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

 

 

 

 

 

 

 

 

By Mark York, Mass Tort Nexus Media

(December 21, 2017)

New Jersey Supreme Court Review Reinstatement Of Accutane Experts

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

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

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

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

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

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

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

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

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

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

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

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

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

Pennsylvania Appeals Court Affirms $29.6M Remitted Zimmer Knee Judgment

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

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

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

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

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

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

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WEEKLY MDL and MASS TORT UPDATE by MASS TORT NEXUS for Week of November 27, 2017

By Mark A. York (November 30, 2017)

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This week in mass torts around the country:

Opioid Crisis: See Mass Tort Nexus Briefcase Re: OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION

> Superseding indictments of Insys Therapeutics Executives Unsealed in USDC of Massachusetts

BOSTON — A federal indictment against seven high-ranking officers of opioid maker Insys Therapeutics Inc. was unsealed Oct. 26 in a Massachusetts federal court charging the men with racketeering, mail fraud and conspiracy for a scheme to pay kickbacks to doctors for, and to fraudulently induce health insurers into approving, off-label prescriptions for the company’s addictive Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

>Doctor Pleads Guilty To Opioid Health Care Fraud, Taking Kickbacks From Insys

PROVIDENCE, R.I. — A Rhode Island doctor on Oct. 25 pleaded guilty to health care fraud and taking kickbacks for prescribing the opioid Subsys to unqualified patients (United States of America v. Jerrold N. Rosenberg, No. 17-9, D. R.I.).

 > Opioid Distributors Support MDL While Municipalities Oppose

WASHINGTON, D.C. — The “Big Three” national drug distributors on Oct. 20 told a federal judicial panel that they support centralization of more than 60 opioid lawsuits filed against them by various cities and counties (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, JPML).

Related Mass Tort Nexus Opiod Articles:

>California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense: Will other insurers say no to opioid coverage? Nov 15, 2017

>Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA Nov 3, 2017

For more Mass Tort Nexus Opiod Crisis Information See: Mass Tort Nexus Newsletters and MDL Updates

IVC FILTERS:

Cook Medical IVC: See Mass Tort Nexus Briefcase Re: Cook Medical IVC Filter MDL 2570

>First Cook IVC Bellwether Trial Starts in USDC SD of Indiana

INDIANAPOLIS — The first bellwether trial in the Cook Medical Inc. inferior vena cava (IVC) filter multidistrict litigation got under way on Oct. 23 in Indianapolis federal court (In re:  Cook Medical, Inc., IVC Filters Litigation, MDL Docket No. 2570, No. 14-ml-2570, Elizabeth Jane Hill v. Cook Medical, Inc., No. 14-6016, S.D. Ind., Indianapolis Div.).

Cordis IVC Filters: See Cordis IVC Filter Litigation Alameda County, California Superior Court

>Cordis IVC Filter Plaintiffs Tell Supreme Court Trial Proposal Is No ‘Mass Action’

WASHINGTON, D.C. — Plaintiffs in an inferior vena cava (IVC) filter case on Oct. 18 told the U.S. Supreme Court that their suggestion of individual bellwether trials does not convert their actions into a mass action under the Class Action Fairness Act (CAFA), 119 Stat. 4 (Cordis Corporation v. Jerry Dunson, et al., No. 17-257, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4013).

Taxotere: See Taxotere MDL 2740 (US District Court Eastern District of Louisiana)

>Taxotere MDL Judge Denies Statute of Limitations Motion by Sanofi

NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere multidistrict litigation on Oct. 27 denied without prejudice a motion by defendant Sanofi-Aventis U.S. LLC to dismiss claims barred by applicable statutes of limitations (In Re:  Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740, No. 16-md-2740, E.D. La.).

Pelvic Mesh: Boston Scientific TVM Litigation MDL 2362

>Exclusion of 510(k) Defense in Boston Scientific Pelvic Mesh Case:

ATLANTA — The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017 U.S. App. LEXIS 20432).

