More States Are Now Filing Lawsuits Against Big Pharma’s Opioid Rx Cash Cow Industry

Florida, Texas, Nevada, North Carolina, North Dakota and Tennessee Join Opioid Litigation

 

 

 

 

 

 

(Mass Tort Nexus Media) Litigation against OxyContin maker Purdue Pharma LP and the rest of the Opioid Big Pharma industry just jumped significantly, as six more states have filed lawsuits against Purdue Pharma, et al. The ongoing allegations against the opioid pharmaceutical industry as a whole, where numerous governmental entities from across the country have asserted that the opiate makers have fueled a national opioid crisis. This is primarily based on corporate boardroom designed deceptive opioid marketing campaigns, designed to sell prescription opioids, and minimize the previously well-known medical risks, including addiction and overdose, while generating billions of dollars in sales.

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/)

Prescription and illegal opioids account for more than 60 percent of overdose deaths in the United States, a toll that has quadrupled over the past two decades, according to the U.S. Centers for Disease Control. Drug overdose deaths in 2015 far outnumbered deaths from auto accidents or guns.

Texas saw 1,186 opioid-related deaths in 2015, while the nation as a whole had 33,000 such deaths that year. Researchers have flagged opioids as one possible factor in Texas’ staggering rise in women’s deaths during and shortly after pregnancy.

State attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee assert 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.

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.

Teva, in a statement, emphasized the importance of safely using opioids, while AmerisourceBergen said it was committed to collaborating with all stakeholders to combat opioid abuse.

The Healthcare Distribution Alliance, an umbrella group for drug distributors, said in a statement that accusations that distributors were responsible for the abuse of opioid prescriptions defied common sense and lacked understanding of the pharmaceutical supply chain.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

THE SACKLERS AND PURDUE

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.”

PURDUE-OXYCONTIN HISTORY

On December 12, 1995, the Food and Drug Administration approved the opioid analgesic OxyContin. It hit the market in 1996. In its first year, OxyContin accounted for $45 million in sales for its manufacturer, Stamford, Connecticut-based pharmaceutical company Purdue Pharma. By 2000 that number would balloon to $1.1 billion, an increase of well over 2,000 percent in a span of just four years. Ten years later, the profits would inflate still further, to $3.1 billion. By then the potent opioid accounted for about 30 percent of the painkiller market. What’s more, Purdue Pharma’s patent for the original OxyContin formula didn’t expire until 2013. This meant that a single private, family-owned pharmaceutical company with non-descript headquarters in the Northeast controlled nearly a third of the entire United States market for pain pills.

OxyContin’s ball-of-lightning emergence in the health care marketplace was close to unprecedented for a new painkiller in an age where synthetic opiates like Vicodin, Percocet, and Fentanyl had already been competing for decades in doctors’ offices and pharmacies for their piece of the market share of pain-relieving drugs. In retrospect, it almost didn’t make sense. Why was OxyContin so much more popular? Had it been approved for a wider range of ailments than its opioid cousins? Did doctors prefer prescribing it to their patients?

During its rise in popularity, there was a suspicious undercurrent to the drug’s spectrum of approved uses and Purdue Pharma’s relationship to the physicians that were suddenly privileging OxyContin over other meds to combat everything from back pain to arthritis to post-operative discomfort. It would take years to discover that there was much more to the story than the benign introduction of a new, highly effective painkiller.

US DEPT OF JUSTICE INDICTMENTS

While the FDA has failed, the US Department of Justice has launched a massive crackdown on opiate drug makers including indictments of company executives, sales & marketing personnel as well as the doctors and pharmacies that have enabled the flood of easy access narcotics into the US market for over 15 years. The question is “how and why” did the FDA drop the ball or was this an intentional lack of enforcement and oversight by the FDA and other agencies due to Big Pharma influence over Congressional members who would blunt any true oversight of drug companies.

For criminal opioid cases see: Federal Venues and Courts Where Opioid Indictments Are Pending As Of July 2017

FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

Former President Bill Clinton pulled no punches as he focused directly on the opiate issues “Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game rests, which is one of the prime issues of the highest importance. The checkbook to pull the country out of this national opiate epidemic will be in the hundreds of billions of dollars and even then, the costs of social and economic damage to date, will never be recovered. Clinton further commented on how the opioid epidemic “creeps into every nook and cranny of our country” and needs to be addressed as both a huge national problem and a community-by-community tragedy, adding “this can rob our country of the future.”

RURAL vs. BIG CITY OPIATES

Almost 2.75 million opioid prescriptions were filled in New York City each year from 2014 to 2016. Which is a very high number for a major city, but not nearly the millions of opiate prescriptions written in the more rural regions of Ohio, West Virginia and Kentucky, where the number of opiates prescribed equaled 100 plus pills per month for every resident in these states, with West Virginia numbers being, 780 million painkillers prescribed in six years.

As more and more cities, states and counties files suits against the opiate drug industry as a whole, there will be a point where Opiate Big Pharm will have to decide whether to admit it’s fault in the opioid crisis, or simply continue to evade responsibility and leave the process up to lawyers and the courts to assign a financial penalty for the alleged corporate opioid abuses.

FDA Failed to Cite Opioid Big Pharma

Perhaps a look at former US Representative Tom Price, will provide insight into how our lawmakers work within the healthcare industry. Rep. Price was appointed by President Trump to head the Department of Health and Human Services, which the FDA reports to, was forced to resign as HHS head due to various transgression within 6 months of being appointed, as well as leaks that while a sitting congressman he enacted a bill favoring a medical device makers extension of a multi-year government contract. Not only did Price enact the bill, he purchased stock in the company prior to the bill introduction and secured a massive profit on the stock price increase after the contract extension was announced. In normal business circles this is considered “insider trading” and is illegal, but when you’re one of those people in charge of creating the rules and regulations, there’s an apparent “get out of jail card” that comes with your congressional seat.

As long as the US Congress fails to correct the lack of oversight by the FDA and other regulatory agencies into what and how dangerous drugs and products are placed into the US marketplace, there will always be bad drugs entering the healthcare pipeline in the United States, with the now enduring default misnomer of “Profits Before Patients” firmly in place in boardrooms and within our government.

As the Opioid litigation expands across the country in both state and federal courtrooms, it remains to be seen if the anticipated payouts will surpass the $200 billion payday for governments in the 1998 Big Tobacco Litigation settlement.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, remains to be seen.

Who will be the advocate to make sure that these individuals as well as their children, families and communities as a whole are placed on the road to recovery. Historically, Big Pharma is not an industry to put the best interests of the paying consumer at the forefront of their agendas.

 

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Opiate Prescribing and Use Keeps Rising While Research Data Shows A Diminishing Return

Opiate Use Has Increased While Realtime Data Shows There’s A Diminishing Return

By Mark A. York (May 11, 2018)

Why was there a 30% rise  in opioid overdoses in 2017 

 

 

 

 

 

 

 

 

 

 

 

 

  • (MASS TORT NEXUS MEDIA) From 2000 to 2016, government research data shows that more than 600,000 people died from drug overdoses — nearly 64,000 in 2016 alone.

  • See the data on the 30% rise in opioid overdoses between 2016 and  2017, click CDC link here.

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 three to fourteen years old, which truly reflects on the unknown number still available opiates that are readily accessible to anyone who has an interest in getting them, and often with an inadvertent and tragic risk to 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.

