Johnson & Johnson Latest Baby Powder Cancer Trial Continues In Missouri

J&J’s Facing Latest Baby Powder Cancer Trial Alone In Missouri Court

By Mark A. York (July 6, 2018)

 

 

 

 

 

 

ANOTHER J&J BABY POWDER OVARIAN CANCER TRIAL

(MASS TORT NEXUS MEDIA) The case of Gail Ingham v. Johnson & Johnson, No. 1522-CC10417, Circuit Court, City of St. Louis, Missouri, Judge Rex Burlison

Johnson & Johnson is flying solo in their latest baby powder cancer trial underway in St. Louis City Circuit Court, in front of Judge Rex Burlison, who has refused the many attempt by J&J to dismiss, remove and simply evade another ovarian cancer trial linked to J&J’s baby powder. This time they’re standing alone, after co-defendant Imerys Talc settled claims with 22 plaintiffs right before the trial began. The US unit of French minerals company Imerys SA settled claims by women for at least $5 million, related to Imerys mined talc supplied to Johnson & Johnson for making baby powder that’s been linked to ovarian cancer in several previous trials across the country.

The question becomes, just when did J&J become aware of the many adverse events and dangers of using its baby focused Talcum Powder products that have also been used by millions of adults worldwide?

See Mass Tort Nexus Briefcase: J&J Talcum Powder Litigation-St-Louis-County-Missouri

At the start of the trial, plaintiff trial attorney Mark Lanier told jurors about a study of infants who had been born dead. “They took biopsies and all of them had asbestos that had migrated from the womb across the placenta.”

Then Lanier showed the jury an internal J&J email where someone at the company recommended moving the product from the baby aisle or replacing talcum with corn starch.

Lanier has stated he’s uncovered stacks of new evidence showing J&J officials knew by the 1960s its baby powder was tainted with at least trace amounts of asbestos and hid the product’s cancer risks to protect its reputation.

Why would Johnson & Johnson be sending internal e-mails of this type, if there weren’t known risks associated with the talc products?

J&J USE OF FRONT COMPANIES AND LOBBYING GROUPS

With J&J at the helm, the Cosmetic Toiletry and Fragrance Association (CTFA), now the PCPC, formed a talc lobbyist group in response to the first epidemiologic studies that discovered an association between ovarian cancer and genital talc use in the early 1980s. J&J and Luzenac, now Imerys Talc, were the primary actors and contributors to the Talc Interested Party Task Force (TIPTF). J&J and Imerys coordinated all the activities of the talc lobbyist group in the District of Columbia.

The stated purpose of the TIPTF was to pool financial resources of primarily J&J and Imerys to collectively defend talc at all costs and prevent regulation of any type over the cosmetic ingredient. The talc lobbyist group hired scientists to perform biased talc safety research studies. Members of the lobbyist group edited research reports by scientists on their payroll prior to submitting them to governmental agencies. Furthermore, TIPTF members knowingly released false information about the safety of talc to the public and used political and economic influence on regulatory bodies to prevent any intervention.

PCPC coordinated the defense of talc and acted as a mouthpiece for TIPTF members, including J&J and Imerys. PCPC’s revenue is generated through a dues system based on its members’ annual sales. $76.5 billion in annual sales puts J&J in the top hundred of the highest grossing companies in the world, and the highest revenue generator in the PCPC. Consequently, the PCPC had an extremely vested interest in protecting J&J’s products and financial interests.

J&J SUPPRESSED ADVERSE FINDINGS ON TALC

According to scientific evidence, there have been studies showing a direct link between talcum powder and ovarian cancer that started emerging close to 50 years ago. How as this kept from public view? Starting in 1971, Dr. W.J. Henderson and other notable researchers in Cardiff, Wales conducted the first study that suggested an association between talc and ovarian cancer.

In 1982, the first epidemiological study on talc powder use in the female genital area emerged. This study found a 92 percent increased risk of developing ovarian cancer in women who reported genital talc use. Shortly after the study’s publication, Dr. Bruce Semple of J&J spoke with lead researcher Dr. Daniel Cramer. Dr. Cramer advised Dr. Semple that J&J needed to place a warning on its talcum powder products about ovarian cancer risks so that women could make informed decisions about their health. Since 1982, there have been more than 27 additional epidemiological studies indicating a significant link between talc and ovarian cancer.

In 1993, a U.S. National Toxicology Program published a study on the toxicity of non-asbestiform talc that determined that there was clear evidence of carcinogenic activity. Consequently. researchers concluded that talc was a carcinogen, with or without asbestos contamination. Then, in 1994, the Cancer Prevention Coalition notified J&J’s CEO that studies as far back as the 1960s “…show conclusively that the frequent use of talcum powder in the genital area poses a serious health risk of ovarian cancer.”

The coalition further indicated that 14,000 women die from ovarian cancer each year and that this type of cancer is very difficult to detect and has a low survival rate. The coalition begged the company to withdraw its talc products from the market or at least provide safety information.

Since then, the World Health Organization, the Canadian government, and various other cancer organizations have classified talc as a carcinogen.

The Ingham v. Johnson & Johnson Missouri Trial

The current case before Judge Burlison is at least the fifth ovarian cancer trial held in his court in the last two years. In previous trials, plaintiffs from across the country have been awarded substantial judgments totaling more than $300 million. One of the first talc trials resulted in a $72 million verdict for Jacqueline Fox, of Birmingham, AL which was vacated by a state appeals court last October, based on the US Supreme Court’s Bristol-Myers Squibb (BMS) v. Superior Court of California decision of June 2017 related to non-resident plaintiffs in state court actions.

This current case filed by Gail Ingham of O’Fallon, Mo. was removed to federal court last year by J&J, but US District Court Judge Stephen Limbaugh remanded it back to Judge Burlison’s court in July.

On May 15, 2018 Burlison told parties to get ready for trial and ruled that he would not sever, transfer or stay claims, finding sufficient contacts between Johnson & Johnson in Missouri to invoke a long arm statute.

WIDELY DIFFERENT VIEWS

Johnson & Johnson has defended lawsuits alleging its baby powder caused ovarian cancer in women in the past, as several trials across the country have linked their illnesses to exposure to asbestos in the company’s talc.

