Mass Torts: Study Doubts the Value of Abilify for Depression

In a report published by the Journal of the American Medical Association (JAMA), researchers at the Veterans Affairs found that the benefits of the antidepressant add-on drug Abilify were minor.

Meanwhile, the FDA has received 164 reports of pathological gambling caused by Abilify from November 2002 through January 2016.

Since October 2016, 234 mass tort lawsuits have been consolidated before Chief US District Judge M. Casey Rodgers in the Northern District of Florida, in MDL 2734, IN RE: Abilify (Aripiprazole) Products Liability Litigation. They charge that Bristol-Myers Squibb and Otsuka Pharmaceuticals Bristol-Myers Squibb knew about the side effect but failed to warn consumers, downplaying risks to protect billions in sales.

Question the use of Abilify

The researchers questioned the use of Abilify for depression: “Given the small effect size and adverse effects associated with aripiprazole, further analysis including cost-effectiveness is needed to understand the net utility of this approach.”

In a 12-week follow-up of a randomized clinical trial of 1,522 patients with major depressive disorder (85% men) unresponsive to previous antidepressant treatment, only 29% achieved remission after adding Abilify with their antidepressant.

It was not until the FDA ordered stronger labels in May 2016 that American patients and doctors were finally warned about uncontrollable urges to gamble, eat, shop, or have sex.

Europe required BMS and Otsuka to add a warning label about “pathological gambling” from Abilify in November 2012, as well as recommending caution in patients with a history of gambling addiction.

Abilify is one of the top-selling medications in the U.S., with sales of more than $6 billion per year. It is an antipsychotic drug that the FDA approved in 2002 for schizophrenia, bipolar disorder, and major depressive disorders. Today, Abilify is widely used “off-label” to treat irritability, aggression, and mood swings.

Philadelphia Jury Awards $57.1 Million in Ethicon Pelvic Mesh Verdict

Mesh manufacturer knowingly continued use of resin dangerous to human bodies.

A jury in Philadelphia awarded more than $57 million to a woman who was internally scarred and left incontinent by a defective Ethicon pelvic mesh implant made by Johnson & Johnson. The award, the largest so far in several recent mesh injury trials in the state, includes $50 million in punitive damages.

The jury found in favor of plaintiff Ella Ebaugh, determining that two of Ethicon’s mesh devices had caused internal mutilations permanently impairing her urinary system. The case is In Re: Pelvic Mesh Litigation, Case No. 140200829.

Attorneys in the case said the verdict sends a message to J&J and Ethicon about the impropriety of their conduct surrounding the design and marketing of the dangerous surgical mesh devices. Of the two mesh devices that were the subject of the lawsuit, one has been recalled but the other, Ethicon’s TVT product, remains on the market even as substantial numbers of mesh injury lawsuits continue to move through the courts.

29,905 federal lawsuits

In separate litigation, Ethicon faces 29,905 federal lawsuits consolidated before US District Judge Joseph R. Goodwin in MDL 2327, IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation.

The previous highest-result mesh injury case from the series ongoing in Pennsylvania was $20 million. Ethicon has stated it intends to appeal the jury’s decision in Ms. Ebaugh’s case.

The previous highest-result mesh injury case from the series ongoing in the Philadelphia  Court of Common Pleas was $20 million. Some 130 pelvic mesh lawsuits are pending there in a mass tort program. Ethicon has stated it intends to appeal the jury’s decision in Ms. Ebaugh’s case.

Ethicon and Johnson & Johnson have prevailed in a single Pennsylvania pelvic mesh trial.  Four Philadelphia juries have awarded Ethicon plaintiffs $12.5 million, $13.6 million, 17.5 million, and $20 million in damages.

Misleading Regulators, Monsanto Secretly Wrote Bogus Reports Calling Roundup Safe

When the Environmental Protection Agency declared that Roundup weed killer was safe for humans, it relied on scientific reports that were secretly ghostwritten by Monsanto employees, according to company emails.

The emails were released by plaintiff attorneys suing Monsanto on behalf of farmers who claim they got cancer of the lymph nodes from working with Roundup, which contains the herbicide glyphosate.

The bogus “reports” were designed to rebut The World Health Organization’s International Agency for Research on Cancer (IARC) finding in March 2015 that glyphosate is “probably carcinogenic to humans.”

Monsanto was also working with a corrupt EPA official, who bragged to Monsanto that he deserved a medal if he could kill an investigation of whether the company’s Roundup herbicide causes cancer.

A total of 220 mass tort lawsuits have been filed against Monsanto in Roundup Products Liability Litigation before US District Judge Vince Chhabria in MDL 2741 in the Northern District of California.

