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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Second Xarelto Drug Trial Starts in Philadelphia Courtroom

Will this be a long hot summer of trials for Xarelto defense counsel?

 By Mark A. York (April 9, 2018)

 

XARELTO – a drug jointly created by Bayer and J&J subsidiaries Janssen R&D et al

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The second Xarelto bellwether drug trial over dangers related to internal bleeding linked to the anticoagulant blockbuster drug, started Friday April 6, 2018 in the Philadelphia Court of Common Pleas, in front of Judge Michael E. Erdos. This trial, where plaintiff Daniel Russell, of New Jersey claims that after being prescribed Xarelto, for Atrial Fibrillation or Afib, the drug caused massive internal bleeding and other serious medical complications. Mr. Russel’s trial follows the December 2017 verdict where a jury had awarded plaintiff Lynn Hartman $28 million for failure to warn of the dangers of Xarelto, a verdict later reversed in post trial arguments by Judge Erdos.

In opening statements by lead counsel Brian Barr of the Levin Papantonio firm,(see Russell v Bayer et al Trial Transcript Opening Statements April 6, 2018) the jury was told on Friday, that drug makers Bayer AG and Johnson & Johnson units (Janssen Pharmaceuticals, et al) failed to warn doctors about the risk the medication posed when used in combination with other drugs, which include internal bleeding, ischemic strokes and other adverse events. Offering that the companies had known that combining Xarelto with antiplatelet medications including Plavix and even aspirin, the combination would significantly increase the risk of internal bleeding, but that they ultimately opted to keep the information to themselves, and would not offer a formal FDA approved warning.

In the initial Phila bellwether trial, Lynn Hartman and her husband had filed their complaint against the drugmakers in 2015, (see XARELTO Case No. 2349 Philadelphia Court of Common Pleas briefcase) with claims very similar to Mr. Russell, resulting in the jury awarding $1.8 million in compensatory damages and $26 million in punitive damages. This verdict was seen as a high note for plaintiff counsel in the Xarelto litigation, after three prior trial losses, in the Xarelto MDL 2592 bellwether trials in Louisiana and Mississippi in 2017, which took place in federal courts.

The Phila Court Xarelto docket is the hot mass tort ticket now as Judge Fallon decided there will be no more MDL trials in front of him, and started the remand process in the Xarelto MDL 2592 cases, where he’s sending the cases back to original jurisdictions for trial.

The Lynn Hartman trial was just one of about 21,400 lawsuits against Bayer and Janssen pending in federal and state courts blaming injuries on Xarelto, and was the first case selected for trial from more than 1,400 Xarelto cases pending in the Complex Litigation docket of the Philadelphia court. Daniel Russel’s case is the second bellwether trial to go forward in the Xarelto docket, with several additional trials set to follow in the coming months.

The U.S. Food and Drug Administration approved Xarelto in 2011, to be prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms, often after implant surgeries.

Plaintiffs in the Hartman trial as well as in thousands of other Xarelto lawsuits, alleged that the drug was unreasonably dangerous and that Janssen (J&J) and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies and were aware of adverse events for a long period of time. These allegations will be argued aggressively by defense in all forthcoming trials, as the defendants do not seem to be willing to bend on their winning trial strategy.

Bayer and Janssen have defended Xarelto’s label stating that the label adequately warns of bleeding risks. After four trials verdicts, all in their favor, defense seems to be using an effective trial strategy that has worked in venues across the country.

The three bellwether trials in the Xarelto MDL 2592, Xarelto MDL 2592 Briefcase (US District Court ED Louisiana) heard in front of Judge Eldon Fallon,  all resulted in defense wins for Bayer and Janssen, with this Philadelphia trial shifting the focus from the federal Xarelto docket to the Philadelphia court and the bellwether trials scheduled there. This trail will be closely watched by all arties, as the impact of the initial plaintiff’s trial win followed by the Judge Erdos reversal in January during post-trial hearings, was not anticipated by those on the plaintiff bench. Will the Hartman verdict reversal ruling, as well as the peripheral trial conduct issues that were also addressed post-trial by Judge Erdos have any impact on this current Russell trial and the remaining scheduled trials in the Phila Xarelto docket? That is a question that remains to be seen over the course of the upcoming trials in the Philadelphia Court of Common Pleas Xarelto docket

Mass Tort Nexus will be providing daily updates on the Russell vs. Bayer & Janssen trial.

 

 

 

 

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It Was Raining Opiates: How drug companies submerged West Virginia in opioids for years

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

By Mark A. York (February 26, 2016 )

Why West Virginia has the highest rate of overdose deaths in the country

 

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) 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 Kentucy 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.

OPIOID BIG PHARMA INDUSTRY CONSPIRACY

Beside drug distributors, drug manufacturers such as Purdue Pharma and others bare responsibility for the flood of opioids to hard hit areas of West Virginia, Ohio and Kentucky and they are very familiar with the “opiate litigation dance” often paying hundreds of millions in fines without accepting real responsibility or pleading guilty to criminal charges.  They often enter into consent decrees where they pay a huge fines and promise to monitor the bad conduct in the future. This is actually considered a “get out of jail free” card, a very expensive card but a free pass for Opioid Big Pharma, none the less.

Purdue isn’t new to court battles. In 2007, the infamous drug maker and three of its executives pled guilty in federal court and paid out $634.5 million in fines for purposefully misleading regulators, doctors, and patients about the addictiveness of their opioid painkiller. Around the same time, Purdue was also sued by several states, including Washington, over similar allegations. Purdue agreed to a $19.5 million multi-state settlement. And in 2015, Purdue settled a case with Kentucky, agreeing to pay $24 million.

As part of the state settlements, Purdue was supposed to set up monitoring programs to make sure that its opioid drug didn’t wind up in the wrong hands. It was supposed to watch out for shady pharmacies, unusually large orders, or suspiciously frequent orders. But on this front, Everett alleges that Purdue once again put profits over people.

In released letters that were addressed to two regional drug distributors, Ohio-based Miami-Luken and Illinois-based HD Smith, related to both companies having distributed eye-popping numbers of pills to small cities in the state. In the letter, the committee lays out distribution data it has collected and asks questions about the companies’ distribution practices, including why they increased distribution so sharply in some towns and why they didn’t flag suspicious orders.