The talc cases which now number close to 10,000 in state and federal courts, with claims that the company sold talc in its iconic white Johnson’s Baby Powder bottles knowing it either caused ovarian cancer or was tainted with asbestos and failed to warn consumers to protect the brand.

A J&J representative, said in an emailed statement “The talc in Johnson’s Baby Powder does not contain asbestos or cause ovarian cancer and we will continue to defend the safety of our product,”

J&J FACING OVER 9,000 SUITS

Last month, jurors in California awarded a woman who said she routinely used talc on children and herself $25.7 million over her mesothelioma diagnosis. A South Carolina jury couldn’t reach a verdict on similar claims the same week as the California ruling.

Those decisions followed a New Jersey jury’s finding in April that J&J and a unit of talc supplier Imerys SA must pay $117 million to a banker who claimed his cancer was tied to baby powder use.

J&J still faces talc lawsuits by more than 9,000 plaintiffs, primarily focused on ovarian cancer, according to a May securities filing. That number has grown from 1,200 in 2016. An unknown number of consumers claim that J&J’s talc products caused mesothelioma. See J&J Talcum Powder MDL 2738 USDC New Jersey Briefcase.

 WHEN AND WHAT DID J&J KNOW ABOUT TALC DANGERS?

In opening statements, Lanier said the “big fight” in the case was whether there’s asbestos in J&J’s talc products and whether J&J knew it and hid it.

He then offered that multiple studies by universities, companies, agencies and even J&J itself found asbestos in talc, but that J&J had “manipulated the science in more ways than I can count” to obscure the facts. The company was compelled to protect its baby powder brand as its “sacred cow,” based on the millions of dollars earned every year.

“To say that J&J rigged test results is false,” Peter Bicks, J&J’s lawyer  told jurors. “J&J always went above and beyond in testing for asbestos.”

Most of the women in St. Louis trial used baby powder, but others used Shower-to-Shower, another of J&J’s talc-based products which J&J sold the product to Valeant Pharmaceuticals International Inc. in 2012 and Valeant now faces asbestos suits over that body powder product.

The women, whose jobs range from school bus driver to executive director of a job-retraining program, come from states across the country, such as Pennsylvania, California, Arizona and New York. Six of the women have died, so their families are pressing wrongful-death claims against J&J.

When Krystal Kim, one of the women suing, learned testing by her lawyers of the Johnson’s Baby Powder she used showed it was laced with asbestos, she felt sick. “I was scared and mad at the same time,” said Kim, a 52-year-old former computer consultant now battling ovarian cancer. “It certainly wasn’t what I expected to have in my house or to be putting on my body every day.”

Kim traveled to St. Louis for the trial and she’s banking on jurors holding J&J accountable for her cancer after hearing Lanier’s evidence. “I’m hoping this jury says no more little girls should be harmed by this powder,” she said. “I’m hoping it stops here.”

The trial is expected to last another week to 10 days and we will provide updates until a verdict is returned.

The case is Ingham v. Johnson & Johnson, No. 1522-CC10417, Circuit Court, City of St. Louis, Missouri, Judge Rex Burlison

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Purdue Pharma Executives and the Sackler Family Named in Massachusetts Opioid Crisis Lawsuit

Oxycontin Founding Family Are Now Forced to Defend Profits In Court

Complaint: “State of Massachusetts vs. Purdue Pharma and the Sackler Family” June 13, 2018

By Mark A. York (June 20, 2018)

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) As more states and federal agencies continue to scrutinize the opioid drug manufacturers across the country, a clear high value target is emerging in Purdue Pharma, L.P.  and the Sackler family that founded the company. The family has profited to the tune of about $13 billion to date, and have somehow avoided the legal spotlight for the last 10 years. The Sackler family have always been protected by the company shield, even though their most profitable selling opioid drug Oxycontin and its boardroom coordinated marketing campaign was the brainchild and a direct result of the Purdue Pharma company founders, the Sackler brothers and their tried and true business model.

Complaint: “State of Massachusetts vs. Purdue Pharma and the Sackler Family” June13, 2018

That is now changing, as the State of Massachusetts, filed a lawsuit against Purdue Pharma and the Sackler family as well as various Purdue executives over the prescription painkiller OxyContin. Oxycontin is now recognized as the opioid fuse that ignited America’s opioid crisis. This is the first time where Purdue’s leading executives and members of the multibillionaire Sackler family, now known to be feuding over the opioid crisis have been named in civil litigation.

The Sacklers named in the lawsuits include Theresa and Beverly, widows of Purdue founders, brothers Mortimer and Raymond Sackler and Ilene, Kathe and Mortimer David Alfons Sackler, three of Mortimer’s children; Jonathan and Richard Sackler, Raymond’s two sons; and David Sackler, Raymond’s grandson. The Sackler family is worth conservatively, an estimated$13 billion, according to Forbes, which has been generated from sales of OxyContin.  As is normal procedure by the Sackler family and the company itself, the Sackler family feuding members always decline requests for comment on the catastrophic opioid crisis and avoid discussing any Purdue Pharma links to how the crisis came about.

PURDUE PHARMA NAMED IN 600 OPIOID LAWSUITS

Dozens of states, counties and local governments have independently sued opioid drugmakers in both state and federal courts across the country, (see OPIOID-CRISIS-BRIEFCASE-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION by Mass Tort Nexus) with claims alleging all opiate drug makers, distributors and now the pharmacies engaged in fraudulent marketing to sell the powerful painkillers. They also failed to monitor and report the massive increases in opioid prescriptions flooding the US marketplace. Which has now resulted in fueling the nationwide epidemic, that’s reported to have killed over a quarter million people. The now organized approach steps up those efforts as officials sift evidence and are now holding not only the companies, but the executives and owners culpable in the designing the opioid crisis.

Purdue Pharma is facing a legal assault on many fronts, as cities, counties and states have either filed suit or are probing the company for an alleged role in the United States’ opioid and addiction epidemic. Now, a lawsuit from Massachusetts’ attorney general Maura Healey is the first to bring the company’s current and former execs into the mix, including the billionaire family with sole ownership of Purdue.

At a news conference this week, Healey said she’s filing suit against the drugmaker, plus current and former executives and board members, “for their role in creating and profiting from this epidemic that has killed so many.” The suit alleges Purdue downplayed risks and overstated benefits of opioid painkillers, including OxyContin. It seeks to link the deaths of 670 Massachusetts residents to actions at the company.

