C. R. Bard, Inc., Hit With Multimillion Dollar IVC Filter Jury Verdict in Arizona Federal Court

Plaintiff Wins the First Bellwether Trial in Bard IVC Filters Products Liability Litigation MDL 2641

By Mark A. York (March 30, 2018)

Bard G2 Inferior Vena Cava Filter

 

 

 

 

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media)  A Phoenix federal jury awarded $2 million in compensatory damages on Friday to plaintiff Sherr-Una Booker, in the first bellwether trial against IVC filter maker Bard, Inc. and affiliate company Bard Peripheral Vascular, Inc. finding that the clot-stopping vein filter known as a G2 model IVC filter, (an Inferior Vena Cava filter) manufactured by Bard broke apart in her body, and returned a verdict citing that the device maker was responsible for 80 percent of the harm. They also said that Bard is liable for punitive damages in addition to the $2 million in actual damages award, with the hearing on punitive damages taking place right after the initial verdict announcement.

The punitive damages phase of the first bellwether over the IVC device began immediately after the early Friday verdict in the Sherr-Una Booker v. C.R. Bard, Inc et al, Case No. 16-CV-0474-PHX-DCG litigation, US District Court of Arizona in front of Judge David G. Campbell.  The Booker trial is the first “bellwether trial” in the more than 3,500 other IVC filter lawsuits pending in the Bard IVC Filters Litigation MDL 2641, before Judge Campbell. The verdict came fairly quickly after just six-and-a-half hours of deliberations that started Thursday. The jury said Bard was not liable for strict liability, which will probably be appealed by Ms. Bookers counsel. We will update this article with the results of the punitive damage hearing as soon as they become available.

BARD IVC FILTER PROBLEMS

Bard’s IVC filters, including its Recovery, G2, Meridian, and Denali product lines, are the target of over 3,500 injury claims in the Bard IVC Filters Products Liability Litigation MDL 2641 currently pending before the court in the District of Arizona. The thousands of lawsuits  filed against the two Bard companies claim they concealed dangerous side effects associated with their retrievable IVC filters – including filter migration, fracture, organ perforation, embolization, and inferior vena cava punctures – and failed to warn doctors and patients about these risks. In addition to the Bard MDL 2641 cases, there is other litigation against smaller IVC manufacturers, Cordis Corporation Rex Medical, Argon Medical, and B. Braun who are all facing  IVC lawsuits in state and federal courts across the country.

BARD FAILURE TO WARN

IVC filters are implanted into the inferior vena cava – the body’s largest blood vessel – to intercept blood clots before they can travel to the heart and lungs. The devices are indicated for patients at risk for pulmonary embolism, and who are unable to use standard blood-thinning medications. The filters involved in the C.R. Bard and Cook Medical litigations are retrievable, and are intended to be removed once a patient is no longer at risk for pulmonary embolism.

Plaintiffs pursuing IVC filter lawsuits against C.R. Bard and Cook Medical claim that the companies failed to provide doctors with adequate warnings and instructions for removal. They also claim that the devices are defectively designed, and accuse the two companies of concealing the risks associated with their blood clot filters.

The FDA has issued two safety alerts about using retrievable IVC filters.

  • The first was released in August 2010, after the devices were linked to hundreds of adverse events, including reports of filters fracturing and migrating to other areas of the body. In other cases, pieces of the filters perforated organs and blood vessels.
  • The FDA issued a second alert in May 2014 to remind doctors of the importance of IVC filter retrieval. A year earlier, a paper published in JAMA Internal Medicine found only 8.5% of retrievable IVC filters were successfully removed.

“In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the authors of the report concluded. “More comprehensive longitudinal data would likely identify additional complications.”

Additional research has shown in the last 30 years an estimated 30,000 IVC filters have been implanted. But it wasn’t until 2010, after they’d received thousands of adverse event reports, that the FDA finally issued a warning citing the risk of retrievable filter injuries. It took another four years for the FDA to strengthen the warning when in 2014 they implored doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has lessened.

BARD KNEW OF DANGERS

In 2015 after the FDA issued the second IVC warning, a bombshell media report claimed C.R. Bard continued to market and sell their inferior vena cava (IVC) filters even after the company became aware the filters were failing and causing serious injuries and even death. The report went on to link at least 27 deaths and more than 300 injuries to failures associated with C.R. Bards Recovery Model IVC filters. The investigative report also uncovered that IVC devices made by C.R. Bard and Cook Medical had been linked to hundreds of adverse event reports where they punctured the vena cava, tilted out of position or migrated or broke apart and caused metallic fragments to travel to the heart or lungs – a condition known as embolization. Even after C.R. Bard was warned about the problems, they continued to sell the devices, without warning the doctors of the defects and injuries.