PLAVIX: See Mass Tort Nexus Briefcase Re: PLAVIX MDL 2418 USDC NEW JERSEY

>Plaintiff Loses Plavix Case on Summary Judgment Over Late “Learned Intermediary” Declaration

TRENTON, N.J. — The judge overseeing the Plavix multidistrict litigation on Oct. 26 granted summary judgment in a case after ruling that the plaintiff’s “eleventh hour” declaration by one treating physician did not overcome California’s learned intermediary defense for defendants Bristol-Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. Inc. (In Re:  Plavix Products Liability Litigation, MDL Docket No. 2418, No. 13-4518, D. N.J., 2017 U.S. Dist. LEXIS 177588).

Abilify MDL 2734: Mass Tort Nexus Briefcase Re: Abilify MDL 2734

 >Abilify MDL Judge Orders Defendants To Name Settlement Counsel

PENSACOLA, Fla. — The Florida federal judge overseeing the Abilify multidistrict litigation on Oct. 25 ordered the defendants to engage settlement counsel for monthly settlement conferences (In Re:  Abilify [Aripiprazole] Products Liability Litigation, MDL Docket No. 2734, No. 16-md-2734, N.D. Fla., Pensacola Div.).

Mirena IUD: Related-Federal Court Reopens Mirena IUD Product Liability MDL Nov 3, 2016

>2nd Circuit Affirms Exclusion Of Mirena MDL Experts, Termination Of Litigation

NEW YORK — The Second Circuit U.S. Court of Appeals on Oct. 24 affirmed the exclusion of general causation experts in the Mirena multidistrict litigation and a court order terminating the MDL before any trials were held (In Re:  Mirena IUD Products Liability Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals, Inc., Nos. 16-2890 and 16-3012, 2nd Cir., 2017 U.S. App. LEXIS 20875).

Hip ImplantsSee Mass Tort Nexus Briefcase Re: Wright Medical, Inc. MDL 2329 Conserve Hip Implant Litigation

>Wright Medical Settles Remaining Wright Hip Cases; Judge Closes MDL 2329

ATLANTA — Wright Medical Technology Inc. and plaintiffs in a multidistrict litigation have entered two additional agreements settling the remainder of the litigation, a Georgia federal judge said Oct. 18 (In Re:  Wright Medical Technology, Inc., Conserve Hip Implant Products Liability, MDL Docket No. 2329, No. 12-md-2329, N.D. Ga., Atlanta Div

Testosterone Replacement Therapy: See Mass Tort Nexus Briefcase Re: TESTOSTERONE MDL 2545 (AndroGel)

>Testosterone Bellwether Out and Pre-emption Denied

CHICAGO — An Illinois multidistrict litigation judge on Oct. 23 granted summary judgment in one of two testosterone replacement therapy bellwether cases but denied preemption in the second case (In Re:  Testosterone Replacement Therapy Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ill., Eastern Div., 2017 U.S. Dist. LEXIS 176522).

 

>AbbVie, AndroGel Plaintiff Spar Over Mixed Verdict In 1st Bellwether Trial Verdict

CHICAGO — AbbVie on Oct. 25 urged the judge overseeing the testosterone replacement therapy multidistrict litigation to not disturb a bellwether trial verdict where a jury awarded $0 compensatory damages (In Re:  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Jesse Mitchell v. AbbVie, No. 14-9178, N.D. Ill.).

Fosamax MDL 1789: See Mass Tort Nexus Briefcase Re: MDL 1789 Fosamax Products Liability Litigation USDC New Jersey

>Fosamax Femur Plaintiffs Urge Supreme Court To Deny Preemption Review

WASHINGTON, D.C. — Counsel for more than 500 Fosamax femur fracture plaintiffs on Oct. 25 urged the U.S. Supreme Court to deny certiorari to Merck Sharp & Dohme Corp., arguing that their claims are not preempted by “clear evidence” that the Food and Drug Administration would have rejected stronger warnings for the osteoporosis drug (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4064

 

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Boston Scientific Pelvic Mesh Cases Removed From Philadelphia Court of Common Pleas Based on SCOTUS “Plavix” Ruling

Boston Scientific Mass Tort Mesh Cases Removed From Philadelphia Court of Common Pleas Based On Recent Supreme Court  June 2017, Bristol Myers vs. California Superior Court “Plavix” Ruling

 

 

 

 

 

 

Boston Scientific, Marlborough, MA

By Mark A. York (September 7, 2017)

