NJ Jury Awards $15M in Ethicon Pelvic Mesh Verdict

Ethicon, Inc.’s Gynecare Prolift mesh

Ethicon, Inc.’s Gynecare Prolift mesh

 A Bergen County, NJ, jury awarded $15 million to a New Jersey woman who sued Johnson & Johnson after receiving a defective pelvic mesh implant in 2008 that left her in chronic pain

The jury found that one of the two Prolift pelvic mesh devices that plaintiff Elizabeth Hrymoc, of South River, NJ, received in 2008, was defective. It ruled that Ethicon, the Johnson & Johnson subsidiary that designed the product, failed to adequately warn the woman about the severe chronic pain she suffered.

The jury awarded Hrymoc $4 million for pain and suffering and $1 million for loss of conjugal affection, and assessed $10 million in punitive damages against Johnson & Johnson.

Thursday’s verdict is the second in a bellwether pelvic mesh case in New Jersey. It follows another for $11 million that was awarded in 2014. That verdict was later upheld by the Appellate Division, and the Supreme Court declined to take up the case.

The verdict came after nearly three weeks of argument and testimony in just the second pelvic mesh-related lawsuit to go to trial in New Jersey out of nearly 9,000 that are pending.

During opening arguments, plaintiffs’ attorney Adam Slater of Mazie, Slater, Katz & Freeman in Roseland, N.J., told the jury that the mesh used in the devices was defectively designed because it caused the mesh “sling” portion of the device to tighten and create tension in the pelvic area and that the mesh can harden and cause erosion.

For more, click NorthJersey.com.

New AAJ Report Details a Year of Heinous Corporate Misconduct

From Takata’s lethal airbags to Monsanto ghostwriting scientific data, to drug companies profiting from the opioid crisis, corporations have time and again put profits before the health and safety of Americans.

A report released Wednesday by the American Association for Justice (AAJ), Worst Corporate Conduct of 2017, details this year’s worst corporate offenders, the aggressive corporate culture plaguing the United States, and the need for a strong civil justice system to make sure consumers and workers can hold corporations accountable and deter corporate misconduct.

As the report indicates, there are no signs that corporations intend to slow down their attack on Americans as they cut their compliance budgets and attempt to free themselves from regulation.

“The misconduct highlighted in this report is a stark reminder that corporations will stop at nothing to protect their profits – even if that means putting consumers and workers at risk,” said Kathleen Nastri, President of AAJ.  “As this report clearly illustrates, Americans need access to the courts so they can get justice and stand up to the onslaught of misconduct.”

One particularly timely section of the report is dedicated to Fox News, which for years has covered up rampant sexual harassment using forced arbitration clauses in employee contracts. Finally, in August of this year, the network revealed that it had paid nearly $50 million to settle sexual harassment and discrimination cases during the previous fiscal year.

Instances of sexual harassment, like those at Fox News, illustrate the need for reform to compel corporations to improve work environments and rein in misconduct.  The “Ending Forced Arbitration of Sexual Harassment Act,” which was introduced in both the House and Senate last week with bipartisan support, would restore workers’ rights by putting an end to the abusive practice of forced arbitration in workplace sex discrimination claims and give survivors of sexual harassment the opportunity to fight for justice in court.

Click here to download the full corporate misconduct report.

Federal Mass Tort Docket Created for National Prescription Opioid Litigation

The U.S. Judicial Panel on Multidistrict Litigation consolidated more than 100 lawsuits filed by counties, cities and other parties against opioid manufacturer and distributors into the “National Prescription Opiate Litigation MDL No. 2804 earlier today.

The JPML assigned US District Judge Daniel Polster in the Northern District of Ohio to supervise the litigation. While the manufacturers had argued for consolidation in corporate defense friendly New York, and various distributors supported consolidation in West Virginia. The location of this MDL in Ohio, which has been one of the hardest hit states by the “opioid crisis” may have far-reaching implications toward the management and the final resolution of the onslaught of opioid claims.