A Purdue spokesman said the company shares concern about the opioid crisis. Purdue is “disappointed, however, that in the midst of good faith negotiations with many states, the Commonwealth has decided to pursue a costly and protracted litigation process,” he said.

Purdue is no stranger to litigation, in 2007 Purdue agreed to pay $19.5million in civil penalties, but did not admit wrongdoing, to settle lawsuits with 26 states – including Massachusetts – and the District of Columbia after being accused of aggressively marketing OxyContin to doctors while downplaying the risk of addiction. This is a consistent pattern, including the 2007 criminal indictment and plea of senior Purdue Pharma executives, where they agreed to pay over $600 million and plead guilty to a greatly reduced charge of “mislabeling drugs” which seems to have set the stage for the Purdue legal strategy of throwing money at all claim of abuse, thereby setting the Purdue Pharma marketing model loose on the US consumers and the healthcare industry, see USA vs. Purdue Criminal Plea “Oxycontin” usdc.virginia.gov/OPINIONS July 2007

PURDUE PHARMA FIRES ENTIRE SALES FORCE

In what is either an amazing coincidence or a look at corporate political maneuvering, just a week after the Sacklers and company executives were named individually in the latest Purdue Pharma opiate lawsuit, the OxyContin maker laid off its entire sales force.  This puts an end to an era for Purdue that at one point, was the top-selling opioid drug in the country, and became synonymous with the nation’s opioid crisis, while the Sacklers collected billions in profits from Oxycontin sales.

Purdue, had already laid off half of its 600 sales reps in February 2018, as part of the corporate political maneuvering to curry favor with the numerous state and federal investigation that were taking place, when it announced that it would no longer be promoting OxyContin to doctors. On July 19, 2018 six days after the State of Massachusetts filed a complaint naming the company, the founding Sackler family and the executive suite as defendants in a an opioid litigation complaint,  Purdue Pharma confirmed that they had terminated the the remaining 220 employees in its sales force.

While Purdue still manufactures Oxycontin, which accounts for more than 80 percent of the company’s, they will be shifting its focus away from the highly lucrative opiate painkiller market, according to company sources.

PURDUE PHARMA DENIES ALL CLAIMS

We vigorously deny the Commonwealth’s allegations and look forward to presenting our substantial defenses to these claims,” Purdue’s spokesman said in a statement.

Executives named in the suit are current and former Purdue CEOs Craig Landau, John Stewart and Mark Timney, as well as current and former members of the Purdue board of directors, including members of the Sackler family. Dr. John Purdue Gray and George Frederick Bingham founded the company in 1892, and Mortimer and Raymond Sackler purchased Purdue in 1952, which is now owned solely by the Sackler family,.

The lawsuit alleges the company violated Massachusetts’ consumer protection statute, created a public nuisance, and that it was negligent. It seeks restitution, damages and penalties related to the alleged actions, plus injunctive relief. The company has generated more than $500 million in revenue in Massachusetts since 2008, the AG says.

“Time after time, in doctor visit after doctor visit—and there were thousands of doctor visits made to hundreds of doctors around this state—there were misrepresentations,” Healey said at a news conference. “There were lies about the efficacy, about the safety, about the supposed nonaddictive nature of their product.”

The State of Massachusetts lawsuit is the latest in a wave of complaints against the company and Big Pharma opiate drug makers involved in making and distributing opioids. Hundreds of cities and counties have filed lawsuits, and the cases are now grouped in federal court in Cleveland in MDL 2804, Opiate Prescription Litigation in front of Judge Daniel Polster. Early this year, the judge in the multidistrict litigation indicated that the sides might be able to reach a settlement, but the negotiations later hit “barriers.” The judge charted a course for a few cases to go to bellwether trials.

Aside from cities and counties, dozens of state officials and the feds have gotten involved. Attorneys general from 41 states are investigating and discussing a possible settlement with the company. Last month, six states sued Purdue over its role in the epidemic, according to USA Today. The U.S. Department of Justice is also backing cities and counties in their legal efforts.

The Sackler family name graces some of the nation’s most prestigious bastions of culture and learning — the Sackler Center for Arts Education at the Guggenheim Museum, the Sackler Lefcourt Center for Child Development in Manhattan and the Sackler Institute for Developmental Psychobiology at Columbia University, to name a few.

Now for the first time since the opioid crisis came to the attention of America, the Sackler name is front and center in a lawsuit accusing the family and the company they own and run, Purdue Pharma, of helping to fuel the deadly opioid crisis that has killed thousands of Americans.

Congratulations to the Massachusetts Attorney General Maura Healey took the unusual step of naming the eight members of the Sackler family listed above as part of the conspiracy that profited from and cause the catastrophic opioid crisis that’s gripping the USA to this day.

The 80-page complaint (Complaint: “State of Massachusetts vs. Purdue Pharma and the Sackler Family” June13, 2018) that accuses Purdue Pharma of spinning a “web of illegal deceit” to boost profits.

While prosecutors in more than a dozen other states hit hard by the opioid epidemic have sued Purdue Pharma, Healey is the first to name individual Sackler family members, along with eight company executives.

(The Sackler family regularly notes that Arthur Sackler, whose philanthropy got his name on the Smithsonian’s Sackler Gallery in Washington and other cultural institutions, died before Purdue began selling OxyContin. Several of his nieces and nephews help run the company.)

Filed on behalf of 670 Massachusetts residents who were prescribed OxyContin, became addicted to opioids and later died, the suit alleges that Purdue deceived doctors and patients about the risks, pushed prescribers to keep patients on the drugs and aggressively targeted veterans and the elderly.

The civil suit doesn’t name a dollar figure, but Healey asked a judge to order the Sacklers and Purdue to “pay full and complete restitution to every person who has suffered any ascertainable loss by reason of their unlawful conduct.”

Mike Moore, the former Mississippi attorney general who took down Big Tobaccotwo decades ago and is now going after Big Pharma, called Healey’s move “a brilliant legal strategy.”

“It pulls up the corporate curtain of protection that these people hide behind,” Moore said in an email to NBC News. “The Sacklers personally made billions of dollars while tens of thousands of overdose deaths were occurring as a direct result of their lies about the addictiveness and effectiveness of OxyContin, the drug they created and marketed. Just as these folks like to be honored when they write big checks to museums and have their names inscribed on plaques for their contributions to so many causes, they should be held accountable for how they made that money in the first place.”