But Miami-Luken and HD Smith are not the only distributors that have drawn the committee’s attention. The letters are just the latest in the committee’s ongoing probe into what’s referred to as pill dumping amid the opioid crisis. Last year, the committee sent similar letters to three other drug companies, asking about their drug distribution in the state, these included the largest opiate distributors in the country AmerisourceBergen, Cardinal health and McKesson Corp, with all three listed in the top 10 of Fortune 100’s corporate hierarchy.

Miami-Luken followed through by providing some data and requested files, according to the committee. But those new pieces of information “raise a number of additional questions,” according to the committee.

WV FLOODED WITH OPIOIDS

Combining data collected from the Drug Enforcement Administration and Miami-Luken, the House Energy and Commerce Committee dove into the situation in Williamson. Between 2006 and 2016, drug distributors collectively shipped 20.8 million hydrocodone and oxycodone pills to two pharmacies in the small city. Those pharmacies were located roughly four blocks apart from each other, the committee noted. Miami-Luken alone supplied 6.4 million of those pills to just one of the pharmacies between 2008 and 2015. And between 2008 and 2009, the company inexplicably increased the amount of pills it delivered by 350 percent. The committee pressed Miami-Luken to explain how a town of 3,191 people could require such massive supplies and why the increases didn’t raise alarms.

The letter also reveals that in Kermit, West Virginia, a town of just 406 people, the company delivered 6.3 million hydrocodone and oxycodone pills between 2005 and 2011. For just the year of 2008, the numbers work out to Miami-Luken providing 5,624 opioid painkiller pills for every man, woman, and child in the town, the committee notes.

Likewise, Miami-Luken also delivered 4.4 million hydrocodone and oxycodone pills to the 1,394-person town of Oceana, West Virginia, between 2008 and 2015. And in Beckley, West Virginia, the company didn’t hesitate to fulfill a string of orders for tens of thousands of opioid doses placed by one pharmacy in the span of five days.

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.

OPIOID INDUSTRY HAS INFLUENCE

To show the far reaching tentacles of Opioid Big Pharma,  West Virginia Attorney General Patrick Morrisey was a former lobbyist for a trade group that represented Miami-Luken and other drug companies. In 2016, Morrisey ended several state lawsuits with drug companies, including one with Miami-Luken. The lawsuits, filed by the state’s former attorney general, Darrell McGraw, alleged that the companies flooded the state with opioid painkillers.

How this conduct would be viewed outside West Virginia would normally not have become an issue if Morrisey’s halt to the litigation would have been the end of the legal story. But fast forward to December 2018 and the official opening of the “Opiate Prescription MDL 2408”, where hundreds of counties, cities, states, hospitals and others impacted by the opioid crisis across the country, are now able to file lawsuits against all “Opioid Big Pharma” players. The defendants include drug makers, distributors, major pharmacies and others, there may a second long hard look at Patrick Morrisey’ conduct and reasoning for stopping prior legal action against the prescription opioid industry.

 

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This Week In Mass Torts Around The Country: Week of February 19, 2018

By MASS TORT NEXUS MEDIA

 

Opiate MDL 2804 Settlement Talks Start Before Discovery

See also OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION

>Federal Judge Dan Polster has ordered the start of formal settlement talks as the way to begin the Opiate Rx MDL 2804, he’s entered a settlement gag order and strongly suggesting the parties move ahead in this area or he will be forced “let both sides loose on each other and the government via wide open discovery” including access to the FDA and DEA files. The fate of multidistrict litigation over the opioid crisis now rests heavily with 18 plaintiff and defense counsel who’ve been tasked with negotiating a settlement in the historic case. The negotiators, chosen earlier this month, are from two camps: seven attorneys representing local governments that assert grievous financial harm from the opioid crisis, and 11 attorneys representing opioid manufacturers and distributors. Their assignment is daunting: broker a quick and meaningful deal that earmarks money for all parties who’ve been affected by the flood of opioids into the US marketplace over the last 15 years.

Johnson & Johnson Talc Use Will Kill Plaintiff Eventually Per Experts in NJ Talc Trial

See also Johnson & Johnson Talcum Powder Litigation Briefcase

>An occupational medicine expert told a New Jersey state court jury this week that a man alleging Johnson & Johnson’s baby powder contains asbestos faces a painful death from mesothelioma, and that the disease was caused by his daily use of J&J’s products.  According to plaintiff expert occupational health M.D. Jacqueline Moline, of the Feinstein Institute of Medical Research testified on behalf of plaintiff Stephen Lanzo, to support his claim that J&J’s products, including its baby powder, contained the asbestos that caused his mesothelioma.  Earlier this week, another plaintiff expert, William Longo, an electron microscopist told jurors Tuesday that he found asbestos in more than half of the 32 samples of Johnson & Johnson talcum powder products he had examined during a trial alleging that using J&J talc caused  him to develop mesothelioma, In the trials fourth week, Mr. Longo was called to the stand as a materials science and electron microscopy expert to support plaintiff Stephen Longo’s claim that J&J is responsible for his mesothelioma, an asbestos-related disease that is fatal.

 Xarelto Phila Court Bellwether Plaintiff Argues Trial Evidence Ignored

See Also XARELTO Case No. 2349 in Philadelphia Court of Common Pleas Briefcase – Complex Litigation (PA State Court)

>Lynn Hartman, the woman who won a $28 million verdict in December 2017, in the first Philadelphia  bellwether trial over injuries linked to the blood thinner Xarelto has argued the Pennsylvania judge Michael Erdos, who threw out her damages award ignored evidence that additional warnings would not have changed her doctor’s decision to prescribe the medication. In a January 9th hearing Judge Erdos ruled for defense on their Motion to Vacate the Judgment on various grounds, and during the same hearing the judge also ruled on plaintiff trial counsel trial misconduct matters, which resulted in  various sanctions against certain members of Ms. Hartman’s trial team.

 Purdue Pharma Initiated Opioid Crisis With Massive Opiate Rx Marketing Push

See also Targeting Big Pharma and Their Opiate Marketing Campaigns

>Several New Jersey counties and unions have filed suits against OxyContin maker Purdue Pharma and other opioid manufacturers, distributors and retailers in New Jersey state courts, which is outside of the Federal MDL Opiate Prescription MDL 280, in the last 30 days, accusing Purdue of sparking the opioid epidemic with deceptive marketing practices that the others eventually adopted. The claims in NJ sate court appear to be a strategic move to provide local governmental entities with a home court advantage versus jumping into the every growing MDL 2804, where Judge Polster has already moved the parties into settlement talks. There are now many other counties and states that have decided to litigate opioid claims in their own state courts versus joining the masses in the federal MDL, how this plays out in the long run remains to be seen. Several county and state court suits originally placed in the Opiate MDL have already been remanded back to state courts by the federal court.

