree with J&J and other pro-talc defense team members, as over $300 million of the total $417 million judgment was for punitive damages, usually awarded for intentional misconduct, see“New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”.

Many pediatricians also discourage the use of such powder on babies because the particles can cause breathing problems, according to Jennifer Lowry, a pediatrician and environmental health expert at Children’s Mercy Hospital in Kansas City.

More than 22,000 women in the United States will be diagnosed with ovarian cancer this year, and 14,000 will die. The biggest risk factors, all well established, include a family history of breast or ovarian cancer, mutations in the BRCA genes and age.

The debate over talc began decades ago. In the early 1970s, scientists discovered talc particles in ovarian tumors. In 1982, Harvard researcher Daniel Cramer reported a link between talcum powder and ovarian cancer. His study was followed by several more finding an increased risk of ovarian cancer among regular users of talcum powder. Cramer, who at one point advised J&J to put a warning on its products, has become a frequent expert witness for women suing the company. J&J ignored and suppressed Mr. Cramer’s attempts to show them the study data then publicly declared this research as flawed, which J&J still continues to this day.

His studies and the many others that have found a relationship used a case-control approach. A group of women diagnosed with ovarian cancer and a group without it were asked to recall their past diet and activities, and the results were then compared.

Critics say these kinds of studies have serious drawbacks, particularly “recall bias.” Women may forget what they did or, if diagnosed with cancer, might inadvertently overestimate their use of a suspect substance. People without a serious disease may be less motivated to remember details.

Three other studies – considered cohort studies – did not find any overall link. Unlike the case-control studies, these efforts began with a large group of women who did not have cancer and followed the progress of their health, with participants recording what they were doing in real time. The results of this approach, most scientists say, are stronger because they aren’t subject to the vagaries of memory.

One such study included more than 61,000 women followed for 12 years as part of the National Institutes of Health’s well-respectedWomen’s Health Initiative.

But critics, including Cramer, say these investigations have their own flaws. Because ovarian cancer is so rare, they say, prospective studies don’t always end up with enough cancer cases to detect a potential link between talcum powder and the disease.

And evidence can change as new research becomes available. That explains why the NCI, which uses expert “editorial boards” to vet the voluminous information it puts out for doctors and consumers, has amended its language on talc.

In February 2014, one editorial board reviewed an analysis of several case-control studies that found genital-powder use was associated with a “modest increased risk” of ovarian cancer. The board decided to add the article to the NCI website and noted a weak association between talc and ovarian cancer. It also added a link to the website of the International Agency for Research on Cancer, a World Health Organization agency that had concluded years ago that talcum powder was “possibly carcinogenic,” when used in the genital area.

But a year later, the same board scrutinized the Women’s Health Initiative study and took another look at previous studies. That’s when it changed the wording on the NCI’s site to say the “weight of evidence” did not support a link. The board also removed the IARC information. This all occurred after Johnson & Johnson used lobbying pressure and alleged payments to various affiliated entities to influence the NCI change of formal opinion

The FDA has wrestled with the issue, too. In 2014, it denied a citizens’ petition asking the agency to require a warning label on talcum powder; its review of the scientific literature found no link between the product and cancer, officials said.

But because the agency continues to get “adverse event reports” involving talcum powder, it is taking another look at the evidence and launching its own laboratory research. The summary for one study, funded by the FDA’s Office of Women’s Health, says that “talc’s effects on female genital system tissues have not been adequately investigated.”

In a statement after the Los Angeles verdict, J&J said that “we deeply sympathize with the women and families impacted by this disease.” But, it added, the science “supports the safety of Johnson’s Baby Powder.”

No matter what side they are on, scientists agree that more research – through lab studies with animals or human tissue – is needed to understand how talcum powder could potentially cause cancer. One hypothesis is that talc applied to the genital area can migrate up the vagina to the ovaries, causing chronic inflammation that eventually results in malignancies. But that is only a hypothesis.

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Xarelto Trial: Defense Wins Again in Dora Mingo vs. Bayer AG and Janssen R&D In Third Trial Loss for Plaintiffs

Xarelto Trial Update: Defense Wins Again in Dora Mingo vs. Bayer AG and Janssen R&D In Third Trial Loss for Plaintiffs

(Dora Mingo vs. Janssen Research & Development, LLC et al. Case No. 2:15-cv-03469)

 

JACKSON, Miss. – The Dora Mingo vs. Janssen and Bayer trial verdict was entered in favor of the defense this afternoon. This is the third trial verdict for defense in the Xeralto MDL 2592 bellwether trials, the verdict was returned in favor of the defendants not long after after closing arguments completed earlier today August 18, 2017.  Ms. Mingo a resident of Mississippi woman claims that Xarelto which was prescribed as a blood-thinner drug for treatment of a blood clot, caused her to suffer internal bleeding and anemia.

