Why Did The FDA Approve A Drug 10 Times Stronger Than Fentanyl-When Opiates Are Still Killing Thousands

HAS THE FDA LEARNED ANYTHING FROM THE OPIOID CRISIS THEY HELPED CREATE?

Mark A. York (November 6, 2018)

 

 

 

 

 

 

 

 

 

Just The Opioid Facts

Drugs kill more Americans than guns, cars and AIDS. How we got here.

(Mass Tort Nexus Media) More than 175 Americans will die today of drug overdoses, which equals a 737 crashing and killing all the passengers on board every single day. But it’s not a plane crash. It is America’s opioid epidemic, one that unchecked could claim 1 million lives by 2020.

See also: Briefcases/Drugs/254/OPIOID-National-Prescription-Litigation-MDL-2804-USDC-ND-Ohio-(Eastern-Division) by Mass Tort Nexus

Who’s Minding The FDA?

A new opioid tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the Food and Drug Administration Friday as a fast-acting alternative to IV painkillers used in hospitals.

The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic.

Also on Friday, the Drug Enforcement Administration released a report showing that prescription drugs were responsible for the most overdose deaths of any illicit drugs since 2001.

Democratic Senator Ed Markey of Massachusetts urged the FDA to not approve Dsuvia last month, saying “an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill.”

To that, FDA Commissioner Scott Gottlieb said in a statement that “very tight restrictions” will be placed on Dsuvia. This statement flies in the face of reality as proven by assigned federal agencies to monitor and enforce rules on the already existing opiates that have flooded the US marketplace and killed hundreds of thousands of Americans.

So why should we think that anything is different with a new drug that basically comes under the same oversight umbrella as fentanyl, oxycontin and all the other prescription opiates? The DEA, FDA and anyone else assigned to monitor narcotic drug use, prescribing practices as well as marketing have failed miserably again and again.

FDA Claims Restricted Access

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said. The medication, which comes in a single-use package, also should not be used for more than 72 hours. The medicine comes in a tablet that can dissolve under the tongue. Side effects of the potent drug include extreme tiredness, breathing problems, coma and death.

Gottlieb said military use of the drug was “carefully considered in this case” as the FDA wants to “make sure our soldiers have access to treatments that meet the unique needs of the battlefield.”

Combined with the increase in overdoses, the fact that opioids are less effective than presumed creates a substantial public health problem. We are throwing large sums of public and private money at treating opioid addiction and related issues caused by a problem that could have been completely avoided by using more effective (and less habit-forming) medications.

In the midst of a national opioid crisis, the federal agency that monitors drug ads has issued a record low number of warning letters to pharmaceutical companies caught lying about their products.

The Food and Drug Administration has sent just three notice letters to drug makers busted for false marketing their medications to unknowing consumers, the lowest ever since the FDA historic decision to ease strict rules for drug ads in 1997. “It certainly raises questions,” said Dr. David Kessler, head of the FDA from late 1990 through 1996, who’s industry credentials would add weight to the issue of why the FDA is not doing more to monitor false marketing campaigns by Big Pharma and Opioid Drug makers in particular.

The FDA’s Office of Prescription Drug Promotion monitors all ads drug companies issue to make sure patients aren’t being scammed by false assertions or misleading marketing campaigns. This now seems to be the norm, based on the hundreds of lawsuits filed against Opioid Drug Makers in the last 3 months, and recently consolidated into Opiate Prescription MDL 2804 see Opioid Crisis Briefcase-Mass Tort Nexus, where Big Pharma is being sued by states, cities and counties across the country. The primary claim in almost every suit is long-term boardroom coordinated false marketing campaigns designed to push opioid drug prescriptions at any cost.

 FDA Told Not to Approve Dsuvia

https://www.cdc.gov/drug-overdose-data-death counts through Oct 2018

Drug overdose deaths hit the highest level ever recorded in the United States last year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. Most of that was the result of a record number of opioid-related deaths.

 

How Big Pharma got into opiates: In 1898, Bayer released heroin to treat coughs and other health woes. Soon, people became addicted to heroin, a narcotic and precursor to the current Opioid Crisis.

 Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. About a week ago, U.S. Health and Human Services Secretary Alex Azar said overdose deaths, while still slowly rising, were beginning to level off, citing figures from late last year and early this year.

The DEA’s National Drug Threat Assessment, which was recently released, shows that heroin, fentanyl and other opioids continue to be the highest drug threat in the nation. But federal officials are concerned that methamphetamine and cocaine are being seen at much higher levels in areas that haven’t historically been hotspots for those drugs. The DEA is also worried that people are exploiting marijuana legalization to traffic cannabis into the illicit market or to states that don’t have medicinal or recreational-use marijuana laws, according to the report.

The preliminary data also showed 49,060 people died from opioid-related overdose deaths, a rise from the reported 42,249 opioid overdose deaths in 2016.

Fatal heroin overdoses rose nationwide between 2015 and 2016, with a nearly 25 percent increase in the Northeast and more than 22 percent in the South. Most of the heroin sold in the U.S. is being trafficked from Mexico, and U.S. Customs and Border Protection officers seize the most amount of heroin along the Mexico border, near San Diego, California, the report said.

Fentanyl and other related opioids, which tend to be cheaper and much more potent than heroin, remain one of the biggest concerns for federal drug agents.

The DEA has said China is a main source of fentanyl and other synthetic opioids that have been flooding the U.S. market. China has pushed back against the characterization, and U.S. officials have stressed they work closely with their Chinese counterparts as they try to stem the flow of drugs.

Legislation that Trump signed last week will add treatment options and force the U.S. Postal Service to screen overseas packages for fentanyl.

Azar said in a speech last week that toward the end of 2017 and through the beginning of this year, the number of drug overdose deaths “has begun to plateau.” However, he was not indicating that deaths were going down, but that they appear to be rising at a slower rate than previously seen.

Pot Vs. Pills for Pain Relief

Last month, the Centers for Disease Control and Prevention released preliminary figures that appear to show a slowdown in overdose deaths from December to March. In that period, the figures show that the pace of the increase over the previous 12 months has slowed from 10 percent to 3 percent, according to the preliminary CDC figures.

Even if a slowdown is underway, no one is questioning the fact that the nation is dealing with the deadliest drug overdose epidemic in its history. While prescription opioid and heroin deaths appear to be leveling off, deaths involving fentanyl, cocaine and methamphetamines are on the rise, according to CDC data.

The DEA’s report also noted that methamphetamine is making its way into communities where the drug normally wasn’t heavily used, the report said. Chronic use of meth, a highly addictive stimulant, can cause paranoia, visual and auditory hallucinations and delusions, studies have shown.

As the government enacted laws that limited access to cold medicines containing pseudoephedrine — the ingredient used to cook meth with other household chemicals — or required the medications to be placed behind pharmacy counters, officials discovered the number of meth labs began to drop.

But the DEA has found the gap is being filled by Mexican and Latin American drug cartels that had primarily dabbled in heroin and cocaine trafficking. A saturated market on the West Coast is now driving the cartels to peddle methamphetamine into the Northeast, using the same routes they use for heroin and other drugs.

Officials also warn that because of more cocaine production in South American countries including Colombia, they expect to see larger shipments at the Mexican border.

Who Said “Pain Was The Fifth Vital Sign?”

“Pain as the fifth vital sign” became policy at VA clinics as well as VA hospitals across the U.S.

It seemed odd to equate pain with something like breathing, but doctors were advised by Purdue Pharma and other opiate makers to understand the need to “dignify” and take care of pain.

Across the country doctors seemed too willing to prescribe these opioid pills for chronic pain, patients seemed too willing to take them, and insurers seemed too willing to pay.

The Joint Commission began requiring hospitals to assess all patients for pain on a scale of 1 to 10, which some claimed caused more doctors to prescribe opioids.

Purdue gave the commission a grant to produce a pain assessment and management manual.

Officials from the commission and Purdue denied the company had anything to do with the content of the manual, co-written by Dr. June Dahl, who served on the speakers bureau for Purdue.

The manual told health care facilities the side effects of opioids had been exaggerated and that physical dependence had been wrongly confused with addiction. “There is no evidence that addiction is a significant issue when persons are given opioids for pain control,” the manual said.

Paid Endorsements In Studies

Purdue officials explained that studies on opioid addiction depended on many factors, including mental health. They cited a 2008 article by Dr. David Fishbain of the University of Miami, who analyzed 79 published studies, saying he concluded the prevalence of abuse or addiction was 3.27 percent, or 0.19 percent for those with no past addiction.

Fishbain responded that his study was misinterpreted and that addiction could be anywhere between 3.27 and 20.4 percent.

Commission officials denied its new standards encouraged doctors to prescribe more opioids, blaming drug trafficking as well as diversion and abuse by individuals.

At that time, the “evidence was broadly supported by experts across the spectrum that pain was undertreated and a serious problem leading to poor clinical outcomes,” the commission said.

The commission concluded that “millions of people in the United States suffer from pain, and failure to treat their pain is inhumane.”

The Painkiller Market

Since 1987, Purdue Pharma had been selling a timed-release drug named MS Contin, the company’s version of morphine. Seven years later, annual sales topped $88 million — the best performing painkiller Purdue officials had — but they faced problems.

Doctors knew how addictive morphine could be, and most were reluctant to prescribe MS Contin to patients suffering from chronic pain.

The even bigger problem? MS Contin’s patent would expire soon.

That meant generic drug manufacturers could make their own versions of MS Contin and eat into Purdue’s share of the painkiller market.

A generation earlier, Arthur Sackler, the brother of Purdue’s owners, had marketed Valium and other tranquilizers to women experiencing anxiety, tension or countless other symptoms. The drug broke all sales records, turning many women into addicts and Sackler into a multimillionaire.

The Sackler family planned to repeat that success with a timed-release version of OxyContin, the company’s version of oxycodone.

In internal Purdue documents obtained by the USA TODAY NETWORK, company officials gushed that OxyContin could become a hit in “the $462 million Class II opioid marketplace.”

These documents detail their strategy: They would first market OxyContin strictly for cancer pain, where doctors were familiar with oxycodone.

Then the company would pivot to the lucrative market of chronic pain, which afflicted at least 25 million Americans.

Purdue’s plan included targeting primary care physicians, surgeons, obstetricians and dentists. The company even targeted home care and hospice care nurses who would “rate the patients’ pain and make a recommendation on the type of opioid and dosage for pain control.”

The plan also included targeting patients and caregivers through Purdue’s “Partners Against Pain” program. “You are the pain authority,” the website reassured patients. “You are the expert on your own pain.”

The website declared that “there are 75 million Americans living with pain, although pain management experts say they don’t have to,” reassuring patients that doctors could control their pain “through the relatively simple means of pain medications” and that the risk of addiction to opioids “very rarely occurs when under medical supervision to relieve pain.”

To ensure that OxyContin became a hit, Purdue sponsored more than 20,000 educational programs to encourage health care providers to prescribe the new drug and sent videos to 15,000 doctors.

The company also hosted dozens of all-expenses-paid national pain management conferences, where more than 5,000 physicians, pharmacists and nurses were trained for the company’s national speakers bureau.

By 2001, Purdue was spending $200 million on marketing and promotion and had doubled its sales force to 671. Before the year ended, sales bonuses reached $40 million.

No Addiction Knowledge 

Dr. Fannin, who practices in West Virginia remembers sales reps from Purdue flooding doctors’ offices in Appalachia, where poverty and pain are constant realities.

The reps gave away fishing hats, stuffed toys and music CDs titled “Get in the Swing with OxyContin.”

“Every time you turned around, you saw their faces,” Fannin said. “We had a population of doctors with very little grounding in pain, and I think Purdue took advantage of that.”

Many doctors knew about oxycodone from Percocet, which combined a small dosage of the potent opioid with 325 mg of acetaminophen.

What many of those doctors didn’t realize was that oxycodone was nearly twice as powerful as morphine, delivering a powerful high to those who use the drug.

“It’s more like heroin,” explained Dr. Andrew Kolodny, co-director of the Opioid Policy Research Collaborative at Brandeis University. “It crosses the blood-brain barrier more quickly.”

But the sales reps never mentioned that. Instead, they said OxyContin didn’t create highs like other opioids and was less likely to get people addicted.

Fannin recalled sales reps calling OxyContin “a revolution in pain care” and “much more effective” than the old drugs.

They also talked of studies, citing one that found only four of 11,882 patients — less than 1 percent — became addicted after using opioids. Portenoy and others repeatedly cited this research, with some calling it a “landmark study.”

The truth is it wasn’t even a study. It was a five-sentence letter to the editor that a doctor wrote the New England Journal of Medicine.

For the most part, Fannin believed what the sales reps were telling him, and so did other doctors in the region.

“Our knowledge about addiction,” he said, “was about zip.”

So they spread the opioid with their prescription pads, and it settled into the Appalachian mountains like the ever-present morning fog.

OxyContin, which some hailed as a “miracle drug,” became the blockbuster in 2001 that Purdue officials dreamed of, with more than 7 million prescriptions written and nearly $3 billion in revenue.

By 2015, the Sackler family, who owned Purdue, had made $14 billion, joining Forbes’ 2015 list of America’s richest families, edging out the Rockefellers.

MIDWEST AMERICA WAS TARGETED

According to sources at all levels from police and fire first responders to emergency room physicians across the country and analysts at the CDC, there’s been no slowdown in opiate based medical emergencies in the US over the last 2 years. Emergency response and ER visits for opioid overdoses went way up, with a 30 percent increase in the single year period of June of 2016 to June of 2017, according to the Centers for Disease Control and Prevention.

The increased emergency room visits also include more young children aged 3 to 14 years old, which truly reflects on the unknown number of who have access to still available opiates. These young children being able to readily find opiates at that age,  shows that anyone who has an interest in getting opiates can find them.  This often results in the inadvertent and tragic risks associated with younger victims who somehow are exposed and now being swept up in the opioid crisis.

Center for Disease Control’s Acting Director Dr. Anne Schuchat said overall the most dramatic increases were in the Midwest, where emergency visits went up 70 percent in all ages over 25. This is a figure that’s is comparative to prior medical emergency spikes during pandemic healthcare

Recently two important medical reports on opiate abuse have emerged indicating that the opioid crisis may be at its worst point ever.