Dupe the scientific journal

Dozens of internal Monsanto emails, released on Aug. 1 by plaintiffs’ lawyers from Baum, Hedlund, Aristei & Goldman of Los Angeles, reveal how Monsanto worked with a consulting firm to dupe the scientific journal Critical Reviews in Toxicology to publish a supposedly “independent” review of Roundup’s effect on health. The review was published along with four subpapers in September 2016.

According to a Bloomberg report, the emails show that Monsanto’s chief of regulatory science, William Heydens, and other Monsanto scientists were heavily involved in reviewing and editing drafts submitted by the outside experts.

Other emails show that Monsanto’s lead toxicologist, Donna Farmer, who was a co-author of a 2011 study on glyphosate’s reproductive effects, made substantial changes and additions to the paper behind the scenes.

The paper’s Acknowledgment and Declaration of Interest falsely stated that Monsanto did not participate in editing the report, despite the editor’s insistence that the authors make clear how they were hired.

Jury Deliberations Underway in Pennsylvania’s 6th Transvaginal Mesh Trial

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.

Jury deliberations are now underway in Philadelphia, Pennsylvania, where testimony has concluded in the state’s sixth trial involving a transvaginal mesh lawsuit filed against Johnson & Johnson and its Ethicon, Inc. subsidiary.

The case, which is among more than 130 pelvic mesh lawsuits pending in a mass tort program now underway in the Philadelphia Court of Common Pleas, was filed on behalf of a woman who says Ethicon’s TVT mesh devices mangled her urethra and left her to endure life-long incontinence.

Like others pursuing transvaginal mesh lawsuits against Ethicon and Johnson & Johnson, she claims that the implants were defectively designed and alleges that the companies failed to warn doctors and patients about their potential risks. (In Re: Pelvic Mesh Litigation, Case No. 140200829.)

“We look forward to the verdict, as it may provide some clues as to how other juries might decide similar cases involving TVT transvaginal mesh devices,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.

Ethicon Transvaginal Mesh Litigation

Ethicon and Johnson & Johnson have so far prevailed in just one Pennsylvania transvaginal mesh trial.  Four Philadelphia juries have awarded Ethicon plaintiffs $13.6 million, 17.5 million, and $20 million in damages.

Transvaginal mesh implants are approved for use in women who suffer from pelvic organ prolapse and stress urinary incontinence. In 2008, the U.S. Food & Drug Administration (FDA) warned the implants had been associated with at least 1,000 reports of serious injuries and complications over a three-year period. In July 2011, the agency reported that complications related to transvaginal prolapse repair had tripled since 2008 and reversed its stance that such complications were rare.

In 2016, the FDA finalized regulations that reclassified pelvic mesh indicated for transvaginal prolapse repair as Class III (high risk) medical devices. The agency also made the implants ineligible for its 510(k)-clearance program, which had previously allowed transvaginal mesh manufacturers to market the products without first conducting human clinical trials.

Johnson & Johnson and Ethicon are facing more than 55,000 transvaginal mesh lawsuits in courts nationwide. Women involved in this litigation are alleged to have suffered a wide range of painful complications, including the erosion of mesh into the vaginal wall, adhesions and scarring, chronic infections, permanent pain, and incontinence, following implantation of the companies’ products.

FDA: No Association Between 3M Bair Hugger Blankets and Infection

In a potentially damaging blow to plaintiffs in mass tort litigation, the Food and Drug Administration says it “has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.”

Plaintiffs have filed 3,262 lawsuits in federal court against 3M over its Bair Hugger surgical warming blanket.

They include patients who developed hip and knee infections following joint replacement surgery that involved the use of the forced air warmer system. They assert that the Bair Hugger has a design defect that may cause the surgical site to come into contact with bacteria and other contaminants from the operating room floor. They further charge that the 3M Company has been aware of this risk for years, yet failed to make design changes or issue any warnings to the medical community.

The cases are consolidated before U.S. District Judge Joan N. Ericksen in MDL 2666 in Minnesota, IN RE: Bair Hugger Forced Air Warming Devices Products Liability Litigation.

Blankets regulate patient temperature

The Bair Hugger system was developed by Arizant Healthcare, Inc., which was acquired by the 3M Company in 2006. Since its introduction in 1987, the apparatus has been adopted as the standard surgical warming system in thousands of hospitals throughout the U.S.

Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publically available medical literature, operating room guidelines, and ventilation requirements.

In a safety alert, the FDA says it “is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.”

“The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery).”