Plaintiffs who filed suit against Boston Scientific in a Philadelphia court over allegedly defective pelvic mesh, have agreed to have their cases removed from the Pennsylvania Court to other venues based on the June 2017 “Bristol-Myers California Plavix” U.S. Supreme Court opinion.  The Plavix ruling has thrown thousands of non-resident drug and medical device state court cases across the country into turmoil, as the non-resident plaintiffs cannot continue their cases in state courts where they do not reside or the defendant companies are not corporate residents.  This was based on the Supreme Court ruling that stated Bristol-Myers R&D and sales activity in the State of California related to it’s Plavix blood thinner, (see Mass Tort Nexus “Plavix” CA State Court Briefcase) was not enough of a corporate presence to subject them to California state court jurisdiction, resulting in jurisdictional issue across the country for plaintiff firms.

Last month, Boston Scientific filed motions asking the court to remove any cases pending against it in the Philadelphia Court of Common Pleas, citing the Supreme Court’s both the “Bristol-Myers Squibb v. Superior Court of California”, see US Supreme Court Strikes Down State Court Jurisdiction and “BNSF Railway v. Tyrrell”, see SCOTUS Limits What State Court A Corporate Defendant Can Be Sued In.

According to one of the lead attorneys, the parties have agreed to litigate the cases in either Massachusetts, where Boston Scientific has its principal place of business, or in Delaware, it’s state of incorporation.

Kline & Specter attorney Shanin Specter said. “An agreement was reached with Boston Scientific to have the cases heard in a courtroom other than the Philadelphia Court of Common Pleas, so the cases can move forward and litigate without the jurisdictional issue creating legal issues. Although Boston Scientific’s motion last month sought to remove 94 cases, Specter said only three cases had been moving forward against Boston Scientific with calls placed to Boston Scientific defense counsel Shook, Hardy & Bacon and attorney Joseph Blum seeking comment have not been returned.

Judge New Asked to Reconsider

Last month, Boston Scientific had filed a motion requesting Philadelphia Court of Common Pleas Judge Arnold New reconsider his March 2015 decision that the state court had jurisdiction over the mesh cases.  New, who is the supervising judge of Philadelphia’s Complex Litigation Center, issued a one-page order saying Boston Scientific’s motion was moot.

As part of the motion, Boston Scientific had sought to have New’s 2015 ruling vacated to allow for additional arguments on the issue, and allowing defense counsel to begin pleading the removal of thousands of other non-resident plaintiff cases currently in in the court’s complex litigation docket.

Ethicon Mesh Motion for Removal

Another major defendant in over one thousand pelvic mesh mass cases , Johnson & Johnson subsidiary Ethicon, has also filed motions recently seeking to have the cases dismissed based the Supreme Court’s recent decisions. Plaintiffs, however, have requested Judge New pend any rulings on these issues, based on the Pennsylvania Superior Court has agreed to consider the matter in a case that is pending before the intermediate court on appeal.

The Supreme Court’s ruling from June 19, 2017 in Bristol-Myers vs. Superior Court of California (see US Supreme Court Denies California State Court Jurisdiction) now seen as the defining game-changing decision, for mass torts in state courts, that has promised to reshape the geography of mass tort litigation across the country. In the ruling, a majority of the Supreme Court determined that plaintiffs suing Bristol-Myers Squibb in California who were not California residents had failed to establish specific jurisdiction over the pharmaceutical giant, since there was no significant link between the claims and Bristol-Myers’ conduct in California. The ruling, according to observers, makes clear that out-of-state plaintiffs can’t sue companies in states where the defendants aren’t considered to be “at home,” or haven’t conducted business directly linked to the claimed injury.

Johnson & Johnson Files For Missouri Removals

Earlier this month, J&J filed a motion in Missouri seeking to dismiss more than 1,300 lawsuits against it over talcum powder, claiming the lawyers had engaged in “blatant forum shopping on a grand scale.” On June 19, 2017 St Louis City Court Judge Rex Burlison declared a mistrial in the fifth talcum powder cancer trial being heard there, which was the afternoon of the SCOTUS “Plavix” ruling, declaring that the opinion earlier that day prevented the trial from moving forward. The trial was reset for October 2017, and the parties are currently arguing the jurisdictional issues of resuming the trial in front of Judge Burlison, see Mistrial Declared in J&J Talc Trial Due to SCOTUS Ruling.