The first study comes from the Centers for Disease Control and Prevention (CDC), a federal agency tasked with studying – and stopping – the spread of diseases, including everything from viral infections like the flu to mental health issues including drug addiction. Published in the agency’s monthly Vital Signs report, the study demonstrates that the number of opioid overdoses increased by 30% in a little more than one year from July 2016 to September 2017.

The second study comes from a group of VA medical personnel and public health researchers publishing in the Journal of the American Medical Association (JAMA), who wanted to learn how effective opioid prescription drugs were at managing long-term and chronic pain. As it turns out, opioid drugs showed less efficacy than non-opioid pain medications over a 12-month period – and in fact, over time opioids became worse for patients who had to deal with side effects that patients taking non-opioid medications did not have to deal with. Taken together, these two studies show that current opioid drug policies, procedures, prescription practices and standards of patient care clearly need to be rethought.

For Information on Opiate Litigation and other mass torts:

Kevin Thompson will speak on the Opiate NAS Addicted Infant MDL 2872 litigation as well as the status of opioid litigation and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”

November 9-12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

       1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our             mass tort briefcases and professional site MDL briefcases.

      2. To obtain our free newsletters that contain real time mass tort updates, visit www.masstortnexus.com/news and sign up for                free access.

 

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XARELTO RECENT LABEL CHANGE: Is Rat Poison Safer?

A WHITE PAPER REPORT BY MASS TORT NEXUS

(The following information and conclusions are based on opinions formed after a review of relevant facts and data by John Ray and edited by Lisa Powell, Mass Tort Nexus www.masstortnexus.com)

XARELTO LABEL CHANGE AND CLINICAL TRIAL BACKGROUND

On October 11, 2018, Janssen Pharmaceuticals, Inc. (a division of Johnson & Johnson) changed its Xarelto® drug safety label as follows:

Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) for anti-factor XA (FXa) activity is not recommended.

Rivaroxaban is an anticoagulant medication. Anticoagulants thin blood. Rivaroxaban is sold under its trade name, Xarelto®. Xarelto® is used to prevent and/or treat blood clots that could result in strokes in patients with non-valvular atrial fibrillation, in patients undergoing knee and hip reconstruction or replacement surgery, and for secondary prevention in patients who have had an Acute coronary syndrome event.

Prior to FDA approval in 2011, clinical trials were conducted to test the safety and efficacy of Xarelto® and to compare it to other anticoagulants. Trial administrators measured both the medication’s effectiveness in thinning the blood and how long it took to be within the therapeutic range. A blood test is used to measure the international randomized ratio (INR). The INR was used to determine the appropriate dose and dosage (i.e., amount and rate of administration) specific to each patient; or, in this case, each trial participant.

The safety label update made last week by the drug maker, Janssen Pharmaceuticals, Inc. (a division of Johnson & Johnson) in effect states that the INR test used to gain FDA approval—and that doctors continue to use to dose and monitor the effects of Xarelto® in their patients—is arguably defective. Not only would this render the clinical trial results invalid but also bolster plaintiffs’ new and existing claims that the drug maker(s) failed to adequately inform doctors that there was no means by which to determine the correct dose and dosage for any given patient. Essentially a doctor would have to wait until the patient bleeds out or throws a clot before determining that the patient may not be on the right dose and/or dosage. In other words, the INR test likely has no diagnostic value and is no more effective than a shot in the dark.

Summary of Facts and Subsequent Findings

  • On October 11, 2018, the Xarelto® drug safety label was changed to “not” recommend INR testing to monitor the effects Xarelto® on patients
  • INR testing was used in clinical trials to establish the safety and efficacy of Xarelto® and to compare it to other anticoagulants prior to FDA approval and market release in 2011
  • Title 21 of the U.S. Code of Federal Regulation requires that drug labels include a summary of essential scientific information including a statement of the recommended or usual dosage
  • Results from Xarelto® clinical trials using INR testing are at best, questionable, and at worst, invalid
  • A change to the Xarelto® drug safety label likely indicates that the drug makers failed to adequately warn that there was no means by which to determine correct dosage for any given patient
  • A pharmaceutical product for which correct dose and dosage cannot be established for a given patient is arguably defective in a significant way
  • Physicians that rely on INR testing without knowing that it may render inaccurate results could lead them to incorrectly dose Xarelto® potentially causing significant harm to their patients

Methodology Flaws in the Xarelto Clinical Trials

INR testing was used in the original Xarelto® clinical trials known as the ROCKET-AF and EINSTEIN DVT/PE trials. These trials were paid for by the drug makers—Bayer Healthcare and Janssen Pharmaceuticals, Inc. (a division of Johnson & Johnson). These trials were conducted to establish the safety and efficacy of Xarelto® and to compare it to other anticoagulants.

The following is an excerpt from the EINSTEIN DVT/PE clinical trial results:

EINSTEIN DVT/PE trial design: Randomized, phase 3, multicenter, open-label, parallel group,

active-controlled, event-driven noninferiority studies (EINSTEIN DVT and EINSTEIN PE) with patients receiving XARELTO® at an initial dose of 15 mg twice daily with food for the first 3 weeks, followed by XARELTO® 20 mg once daily with food or enoxaparin 1 mg/kg twice daily for at least 5 days with VKA, then VKA only after target INR (2.0-3.0) was reached. Patients were treated for 3, 6, or 12 months at HCP discretion.

In other words, Xarelto® was administered to trial participants and after a target INR was reached, they received a different anticoagulant—a VKA (i.e., vitamin K antagonist).

Given the drug safety update added to the Xarelto® label by Janssen on October 11, 2018:

Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) for anti-factor Xa (FXa) activity is not recommended.

Results from Xarelto® clinical trials using INR testing are at best, questionable, and at worst, invalid.

Thank You for Sharing. Not!

In May 2017—17 months before Janssen changed the Xarelto® label—Clinical Therapeutics, an international peer-reviewed journal, published an article entitled, “International Normalized Ratio Is Significantly Elevated with Rivaroxaban and Apixaban Drug Therapies: A Retrospective Study Published.” An excerpt from the article follows (emphasis added):

Purpose

Direct factor Xa inhibitors such as rivaroxaban or apixaban may prolong prothrombin time (PT) and elevate international normalized ratio (INR). However, these tests are not reliable for assessing the anticoagulation effects of these agents. PT assay sensitivity is relatively weak at therapeutic drug concentrations and is subjected to significant variations depending on the reagent used. Conversion of PT to INR may even increase the variability. We conducted a retrospective cross-sectional study aiming to assess the prevalence and extent of INR elevation in hospitalized patients receiving rivaroxaban or apixaban as part of their home medications and to find out whether other existing factors could elevate INR apart from the drug entity itself. [Emphasis added.]

Methods

The data collected from 218 hospitalized patients׳ charts included PT and INR taken on admission, patients׳ characteristics, laboratory results, other medications regularly used, and coexisting clinical conditions.

Findings

No statistically significant association between INR elevation and the parameters examined was found in our study. INR was significantly elevated in both drug groups (P < 0.001), with 84.2% of rivaroxaban patients and 78.3% of apixaban patients presenting with INR levels above the higher limit of the normal range. Furthermore, INR was significantly higher in the rivaroxaban group than in the apixaban group (P < 0.001).

Implications

Both of the reviewed drugs significantly elevated INR. Moreover, rivaroxaban elevates INR significantly more than apixaban, and there are apparently no other factors affecting INR but the drugs themselves. Larger prospective studies are needed to confirm and clarify the clinical significance of these results.

In that the common tests used to determine the correct administration of Xarelto® are not recommended by the drug maker, how are doctors to determine what dose and dosage of Xarelto® is correct vs. what dose and dosage may render a patient over anticoagulated and more likely to experience severe bleeding, or under anticoagulated, leaving patients more likely to suffer the adverse events Xarelto® is intended to treat?

In other words, doctors have relied on—and may continue to rely on—the test that the makers of Xarelto® now say is not recommended to determine the blood-thinning effects of the drug without knowing that these tests were likely rendering inaccurate results which could lead to their treating patients in a manner likely to cause them significant harm.

If the means to determine the correct dosage to administer to a given patient does not exist, the product is arguably defective. In addition, it would be impossible for a drug maker to comply with the requirements of Title 21, as follows:

21 CFR § 201.56 (a)(1): The labeling must contain a summary of the essential scientific information needed for the safe and effective use of the drug.

21 CFR § 201.100(b)(2): Requires labels for prescription drugs bear a statement of the recommended or usual dosage.

Janssen’s Misleading Advertising Campaign

There are three types of anticoagulants used in the United States. Xarelto® is a direct factor Xa inhibitor type. Benefits claimed by its U.S. manufacturer, Janssen Pharmaceuticals, Inc., include once daily administration of an oral pill, no dietary restrictions, and less testing requirements resulting in fewer blood draws. Warfarin, another type of anticoagulant, is a vitamin K inhibitor.  If a patient’s blood becomes too thin after taking warfarin, vitamin K is administered to reverse its blood-thinning effects (i.e., an antidote or reversal agent). While the INR measurement is an effective test to dose and monitor warfarin in patients, Janssen’s advertising campaign touting less testing requirements for Xarelto® as a benefit is laughable given that the INR test used repeatedly to demonstrate the safety and efficacy of Xarelto® “is not recommended.” Until early 2018—approximately seven years after its market release–Xarelto® did not have a reversal agent, and to date, there is not a “recommended” test for doctors to accurately dose and monitor the effects of Xarelto® in their patients.

In 2014, the FDA required Janssen to add new language to its official warnings and precautions including an update to its “black box” because the test equipment used to measure the INR during clinical trials was deemed faulty. The black box is the strongest and most urgent FDA warning added to an official drug label. The update notifies patients and caregivers about certain risks and potentially dangerous side effects from Xarelto®. A year earlier, the FDA cited Johnson & Johnson for its misleading advertising campaign in contradiction to U.S. laws and regulations.

According to Recall Center, a consumer protection organization:

Since the drug’s release, there have been multiple updates to the label warning users of possible risks. In 2013, the FDA issued a determination letter to Johnson & Johnson advising them that their print advertising published in WebMD magazine earlier that year was misleading. They cited the following deficiencies:

  • Effects of the drug to potential patients were downplayed
  • Efficacy claims appeared to be disassociated from the potential risks
  • Assertions that Xarelto has “no dosage adjustments,” which the FDA noted is inaccurate according to the product information’s section on warnings and precautions, as well as its section on dosage and administration.

Because of these allegations, the FDA declared Johnson & Johnson to be in violation of U.S. laws and regulations that oversee drug marketing. [U.S. Food & Drug Administration. “Letter to Roxanne McGregor-Beck, RE: NDA #202439.” (June 6, 2013) FDA.gov. Accessed Oct. 27, 2014]

According to a 2017 PR Newswire press release published by Business Insider (emphasis added):

Johnson & Johnson (NYSE: JNJ), Janssen Pharmaceuticals and Bayer Healthcare (OTC: BAYRY) are accused of downplaying the risks of taking Xarelto and aggressively marketing the drug as an alternative for warfarin in patients needing blood thinners to reduce the risk of dangerous clots. The companies positioned the drug as more convenient, calling for a once-a-day dose and eliminating the need for regular monitoring of a patient’s blood. However, the lawsuits charge that doctors and patients were not fully informed of the risks.

While Janssen’s Xarelto® advertising campaign claims:

And with XARELTO® you can

  • Spend your time how you want to spend it, with no regular blood monitoring

MISLEADING. A more accurate statement would arguably be:

Regular blood monitoring would be useless because it will not identify whether a patient is under anti-coagulated [i.e. clotting too much] or over anti-coagulated [i.e., bleeding too much].

  • Enjoy a full variety of healthy foods with no known dietary restrictions

TRUE.

  • Know it’s working, with no frequent dosage adjustments

MISLEADING. A more accurate statement would arguably be:

There is no means by which to determine if a dosage adjustment is needed in that the common tests to make such a determination are inaccurate in patients who have been administered Xarelto®.

It bears repeating:

A pharmaceutical product for which correct dosage cannot be established or determined for any given patient is arguably defective in a significant way.

With Testing, Rat Poison Can Be Correctly Dosed for Benefit

There may be no better example of why correctly dosing an anticoagulant is important than warfarin. Warfarin first came into commercial use as a rat poison in 1948. Correctly dosed, warfarin is an effective anticoagulant for humans; incorrectly dosed, warfarin is poison.

Unlike Xarelto®, INR testing is reliable for dosing warfarin. To optimize the therapeutic effect without risking dangerous side effects such as bleeding, close monitoring of the degree of anticoagulation is required. During the initial stage of treatment, the INR is checked daily. Intervals between tests can be lengthened if the patient manages stable therapeutic INR levels on an unchanged warfarin dose. Newer point-of-care testing is available and has increased the ease of INR testing in the outpatient setting. Instead of a blood draw, the new INR point-of-care test involves a simple finger prick.

Therefore, an anticoagulant that cannot be accurately dosed is arguably not as safe as rat poison.

———-

The foregoing is an observation of statistics and data related to Xarelto®. The conclusions contained herein are based on opinions formed by the author after a review of the relevant data. We acknowledge that others could draw differing conclusions and opinions based on the same observations.

 References:

https://www.clinicaltherapeutics.com/article/S0149-2918(17)30242-4/pdf

https://www.recallcenter.com/xarelto/fda-news/

https://markets.businessinsider.com/news/stocks/report-more-than-15-000-adverse-events-linked-to-xarelto-in-2016-1002203317

https://www.xareltohcp.com/dvt-pe/clinical-trials

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XARELTO INITIAL ROCKET & EINSTEIN CLINICAL TRIALS NOW SEEN AS FLAWED: ADD THE MAY 2018 FAILURE OF TWO LATEST BAYER/JANSSEN STUDIES = BAD SCIENCE

Xarelto Study Red Flags Ignored: Why were medical research professionals ignored when red flags were raised over the viability of the Xarelto Rocket AF and Einstein DVT study results? Now the clinical trials for both are considered flawed, and the two most recent studies, the “Commander HF” and “Mariner,” failed to produce clear evidence that Xarelto is able to reduce the rate of blood clots in certain high-risk patients or after an acute decline in their condition.