SACKLER FAMILY KNOWN FOR PHILANTHROPY

Juliet Sorensen, a former federal prosecutor in Chicago who is now a professor at Northwestern University’s Pritzker School of Law, said that the Sacklers are known for their philanthropy — “not for being the driving force behind the opioid epidemic through which they gained their billions.”

“The Sacklers’ collective silence signals a lack of remorse for their role in the opioid epidemic,” she said in an email. “The complaint is a form of exposure.”

“If the Sacklers were not actually defendants that were sued, but rather named and discussed in the body of the complaint, that would be naming and shaming but without legal consequences,” she said. “In this case, however, they are named as defendants, so the naming and shaming ‘pitiless publicity’ effect comes along with potential legal liability.”

The Sacklers named in the complaint are now used to defending thensleves individually and when asked to cooment, the standard Purdue reply was offered by Purdue Pharma spokesman Bob Josephson in an email not a personal quote, “Not at this time.”

Purdue Pharma denied the allegations in the lawsuit, saying it was “disappointed” that, amid negotiations with other states that have sued, Massachusetts “decided to pursue a costly and protracted litigation process.”

“We will continue to work collaboratively with the states towards bringing meaningful solutions,” the company said.

MASSACHUSETTS HOLDS SACKLERS LIABLE

Emalie Gainey, a spokeswoman for Healey, said the attorney general’s intent in naming the Sacklers was “to hold them individually liable for the role we allege they played.”

“Not only did we name the company today, but we’ve also chose to name executives and directors,” Healey said when the lawsuit was announced. “Ours is the first lawsuit in the country to name those executives personally and tell the story of how they contributed to this deadly crisis.”

Mississippi was the first state to sue Purdue Pharma and the other big pharmaceutical companies, and the state’s attorney general, Jim Hood, said he approved of the message Massachusetts is sending.

“No individual should be above the law and allowed to hide behind corporate protections to shield them from personal responsibility,” Hood said via a spokeswoman. “That includes the Sackler family. Mississippi applauds the efforts of Massachusetts in joining our efforts and seeking accountability wherever it lies.”

In Ohio, the second state to go after the drug companies, including Purdue Pharma, Dan Tierney, a spokesman for Attorney General Mike DeWine, said individual Sackler family members “would certainly be covered” by the state’s action.

The Sackler family is the 19th richest in the nation, with an estimated fortune of $13 billion, according to Forbes.

The Sacklers involved with Purdue Pharma are the descendants of brothers Mortimer and Raymond Sackler. Their eldest brother, Arthur, died in 1987, well before Purdue began making and selling OxyContin. Arthur also worked in pharmaceuticals and developed a reputation for cleverly marketing new drugs directly to doctors, convincing them to prescribe medications including tranquilizers to their patients.

Arthur was inducted into the Medical Advertising Hall of Fame after his death, but he has also been criticized for originating “most of the questionable practices that propelled the pharmaceutical industry into the scourge it is today,” as Allen Frances, the former chair of psychiatry at Duke University School of Medicine, told the New Yorker last year.

Arthur’s family has made a point of noting that he was not involved in the sale of OxyContin and would prefer him to be remembered for his philanthropy, including funding the Arthur M. Sackler Gallery of Chinese Stone Sculpture at The Metropolitan Museum in Manhattan and the Arthur M. Sackler Museum at Harvard University.

“None of the charitable donations made by Arthur prior to his death, nor that I made on his behalf after his death, were funded by the production, distribution or sale of OxyContin or other revenue from Purdue Pharma,” his widow, Jillian Sackler, said in a February statement. “Period.”

Seven of the Sacklers named in the suit have been on the Purdue board since the 1990s, according to the suit, while David Sackler, the grandson, has served since 2012.

The board met on a weekly — sometimes daily — basis while the company was being investigated by 26 states and the Justice Department from 2001 to 2007, according to the lawsuit. In 2007, the board settled and agreed to pay a $700 million fine after the company’s CEO at the time, Michael Friedman, and two other high-ranking company officials pleaded guilty to misleading doctors and patients about opioids.

KENTUCKY LEGAL FIGHT TO KEEP SACKLER TESTIMONY SEALED

In an example of the past coming back to haunt the present, in 2015 Purdue Pharma agreed to pay $24 million to settle a lawsuit filed by Kentucky, December 22, 2015 Purdue Pharma Settlement With State of Kentucky,  which Purdue thought would end that problem by paying a fine and moving on, which isn’t the case it seems. See Purdue Pharma settles with Kentucky over Oxycontin claim(statnews.com/pharmalot) for information on the claims in Kentucky.

That state court litigation is now subject to an ongoing legal battle in the Kentucky courts where Purdue is fighting to keep the original court records from that settlement sealed, due to the only deposition testimony of one of the Sackler brothers is known to be located. The Purdue court records were unsealed by Pike County Judge, Stephen Combs in May 2016 and Purdue immediately appealed with oral arguments taking place June 26, 2017 in front of a three judge panel of the Kentucky Court of Appeals, which as of June 20, 2018 has not issued a ruling on releasing the records. The original Kentucky vs. Purdue docket information is case no. 07-CI-01303, Judge Stephen Combs, Pike County Circuit Court of Kentucky.

OxyContin was hailed as a medical marvel when it debuted in 1995. Pitched as balm for people suffering from moderate to severe pain, it reportedly generated more than $35 billion in revenue for Purdue Pharma.

But its chief ingredient is oxycodone, a cousin of heroin. And prosecutors say Purdue played down the dangers of addiction while getting hundreds of thousands of Americans hooked on opioids.

Purdue has argued that OxyContin is approved by the Food and Drug Administration and accounts for just 2 percent of the opioid prescriptions nationwide.

There are now more than 600 lawsuits naming Purdue Pharma, LP as a defendant in both federal and state court actions, this does not include the potential criminal indictments of not only the company but the Purdue family members that may be emerging. Damages are expected to easily exceed $100 billion versus the company and now that the Sacklers and company executives have been named individually the whole scope of litigation may be changing for the better, as those who profited most from the opioid crisis are now being held accountable.