Pennsylvania Supreme Court Hears Risperdal SOL Dismissal Arguments

 See also  RISPERDAL – PHILADELPHIA COURT of COMMON PLEAS

 >A Johnson & Johnson unit on Tuesday urged the Pennsylvania Supreme Court to leave standing a recent decision jeopardizing thousands of pending lawsuits by rolling back the clock on when claims of abnormal breast growth allegedly linked to the antipsychotic drug Risperdal began to expire. The justices are weighing whether to hear an appeal of a November ruling from the state’s Superior Court finding that a two-year statute of limitations of Risperdal-related lawsuits, more than 6,600 of which are pending in Philadelphia County, should have started the Statute of Limitations clock, which if upholds the decisions, will cause the dismissal of many of the cases in the Phila court Risperdal docket. J&J has not fared well to date in the Risperdal cases, with verdicts against now reaching the hundreds of millions of dollars and a recent ruling that Punitive damages are now permitted for many cases. J&J’s Janssen R&D division is also facing thousands of suit in the Xarelto litigation also filed in the Phila Court of Common Pleas docket.

Pennsylvania Appeals Court Won’t Overturn Plaintiff Risperdal Verdict

See also Punitive Damages Now Allowed in Philadelphia Risperdal Suits Per Superior Court Ruling

>A Pennsylvania appeals court on Tuesday rejected efforts by a Johnson & Johnson unit to challenge expert testimony relied on by jurors in finding that the antipsychotic drug Risperdal had caused a Maryland boy to grow female breast tissue. A three-judge Superior Court panel shot down arguments from Janssen Pharmaceuticals Inc. that Dr. Francesco DeLuca had improperly relied on an 8-year-old photograph to conclude that Nicholas Murray had been suffering from gynecomastia, or the abnormal growth of female breast tissue in males, at the time the drug was prescribed. However the Superior Court panel did rule that  the Murray v. Janssen Pharmaceuticals, case would go back to the trial court for further determination as to the jury award cap based on Maryland law, wher the plaintiff resides,  and taking into account the recent Superior Court ruling that permits punitive damages in the Risperdal litigation. The Murray trial which was the third case to go to trial in the Risperdal mass tort docket in the Philadelphia Court of Common Pleas. The plaintiff was initially awarded a $1.75 million verdict, which was later reduced by the trial court to $680,000, pursuant to the Maryland statute capping damages.  The unanimous panel rejected defendant Janssen Pharmaceutical’s attempt to overturn the verdict and affirmed the trial judge’s decision to limit the jury award based on a Maryland law that caps noneconomic damages.  However, citing its decision in a case last month that opened the doors for Risperdal plaintiffs to seek recovery of punitive damages, Judge John Bender remanded the case to the trial court to determine whether plaintiff Nicholas Murray, a Maryland resident, should be allowed to seek punitive damages in the case.

State of Kentucky Files Opioid Suit in State Court

See State of Kentucky and Counties vs. Opioid Makers and Distributors

 >Drug distributor Cardinal Health has exacerbated the opioid epidemic by filling suspicious drug orders and neglecting to alert the authorities about them, Kentucky’s attorney general claimed in a suit filed Monday in state court. Andy Beshear, lead plaintiff counsel claims Cardinal shipped massive opioid orders throughout Kentucky for years, that were unusually large, frequent and deviated from a past pattern, shunning its own data and “common sense” in favor of profits and market share. Beshear had previously sued McKesson Corp., who along with Cardinal and AmerisourceBergen, distributes 85 percent of the country’s prescription opiates, and are alleged to have engaged in an organized and boardroom acknowledged policy of not reporting massive opiate order increases or failing to accurately track the millions of opiate pills that made their way into so many small towns in the region of Kentucky, West Virginia and Ohio. How the drug distribution monitors at these companies couldn’t recognize that often 2 million plus opioid tablets were being shipped to towns that had populations of less than 2,000 remains as the big question, that nobody at these Fortune 50 companies will admit to or acknowledge was an issue.  The lack of oversight and re[porting took place during the last 15 years of record breaking profits where billions of dollars in revenue were collected year in and year out by drug distribution companies.

Settlement Agreement Reached In Zimmer NexGen Knee MDL 2272

 See also ZIMMER NexGen Knee MDL 2272 Briefcase (USDC ND Illinois)

>Federal Judge Rebecca Pallmeyer enterd CMO No. 13 on February 12, 2018 placing a stay on proceeding in MDL 2272, pending the outcome of the finalization of the settlement discussion and a full resolution of the Zimmer NexGen Knee litigation. Lead counsel in the Zimmer NexGen litigation on Feb. 6 told Judge Pallmeyer, that they have reached an agreement in principle that will potentially resolve all MDL cases and similar cases filed in state court as of Jan. 15, 2018.  If approved, the settlement will end seven years of litigation, during which some 300 plaintiffs alleged the engineering changes that Zimmer made to allow a greater degree of flexibility in its NexGen components in fact caused greater stress on the knee implants. The NexGen high-flex components theoretically allow patients to bend their knees by 155 degrees, while standard NexGen components provide for up to 125 degrees of bending, according to the plaintiffs.

The Zimmer NexGen knee replacement system has been on the market, almost half a million people in the US alone have had Zimmer knee implants. However, the Zimmer knee replacement, namely the NexGen CR-Flex Porous Femoral component, has been linked to a variety of problems, from loosening of the implant to failure of the replacement knee, requiring revision surgery, as the plaintiffs in the MDL also allege.