Boston Scientific Argument

In requesting reconsideration regarding the recent Supreme Court decisions, Boston Scientific contends that Pennsylvania state courts no longer have jurisdiction over it. Specifically, the motion said Boston Scientific is a Delaware corporation with its principal place of business in Massachusetts, it does not have sufficient ties to Pennsylvania to render it “at home” in the state, and the plaintiffs are not Pennsylvania residents. The company further says that finding Pennsylvania has jurisdiction simply because the company complies with the state’s business registration statute violates the due process clause of the U.S. Constitution and the now precedent “California Plavix” decision, .

“It is undisputed that Boston Scientific’s principal place of business is Massachusetts while its place of incorporation is Delaware,” the motion said. “Those are the only two jurisdictions where Boston Scientific is so heavily engaged in activity as to render it ‘at home.”

State Court Removal and Refiling Across The Country

The Philadelphia Court of Common Please Complex Litigation Docket appears to be preparing for a departure of many of the thousands of product liability cases, which prior to June 19, 2017 were moving along quite well in the under the direction of Judge Arnold New. State court dockets across the country are now forced to consider the removal of many cases as well as the potential refiling of thousands of cases in the state of incorporation for the medical device and pharmaceutical manufacturers.

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Endo International Agrees To An Additional $775 Million to Settle Remaining Mesh Lawsuits For A Total of $2.6 Billion

 

Endo International Plc has agreed as of August 7, 2017 to set aside an additional $775 million to resolve the remaining lawsuits alleging the company’s vaginal-mesh implants eroded in some women, leaving them incontinent and in pain related to the Transvaginal Mesh Multidistrict Litigation pending in the US District Court of West Virginia, see the Mass Tort Nexus briefcase, American Medical Systems MDL 2325 TVM Litigation Link, a subsidiary of Endo sold to Boston Scientific in 2015.

The agreement to fund settlement of the remaining 22,000 mesh suits means the company has now set aside more than $2.6 billion to finalize the litigation claims related to the American Medical Systems flawed medical devices, according to document filed with the U.S. Securities and Exchange Commission.

This comes a year after Dublin-based Endo shut down one of its units that makes mesh implants, used to support internal organs or treat incontinence, after being hit with many thousands of complaints over the devices.

“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,” Paul Campanelli, Endo’s president and chief executive officer, said Monday in a statement.

Other mesh-insert makers, including Johnson & Johnson and Boston Scientific Corp., still face thousands of claims in the U.S. and worldwide from women who blame the devices for injuring them. More than 100,000 transvaginal mesh lawsuits have been filed, making it one of the largest mass torts in history. About 75% of mesh lawsuits are consolidated in West Virginia federal court through seven multi-district litigation (MDL) cases. The rest are contained in state courts, including those in Pennsylvania and West Virginia.

J&J, based in New Brunswick, New Jersey, said in SEC filings in February that it was defending 54,800 cases over its inserts while Marlborough, Massachusetts-based Boston Scientific said that same month it faced 43,000 mesh claims. Both companies have settled some mesh suits. The U.S. Food and Drug Administration increased regulatory restrictions on the mesh inserts after concluding in 2014 they were high-risk. The agency ordered Endo’s American Medical Systems unit, J&J and other mesh makers to study organ-damage rates linked to the devices. J&J dropped some of its mesh lines in 2012.

The consolidated AMS cases are In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, U.S. District Court, Southern District of West Virginia (Charleston). Endo paid $150 million in legal settlements related to its vaginal mesh in the 4th quarter of 2016 and now more payments are on the way. The company recorded a $834 million pretax charge to increase the estimated product liability accrual. It had already set aside $1.4 billion to cover the legal costs at the end of the previous settlements.

In 2015 Endo sold the men’s health portion of its American Medical Systems device unit to Boston Scientific for $1.6 billion, and renamed the remaining portion Astora Women’s Health. Endo had acquired AMS for $2.9 billion in 2011, making the purchase a significant misjudgment of corporate strategy in what was even then a highly litigated medical device area, as TVM was widely known as a product that was prone to high numbers of adverse events and regulatory scrutiny.