“A small West Virginia town of 3,000 people got 21 million pills”

Drug companies deluged tiny towns in West Virginia with a monsoon of addictive and deadly opioid pills over the last decade, according to ongoing investigations by various public and private entities. After Opioid Big Pharma has reaped billions in profits over the last 15 years at the expense of US citizens, often those in the most rural and distressed areas of the country, it now appears that the time has come for Big Pharma to be called to answer for its conduct.

For instance, drug companies collectively poured 20.8 million hydrocodone and oxycodone pills into the small city of Williamson, West Virginia, between 2006 and 2016, according to a set of letters the committee released Tuesday. Williamson’s population was just 3,191 in 2010, according to US Census data.  These numbers are outrageous, and we will get to the bottom of how this destruction was able to be unleashed across West Virginia,” committee Chairman Greg Walden (R-Ore.) and ranking member Frank Pallone Jr. (D-N.J.) said in a joint statement to the Charleston Gazette-Mail.

The nation is currently grappling with an epidemic of opioid addiction and overdose deaths. The Centers for Disease Control and Prevention estimate that, on average, 115 Americans die each day from opioid overdoses. West Virginia currently has the highest rate of drug overdose deaths in the country. Hardest hit have been the regions of West Virginia, Ohio and Kentucky where for some reason the opioid industry chose to focus on, the how and why will be address in the federal and state courts across the country, as the opioid crisis has caused the “Opiate Prescription Multidistrict Litigation MDL 2804”, to be created and heard in the US District Court-Northern District of Ohio, in front of Judge Dan Polster, see Opiate Prescription MDL 2804 Briefcase.

WHERE WAS THE OFFICIAL OVERSIGHT?

The House committee repeatedly asked if the company thought these orders were appropriate and what limits—if any—it would set on such small towns.  Miami-Luken would not respond to a request for comment. The committee had similar questions for HD Smith, who delivered 1.3 million hydrocodone and oxycodone pills to a pharmacy in Kermit—the 406-person town—in 2008.

“If these figures are accurate, HD Smith supplied this pharmacy with nearly five times the amount a rural pharmacy would be expected to receive,” the committee wrote. It noted that the owner of that Kermit pharmacy later spent time in federal prison for violations of the Controlled Substance Act. Still, the committee pressed the question of whether HD Smith thought its distribution practices were appropriate.

“We will continue to investigate these distributors’ shipments of large quantities of powerful opioids across West Virginia, including what seems to be a shocking lack of oversight over their distribution, all the while collecting record breaking profits and paying sale reps in the field enormous bonuses.  This is the pattern that all Opioid Big Pharma has followed across the United states for the last 20 years, pay field sales rep many thousands of dollars on bonuses, to push opiates on doctors, hospitals and anyone else who can move drugs into the healthcare treatment assembly line.

 OPIOIDS FOR CASUAL PAIN MANAGEMENT PUSHED BY BIG PHARMA

Why did the emphasis on pain management in the 1990s result in a focus on opioid prescriptions? One reason may have been aggressive marketing efforts by opioid drug makers. For example, from 1996 to 2001, Purdue Pharma held more than 40 pain management conferences for healthcare providers to promote the use of its new OxyContin® extended-release formula of oxycodone. Sales surged from $45 million in 1996 to $1.1 billion a year in 2000—an increase of well over 2000%.

“We were told way back in the ’90s that these drugs were safe, that they wouldn’t hurt people, and that it was imperative to control pain,” Dr. Kalliainen recalls. Then, in 2007, Purdue admitted it had misled doctors into thinking OxyContin was less easily abused than other drugs in its class. It agreed to pay $600 million in fines and other fees to the Justice Department. Something else has changed in the culture as well, says Dr. Kalliainen. Patients seem to be in as much emotional pain as physical pain. “I’ve been in practice for 16 years now, and there’s been a huge increase in free-floating anxiety in patients,” she says.

US physicians often that find writing a prescription for an opioid is the most convenient way to respond to their patients’ demands, Dr. Kallianen says. As a resident in the 1990s, she remembers being told by the attending physician to write prescriptions for 60 or 70 opioid tablets for nearly every surgery patient. “You started a whole generation of physicians who are out there saying, ‘Write them for 60 [tablets] so they don’t call in.’”

One reason the practice has persisted is that surgeons often don’t know what effect their prescriptions are having, says Dr. Kalliainen. “We don’t see somebody dying of an overdose or becoming addicted. We don’t know if somebody is coming in and stealing their medications from their medicine cabinet and then having a problem. All the negative effects are away from our direct vision. So we’re not taking as much responsibility.” But research shows that once they have received opioid drugs, many patients can’t stop using them. One study found that 8.2% of patients who took opioids for the first time after total knee arthroplasty were still using them 6 months later, despite weak evidence that the drugs are effective for chronic pain management.

Among people already abusing drugs, some studies suggest that the opioids serve as a bridge between other substances and heroin.] Even when patients don’t abuse the opioids themselves, the drugs prescribed to them may end up in the hands of people who do. Surveys of people who abuse opioids show that as many as 23.8% obtained the drugs from clinicians, and 53% obtained them from friends or relatives, most of whom obtained them from clinicians.

“It’s not like these are stolen off the truck,” says Brent J. Morris, MD, a shoulder and elbow surgeon at the Shoulder Center of Kentucky in Lexington, who has published extensively on opioid prescribing patterns. “Certainly, physicians play a role in this.”

RECENT FDA COMMENTS ON OPIOIDS

Opana ER: June 2017  U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.

Codeine and Tramadol Can Cause Breathing Problems for Children

FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women issued on April 20, 2017.

These medicines can cause life-threatening breathing problems in children. Some children and adults break down codeine and tramadol into their active forms faster than other people. That can cause the level of opioids in these people to rise too high and too quickly.

January 2018 FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older

The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18.

FIGHTING THE OPIOiD FIGHT

In the United States, has been fighting a losing opioid battle for a long time now. With one study reporting that Americans consume approximately 80% of the world’s opioid drug supply. Given that painkillers make up the one of the largest classes of drugs manufactured around the globe, second only to cancer drugs, this is a rather staggering statistic: According to the CDC, more than a quarter of a billion prescriptions for opioid painkillers were written in 2013, the latest year for which data is available, and that number has almost certainly risen in recent years.

As these two latest studies show, not only are we losing the battle against opioid use – and, more importantly, abuse – but the battle itself is largely one that we should never have had to wage in the first place. A large portion of people who become addicted to opioids do so after receiving a prescription for long-term pain management. But as the JAMA study shows, it appears opioids are actually worse at managing chronic pain than non-opioid medications.

The primary reason for addiction and the correlating social problems is the casual acceptance by so many that opioids prescribed by a doctor are well intended and okay to use, not realizing that over time people tend to build up a tolerance for them. This means that patients have to take larger and larger doses in order to receive the same benefit as they did previously with smaller doses. This has been long known by doctors and researchers, including the Big Pharma Opioid marketing and sales teams, which was reinforced in the JAMA study. Participants reported that opioids were more effective than non-opioids early in the study, but at around six months they started to report that opioids the same or even less effective at managing pain than their non-opioid counterparts.

Other side effects include nausea and vomiting, mental health problems (including everything from confusion to depression), and full-blown chemical dependence. Then, there are the problems associated with opioid withdrawal. The upshot of all these side effects is that, even when opioids are working, they well may wind up causing the patient harm in other ways.

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.

IS THERE A SOLUTION FOR THE OPIOID CRISIS?

