LIMBREL EMERGING LITIGATION

    Emerging Limbrel Litigation (flavocoxid)

Limbrel (flavocoxid) by Primus  Pharmaceuticals, Inc.

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS) Limbrel (flavocoxid) is marketed as an FDA-regulated medical food for the clinical dietary management of osteoarthritis (OA) to be used under physician supervision. Flavocoxid is composed mixture of baicalin and catechin and represents a non-targeted anti-inflammatory which works differently than non-steroidal anti-inflammatory drugs (NSAIDs)

Primus Pharmaceuticals voluntarily ceased its promotion and distribution of Limbrel on December 21, 2017, and issued a recall of Limbrel after a request from the FDA, see Limbrel-(Osteoarthritis-Drug)-FDA-Recall-Investigation.

Adverse events now associated with Limbrel include potential liver damage and hypersensitivity pneumonitis, according to records obtained from the FDA.

Learn More About the Emerging Limbrel Litigation, see Limbrel Emerging Litigation Briefcase by Mass Tort Nexus

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

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

 

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

 

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country who’ve attended the Mass Tort Nexus Immersion Course have provide endorsements below>

 

 

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

 

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NUPLAZID EMERGING LITIGATION

Emerging Nuplazid Litigation

 

NUPLAZID by Acadia Pharmaceuticals, Inc. (pimavanserin)

 

 

 

 

 

 

 

 

 

 

 

Nuplazid (pimavanserin) made by Acadia Pharmaceuticals Inc. was approved by the FDA in April of 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Based on a review of the FDA adverse event reporting system,(FAERS) more than 5000 adverse events reports have been filed related to Nuplazid since its approval in 2016. Approximately 700 of these adverse event reports involved the death of the patient.

The FDA approved Nuplazid via the “Fast Track” process allowed for certain pharmaceutical products considered “break through therapies”

 Learn More About the Emerging Nuplazid Litigation

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

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

 

 

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

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See endorsements below of some of the top mass tort trial lawyers in the country who’ve attended the Mass Tort Nexus Immersion Course>

 

          DARIN SCHANKER, Bachus & Schanker, LLC  

 

 

            JERRY PARKER, Firm Founder, Parker Waichman, LLP

 

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

 

 

 

 

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

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

By Mark A. York (April 26, 2018)

 

 

 

 

 

 

 

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

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

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

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

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

PLAINTIFFS ARE AHEAD IN TRIAL VERDICTS

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

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

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

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

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

ANDROGEL WAS A BLOCKBUSTER FROM FIRST RELEASE

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

HEART ATTACK AND STROKE RISK

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

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

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

FDA ISSUED A WARNING

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

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

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

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

 

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

By Mark A. York (April 24, 2018)

“BY REMOVING FDA OVERSIGHT BIG PHARMA RUNS AMOK”

 

 

 

 

 

 

 

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

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

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

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

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

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

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

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

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

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

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

WHAT IS “OFF-LABEL” MARKETING?

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

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

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

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

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

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

 J&J RISPERDAL MARKETING ABUSE

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

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

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

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

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

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

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

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

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

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

NURSING HOME PATIENT ABUSES BY J&J

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

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

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

OFF-LABEL USE OF HEART DRUG NATRECOR

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

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

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

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

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

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

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

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

FEDERAL AND STATE JOINT CRIMINAL INVESTIGATIONS

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

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

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

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

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

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

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

 

 

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Bill Clinton On The Opioid Crisis “Nobody Gets Out For Free”

“FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

By Mark A. York (April 18, 2018)

 

Former President Bill Clinton Speaks On The Opioid Crisis

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Former President Bill Clinton pulled no punches as he focused directly and 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.”

President Clinton was the keynote speaker at the National Rx Drug Abuse & Heroin Summit, which drew more than 3,000 experts in fields such as addiction treatment, law enforcement and medicine from across the country recently in Atlanta. He shared his own personal experiences as well as voicing his opinions on opioid solutions and strategies that work and the many challenges facing the country in the future.

He was very clear when stating that there’s no room for stigma in the face of such an urgent and widespread problem. Nearly every family is touched by the issue — including his. Not only does he have family members who have struggled with drug abuse, he said at least five close friends have lost children and family members to overdoses, including two native Arkansans, first-generation immigrants from India and Kosovo and African-American preachers. This is the common thread in the opioid crisis fabric, there is no social or demographic group that is exempt from the epidemic.

“Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game issue 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.

From 2000 to 2016, government research data shows that more than 600,000 people died from drug overdoses — nearly 64,000 in 2016 alone. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

The former president referred to the work done by his Clinton Foundation, who’ve provided both training and resources to communities fighting addiction and makes the opioid antidote naloxone more available to the public at a low cost.

He discussed programs elsewhere that he believes work well, including a unique medical system in eastern Pennsylvania where no doctors prescribe opioids. When a patient comes in who may legitimately need the painkillers, a panel headed by a highly educated pharmacist looks at that option as well as other alternatives. The panel does all the opioid prescribing, he said, and opioid prescriptions have dropped dramatically.

Clinton praised community health centers, local county health units and faith based community groups who are spearheading efforts in in caring for people struggling with addiction. He said grass roots solutions often work best because each place is different, and its residents know it best.

He also added the United States as a whole faces many challenges, including the rise of the deadly synthetic opioid fentanyl, which is making its way “into the bloodstream of America” from China. He said the United States “ought to get the Chinese to help us” and must also do more to stop the heroin flowing in from Mexico. Many others in government have directed attention to the Chinese government for help, but to date, there has been very limited assistance from China on this.

He further stated that the country must do more to reduce demand for drugs. And that will mean addressing issues at the root of addiction, such as hopelessness and poverty. Many overdose victims, he said, are ultimately “dying of a broken heart.” How treatment programs can be more widely accepted as well as becoming approved as a disease treatment versus a “drug addict” problem, remains to be seen.

“The roots of this are deep in our soul,” Clinton said. “You know it and I know it.”

During the Clinton years in office, he enacted various drug control programs and strategies which primarily focused on drug abuse prevention, drug use education, drug treatment and enforcement. Clinton White House archives, show he elevated the position of “drug czar” to a cabinet-level post, expanded drug courts, provided funding across the country and stepped up drug-related enforcement efforts. To support these programs and efforts, overall funding for anti-drug efforts rose from $12.2 billion in 1993 to $18.5 billion in 2000.

Although there were critics the time, many were determined to be politically motivated and more of a rhetorical attack on Bill Clinton politics as a whole. These included the 1994 report by the conservative Heritage Foundation titled, “How the Clinton Administration is Abandoning the War Against Drugs,” which falsely claimed Clinton’s “new direction will allow more cocaine, heroin and marijuana to reach American streets, and it will cut federal enforcement personnel.” Which simply furthered the now misguided correlation between marijuana use and hard drugs. The group also said one of the first announced goals of then-Attorney General Janet Reno was to reduce mandatory minimum sentences for drug trafficking and other related crimes, sentences the group argued “put teeth in drug enforcement.” This has been proven to be inaccurate and a distortion of the attempts to bring crime and punishment more in line with the times and how criminal sentencing were applied in lower economic areas of the country.

Clinton said today’s fight against drugs must be a bipartisan effort that pulls together Americans from all parts of the political spectrum. Although this would be a sincere effort to bring political parties together to address a problem that is now firmly implanted across the United States.

 “We can do this. And it will be really good for us, because it’s about time we did something together again,” he said. “Last time I checked, anytime we did anything together, we never lost.”  Mr. Clinton’s stance on a joint effort to address the opioid crisis seems genuine, but based on the many views within the current DC political world, beginning with President Trump and his view that the problem is drug users versus taking a step back view that society itself along with Big Pharma are accountable for the current opiate epidemic.

What the solutions are for solving the Opioid Crisis across the country remain to be seen and as stated by President Clinton “nobody gets out for free.”

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

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

Mark A. York (April 18, 2018)

SYNTHETIC MESH COMPANIES FACING THOUSAND OF LAWSUITS

 

 

 

 

 

 

 

 

 

 

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

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

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

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

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

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

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

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

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

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

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

 

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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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Update: Last Weeks J&J $37 Million Talcum Powder Mesothelioma Verdict—Add $80 Million In Punitive Damages

J&J TALCUM POWDER CAUSES MESOTHELIOMA – WHO KNEW AND WHEN?

By Mark A. York (April 12, 2018)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In a very loud and direct voice, Johnson & Johnson and their talc supplier, Imerys SA suffered an additional $80 million in punitive damages award on top of the initial $37 million jury verdict awarded last week. This brings the total trial verdict to $117 million they must pay to a retired New Jersey husband and wife, after a trial found that plaintiff Stephen Lanzo’s decades long use of J&J talcum powder products caused him to be afflicted with mesothelioma. A fatal form of cancer not often affiliated with use of talcum powder products.