FDA recommends

It adds, “the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

Meanwhile, Judge Ericksen scheduled five bellwether cases involving the 3M Bair Hugger for trial on February 26, 2018:

  • Kamke v. 3M Co., et al. – 16cv1225 (JNE/FLN)
  • Nugier, et al. v. 3M Co., et al. – 16cv4246 (JNE/FLN)
  • Walker v. 3M Co., et al. – Ramsey Cty. Case No. 62-cv-16-1257
  • Skaar, et al. v. 3M Co., et al. – 16cv2969 (JNE/FLN)
  • Gareis v. 3M Co., et al. – 16cv4187 (JNE/FLN)

Experts on specific causation as to Kamke and Nugier must be disclosed under Rule 26(a)(2) by October 9, 2017. Rebuttal expert reports and disclosures of the identity of rebuttal expert witnesses must be exchanged by October 30, 2017. Depositions of expert witnesses must be completed by December 15, 2017.

Defense Wins 3rd Xarelto Mass Tort Bellwether in a Row

XareltoA jury in federal court in Missouri returned the third verdict in favor of Janssen Pharmaceuticals and Bayer in a bellwether trial over the blood-thinner Xarelto. The companies are facing 18,000 similar lawsuits charging that the drug causes uncontrollable bleeding.

Juries in the multidistrict litigation docket, MDL 2592 before U.S. District Judge Eldon E. Fallon in the Eastern District of Lousiana, also returned defense verdicts on May 3 and June 12 this year.

The plaintiff Dora Mingo of Summit, Mississippi, alleged under Miss. Code Ann. Sec. 11-1-63 that Xarelto was defectively designed because there is no antidote and that it is unreasonably dangerous because of an inadequate warning to physicians about uncontrollable bleeding.

Mingo, a 69-year-old retired schoolteacher, suffered acute gastrointestinal bleeding and severe blood loss after taking Xarelto for a month in 2015 to prevent blood clotting after surgery. Plaintiff attorney Andy Birchfield of Beasley, Allen, Crow, Methvin, Portis & Miles of Montgomery, AL, said the companies should have instructed doctors to conduct a simple Prothrombin Time (PT) blood test, to assess a patient’s risk of bleeding.

As in the previous trials, the jury returned the verdict after a few hours of deliberation.

Xarelto is Bayer’s best-selling drug and in 2016 it generated $3.41 billion in revenues to the German company. Johnson & Johnson, the parent company of Janssen, reported $2.2 billion in revenues from Xarelto.

The FDA approved the drug in 2011 for patients with a heart rhythm disorder known as atrial fibrillation and to treat the risk of deep vein thrombosis and pulmonary embolisms.

Representing Janssen was Richard Sarver of Barrasso Usdin Kupperman Freeman & Sarver in New Orleans, who was involved in the first Xarelto trial. Bayer was represented by Lyn Pruitt of Mitchell Williams in Little Rock, Arkansas, and Walter T. Johnson at Watkins & Eager in Jackson, Mississippi.

Nexium, Priosec and PrevAcid Mass Tort Litigation Consolidated in New Jersey

The US Judicial Panel on Multidistrict Litigation consolidated 161 proton-pump inhibitor (PPI) products liability lawsuits into new federal MDL No. 2789 in federal court in New Jersey.

It was the second, successful try by the plaintiffs. In January, the Panel denied a motion that also sought centralization of the claims. At the time, it cited the small number of filings (only 15), the differing heartburn drugs involved and the need to protect trade secrets among the various defendants.

Since then, the size of the litigation has grown. Further, two defendants, AstraZeneca and Pfizer, had also changed course, and now supported consolidation. There are 34 tag-along actions in addition to the 161 cases consolidated by the Panel.

US District Judge Claire C. Cecchi, who is already managing PPI cases in the district, will oversee the MDL litigation. Heartburn drugs in the MDL:

  • Nexium
  • Nexium 24HR
  • Prilosec
  • Prilosec OTC
  • PrevAcid
  • PrevAcid 24HR
  • Dexilant
  • Protonix

Causes kidney damage

The defendants are AstraZeneca Pharmaceuticals LP, Pfizer, Inc., Wyeth Pharmaceuticals Inc., Wyeth LLC, Wyeth-Ayerst Laboratories, Procter & Gamble Company, Takeda, Novartis Consumer Health, Inc., Novartis Pharmaceuticals Corporation, Novartis Vaccines and Diagnostics, Inc. and Novartis Institute for Biomedical Research Inc.

In the 161 personal injury and wrongful death actions, plaintiffs allege that as a result of taking one or more proton-pump inhibitors (PPIs), they or their decedents suffered kidney injury (e.g., chronic kidney disease (CKD), acute interstitial nephritis, end stage renal disease, or kidney failure). Plaintiffs allege that defendants failed to adequately warn of the negative effects and risks associated with PPIs.

“Although several of the grounds on which we denied centralization in Proton-Pump I remain largely valid, we find that the significantly larger number 6 of involved actions, districts, and counsel, the concomitant increase in burden on party and judicial resources, and the opportunity for federal-state coordination, coupled with most defendants’ change in position to now support centralization, tip the balance in favor of creating an MDL,” the Panel said. “Centralization will facilitate a uniform and efficient pretrial approach to this litigation, eliminate duplicative discovery, prevent inconsistent rulings on Daubert and other pretrial issues, and conserve the resources of the parties, their counsel, and the judiciary,” the Panel said.