The case is MDL 2272  Re: Zimmer NexGen Knee Implant Products Liability Litigation, (MDL Docket No. 2272, U.S. District Court for the Northern District of Illinois)

 

 

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Orange County and Santa Clara County Suits Against “Opiate Big Pharma” In California State Court Can Proceed

Ruling Rejects Opioid Manufacturers’ Arguments To Dismiss Deceptive Marketing Litigation

By Mark A. York (February 19, 2018)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) On February 13, 2018, the Orange County Superior Court rejected efforts by opioid manufacturers to dismiss a lawsuit brought by the Santa Clara County Counsel and the Orange County District Attorney on behalf of the People of the State of California. The lawsuit, filed in May 2014, alleges that the defendants—including opioid manufacturers Purdue Pharma L.P., Janssen Pharmaceuticals, Inc., Endo Health Solutions, Inc., and Actavis PLC—engaged in a deceptive marketing scheme that trivialized the risks of opioids, resulted in rampant over-prescribing, and led to a nationwide epidemic of opioid abuse and addiction.

“The court’s ruling puts an end to years of delay tactics by the defendants,” said Santa Clara County Counsel James R. Williams. “Now we will finally be able to move forward with the litigation and obtain key documents demonstrating the manufacturers’ misconduct. This is a critical step in addressing the opioid crisis that plagues California and the nation, and we will fight to hold opioid manufacturers accountable for their actions.”

STATE COURTS AHEAD OF FEDERAL OPIATE LITIGATION

In addition to the California counties suing in state court there are more than 200 counties from across the country as well as 30 major cities that have filed suits against opioid manufacturers in Opiate Prescription Multidistrict Litigation MDL 2804, pending in the US District Court of Northern Ohio in front of Judge Dan Polster, see Prescription Opiates MDL 2804 Briefcase. In addition to governmental entities, Judge Polster has also permitted unions and hospitals to join in the consolidated opioid litigation against Purdue Pharma, et al. The age of “Profits Before Patients” by Big Pharma may finally have started to come to an end, but it will not occur with very aggressive legal tactics and maneuvering by the opioid makers defense teams.

INSURERS ARE FIGHTING BACK

Earlier this year Travelers Insurance and St Paul Fire and Marine Insurance scored a legal victory when they were granted a declaratory judgment win related to defending Watson and it’s parent company Activis, Inc in the Orange County-Santa Clara County litigation, after the California Appellate Court declared the Traveller’s/St Paul  opioid coverage policy void due to the “Watson’s Deliberate Conduct” in relation to sales and marketing of opioid prescription drugs, which was determined to be improper. The decision also voided the Watson-Activis coverage in the City of Chicago vs. Watson et al, in Chicago federal court, see  California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense. This may be a trend for insurance carriers as they’ve filed other legal action to void coverage on behalf of opioid drug makers including Insys Therapeutics, Inc and defense of its Subsys fentanyl fast acting drug.

OPIOID RX DRUG MAKERS CHANGING TACTICS

The ruling comes the same week that Purdue Pharma, maker of the opioid OxyContin, announced that it will cut its salesforce in half and stop promoting opioids to doctors. The lawsuit brought by the Santa Clara County Counsel and the Orange County District Attorney was among the first lawsuits brought by government officials to hold opioid manufacturers responsible for their role in the opioids crisis. Manufacturers like Purdue now face pressure from hundreds of additional lawsuits nationwide.

The lawsuit was filed on May 21, 2014, against major opioid manufacturers. (People of the State of California v. Purdue Pharma, et al., Orange County Superior Court, Case No. 30-2014-00725287-CU-BT-CXC.) In 2015, defendants moved to stay the lawsuit, and the case was stayed until October 2016, when the court partially lifted the stay to consider defendants’ arguments that the case should be dismissed. The court has now lifted the stay entirely, and its ruling allows the lawsuit to go forward.

UP TO $500 BILLION SETTLEMENT

The current “Opiate Prescription Litigation MDL 2804” is being compared to the 1998 Tobacco Litigation settlement where Big Tobacco paid a settlement of $200 billion to cities, states and other governmental entities. The Opioid Litigation is expected to reach settlement figures of 3 to 4 times that amount, projected to be at the $500 billion plus figure, due to the rampant corporate boardroom directed policies that flooded the US marketplace for the last 15 years. Corporate sales and marketing policies and lack of oversight, enabled hundreds of millions of opioid prescription drugs to reach all areas of the country, thereby causing in excess of 100 thousand deaths and unknown catastrophic economic damages in every corner of the United States.

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Xarelto Federal Court Hearing – Judge Fallon “Need to devise an end game for this MDL”

Xarelto MDL 2592 – Judge Fallon “I need to devise an end game for this MDL”

Are Settlement Talks Coming to Xarelto Litigation?

By Mark A. York (January 30, 2018)

 

XARELTO: A BAYER CORP. AND JANSSEN PHARMACEUTICALS JOINT EFFORT

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) During the January 30, 2018 monthly status conference hearing in Xarelto products liability MDL No. 2592, US District Court Judge Eldon Fallon stated that this MDL is nearing its end, and “I need to devise an end game,” as he now seems to be pushing both sides toward a resolution. He also referred to selection of cases to remand where 400 cases each will be selected by plaintiff and defense counsel and 400 more by the court, for a total of 1200 cases being designated for remand back to the court of original jurisdiction for trial or settlement.

Judge Fallon also referred to resolving any lingering discovery issues that remain in certain cases to avoid mounting discovery costs in getting those case resolved, while trying to put a time frame on the proposed process of winding down the Xarelto MDL.

The sprawling nationwide litigation has produced over 21,000 lawsuits since the federal MDL was created in 2014 in New Orleans, and the number of new cases filed each month remains the same at about 400 per month. Even more cases have been filed in state courts in Philadelphia and Los Angeles, with there being about 1200 cases in the Philadelphia Court of Common Pleas docket in front of Judge Arnold New.

Michael Weinkowitz, lead plaintiff counsel in the recent Philadelphia trial verdict of $29 million, awarded to plaintiff Lynn Hartman, provided an update to the court, including a discussion on the January 9, 2018 ruling that overturned the Hartman verdict in a contentious post trial hearing, where Judge Michael Erdos granted a defense Motion for Judgement Notwithstanding the Verdict. The Philadelphia court post-trial issues of attorney misconduct were also interjected into Judge Fallon’s courtroom by defense counsel, which seemed to be totally unwarranted and out of place in the MDL hearing, when Bayer defense counsel felt the need to advise the federal court of “allegations of trial misconduct” that were heard at the January 9th hearing, even though the Hartman verdict was overturned based on proximate cause issues, not in any way related to plaintiff attorney misconduct,” as defense counsel seemed to offer to the court.