 

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HOW CAN WE SOLVE THE OPIOID CRISIS STARTING NOW? With An Opioid Crisis Summit Like No Other

A Definitive Opioid Crisis Solutions Event

By Mark A. York (May 29, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) It’s been called the most perilous drug crisis ever in the United States, the epicenter of the opioid epidemic, overdose deaths have quadrupled since 1999, killing more than 100 people every day. Pharmaceutical opiate pain relief is an essential clinical tool, but with physicians writing over 240 million opioid prescriptions to Americans every year, the potential for catastrophe is enormous. Now it seems to be coming into realization that the opioid crisis is here and the damage is catastrophic, gauged against the devastating impact on families and communities across the United States.  How can we get the message out that addiction is now  recognized as a medical, not a criminal problem, and new treatments are on the horizon. How do we protect the population from misusing opioids? An Opioid Crisis Summit featuring national leaders who are involved in the day to day efforts to fight this opiate crisis on all levels, including Ohio Lieutenant Governor Mary Taylor, Dr. Rahul Gupta, West Virginia Director of Public Health and others who are involved in providing real time solutions to the opiate epidemic as well as treating physicians and legal professionals who are active in offering solutions.

The Definitive Opioid Crisis Summit For All of America:

July 21-22, 2018

www.opioidcrisissummit.com

OPIOD CRISIS SUMMIT

By Mass Tort Nexus

Fort Lauderdale, FL

 How did the opioid crisis happen?

In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive. Opioid overdose rates began to increase. In 2015, more than 33,000 Americans died as a result of an opioid overdose, including prescription opioids, heroin, and illicitly manufactured fentanyl, a powerful synthetic opioid.1That same year, an estimated 2 million people in the United States suffered from substance use disorders related to prescription opioid pain relievers, and 591,000 suffered from a heroin use disorder (not mutually exclusive).

 What do we know about the opioid crisis?

  • Roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them.
  • Between 8 and 12 percent develop an opioid use disorder.
  • An estimated 4 to 6 percent who misuse prescription opioids transition to heroin.
  • About 80 percent of people who use heroin first misused prescription opioids.
  • Opioid overdoses increased 30 percent from July 2016 through September 2017 in 52 areas in 45 states.
  • The Midwestern region saw opioid overdoses increase 70 percent from July 2016 through September 2017.
  • Opioid overdoses in large cities increase by 54 percent in 16 states.

Quarterly rate of suspected opioid overdose, by US region
Source: Centers for Disease Control and Prevention.

This issue has become a public health crisis with devastating consequences including increases in opioid misuse and related overdoses, as well as the rising incidence of neonatal abstinence syndrome due to opioid use and misuse during pregnancy. The increase in injection drug use has also contributed to the spread of infectious diseases including HIV and hepatitis C. As seen throughout the history of medicine, science can be an important part of the solution in resolving such a public health crisis.

 The Opioid Crisis Summit Agenda

An unprecedented group of elected officials, political and medical experts, and academic leaders from around the country are set to examine the crisis and offer insight and solutions.

On July 21-22, 2018, the definitive Opioid Crisis Summit presented by Mass Tort Nexus will convene a symposium to present a firsthand account as to the depth and severity of the crisis. The research team at Mass Tort Nexus has brought together influential speakers including the Lieutenant Governor of Ohio, Mary Taylor; State Attorney for Palm Beach County Florida, Dave Aronberg, Esq.; Director of Public Health, State of West Virginia, Rahul Gupta, MD; Executive Director, Novus Medical Detox Centers, Kent Runyon; The Amy Winehouse Project Addiction Recovery Center, Susan Anderson and Blades Williamson; Opioid Crisis Advocate, Stephen Gelfand, MD and Opioid Crisis Expert, John Ray.  These speakers are coming together to give our attendees a firsthand look at just how dramatic the impact of the opioid crisis is within our communities.

Summit attendees including attorneys, elected officials and healthcare officials will be giving specific information regarding the legal aspects of the Opioid Crisis as well. This relates to the Opiate Prescription MDL 2804, where hundreds of counties, states and cities across the country have filed lawsuits against the opiate pharmaceutical industry as a whole. This includes key MDL 2804 leadership counsel who will discuss signing of both entity and individual cases, regarding case criteria, damage models and estimated timeframes for settlement. See MDL 2804 Opiate Prescription Litigation US District Court of Ohio, for the National Prescription Opiate Litigation docket information.

This level of professional expertise and real time awareness of the issues regarding the opioid crisis in the United States has never been assembled on a scale such as this and if you are wanting to get the most critical and complete information, please contact someone at Mass Tort Nexus before all seats are taken.

Media Contact: media@masstortnexus.com 954.870.7323, Mark A. York

Event Contact:

Barbara Capasso

Jenny Levine

954.530.9892

barbara@masstortnexus.com

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Johnson & Johnson Liable For Talc Mesothelioma Verdict Of $21.7 Million In Actual And $4 Million In Punitive Damages

Will Industrial Talc Litigation Become Another Asbestos? The Litigation Is Moving That Way!

By Mark A. York (May 24, 2018)

 

 

 

 

 

 

 

 

Is Industrial Talc Litigation The Next Major Mass Tort?

(MASS TORT NEXUS MEDIA) Johnson & Johnson lost another talcum powder cancer trial, when a California jury awarded $4 million in punitive damages on top of $21.7 million in compensatory damages on Wednesday May 23, 2018 to Joanne Anderson and her husband, Ms. Anderson is a 68-year-old woman who sued J&J alleging that he cancer was caused by asbestos in the company’s baby powder. The case is Anderson v. Borg Warner Corp., BC 666513, California Superior Court, Los Angeles County (West Covina).

The jury found that J&J (JNJ.N), was 67 percent responsible for her mesothelioma, a cancer linked to asbestos exposure. Anderson’s lawyers said she was exposed to baby powder laced with the carcinogen when she used it on her children and while bowling.

The verdict against J&J was linked to company documents produced in the trial, “When jurors are given the opportunity to see internal documents and conduct of J&J — things the FDA and government haven’t seen — there is only one choice in how to rule.” According to Chris Panatier, plaintiffs’ lawyer.