The JPML said, “We find that the actions in this litigation involve common questions of fact, and that centralization in the Northern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”

Defendants include AmerisourceBergen Drug Corp., AmerisourceBergen Corp., McKesson Corp., Cardinal Health, Inc., and Cardinal Health subsidiary The Harvard Drug Group, L.L.C

Plaintiffs include cities, counties, and states that allege that: (1) manufacturers of
prescription opioid medications overstated the benefits and downplayed the risks of the use of their opioids and aggressively marketed (directly and through key opinion leaders) these drugs to physicians, and/or (2) distributors failed to monitor, detect, investigate, refuse and report suspicious orders of prescription opiates.

All the actions involve common factual questions about the manufacturing and distributor defendants’ knowledge of and conduct regarding the alleged diversion of these prescription opiates, as well as the manufacturers’ alleged improper marketing of such drugs. Both manufacturers and distributors are under an obligation under the Controlled Substances Act and similar state laws to prevent diversion of
opiates and other controlled substances into illicit channels.

Plaintiffs assert that defendants have failed to adhere to those standards, which caused the diversion of opiates into their communities. Plaintiffs bring claims for violation of RICO statutes, consumer protection laws, state analogues to the Controlled Substances Act, as well as common law claims such as public nuisance, negligence, negligent misrepresentation, fraud and unjust enrichment.

The text of the transfer order is available at http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2804-Initial-Transfer-11-17.pdf

11th Circuit Upholds $6.7 Million Transvaginal Mesh Mass Tort Verdict

law news, legal news, verdict, settlement

Pelvic mesh has been found to cause serious and permanent internal damage, significant pain, urinary incontinence, and repeated cases of pelvic organ prolapse.

The 11th US Circuit Court of Appeals upheld a $6.7 million award to a woman who experienced severe complications after having Boston Scientific transvaginal mesh implanted in her in 2008.

The case is one of 8,603 mass tort  actions consolidated before US District Judge Joseph R. Goodwin in MDL  2326, IN RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, in the Southern District of West Virginia.

Amal Eghnayem is one of four plaintiffs whose cases were consolidated for trial. After eight days of trial in 2014, the jury awarded $6,722,222 in damages to Eghnayem, $6,533,333 to Mania Nuñez, $6,766,666 to Margarita Dotres, and $6,722,222 to
Juana Betancourt. See Docket Nos. 1:14-cv-24061-JRG and 1:14-cv-24064-JRG.

Appeal fails

Boston Scientific chose to challenge Eghnayem’s verdict, and lost on all of its claims.

The case involved the Pinnacle Pelvic Floor Repair Kit, a transvaginal mesh prescription medical device manufactured and sold by Boston Scientific. After it was inserted, Eghnayem began to experience bleeding and pain during intercourse, incontinence, and pelvic pain and pressure. The mesh had exposed through her flesh and she had to have two corrective surgeries, which left her with diminished sensitivity.

She charged that the Pinnacle mesh was defectively designed and that Boston Scientific failed to warn about its dangers.

On appeal, Boston Scientific said that the trial court erroneously consolidated the four lawsuits arguing that individual issues predominated and the consolidation resulted in prejudice to the company. It also argued that the District Court improperly excluded evidence concerning the Pinnacle’s clearance through the U.S. Food & Drug Administration’s short-cut 510(K) process.

The appeals court shot down both arguments.

“Although each plaintiff’s proof of causation was necessarily different, generally differences in causation are not enough, standing alone, to bar consolidation of products liability claims,” the appeals court said. “And any danger of prejudice arising from the consolidation was reduced in this case, because the district court explained the consolidated nature of the trial to the jury and expressly instructed it to consider each plaintiff’s claims separately.”

The appeals court also ruled that the trial court had acted within its discretion in excluding evidence about the Pinnacle’s 501(k) clearance, which allows a medical device to come to market without undergoing clinical trials to prove that it is safe and effective.

“BSC claims that the evidence is relevant because the plaintiffs based much of their case on the theory that BSC didn’t perform sufficient safety testing,” the appeals court said. “But these points simply beg the question; because 510(k) is not a safety regulation, approval under that process cannot show that BSC performed sufficient testing or complied with applicable safety regulations.”