People in many different professional areas are looking for ways to address the addiction problem that has arisen while simultaneously working to prevent future addictions. The concern is having the crisis split along political lines where conservative push for draconian solutions and liberals push for free treatment for everyone. Both solution are untenable and misdirected, but there are proponents for both strategies forming in camps across the country. .

Given the reduced effectiveness of opioid painkillers over time, doctors must look at finding newer and better ways to treat long-term and chronic pain, with a more fully evolved treatment protocol. This includes research and developing into safer medications, more active lifestyle review and changes by patients and a wider acceptance by the medical community of complementary therapies, such as meditation, yoga, tai chi, and massage – including the use of medical marijhuana.  Awareness about these alternative pain relief methods need to be be included as part of any sincere program that provides solutions to the opioid crisis.

THE PRESCRIPTION OPIATES BEING PRESCRIBED

  • oxycodone (OxyContin, Percodan, Percocet)

  • hydrocodone (Vicodin, Lortab, Lorcet)

  • diphenoxylate (Lomotil)

  • morphine (Kadian, Avinza, MS Contin)

  • codeine

  • fentanyl (Duragesic)

  • propoxyphene (Darvon)

  • hydromorphone (Dilaudid)

  • meperidine (Demerol)

  • methadone

For another thing, public policy on illegal drugs needs to be significantly reconsidered, especially for less-addictive drugs like marijuana.  A study published last year in the American Journal of Public Health showed that legalizing marijuana for recreational use can significantly reduce the number of opioid deaths. Considering there have been no known reports of a marijuana overdose ever according to the U.S. Drug Enforcement Administration (DEA), that seems like a pretty good tradeoff from a simple public health policy perspective.

Another way to fight the problem is to increase the availability of opioid agonist drugs, such as naloxone, not only to health care providers and emergency department staff but to trained first responders and others as well. Naloxone reverses the effects of both prescription opioids and illegal drugs, such as heroin, and it can be an important first step toward helping those with substance use disorders become well.

Finally, IN the emerging MDL 2804 (Opiate Prescription Litigation) the opioid drugmakers, distributors and pharmacies are being held accountable for marketing tactics and self-funded studies that may have overblown the effectiveness of their drugs.  Many state, county, and local governments are bringing lawsuits, including RICO claims, against pharmaceutical companies in an attempt to offset costs for public health services that have been used to treat addictions and other medical conditions caused by opioid abuse. The DEA and the Department of Justice recently agreed to provide its data on prescription opioid sales to states and municipalities that are pursuing lawsuits.

The comparison is made to the Tobacco Litigation of the 1990’s which settled in 1998 for $200 billion, WITH he Opiate MDL 2804 litigation being expected to easily surpass that figure with conservative estimates reaching between $750 and $900 billion dollars.

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Abilify, Taxotere and Ethicon Multi-Layered Hernia Mesh Lawsuits Being Consolidated in New Jersey State Court

New Jersey State Court MCL Designations: Is NJ the emerging state court mass tort venue for lawsuits against Big Pharma?

By Mark A. York (May 11, 2018)

(Mass Tort Nexus Media) In late 2017 plaintiffs and defendants in the Abilify litigation in New Jersey state court moved to have the litigation designated as a multicounty litigation (MCL) on December 27, 2017 and which was approved as an MCL on May 9, 2018, see links below for both court filings.

Abilify New Jersey State Court MCL Notice to the Bar December 27, 2017

Abilify New Jersey MCL Designation – Atlantic County May 9, 2018

 

 

 

 

 

 

 

The  New Jersey judiciary site provides multicounty litigation docket information where you will see there are more MCL dockets that parallel existing federal MDL’s being brought in Big Pharma’s backyard. These multicounty litigations involve large numbers of claims that are associated with pharmaceuticals and medical devices based in New Jersey, and there appears to be an emerging consensus that confronting J&J, Sanofi and others in their home state venue is now a very viable litigation option for mass tort firms across the country. The recently consolidated Abilify MCL is a prime example, as is the pending Taxotere MCL application.

There were nearly 50 Abilify cases filed in Bergen County in New Jersey Superior Court, with that number expected to rise over the next few months, with Superior Court Judge James DeLuca having been the initial judge handling the docket, both plaintiff and defense had agreed that the cases should remain with Judge DeLuca. However, the May 7, 2018 order designated Superior court Judge Nelson C. Johnson and the Atlantic county court as the Abilify New Jersey MCL venue, Abilify New Jersey MCL Designation Atlantic County May 7, 2018.

The motion for MCL designation was filed to ensure that any Abilify case filed in New Jersey will be transferred into the designated state court venue and remain there. There is already a multidistrict litigation (MDL) designation in the Abilify federal litigation, which is consolidated in Northern District of Florida, where the three upcoming bellwether trial were just settled, as well as pending “global settlement order, see Abilify MDL 2734 Global Settlement Order, where Judge Casey Rodgers ordered the parties to reach an agreement within 120 days of the May 1, 2018 order entry date.  The MDL for Abilify was consolidated in October 2016, before U.S. District Judge M. Casey Rodgers.

NEW JERSEY STATE COURT ETHICON MESH CONSOLIDATION

Ethicon now faces a home state hernia mesh legal battle as the New Jersey Supreme Court posted the Application for Multicounty Litigation (MCL) status on April 11, 2018 regarding the emerging Ethicon/J&J multi-layered hernia mesh products litigation pending in New Jersey state courts, Ethicon Hernia Mesh Litigation MCL Notice – New Jersey State Court April 11, 2018. The filing requests the Ethicon hernia mesh cases be consolidated in Bergen County in front of Judge Rachell Harz, over litigation related to Ethicon’s Proceed, Physiomesh and Prolene synthetic hernia mesh products. For information regarding the New Jersey Ethicon Hernia Mesh Litigation see Mass Tort Nexus Briefcase Re: Ethicon Hernia Mesh New Jersey State Court Consolidation, adding another docket of mesh cases to the ever growing J&J/Ethicon defense of its synthetic surgical mesh products.

 

 

 

 

 

As a growing number of hernia mesh lawsuits continue to be filed against Johnson & Johnson and it’s Ethicon subsidiary in New Jersey state court, each involving complications allegedly caused by the design of multi-layered patch products sold in recent years, a request has been filed to centralize the litigation before one judge for coordinated pretrial proceedings.

On April 11, Glenn A. Grant, acting administrative director of New Jersey state courts, issued a Notice To The Bar (PDF), indicating that the state Supreme Court has received an application to create a multicounty litigation (MCL) for all product liability lawsuits over Ethicon multi-layered hernia mesh.

TAXOTERE EMERGING MCL

The most recent MCL application to be filed and listed by the New Jersey Courts is the Taxotere (docetaxel) cancer chemotherapy drug litigation against Sanofi-Aventis US, Sandoz, Inc. and Actavis, Inc with the MCL Notice posted on April 11, 2018 see Taxotere New Jersey MCL Notice To The Bar April 11, 2018.

There is already an existing Taxotere MDL 2740 in the US District Court ED Louisiana see Mass Tort Nexus Briefcase TAXOTERE-MDL-2740-(US-District-Court-Eastern-District-of-Louisiana, where there are more than 5,000 claims pending in front of the very soon to depart Chief Judge Kurt D. Englehardt, who recently received full US Senate approval to move up to the Forth Circuit Court of Appeals, replaced by sitting US District Court Judge, Jane Triche Milazzo.