Endo International/American Medical Systems Settlement History

Endo International plc (Endo) acquired device maker American Medical Systems Holdings, Inc. (AMS) in 2011. Endo has agreed to pay out roughly $2.6 billion to settle cases claiming injuries from its vaginal mesh devices, which include the Perigee, Apogee and Elevate implants. The company has previously ceased production of AMS transvaginal mesh.

The following settlements amounts were agreed to by Endo in attempts to resolve mesh implants made by AMS:

$775 million settlement to resolve 22,000 mesh lawsuits in August 2017. This settlement resolves the remaining lawsuits against AMS mesh implants.

Approximately 450 mesh lawsuits resolved through two separate settlements in April and May 2015.

$400+ million to settle more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. With the move, Endo said that it resolved “substantially all” the remaining lawsuits against its AMS unit. The $400 million was in addition to $1.2 billion already pledged by Endo to cover mesh litigation.

$830 million settlement to resolve around 20,000 mesh lawsuits (~40,000 per case) in May 2014. The 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. “The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims,” Endo said in a statement at the time.

$55 million paid in June 2013 to settle an undisclosed number of lawsuits, according to a filing with the U.S. Securities and Exchange Commission.

 

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Brazilian Health Insurers Sue Boston Scientific, Arthrex and Zimmer Biomet Over Kickbacks to Doctors

boston scientificAn association of 177 health insurance companies and medical providers in Brazil sued Boston Scientific Corporation, Arthrex, Inc. and Zimmer Biomet Holdings, Inc. in US federal court, charging that the companies paid millions in kickbacks to doctors so they would use their medical products — regardless of the need or cost of the products.

Abramge (short for Associação Brasileira De Medicina De Grupo) is an organization that represents the health insurers and medical service providers in a complaint filed in US District Court in Delaware, Case. No. Case 1:16-cv-01184-GMS.

Brazil has the second-largest private health insurance market by population in the world after the US. The doctors were paid a 20% to 40% commission for using the companies’ medical devices, according to the complaint. The corrupt doctors induced Brazilian the medical providers to (1) buy medically unnecessary amounts of Defendants’ devices; (2) conduct unnecessary medical procedures, in order to use more of Defendants’ products; and (3) overbill insurers for Defendants’ products and medical procedures.

The “Prosthetic Mafia”

The Brazilian television news program Fantastico (similar to 60 Minutes) featured a series of reports in January 2015, showing Brazilian medical device distributors offering secret cash commissions to an undercover reporter posing as a Brazilian surgeon. This caused the National Congress of Brazil to conduct  hearings investigating the corruption by the “Prosthetic Mafia.”

The final report issued by the Brazilian congress found that the improper payments have “grown alarmingly” and that the fraudulent scheme was “endangering the lives of patients in favor of the companies’ profit.”

The defendants are:

  • Boston Scientific Corporation is a Delaware corporation headquartered in Massachusetts. It manufactures a vast array of products used in a range of interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology. Boston Scientific is a known for its stents, implantable cardioverter defibrillators, pacemakers, stents and spinal cord stimulator systems.
  • Arthrex, Inc. is a Delaware corporation headquartered in Florida. Arthrex manufactures implants for sports medicine and joint prosthetics. It also develops and manufactures orthobiologics, which are substances many orthopaedic surgeons use to assist in the healing process of injuries.
  • Zimmer Biomet Holdings, Inc. is a Delaware corporation headquartered in Indiana. It manufactures and markets orthopedic products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses.

Phony consulting agreements

The Brazilian Federal Police investigated the kickback scheme, launched in 2006, leading to the indictment of distributors and doctors in Brazil. A prominent São Paulo hospital studied the difference in certain medical procedures before and after the public disclosure of the medical device scandal and found a 30% reduction in those procedures.

According to the complaint, sales representatives working for Boston Scientific would approach doctors and offer to pay a fee for every Boston Scientific device or product the doctor used. The doctors signed phony consulting agreements to legitimize the bribery.

In one example Signus, on behalf of Boston Scientific, approached three doctors and paid them $27,000 per month for using its products. During six months from June to December 2012, the kickbacks totaled $189,000.