In a recent Form 10-Q filing with the U.S. Securities and Exchange Commission, Boston Scientific said that it had been named a defendant in more than 48,000 product liability claims involving its transvaginal mesh devices in the US, Canada and UK.

“As of July 26, 2017, we have entered into master settlement agreements in principle or are in final stages of entering one with certain plaintiffs’ counsel to resolve an aggregate of approximately 38,000 cases and claims. These master settlement agreements provide that the settlement and distribution of settlement funds to participating claimants are conditional upon, among other things, achieving minimum required claimant participation thresholds,” the filing says. “Of the approximately 38,000 cases and claims, approximately 14,500 have met the conditions of the settlement and are final. All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing.”

Jury Awards $247 Million in DePuy Pinnacle Hip Mass Tort Trial

A federal jury in Dallas, TX, awarded six plaintiffs who were harmed by the DePuy Orthopaedics Inc. Pinnacle hip a total of $247.49 million in damages.

It was the latest bellwether trial, or test case, in In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, MDL 2244. There are 9,226 cases before US District Judge James Edgar Kinkeade in the Northern District of Texas.

The plaintiffs, all from New York, are Ramon Alicea, Uriel Barzel, Karen Kirschner, Hazel Miura, Michael A. Stevens and Eugene Stevens Jr. The jury awarded each plaintiff between $9.3 million and $20.63 million in past and future medical expenses and pain and suffering. It then added $28 million in punitive damages for each plaintiff against defendants DePuy and parent company Johnson & Johnson.

Metal-On-Metal Design

The plaintiffs were each implanted with a Pinnacle Ultamet metal-on-metal design hip prosthesis. Each proved that the hip failed prematurely and shed metal that caused pain, inflammation, and damage to soft tissue and bone tissue and required surgical replacement.

The jury found DePuy and Johnson liable for design defect, negligent design, inadequate warning, manufacturing defect, negligent manufacture, negligent misrepresentation, fraudulent concealment to both plaintiffs and surgeons and deceptive business practices.

It also held Johnson & Johnson liable for negligent undertaking as to each plaintiff, aiding and abetting tortious conduct by DePuy and giving substantial assistance or encouragement to DePuy for negligent manufacture.

DePuy stopped selling the Pinnacle hip replacement in 2013. It had been approved through the FDA’s short-cut 510(k) approval process. The 510(k) process allows manufacturers to get FDA approval to sell a medical product if it is “substantially equivalent” to a product that the FDA has already approved.

Due to increasing safety concerns, the FDA announced that it would require all metal on metal hip replacements to undergo extensive testing and studies to prove that it was safe for patients. DePuy cited the FDA’s decision as one of the reasons it is stopping sales.

The plaintiff’s counsel is Mark W. Lanier of the Lanier Law Firm in Houston. The Nov. 16 verdict was the third in favor of the plaintiffs:

  • In March 2016 a federal jury awarded five Texas plaintiffs a $502 million verdict that was reduced to $150 million.
  • In December 2016 a jury awarded six California plaintiffs a $1 billion verdict that was reduced to $542 million.
  • In 2014 a jury returned a defense verdict.

 

Judge in Abilify Mass Tort Case Orders Defendants to Name Settlement Counsel

US District Judge M. Casey Rodgers ordered lawyers for Otsuka Pharmaceutical and Bristol-Myers Squibb to engage settlement counsel and to have them attend monthly settlement conferences in mass torts litigation over Abilify, an atypical anti-psychotic medication.

Some 374 cases have been consolidated before Judge Rodgers in the Northern District of Florida in MDL 2734, IN RE: Abilify (Aripiprazole) Products Liability Litigation.

Compulsive gambling

Plaintiffs allege that Abilify (aripiprazole), an atypical anti-psychotic medication commonly prescribed to treat schizophrenia, bipolar disorder, depression, and Tourette syndrome, can cause compulsive gambling behaviors.

All the lawsuits allege that Abilify was defectively designed or manufactured, that the defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and that the defendants failed to provide adequate instructions and warnings with this product.