CASE DEMOGRAPHICS

Jacob Woody, of Brown Greer’s MDL Centrality program provided current data as to case numbers and plaintiff demographics including 21,465 cases currently filed into the Xarelto MDL, averaging 450 new filings each month. As well as:

  • Texas, Florida and California having the most plaintiffs with over 1,000 each
  • Hawaii having the fewest at just fourteen
  • Plaintiff age groups: age 60 – 69 = 20%, age 70 – 79 = 30% and age 80 – 89 = 30%
  • 48% of plaintiffs allege a gastrointestinal bleed as the primary medical issue
  • The number of new case filings per month has remained steady for the last 3 years

PHILADELPHIA XARELTO DOCKET

While Judge Fallon is seeking an apparent end to the federal Xarelto MDL in New Orleans, Judge Arnold New in the Philadelphia Court of Common Pleas, has set a rather aggressive trial schedule in the Xarelto docket there, including trial start dates of March 19th, April 16th and June 11, 2018 with additional trials being set at “one to two trials per month for perpetuity” quoting Judge Fallon on his interaction with the Philadelphia court. The appeal of Judge Erdos’ January 9th reversal of the Lynn Hartman $29 million verdict was filed today as well, on January 30 2018 in the Superior Court of Pennsylvania.

PROBLEMS WITH XARELTO

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

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

Plaintiffs assert claims against Xarelto makers Bayer, Janssen and Johnson & Johnson of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud as well as violation of consumer protection laws where permitted by state statutes and loss of consortium when possible.

The GI bleed issue which is the most common allegation in the Xarelto complaints is by no means the only medical issue to arise in litigation over the block-buster blood thinner, with claims of both hemorrhagic and ischemic strokes, sudden uncontrolled internal bleeding, lack of an antidote to stop traumatic bleeding events related to trauma as well as thousands of deaths related to taking Xarelto after being prescribed the drug by doctors.

Bayer and Janssen have aggressively defended the safety of Xarelto and proclaim the previous three defense verdicts in the Xarelto bellwether trails that took place in 2017, show that Xarelto is a safe drug. Medical and scientific data do not seem to support that position, but the 21,000 remaining lawsuits waiting to be returned to federal court dockets across the country may well force the defendants to rethink their legal strategy due to the catastrophic costs associated with defending and preparing cases for that number of potential trials.

XARELTO CALIFORNIA JCCP DOCKET

In January, California Superior Court Judge Kenneth R. Freeman in Los Angeles appointed the plaintiffs’ liaison counsel in the state’s Judicial Council Coordinated Proceedings (JCCP) for all Xarelto cases in the state courts, JCCP Case No. 4862. The California Xarelto docket is moving forward as cases filed there continue to increase monthly, with almost 300 cases currently pending in the California state courts. A recent status conference was held in December, when the parties agreed to submit plaintiff and defendant fact sheets.

XARELTO MDL 2592 FUTURE

Even though Judge Fallon has determined that there will be no more bellwether trials in his court as a sitting MDL judge, there are individual Xarelto cases that will remain in the US District Court of Louisiana docket that he may be ruling on. He will also have to address the various housekeeping and legal issues that will arise in winding down such a large MDL docket where the cases are still active and viable and both sides don’t seem to be looking toward a quick settlement at this point.

The thousands of cases being placed in front of federal judges across the country could possibly force the parties to come to the settlement table sooner as opposed to later, with a push here and there from individual courts, as already overloaded federal courts are probably not readily agreeable and inviting of this large a number of cases that are returning to home venues.

At this point the ball rests with defense counsel and their primary clients Bayer Pharma AG and Janssen Pharmaceuticals et al, and the corporate decision makers who are also facing the recently started Opiate Prescription Drug MDL 2804, which may require defense legal talent to switch from the Xarelto docket to the Opioid crisis litigation. The Opiate Prescription MDL may easily dwarf the prior Tobacco Litigation, to which it’s being compared. Big Pharma has some key decisions to make when it comes to where and how they will assign future resources and capital in defending past decisions in the manufacture and marketing of their prescription pharmaceuticals.

 

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Punitive Damages Now Allowed in Philadelphia Risperdal Suits Per Superior Court Ruling

Janssen Facing Over 6,400 Cases in Philadelphia Court of Common Pleas

By Mark A. York (January 18, 2017)

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Plaintiffs in the Risperdal litigation, may now seek punitive damages under a recent ruling by the Pennsylvania Superior Court.  Previously, plaintiffs were prevented from seeking punitive damages because the laws of New Jersey, applied to the Risperdal cases filed in the Philadelphia Court of Common Pleas, see Risperdal Re: Janssen: Philadelphia Court of Common Pleas. Johnson & Johnson is headquartered in New Jersey, with the courts previously applying those laws which barred punitive damages.

More than 6,000 Risperdal lawsuits in the Philadelphia docket allege Risperdal caused young men and boys to develop a condition called gynecomastia, where female breasts develop in male patients, with J&J’s Janssen Pharmaceuticals failing to warn about the risk.

The three-judge Superior Court panel ruled on January 9, 2018, that plaintiffs in the Philadelphia cases may apply the law of their home state to seek punitive damages, which opens up an entirely new legal avenue for plaintiffs.

Johnson & Johnson stated they were “disappointed in the ruling” and will be considering all options moving forward, while plaintiff counsel commented “This is something we’ve been right about from the beginning and maybe now, once and for all, J&J will recognize they’re facing punitive damages.”

Now that there is a threat of punitive damages, J&J will have to determine long term case strategy, as the punitive awards against J&J in 2016 – 2017 in other mass torts amounted to over eight hundred million dollars, and plaintiffs’ attorneys hope J&J will consider settling the remaining cases.

Plaintiffs have filed more than 6,400 product liability cases resulting from the use of anti-psychotic drug Risperdal in the complex litigation docket of the Philadelphia Court of Common Pleas. Plaintiff lead counsel, Tom Kline of Kline & Specter in Philadelphia, says “stakes in these cases will be raised now that the prospect of punitive damages is in play.”

On Jan. 8, Superior Court Judges Jack A. Panella, Alice Beck Dubow and Kate Ford Elliott ruled that plaintiffs in the Philadelphia-based Risperdal litigation may apply the respective laws of their home states to attempt to obtain punitive damages from Janssen Pharmaceuticals, the developer of Risperdal and a subsidiary of Johnson & Johnson.