With 3,500 additional cases remaining the the Bard IVC Filter litigation docket, it seems that the Bard entities may need to prepare for a long and protracted legal fight, unless they determine settlement discussions are the best legal strategy to prevent future plaintiff wins.

 

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WEEKLY MDL and MASS TORT UPDATE by Mass Tort Nexus (February 2, 2018)

 

Week of January 29, 2018

This Week in Mass Torts Around The Country:

By Mark A. York

 

 

Xarelto MDL 2592: Are Settlement Talks Coming to Xarelto Litigation?

> During the January 30, 2018 monthly status conference hearing in Xarelto products liability MDL No. 2592, US District Court Judge Eldon Fallon stated that this MDL is nearing its end, and “I need to devise an end game,” as he now seems to be pushing both sides toward a resolution. He also referred to selection of cases to remand where 400 cases each will be selected by plaintiff and defense counsel and 400 more by the court, for a total of 1200 cases being designated for remand back to the court of original jurisdiction for trial or settlement.

Full hearing transcript: XARELTO MDL 2592 Judge Fallon January 31, 2018 Hearing Transcript

 Related-Xarelto Docket briefcase: XARELTO MDL 2592 US District Court ED Louisiana Judge Fallon

Opioid Crisis:

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

>  Insys Therapeutics Sued by New York Attorney General for “Opioid Marketing Abuses” Even After MDL Judge Schedules Settlement Conference Inviting State AG’s

How will Opiate MDL 2805 Judge Polster view NY AG’s suit after he requested states attend his January 31, 2018 full day opioid “settlement” meeting in Cleveland? More than 200 attorneys for city and county governments as well as unions and others met all day in closed door meetings. The day included presentations by non-legal “opioid experts” including Dr. Anna Lembke from Stanford, Dr. Aaron Kesselheim from Harvard Medical School who offered views on the who, how and why the opioid drug makers were able to create the opioid crisis, including how Congress hindered attempts at controlling Big Pharma as well as Joseph Rannazzi, former DEA Head of Diversion Control who spoke to restrictions on DEA enforcement against opioid abuses by drug manufacturers and distributors.  

>New York State Attorney General Eric T. Schneiderman on Thursday became the latest attorney general to sue Insys Therapeutics Inc. for allegedly misrepresenting that a spray version of the opioid fentanyl is safe for non-cancer patients and appropriate for mild pain.
Schneiderman alleged in state court that Insys’ marketing of the drug Subsys for unapproved uses caused physicians to overprescribe the treatment, exacerbating the opioid epidemic currently affecting New York and many other states. The MDL judge has stated he wants all parties to come to the settlement table with an open mind, however behind the scenes parties are expressing different views on a quick settlement, since more and more of the suits filed against “Opioid Big Pharma” are RICO claims and some parties want to punish the drug makers for creating the opioid crisis.

 Opioid Indictments:

Pennsylvania Appeals Court Affirms Doctor Conviction For Opioid Prescriptions

 

>A Pennsylvania appeals court panel on Jan. 26 affirmed a doctor’s sentence for illegally prescribing opioid medications and submitting fraudulent bills to insurance companies after finding that the jury was properly instructed about the state’s standards for properly prescribing the drugs (Commonwealth of Pennsylvania v. Lawrence P. Wean, Nos. 1165 EDA 2016, 1167 EDA 2016, Pa. Super., 2018 Pa. Super.

Insys Therapeutics Sales Manager Wants Term “Opioid Crisis” Barred From Trial

>A former Insys Therapeutics Inc employee going to trial for paying kickbacks to doctors to prescribe fentanyl, has requested the court bar U.S. prosecutors from referring to the “opioid crisis” at his trial. Defendant, Jeffrey Pearlman, a former Insys district sales manager , filed a motion asking a Connecticut  federal judge to bar references at his trial to the crisis and evidence the dangers opioids pose. His lawyers cited the “rampant media attention” devoted to opioids, stating  “jurors would likely have strong biases against someone like Pearlman whose company sold and marketed opioids:, even though Pearlman and Insys engaged in rampant illegal sales and marketing of Subsys, the Insys Theraputics, Inc. fast acting fentanyl based opioid drug. . Pearlamn is jusyt one of more than 15 people at Insys to be indicted, including billionaire founder, John Kapoor, and the entire Board of Directors, for marketing off-label prescriptions of Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

Rhode Island Doctor Pleads Guilty to Taking Kickbacks from Insys Therapeutics, Inc

>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.).