Back in the US in 2009, Boston Scientific agreed to pay $22 million to settle allegations brought by the Department of Justice that it paid kickbacks to doctors to participate in post-market studies, in order to boost sales of Boston Scientific pacemakers and defibrillators. Further, in 2011, two former employees of Boston Scientific filed a lawsuit in the District of New Jersey alleging that Boston Scientific paid kickbacks to doctors to encourage use of Boston Scientific’s spine products.

“Both of these instances are strikingly similar to what Plaintiff has discovered Boston Scientific has been doing in Brazil,” the complaint says. Arthrex and Zimmer Biomet are accused of similar acts.

In fact, on March 26, 2012, Biomet entered into a Deferred Prosecution Agreement with the DOJ and a Consent to Final Judgment with the U.S. Securities and Exchange Commission to end investigations into Biomet’s violations of the Foreign Corrupt Practices Act. Biomet was bribing doctors in Brazil as part of its marketing and sales strategy in that country.

The complaint, filed by attorney Karen B. Skomorucha Owens of Ashby & Geddes in Wilmington, Delaware, seeks damages for fraud, conspiracy, tortious interference, negligent misrepresentation and unjust enrichment.

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Boston Scientific Settles Nearly Half of 40,000 Transvaginal Mesh Cases


Boston scientific tvc pelvic mesh
In its latest 10-Q filing with the Securities and Exchange Commission, Boston Scientific announced that as of Oct. 31 it has settled 19,000 of 40,000 product liability cases filed against it concerning its transvaginal mesh product.

A total of 17,277 actions are filed in federal MDL 2326 consolidated before US District Judge Joseph R. Goodwin in In RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, Case No. 12-md-2326, D. Mass.).  The company said that more than 3,100 cases are pending in Massachusetts state court.

In addition, the company says it has “made substantial progress” in settlement talks underway with plaintiffs’ counsel representing approximately 3,000 additional cases and claims.

Multiple verdicts

All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing,” the company states.

Boston Scientific has been hit with verdicts of $18.5 million, $26.7 million and $73.4 million in 2014, and the $100 million award, which later was reduced to $10 million.

Plaintiffs allege the company knew or should have known that the TVM devices created an increased risk of serious personal injury, including mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence and, prolapse of organs.

Litigation is pending against 8 TVM manufacturers:

  1. Caldera TVM Class Action In California
  2. Boston Scientific TVM Litigation MDL 2362
  3. Bard TVM Litigation MDL 2187
  4. Ethicon (J&J) Transvaginal Mesh Litigation MDL 2327
  5. Neomedic TVM Litigation MDL 2511
  6. Cook TVM Litigation MDL 2440
  7. Coloplast TVM Litigation MDL 2387
  8. American Medical Systems TVM Litigation, MDL 2325

Transvaginal mesh was approved under a fast-track FDA process that deemed it similar to older mesh products. It took the FDA until the beginning of this year to classify the transvaginal mesh as a class III, or high-risk, medical device.

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Judge Upholds $14.3 Million Verdict Against Boston Scientific in Pelvic Mesh Trial

vaginal-mesh-TVM-US District Judge Joseph R. Goodwin upheld $14.3 total verdict in favor of three women who suffered ongoing pain from the Obtrx transvaginal mesh system manufactured by Boston Scientific Corporation.

“There was more than sufficient evidence from which a reasonable jury could find in favor of the plaintiffs on each of their claims,” the judge wrote.

Boston Scientific was found liable of strict liability for defective design, strict liability for failure to warn, negligence and punitive damages. A jury in US District Court in the Southern District of West Virginia in Charleston returned the verdict for the plaintiffs in November 2014. The case is Carol Sue Campbell v. Boston Scientific Corporation, Case No. 2:12-cv-08633 (Oct. 3, 2016).