“This is a pivotal decision in the Risperdal litigation. The Court found that the trial evidence justified the verdict in plaintiff’s favor. In addition, the stakes in any mass tort are raised when punitive damages are recoverable. This thoughtful and thorough opinion will now provide guidance for the entire litigation moving forward,” Kline said.

J&J and Janssen official statement is “We are disappointed in the Court’s ruling and will consider our options going forward. Contrary to the impression plaintiffs’ attorneys have attempted to create over the course of this litigation, Risperdal (risperidone) is an important FDA-approved medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions,” there was no comment released by Janssen defense counsel.

Currently, most of the 6,400 lawsuits based in the Philadelphia Risperdal docket have been filed by out-of-state plaintiffs, who assert Risperdal causes young males to contract gynecomastia, or the development of female breast tissue, and that Johnson & Johnson failed to adequately warn of these side effects from the drug.

The Superior Court’s new ruling applies across-the-board, as even plaintiffs who have previously received jury verdicts in Risperdal litigation, can now petition the court for new trials or request hearings to enhance verdict awards by adding punitive damages. One prior jury verdict was for more than $70 million and plaintiffs can now request additional punitive damages be awarded.

Before this ruling, seeking of punitive damages in Risperdal cases was prohibited according to New Jersey state law – because Johnson & Johnson is headquartered there.

The ruling on Risperdal punitive damages started when Johnson & Johnson appealed the Stange vs. Janssen Pharmaceuticals verdict; where Wisconsin plaintiff Timothy Stange asserted an inadequate warning of developing gynecomastia from taking Risperdal.

Mr. Stange used Risperdal for three years during his childhood, for treatment of Tourette’s syndrome, and at the close of the trial, a Philadelphia jury awarded him $500,000, and the recent Superior Court ruling has now upheld plaintiff arguments that an inadequate warning of the gynecomastia risks directly caused his injuries.

According to reports from the Philadelphia Court of Common Pleas, of the suits filed in the first 3 months of 2017, about 80 percent of cases in the Complex Litigation docket, came from out-of-state plaintiffs. With this recent ruling, it would seem logical that the number of Risperdal lawsuits filed in the Philadelphia court, may increase dramatically as the potential verdict award amounts have just risen to unknown numbers at this point.

One explanation for the surge in Risperdal filings can be directed toward defendants Johnson & Johnson, when they decided to cancel tolling agreements on thousands of cases. Knowing this strategy would increase the number of cases filed and the burden on the Court.

Tolling agreements pause the statute of limitations to file a lawsuit, and J&J actions seem to indicate that they wanted more lawsuits, not less, with J&J deciding to cancel the agreement after the $77 million verdict.

To date, eight Risperdal case have gone to trial in Philadelphia, with four juries ruling in favor of the plaintiffs, and J&J getting the other four cases dismissed.

The first case to trial, filed by Austin Pledger of Alabama was heard in 2012, with the jury siding with Pledger, finding J&J and Janssen failed to warn the drug could cause gynecomastia, and the jury awarded $2.5 million to Mr. Pledger.

After two more verdicts of $500,000 and $1.75 million were awarded to plaintiffs, in 2016 a Philadelphia jury handed a landmark verdict of $70 million to Andrew Yount of Tennessee, with. Judge Paula Patrick adding nearly $7 million in additional damages over intentional delays during the legal proceedings.

With the new rules regarding punitive damage,  including permitting retroactive claims by successful plaintiffs to now request punitives, Johnson & Johnson/Janssen Pharmaceuticals may need to rethink their long term case strategy, as having a punitive sword hanging over the 6,400 plus remaining cases, should cause defense counsel to re-evaluate their position sooner versus later.

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New York City sues Big Pharma over opioids – joining Chicago, Seattle, Milwaukee and other major cities

New York City Joins Chicago, Seattle, Milwaukee in Suing Opioid Industry Players

“PROFITS OVER PATIENTS BY BIG PHARMA CONTINUES”

 

MAJOR CITIES SUE BIG PHARMA OVER OPIOIDS

 

                                           

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) New York City has filed a lawsuit against pharmaceutical companies that make or distribute prescription opioids, on Tuesday the complaint was filed in New York state court, Superior Court of Manhattan, which is a break from other Opioid lawsuits filed by cities, who filed into federal court, see OPIOID-CRISIS: MDL-2804-OPIATE-PRESCRIPTION-LITIGATION. The primary claims state that the opiate drug companies fueled the deadly epidemic now afflicting the most populous U.S. city, joining Chicago, Seattle, Milwaukee and other major cities across the country in holding Big Pharma drug makers accountable for the opioid crisis.

New York Mayor Bill de Blasio stated the lawsuit seeks $500 million in  damages to help fight the crisis, which kills more people in the city annually than homicides and car accidents combined, which at last count was more than 1,100 from opioid-induced overdoses in 2016.

He also clarified “Big Pharma helped to fuel this epidemic by deceptively peddling these dangerous drugs and hooking millions of Americans in exchange for profit,” making his point clear as to where responsibility for the opioid crisis rests.

Named defendants include manufacturers Allergan Plc (AGN.N), Endo International Plc (ENDP.O), Johnson & Johnson (JNJ.N), Purdue Pharma LP and Teva Pharmaceutical Industries Ltd (TEVA.TA), and distributors AmerisourceBergen Corp (ABC.N), Cardinal Health Inc (CAH.N) and McKesson Corp (MCK.N), sourced from Reuters.

 

All were accused in the city’s complaint of creating a public nuisance, and the distributors were cited for negligence. The same allegations have been asserted in other complaints, including RICO claims by many plaintiffs who assert the companies conspired and created the opioid crisis by developing questionable opioid marketing plans, including offering financial incentives and making payments directly to doctors and others to write opiate prescriptions.

Allergan, Endo, J&J, Purdue, Teva, AmerisourceBergen and McKesson have all stated that they historically emphasized the importance of using opioids safely, in their business operations

BIG PHARMA OFF-LABEL DRUG ABUSES

Endo, J&J and Purdue denied the city’s allegations, with McKesson and Cardinal Health not immediately responding to requests for comment. All companies listed in the complaint have repeatedly been cited, fined and entered into consent decrees with the federal and state governments regarding questionable marketing practices related to prescription drugs. Often these fines have totaled hundreds of millions of dollars and never admit liability, simply agreeing to stop the cited activity, which as reflected in the hundreds of opioid based complaint recently filed, the agreement to cease and desist in “off label” or inappropriate drug marketing efforts has not been applied to the opiate prescription industry.