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:

See Bard IVC Filter MDL-2641 Briefcase

510(k) Defense Allowed In Bard IVC Bellwether Trial

>An Arizona federal judge overseeing the C.R. Bard Inc. inferior vena cava (IVC) filter multidistrict litigation on Jan. 29 denied a plaintiff motion to preclude evidence about the devices’ 510(k) clearance in an upcoming bellwether trial, but said he will put the evidence in context and will not allow it to be used as evidence that the devices are approved by the Food and Drug Administration (In Re:  Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641, No. 15-2641, Sherr-Una Booker v. C.R. Bard, Inc., et al., No. 16-474, D. Ariz.)

Cordis IVC Filters:

See Cordis IVC Filter Litigation Alameda County, California Superior Court

>California State Court Cordis IVC Plaintiffs Argue “No Mass Action” To US Supreme Court

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)

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.)

 Hip Implant Litigation

UTAH FEDERAL JUDGE ASK STATE SUPREME COURT “Does Unavoidably Unsafe Apply To Medical Devices”

A Utah federal judge on Jan. 23 asked the Utah Supreme Court whether the state recognizes the unavoidably unsafe product doctrine for medical devices, such as hip implants, as well as drugs  (Dale Burningham, et al. v. Wright Medical Group, Inc., No. 17-92, D. Utah)

Most Wright Profemur Hip Claims Dismissed in Iowa Federal Court Ruling

See: Wright-Medical-Inc-MDL-2329-Conserve-Hip-Implant-Litigation

>An Iowa federal judge on Jan. 26 dismissed most claims in a metal-on-metal hip implant lawsuit and found no personal jurisdiction of Wright Medical Group Inc. (Rebecca Dumler, et al. v. Wright Medical Technology, Inc., et al., No. 17-2033, N.D. Iowa, Eastern Div).

Related Article: Federal Judge Joins Plaintiff Cases in Wright Profemur Hip California Litigation

Diabetes Drugs

Actos Cases Dismissed in California Court: 2014 Global Settlement Applies

>A California federal judge on Jan. 25 dismissed for lack of jurisdiction an Actos class action because the four plaintiffs previously settled their individual claims against the diabetes drug maker Takeda Pharmaceuticals America Inc. (Gary Bernor, et al. v. Takeda Pharmaceuticals America Inc., et al., No. 12-04856, C.D. Calif)

Birth Control

Non-Missouri Plaintiffs Dismissed From Essure Litigation “No Personal Jurisdiction”

>A Missouri federal judge dismissed 92 plaintiffs from a multiplaintiff Essure lawsuit Jan. 24, finding that the court lacked personal jurisdiction over the non-Missouri plaintiffs see Bayer-Essure Missouri Federal Court Order Dismissing All Non- Missouri Plaintiffs Jan 24, 2018 (Nedra Dyson, et al. v. Bayer Corporation, et al., No. 17-2584, E.D. Mo., Eastern Div.)

Mirena IUD:

>2nd Circuit Appeals Court Excludes Mirena MDL Experts—Litigation Terminated

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)

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

Testosterone Replacement Therapy:

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

>Seventh Circuit Appeals Court: “Premeption Applies to Thousands of Depo-T Cases”

CHICAGO — The Seventh Circuit U.S. Court of Appeals on Jan. 19 said a regulatory quirk in how the testosterone drug Depo-T is classified means that thousands of product liability claims involving the drug are preempted (Rodney Guilbeau, et al. v. Pfizer Inc., et al., No. 17-2056, 7th Cir., 2018 U).

>Defense Wins 4th AndroGel MDL Bellwether Trial

An Illinois federal jury on Jan. 26 returned a defense verdict for AbbVie Inc. in the fourth AndroGel multidistrict litigation bellwether trial (Robert Nolte v. AbbVie, Inc., et al., No. 14-8135, N.D. Ill.)

Fosamax MDL 1789:

See Mass Tort Nexus Briefcase Re: MDL 1789 Fosamax Products Liability Litigation USDC New Jersey and FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS) BRIEFCASE

>Fosamax Plaintiffs Request Supreme Court To Deny Merck Preemption Argument

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.)