Abilify entered the market in 2002. Abilify floods the brain with dopamine, creates uncontrollable urges on the reward system, and impairs decision-making. Reports of compulsive behavior began showing up in 2008, according to attorney Lexi Hazam of Levin Papantonio.

Patients experience such overwhelming gambling urges while taking Abilify that
they are driven to crime to support their compulsions, according to research by Gavaudan et al., Partial Agonist Therapy in Schizophrenia: Relevance to Diminished Criminal Responsibility, 55 J. FORENSIC SCI. 1659, 1659-60 (2010).

There have been many reports of compulsivity from Abilify in medical literature:

▪ Johannes D.M. Schlachetzki & Jens M. Langosch, Letter to the Editors:
Aripiprazole Induced Hypersexuality in a 24-Year-Old Female Patient With
Schizoaffective Disorder? 28(5) J. CLINICAL PSYCHOPHARMACOLOGY 567, 567-68 (2008).
▪ Gilles Gavaudan et al., Partial Agonist Therapy in Schizophrenia: Relevance to
Diminished Criminal Responsibility, 55 J. FORENSIC SCI. 1659, 1659-60 (2010) (2
Cases).
▪ Milton G. Roxanas, Pathological Gambling and Compulsive Eating Associated
with Aripiprazole, 44 AUSTRALIAN & NEW ZEALAND J. OF PSYCHIATRY 291, 291 (2010).
▪ M. Kodama & T. Hamamura, Aripiprazole-Induced Behavioural Disturbance
Related to Impulse Control in a Clinical Setting, 13 INT’L J.
NEUROPSYCHOPHARMACOLOGY 549, 549-50 (2010) (2 Cases).

The defendants put a warning on the drug in Europe in 2012 after reports of 19 cases of “pathological gambling.” In 2015 Canadian regulators concluded that there is “a link between the use of aripiprazole and a possible risk of pathological gambling or hypersexuality” and found an increased risk of pathological (uncontrollable) gambling and hypersexuality with the use of Abilify.”

But it was not until 2016 warning added to drug label in US. “These defendants put a warning label on the drug in other countries, but they were making the biggest profit in the US, but not giving consumers the benefit of that information,” Hazam said.

For more information read FDA Links Abilify to Compulsive Gambling, Eating, Shopping and Sex

 

First Xarelto Trial Underway in Philadelphia Mass Tort Program

XareltoA trial over the blood thinner Xarelto, made by Janssen Pharmaceuticals Inc. and Bayer Pharma AG, is underway in the Philadelphia Court of Common Pleas, where more than 1,500 Xarelto bleeding claims have been centralized in a mass tort program.

Lynn Hartman of Indiana charges she suffered serious gastrointestinal bleeding after using the novel anticoagulant for a little over a year.  (Case No. 160503416)

During the opening statements, the plaintiff attorney Gary Douglas of Douglas & London asserted that the drug’s manufacturers manipulated clinical trial data and downplayed important safety information to make Xarelto appear safer and more effective than competing blood thinners, such as warfarin.

“Our firm is representing a number of plaintiffs who are pursuing similar Xarelto claims. We will be watching the Philadelphia trial closely for any developments that could impact our clients’ cases,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP.

Xarelto Bleeding Allegations

Approved by the U.S. Food & Drug Administration in October 2011, Xarelto is jointly marketed by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary. The blood thinner is currently indicated for the prevention of strokes in people with atrial fibrillation; the treatment of patients suffering from deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in people undergoing hip or knee implant surgery.

Like other new-generation blood thinners, Xarelto has been touted as an improvement over decades-old warfarin. However, internal bleeding caused by warfarin can be stopped by the administration of vitamin K. There is currently no approved agent to reverse Xarelto bleeding.

Johnson & Johnson’s most recent earnings statement indicates that more than 21,000 Xarelto lawsuits have been filed in courts throughout the United States.

Plaintiffs involved in this litigation claim that the drug’s manufacturers downplayed the potential for Xarelto bleeding and wrongly promoted the drug as a superior alternative to warfarin. In addition to noting the lack of a reversal agent for Xarelto bleeding, plaintiffs take issue with the medication’s one-size-fits-all dosing regimen and dispute the defendants’ assertions that there is no need to subject Xarelto patients to routine blood monitoring.