Anderson and her husband had sued J&J, a unit of Imerys SA (IMTP.PA), Cyprus Amax Minerals, a unit of Brenntag (BNRGn.DE), Honeywell International (HON.N) and other local talc suppliers, which are now becoming targets more and more in the emerging talc litigation exploding across the country.

J&J’s lawyers have stated that Anderson’s mesothelioma may not have been caused by asbestos in talc, but could have occurred “spontaneously.’’ They also said the woman had a family history of lung and breast cancer. Even though there has been ample evidence shown in court after court, both state and federal that J&J’s talcum powder products are known to be cancer causing. J&J and others have been diligent in suppressing the research and scientific studies showing the cancer links, going so far as to pay “ghost writers” to submit company sponsored “talc is a good product” papers as legitimate scientific materials to recognize medical journals. This conduct dates back to at least the mid-10970’2 when internal J&J consultants working on Talc R&D projects raised red flags on the dangers of talc and the link to cancer.

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

This is the second jury in less than two months to conclude J&J sold its iconic baby powder knowing it contained at least trace amounts of asbestos and posed a cancer risk to users. In April, jurors in J&J’s hometown of New Brunswick, New Jersey, ordered the company and a unit of Imerys SA, a talc supplier, to pay a total of $117 million to a banker who showed his cancer was tied to baby powder use. See For J&J $37 Million Talcum Powder Mesothelioma Verdict—Add $80 Million In Punitive Damages.

Litigation over J&J’s baby powder is accelerating. The company is facing claims by more than 9,000 plaintiffs, primarily connecting talc to ovarian cancer, according to a May 1 securities filing. J&J didn’t break out the number of ovarian cancer cases versus the number of mesothelioma cases allegedly tied to talc. See Johnson & Johnson Talcum Powder Litigation MDL 2738 (USDC New Jersey).

In MDL 2738 J&J is facing more than 6,000 cases claiming its baby powder caused ovarian cancer, but the talc litigation has taken a new focus in recent months with plaintiffs claiming the widely used product causes mesothelioma due to alleged asbestos contamination.  These casese are being in in US District Court of New Jersey, in front of Judge Freda Wolfson, who has not been perceived as a plaintiff friendly judge so far. But science is science and as more of the data is released and becomes accepted, J&J’s home court advantage in New Jersey courts will continue to

J&J, talc supplier Imerys  and retail seller incuding Rite-Aid pharmacy (RAD.N) are currently facing similar claims in a trial underway in South Carolina over asbestos talc allegations.

Anderson argued she used J&J’s talc products on her children in the 1970s and on herself in the 1980s and 1990s when she would powder her hands and feet while bowling. She claimed at one point, she went through two bottles a month.

Notable Cosmetic Talc/Asbestos Contamination Verdicts

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

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

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

 Talc History

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

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

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

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

Cosmetic Talc Litigation – Ovarian Cancer

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

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

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

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

Cosmetic Talc Cases Alleging Asbestos Contamination

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

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

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

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

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

 

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

By Mark A. York (May 24, 2018)

 

 

 

 

 

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Ohio Filed First

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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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ETHICON, INC. AND J&J FACING THOUSANDS OF TVM AND HERNIA MESH LAWSUITS: WILL THEY SETTLE SOONER OR LATER?

“New Jersey State Court Opens Ethicon Hernia Mesh Consolidation”

Mark A. York (April 17, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Ethicon’s Pelvic Repair System litigation also known as Transvaginal Mesh (TVM) litigation, (see Mass Tort Nexus Ethicon TVM MDL 2327 Briefcase) and the more recent hernia mesh legal filings, are the latest in a series of ongoing legal battles facing Johnson & Johnson and its Ethicon subsidiary. Ethicon is facing over 50,000 mesh lawsuits in state and federal courts across the country where plaintiffs have filed suits over their synthetic mesh surgical implants. The numbers are increasing daily as the TVM plaintiffs are being joined by plaintiffs filing “hernia mesh” lawsuits, where the allegations are very similar to claims asserting that J&J’s failed to warn and choosing to ignore the thousands of FDA filed adverse events related to its hernia mesh products.

EMERGING 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. 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.

Ethicon TVM litigation has been underway for close to six years in MDL 2327, (MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation court link) currently pending in the U.S. District Court in West Virginia, where U.S. District Judge Joseph Goodwin is also overseeing seven other  multidistrict litigations (MDLs) established for cases against different manufacturers. When you add in other synthetic mesh manufacturer lawsuits besides J&J, there are more than 100,000 mesh lawsuits pending against Ethicon and other manufacturers, including Boston Scientific, C.R. Bard, American Medical Systems (AMS) acquired by Endo, Coloplast, Cook Medical, Neomedic and others.

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.

Only American Medical Systems, Inc has resolved substantially all of their claims over their mesh products, agreeing to pay about $1.6 billion to resolve more than 20,000 claims.

PRIOR MESH SETTLEMENTS

While manufacturers have had some success in defending the safety of the products in a handful of cases, most of the claims that have gone before a jury so far have resulted in substantial damage awards, suggesting that TVM settlements will likely cost the companies several billion dollars.  There have been settlements by some mesh makers including End International, Inc. on behalf of American Medical Systems, Inc, where Endo agreed to pay $775 million in August 2017 to resolve the remaining cases, where there had been over 22,000 lawsuits filed over its vaginal mesh implants. They had previously agreed to a $400 million settlement of more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. This has been part of Endo’s decision to exit “substantially all” the remaining lawsuits against its AMS unit, with the $400 million being in addition to $1.2 billion previously pledged by Endo to cover mesh litigation. Including its $830 million settlement to resolve thousands of mesh lawsuits (~40,000 per case) in May 2014. That settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny.

ETHICON TRIAL VERDICTS

Although Ethicon attempts to defer blame and causation for the often life altering medical conditions that occur post mesh implant surgery, they are often found liable at trial with verdicts being anywhere from $1.5 million to more than $100 million and often include major punitive damages. The punitive damages, which are designed to punish Ethicon for conducting its business with malice towards women who were implanted with the products, finding that the company knew that the synthetic mesh products caused severe complications, but failed to warn the medical community.