By Mark A. York (October 23, 2018)

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Xarelto (rivaroxaban) is a prescription blood thinner created by Bayer and Janssen Pharmaceuticals that was approved by the Food and Drug Administration (FDA) in 2011. This drug is an anticoagulant for preventing blood from clotting, often used to treat deep vein thrombosis, atrial fibrillation, pulmonary embolism, stroke, and other conditions.

More than one study has shown Xarelto can cause a higher rate of internal bleeding, than other anticoagulant drugs and until very recently, there was no available “antidote” for stopping internal bleeding in patients taking Xarelto. With warfarin, vitamin K has been shown to stop bleeding but there is no vitamin K “parallel” for people taking Xarelto. For Xarelto, it can take 24 hours for a dose to get out of the body. That means that if internal bleeding starts, the patient may simply have to wait it out and hope it stops on its own.

What The Medical Studies Say About Xarelto?

The FDA has received thousands of adverse event reports regarding Xarelto and medical studies have examined the safety of this drug:

  • New England Journal of Medicine (2011): Published the ROCKET-AF study, which compared Xarelto to Warfarin in patients suffering from atrial fibrillation. This was the biggest clinical trial of this medication and it compared the effects of Xarelto to the effects of a similar drug known as Warfarin in over 14,000 patients. The study concluded that “there was not significant between-group difference in the risk of major bleeding.”
  • Archives of Internal Medicine (2012): The study discussed the risk of uncontrollable bleeding outweighing the benefits for several different blood thinners including Xarelto. The researchers in this study found that there was a tripled risk of bleeding among the patients, who were given the drug, and no improvement in overall survival rates.
  • Institute for Safe Medication Practices (2012): Issued a report based on FDA data from the first quarter of 2012. During this period, the FDA received 356 adverse event reports of Xarelto side effects including “serious, disabling, or fatal injury.” Additionally, 158 reports indicated blood clots were the serious side effect.
  • New England Journal of Medicine (2013): Published the results of the ROCKET study, which found that Xarelto may carry an increased risk of bleeding.
  • Medscape (2013): Xarelto is associated with a higher risk of bleeding in certain patients. It caused a nearly 3-fold increase of the risk of bleeding in “acutely ill patients” and 4-fold increased risk of major bleeding in patients that had “Acute Coronary Syndrome” (ACS).

Drug Makers Failed To Disclose Faulty Device In Xarelto Trials

 Rivaroxaban and the ROCKET AF trial issue chronicles: A closer look at benefit risk profile of the drug.

  • BMJ2016354 doi: https://doi.org/10.1136/bmj.i5131 (Published 28 September 2016)Cite this as: BMJ 2016;354:i5131
  • Study Analysis: There has been a lot of hue and cry over the recent question raised about the ROCKET AF[1] trial for rivaroxaban which was the only trial used by the company for drug approval from USFDA. This is indeed a very important concern as it directly impacts the well-being of the patients who are at the receiving end of this very highly prescribed anticoagulant drug in 2014.[2] The main concern with this whole confusion surrounding the ROCKET AF trial is that the device used for measuring the INR in trial arm of warfarin patient was faulty and gave lower INR values than it should have, leading to over dosing of warfarin and thereby increasing bleeding problems with the same, compared to the trial arm of rivaroxaban. However, there has been a reanalysis done by the ROCKET AF researchers, which again reinforced the prior result database of the trial and which was accepted by FDA as well[3]. In the reanalysis, the US FDA clearly mentioned that the effect of the faulty device results in causing bleeding episodes, both minor and major, was minimal.[4]
  • However, following this reanalysis, not everyone who raised the question in the first place was convinced and there was a demand that the data of the complete ROCKET AF trial should be made public for everyone to assess and understand the risks. But since the trial was done and results released before the principles on responsible clinical trial data sharing came into effect, the parent pharmaceutical company for rivaroxaban refused to share the patient level details, citing concerns on privacy and transparency policy [5].
  • In spite of everything said and written for and against this issue, a simple question arises, regarding the amount of belief, honesty and hard work that goes without questioning when you bring a new chemical entity to the research stage, get it approved and then bring it to market. For this to happen, there have to be maintained a very fine balance between pharmaceutical companies, drug regulatory authorities and marketing people. In this case, after initial suspicions, the drug regulatory authorities have cleared and supported the approval of rivaroxaban after reanalysis and that should have a say, in case we want to continue trust with this process of drug entry into the market.
  • Rivaroxaban has shown its efficacy and safety both in patients who required adequate anticoagulation e.g. those who had atrial fibrillation and underwent cardioversion. There are few other trials where rivaroxaban has performed better or equally good than warfarin in terms of both efficacy and safety [6]. These results lead us to believe that all was not wrong with the ROCKET AF trial results. All these, combined with personal experiences of those physicians who had been using the drug rivaroxaban for the last couple of years with a hugely favorable result clearly imply that the drug rivaroxaban is holding its side strongly in the midst of all the controversies surrounding its approval and efficacy and it is here to stay. Adding a last word to all this discussion is that rivaroxaban will always hold an upper hand compared to warfarin when prescribed because of its very favorable and easy to use once daily dosing. We cannot discard all the positive reports and positive experiences associated with this drug, based on real time data, only because of the question raised by some, and considering the fact that the question had been satisficatorily answered with a re analysis with no change in the result.

What Did Or Didn’t The FDA Do About Xarelto?

  • In July, 2011, the U.S Food and Drug Administration (FDA) initially approved the medicine for sale on the market for a limited group of people. This included people who had knee or hip replacement surgery because they were considered to be at a higher risk of blood clotting. Read the FDA News Release here.
  • In November, 2011, Xarelto was approved for a larger group of people, including people with an abnormal heart rhythm, and was used to prevent stroke. Read further.
  • In June, 2012, an FDA advisory panel voted against approving this medicine for the treatment of acute coronary syndrome.
  • In November, 2012, Xarelto was later approved for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) after a fast track regulatory review by the FDA. Read more.
  • October 22, 2014, the FDA issued a recall for approximately 13,500 bottles of Xarelto after receiving a customer complaint about contamination in a sales sample.
  • January 12, 2015 – An antidote may have been discovered by Portola Pharmaceuticals for Xarelto. A late-stage clinical trial of the intravenous medication, andexanet alfa, met its goal of “immediately and significantly” reversing Xarelto.

The approval history for Xarelto was actually pretty controversial. FDA reviewers originally said that they recommended against approval, then there was an FDA advisory committee (independent group of key opinion leaders) and they voted in favor, so the FDA approved the drug. Their concern was with how the Phase III trials were run and whether Xarelto had really proved its efficacy. The tests compared patients on warfarin to patients on Xarelto, but the patients on the warfarin run had poor TTR. That means the patients weren’t well controlled on warfarin to begin with, which skews the data in favor of Xarelto.

During the approval process, Xarelto actually wanted a superiority label, which would say that the drug was better than warfarin and other blood thinners. Because of the concerns with the Phase III data, the FDA only gave them a non-inferior label, which says they’re essentially the same in terms of effectiveness.

The INRatio device was the subject of two FDA warning letters about inaccurate readings just as the trial was starting in 2005 and 2006. In 2014, the device was recalled. The use of the INRatio device may have skewed the results with inaccurate readings, making Xarelto look better in comparison with warfarin.

In a 2017 annual report issued by the Institute for Safe Medication Practices (ISMP), it was stated that oral anticoagulant drugs, including Xarelto (rivaroxaban), showed “unacceptably high risks,” according to two government data sources, the FAERS adverse events reports for 2016 and a new systematic study by the Centers for Disease Control and Prevention (CDC).

Overall, the CDC found in its systematic study that the FDA’s FAERS voluntary reporting underestimates anticoagulant drug-related injuries. The CDC discovered that approximately 228,600 emergency department visits occur each year due to the use of blood thinner drugs, including Xarelto, which is 10 times more than the FAERS total number of voluntary reports.

Xarelto Clinical Trial Red Flags

Controversy Surrounding ROCKET-AF: A Call for Transparency, But Should We Be Changing Practice?

Jason D Matos1 and Peter J Zimetbaum1,,2

Arrhythm Electrophysiol Rev. 2016 May; 5(1): 12–13.

doi:  [10.15420/aer.2016.24.2]

Prior to the emergence of novel oral anticoagulants (NOACS), nearly all patients were prescribed vitamin K antagonists for thromboembolic prophylaxis in non-valvular atrial fibrillation (AF). Rivaroxaban (Xarelto, Bayer/Johnson & Johnson), an oral factor Xa inhibitor, is now one of the most frequently prescribed NOACs used for this indication.1,2

ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), published in the New England Journal of Medicine in 2011, demonstrated the non-inferiority of rivaroxaban compared with warfarin for the primary prevention of stroke or systemic embolism in patients with AF. This double-blinded randomised trial, which included 14,264 patients across 45 countries, also showed no significant difference in the risk of major bleeding between these two groups.3

Rivaroxaban use in AF has become widespread since the publication of this trial and US Food and Drug Administration (FDA) approval. Two additional Factor Xa inhibitors, apixaban and edoxaban, have also been evaluated in similar randomised trials and have demonstrated non-inferiority to warfarin for stroke or systemic embolism prophylaxis in patients with non-valvular AF with no significant difference in major bleeding.4,5

In recent months, the results of ROCKET-AF have come into question after the FDA issued a recall notice for the device used to obtain International Normalised Ratio (INR) measurements in the warfarin control group. The FDA found that lower INR values were seen with the ‘point-of-care’ INRatio Monitor System (Alere) compared with a plasma-based laboratory in patients with certain medical conditions.2 These conditions included abnormal haemoglobin levels, abnormal bleeding and abnormal fibrinogen levels.6Since the FDA recall of this device, there has been widespread concern that falsely low INR readings in ROCKET-AF may have led to warfarin overdosing. Inappropriately high warfarin dosing could have increased bleeding rates in the control group and therefore made the rivaroxaban arm appear falsely favourable.7 This point-of-care device recall also highlighted a lack of transparency of the specifics of devices used in large clinical trials.

In response, the authors from ROCKET-AF released a correspondence in February 2016, citing the FDA recall. They also provided a post hoc analysis of patients who may have been affected by the recall. They found that major bleeding was greater in patients with conditions affected by the recall, but, reassuringly, the bleeding risk was greater in those who were on rivaroxaban and not warfarin.6

Despite this post hoc analysis, concern has arisen regarding the generalisability of ROCKET-AF given the faulty point-of-care INR readings. There has been a call for complete transparency of the data from this trial and a better explanation of the mechanism of the incorrect INR measurements.7

Once published, the data supporting an FDA-approved treatment should be available for independent analysis. One issue is that rivaroxaban was approved in the US prior to 1 January 2014, before a new transparency policy on clinical trial data sharing was approved by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).2 Drug companies are refusing to share any data on pharmaceuticals approved before 2014.

A device malfunction in a large clinical trial also should raise concern, especially when that trial has altered clinical practice for millions of patients. On review of Patel et al’s correspondence regarding the point-of-care malfunction, there is inadequate explanation of the mechanism of these faulty readings. Why are they only seen only in patients with abnormal haemoglobin and fibrinogen levels? How inaccurate could the readings be – within 0.1 or 1.0 of a gold standard value? Most alarming is the revelation that the manufacturer had evidence of faulty readings in similar models dating back to 2002.2

Despite legitimate concerns regarding the absence of data transparency and the faulty point-of-care device, rivaroxaban need not be removed from clinical practice for AF patients. In ROCKET-AF, the drug demonstrated non-inferiority to warfarin in preventing thromboembolic events. In addition, data has shown that patients potentially affected by the faulty point-of-care device actually bled more on rivaroxaban than warfarin.6 Therefore, the original risk–benefit ratio presented in ROCKET-AF remains true.

There are other, albeit smaller, randomised trials with shorter follow-up times that compare rivaroxaban and warfarin for thromboembolic prophylaxis.8,9 For example, Cappato et al in 2014, randomised 1,504 patients to show that oral rivaroxaban was non-inferior to warfarin in preventing a composite endpoint of stroke, transient ischaemic attack, peripheral embolism, myocardial infarction and cardiovascular death in patients with AF undergoing cardioversion. Major bleeding rates in the rivaroxaban and warfarin arms were similar (0.6 % versus 0.8 % respectively).8

The prospective observational trial XANTUS (Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation) followed 6.784 patients on rivaroxaban for AF during a mean time of 329 days at 311 different hospitals. Major bleeding occurred in 128 patients (2.1 events/100 patient years) and 43 patients (0.7 events/100 patient years) suffered a stroke. These numbers are more reassuring than those seen in ROCKET-AF, though the patient population had a lower risk profile, with an average CHADS2 score of 2.0 compared with 3.5 in ROCKET-AF.10

To further mitigate concern regarding inaccuracies of bleeding rates in the ROCKET-AF control group, it is helpful to compare bleeding rates in the warfarin arms of the other major NOAC trials. The RE-LY (Randomised Evaluation of Long-Term Anticoagulation Therapy) trial, had a warfarin-arm major bleeding rate of 3.4%/year.11 The ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, had a warfarin-arm major bleeding rate of 3.1%/year.4 The ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) trial, had a warfarin-arm major bleeding rate of 3.4 %/year.5The warfarin arm of ROCKET-AF had a 3.4 %/year major bleeding rate, comparable to the other studies. Furthermore, the ROCKET-AF patients are known to be at higher risk for stroke and bleeding; their average CHADS2 score was highest among these studies (3.5 compared with 2.1–2.8).3 In addition, ROCKET-AF had a very high percentage of patients with a HAS-BLED score ≥3 (62 %) compared with the other studies (23 % in ARISTOTLE and 51 % in ENGAGE AF-TIMI 48).1214

Several large randomised trials have compared the safety and efficacy of rivaroxaban versus warfarin for venous thromboembolic disease. The warfarin arm of the EINSTEIN-PE trial (Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients with Acute Symptomatic Pulmonary Embolism), which randomised patients with pulmonary embolism to warfarin or rivaroxaban, had a major bleeding rate of 2.2 %. The bleeding rate was lower in the rivaroxaban arm (1.1 %) and notably patients received a higher loading dose of rivaroxaban for the first 3 weeks (15 mg twice daily) compared with the daily 20 mg daily in ROCKET-AF.15

The recent uncertainties surrounding ROCKET-AF demonstrate the need for widespread data transparency for major trials with the capability of so greatly affecting patients’ lives. These are complicated issues both for the companies’ manufacturing products and the clinical trial organisations who carry out these studies and analyse the data. Ultimately the goal of full transparency to allow increased confidence in trial results should be sought. In this instance there is no compelling evidence of imminent danger of excessive bleeding with rivaroxaban. We should take notice of the recent findings, but there is no need to change practice.