 

 

 

 

 

How the New Jersey state court Taxotere MCL compares to the Taxotere MDL 2740 remains to be seen, but the New Jersey based pharmaceutical giants are now being forced to address mass torts more and more often in their home state courts, which previously was perceived as a venue of last resort for many plaintiff firms across the country.

With these three newest mass torts emerging in New Jersey state courts, along with the many pre-existing MCL’s that have been very successful there, will New Jersey now be considered the “go to” venue for filing litigation against Big PharMa?

 

 

 

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Lamictal (lamotrigine) Emerging Litigation – By GlaxoSmithKline plc

Lamictal Emerging Litigation a Drug Made By GlaxoSmithKline plc

By Mark A. York (May 8, 2018)

Emerging Litigation: Lamictal (lamotrigine)

(MASS TORT NEXUS MEDIA) Lamotrigine was approved in 1994 and is available under the brand name Lamictal (GlaxoSmithKline) and in generic forms. Since approval 24 years years ago, the FDA has identified eight cases (two in the United States and six abroad) of confirmed or suspected HLH associated with lamotrigine in children and adults. The FDA has stated “there are likely many more additional cases” that they are unaware of, based on lack of information and awareness of the adverse events.

The anticonvulsant medication lamotrigine can cause the rare but serious immune system reaction hemophagocytic lymphohistiocytosis (HLH), the US and Food and Drug Administration said today in a safety communication.  

The FDA said a warning about the risk for HLH will be added to the prescribing information on lamotrigine drug labels.

Lamotrigine is used alone or with other medicines to treat seizures in patients age 2 years and older. It is also indicated for maintenance treatment in patients with bipolar disorder to help stave off mood episodes (depression, mania or hypomania, and mixed episodes).

HLH is a hyperinflammatory syndrome that can lead to hospitalization and death, especially if not diagnosed and treated quickly. Diagnosis is often complicated because early signs and symptoms, such as fever and rash, are not specific, the FDA notes.  HLH may also be confused with other serious immune-related adverse reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS).

To Learn More About the Emerging Lamictal Litigation:

The emerging Lamictal Litigation will be used as a case study in the May 18 to 21, 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

FDA LAMICTAL DRUG SAFETY COMMUNICATION

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm605628.htm

Lamictal (lamotrigine): Drug Safety Communication – Serious Immune System Reaction

Posted April 25, 2018

AUDIENCE: Health Professional, Patient, Pharmacy

ISSUE: The FDA is warning that the medicine Lamictal (lamotrigine) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.

BACKGROUND: The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system. HLH typically presents as a persistent fever, usually greater than 101°F, and it can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs.

Lamotrigine is used alone or with other medicines to treat seizures in patients two years and older. It may also be used as maintenance treatment in patients with bipolar disorder to help delay the occurrence of mood episodes such as depression, mania, or hypomania. Stopping lamotrigine without first talking to a prescriber can lead to uncontrolled seizures, or new or worsening mental health problems. Lamotrigine has been approved and on the market for 24 years, and is available under the brand name Lamictal and as generics.

RECOMMENDATION: Healthcare professionals should be aware that prompt recognition and early treatment is important for improving HLH outcomes and decreasing mortality. Diagnosis is often complicated because early signs and symptoms such as fever and rash are not specific. HLH may also be confused with other serious immune-related adverse reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Evaluate patients who develop fever or rash promptly, and discontinue lamotrigine if HLH or another serious immune-related adverse reaction is suspected and an alternative etiology for the signs and symptoms cannot be established. Advise patients to seek immediate medical attention if they experience symptoms of HLH during lamotrigine treatment. A diagnosis of HLH can be established if a patient has at least five of the following eight signs or symptoms:

  • fever and rash
  • enlarged spleen
  • cytopenias
  • elevated levels of triglycerides or low blood levels of fibrinogen
  • high levels of blood ferritin
  • hemophagocytosis identified through bone marrow, spleen, or lymph node biopsy
  • decreased or absent Natural Killer (NK) Cell activity
  • elevated blood levels of CD25 showing prolonged immune cell activation

Patients or their caregivers should contact their health care professionals right away if they experience any symptom of HLH while taking lamotrigine. HLH can occur within days to weeks after starting treatment. A physical examination and specific laboratory blood tests and other evaluations are used to diagnose HLH. Signs and symptoms of HLH include but are not limited to:

  • fever
  • enlarged liver; symptoms may include pain, tenderness, or unusual swelling over the liver area in the upper right belly
  • swollen lymph nodes
  • skin rashes
  • yellow skin or eyes
  • unusual bleeding
  • nervous system problems, including seizures, trouble walking, difficulty seeing, or other visual disturbances

FDA LAMICTAL WARNING PODCAST

FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)

https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm606094.htm

Lamictal Podcast Transcript:

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On April 25, 2018, FDA warned that the medicine lamotrigine (brand name Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.

The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system and typically presents as a persistent fever, usually greater than 101°F. HLH can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs.

Lamotrigine is used alone or with other medicines to treat seizures in patients two years and older. It may also be used as maintenance treatment in patients with bipolar disorder.

Health care professionals should be aware that prompt recognition and early treatment is important for improving HLH outcomes and decreasing mortality. Diagnosis is often complicated as early signs and symptoms such as fever and rash are not specific. HLH may also be confused with other serious immune-related adverse reactions. Evaluate patients who develop fever or rash promptly, and discontinue lamotrigine if HLH or another serious immune-related adverse reaction is suspected and an alternative etiology for the signs and symptoms cannot be established.

Since lamotrigine’s 1994 approval, FDA identified eight cases worldwide of confirmed or suspected HLH associated with the medicine in children and adults. This number includes only reports submitted to FDA and found in the medical literature, so there are likely additional cases about which we are unaware. We determined there was reasonable evidence that lamotrigine was the cause of HLH in these eight cases based on the timing of events and order in which they occurred. These patients required hospitalization and received drug and other medical treatments, with one dying.

Side effects involving lamotrigine should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications.

If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

 

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Ocaliva Emerging Litigation

Emerging Ocaliva Litigation

Ocaliva: An Emerging Litigation

 

 

 

 

 

 

 

 

 

 

Ocaliva (obeticholic acid) made by Intercept Pharmaceuticals, Inc. was first approved by the FDA subsequent to New Drug Application (NDA: 207999) in May 2016.

Ocaliva is “indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA.

Recent FDA Communications Excerpts:

September 21, 2017, The FDA is notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for OCALIVA (obeticholic acid). This information pertains to the risk of liver injury, liver decompensation, liver failure and death in primary biliary cholangitis (PBC) patients withmoderate to severe hepatic impairment.

Additionally, we refer to our letter dated October 26, and December 7, 2017, notifying you, under Section 505(o)(4) of the FDCA, extension of discussion period warranted for new safety information that we believe should be included in the labeling for OCALIVA (obeticholic acid) Tablets. This information pertains to the risks liver injury, liver decompensation, liver failure and possibly death in primary biliary cholangitis (PBC) patients with moderate to severe hepatic impairment.

FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease:  (see link below)

FDA Warning of September 21, 2017:   https://www.fda.gov/Drugs/DrugSafety/ucm576656.htm

  >To Learn More About the Emerging Ocaliva Litigation:

The emerging Ocaliva Litigation will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Couse, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

 

 

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

Course attendees will receive the benefit of a step by step analysis of the emerging Ocaliva Litigaton, using these primary metrics:

 

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including Jerry Parker, Founder of the Parker-Waichman Firm>

 

 

 

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

 

 

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12 Judges Will Try 20 AndroGel Trials In MDL 2545 Starting In Fall of 2018

“US District Court of Illinois Enacts A Real Rocket Docket In AndroGel MDL”

By Mark A. York (April 26, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Judge Matthew F. Kennelly, the Illinois federal judge overseeing AndroGel MDL 2545 also known as the Testosterone Replacement Therapy Multidistrict Litigation, has decided to go along with the 11 fellow district court judges who volunteered to try 20 bellwether trials involving AbbVie Inc.’s AndroGel between Oct. 2, 2018 and March 2019, see AndroGel MDL 2545 CMO No. 114 Re: Setting 20 Trials In Front of 12 Federal Judges, in the  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ilinois.

Judge Kennelly ordered the cases to be trial-ready by September 2018 and a second group by December.  He also told counsel that other judges in the district volunteered to assist him by trying cases throughout the fall and winter of 2018 and into the spring of 2019, with both sides agreeing to have the cases tried before different judges.  The judge said he will rule on all pretrial matters in the 20 cases, including summary judgments and in-limine motions, jury instructions and Daubert expert witness rulings, with each judge being given a trial-ready package of his rulings.

The judges who have agreed to hear trials in support of Judge Kennelly will be Chief Judge Ruben Castillo and Judges Virginia Kendall, Manish Shah, Rebecca Pallmeyer, Sara Ellis, John Lee, John Blakey, Robert Dow, Edmond Chang, Gary Feinerman and Jay Tharp.
Judge Kennelly said further trial dates after March 4 may be set by a future order.

AbbVie is facing more than 3,770 MDL Cases, see Mass Tort Nexus Briefcase Re: ANDROGEL-TESTOSTERONE-MDL-2545, which to date have resulted in plaintiffs bellwether trial verdicts in amounts ranging from $3 million up to $140 million with a single defense win. One main defendant, Eli Lilly chose to settle all their cases related the Axiron product line, see Eli-Lilly-Announces-Settlement-Of-All-Testosterone-Cases-in-MDL-2545. The Lilly action may have been a smart legal move, as the stacked up trials would be not only financially burdensome but would put major pressure on defense trial teams.

AbbVie declared 3,770 AndroGel claims in the MDL in its Nov. 11, 2017 10-Q report, and about 205 claims in various state courts, including more than 200 additional testosterone drug cases await judgment in Cook County Circuit Court, many involving Illinois plaintiffs. In one trial in the Cook County court,  involving a 66-year-old man who suffered a heart attack while taking AndroGel, resulted in a verdict in favor of AbbVie, but the man’s attorneys are seeking a new trial that will allow them to present evidence on the internal decision-making behind the company’s sales tactics. That evidence was not permitted in the initial trial.

PLAINTIFFS ARE AHEAD IN TRIAL VERDICTS

The first federal AndroGel case to go to trial in 2017 resulted in just a punitive damages award of $150 million, which was later vacated and a new trial ordered.  The retrial resulted in a $3.2 million verdict with compensatory and punitive damages. The second bellwether trial resulted in a $140.1 million verdict in 2017, with the third bellwether trial resulting in a verdict for the defense.

In the fall of 2017 Konrad bellwether trial, resulting in the punitive damage verdict of $150 million, which was the first case in the series of bellwether trials aimed at helping plaintiffs and manufacturers of AndroGel gauge the range of damages and define a legal strategy and settlement options, even though the large verdict was vacated, it sent a clear message to the parties.

With defense losing both of the initial bellwether trials doesn’t look good for the defense, see “ANDROGEL” JURY RETURNS $150 MILLION VERDICT IN 1st TESTOSTERONE TRIAL.  That jury’s decision to award punitive damages without granting compensatory damages was unusual and both sides continue to fight over the verdict’s validity in court, but shows that the plaintiffs seem to have viable claims at trial.

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

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

ANDROGEL WAS A BLOCKBUSTER FROM FIRST RELEASE

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

HEART ATTACK AND STROKE RISK

Testosterone replacement drugs are approved to treat certain low-testosterone conditions in men. Plaintiffs allege that manufacturers invented a condition called “low-t” and marketed it for the treatment of the normal aging process and to restore strength and virility. Instead, the plaintiffs say testosterone drugs cause heart attacks and strokes.

AbbVie and predecessor Abbott Laboratories Inc. make AndroGel, a topical gel, AbbVie has owned AndroGel for only part of the drug’s history. Abbott Laboratories acquired AndroGel in 2010, and AbbVie was spun off from the company three years later.

Other defendants included Eli Lilly and Co. which makes Axiron, also a topical gel, and as previously mentioned has chosen to settle all claims in the litigation.. Endo Pharmaceuticals Inc. makes Aveed and Delatestryl, both injection drugs, and Fortesta, a topical gel. Actavis plc makes AndroDerm, an adhesive skin patch. Auxilium Pharmaceuticals Inc. makes Testim, a gel. Pfizer Inc. and Pharmacia Inc. make Depo-Testosterone, an injection drug.

FDA ISSUED A WARNING

As listed in the Chicago Tribune article of March 4, 2015, see Testosterone drugs overused per FDA warning. Testosterone injections were first approved in the 1950s for men who had been diagnosed with hypogonadism, a form of abnormally low testosterone caused by disorders of the testicles, brain and other hormone-related organs. The But current labeling on the drugs is vague enough that companies have been able to promote them to millions of otherwise healthy men who simply have lower-than-normal levels of testosterone.

The FDA began reviewing the safety of testosterone drugs in January 2014 after two federal studies associated them with increased rates of heart attack, stroke and other serious problems. But other studies associated testosterone replacement with longevity.”The benefits and safety of this use have not been established,” the FDA said in a statement released in March 2015.

While men’s testosterone levels naturally decline after age 40, experts disagree on whether that drop actually leads to the issues like decreased energy and lower bone density. Additionally, testosterone levels change by the hour and are affected by a range of environmental factors, such as stress and sexual arousal.

How this unusual judicial move goes over at the trialsl remains to be seen, but there is a distinct message being sent by the courts, that failure to engage in serious settlement talks will result in cases being set for trial. Perhaps other courts across the country should try accelerating MDL case dockets to trial via such unexpected rulings, thereby resulting in more years long case dockets being cleaned up. Who this may benefit remains to be seen, as there will be 20 trial verdicts coming sooner as opposed to later , to answer questions such as this.

 

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While Big Pharma “Off-Label” Drug Marketing Continues – FDA Does Nothing

By Mark A. York (April 24, 2018)

“BY REMOVING FDA OVERSIGHT BIG PHARMA RUNS AMOK”

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In 2017 and continuing into 2018, Big Pharma has been fighting major legal battles related to off-label marketing of drugs for unintended uses. They also engaged in a parallel strategy, where they were influencing the FDA and other policy making agencies behind the scenes in Washington DC. Big Pharma was paying millions to lobbyists, making campaign donations and generally buying influence as they always have. It was a foregone conclusion that with the Trump administration view of , “no regulatory oversight required” that there would be some loosening of the FDA regulatory shackles.