The majority of Xarelto lawsuits are currently pending in a federal multidistrict litigation underway in the U.S. District Court, Eastern District of Louisiana, where three trials have already concluded with defense verdicts. There are 18,526 lawsuits pending before US District Judge Eldon E. Fallon in MDL 2592, IN RE: Xarelto (Rivaroxaban) Products Liability Litigation. Additional Xarelto bleeding claims have been filed in DelawareCalifornia and Missouri state courts.

Xarelto patients who allegedly experienced bleeding-related complications may be entitled to compensation for their medical bills, lost wages, pain and suffering, and more.

Defense Verdict in First Mass Tort Trial Over IVC Filters

Cook Platinum Celect IVC Filter

This is an update of our “First Trial Underway in Cook IVC Filter Mass Tort Case” published on 

A federal jury in Evansville returned a defense verdict in favor of Cook Medical, the Bloomington-based maker of medical devices, following a three-week trial over its blood-clot filters, which thousands of patients have complained are defective.

Doctors implant about 200,000 blood clot filters nationwide each year. The market for IVC filters is $435 million, according to market research firm Axis Research Mind.


The plaintiff’s case is underway in the first of three mass tort trials on whether Cook Medical Inc. is liable for selling a defective IVC filter that migrated through a blood vessel and punctured the plaintiff’s intestine.

“Defendants know its Cook filter was defective and knew that defect was attributable to the design’s failure to withstand the normal anatomical and physiological loading cycles,” the complaint states. The case is Hill v. Cook Medical, Inc., et al, 1:14-cv-6016.

It is the first bellwether, or test case, of 2,897 cases before US District Chief Judge Richard L. Young of the Southern District of Indiana in MDL 2570, IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation. 

Cook Medical Inc. of Bloomington, Indiana, won FDA approval for its “removable” Celect blood clot filter in 2003 using the 510(k) shortcut procedure, as opposed to the more rigorous premarket approval (PMA) process. FDA approval through Sec. 510(k) of the Medical Device Amendments of 1976 merely requires that a new device is “substantially equivalent” to a predicate device — but not a review of its safety or efficacy as would happen in a premarket approval application (PMA).

Perforated intestine

Plaintiff Elizabeth Jane Hill of Dunnellon, Florida, had a removable Cook Celect filter implanted in her vena cava, a large vein carrying blood into the heart, before back surgery on Nov. 17, 2010. By March 23, 2011, doctors tried unsuccessfully to remove the filter. Hill developed severe gastrointestinal symptoms, fatigue, diarrhea, vomiting and abdominal pain.

She underwent an endoscopy that revealed the filter had perforated through her inferior vena cava and into her small intestine. She went to Penn State Hershey Medical Center, a specialized hospital where the filter was finally taken out. As a result, the vena cava was permanently narrowed at the removal site.

The FDA recommends removing temporary filters between 29 and 54 days after implantation. However, studies have found that 43 percent of Celect filters perforate the vena cava within two months.

Hill charges that Cook failed to tell doctors that the filter cannot be removed and that it poses a risk of migrating, perforating and damaging the major blood vessel.

“The Cook filter had a safety profile that was not as good as or better than its predicate device,” the complaint states. “Defendant’s statements regarding the safety of the filter were false and misleading yet defendants continued to promote the Cook filter as safe an effective even though the data available studies, literature and clinical trial did not support long or short term safety and efficacy.”

Trial Judge Reverses $417 Million Verdict in Talcum Powder Cancer Case

Citing jury misconduct and a lack of evidence, a California trial judge reversed a $417 million verdict against Johnson & Johnson in a case where a woman charged she got ovarian cancer from the company’s talcum powder.

Judge Maren Nelson of Los Angeles Superior Court granted the company a new trial, citing several reasons:

  • Three jurors who voted against liability were improperly excluded from determining damages during deliberations.
  • There was no clear and convincing showing that J&J active with malice to support a punitive damages award.
  • There was insufficient proof of causation.
  • The parent company, which is a legally separate entity from its Johnson & Johnson Consumer Inc. subsidiary, can’t be held liable for failure to warn if it isn’t the one manufacturing and marketing the product.