The Middlesex County, New Jersey, jury ordered the companies to pay $80 million in punitive damages Wednesday, after post-trial arguments on punitive damages. Last week, the jury awarded the Mr. Lanzo $30 million in compensatory damages and his wife $7 million in damages.

Lanzo claims his use of Johnson & Johnson name brand products like Shower to Shower and Baby Powder for more than 30 years, and  that inhaling the powder caused his mesothelioma, an aggressive and deadly cancer that impacts the lining of the lungs. The $80 million in punitive damages in J&J’s home state of New Jersey, where traditionally they have avoided adverse trial verdicts, and enjoyed a “home team” sense of security, may now send a message J&J’s withholding of scientific data and information that shows their consumer product have dangers and the company has been aware for decades has come full circle.

Deposits of talc, one of Earth’s softest minerals are often located near deposits of the minerals that constitute asbestos, and studies have shown the risk of cross-contamination during mining. Johnson & Johnson said its talc products do not contain asbestos, which, it noted, has been a legal requirement since the 1970s.

SCIENCE SAYS TALC IS DANGEROUS

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

As other talcum powder meso cancer cases are pending in courts across the country, with one set to go to trial in May in South Carolina, J&J and its affilaites may have to gear up to defend a flood of additional new cases if the talc-meso linked plaintiff verdicts continue,  jury in California found in favor of Johnson & Johnson in an asbestos-related case in November 2017.

Lanzo’s case was the first to go to trial in New Jersey, where of Johnson & Johnson is headquartered, with the trial taking place in a state court versus a more traditional federal venue, where J&J are more accustomed to defending their consumer, pharmaceutical and medical device product line. If all pending litigation against J&J and its affiliated divisions for their products are totaled, you will find that the number of lawsuits being defended by J&J easily surpasses 100 thousand individual lawsuits filed in federal and state courts across the country.

Johnson & Johnson and other talcum powder companies face thousands of talcum powder cancer lawsuits elsewhere that draw a connection between genital talc use and ovarian cancer, where there are been massive verdicts as high as $400 million last year in California and in a St Louis courtroom where talcum powder ovarian cancer verdicts have totaled over $300 million in the last three years.

Johnson & Johnson is facing hundreds of additional lawsuits in a federal multi-district litigation also in New Jersey, see Johnson & Johnson Talcum Powder MDL 2738 (USDC New Jersey), this litigation is related primarily to the ovarian cancer claims brought by women across the country, who claim that J&J talcum powder products cause ovarian cancer, which combined with the emerging talc mesothelioma lawsuits, would open an entire new area of mass tort litigation for J&J and its affiliates to defend.

The Lanzos’ lawyers accused the company of holding back information from its customers about the health risks of asbestos in its talc products since the 1960s. This has bene a key plaintiff legal strategy in most every case against J&J, as they have been found to have made concerted and boardroom facilitated efforts to suppress and change public opinion about their product dangers.

Efforts to conceal this fact included J&J’s paying respected medical, science and other respected researchers to write and publish article and research papers mitigation the adverse findings posted in independent journals alleging that asbestos was found in talc products. Trial testimony also showed that J&J had made multiple and unsuccessful attempts to remove asbestos from their talc products, dating back to the 1970’s, yet at trial they claimed there was no asbestos risk in their talcum powder products. With one defining trial comment being “Why do you try so hard to get it out, it’s because it is there,” which would seem to define plaintiff claims that J&J was aware of the risks long ago.

Johnson & Johnson argued that it did extensive testing to make sure its products were not contaminated. The science J&J relies on has been the subject of research since at least 1975 and many times the findings were found to be adverse to the consumer product giants sales and marketing agenda, and were often discredited by an organized corporate strategy.

“Johnson’s Baby Powder has been used for more than 120 years and it does not contain asbestos or cause mesothelioma,” the company offered. “After suffering multiple losses through court rulings and at trial, plaintiff’s attorneys have shifted their strategy and are now alleging that talcum powder is contaminated with asbestos, despite multiple independent, non-litigation-driven scientific evaluations which have found that our baby powder does not contain asbestos.

“Throughout this trial, we were prevented from presenting evidence we believe would have been important to the jury in their deliberations, which forced us to file multiple mistrial motions. We will continue to defend the safety of Johnson’s Baby Powder and immediately begin our appeal, and we believe that once the full evidence is reviewed, this decision will be reversed.”