What Are Xarelto Side Effects?

The most dangerous Xarelto side effect is uncontrollable bleeding. Blood thinning drugs have also been associated with bleeding complications. Other side effects include:

  • Blood clots
  • Gastrointestinal bleeding
  • Spinal bleeding
  • Intracranial bleeding
  • Epidural bleeding
  • Cerebral bleeding
  • Stroke
  • Difficulty breathing

For Information on Xarelto and other mass torts see:

Michael Brady Lunch will speak on the Xarelto litigation as well as the status of Pradaxa litigation and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”

November 9 -12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

  • For the most up to date information on all MDL dockets and related mass torts visit  masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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REFERNCES CITED IN STUDIES SHOWN ABOVE

 Rivaroxaban and the ROCKET AF trial issue chronicles: A closer look at benefit risk profile of the drug. References:
BMJ 2016354 doi: https://doi.org/10.1136/bmj.i5131 (Published 28 September 2016)Cite this as: BMJ 2016;354:i5131
  1. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365:883-891. Article
    2. Top 50 pharmaceutical products by global sales. PMLiVE, Available here.
    3. FDA analyses conclude that Xarelto clinical trial results were not affected by faulty monitoring device.https://www.fda.gov/Drugs/DrugSafety/ucm524678.htm
    4. ROCKET AF Reanalysis Reviews.http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202439Orig1s000Ro…
    5. Joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing Become Effective.http://www.efpia.eu/mediaroom/132/43/Joint-EFPIA-PhRMA-Principles-for-Re…
    6. Cappato R, Ezekowitz MD, Klein AL, et al. Rivaroxaban vs vitamin K antagonists for cardioversion in atrial fibrillation. Eur Heart J 2014; 35:3346-3355.

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Controversy Surrounding ROCKET-AF: A Call for Transparency, But Should We Be Changing Practice? References
Jason D Matos1 and Peter J Zimetbaum1,,2 Arrhythm Electrophysiol Rev. 2016 May; 5(1): 12–13.; doi:  [10.15420/aer.2016.24.2]
  1. Kubitza D, Becka M, Wensing G, et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939 – an oral, direct Factor Xa inhibitor – after multiple dosing in healthy male subjects. Eur J Clin Pharmacol. 2005;61:873–80. PMID: 16328318. [PubMed]
  2. Cohen D. Rivaroxaban: can we trust the evidence? BMJ. 2016;352:i575. DOI: 10.1136/bmj.i575; PMID: 26843102. [PubMed]
  3. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–91. DOI: 10.1056/NEJMoa1009638; PMID: 21830957. [PubMed]
  4. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981–92. DOI: 10.1056/NEJMoa1107039; PMID: 21870978.[PubMed]
  5. Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093–104. DOI: 10.1056/NEJMoa1310907; PMID: 24251359. [PubMed]
  6. Patel MR, Hellkamp AS, Fox KA, et al. Point-of-care warfarin monitoring in the ROCKET AF Trial. N Engl J Med. 2016;374:785–8. DOI: 10.1056/NEJMc1515842; PMID: 26839968. [PubMed]
  7. Mandrola J. Rivaroxaban: It’s not time to cut the rope, yet. Medscape. 9 February 2016. Available at: www.medscape.com/viewarticle/858648. (accessed 6 May 2016.
  8. Cappato R, Ezekowitz MD, Klein AL, et al. Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. Eur Heart J. 2014;35:3346–55. DOI: 10.1093/eurheartj/ehu367; PMID: 25182247.[PubMed]
  9. Cappato R, Marchlinski FE, Hohnloser SH, et al. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J. 2015;36:1805–11. DOI: 10.1093/eurheartj/ehv177; PMID: 25975659. [PMC free article] [PubMed]
  10. Camm AJ, Amarenco P, Haas S, et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016;37:1145–53.DOI: 10.1093/eurheartj/ehv466; PMID: 26330425. [PMC free article] [PubMed]
  11. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51. DOI: 10.1056/NEJMoa0905561; PMID: 19717844.[PubMed]
  12. Sherwood MW, Nessel CC, Hellkamp AS, et al. Gastrointestinal bleeding in patients with atrial fibrillation treated With rivaroxaban or warfarin: ROCKET AF trial. J Am Coll Cardiol. 2015;66:2271–81.DOI: 10.1016/j.jacc.2015.09.024; PMID: 26610874. [PubMed]
  13. Lopes RD, Al-Khatib SM, Wallentin L, et al. Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomised controlled trial. Lancet. 2012;380:1749–58. DOI: 10.1016/S0140-6736(12)60986-6; PMID: 23036896. [PubMed]
  14. Eisen A, Giugliano RP, Ruff CT, et al. Edoxaban vs warfarin in patients with nonvalvular atrial fibrillation in the US Food and Drug Administration approval population: An analysis from the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial. Am Heart J. 2016;172:144–51. DOI: 10.1016/j.ahj.2015.11.004; PMID: 26856226. [PubMed]
  15. EINSTEIN-PE Investigators, Buller HR, Prins MH, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366:1287–97. DOI: 10.1056/ NEJMoa1113572. PMID: 22449293. [PubMed]

 

 

 

 

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Why the New Opioid Infant Addicted-NAS MDL 2872 Was Filed At The Right Time -The Opioid Industry Model of “Profits Before Patients” Is Killing Children

How Will Opiate Big Pharma Address Thousands of Addicted Infants?

By Mark A. York (October 4, 2018)

 

 

 

 

 

 

 

See Mass Tort Nexus Briefcase MDL-2872 Children-Born-Opioid-Dependent-(Infant NAS) Filed September 20, 2018 for related Infant/NAS case filing information

(MASS TORT NEXUS MEDIA)  Tens of thousands of infants born in the U.S. each year now have NAS, and a recent  Centers for Disease Control report  said the rate of NAS deliveries at hospitals quadrupled during the past 15 years.  The period of hospitalization for NAS infants averages 16 days and hospital costs for a typical newborn with NAS are $159,000-$238,000 greater than those of healthy newborns, according to the attorneys representing the NAS (neonatal abstinence syndrome) babies.

With the filing of a New Motion to Consolidate Opiate Addicted Infant Case as MDL 2872 with the Joint Panel on Multidistrict Litigation, the fire may be lit to move the most vulnerable victims of the opioid crisis into the forefront of the litigation. Will this force Opiate Big Pharma to pay for 20 years of bad conduct in pushing opiate prescriptions on American commerce?  See MDL 2872 Motion to Consolidate Infant-NAS Addicted Opiate Litigation

In West Virginia, home of the highest overdose rates in the nation, the foster care population has increased by 42 percent since 2014.   Federal Centers for Disease Control and Prevention data, from 2013 and released in 2016, suggested West Virginia had the highest rate of neonatal abstinence syndrome (NAS) of 21 states analyzed.

Later data collected by the state showed the state’s rate was higher than the CDC report indicated, said Christina Mullins, director of the state Department of Health and Human Resources’ Office of Maternal, Child and Family Health.

The 2016 CDC report, which said NAS “occurs primarily among opioid-exposed infants,” showed that as of 2013, West Virginia’s NAS rate was 3.34 percent of all hospital births, a hair higher than Vermont’s 3.33 percent.

After those two states, the rate plummeted significantly, with Kentucky’s 1.5 percent being the next highest – although Maine, which had no data reported in 2013, did have a 3.04 percent rate in 2012, lower than Vermont’s then-No. 1 rate of 3.05 percent and higher than West Virginia’s then-No. 3 rate of 2.17 percent.

Mullins said the data previously came from hospital discharge data, and it’s not easily comparable across all states. She said that when the state began collecting real-time data in October 2016, it got a rate of about 5 percent of all births.

Mullins presented Monday to a legislative interim committee that heard several reports regarding likely impacts of the opioid crisis on kids and education.

The reports indicated that the state was No. 1 or No. 2 in the country in removing children from their homes; the number of youth in state custody increased 46 percent from October 2014 to October of last year; there’s been a 22 percent increase in accepted abuse/neglect referrals over three years; and 85 percent of open child abuse/neglect cases involve drugs.

The number of children in state or foster care hit a record low in Massachusetts earlier this decade. Since then, that number has risen by a quarter, and there are now more children in state care than ever before.

>States, Counties, Cities and others are suing opioid drug makers and distributor in both state and federal courts, see Mass Tort Nexus Briefcase “Opioid Litigation Versus Opiate Prescription Industry MDL 2804, US District Court of Ohio”

 Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.

In Canada, during the past decade, the number of babies exposed to opioids in the womb has increased 16-fold in Ontario. And according to Ontario’s Provincial Council for Maternal and Child Health (PCMCH), more than 950 infants were born to opioid-addicted mothers last year. Just over half of them will live the toughest days of their lives in their first week outside the womb.

Until the governments at the federal, state and local levels can all agree on a long-term viable solution to the opioid crisis and the impact on school age children, infants born addicted and society as a whole, the opiate drug crisis will linger for generations long into the future.

In Ohio, the number of children in state custody has grown by 28 percent since 2015. Foster care populations are up more than 30 percent in Alabama, Alaska, California, Idaho, Indiana, Minnesota and New Hampshire since 2014. States like Illinois, Oklahoma, Massachusetts, Pennsylvania, Colorado and New Jersey now adopting new approaches to help keep parents and children together, even as parents are receiving treatment for their addictions.

The opioid epidemic plaguing the nation is taking a catastrophic toll on our most vulnerable group, the children of the opiate addicts and those with substance use disorders. Many children are sent to live with grandparents or other family members, often due to a parent overdose or other addiction displays other problems but tragically, a growing number are being placed in the foster-care system, with many states unable to keep up with the demand from both a budget as well as staffing overload.

From 2013 to 2015, the number of children in foster care nationwide jumped almost 7 percent to nearly 429,000, according to the U.S. Department of Health and Human Services’ Administration on Children and Families, the 2016 to 2018 numbers have moved that number closer to 550,000. Parental substance use was cited as a factor in about 32 percent of all foster placements. From 2000 to 2015, more than half a million people died of an overdose, and currently 91 people a day die from opiate overdoses.

Unfortunately, many children, the indirect victims of the crisis, are not getting the care and services they need. “This is a neglected subpopulation,” says John Kelly, PhD, associate professor of psychiatry in addiction medicine at Harvard Medical School, and the founder and director of the Massachusetts General Hospital. “Because we’re trying to put out the fire in terms of stopping overdose deaths, we haven’t really been attending to other casualties, including kids most importantly.”

To lessen the long-term effects on children, psychologists are treating children in the foster-care system in outpatient, inpatient and residential treatment programs and in school-based mental health programs.

“Treating Women Who Are Pregnant and Parenting for Opioid Use Disorder and the Concurrent Care of Their Infants and Children: Literature Review to Support National Guidance.  https://www.ncbi.nlm.nih.gov/pubmed/28406856

[STUDY OBJECTIVES: The prevalence of opioid use disorder (OUD) during pregnancy is increasing. Practical recommendations will help providers treat pregnant women with OUD and reduce potentially negative health consequences for mother, fetus, and child. This article summarizes the literature review conducted using the RAND/University of California, Los Angeles Appropriateness Method project completed by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration to obtain current evidence on treatment approaches for pregnant and parenting women with OUD and their infants and children]

Drug users’ children flooding to foster care

In Washington state, this number is alarming but not widely known, 10,000 high-school seniors said they used heroin or gotten high on opioid-derived painkillers in 2016, those numbers were about the same as two years prior, but foster care placements have surged.

 

Between 2011 and 2017, the state took children from drug-abusing parents nearly 14,000 times. Last year’s rate was the highest for drug-related causes since 2010 — up 16 percent over 2015 — while state hospitals report a steady increase in substance-exposed newborns.

Child-welfare workers hear complaints about increasingly severe problems in school — more physical violence toward peers, or kids who need to be taught separately — from students whose parents are staggering through addiction, said Jenna Kiser, who oversees intake at the state Children’s Administration.

Jenny Heddin, a state agency supervisor stated, “These numbers are very concerning, when children from these homes come into foster care, they can be very difficult to serve.”

This represent one corner of a national wave. More than 37 states report unprecedented numbers of kids entering foster care, many of them for reasons related to a parent’s substance abuse, according to the federal Department of Education.

Damaging children’s futures

By the time Child Protective Services is knocking on someone’s door, the problem is already severe. And so far efforts to respond might best be described as triage — focused more on addiction treatment than prevention, both in Washington and across the country.

As in many other states, political infighting prevents treatment, earlier this year Washington Gov. Jay Inslee proposed spending $20 million on a multipronged effort to combat opioid addiction. The bill never made it to the floor for a full vote, and it contained little funding for prevention. (But $1.7 million targeted for youth did get funding.)

Yet researchers warn that ignoring that aspect of the crisis virtually guarantees costly problems to come as the children of addicts grow into adulthood. Kevin Haggerty, a professor at the University of Washington who studies risk factors for drug abuse, authored one of the few peer-reviewed studies tracking life outcomes for these young people.

In the early 1990s, Professor Haggerty identified 151 elementary and middle-school children in Washington who were growing up with heroin-addicted parents. Fifteen years later, 33 percent had dropped out of high school. The vast majority were addicts themselves, and half had criminal records. Only 2 percent had made it through college. (Nationally, 33 percent of all kindergartners in 1992 grew up to earn a college degree.)

“The results are astounding at how poor the outcomes are, when having a drug-addicted parent,” said Caleb Banta-Green, principal research scientist at the Alcohol and Drug Abuse Institute at the University of Washington’s School of Public Health.

“We need to be doing a lot more for kids being parented by opiate-addicted parents — and we’re not.”

“Families literally bring their problems to our door now to help them navigate their lives,” Harrington-Bacote said. “Public schools are doing things that fall way outside of regular academic education. But if they don’t, it’s not going to get addressed at all.”