New York City, with over 4 million residents, has joined a long list of U.S. states and municipalities suing drug companies over opioid abuse, often referring to the drug makers “off label” use, where sales reps have continuously pushed an agenda of the opiates being “non-addictive” and part of proper healthcare.

OPIATES: A PUBLIC HEALTH EMERGENCY

The national opioid crisis incited President Trump to designate the it as a national public health emergency in November 2107, and the administration extended the emergency as of January 19, 2018. Although it should be noted that President Trump has not applied any federal funding to the now official “public health emergency” thereby leaving the state and local governments to push forward in the efforts to combat the opioid crisis on their own.

Opioids, including prescription painkillers and heroin, played a role in 42,249 U.S. deaths in 2016, up 28 percent from 2015 and 47 percent from 2014, according to the U.S. Centers for Disease Control and Prevention.

The complaint filed in state court in Manhattan, New York accused manufacturers of having for two decades misled consumers into believing that prescription opioids were safe to treat chronic non-cancer pain, with minimal risk of addiction.

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.

MILLIONS OF PILLS PRESCRIBED

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 state, with West Virginia numbers being 780 million painkillers 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 appoint where 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 simply assign a financial penalty for the alleged corporate opioid abuses.

The case docket information is: City of New York v Purdue Pharma LP et al, New York State Supreme Court, New York County, No. 450133/2018.

 

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$28 Million Xarelto Jury Verdict Reversed by Judge in Philadelphia Court

Defense gets fourth win in the four Xarelto bellwether trials

By Mark York (January 11, 2018)

 Xarelto Blood Thinner Developed by Bayer and Janssen

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The December 2017 Xarelto jury verdict of $27.8 million awarded to an Indiana couple, was overturned earlier this week, when the trial judge vacated the verdict. The plaintiffs had accused Bayer AG and Janssen Pharmaceuticals, Inc., a Johnson & Johnson subsidiary, of failing to warn of internal bleeding risks of their drug Xarelto.

Judge Michael Erdos, Philadelphia County Court of Common Pleas, heard arguments on January 9, 2018 in a motion hearing to reverse the December verdict, which was the first defense trial loss in litigation over the Xarelto blood thinner, and also the first trial outside the Xarelto MDL 2592, (see XARELTO MDL 2592 US District Court ED Louisiana briefcase) in front of Judge Eldon Fallon, US District Court of Louisiana.

Judge Erdos issued his ruling from the bench after the hearing on defense motions for a new trial or alternatively, for a judgement notwithstanding the verdict, and at the close of a full day of arguments stating, “a new trial is not necessary because plaintiff did not adequately demonstrate responsible cause,” and he then entered judgement for the defendants.

“J&J’s Janssen Pharmaceuticals Inc and Bayer, which jointly developed Xarelto, welcomed the decision and issued statements saying they will continue to defend against the allegations in all Xarelto litigation, with a total of more than 20,000 pending lawsuits now in both state and federal Xarelto dockets.

Bayer stated “Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”

The December 5, 2017 verdict came in a lawsuit filed by Lynn Hartman, who was prescribed Xarelto as treatment for an irregular heartbeat also known as atrial fibrillation, to prevent strokes. The testimony and opinions of Ms. Hartman’s treating physician and views on continued willingness to prescribe Xarelto, had a significant impact on the final ruling to overturn the verdict by Judge Erdos.

Hartman claimed she was prescribed the drug for a little more than a year, starting in February 2013, and was hospitalized with severe gastrointestinal bleeding in June 2014, at age 72, with the bleed attributed to taking Xarelto. The court record reflected that Ms. Hartman has since recovered from the hospitalization.

Lynn Hartman and her husband filed their complaint against the drugmakers in 2015, (see XARELTO Case No. 2349 Philadelphia Court of Common Pleas briefcase) with the six week trial starting the first week of November 2017, resulting in the jury awarding $1.8 million in compensatory damages and $26 million in punitive damages. This verdict was seen as a high note for plaintiff counsel in the Xarelto litigation, after three prior trial losses, in Xarelto MDL 2592 bellwether trials in Louisiana and Mississippi.

The Hartman trial is just one of about 21,400 against Bayer and Janssen pending in federal and state courts blaming injuries on Xarelto, and the first selected for trial from more than 1,400 Xarelto cases pending in the Complex Litigation docket of the Philadelphia court.

Plaintiff trial counsel Michael Weinkowitz, said the decision related to a “very narrow issue related to Mrs. Hartman’s prescribing physician.” He said he looked forward to trying the next series of Xarelto-related cases in Philadelphia. The post trial legal arguments were related to the “learned intermediary doctrine and proximate cause” and was raised by defense in post trial motions and aggressively argued, which plaintiff counsel was unable to overcome in the full day hearing.

The U.S. Food and Drug Administration approved Xarelto in 2011, to be prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms, often after implant surgeries.

Plaintiffs in the Hartman trial as well as in thousands of other Xarelto lawsuits, alleged that the drug was unreasonably dangerous and that Janssen (J&J) and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies and were aware of adverse events for a long period of time. These allegations will be argued aggressively by defense in all forthcoming trials, as the defendants do not seem to be willing to bend on their winning trial strategy.

Bayer and Janssen have defended Xarelto’s label stating that the label adequately warns of bleeding risks. After four trials verdicts, all in their favor, defense seems to be using an effective trial strategy that has worked in venues across the country.

The three bellwether trials in the Xarelto MDL 2592, all resulted in defense wins for Bayer and Janssen, with this Philadelphia trial shifting the focus from the federal Xarelto docket to the Philadelphia court and the Hartman trial. What impact the initial plaintiff’s trial win followed by the Judge Erdos reversal this week has on both Xarelto dockets remains to be seen.