The Lanzo trial started on January 29, 2018 and was closely watched as the first “talc” lawsuit to go to trial in Johnson & Johnson’s home state over allegations that talcum-based hygiene products like Baby Powder and Shower to Shower contained asbestos and that J&J failed to warn of the risk as well as hid data that showed asbestos was in its products. The asbestos allegations are now an evolving legal fight for J&J, as most prior litigation over its Baby Powder and Shower to Shower products were over claims that the products have caused ovarian cancer in women. Those 5 cases case have been in the Missouri and California state courts over the last 2 years, with plaintiffs winning all but 1 of those trials, see J&J Talcum Powder Litigation, Missouri State Court, St Louis County Docket.

J&J DID WIN 1ST CALIFORNIA MESO TRIAL

Of note is the California court trial verdict of November 16th where J&J did win a victory in the first mesothelioma trial; where J&J and co-defendant Imerys Talc America successfully defended claims by plaintiff Tina Herford that J&J’s Baby Powder caused

Suppressing adverse research findings and manipulating science related to discoveries that Johnson & Johnson products pose significant health risks are cornerstones of most litigation against J&J and its various medical products divisions, often resulting in much higher verdicts based on the intentional failure to warn and failure to disclose the dangers to consumers. Often the trial data shows that J&J has been aware of many dangers as far back as the middle 1970’s, and yet they went to extraordinary lengths to suppress this information from being released to the marketplace and consumers.

J&J was defended by the Chicago firm of Kirkland & Ellis LLP a highly respected and very aggressive defense firm, who are rather new to the J&J world of medical device litigation and were unsuccessful. They argued that any link between talc products and mesothelioma is based on the tried and sometimes untrue defense of faulty testing methods, and plaintiff claims of limited and outdated studies, defense counsel even went so far as to state that Lanzo was exposed to asbestos in his childhood home and at school.

Defense claimed that J&J’s products never contained asbestos, and that they have performed careful testing to confirm that, which based on the jury verdict fell on deaf ears.

WHO’S LIABLE IF MESO-TALC LITIGATION EXPLODES

While the ovarian cancer cases have dominated the headlines, the cosmetic talc asbestos contamination cases may present the bigger risk to defendants and a much greater reward to plaintiff counsel. Thousands of companies used cosmetic talc in their products over the last hundred years. The entire population could claim exposure, especially to defendants that sold personal care products that could be ingested, inhaled or exposed via air-borne contact. The risk is that the cosmetic talc defendants become the defendant of last resort when a plaintiff has no other convincing credible sources of exposure to asbestos, especially when the original product source is now a bankrupt entity.

Science of Cosmetic Talc Claims: While it may be difficult to challenge long-established trigger approaches if a talc claim involves a claim of asbestos contamination, ovarian cancer talc claims may require a new look at trigger issues because the underlying science of how talc exposure may cause ovarian cancer is different from how asbestos inhalation damages the respiratory system. Having learned from previous trigger battles in asbestos, the insurers are likely to challenge the science that the first exposure to cosmetic talc causes injury that can be associated with the development of ovarian cancer and characterized as “bodily injury” as required in their policies. They may seek out scientific opinion that ovarian cancer caused by cosmetic talc is not progressive in nature, and thus not warranting the imposition of a continuous trigger. And, generally, the insurers will likely seek to limit the spread of potentially triggered policies to as few years as possible, and as close to the manifestation of the disease as possible.

DOES J&J TALCUM POWDER CAUSE CANCER?

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

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

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

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

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

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

IS “MESOTHELIOMA TALC” THE NEW MASS TORT?

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 earlier J&J talc cases. Further, both juries found that the defendants acted with malice. However, the cases were confidentially settled before the respective punitive damage phases.

Will “Talc Mesothelioma” be the next mass tort against Johnson & Johnson and its affiliates? Mass Tort Nexus will continue to report on this as additional information becomes available.

The Stephen Lanzo case docket can be found under: Lanzo v. Cyprus Amex Minerals Co, et al., Docket No. L00738516 in Middlesex County Superior Court.

 

 

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Second Xarelto Drug Trial Starts in Philadelphia Courtroom

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

 By Mark A. York (April 9, 2018)

 

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

 

 

 

 

 

 

 

 

 

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

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

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

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

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

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

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

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

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

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

 

 

 

 

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