Big Pharma was getting ready for freedom to sell, sell, sell their drugs in any way they could, including off-label marketing of the drugs for unintended use purposes. A corporate policy, that’s technically illegal, yet results in billions of dollars in profits every years for Big Pharma. Then the FDA rolled out an unexpected new proposed rule, in March 2017 cracking down on “off-label’ marketing of drugs. This new rule change wasn’t in Big Pharma’s bests interests, sending the drug industry into a furious lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials that were recruited, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

Trump stops FDA enforcement rule change: January 12, 2018 Food and Drug Administration Press Release: FDA Delays Change to “Off-Label” Drug Use Enforcement Rules

This seems to be further evidence of the Trump administration permitting private corporations to control what goes on behind the scenes in federal regulatory agencies these days. The same loosening of enforcement rules has been seen in the EPA as well as in Dept. of Energy oversight enforcement authority. Whatever else you might think about the ramped up Trump vs. Obama administration mindset, this rule delay is an example of the new FDA leadership doing what is in the best interests of those they are supposed to be regulating, the drug makers, and not in the interests of the US consumers.

To put this into perspective, consider the current “Opioid Crisis” gripping the entire country, where “off-label” marketing of opiates for the last 20 years by drug makers, has resulted in thousands of deaths each year, unknown financial losses and the related social impact felt in every state across the country. Another result is the Opiate Prescription Litigation MDL 2804, (see OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION) where litigation started when hundreds of counties, states and cities and other entities impacted by the catastrophic expense related to combatting the opiate healthcare crisis fought back. The various parties have filed lawsuits against opioid drug makers and distributors, demanding repayment of the billions of dollars spent on addressing the massive costs related to opioid abuse, primarily due to opioid based prescription drugs flooding the country.

When the Obama administration ended on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was meant to enable additional enforcement and control over drug makers rampant “off -label” marketing of drugs for purposes that were never FDA approved. This was an attempt by the FDA to have the ability to punish off-label promotions, where previously the process was a two-step regulatory review, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. These regulations have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.

In a 2015 proposed rule, the FDA referred to striking the language from regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use, which would have further enabled Big Pharma drug marketing abuses to go unchecked. But then, the FDA’s January 9, 2017 proposal reversed course, stating that retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard. This would have enable the FDA to begin oversight and enforcement of practices such as the blatant and wide open “off-label” marketing of opioid prescription drugs that started in the mid-1990’s and never stopped.

Instead of putting a check on Big Pharma abuses, we have the Trump administration placing a hold on new regulations, and delaying the “intended use” regulation change to March 19, 2018, so that comments could be received and considered, and thereby enabling the Big Pharma “lobby machine” to become fully engaged across all DC circles, ensuring that the FDA changes are effectively put to rest.

The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations on “off-label” drug use, when describing the types of evidence that may be considered in determining a medical product’s intended uses.  The FDA will receive comments on this proposal through February 5, 2018.

Here is the official FDA publication of January 16, 2018:

The Federal Register:  https://www.federalregister.gov/documents/2018/01/16/2018-00555/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or

WHAT IS “OFF-LABEL” MARKETING?

Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” stated Eric Holder, then US Attorney General, “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud.  And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people” he added.

The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.

“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West.  “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”

The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information.  Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA.  Before approval, the FDA must determine that the drug is safe and effective for those specified uses.  Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded.  The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.

“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth.  “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health.  The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”

 J&J RISPERDAL MARKETING ABUSE

In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities.  The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.

“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger.  “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”

In its complaint, the government alleges that the FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.”  The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”

The complaint further alleges that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks.  For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events.  A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that “[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”

The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).”  When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.

The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly.  In business plans, Janssen’s goal was to “[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.”  The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients.

In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities.  The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production.  Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients.  Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism.  Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.

The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal.  Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.

In addition to allegations relating to Risperdal, today’s settlement also resolves allegations relating to Invega, a newer antipsychotic drug also sold by Janssen.  Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.

As part of the global resolution, J&J and Janssen have agreed to pay a total of $1.391 billion to resolve the false claims allegedly resulting from their off-label marketing and kickbacks for Risperdal and Invega.  This total includes $1.273 billion to be paid as part of the resolution announced today, as well as $118 million that J&J and Janssen paid to the state of Texas in March 2012 to resolve similar allegations relating to Risperdal.  Because Medicaid is a joint federal-state program, J&J’s conduct caused losses to both the federal and state governments.  The additional payment made by J&J as part of today’s settlement will be shared between the federal and state governments, with the federal government recovering $749 million, and the states recovering $524 million.  The federal government and Texas each received $59 million from the Texas settlement.

NURSING HOME PATIENT ABUSES BY J&J

The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients.  In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.”  These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes.  Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients.  Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”

J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs.  The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million.  In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.

“Consultant pharmacists can play an important role in protecting nursing home residents from the use of antipsychotic drugs as chemical restraints,” said U.S. Attorney for the District of Massachusetts Carmen Ortiz.  “This settlement is a reminder that the recommendations of consultant pharmacists should be based on their independent clinical judgment and should not be the product of money paid by drug companies.”

OFF-LABEL USE OF HEART DRUG NATRECOR

The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor.  In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity.  This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.

In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs.  These infusions generally involved visits to an outpatient clinic or doctor’s office for four- to six-hour infusions one or two times per week for several weeks or months.

The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these outpatient infusions and misleadingly used a small pilot study to encourage the serial outpatient use of the drug.  Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor.  Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.

As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor.  In October 2011, Scios pleaded guilty to a misdemeanor FDCA violation and paid a criminal fine of $85 million for introducing Natrecor into interstate commerce for an off-label use.

“This case is an example of a drug company encouraging doctors to use a drug in a way that was unsupported by valid scientific evidence,” said First Assistant U.S. Attorney for the Northern District of California Brian Stretch.  “We are committed to ensuring that federal health care programs do not pay for such inappropriate uses, and that pharmaceutical companies market their drugs only for uses that have been proven safe and effective.”

Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement

In addition to the criminal and civil resolutions, J&J executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG).  The CIA includes provisions requiring J&J to implement major changes to the way its pharmaceutical affiliates do business.  Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct.  J&J may recoup monies from executives who are current employees and from those who have left the company.  The CIA also requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians.  On an annual basis, management employees, including senior executives and certain members of J&J’s independent board of directors, must certify compliance with provisions of the CIA.  J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations.

“OIG will work aggressively with our law enforcement partners to hold companies accountable for marketing and promotion that violate laws intended to protect the public,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson.  “Our compliance agreement with Johnson & Johnson increases individual accountability for board members, sales representatives, company executives and management.  The agreement also contains strong monitoring and reporting provisions to help ensure that the public is protected from future unlawful and potentially harmful off-label marketing.”

FEDERAL AND STATE JOINT CRIMINAL INVESTIGATIONS

This resolution marks the culmination of an extensive, coordinated investigation by federal and state law enforcement partners that is the hallmark of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaborations to fight fraud.  Announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius, the HEAT initiative has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.

The criminal cases against Janssen and Scios were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania and the Northern District of California and the Civil Division’s Consumer Protection Branch.  The civil settlements were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania, the Northern District of California and the District of Massachusetts and the Civil Division’s Commercial Litigation Branch.  Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, the FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.

This matter was investigated by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, the Office of Personnel Management’s Office of Inspector General, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the U.S. Postal Inspection Service’s Office of the Inspector General and the FBI.

One of the most powerful tools in the fight against Medicare and Medicaid financial fraud is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $16.7 billion through False Claims Act cases, with more than $11.9 billion of that amount recovered in cases involving fraud against federal health care programs.

The department enforces the FDCA by prosecuting those who illegally distribute unapproved, misbranded and adulterated drugs and medical devices in violation of the Act.  Since 2009, fines, penalties and forfeitures that have been imposed in connection with such FDCA violations have totaled more than $6 billion.