 

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The Week In Mass Torts By Mass Tort Nexus for December 18, 2017

 

 

 

 

 

 

 

 

By Mark York, Mass Tort Nexus Media

(December 21, 2017)

New Jersey Supreme Court Review Reinstatement Of Accutane Experts

The New Jersey Supreme Court recently granted petitions and cross-petitions to appeal a state appellate court’s reversal of expert exclusions in the state’s Accutane multicounty litigation and the reinstatement of 2,076 dismissed cases (In Re:  Accutane Litigation, C-388 September Term 2017, C-329 September Term 2017 and C-390 September Term 2017, N.J. Sup.) See Mass Tort Nexus Accutane Briefcase Accutane New Jersey State Court Litigation.

New Trial Denied in 3rd Xarelto MDL Bellwether Case After Defense Verdict

Judge Eldon Fallon, overseeing the Xarelto multidistrict litigation, recently denied a motion for a new trial by the plaintiff in the third bellwether trial, where Bayer was found not liable in the Dora Mingo trial that took place in a Mississippi federal court in front of Judge Fallon. He ruled that plaintiff was unsuccessful in presenting new findings, among other things, that the plaintiff’s “newly discovered evidence” is actually cumulative of previously known and admitted evidence (In Re:  Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, E.D. La., 2017 U.S. Dist. LEXIS 205422). See Mass Tort Xarelto Briefcase for the entire Mingo trial transcripts as well as full transcripts of the Orr and Boudreaux trials, XARELTO MDL 2592 US District Court ED Louisiana Including Trial Transcripts.

 With Last 2 Cases Gone, Pradaxa MDL Judge Again Recommends Termination

With the final two pending cases now closed, the Illinois federal judge overseeing the Pradaxa multidistrict litigation on Dec. 11 again recommended that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL (In Re:  Pradaxa [Dabigatran Etexilate]Products Liability Litigation, MDL No. 2385, No. 12-md-2385, S.D. Ill.).  After a global settlement was reached in 2014 with defendant Boehringer Ingelheim Pharmaceuticals Inc., the JPMDL suspended the transfer of tag-along actions into the MDL, and now the judge has moved for termination of the Pradaxa MDL. However, there remains over 700 Pradaxa cases pending in the State Court of Connecticut, Complex Litigation Docket, known as “Connecticut Pradaxa Actions”, see Mass Tort Nexus Pradaxa Case Briefcase,  Connecticut Consolidated Pradaxa Litigation.

Boehringer To Pay $13.5M To End Off-Label Marketing Claims

Drugmaker Boehringer Ingelheim Pharmaceuticals Inc. has agreed to distribute $13.5 million among all 50 states and the District of Columbia to end allegations that it marketed four of its prescription drugs for off-label uses, attorneys general announced Wednesday.
The settlement would resolve allegations that Boehringer marketed its prescription drugs Micardis, Aggrenox, Atrovent and Combivent for uses that weren’t approved by their labels or backed by scientific evidence. (Getty) The settlement, of which New York will receive about $490,000, would resolve allegations that the drugmaker marketed it products for off-label use, which often leads to unknown or studied adverse events and medical complications for patients taking these drugs for unapproved purposes.

 J&J Fined $30 Million Over French Opioid Drug Smear Campaign In Efforts To Sell Fentanyl Patch

France’s antitrust enforcer fined Johnson & Johnson and its Janssen-Cilag unit €25 million ($29.7 million) on Wednesday for hindering the marketing and sale of a generic version of the company’s Durogesic pain patch.The French Competition Authority found that Janssen and J&J had not only successfully delayed a generic competitor for the powerful opioid for several months, but had also done lasting damage by discrediting rival versions of the drug with doctors and pharmacists in a country where medical professionals still remain reluctant to opt for prescribing opioids.  The J&J conduct reflects the same claims being asserted against opioid drug makers in the US, where lawsuits have been consolidate into Opiate Prescription Litigation MDL No. 2804, in the US District Court of Ohio, see Mass Tort Nexus Opioid Crisis Briefcase, OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION.

11th Circuit Affirms Pelvic Mesh Group Trial, Exclusion Of 510(k) Status

(October 24, 2017, 1:25 PM EDT) -The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017)   See Mass Tort Nexus Mesh Case Briefcase, All Pelvic Mesh Litigation Case Files.

Preemption Summary Judgment Reversed By 9th Circuit In Incretin Mimetic MDL Appeal

The Ninth Circuit U.S. Court of Appeals on Dec. 6 unsealed its Nov. 28 opinion reversing summary judgment in the incretin mimetic multidistrict litigation, saying the MDL judge misapplied a U.S. Supreme Court precedent, improperly blocked discovery, misinterpreted what constituted new evidence and improperly disqualified a plaintiff expert (In Re:  Incretin-Based Therapies Products Liability Litigation, Jean Adams, et al. v. Merck Sharp & Dohme Corp., et al., No. 15-56997, 9th Cir., 2017 )

Pennsylvania Appeals Court Affirms $29.6M Remitted Zimmer Knee Judgment

A Pennsylvania appeals court panel on Dec. 15 said a trial judge did not err when remitting a Zimmer Inc. knee verdict to $29.6 million and said it declined to substitute its judgment in place of the jury’s (Margo Polett, et al. v. Public Communications, Inc., et al., No. 80 EDA 2017, Pa. Super., 2017 Pa. Superior Court)

Risperdal Gynecomastia Cases Barred By Michigan Shield Law, Pennsylvania Panel Says

A Pennsylvania state appeals panel on Nov. 28 affirmed the dismissal of 13 Risperdal gynecomastia cases, agreeing with a trial judge that the plaintiffs’ claims are preempted by Michigan’s drug shield law and that the plaintiffs could not prove that the fraud exception

applied to their claims (In Re:  Risperdal Litigation versus Janssen Pharmaceuticals Inc., et al., No. 55 EDA 2015, et al., Pennsylvania Court of Appeals, 2017.

U.S. Supreme Court Asks Solicitor General To Weigh In On Fosamax Preemption

The U.S. Supreme Court on has invited the U.S. solicitor general to express the views of the United States on whether there is “clear and convincing evidence” that the Food and Drug Administration would have rejected a stronger warning about femur fractures from the osteoporosis drug Fosamax (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Supreme Court)  This is a unique turn when the Supreme Court is seeking input from an outside agency in what is now a common legal issue placed in front of the court, where dug makers are using the FDA regulatory process as a shield in defending thousands of claims where warnings of drug dangers are not clear or not provided. See Mass Tort Nexus Fosamax Case Briefcase, FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS).

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