A jury of five men and four women were sitting in the U.S. District Court for the Southern District of Mississippi in front of visiting Judge Eldon Fallon, of the US District Court ED Louisiana, who heard closing arguments earlier today, and are now in deliberations.  The case relates to 69 year-old Dora Mingo of Summit, MS against the Bayer Companies and Janssen R&D and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

In previous back-to-back federal bellwether trials, juries have cleared the manufacturers of Xarelto of liability relating to claims that the drug caused internal bleeding, which plaintiff attorneys allege led to severe injuries or deaths in patients who used it.

The Food & Drug Administration (FDA) approved Xarelto in 2011 for prescription to patients suffering from a rhythmic heart disorder called atrial fibrillation and to prevent blood clots which can lead to heart attacks, strokes and pulmonary embolisms.

However, plaintiffs and their counsel charge Xarelto’s manufacturers with failing to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.

Plaintiff counsel asserted a Prothrombin Time (PT) test, used to assess a patient for bleeding risks, was something Xarelto’s manufacturers didn’t inform and instruct doctors about. However, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable in their view.

Mingo, a grandmother and retired schoolteacher, was prescribed Xarelto in January 2015 for treatment of a blood clot in her leg. After taking Xarelto, Mingo alleges she suffered severe upper gastrointestinal bleeding and acute blood loss anemia.

As soon as the trial verdict is released Mass Tort Nexus will send update.

 

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Xarelto Trial Update: Dora Mingo vs. Bayer AG and Janssen R&D Trial Finished Earlier Today

Xarelto Trial Update: Dora Mingo vs. Bayer AG and Janssen R&D Trial Finished Earlier Today

(Dora Mingo vs. Janssen Research & Development, LLC et al. Case No. 2:15-cv-03469)

 

JACKSON, Miss. – The third bellwether Xeralto MDL 2592 trial has ended, closing arguments completed earlier today August 18, 2017. Ms. Mingo a resident of Mississippi woman claims that Xarelto which was prescribed as a blood-thinner drug for treatment of a blood clot, caused her to suffer internal bleeding and anemia.

A jury of five men and four women were sitting in the U.S. District Court for the Southern District of Mississippi in front of visiting Judge Eldon Fallon, of the US District Court ED Louisiana, who heard closing arguments earlier today, and are now in deliberations.  The case relates to 69 year-old Dora Mingo of Summit, MS against the Bayer Companies and Janssen R&D and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

In previous back-to-back federal bellwether trials, juries have cleared the manufacturers of Xarelto of liability relating to claims that the drug caused internal bleeding, which plaintiff attorneys allege led to severe injuries or deaths in patients who used it.

The Food & Drug Administration (FDA) approved Xarelto in 2011 for prescription to patients suffering from a rhythmic heart disorder called atrial fibrillation and to prevent blood clots which can lead to heart attacks, strokes and pulmonary embolisms.

However, plaintiffs and their counsel charge Xarelto’s manufacturers with failing to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.

Plaintiff counsel asserted a Prothrombin Time (PT) test, used to assess a patient for bleeding risks, was something Xarelto’s manufacturers didn’t inform and instruct doctors about. However, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable in their view.

Mingo, a grandmother and retired schoolteacher, was prescribed Xarelto in January 2015 for treatment of a blood clot in her leg. After taking Xarelto, Mingo alleges she suffered severe upper gastrointestinal bleeding and acute blood loss anemia.

As soon as the trial verdict is released Mass Tort Nexus will send update.

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New Jersey Appellate Court Ruling of July 25, 2017 Reinstates Accutane Litigation

New Jersey Appellate Court Ruling of July 25, 2017 Reinstates Accutane Litigation

07/28/17 IN RE: ACCUTANE LITIGATION
New Jersey Appellate Court Opinion A-4698-14T1/A-0910-16T1
(CONSOLIDATED)

In the multicounty litigation (MCL) New Jersey Accutane product liability cases, the Appellate Division held that the trial court erred in barring plaintiffs’ experts from testifying as to certain epidemiological issues, and that Accutane can cause Crohn’s disease. Accordingly, the 2015 orders dismissing the lawsuits are reversed and the cases are remanded to the trial court for further proceedings per the July 25, 2017 order. The opinion reviews the legal principles applicable in a Kemp hearing, and provides some guidance for handling MCL cases in which the scientific evidence concerning the product develops over the protracted course of the litigation.

http://www.judiciary.state.nj.us/…/unp…/a4760-14a0164-15.pdf

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