The civil settlements described above resolve multiple lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery.  From the federal government’s share of the civil settlements announced today, the whistleblowers in the Eastern District of Pennsylvania will receive $112 million, the whistleblowers in the District of Massachusetts will receive $27.7 million and the whistleblower in the Northern District of California will receive $28 million.  Except to the extent that J&J subsidiaries have pleaded guilty or agreed to plead guilty to the criminal charges discussed above, the claims settled by the civil settlements are allegations only, and there has been no determination of liability

With the Trump Administration still claiming that no regulatory oversight is needed to monitor the US drug industry, that they can self-regulate, it appears that there will be no letup in the rampant “off-label: and unintended use marketing of pharmaceutical drugs in the United States.  The one way that Big Pharma is held accountable is in the courtroom, although financial damages and penalties against the drug companies amounting to billions of dollars each year being awarded by juries, wont change FDA policy, it does provide a small amount of official recognition that there are ongoing abuses by the pharmaceutical industry in the USA.

 

 

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$35 Million In Punitives Added To Bard TVM Trial Verdict in NJ Court

“TOTAL VERDICT OF $68 MILLION IN SYNTHETIC SURGICAL MESH TRIAL”

Mark A. York (April 18, 2018)

SYNTHETIC MESH COMPANIES FACING THOUSAND OF LAWSUITS

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) C.R. Bard, Inc. was ordered to pay an additional $35 million in punitive damages, added to the $33 million the jury initially award for a total of verdict of $68 million in the first Transvaginal Mesh trial for Bard in New Jersey state court. Plaintiff Mary McGinnis was successful in her claims that Bard’s synthetic vaginal mesh implants are defective, asserting that Bard defectively designed the product, ignored warnings and related FDA notices about the numerous adverse events related to their synthetic surgical mesh products.

Bard, a subsidiary of global medical supplier Becton-Dickinson of Franklin Lakes, says it will appeal the verdict. In a statement, the company said McGinnis knew of the inherent risks in having the vaginal implants. This case docket can be found under Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14, Bergen County Superior Court, Judge James DeLuca.

The punitive damage award was added after the initial $33 million verdict was returned and the judge set a hearing to address the punitive damages award. The jury decided that there were grounds to award plaintiff Mary McGinnis and her husband the large verdict based on trial testimony and evidence that Bard was aware of the mesh product dangers and chose to ignore the thousands of adverse events reported related to post-surgery complications claimed by women across the country.

The Bard synthetic mesh products are designed to provide pelvic support for any number of medical issues primarily affecting women, with synthetic mesh recognized as often causing major medical complications and leaving patients in permanent pain. The jury held the company liable for two products that McGinnis had implanted in March of 2009: an Avaulta Solo mesh, and an Align Transobturator and Bard was forced to concede that both products have been taken off the market.

The verdict comes as Murray Hill, New Jersey-based Bard is pushing to a flood of litigation its surgical mesh implants , which have been criticized by women for damaging internal and often affecting or stopping normal sex lives. Bard has settled more than 13,000 cases since 2014, and as of September 2017, the company still faced more than 3,000 suits over allegedly defective synthetic mesh devices still in litigation. Those cases are part of the Bard-TVM-Litigation-MDL-2187 Briefcase, in front of Judge Goodwin, US District Court of West Virginia.  While Bard still faces another 150 lawsuits in New Jersey state court, which previously had been perceived as a favorable home court legal venue by the company.

McGinnis alleged Bard’s Avaulta and Align implants shrank after being implanted, causing nerve damage and leaving her unable to engage in sexual activity and that she was forced to undergo four surgeries in attempts to remove all the mesh from her body.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market.J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin.  Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Bard has been accused in many lawsuits of using a form of polypropylene mesh in the devices, that their mesh supplier and manufacturer had warned wasn’t suitable for human implantation. Bard officials countered that the mesh was a safe substance from which to make the inserts, ignoring the safety sheet warning issued by the polypropylene mesh product maker.

Last year, C.R. Bard was acquired by medical-device company Becton, Dickinson & Co. $24 billion, combining two of the world’s biggest health-care suppliers.  How the thousands of remaining mesh lawsuits affect the company business model and potentially moves them towards serious settlement discussions remains to be seen.

This case can be found at: Mary McGinnis v. C.R. Bard, Inc., Docket No.: BERL1754314, Bergen County, New Jersey Superior Court (Hackensack).

 

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“PELVIC MESH” – WHAT’S CHANGED SINCE JANUARY 2016? HAS THE FDA LOOKED CLOSER AT THE THOUSANDS OF FILED ADVERSE EVENTS? MESH IS NOW A CLASS III HIGH RISK MEDICAL DEVICE

Who’s Telling Who About The High Risk Of Synthetic Surgical Mesh?

By Mark A. York (February 21, 2018)

Do you want polypropylene “fishing line” in your body? That’s what surgical mesh is made of.

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) FDA labels pelvic mesh as a “High Risk Medical Device” yet minimal review, investigation or action has been undertaken regarding the thousands of annual adverse events that are recognized in the medical industry as caused by “plastic or synthetic mesh” which is comparative to high quality polypropylene fishing line, which in both mesh and fishing line is available in various strengths. Is this something that’s either disclosed by your doctor and would it have an affect on your surgical decision?

WHO DISCLOSES RISK?

In January 2016, the FDA said vaginal mesh will now be classified as a “high-risk” medical device with a class III warning. Previously the implants were considered “moderate-risk” devices and carried a class II warning. Are healthcare professionals and surgical mesh manufacturers making sure this is a known factor in pre-surgical decisions? If notice to the public of the high risk designation of surgical mesh devices follows historical medical device manufacturers standards, that answer is an emphatic “NO”- medical device makers and their sales and marketing staff do not advertise or declare FDA and other regulatory defined risks to the public unless forced to, which includes patients undergoing surgeries. You physician may disclose whatever minimal product warning or risk statements that they’ve been provided by the medical product manufacturer.

DOES THIS HELP PATIENTS?

Mesh surgical implants used to repair pelvic organ prolapse in women, a condition that frequently develops after childbirth, will face tougher federal scrutiny following thousands of injuries reported with these devices.

The Food and Drug Administration said Monday that pelvic mesh will now be considered a class III, or high-risk, medical device, and manufacturers will be required to submit premarket approval applications demonstrating the safety and effectiveness of their products.

The change follows years of reports of pain, bleeding and infection among women who had the devices implanted to correct pelvic organ prolapse (POP). The condition occurs when the bladder or other reproductive organs slip out of place, causing pain, constipation and urinary issues. The new FDA requirements do not apply to mesh products used to treat other conditions such as hernias or urinary incontinence.

Plastic mesh is often used to strengthen the pelvic wall and support internal organs in cases of prolapse. The mesh is often inserted through the vagina, using a small surgical incision. The Washington Post recently reported that as many as half of women may experience pelvic floor symptoms in their lifetime, and 200,000 undergo such operations each year.

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.

WHAT IS MESH?

Animal-derived mesh are made of animal tissue, such as intestine or skin, that have been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine).

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement in strength to the urogynecologic repair. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.

Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI. There are three main surgical procedures performed to treat pelvic floor disorders with surgical mesh:

  • Transvaginal mesh to treat POP
  • Transabdominal mesh to treat POP
  • Mesh sling to treat SUI

MESH REPAIR VERSUS SUTURES

The FDA action comes more than four years after the agency concluded that women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches. Mesh products were introduced for pelvic repair in the 1990s and promoted as a way to speed patients’ recovery time. But the FDA said in 2011 that about ten percent of women experienced complications from mesh, sometimes requiring multiple surgeries to reposition or remove it.