 

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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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Court Sets Lineup for Cook IVC Filter Bellwether Trials

Cook Celect® IVC Filter
Cook Celect® IVC Filter

US District Judge Richard L. Young, overseeing Cook Medical, Inc., IVC Filters Product Liability
Litigation, MDL 2570, ruled that the first bellwether trial will focus on the Celect IVC filter, and the second on the Gunther Tulip filter.

The current lineup is:

  1. Hill v. Cook Medical, Inc., 1:14- cv-6016-RLY-TAB. In this case, the Celect filter was implanted before Ms. Hill’s scheduled back surgery. She claims the filter migrated and perforated her vena cava and duodenum. She was 57 years old at the time. After at least one failed retrieval attempt, the Celect filter was successfully removed percutaneously two years after implant using advanced retrieval techniques.
  2. Gage v. Cook Medical, Inc., 1:14-cv-1875-RLY-TAB. Mr. Gage was implanted with the Günther Tulip filter after experiencing gross hematuria while on anti-coagulation medicine. He was 61 years old at the time, and has a history of pulmonary embolism and deep vein thrombosis. Mr. Gage alleges that the Günther Tulip filter perforated his vena cava and cannot be removed.
  3. Brand v. Cook Medical, Inc., 1:14-cv-6018-RLY-TAB.  Ms. Brand was implanted with a Celect filter before her scheduled back surgery, as she had experienced a deep vein thrombosis in 2007. She was 51 years old at the time of the implant. More than two years after surgery, she learned that the Celect filter had two fragmented legs. An attempt to remove the filter percutaneously was abandoned after several unsuccessful attempts to snare the hook of the filter from her caval wall. Four years later, she underwent an open surgery, wherein the filter was removed but the fractured pieces from the filter could not be recovered and remain in her body.

900+ cases

More than 900 cases against Cook Medical are consolidated in a multi-district litigation docket (MDL) in the Southern District of Indiana in Indianapolis. The small, umbrella-like devices are implanted for prevention of pulmonary embolism and they perforate the vena cava, migrated out of position or fracture, sending fragments or metal shards into the heart or lungs.

“Gage is more representative than Brand of the types of injuries and retrieval challenges at issue in this MDL,” Judge Young wrote. Furthermore, according to Cook, approximately 45% of the plaintiffs in the  MDL had a Günther Tulip filter implanted. Gage is the only Günther Tulip case selected as a bellwether. “For these reasons, the court finds trying Gage second furthers the goals of the bellwether selection process. Accordingly, Gage will be the second bellwether trial.”

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New Research: IVC Filters Don’t Save Lives in Trauma Patients

Bard Denali IVC Filter
Bard Denali IVC Filter

New research in JAMA Surgery concludes that IVC filters don’t save lives in trauma patients, who are at increased risk of bleeding and thrombosis, and the devices should not be placed in trauma patients in an effort to decrease all-cause mortality.

“The research herein demonstrates no significant difference in survival in trauma patients with vs without placement of an IVC filter, whether in the presence or absence of venous thrombosis. The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place,” the study concludes.

See Association Between Inferior Vena Cava Filter Insertion in Trauma Patients and In-Hospital and Overall Mortality by Shayna Sarosiek, MD, Denis Rybin, PhD, Janice Weinberg, ScD, Peter A. Burke, MD, George Kasotakis, MD, and J. Mark Sloan, MD.

Should not be placed in trauma patients

“The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place,” the researchers said. “Given the expected morbidity of long-term IVC filter use, filters should be removed as soon as a patient’s contraindication to anticoagulation resolves.”

“Overall, these data indicate that IVC filters should not be placed in trauma patients in an effort to decrease all-cause mortality.”

Litigation against the makers of IVC filters is one of the largest mass torts today. “All these products are defective,” Mass Tort Consultant John Ray said, speaking in a webinar presented by The National Trial Lawyers. “I cannot say that one product is less defective than other.”

  • There are 886 cases in Bard IVC Filter Litigation in MDL 2641 before Judge David G. Campbell in US District Court in Arizona.
  • There are 993 cases in Cook Medical IVC Filter Litigation in MDL 2570 before Chief Judge Richard L. Young in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark.
  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Ray.
  • Similarly, there is no MDL for cases against Rex Medical and Argon Medical. Plaintiffs have filed cases in the Philadelphia Court of Common Pleas before Judge Arnold New, who has assigned them to the complex litigation track.