With Ethicon (Johnson & Johnson) facing more vaginal mesh lawsuits than any other manufacturer. Here are trial verdicts from lawsuits that have resulted in major losses for Ethicon/J&J again and again:

  • In March 2018, a jury in Indiana awarded $35 millionto Barbara and Anton Kaiser. They’d sued Ethicon (a subsidiary of Johnson & Johnson) after Barbara Kaiser’s Prolift mesh allegedly caused her pelvic pain. They awarded her $10 million in damages and hit Ethicon with $25 million in punitive damages.
  • In December 2017, a Bergen County, NJ jury awarded$15 million to Elizabeth Hrymoc. Ms. Hrymoc said she received a defective Prolift mesh implant in 2008, which left her in such pain that she had to have it removed and replaced. She cried as the jury announced their verdict.
  • In September 2017, a Philadelphia jury awarded $57.1 millionto Ella Ebaugh, who says she suffered chronic pain and incontinence because of two Ethicon pelvic mesh implants that eroded into her urethra. Ms. Ebaugh says she required three surgeries to remove the mesh. Ethicon vowed to appeal.
  • In April 2017, a Philadelphia jury awarded $20 millionto a woman who claimed she was in constant pain because of her TVT-Secur transvaginal mesh, a product of Johnson & Johnson subsidiary Ethicon. A spokesperson for Ethicon said the company would appeal the decision, but it was the fifth major loss over the mesh products since 2014.
  • $13.5 million verdict awarded to Sharon Carlino of New Jersey in February 2016. According to the lawsuit, Carlino received Ethicon’s transvaginal tape (TVT) for stress urinary incontinence and it left her with constant pain and discomfort. Two surgical attempts to fix the device did not rid her of pain. $10 million of the verdict came in the form of punitive damages. The jury said that Carlino’s doctor would not have used the Ethicon mesh had the device risks been known.
  • $4.4 million jury award to Florida resident Tessa Taylor in February 2016. The jury found that ObTape sling (made by J&J subsidiary Mentor) caused Taylor’s back pain, bladder pain, and difficulty urinating over a 7 year period. Taylor received the mesh to treat urinary incontinence, but she was re-diagnosed with the condition in spite of the device. $4 million of the verdict was for punitive damages to “discourage others from behaving in a similar way.”
  • J&J agreed to pay $120 million to settle 2,000-3,000 mesh lawsuitsin January 2016. The settlement marked the first serious attempt by J&J to settle a significant number of mesh lawsuits. A regulatory filing at the time showed that J&J still faced more than 42,000 mesh cases.
  • $12.5 millionverdict awarded to Indiana resident Patricia Hammons, including $7 million in punitive damages. Hammons was implanted with Ethicon’s Prolift device, which she says caused severe pain, sexual difficulties, and incontinence–even after corrective surgery.
  • $5 millionsettlement reached in September with plaintiff Pamela Wicker, implanted with Ethicon’s Prolift mesh device. Wicker claims that Prolift eroded inside of her and necessitated numerous surgeries to remove the device. A law professor said that the large settlement showed the costs of dealing with mesh litigation would be a lot higher than expected.
  • $5.7 millionverdict awarded to Coleen Perry in March 2015 by a California jury. Perry was implanted with the J&J/Ethicon TVT Abbrevo and says she expects to have pain the rest of her life. The jury found that the TVT Abbrevo has design problems and that Ethicon failed to warn about potential health risks. The verdict included $5 million in punitive damages for conduct that amounted to “malice.”
  • Two confidential settlementsinvolving 115 mesh victims were reached in January 2015. One of the settlements resolved 4 cases in Missouri over Ethicon’s Prolift mesh device and the other resolved 111 cases in Georgia over the ObTape Transobturator Sling (made by J&J subsidiary Mentor). The Missouri women claimed that the mesh in Ethicon’s Prolift insert shrinks and damages organs, causing constant pain and making sexual intercourse difficult, while the Georgia women alleged that ObTape causes permanent injuries.
  • $3.25 millionverdict awarded to plaintiff Jo Husky over the J&J/Ethicon Gynecare TVT-O mesh device. The verdict was reached by a West Virginia jury in September 2014 following a two-week trial. Jurors found that the TVT-O was faulty and that Ethicon failed to warn of side effects.
  • $1.2 millionverdict awarded to Linda Batiste, implanted with the Gynecare TVT Obturator (TVT-O) mesh sling (made by J&J unit Ethicon) in April 2013. The jury concluded that the device’s design was flawed.
  • $11.1 millionverdict (including $3.35 million in compensation and $7.76 million in punitive damages) awarded to Linda Gross of South Dakota, who was implanted with J&J’s Gynecare Prolift vaginal mesh device. A New Jersey jury reached the verdict in February 2013, saying that J&J fraudulently misled Gross about device risks.

ETHICON MESH LITIGATION

Judge Goodwin is overseeing coordinated pretrial proceedings for all federal vaginal mesh lawsuits, as the cases involve nearly identical allegations that the products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women are defectively designed and can cause severe and deforming complications, including infections, puncturing organs and eroding through the vagina.

The MDLs were established for cases against each manufacturer to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts. However, as hundreds of cases become “trial ready”, and manufacturers continue to make little progress in settling claims, Judge Goodwin faces the prospect of remanding large numbers of lawsuits back to U.S. District courts nationwide for individual trials, which could take decades to complete.

Plaintiff complaints against Ethicon all consistently assert that Ethicon was and is aware of the dangers posed by their synthetic mesh products, and choose to ignore the thousands of adverse event reports filed with the FDA as well as the fact that more than 50,000 plaintiffs have filed lawsuits over Ethicon synthetic mesh implants. The legal claims assert injuries due to the defective design of the most every synthetic mesh product made by Ethicon regarding its vaginal mesh, including mesh erosion, mesh contraction, inflammation, pain during sexual intercourse, urinary incontinence, chronic pain, and recurring prolapse of organs.

As a result of the post surgical complications, plaintiffs have been known to undergo as many as four operations to have the mesh removed, often resulting in massive levels of pain as well as financial impact of repeated surgeries and rehabilitation.  There are many instances where the the surgeons were unable to remove all the mesh due to the mesh adhesion to internal organs and surfaces within the body that were never intended as a post surgical complication.