50,000+ MESH LAWSUITS FILED

Patients have filed tens of thousands of lawsuits against mesh manufacturers, including Johnson & Johnson, Boston Scientific and Endo International. In 2014, Ireland-based Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits.  For more information see Mesh Litigation Briefcase -50,000 Cases Pending and More Each Day along with TVM mesh cases there are now two more “hernia mesh” multidistrict litigation cases , designated as “Ethicon Physiomesh MDL 2782 (Ethicon Physiomesh MDL 2782 Briefcase Re: Hernia-Mesh-Litigation) and the Atrium Medical C-Qur Hernia Mesh MDL 2753 (ATRIUM MDL 2753 Re: C-QUR-HERNIA-PATCH Briefcase) these case apply to synthetic hernia mesh complication with adverse systems and long term medical complications, being the same as those alleged in the massive TVM litigation, which are pending in federal court across the country.

In a second rule, the FDA said vaginal mesh will now be classified as a “high-risk” medical device with a class III warning. Previously the implants were considered “moderate-risk” devices and carried a class II warning.

FDA recommends that women be aware of the risks associated with surgical mesh. On an advice page on the FDA website, the agency writes: “Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options.”

Non-surgical options include pelvic floor exercises known as Kegels. There are also non-invasive devices such as the PeriCoach, a smartphone-connected pelvic floor muscle training device for incontinence.

WHY WAS THERE AN FDA DELAY?

The FDA first proposed the 2016 changes in 2014 draft orders, why would a regulatory safety agency wait two years to announce the high risk designation of a product being used over 200 thousand times a year in the USA? This reflects the back office control and influence of the medical manufacturing industry as a whole and how they use influence to defer and often stop disclosure of adverse risk s related to the medical products they sell to consumers. Profits before patient in the general rule in most device manufacturer boardrooms..

Like 90 percent of medical devices sold in the U.S., pelvic mesh was originally cleared under a streamlined FDA review process for devices deemed similar to older products. This has resulted in billions of dollars in profits for major medical manufacturers and the medical field as a whole, while thousands and thousands of patients have been afflicted with life changing post-surgical complications and until the FDA or other parties make the high risks known, many thousands more patients will have plastic products surgically implanted into their bodies, without knowing the true risks.

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DePuy Pinnacle Plaintiffs Request Cases Be Remanded For Trial in Hip Implant MDL 2244

Plaintiffs Request Remaining Pinnacle MDL 2244 Cases Be Remanded For Trial 

Mark A. York (February 9, 2018)

A DePuy Pinnacle Hip Implant Component

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Plaintiffs have asked U.S. District Court Judge Ed Kinkeade, Northern District of Texas, who’s hearing thousands of hip implant lawsuits in the DePuy Orthopaedics’ Pinnacle Hip MDL 2244, to remand their cases to the original court of filing for individual trial dates.

According to the February 5th motion filed with the U.S. District Court, plaintiffs request the Court begin an “orderly and efficient staggered remand process,” where both plaintiffs and defense would select 10 cases each for remand to federal courts in California, New York and Texas, for a total of 60 cases being set for trial starting in 2019.

There were further requests that the Court begin not only the remand process, but start phased MDL discovery as well in peripherally related cases alleging RICO, qui tam and other non-personal injuries as part of the metal-on-poly hip revision lawsuits currently pending in the multidistrict litigation.

DePuy Pinnacle Implants and Metallosis

DePuy Orthopaedics,  a subsidiary of Johnson & Johnson, have been named in more than 9,500 hip replacement lawsuits involving the metal-on-metal Pinnacle hip system, which utilizes the Ultamet liner, pending in the multidistrict litigation (see DEPUY MDL 2244 Pinnacle Hip Implant Briefcase) currently underway in the Northern District of Texas.

Plaintiffs allege that the metal-on-metal design within the Ultamet liner configuration can cause dangerous amounts of toxic metal debris to be released into the joint surround the hip, and into the blood stream resulting in metallosis, causing adverse local tissue reactions, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the DePuy hip implant components.

 DePuy/J&J Loses Bellwether Trials

So far, the Pinnacle hip MDL 2244 litigation has convened four bellwether trials related to the metal-on-metal implants with the trial in October 2014, ending with a verdict for DePuy and Johnson & Johnson, which to date, is the only defense win in this litigation.

In the second trial, plaintiffs were awarded a verdict of $500 million in March 2016, however, Judge Kinkeade ultimately reduced the award to $151 million, based on Texas statutes that limit punitive damages. The third bellwether trial ending in December 2016, resulted in a massive billion dollar verdict, when six Pinnacle recipients who were residents of California were awarded more than $1 billion, with 90 percent of the verdict being punitive in nature, meant to send a clear message to the defendants. California does not have a limit on punitive damages, but the judge reduced the award to $543 million, based on the US Supreme Court ruling limiting excessive punitive damages. The most recent trial resulted in the plaintiff being awarded $247 million in November 2017.

J&J Wants To Avoid More Massive Verdicts

J&J are simply using every legal tool available to them, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip  trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to its various medical device and pharmaceutical product lines.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials. Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure.  Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the Pinnacle hip system. The New York Times stated that the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

Artificial hips are designed to last for 15 years in the best of situations, often that is not the case with many implants failing after just 10 years, and in the case of design defects such as those alleged in Pinnacle devices and many other hip implants, onset of metallosis and other adverse conditions resulting, as well as the ever present implant mechanical breakdown, which cause life altering health problems for patients.

FDA Issues Pinnacle Warning

The U.S. Food & Drug Administration issued a warning in January 2013, stating that patients receiving metal-on-metal hip replacements were more likely to experience premature device failure compared to those who received other types of implants.

In November 2013, DePuy Orthopaedics announced a $2.5 billion settlement in the DePuy ASR Hip Impant MDL2197 ( MDL 2197 DePuy Orthopaedics, Inc. ASR Hip Implant Briefcase), related to the ASR line of metal-on-metal hip implant components. DePuy ended sales of the all-metal Pinnacle hip system that same year, purportedly due to “low clinician use”. However, the company has so far declined to settle the Pinnacle hip litigation.

J&J Facing Many Legal Hurdles

Johnson & Johnson has been hit with numerous large jury verdicts across all areas of the J&J pharmaceutical and medical device operations, with plaintiff trial verdicts Risperdal, Ethicon TVM, Talcum Powder, Xarelto and other products, where recent combined trial verdicts have easily exceeded an additional $200 million. J&J and it’s subsidiaries are now facing more than 100 thousand lawsuits over it’s drug and medical device product lines, in both federal and state courts across the country. To complicate matters further for J&J, the recently started Opiate Prescription MDL 2804 (MDL 2804 Re: NATIONAL PRESCRIPTION OPIATE LITIGATION MDL 2804 Briefcase) names Johnson & Johnson as a defendant in suits filed by more than 400 cities, counties and states across the country.

 They Have Opioid MDL Issues Too

Perhaps J&J should look at settling some of the cases they’ve defended so aggressively over the last 5 years, such as the Pinnacle MDL 2244 to prepare for the Opioid Crisis litigation, which is now looking to displace Tobacco Litigation as far as size and scope as well as the massive multi-billion dollar settlements and years of ongoing litigation that came from lawsuits filed initially by governmental entities.

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