OHIO EXAMPLES – HOW BIG PHARMA OPIOID MONEY DESTROYS LIVES

Way before social workers showed up in his living room this March, Matt McLaughlin, a 16-year-old with diabetes, had taken to a routine not of his doing, trying to scrounge up enough change for food while his mom, Kelly, went out to use heroin. On a good night, the high school junior would walk his neighborhood in Andover, Ohio to pick up frozen pizza from the dollar store, and on bad nights, he’d play video games to keep his mind off his hunger and unknown blood sugar levels.

When Matt was little, his mom Kelly was a Head Start caseworker who taught parents how to manage their autistic children and who hosted potlucks and played Barbie with Matt’s sister, Brianna. “Growing up, we were the house that everyone wanted to come to,” remembered Brianna, now 20. “I loved every minute of it.”

Kelly had neck surgery and got addicted to OxyContin, and by 2015, she was spending her days napping, disappearing for hours at a time, or going to her neighbor’s house, where she would exchange cash for packets of heroin. She started yelling at the kids, food became scarce, life changed for the worse, “It’s like her personality did a 180,” Brianna said. “I felt like I lost my mom to this pit that I couldn’t pull her out of.”

Ashtabula County Children Services answered a tip when someone called the police and urged them to check on the family.

She’d been to detox several times over the years, trying to rid herself of what felt like a demon that had taken over her brain. Last year, she managed to stay clean for 63 days, until a friend came over “and laid out a line—and that was all it took.” There are five heroin dealers within a five-mile radius and all are more than willing to provide an addict the opiate of choice, which is the norm for rural Ohio anymore.

Her kids were once again forced to pack their bags as Kelly would go to detox another time, they were lucky to have relatives nearby. The spiraling opioid epidemic has disrupted so many families that all the foster homes in Ashtabula County are full, with this story being repeated across the country every day.

The scourge of addiction to painkillers, heroin, and fentanyl sweeping the country has produced a flood of bewildered children who, having lost their parents to drug use or overdose, are now living with foster families or relatives. In Ashtabula County, in Ohio’s northeast corner, the number of children in court custody quadrupled from 69 in 2014 to 279 last year. “I can’t remember the last time I removed a kid and it didn’t have to do with drugs,” says a child services supervisor.  Her clients range from preschoolers who know to call 911 when a parent overdoses to steely teenagers who cook and clean while Mom and Dad spend all day in the bathroom. Often, the kids marvel at how quickly everything changed—how a loving mom could transform, as one teenager put it, into a “zombie.”

The pattern mirrors a national trend: Largely because of the opioid epidemic, there were 30,000 more children in foster care in 2015 than there were in 2012—an 8 percent increase. In 14 states, from New Hampshire to North Dakota, the number of foster kids rose by more than a quarter between 2011 and 2015, according to data amassed by the Annie E. Casey Foundation. In Texas, Florida, Oregon, and elsewhere, kids have been forced to sleep in state buildings because there were no foster homes available, says advocacy group Children’s Rights. Federal child welfare money has been dwindling for years, leaving state and local funding to fill in the gaps. But Ashtabula County is one of the poorest counties in Ohio, and despite a recent boost in funding, the state contributes the lowest share toward children’s services of any state in the country. 

More Broken Families, Less Funding

 Ohio also has one of the nation’s highest overdose rates. In 2016, at least 4,149 Ohioans died of drug overdose—a 36 percent jump from the year before, according to the Columbus Dispatch. In 2015, 1 in 9 US heroin deaths occurred in Ohio.

It’s hard to overstate just how pervasive the epidemic feels here. Detective Taylor Cleveland, who investigates drug cases in Ashtabula, told me, “I’m dealing with ruined homes two and three times a day.” Cleveland, who coaches youth soccer and recently adopted a 17-year-old player whose mom overdosed, leads a task force that responds to every overdose in the county. Once, he arrived at an overdose scene only to realize that the victim slouched over in the motel room was his cousin, whose young daughter had called 911. “Every OD that happens, I get a text. I’ve gotten two texts while we’ve been talking.” We’d been talking for less than an hour.

Given the scale of the crisis, it’s not hard to understand why, when Donald Trump promised Ohioans on the campaign trail to “spend the money” to confront the opioid crisis and build a wall so drugs would stop flowing in, locals in this historically blue county took notice. In late October, Trump became the first presidential candidate since John F. Kennedy to visit Ashtabula County. He promised to bring back jobs, to open the long-shuttered steel plants, to build the wall. Twelve days later, Ashtabula residents voted for a Republican president for the first time since Ronald Reagan in 1984.

WHITE HOUSE PROMISED ON OPIOIDS BUT DIDN’T DELIVER

But since he took office, Trump’s plans to tackle the epidemic head-on have fizzled. Republicans’ recent effort to repeal and replace Obamacare would slash funding for Medicaid, which is the country’s largest payer for addiction services—and which covers nearly half of Ohio’s prescriptions for the opioid addiction medication buprenorphine. The bill would enable insurers in some states to get out of the Obamacare requirement to cover substance abuse treatment. A memo leaked in May revealed Trump’s plans to effectively eliminate the White House’s drug policy office, cutting its budget by 95 percent. (The administration has since backpedaled on the plans, following bipartisan criticism.) Trump’s 2018 budget proposes substantial cuts to the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, and the Temporary Assistance for Needy Families program.

“I think some people felt as though nothing else is working,” said one Ashtabula resident when I asked why so many in a Medicaid-dependent area would vote for Trump. Now, she says, “I’m really, really scared. You don’t get it until you live in a small town and you see people die every day.”

Like so many other Midwest Rust Belt counties, Ashtabula, Ohio has seen better days. Locals proudly tell me that the Port of Ashtabula used to be one of the biggest in the world, where barges unloaded iron mined from Minnesota’s Mesabi Range onto trains headed for the steel mills of the Ohio River Valley. Today, once-bustling streets have given way to vacant storefronts and fast-food chains; the surrounding countryside is made up of farm fields, trailer parks, and junkyards. One in three kids now live below the federal poverty line, less than half of adults have a high school education. The financial downturn accelerated in the ’90s when manufacturing jobs started disappearing.

Then Opiate Big Pharma and their marketing campaigns introduced newer “less addictive” painkillers like OxyContin and others like Vicodin were liberally prescribed in communities wrestling with dwindling economic opportunity and rife with workplace injuries common to mines, lumberyards, and factories. As authorities started to tighten the rules on prescribing drugs like OxyContin, the use of heroin, which is chemically nearly identical to opioid painkillers, crept up. But the tipping point, for Ohio and the country, came over the past couple of years, when illicit fentanyl, an opioid up to 100 times more powerful than morphine, started making its way into the heroin supply. Since then, says Dr. Thomas Gilson, the medical examiner for nearby Cuyahoga County, the deaths have been coming “like a tidal wave.”

About five years ago, Ohio noticed a major uptick in the number of parents using heroin. More recently, elected officials have learned more about the parasitic way that opioids co-opt the brain and the complex pull of addictions attitudes have softened, with most realizing there is no good guy or bad guy, once addiction takes hold. The long-term problems are often multiplied many times over by lack of short-term treatment.

Gov. John Kasich, a notorious budget hawk, made national news when he pushed Medicaid expansion through Ohio’s conservative Legislature. “When you die and get to the meeting with St. Peter,” he told one lawmaker, “he’s probably not going to ask you much about what you did about keeping government small, but he is going to ask you what you did for the poor.” He made news yet again last week, when he signed a 2018 budget that will, for the first time in years, increase the state’s funding for children’s services. Yet the $30 million boost in funding over two years, which will pay foster parents and provide counseling for the kids, won’t make up for the $55 million increase in child placement costs over the past three years. Other than county pilot programs, “No policy or state investment has focused specifically on the children flooding into county agency custody as a result of the opioid epidemic,” concluded a report by the Public Children Services Association of Ohio this spring.

Meanwhile, federal funding for children’s services decreased by 16 percent between 2004 and 2014. That’s due in part to an arcane law stipulating that the largest pot of federal money for children’s services applies only to kids from below a certain income threshold. In many states, that threshold is about half the poverty level—in Ohio, it’s roughly $14,000 per year for a family of four. But the opioid epidemic has afflicted families of all stripes. “A few years ago, I was constantly just in homes that were clearly in poverty,” says Mongenel. Now she’s struck by her new clients’ well-kept houses: “You pull up to it and it’s like, ‘Really?’”

The director of one Ohio county stated “that more caseworkers are quitting than ever before, unable to reconcile the overwhelming caseload with the paltry salary, which starts at $28,500..’”

CPS and affiliated social services agencies across the United States are now becoming much more familiar with the latest addiction research on ACEs and impacts on young children. They know that a child with four or more ACEs is twice as likely as other kids to develop cancer and ten times more likely to inject drugs themselves. When they encounter someone like Lisa, they are torn between mitigating one ACE, exposure to parental substance abuse, and catalyzing another: separating a child from her parents, which is what makes these conversations so heart-wrenching.

For county and state professionalsone of the most difficult things about managing opioid cases is how unpredictable they can be, never knowing how a client’s drug-addicted parent will do after detox. Some thrive and are quickly reunited with their families. Others can’t pull themselves out of the black hole of addiction.

Every 19 minutes, an opioid addicted baby is born in America, while many of us are well aware of the repercussions of addiction in adults, but very little is understood about the impact it has on infants. After months of being fed opioids through the mother, these babies suffer through excruciating pain.

Imagine, then, how it feels for a baby. Infants who have been exposed to opioid painkillers like morphine, codeine, oxycodone, methadone treatment or street drugs such as heroin while in utero are literally cut off from the drugs when they are born. Within their first 72 hours of life, about half of the babies who have been exposed begin having withdrawal symptoms.

The medical term for this is neonatal abstinence syndrome, or NAS, and rates of babies born with it are rising along with the exponential increase of painkiller use and abuse.

A recent analysis by the Centers for Disease Control estimated that nearly six out of every 1,000 infants born in the U.S. are now diagnosed with NAS. However, experts say that rate is likely higher, as not all states regularly collect such data.

In Tennessee which is currently the only state in the country that equates substance abuse while pregnant with aggravated assault, the penalty is punishable by a 15-year prison sentence. Eighteen other states consider it to be child abuse, and three say its grounds for civil commitment. Four states require drug testing of mothers and 18 require that healthcare professionals report when drug abuse is suspected. There are also 19 states that have created funding for targeted drug treatment programs for pregnant women.

Opponents of the punishment philosophy claim that punishing addicted pregnant women will not stop them from abusing drugs – instead it will stop them from seeking prenatal care. Many also claim that these policies would unfairly punish mothers for drug use compared to fathers. Organizations, such as the American Civil Liberties Union (ACLU) and the American Congress of Obstetricians and Gynecologists (ACOG), have encouraged a treatment over punishment approach for pregnant mothers with drug addictions.

For the most up to date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.

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XARELTO STUDIES FAIL IN BAYER/J&J ATTEMPTS TO EXPAND MARKET CONTROL

THE RECENT FAILURE OF TWO XARELTO STUDIES STOPPED BAYER AND JOHNSON & JOHNSON ATTEMPTS TO INCREASE BLOOD THINNER MARKET-SHARE

By Mark A. York (August 28, 2018)

 

 

 

 

 

 

 

Two recent Xarelto studies fail to show additional benefits when Bayer and Johnson & Johnson’s attempted to expand the patient group for their heart drug Xarelto.

The recent Xarelto blood thinner “Commander HF” study, (see  https://clinicaltrials.gov/ct2/Bayer/J&J (Commander AF Study), could not show any statistical improvements in helping heart failure patients after an acute decline in their condition, results from the so-called study showed on Monday. The primary study goal of reduction in the risk of death, heart attack and stroke was unsuccessful.

A second Bayer/J&J study known as “Mariner” also failed to produce clear evidence that Xarelto is able to reduced the rate of blood clots in certain high-risk patients after a hospital release.

Bayer earned $3.84 billion in sales of Xarelto revenues last year, primarily from stroke prevention in the elderly, with projected annual sales to rise above $5 billion in 2019 and beyond.

Bayer retains marketing rights for Xarelto outside the United States while partner J&J sells Xarelto in the U.S., with Bayer being eligible for royalties on U.S. sales of 20 to 30 percent.

Both Bayer and J&J’s Janssen R&D are facing thousands of lawsuits across the country over failure to warn and disclose the significant dangers of being prescribed Xarelto and the inability to stop the bleeding as there hasn’t been an antidote for Xarelto until 2018.

XARELTO MDL 2804 AND PHILADELPHIA COMPLEX LITIGATION DOCKET

Between the Xarelto MDL 2804 federal docket of 25,000 plus and the 1,700 in Philadelphia Court of Common Pleas there seems to be significant concern for the use of Xarelto when a comparison is made to the pre-Xarelto blood thinners i.e. Coumadin and Warfarin which required additional monitoring, are not known as a drug that can kill you.

Mass Tort Nexus Briefcase Re: XARELTO-Case-No-2349-in-Philadephia-Court-of-Common-Pleas–Complex-Litigation-(PA-State-Court)

Mass Tort Nexus Briefcase Re: XARELTO-MDL-2592-US-District-Court-ED-Louisiana

HOW XARELTO WAS APPROVED BY THE FDA

Xarelto was first approved by the FDA July 2011, representing a major advancement in blood thinning (anticoagulant) medication according to Bayer and Johnson & Johnson, developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anticoagulant, it was intended to prevent pulmonary embolism (PE) and deep vein thrombosis (DVT) and strokes. Xarelto was also intended to help those patients with atrial fibrillation, a group of people more vulnerable to PE, DVT, and stroke after surgery. Eventually, the FDA expanded approval of Xarelto to treat all patients with PE, DVT and atrial fibrillation.

More than one study has shown Xarelto can cause a higher rate of internal bleeding, than other anticoagulant drugs and there is no available “antidote” for stopping internal bleeding in patients taking Xarelto. With warfarin, vitamin K has been shown to stop bleeding, but there is no vitamin K “parallel” for people taking Xarelto. For Xarelto, it can take 24 hours for a dose to get out of the body. That means that if internal bleeding starts, the patient may simply have to wait it out and hope it stops on its own.