Venous thromboembolism is a significant cause of death in the United States. Approximately 900,000 patients per year have a clinically significant deep vein thrombosis or pulmonary embolism. Since the invention of the permanent percutaneous IVC filter in 1973 and the retrievable IVC filter in the 1990s, its use has become a standard part of treatment for select patients with acute lower-extremity venous thrombosis who cannot receive anticoagulation.

 

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No Deposition for Bard President over Memo on IVC Filter Study

Jim C. Beasley Group President
Jim C. Beasley
Group President

US District Judge David G. Campbell ruled that plaintiffs in the Bard IVC Filters Products Liability Litigation cannot depose a top company executive about a 2010 memo he wrote to six Bard executives about a filter study.

However, the plaintiffs are free to try again later.

The executive, Jim Beasley, is a group president of C.R. Bard Inc. and was president of Bard Peripheral Vascular Inc. from 2007 to 2012. At the time Beasley was responsible for hundreds of Bard products.

The plaintiffs want to question him about the mystery memo, but the judge said “no” on August 29.  There Are 810 cases pending in MDL 2641, Case No. 15-md-2641 (Click to see sample long form complaints).

“The Court concludes that Beasley ‘is clearly a high-level executive,’ and that the apex doctrine therefore applies,” the judge held.  Klungvedt v. Unum Grp., Case No. 2:12-CV-00651-JWS, (D. Ariz. Feb. 13, 2013). “The relevant questions, then, are ‘whether the executive has unique, first-hand, non-repetitive knowledge of the facts at issue in the case and whether the party seeking the deposition has exhausted other less intrusive discovery methods.’”

The exhibits provided by Plaintiffs:

  • Suggest that someone named Mark was going to talk to Beasley about a filter study.
  • Confirm that Beasley was the author of a management memo written in 2010.
  • Beasley addressed the memo to Tim Ring and copied to at least five others.
  • It contained speculation by Daniel Orms about what Beasley might have known or done in connections with the memo.

However, the materials did not show that Beasley has unique, first-hand, non-repetitive knowledge of the facts at issue in this case, nor that Plaintiffs have exhausted other less intrusive discovery methods to obtain relevant information.

“The Court therefore concludes that Beasley should not be deposed at this time. If Plaintiffs conclude that they can make the required showing at a later point during the discovery period, they may raise this issue again with the Court.”

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New IVC Filter Lawsuit Filed in Arizona MDL

Bard Meridian IVC Filter 2011
Bard Meridian IVC Filter 2011

A woman who was injured by a defective Meridian IVC Filter made by C.R. Bard has filed a lawsuit, according to the Daily Hornet.

The lawsuit was filed by Juliette Boyd, a woman from Florida who was implanted with the Meridian® Vena Cava Filter in September 2012. She is represented by Ben C. Martin of the Law Offices of Ben C. Martin in Dallas, Texas.

She accuses C.R. Bard of negligence for selling a defective medical device, failing to warn about side effects, and concealing safety risks.

It took the FDA 10 years to issue a safety communication stating on May 6, 2014 that “the risk of having an IVC filter in place is expected to outweigh the benefits.” Later that year the FDA started a nine-month investigation and issued two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC-filters facilities.

800 lawsuits

US District Judge David G. Campbell has ordered that cases be heard together in In Re Bard IVC Filters Product Liability Litigation, MDL 2641, where at least 810 lawsuits are pending against C.R. Bard. Another 800 lawsuits are pending in a similar litigation against Cook Medical.

Meridian is a temporary filter that is implanted in the inferior vena cava (IVC). It catches blood clots before they travel to the lungs and cause a pulmonary embolism.

The Meridian is very similar to other IVC filters made by C.R. Bard — including the G2 and Recovery — which have been linked to a 12% fracture risk in recent studies.

The FDA now recommends removing temporary IVC filters within 29-54 days. The longer they remain implanted, the higher the risk of complications.

The case was consolidated in a Multi-District Litigation (MDL No. 2641)

The lawsuit was filed on August 19 in the U.S. District Court for Arizona, Case No. 2:16-CV-02791.

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Federal Court Orders Bellwether Trials in Cook IVC Filter Cases

Cook Celect® IVC Filter
Cook Celect IVC Filter

U.S. District Judge Richard Young ordered that three IVC filter cases pending against Cook Medical go to trial in 2017. The cases will be tried in MDL No. 2570 IN RE: Cook Medical, Inc., in the Southern District of Indiana.