Just last August a jury awarded $68 million in compensatory damages against the parent company and $2 million against the consumer unit, plus $340 million in punitive damages against the parent company and $7 million against the consumer unit.

The plaintiff was Eva Escheverra, 63, who had a 10-year fight with cancer that spread to her spleen, liver, kidneys, intestine, pancreas, and spine. She died after the verdict was returned. The case is Eva Echeverria v. Johnson & Johnson, No. BC628228 in Los Angeles County Superior Court.

The ruling is the second recent setback for talcum powder users. Last week a Missouri Appeals Court Vacated $72 Million Talc Cancer Verdict for a Non-Resident Plaintiff. It ruled that the trial court could not take jurisdiction over the company because its activities in Missouri did not give rise to the claims of non-residents who bought and used its products elsewhere.

Johnson & Johnson is facing 4,800 talcum powder claims in California, Missouri, New Jersey and Delaware state courts, as well as New Jersey federal court. The company faces 1,252 lawsuits in MDL 2738 in New Jersey before US District Judge Freda L. Wolfson, IN RE: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation. 

MO Appeals Court Vacates $72 Million Talc Cancer Verdict for Non-Resident Plaintiff

A family photo of Jacqueline Fox and her son, Marvin Salter.

A family photo of Jacqueline Fox and her son, Marvin Salter.

The Missouri Court of Appeals vacated a $72 million verdict against Johnson & Johnson, ruling that the trial court could not take jurisdiction over the company because its activities in Missouri did not give rise to the claims of the non-residents who bought and used its products elsewhere.

In February 2016, a St. Louis Circuit Court jury awarded $72 million to the family of Jacqueline Fox of Birmingham, AL, who used Johnson’s baby powder for 35 years. She was diagnosed with ovarian cancer in 2013 and died last year.

Fox was one of 63 out-of-state plaintiffs who sued J&J under Missouri Rule 52.05, which allows non-residents to join resident plaintiffs when all their claims arise out of the same transactions or occurrences.

J&J is incorporated and headquartered in New Jersey. Missouri courts historically have exercised personal jurisdiction over defendants as to joined non-residents’ claims so long as jurisdiction exists as to the residents’ claims.

Consistent with this practice, the trial court determined that specific personal jurisdiction existed, reasoning that J&J’s alleged conduct satisfied Missouri’s long-arm statute (§506.500) and minimum contacts.

Reversal due to Bristol-Myers Ruling

The appeals court reversed and vacated the verdict based on the 2017 U.S. Supreme Court decision in Bristol-Myers Squibb Co. v. Superior Court (BMS) that a non-resident plaintiff must establish an independent basis for specific personal jurisdiction over the defendant in the state.

In BMS, a group of more than 600 plaintiffs, mostly non-residents, sued BMS in
California for injuries allegedly caused by the drug Plavix. The California courts had
rejected BMS’s challenge to personal jurisdiction on the non-residents’ claims, reasoning, similar to the Missouri trial court, that BMS’s extensive contacts in the state supported jurisdiction, particularly because the non-residents’ claims were similar to residents’ claims.

The U.S. Supreme Court reversed, holding that specific personal jurisdiction requires a connection between the forum state and the specific claims at issue. “When there is no such connection, specific jurisdiction is lacking regardless of the extent of a defendant’s unconnected activities in the state.” 137 S.Ct. at 1781.

The Missouri appeals court said, “The fact that resident plaintiffs sustained similar injuries does not support specific jurisdiction as to non-resident claims.”

The ruling could overturn three other recent St. Louis jury verdicts of more than $200 million combined against the New Jersey-based health care giant, which has also appealed the cases.

The plaintiffs in the talc cases allege strict liability for failure to warn, negligence, breach of express and implied warranty, civil conspiracy, concert of action, and negligent representation, alleging that Johnson & Johnson marketed and sold its talc products knowing that they increased consumers’ risk of ovarian cancer.