The case is part of consolidated litigation in MDL 2326, which contains 19,000 individual cases. There are six other MDLs against the transvaginal mesh manufacturers, with more than 70,000 cases currently pending:

  1. Boston Scientific TVM Litigation MDL 2326
  2. Bard TVM Litigation MDL 2187
  3. Ethicon (J&J) Transvaginal Mesh Litigation MDL 2327
  4. Neomedic TVM Litigation MDL 2511
  5. Cook TVM Litigation MDL 2440
  6. Coloplast TVM Litigation MDL 2387
  7. American Medical Systems TVM Litigation
  8. Caldera TVM Class Action In California

Plaintiffs Chris Wilson, Carol Campbell and Jeanie Blankenship had the Obtryx Transobturator Mid-Urethral Sling System implanted between 2009 and 2011. All suffered severe pain in their abdomen, pelvis, vagina, dyspareunia (painful intercourse) and painful urination. Each had unsuccessful revision surgery, which also left them with continuing pain.

  • Wilson recovered $3.75 million in compensatory damages and $1 million in punitive damages.
  • Campbell recovered $3.25 million in compensatory damages and $1 million in punitive damages.
  • Blankenship recovered $4.25 million in compensatory damages and $1 million in punitive damages.

Boston Scienfitif argued that it met the standard of care in the medical community, which did not require clinical trials. “However, as mentioned above, compliance with industry standards is not necessarily proof of reasonable conduct,” the judge held.

A key point of evidence was the Material Safety Data Sheet issued by Chevron Phillips Chemical Company LP with regard to their Marlex polypropylene. The plaintiffs presented evidence at trial that the MSDS included a Medical Application Caution, which stated: “Do not use [Chevron Phillips] material in medical applications involving permanent implantation in the human body . . . .”

Yet after learning this, Boston Scientific never performed any testing of their mesh inside the human body, didn’t halt the release of the Obtryx and didn’t disclose the new information.

The plaintiffs presented evidence related to a study conducted by Dr. Hilary Cholhan and funded in part by BSC. The Cholhan study “identified pariurethral banding as a previously unreported complication” of the Obtryx and noted that “[s]urgeons should be aware of the pariurethral banding and subsequent internal dyspareunia as a potential complication.”

When asked about the study, Alex Robbins, a BSC sales representative and training manager, stated that, because of its negative outcome, the study would not be useful to the sales force and should not be given to physicians.

The judge disagreed with Boston Scientific’s arguments that the verdict was against the weight of the evidence, that jury instructions were confusing, or that in closing arguments a plaintiff attorney improperly tried to appeal to the jury’s sympathy.

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Pelvic Mesh Case Revived Against Boston Scientific

Vaginal-Mesh-POP-331x269-e1370009513525
Some 39,000 pelvic mesh cases have been filed against Boston Scientific.

A Massachusetts appeals court revived a pelvic mesh product liability case against Boston Scientific Corp. (BSC) because the trial court had wrongly excluded three pieces of evidence to rebut the company’s claims that the FDA had “cleared” its Pinnacle pelvic floor repair kit for sale.

A state court jury returned a defense verdict in favor of the company in 2014 in the first product liability lawsuit involving the its pelvic mesh products to go to trial.

Plaintiff Diane Albright of Ohio filed suit in 2012 the Massachusetts Superior Court against BSC, which is based in Massachusetts, seeking damages for injuries after the Pinnacle device was surgically implanted to treat her pelvic organ prolapse (POP) condition.

“The repeated reference to the FDA’s clearance aided BSC’s defense, and handicapped Albright’s case, on the central product safety issue in the case,” the appeals court said. The case is Diane Albright v. Boston Scientific Corporation (PDF), No. 15-P-633 (Sept. 13, 2016).

Trial judge Diane M. Kottmyer erroneously excluded key evidence:

  1. A medical application caution in the 2004 material safety data sheet provided to BSC by its supplier of the polypropylene material used to fabricate the mesh in the Pinnacle device. It states, “Do not use this [polypropylene] material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” The appeals court ruled, ” the MSDS caution was relevant, material evidence admissible for the limited purpose of showing that BSC, which had received the MSDS well before 2009, had notice or knowledge of the content of the caution.”
  2. A letter from the FDA ordering BSC to conduct a “postmarket surveillance” study of the Pinnacle device to address concerns as to the safety and efficacy of the device in treating POP.
  3. A second letter from the FDA, agreeing to a request from BSC to suspend its postmarket surveillance study because the company planned to stop the manufacture and marketing of the Pinnacle device.