 MAYO CLINIC XARELTO STUDY RESULTS NOT POSITIVE

In the journal Gastroenterology, a team of physicians and researchers from the Mayo Clinic studied thousands of patients who took Xarelto (rivaroxaban), Pradaxa (dabigatran), and Eliquis (apixaban). The goal was to figure out which of these three anticoagulant drugs had “the most favorable GI safety profile,” which is medical-research-speak for “which one of these drugs is least likely to hurt patients.”

This is how the study worked: The researchers studied health insurance administrative claims information on thousands of patients between October 1, 2010 and February 28, 2015. These patients had atrial fibrillation, or Afib, which is a heart arrhythmia, a quivering or irregular heartbeat. Afib can lead to serious health problems such as stroke, blood clots, heart failure and other health complications. The researchers looked at the incidents of gastrointestinal bleeding among the thousands of patients who took Xarelto or Pradaxa or Eliquis.

MAYO STUDY SHOWS NEGATIVE RESULTS

Patients who took Xarelto had a higher incidence of gastrointestinal (GI) bleeding patients who took Pradaxa or Eliquis. The statistics show that patients taking Xarelto may have a 20% greater risk of internal bleeding than with those taking Pradaxa or Eliquis, with the rates of GI bleeding increased in patients over seventy-five (75) years old. Turns out, Eliquis “had the most favorable GI safety profile among all age-groups.” While clearly showing Xarelto, unfortunately, had the “least favorable” safety profile among the three prescription anticoagulant drugs.

FDA Investigation of Xarelto Trials

The approval history for Xarelto was actually pretty controversial. FDA reviewers originally said that they recommended against approval, then there was an FDA advisory committee (independent group of key opinion leaders) and they voted in favor, so the FDA approved the drug. Their concern was with how the Phase III trials were run and whether Xarelto had really proved its efficacy. The tests compared patients on warfarin to patients on Xarelto, but the patients on the warfarin run had poor TTR. That means the patients weren’t well controlled on warfarin to begin with, which skews the data in favor of Xarelto.

During the approval process, Xarelto actually wanted a superiority label, which would say that the drug was better than warfarin and other blood thinners. Because of the concerns with the Phase III data, the FDA only gave them a non-inferior label, which says they’re essentially the same in terms of effectiveness.

One of the clinical trials that played a key role in its approval for stroke prevention in patients with atrial fibrillation is now under investigation by the FDA. This trial compared Xarelto’s performance to warfarin’s, but it used a device called INRatio to test the warfarin patients.

The INRatio device was the subject of two FDA warning letters about inaccurate readings just as the trial was starting in 2005 and 2006. In 2014, the device was recalled. The use of the INRatio device may have skewed the results with inaccurate readings, making Xarelto look better in comparison with warfarin.

The FDA’s medical experts originally recommended against improving the drug due to concerns about its efficacy. They found that Xarelto was not as effective as warfarin. However, a review board eventually approved the drug over the objections.

The FDA has issued a number of warnings about Xarelto and has required the makers of the drug to change its labeling multiple times. Specifically, the FDA warned about the risks of uncontrolled bleeding. It also added a black-box warning, its most serious kind of warning, about the increased risk of stroke when patients prematurely stop taking Xarelto and about the increased risk for swelling and damage associated with the use of epidural anesthesia while taking Xarelto.

The makers of Xarelto recently applied to the FDA to expand the approved uses of the drug to include treatment for acute coronary syndrome (ACS). For the third time, the FDA unanimously denied the expansion. Johnson & Johnson and Bayer are expected to continue to apply for approval due to the high value of that market. More than 1 million patients are hospitalized with ACS each year. That offers serious potential for growth for Xarelto, which already earns almost $1 billion in sales annually.

Johnson & Johnson also is claiming that Xarelto helps patients with peripheral artery disease (PAD) in reducing their heart attack and blood clot risks.

WHAT THE VETERANS ADMINISTRATION SAYS ON XARELTO USE

“The good news is you now have an alternative to warfarin … The bad news is you can kill a patient as easily with the new drug as you could with the old drug.”Dr. Alan Jacobson, Director of anti-coagulation services at the VA in Loma Linda, Calif.

The makers of Xarelto say it takes time for doctors to get up to speed on new types of treatments and how to best administer them outside the controls of clinical trials.

“This is a shift in medical practice,” said Dr. John Smith, senior vice president for clinical development at Boehringer. “Individual physicians have to determine what the follow-up plan will be, to use common medical-sense judgment.”

XARELTO MAKERS SAY NO FOLLW-UP CARE REQUIRED

Dr. Peter Wildgoose, a senior director of clinical development at J&J, said the company has not provided special advice on follow-up care for patients on Xarelto.

“There’s nothing more than for any other drug that people regularly take,” he said, adding that most atrial fibrillation patients probably see their doctors on a regular basis. “These drugs have been tested long term, for several years at a time, with very good outcomes.”

Johnson & Johnson officials stressed there was far less evidence in trials of brain bleeding – the most worrisome side effect of anti-coagulants – in patients taking Pradaxa and Xarelto than those taking warfarin.

WAS XARELTO EVEN NEEDED?

Even though warfarin (Coumadin) has been the standard in anticoagulant (blood thinner) drugs for more than 50 years, it lacked perfection, making way for a new generation of blood thinners, including Xarelto. In clinical studies, Xarelto was shown to be more effective than warfarin in treating patients with atrial fibrillation (AF) who are at an increased risk for stroke. And while Xarelto had less cranial hemorrhage (bleeding in the brain) incidents than warfarin, it was shown to have a similar overall number of bleeding incidences when compared to the number of bleeding events in patients taking warfarin.

Despite this finding, and – until recently – its lack of antidote (reversal agent) for serious bleeding, Xarelto rose to popularity, making up a significant portion of the billion-dollar anticoagulant drug industry in the United States. Even after an investigation into into the clinical trial ROCKET-AF study, upon which its U.S. Food and Drug Administration (FDA) approval hinged, the drug continues to be prescribed by doctors to patients with AF and as a prophylaxis for deep vein thrombosis (DVT), which can lead to pulmonary embolism (PE) after total hip and knee replacement surgeries.

But as more evidence surfaced regarding the drug risks for patients taking Xarelto, including an increased risk of wound complications following surgical procedures, severe bleeding with no easily available antidote to stop its serious consequences, as well as reports of platelet deficiencies, hepatitis and Stevens-Johnson syndrome (SJS) (a severe skin reaction), some heart doctors are becoming a bit more cautious with the blood thinner.

Xarelto and Internal Bleeding?

Janssen and parent company Johnson & Johnson market its anticoagulant drug Xarelto as a safe and more convenient choice in blood thinners compared to warfarin. But pre-market clinical studies and post-marketing reports have shown that taking Xarelto leaves many patients vulnerable to internal bleeding that can result in death for some users.

In a 2017 annual report issued by the Institute for Safe Medication Practices (ISMP), it was stated that oral anticoagulant drugs, including Xarelto (rivaroxaban), showed “unacceptably high risks,” according to two government data sources, the FAERS adverse events reports for 2016 and a new systematic study by the Centers for Disease Control and Prevention (CDC).

XARELTO ACCOUNTS FOR 75 PERCENT OF ALL AE’s IN ANTI-COAGULANTS

Of the 22,000 reports of serious injuries resulting from anticoagulant drugs, Xarelto accounted for 15,043 cases alone, the FDA said.

“According to an analysis of 2016 FDA adverse event data conducted by the ISMP, anticoagulant (blood thinner) drugs accounted for nearly 22,000 reports of serious injuries in the United States, led by Xarelto, which accounted for 15,043 cases alone. These numbers also included 3,018 reported deaths, with most injuries being the result of hemorrhages, making bleeding one of the most adverse events.”

Gastrointestinal hemorrhages made up the MOST INJURIES, followed by cerebral hemorrhages. From early testing, hemorrhage has always been an apparent increased risk associated with lowering the risk of strokes from blood clots.

In late 2016, the CDC released a separate study that found that “anticoagulant drugs accounted for more emergency department visits for outpatient adverse effects than any other class of drugs currently in therapeutic use, including opioids (non-abuse visits), antibiotics and diabetes drugs.” Most of these adverse events were severe, with nearly 50 percent requiring a hospital stay. The ISMP estimated in its QuarterWatch report that just over 6 percent of patients using anticoagulants for one year will need to visit the emergency room, with about half of those patients requiring hospitalization. That is a major number of injuries that can be attributed to a drug that is advertised as life saving and designed to prevent injuries.

Overall, the CDC found in its systematic study that the FDA’s FAERS voluntary reporting underestimates anticoagulant drug-related injuries. The CDC discovered that approximately 228,600 emergency department visits occur each year due to the use of blood thinner drugs, including Xarelto, which is 10 times more than the FAERS total number of voluntary reports.

The Symptoms of Internal Bleeding

At its onset, unless it’s a severe hemorrhage, internal bleeding may not cause any symptoms apparent to the patient taking Xarelto. However, dependent on where the bleed is located in the body, the patient will soon begin exhibiting signs and symptoms that will be their indication to seek immediate medical attention. Patients who are in poor health or are over the age of 64 and the targeted audience seem more likely to suffer serious, potentially life-threatening bleeding complications.

The end result of Bayer and J&J’s attempts to secure the blood thinner market may continue unabated until the more than 25,000 lawsuits over the injuries and deaths that are affiliated with taking Xarelto will force both companies to come to either the settlement table or begin trying the Xarelto MDL 2592 lawsuits being remanded back to original courts for trials and blocks of 1200 cases at a time. Xarelto MDL Judge Eldon Fallon, USDC Eastern District of Louisiana has already started the remand process for 23,000 cases pending in his federal court, due to the lack of progress in settlements and cooperation by Bayer and Johnson & Johnson.

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INDIVIDUAL CLAIMS = INFANT “NAS”, RICO, WRONGFUL DEATH, NEGLIGENCE AND MORE…

Individual Opioid Injury Claim Types

 

A MASS TORT NEXUS OVERVIEW:

by John Ray

A great deal of media attention has focused on lawsuits filed by States, Counties and Cities against the manufacturers of opioids, yet less attention has been given to viable individual opioid patient claims against these same companies. This article is the second in a series published by Mass Tort Nexus to have you gain a better understanding of the vast number of opioid claims, which may be filed on behalf of individual victims of the opioid crisis. Please also read the first article in the series (link to the first article).

This article is intended to cover the major categories or types of potential opioid individual claims based on injury or adverse event type.

  1. Overdose resulting in death

  2. Overdose without death

  3. Opioid Addiction

  4. Neonatal Abstinence Syndrome

  5. Birth Defects

  6. Heart attack

Attend the July 20-22, 2018 Mass Tort Nexus Opioid Crisis Summit to learn more about what your firm can do to help individual victims of the opioid epidemic.

In addition to providing information related to the types of claims that may be brought against the opioid defendants on behalf of individual plaintiffs, you will also receive information related to marketing to obtain these clients, as well as vital information related to the complex issues related to qualifying clients for each category of opioid injury.

To register for the Opioid Summit contact Jenny Levine at 954-530-9892 or email at jenny@masstortnexus.com. You may also register online at  https://www.opioidcrisissummit.com

Opioid Litigation Individual Claims

Given the publicity surrounding the opioid crisis gripping our nation, most of the country is aware that opioid addiction and overdose risk is far greater than the opioid litigation defendants, their Key Opinion Leaders and Front Groups led us to believe.

The researchers at Mass Tort Nexus estimate that there are approximately 250,000 individuals and families with viable claims against the opioid litigation defendants; however, yet few firms have engaged in an effort to retain these clients and provide the legal representation they desperately need and deserve. This fact is somewhat astounding given that many of these potential plaintiffs have been represented by your personal injury firm in the past.

Overdose Resulting in Death

  When an individual, often a juvenile, dies from an opioid overdose, family members are left behind to suffer the pain and costs.

Significant evidence exists to demonstrate that the opioid manufacturers negligently and wantonly deceived doctors and the public about the risks associated with opioids. They continued to do so, even after it was apparent that their deceptions were resulting in loss of life and other severe injuries caused by their products.

The potential number of wrongful death claims which could be brought against the opioid defendants, could exceed the total number of wrongful death claims brought for any other reason over the next decade.

 Overdose Deaths Soared as Big Pharma Reaped the Profits

According to the National Institute for Drug Abuse revised report from March 2018, despite the efforts to stem the opioid crisis, 115 people in the United States die from an Opioid overdose every day.

Overdose deaths, once rare, are now the leading cause of accidental death in the U.S., surpassing peak annual deaths caused by motor vehicle accidents, guns and HIV infection.

More Americans died from drug overdoses in 2016 than the number of American lives lost in the entirety of the Vietnam War, which totaled 58,200.

 

 

 

 

 

 

 

 

 

 

Prescription opioid deaths account for the majority of the increase in overdose deaths since 1999. It is no coincidence that the astounding increase in drug over dose statics beginning in 1999 coincides with the opioid manufactures campaign (beginning in the late 1990s) to convince doctors, based on false information, that past concerns related to opioids were unwarranted.

The opioid manufacturers are accused of using big tobacco style techniques to increase the consumption (and their profits) from increased sales of opioids. The manufacturers are accused of taking a page from the big tobacco play book, using front groups and key opinion leaders in the health field to promote the narrative that the risk associated with opioids was not significant.  The false narrative promoted by the opioid manufacturers has been unveiled at the cost of an enormous loss of human life and suffering.

The link between the success of the opioid manufacturers deceptions, and the devasting effects caused by their fraudulent acts can be seen in a single chart. As the opioid manufacturers made billions of dollars, individual patients relying on these companies paid the price.

 

 

 

 

 

 

 

Overdose Without Death

Opioid overdose deaths are devasting to the family of the victim. Opioid overdoses that do not result in death can be equally or even more devasting.

Victims of opioid overdoses often suffer brain damage, heart damage and other adverse events that will impact their lives and their families permanently.

In many cases, the financial and other damages caused by an overdose not resulting in death will exceed those of overdose cases resulting in death.

Opioid Addiction

Despite the opioid litigation defendants attempts to blame the victims and their doctors, the blame for the meteoric rise in opioid addiction coincided with the opioid manufacturers fraudulent practices designed to deceive doctors and the public about the risk of opioid use.