While the outcome of the MDL cases and other trials are not binding on other cases in the vaginal mesh litigation, Ethicon and its parent Johnson & Johnson should gauge how juries have responded to certain evidence and testimony via recent major trial verdicts in most every mesh trial they’ve faced in both federal and state courts. How Ethicon counsel views the recent trial verdicts and the impact on the thousands of other cases they face, and the potential for the trial results to be repeated throughout these cases, would seem to have an impact on J&J’s views of starting substantive settlement negotiations. To date, this has not been a significant part of the Johnson & Johnson legal business strategy, potentially resulting in an ongoing windfall for the thousands of plaintiffs for years to come.

 

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Bard Loses $33 Million In Pelvic Repair Mesh Trial In New Jersey State Court: Punitive Damage Hearings Today

“New Jersey State Courts Not Legal Safe Haven Lately For Companies HQ’d There”

By Mark A. York (April 13, 2018)

C.R. Bard Avaulta Synthetic Surgical Mesh

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In another win for plaintiffs, a jury in Bergen County, New Jersey awarded plaintiff Mary McGinnis $23 million and her husband Thomas, an additional $10 million in actual damages, with a hearing taking place today on how much in punitive damages will be be added. This $33 million verdict in New Jersey state court, where defendant C.R. Bard is headquartered, closely follows the $117 million verdict of last week against another New Jersey company, Johnson & Johnson in a baby powder trial.  This was the first C. R. Bard case to go to trial in the Bard consolidated New Jersey state court docket, where Bard is facing hundreds of additional lawsuits over its defective pelvic mesh implants, also known as Transvaginal Mesh or TVM.

The jury directed the company to pay the $33 million in compensatory damages over claims the business knew its pelvic mesh products were unsafe and failed to warn doctors about potential risks related to devices that caused a woman debilitating pain and related inability to enjoy life as she did prior to the surgical implant of the synthetic mesh device.  Bard and others makers of both TVM and hernia mesh products are under highly increased scrutiny and being hot with major trial verdicts over claims they ignored the dangers of implanting synthetic mesh products, primarily made from polypropylene, the same product most fishing line is made from, into the human body. 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 jury took less than a day to decide on the verdict following the four-week trial, after finding that Bard was responsible for a defective design of the Avaulta mesh product and failure to warn doctors or consumers of the defective design. . Of note is that Bard had removed the Avaulta mesh line from the market by 2016.

The jury found that Bard’s Avaulta and Align synthetic mesh products, which were  implanted to treat McGinnis’s bladder prolapse and stress urinary incontinence were defectively designed and caused incapacitating injuries as well as impacting her relationship with her husband. Bard claimed repeatedly that they tested Avaulta extensively as well as their other mesh products, and Mrs. McGinnis’ unrelated medical conditions caused her injuries

Hearings over punitive damages and how much they should be are scheduled to start this morning. Bard is probably keeping in mind the $80 million in punitive damages awarded last week in a similar state court punitive damages hearing in the J&J talcum powder cancer trial in New Brunswick, which is less than 50 miles from the Bergen County court.

Bard has historically been hit with ongoing verdicts over its synthetic mesh line of products in trial across the country, as far back as 2012 where a previous Avaulta mesh trial in California state court ended in a $5.5 million verdict and in a 2013 West Virginia federal court trial, a verdict was returned for  $2 million verdict against Bard and its Avaulta mesh.

TVM MESH IS SUBJECT TO MAJOR LITIGATION

Surgical Mesh Makers Facing Litigation

 

 

 

 

 

 

 

Major litigation against CR. Bard/Davol, Ethicon (J&J), Boston Scientific and other surgical mesh manufacturers has been ongoing for few years in both federal and state courts and will continue into the foreseeable future, based on the hundreds of thousands of synthetic mesh implants used in surgical procedures in the United States over the last 15 years.

Bard has been known to settle mesh cases, in the Wise v. Bard, bellwether case selection, that was set for trial back on February 18, 2015, settled a week before the trail start date for a confidential amount. The Wise lawsuit was part of the Bard MDL 2187, see Bard-TVM-Litigation-MDL-2187 Briefcase, where thousands of lawsuits are still pending against C.R. Bard, additionally there are other MDL’s where every other synthetic surgical mesh manufacturer in the US marketplace is facing more than 50 thousand lawsuits over their synthetic mesh surgical products.” See Ethicon (J&J) Pelvic Mesh Litigation MDL-2327-TVM Briefcase.

OTHER TVM MESH VERDICTS

 There were $26.7 million and $18.5 million mesh verdicts against Boston Scientific see  Boston-Scientific-TVM-Litigation-MDL-2362 Briefcase, in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014,  a Charleston, West Virginia jury awarded $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.

The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include:

Transvaginal Mesh Adverse Events

Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement.

Complications and Adverse Events Include:

  • erosion through the vaginal tissue
  • mesh contraction
  • mesh extrusion
  • inflammation
  • fistula
  • infection and abscess
  • pain
  • blood loss
  • chronic and acute nerve damage
  • pudendal nerve damage
  • pelvic floor damage
  • scar tissue
  • chronic pelvic pain
  • urinary problems and/or incontinence
  • recurrence of prolapse
  • bowel, bladder, and blood vessel perforation
  • dyspareunia or pain during sexual intercourse

Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications.

In July 1, 2012, Bard stopped selling the Avaulta Meshin the United States because the FDA required additional clinical trials and testing.

On June 4, 2012: Johnson and Johnson/Ethicon withdrewfour mesh products from the US Market, including its controversialGynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.

History of Warnings

Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.

Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.

However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.

On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.

On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of lifeover other surgical methods.

On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.

Transvaginal Mesh Products & Manufacturers

Ethicon

  • Secure
  • Prolift
  • Prolift +M
  • Gynemesh/Gynemesh PS
  • Prosima
  • TVT
  • TVT-Obturator (TVT-O)
  • TVT-SECUR (TVT-S)
  • TVT-Exact
  • TVT-Abbrevo
  1. R. Bard
  • Align
  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
  • PelviLace
  • InnerLace
  • Uretex

American Medical Systems 

  • SPARC®
  • Mini-Arc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • BioArc

Boston Scientific

  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Obtryx Transobturator Mid-Urethral Sling System
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Uphold Vaginal Support System
  • Pinnacle Pelvic Floor Repair Kit
  • Advantage Transvaginal Mid-Urethral Sling System
  • Advantage Fit System
  • Solyx SIS System

Coloplast

  • T-Sling-Universal Polypropylene Sling

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