“Albright ought to have been allowed to use the letters for the limited purpose of cross-examining BSC’s witnesses, who had testified, without qualification, that the Pinnacle device was safe as of the time of trial,” the appeal court ruled.

The same documents have been allowed into other trials, including one in Delaware that landed a $100 million verdict last year. Boston Scientific has been hit with verdicts of $18.5 million, $26.7 million and $73.4 million in 2014, and the $100 million award, which later was reduced to $10 million.

Some 39,000 pelvic mesh cases have been consolidated in MDL 2327 before US District Judge Joseph R. Goodwin in the Southern District of West Virginia. There are six other MDLS, making it the largest ongoing medical device litigation in the country. The Judicial Panel on Multidistrict litigation lists 75,000 cases in dockets involving different manufacturers.

A surgeon inserted the Pinnacle device into Albright in 2010. Within six months, she experienced pain and discomfort when urinating and other “hardto-describe” pain in her pelvic area. Two other doctors examined her and concluded that Albright was suffering from painful bladder syndrome and other complications due to the erosion and degradation of the mesh in her body.

 

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Family Sues Boston Scientific over Defective IVC Filter that Killed Truck Driver

Boston Scientific makes the dangerous Greenfield Vena Cava Filters.
Boston Scientific makes the dangerous Greenfield Vena Cava Filters.

Federal litigation is building against Boston Scientific Corp. over defects in its IVC filter, a device implanted to control pulmonary embolisms (PE), a sudden blockage in a lung artery.

The family of a woman truck driver from Ohio filed a wrongful death suit after the company’s IVC filter perforated her inferior vena cava vein, killing her.

Even though plaintiffs are filing more cases against Boston Scientific over its Greenfield Vena Cava Filter, today there is no multidistrict litigation docket (MDL) for the litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be filed in an effort to form an MDL,” said John Ray, a leading consultant who has advised attorneys who practice in Mass Torts for more than a decade.

Greenfield Vena Cava Filter
Greenfield Vena Cava Filter

Boston Scientific, headquartered in Marlborough, Massachusetts, designed, manufactured, marketed and sold the Greenfield IVC Filter. It is a basket-like structure with 6 struts, each with a curved hook, and is designed to catch blood clots.

FDA warning and recall

The FDA recalled the Greenfield IVC Filter in May 2007 after reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters, causing a risk of cardiac and pulmonary embolization.

It also issued a warning on August 9, 2010 against leaving IVC filters in for extended periods of time, because they have a tendency to cause life-threatening problems.

The FDA reported that since 2005, there were 921 adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved detachments of device components and embolizations, 70 involved perforation of the IVC, and 56 involved IVC filter breaks.

Dangerous medical device

The co-administrators of estate of Cindi K. Ratliff filed a lawsuit in US District Court for the Southern District of Ohio, Eastern Division, alleging product liability, breach of warranty, negligence and wrongful death, Case: 2:15-cv-00076-GLF-NMK.

In 2004 Ratliff, of East Fultonham, Ohio, was diagnosed with deep vein thrombosis (DVT), which occurs when a blood clot (thrombus) forms in one or more of the deep veins in your body, usually in your legs. That year a surgeon implanted a Boston Scientifi IVC filter in her right inferior vena cava.

On May 3, 2013, she was working as a long‐haul truck driver and traveled to Oregon. While stopped at a rest area located on I‐5 in the vicinity of Coburg, Oregon, she suffered a medical emergency.  Shortly afterwards she was pronounced dead by medics who had been called to the scene. An autopsy that day determined the immediate cause of death was “Perforation of Inferior Vena Cava by Greenfield Filter with Retroperitoneal Hemorrhage.”

The lawsuit charges:

  • Boston Scientific knew or should have known that its Greenfield Vena Cava Filter when used as expected and intended, carrie the risk of breaking free from its implantation site, migrating, perforating the vena cava, and causing serious injury and death to patients.
  • Boston Scientific failed to properly design and manufacture Greenfield Vena Cava Filter.
  • Boston Scientific failed to give adequate warnings about the hazards associated with the filter.
  • Boston Scientific violated Ohio’s Product Liability Act.

The next of kin seek damages for loss of support, loss of services, loss of society of the decedent including loss of companionship, loss of prospective inheritance, and extreme mental anguish as a result of her death.

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