New On-Demand Webinar: Summer 2017 Mass Torts Update

Overview:

  • US Supreme Court decision limiting personal jurisdiction for mass torts in state courts. SCOTUS kicks out 592 non-resident plaintiffs.
  • The best path forward for mass tort plaintiffs.
  • 3 Mass torts heading for settlement:
    • Taxotere: 1,272 cases filed before Chief US District Court Judge Kurt D. Engelhardt, in the Eastern District of Louisiana, MDL 2740.
    • IVC filter: 2,342 cases before Chief US District Court Judge Richard L. Young, in the Southern District of Indiana, MDL 2570.
    • Fluoroquinolones (FLQs): 752 cases before Chief US District Court Judge John R. Tunheim in the District of Minnesota, MDL 2642.
  • Case to watch – Xarelto: 17,593 cases filed before US District Judge Eldon E. Fallon, Eastern District of Louisiana, MDL 2592, In re: Xarelto (Rivaroxaban) Products Liability Litigation
  • Using the 5 W’s to generate new business online
    Watch 20now
  • Watch now. It’s free. No registration required.

$300 Million Settlement for Benicar Blood-Pressure Drug

Daiichi Sankyo Company announced a $300 million settlement related to its blood pressure drug Benicar. Despite this, the company admitted no liability for any wrongdoing.

Patients who have been injured by Benicar can take part in the $300 million settlement if they have a retainer in place with a qualified Benicar attorney by August 23, 2017.


See our earlier report Picking 6 Winners in Mass Torts Litigation.


A total of 1,942 lawsuits have been filed in MDL 2606, IN RE: Benicar (Olmesartan) Products Liability Litigation, before US District Judge Robert B. Kugler in New Jersey as of July 15.

Benicar, Benicar HCT, Azor, and Tribenzor are angiotensin II receptor blockers that lower blood pressure associated with hypertension. It is also linked to severe gastrointestinal injuries, including:

  • Sprue-like enteropathy, which has symptoms similar to those of celiac disease.
  • Lymphocytic colitis, microscopic colitis, and collagenous colitis.
  • Patients may suffer from chronic diarrhea, vomiting, nausea, abdominal pain, kidney failure, and significant weight loss.

Starting in January 2014, plaintiffs began filing Benicar-related injury lawsuits, and in March 2015, the Judicial Panel on Multidistrict Litigation created the Benicar MDL. On August 1, 2017, Judge Kugler approved the $300 million settlement.

Patients who experienced Benicar-related side effects can still take part in the settlement, but only if they are represented by a Benicar attorney by the August 23, 2017, deadline.

According to the master settlement agreement, the fund will start to be paid out when 95 percent of all eligible litigants and claimants opt into the settlement under various conditions. Once the thresholds are met, claimants who meet specified criteria will receive compensation from the settlement fund.

Endo Settles ‘Virtually All Known’ Mesh Suits for $775 Million

law news, legal news, jury verdict, case settlement

Endo International Plc announced that it has reached agreements to resolve virtually all known U.S. vaginal-mesh implants product liability claims for $775 million. Women suing the company accuse it of selling defective devices that caused injuries such as chronic pain, incontinence, bleeding and infection.

The Dublin-based company said it is engaged in discussions to resolve the known remaining U.S. claims at reasonable values. Under the agreements, Endo will make installment payments beginning in the fourth quarter of 2017 and continuing through the fourth quarter of 2019.

Endo’s settlement of the remaining 22,000 mesh suits means the company has now set aside more than $2.6 billion to wipe out cases over the flawed medical devices, according to filings with the U.S. Securities and Exchange Commission.

As part of its second quarter 2017 results, the company intends to increase its mesh product liability accrual by $775 million, which is expected to cover approximately 22,000 U.S. mesh claims, as well as all known international mesh product liability claims and other mesh-related matters.

Endo said it is unaware of any mesh-related matters not covered by the foregoing accrual increase.

“Beginning in the second quarter of 2017, we aggressively executed a settlement strategy in connection with Endo’s mesh litigation. We believe it is a very important milestone for Endo to have reached agreements to resolve virtually all known U.S. mesh product liability claims,” said Paul Campanelli, Endo’s President and Chief Executive Officer. “While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward with an even greater focus on executing against our core strategic priorities,” he added.

Meanwhile, Johnson & Johnson said in SEC filings in February that it was defending 54,800 cases over its pelvic mesh inserts while Boston Scientific said that same month it faced 43,000 mesh claims. Both companies have settled some mesh suits.