According to the CDC, by 2016 2.1 million Americans suffered from opioid addiction (opioid use disorder) and 2.1 million more Americans received their first opioid prescription in the same year, guaranteeing the continuation of the Country’s opioid addiction epidemic.

 

Not every opioid addict will have a viable claim for damages against the opioid manufacturers.

Qualifying opioid addiction clients is complex. Attend the Mass Tort Nexus July 20 -22

Opioid Crisis Summit to learn more about qualifying clients with viable opioid addiction claims.

Neonatal Abstinence Syndrome

 By 2012, the National Institute for Health had recognized a dramatic increase in Neonatal Abstinence Syndrome (NAS) and the number of babies born with NAS has continued to increase since that time.

 

 

 

 

 

 

 

 

 

NAS occurs when a mother ingests opioids during pregnancy. Despite the risks associated with NAS and opioids, the opioid manufacturers are accused of aggressively promoting the use of opioids for pain commonly associated with pregnancy.

In addition to damage to the fetus before birth, opioid consumption during pregnancy often results in the infant being born addicted to opioids. The long term impact of NAS, often results in consequences that will plague the infant for the remainder of their lives.

Impaired cognitive abilities, severe behavioral issues, as well as an increased susceptibility to opioid use and addiction later in life are among a long list of complications associated with NAS.

Babies born with NAS and opioid related birth defects will often suffer from the day they are born until the day they die. The opioid defendant’s actions leading to the harm of infants should be a great source of shame for the opioid defendants; however, at this point, it appears that the opioid defendants have no shame.  They continue to blame others for what is clearly their fault.

Birth Defects

There is significant support in the medical literature demonstrating opioids cause numerous severe birth defects.

One of the types of birth defects potentially caused by maternal opioid use is Tetralogy of Fallot.

 

 

 

 

 

 

 

Tetraolgy of Fallot is a heart defect that presents with some or all of the following defects in the infants heart: Overriding Aorta, Pulmonary Stenosis, Ventricular Septal Defect and Right Ventrial Hypertrophy.

Any of the defects associated with Tetraolgy of Fallot can result in infant death or the need for multiple cardiac surgeries and a permeant decrease in quality of life.

Neural Tube Defects may also be caused by maternal opioid use. Neural Tube Defects include Spina Bifida, Anencephaly and Encephalocele. Any of these birth defects can result in infant death, the need for multiple corrective surgeries over numerous years, as well as a permanent decrease in quality of life.

 

 

 

 

 

 

 

The above is only a partial list of birth defects which are associated with maternal opioid use. Given the increase in clinical interest and study surrounding opioid use, we expect to see additions to the medical literature demonstrating a large number of opioid associated birth defects, in the near future.

HEART ATTACK

      There is overwhelming support in the medical literature demonstrating an increased incident of heart attack and other coronary issues associated with opioid use.

Cardiac damage and heart attack are common secondary issues related to opioid overdose; however, these adverse events appear to occur at a high rate in all opioid users without regard to the occurrence of an overdose.  The increased risk appears to exist for patients that are predisposed to cardiac problems, as well as those who are not.

The conditions and adverse events associated with opioid use covered in this article do not include all the medical issues associated with opioid use.

Attend the July Mass Tort Nexus Opioid summit for a more through understanding of the medical conditions which may give rise to viable individual claims against the opioid defendants.

To register for the Opioid Summit contact Jenny Levine at 954-530-9892 or by email at jenny@masstortnexus.com.

You can also register online at https://www.opioidcrisissummit.com

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The Case for Individual Opioid Claims

Individual Opioid Claims 

Attend the July 20-22, 2018 Mass Tort Nexus Opioid Crisis Summit, to learn more about what your firm can do to help individual victims of the opioid epidemic.

The Opiod Crisis Summit will provide information related to the types of claims that may be brought against the opioid defendants on behalf of individual plaintiffs. Additionally, you will receive the proven criteria questions to obtain these clients, as well as vital information related to the complex issues related to qualifying clients for each category of opioid injury.

To register for the Opioid Crisis Summit contact Jenny Levine at 954-530-9892 or email at jenny@masstortnexus.com.

You can also register online at  https://www.opioidcrisissummit.com

Many of your firms’ past P.I. clients may have claims against the opioid defendants

If your personal injury firm is not reaching out to its past clients and engaging in “public awareness marketing,” to obtain opioid clients, you are missing out on an opportunity to help the several hundred thousand individuals and families, that have potential claims against the opioid litigation defendants.

Personal Injury firms are in a unique position to help individuals harmed by the opioid epidemic, as many of these potential clients will have been previously represented by your firm.  The first opioid prescription issued to an individual often occurs after a personal injury, such as an auto accident or work place injury. If your firm does not reach out to its past clients and offer to represent them in their potential claim against the opioid defendants, you can rest assured that other firms will eventually sign these cases.

Misconceptions about the Learned Intermediary Doctrine

Numerous firms have expressed concerns related to opioid individual cases being eviscerated by the Learned Intermediary Doctrine. This concern may arise from opioid individual cases from over a decade ago, that resulted in defense wins based on learned intermediary doctrine arguments.

Despite the defense Learned Intermediary Doctrine wins from over a decade ago, the researchers at Mass Tort Nexus and many others do not believe the Learned Intermediary Doctrine will be a significant factor in individual opioid cases filed now or in the future.

Why?

Much has occurred since the defense “Learned Intermediary Doctrine” wins of the past.

  1. The FDA has issued multiple new Black Box Warnings for all opioid products and more are expected.
  2. The FDA, CDC, NIH and even State Medical Boards have issued new guidelines for opioid prescribing and even stricter guidelines are expected in the future.

Considering all that is now known, it is unlikely that any physician would testify that he/she would continue to prescribe opioids, in the same manner as the past.

This is what the Surgeon General had to say

The current U.S. Surgeon General, Jerome Adams and immediate past U.S. Surgeon General, Vivek Murthy have issued statements containing language like the excerpt below, from a letter sent by Mr. Murphy to every prescriber in the United States:

Nearly two decades ago, we were encouraged to be more aggressive about treating pain, often without enough training and support to do so safely. This coincided with heavy marketing of opioids to doctors. Many of us were even taught – incorrectly – that opioids are not addictive when prescribed for legitimate pain.”

It is worth noting that the current Surgeon General Jerome Adams has been personally impacted by the opioid crisis. His brother is one of the many victims.

The Bottom Line

The learned intermediary was not “learned” in the past, doctors were misinformed or incorrectly “learned.” Defendants would face great challenges in succeeding in arguments sounding in the Learned Intermediary Doctrine given all that is now known.

New Black Box Warnings

In June of 2018, the FDA required new Black Box Warnings be added to the prescribing labels of all instant release opioid products partially because prescribers were miseducated by the opioid defendants, their front groups and key opinion leaders.

New Black Box Warning requirements were imposed on all opioid instant release products, as of June 2018. The intent was to ensure that previously miseducated doctors (learned intermediaries) gain an understanding of current proper opioid prescribing standards and cease prescribing opioids based on the past misinformation (incorrect learning) they received over the past several decades.

 

 

 

 

 

 

Mass Tort Nexus invites you to attend our July 20-22 Opioid Crisis Summit and hopes that your firm will join the fight on behalf of the hundreds of thousands of individual opioid victims needing legal representation.

To register for the Opioid Crisis Summit contact Jenny Levine at 954-530-9892 or email at jenny@masstortnexus.com.
You can also register online at  https://www.opioidcrisissummit.com

 

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New York And Other State Court Opioid Litigation Moves Forward Along With Federal Opiate Rx MDL 2804

“LAWSUIT FLOOD VERSUS ENTIRE OPIOID INDUSTRY IS GETTING BIG PHARMA’S ATTENTION”

By Mark A. York (June 11, 2018)

 

 

 

 

 

 

Opioid litigation in New York and other state courts, where hundreds of counties and cities have filed lawsuits against opioid manufacturers and distributors,  are now moving forward even with the explosion in the Federal Opiate Litigation MDL 2804 OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION, where more than 500 states, counties, cities as well as unions, hospitals and individuals have filed lawsuits against the opioid industry as a whole.

At one point, the opiate industry attempted to raise arguments stating that the Food and Drug Administration hasn’t yet determined whether narcotic painkillers are unnecessarily dangerous – a central question in any litigation, which was quickly denied and seems to show that Opiate Big Pharma is once again attempting to hide behind the FDA shield.

In a two-page order issued in March by Judge Jerry Garguilo of the Suffolk County Supreme Court, New York where he ruled that there is “no compelling reason to impose a stay of proceedings” until the FDA completes its own review of the benefits and risks of opioids. The lawsuits by most of the counties in New York, which have been consolidated in Garguilo’s court, are “backward-looking” toward allegedly fraudulent marketing materials and tactics the drug companies used to convince doctors and patients their products had low risk of addiction.

In another state court, the first of many opioid litigation trials to be scheduled is now set in Oklahoma, where Cleveland County District Judge Thad Balkman set May 28, 2019 for the start of the trial. ate has been set for a lawsuit by a state against pharmaceutical companies over the opioid epidemic, according to Oklahoma‘s attorney general. See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

Oklahoma, one of at least 20 states besides New York that have opioid lawsuit dockets against drugmakers, alleges fraudulent marketing of drugs that fueled the opioid epidemic in the lawsuit filed in June 2017, and seeks unspecified damages from Purdue Pharma, Allergan, Janssen Pharmaceuticals, Teva Pharmaceuticals and several of their subsidiaries.

The New York state court lawsuits are joined by another somewhat unique group of plaintiffs in the legal battle over the opioid-epidemic with class actions filed by consumers who claim they’re seeing skyrocketing health insurance costs as a result of the crisis.

The suits, filed in New York and four other states, were brought by individual persons against opioid manufacturers and distributors, and are among the few class actions filed against drug makers and marketers. The vast majority of cases have been separate actions brought by government entities like cities and counties.

The plaintiffs in this new wave of cases have filed across the country in federal courts in  USDC SD New York (Complaint) , a New Jersey Complaint,  a Massachusetts Complaint, an Illinois Complaint as well as a California Complaint  where they’ve filed lawsuits on behalf of those who paid increased health insurance costs–including higher premiums, deductibles and co-payments–because of effects attributable to the opioid epidemic.

The proposed classes include businesses and individuals who paid for health insurance as part of employer-sponsored plans.

“We don’t know anyone who in the litigation is addressing the private sector harms to consumers and businesses from increased premiums and other insurance costs that flow to anyone in the health insurance market as a result of the fact that insurers are paying more for addictions,” said Travis Lenkner, one of the plaintiffs attorneys filing the cases.

The opioid cases add a new type of plaintiff into the wide-reaching opioid litigation, which have also includes states, Native American tribes, pension funds and hospitals.

John Parker, senior vice president of the Healthcare Distribution Alliance, speaking on behalf of distributors AmerisourceBergen Drug Corp., Cardinal Health Inc. and McKesson Corp., all named as defendants, called the opioid epidemic a “complex public health challenge.”

“Given our role, the idea that distributors are responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and is regulated,” he said in a statement. “Those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation.”

Purdue Pharma spokesman Bob Josephson noted that his company’s products account for less than 2 percent of all opioid prescriptions. Johnson & Johnson’s Janssen Pharmaceuticals defended the labels on its prescription opioids and called the allegations “baseless and unsubstantiated.”

Representatives of the other manufacturing defendants, which include Endo Health Solutions, Teva Pharmaceutical Industries and Insys Therapeutics Inc., did not respond to requests for comment.

It is now fairly common knowledge in the legal world that there is more than enough data that links increased health insurance costs to the opioid epidemic as well as the overall catastrophic impact of the flood of opioids into the America marketplace.

The suits cite statistics. In California, for instance, health insurance premiums for family coverage increased 233.5 percent from 2002 to 2016. Monthly premiums for the plaintiff in that case, Jordan Chu, jumped from $160.52 in 2016 to $240.76 this year. New Jersey residents with private health insurance spent $5,081 in insurance premiums in 2014, up from $2,454 in 2001. And an average family plan in New York with annual costs of $9,439 in 2003 had jumped to $19,375 in 2016.

Plaintiff counsel stated that they will be filing suits in more states and fight any attempts to transfer these cases to the Northern District of Ohio, where U.S. District Judge Dan Polster is overseeing the opioid multidistrict litigation, MDL 2804, even though the cases were filed in federal courts. A damaging discovery win for the plaintiffs was the order of May 18, 2018, see DEA ARCOS Database Access Order May 8, 2018 MDL 2804, where Judge Polster ordered the DEA to turn over distribution data for all 50 states based on the revelations in a prior DEA related order where the Opioid Drug distribution data provided very solid information on all the parties involved in creating the opioid crisis over the last 15 years.

The New York court docket parallels the federal and many other opioid based complaints, filed in state courts across the country where parties have decided to pursue their claims in their state courts versus the federal docket. These filings in both state and federal courts, will only increases the pressure on manufacturers and wholesalers to either win dismissal of these cases or prepare for an accelerated trial schedule.

There are currently more than 500 of the nation’s 3,200 counties have sued and plaintiff lawyers hope to soon get that number to 1,500, which some lawyers consider critical mass for a settlement.

The defendant companies argue they can’t be held liable for selling a legal product sold only with a doctor’s prescription whose distribution was controlled and overseen, from manufacturing to retail sales, by federal and state regulators.

The plaintiffs argue manufacturers used a variety of tactics, including misleading marketing materials and highly paid physician-influencers, to convince prescribing physicians their products were safe for treating chronic pain when, in fact, they were highly addictive.

In the March order, Judge Garguilo rejected the defendants’ claim that the FDA has exclusive authority to determine whether, in effect, opioids should be sold for anything other than relieving the pain of terminal illness. Regardless of what the FDA determines, the judge said, the municipal plaintiffs have the right to seek redress for their costs associated with addiction.

“Because the focus of this lawsuit is on the state of scientific knowledge that existed when the defendants made their marketing claims, there is no risk of inconsistent rulings, and none of the current studies will have any bearing on whether the defendants’ representations were misleading when made,” the judge wrote. The court isn’t being asked to decide the risks and benefits of opioids but whether the defendants misrepresented those risks and benefits, he added.

In case the defendants didn’t grasp the judge’s ultimate goal, the judge restated his “previously expressed desire” for a “prompt resolution of this matter.” The federal judge overseeing multidistrict litigation in Ohio, Judge Dan Aaron Polster, has similarly urged defendants to engage in settlement talks, although a global resolution of the litigation could prove difficult to negotiate.

In addition to hundreds of cases consolidated in federal court, the defendants face a wave of litigation in state court, like the New York cases, as well as lawsuits and investigations by state attorneys general and the federal government. Any settlement would have to protect the defendant companies from future lawsuits over the same issue and that may be difficult to negotiate given all the concurrent litigation in different courts. The time has now arrived for Opioid Big Pharma, in all forms to face the facts that for close to 20 years they have flooded the mainstream commerce of America with massive amounts of opiates with little to no oversight, which whether caused by a catastrophic systemic failure on many levels, or simple greed, the time has now come for the opiate industry to face the music of complex litigation in state and federal court venues across the country.

For those looking to tap into the opioid litigation or learn what the current status is in both state and federal court opioid litigation, please visit www.opioidcrisissummit.com where Mass Tort Nexus is hosting national political leaders and lead opiate counsel who are active in the day to day opioid crisis and have the most up to date case information during the two day event taking place July 21-22, 2018 in Fort Lauderdale.

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How Insys Theraputics, Inc. Sold Stock And Killed Americans With The Help Of Doctors

How Insys Theraputics, Inc. Sold Stock And Killed Americans At The Same Time 

The Opioid Crisis Behind The Scenes

by Mark A. York (June 8, 2018)

Subsys – an Insys Therapeutics, Inc. Pharmaceutical Opioid Product

 

 

 

 

 

 

 

 

 

 

 (MASS TORT NEXUS MEDIA)  Here’s a perfect example of how corporate greed and licensed medical providers helped create the now rampant US opioid crisis– how payments to doctors and prescribers across the country caused addictive painkillers, like “Subsys” a fentanyl based opioid, to suddenly rip through our country like a flash fire.

Insys Therapeutics,a publicly traded pharmaceutical company based in Arizona, is just one small example of what Big Pharma has been doing for the last 10 years in every city and state in the United States, often increasing corporate earnings right alongside the catastrophic opioid related death rates. For Insys Theraputics executives, the sales team and its nationwide cadre of fraudulent doctors, the results have been felony indictments and long federal prison sentences, with many more to come.

INSYS EXECUTIVES INDICTED

December 2016 saw Insys Therapeutics CEO Michael Babich and five other senior executives indicted on criminal charges for paying kickbacks and bribes to medical professionals and committing fraud against insurance companies across the country for offering a highly addictive Fentanyl prescription product “Subsys” to the masses. The Insys boardroom was indicted in the US District Court of Massachusetts, where the entire team has engaged a stable of top national law firms to defend the indictments. The “Subsys” sales teams were charged in federal indictments across the country, including Arkansas, Connecticut, Alaska and New York and the indictments will only increase as those cases proceed and “cooperating witnesses” decide that prison isn’t an option.

To compound further harsh scrutiny for Insys, it’s new CEO Saeed Motahari, moved over from Purdue Pharmaceuticals, the Oxycontin maker, who’s also a major target of criminal and civil investigations across the country by local state and federal agencies. Purdue is charged with false marketing, off-label use and ignoring the Oxycontin highly addictive dangers for years, while bringing in literally billions of dollars in profits, but Purdue’s transgressions are in Part 2 of our ongoing reports on big pharma and opioid abuses.

DOCTORS FACING NUMEROUS CHARGES

Doctors and their pain clinics, medical centers and other healthcare facilities have been indicted for fraudulent prescription writing, submitting false claims to insurance companies and numerous other federal charges and all face a minimum of 20 to 50 years in federal prison. Two of the busiest “Subsys” prescription writers in the country were Alabama doctors, John Couch and Xiulu Ruan, who earned over $40 million from Insys, and were charged with running a pill mill between 2013 and 2015, have been convicted and sentenced to 20 years each in federal prison. The top “Subsys: prescriber of all, Dr. Gavin Awerbach, of Saginaw, MI pled guilty to defrauding Medicare and Blue Cross out of $3.1 million in improper Subsys prescriptions, his criminal sentence is pending. To show the far reach of Insys and it’s corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with heading a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which the caused the revocation of his medical license in Arkansas.

INSURANCE COMPANIES FILED SUIT

Adding weight to this tragedy is Anthem Insurance — you may recognize them as Blue Cross, one of the largest insurers in the country, now setting their sights on Insys Theraputics and it’s executives.

Anthem is suing Insys Therapeutics, the maker of the powerful opioid Subsys, for allegedly lying, cheating and defrauding its way into the medicine cabinets of Anthem clients across the country. The drug according to Anthem’s complaint, was off market prescribed to thousands of patients for years. Review shows that 54% of patients who are taking Subsys don’t really have cancer — one of the requirements for prescribing the drug, Subsys was FDA approved for “treatment of pain related to cancer” and any other use is unauthorized or off-label use.

Anthem says that’s because Insys devised an elaborate scheme to get around Anthem’s system — by falsifying records and posing as medical professionals, often with the complete knowledge and cooperation of medical doctors across the country who then received thousands of dollars in kickbacks. These doctors chose to exchange high fees from Insys in exchange for writing off-label prescriptions to patients seeking pain relief for non-life threatening conditions.

Anthem claims it ultimately paid $19 million more for Subsys than it should have. “But the harm inflicted by Insys’s conduct is not merely financial in nature,” the complaint states “Insys put Anthem’s members’ health at risk.”

THE OFF LABEL CAMPAIGN

The only people who are supposed to be taking Subsys are adult cancer patients, according to the FDA “Subsys” approval files, anything other than that is an “off label” indication. Now you can take a drug to treat something off label if you want to, but you have to get your doctor to get pass a prior authorization.

Anthem alleges that Insys has an entire unit to get around this requirement — it’s titled the “reimbursement unit.” Investigative journalists exposed this fraud initially as far back as 2015 on behalf of the Southern Investigative Reporting Foundation, see Insys Therapeutics “Subsys” Off Label Rx Fraud.

The Reimbursement Unit claim was basically the company’s fraudulent  prescription approval factory, which helped participating doctors process claims (the doctors had so many they couldn’t handle them all). The unit falsified records to show patients had cancer and called insurers, pretending to be patients or other medical professionals, to facilitate approval of payment for off-label treatment.

This is the Unit’s script for obtaining off-label approval (taken from the Anthem suit):

The script read: “The physician is aware that the medication is intended for the management of breakthrough pain in cancer patients. The physician is treating the patient for their pain (or breakthrough pain, whichever is applicable).” The script deliberately omitted the word “cancer as applied to the patient treatment under discussion.”

DO STOCKS RISE AND FALL ON INDICTMENTS

 

 

 

 

 

 

 

 

In late 2016 the entire top level of Insys executives, including former CEO Michael Babich, and five others were indicted and charged with multiple counts of fraud and conspiracy. Since then a number of sales reps and medical practitioners have pled guilty to charges that they gave or accepted kickbacks in furtherance of the fraudulent prescription scheme. The manager of reimbursement services, Elizabeth Gurrieri, pleaded guilty to wire fraud in June. There have been numerous deaths and related overdoses attributed to the over prescribing of Subsys across the country, which to date, show most parties involved being able to avoid the scrutiny of criminal charges related to off-label marketing and prescribing. Insys has tried to re-shuffle the executive board by bringing in new members, but business as usual in the Big Pharma boardroom goes on, as they simply brought in other more experienced “opioid industry” insiders to help further the continued use of “Subsys” and purportedly the major Insys New Pharma” entry, a line of complex medical marijuana products, that may enable them to shake off the current Insys label as the United States leading “opioid abuse by boardroom design” corporation.

As part of the boardroom strategy to get doctors to prescribe Subsys, Insys spent millions paying them off through a fraudulent “speakers program” meant to educate medical professionals about the drug. The speaking engagements were a veiled attempt to cover-up the direct payment to doctors for writing prescriptions, the more prescriptions you wrote, the higher your “speaking fees” increased. There are e-mails, texts and other Insys communications from all levels of company personnel stating “if they not writing prescription, they’re off the speaking program”, this policy resulted in one Alabama sales rep being paid over $700 thousand in Subsys based Rx commissions for one year, while her base salary was $40 thousand.

“While the exact amount of those kickbacks has yet to be determined, criminal indictments of the recipients indicate that Insys paid “speaker fees” of millions, of dollars, which may result in additional criminal charges against the doctors as well as the doctors facility staff who often worked hand in hand with Insys staff.

SALES REP NATALIE REED PERHAC

In the plea, Perhacs admitted that she was hired to be the personal sales representative for one of Insys’s most important prescribers, Dr. Xiulu Ruan. Ruan is one of two Alabama doctors who picked up over $115,000 in speaker fees from 2012 to 2015, and earned in excess of $40 million in related medical earnings during the same period. Earlier this year they were sentenced to 20 years in jail each for running a “pill mill” and helping Insys sales rep Natalie Reed Perhacs sell Subsys, for which she was paid in excess of $700 thousand in commissions, see Perhac Guilty Plea in Alabama Federal Court.

Perhac Plea Excerpts:

Admision No. 78: . Perhacs admitted that her primary responsibility at Insys was to increase the volume of Subsys® prescribed by Dr. Ruan, and his partner Dr. John Patrick Couch. This… was accomplished by (1) handling prior authorizations for their patients who had been prescribed Subsys®; (2) identifying patients who had been at the same strength of Subsys® for several months and recommending that Dr. Ruan or Dr. Couch increase the patients’ prescription strength; and (3) setting up and attending paid speaker programs.

Admission No. 79:. Ms. Perhac admitted that because of her involvement in the prior authorization process, she knew that the vast majority of Dr. Ruan and Dr. Couch’s patients did not have breakthrough cancer pain.

As you can see by the Perhac admissions, numbers 78 and 79, which reflect the vast number of charges lodged against her, the federal government is cracking down on everyone involved with the “Subsys” fraud. According to confidential sources, the recent June 2017 FDA “Opioid Crisis” Conference and related strategic review of the opioid crisis, will result in many more indictments and charges against drug makers and the medical providers who’ve helped facilitate the opioid epidemic that is currently in place across the United States.

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First State Court Opioid Crisis Trial Set In Oklahoma With May 2019 Start Date

By Mark A. York (May 24, 2018)

 

 

 

 

 

 

 

May 28, 2019 trial date set in the first opioid litigation case to go to trial where a  state filed suit versus the opioid pharmaceutical companies

(MASS TORT NEXUS MEDIA) The first of many opioid litigation trials where states, counties and cities have filed lawsuits against the Opioid Big Pharma industry and it’s affiliates, is now set in Oklahoma where Cleveland County District Judge Thad Balkman set May 28, 2019 for the start of the trial.  The trial date date has been anticipated in the lawsuit by the State of Oklahoma against pharmaceutical companies over the opioid epidemic, according to Oklahoma‘s attorney general Mike Hunter. See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

To summarize the view in Oklahoma and other states who are pursuing the Opioid prescription drugmakers in courts all across the country, Oklahoma Attorney General Mike Hunter stated in his filings  “Defendants created the worst public health crisis in modern history. Families destroyed,”adding “Children killed. Babies addicted. Morgues overflowing. Prisons full.” This is a common view across the entire United States at this point.

Oklahoma, one of at least 13 states that have filed lawsuits against drugmakers, alleges fraudulent marketing of drugs that fueled the opioid epidemic in the lawsuit filed in June 2017, and seeks unspecified damages from Purdue Pharma, Allergan, Janssen Pharmaceuticals, Teva Pharmaceuticals and several of their subsidiaries.

“We appreciate the urgency Judge (Thad) Balkman saw in getting the case to trial,” Attorney General Mike Hunter said. “Oklahomans who have suffered immeasurably from the years of fraudulent marketing campaigns will see this case resolved sooner rather than later.” Hunter said Balkman scheduled the trial to begin May 28, 2019.

For up to date information on the Opioid Litigation across the country see, OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION (https://www.masstortnexus.com/Briefcases/Drugs/254/)

Within the last 2 weeks, state attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee lawsuits have now joined many other states who have filed lawsuits asserting that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Joining, Oklahoma are states who’ve previously filed claims against opiate drugmakers are Ohio, AlaskaKentuckyLouisianaMississippiMissouriMontanaNew HampshireNew JerseyNew MexicoSouth Carolina and Washington state. West Virginia has been catastrophically affected by the opioid crisis and has previously attempted to stop Opioid Big Pharma from pushing opiates into their communities, without much success.  See How drug companies submerged West Virginia in opioids for years: “A small West Virginia town of 3,000 people got 21 million pills”

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

The companies deny wrongdoing and say they complied with Federal Drug Administration requirements that include warning labels showing potential risks that come with using their drugs. “We are deeply troubled by the prescription and illicit opioid abuse crisis, and are dedicated to being part of the solution,” Purdue Pharma said in a statement Friday. “We vigorously deny these allegations and look forward to the opportunity to present our defense.”

Ohio Filed First

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

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

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

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

The state lawsuits are separate from pending lawsuits in Ohio by dozens of local governments, and lawsuits by Native American tribes in the Dakotas and Oklahoma.

In South Dakota, the Rosebud Sioux Tribe, Flandreau Santee Sioux Tribe and the Sisseton Wahpeton Oyate filed a federal lawsuit in January against 24 opioid industry groups. See https://www.indianz.com/News/2018/04/11/navajonationopioid.pdf.  n Oklahoma, a federal judge has ruled that another similar lawsuit by the Cherokee Nation cannot be tried in tribal court, and Cherokee Nation Attorney General Todd Hembree told the Tulsa World that the tribe will re-file the lawsuit in state court.

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country.  At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

Will litigation in most every state in the union paired with the National Opiate Prescription MDL 2804 reign in the Opioid industry that’s earned billions and billions of dollars over the last 20 years, all at the expense of the people of the United States and their families?  If history is a gauge of how things will end up, chances are a big “NO” as money and greed at the corporate levels have traditionally overruled anything affiliated with long term public health concerns in our for-profit healthcare system currently entrenched in the United States.

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