Judge Young on July 19 identified three trial plaintiffs and types of filter:

  • Brand v. Cook Medical, Inc. et al., Case No. 1:14-cv-6018 (Celect)
  • Gage v. Cook Medical, Inc. et al., 1:14-cv-1875 (Günther Tulip)
  • Hill v. Cook Medical, Inc., et al, 1:14-cv-6016 (Celect)

Hundreds of Cook and Cordis IVC Filter cases are already filed, and hundreds of thousands of potential clients nationwide who need attorneys.

Rapacious greed of two companies

The cause of the litigation is the rapacious greed of the two companies competing to get market share, rolling out one defective product after another for the last 16 years, brushing aside reports of patient deaths and lying to the FDA about it.

  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • Bard IVC Filter Litigation is consolidated in MDL 2641 (multi-district litigation docket) in US District Court in Arizona.
  • Cook Medical IVC Filter Litigation is consolidated in MDL 2570 in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark. The federal district court has created a short form complaint.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Mass Tort Consultant John Ray.

The small, umbrella-like devices are implanted for prevention of pulmonary embolism and they perforate the vena cava, migrated out of position or fracture, sending fragments or metal shards into the heart or lungs.

On May 12, Magistrate Baker denied Cook’s motion for a protective order. “Cook tries to distinguish Bard [Bard IVC Filters Products Liability Litigation, MDL 15-02641-PHX DGC (D. Ariz. April 1, 2016] on the basis that the defendant in that case had received an FDA warning letter, whereas Cook has not. This strikes the Court as the proverbial distinction without a difference. Warning letter or not, case law supports a finding that this information is relevant and discoverable,” he wrote.

 

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IVC Filter Litigation Is the Hot, Trending Practice Area

Lawyer Troy Brenes
Troy Brenes

Litigation involving Cook and Cordis IVC Filters is now the hot, trending practice area for mass tort lawyers, with hundreds of cases already filed, and hundreds of thousands of potential clients nationwide who need attorneys.

“These devices cause the one thing they are design to prevent —  blood clots,” says said Troy Brenes of Aliso Viejo, California, a lawyer who is active in IVC Filter litigation. “They cause the development and increase risk of thrombosis and pulmonary embolism.”

The cause of the litigation is the rapacious greed of the two companies competing to get market share, rolling out one defective product after another for the last 16 years, brushing aside reports of patient deaths and lying to the FDA about it.

  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • Bard IVC Filter Litigation is consolidated in MDL 2641 (multi-district litigation docket) in US District Court in Arizona.
  • Cook Medical IVC Filter Litigation is consolidated in MDL 2570 in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark. The federal district court has created a short form complaint.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Mass Tort Consultant John Ray.

Brenes and John Dalimonte of Boston spoke on a recent webinar about the litigation sponsored by the Consumer Attorney Marketing Group. 

Plaintiff Numerosity

John Dalimonte
John Dalimonte

The number of potential plaintiffs is immense: Since 2000, Cook has sold 264,006 Tulip Filters and 129,089 Celect Filters. Attorneys Brenes and Dalimonte estimate that 200,000 Cordis filters have been inserted into patients.

Settlement values of the cases are unknown, and a settlement conference on June 7 with Cook “went nowhere.” The first bellwether trials are scheduled for next year.

IVC filters are small, cage-like devices that are inserted into the inferior vena cava – a major vein leading directly to the heart. They were supposed to capture blood clots and prevent them from reaching the lungs.

However, Dalimonte identified three issues with the Cook Tulip and Celect IVC Filters:

  • Migration downward and upward. The IVC Filters can tilt or shift, making them almost impossible to remove.
  • Device fracture, causing blood clots (embolism) in the heart, lung, liver and kidneys. Research shows that the devices experienced fracture rates of 37% to 40% after five and a half years.
  • Perforation, where stress on the IVC Filter struts leads to fractures that puncture adjacent organs and vessels.

“There are a lot of cases out there,” Dalimonte says, because the manufacturers conducted off-label marketing directly to bariatric patients, trauma patients and orthopedic surgery patients.

Brenes and Dalimonte will be speaking at the upcoming AAJ annual convention, July 22-25 in Los Angeles. 

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Class Action Charges Company Lied to Cover Up Defective Bard IVC Filter

Bard Recovery IVC Filter
Bard Recovery IVC Filter

A federal judge consolidated a new class action lawsuit — brought by patients in 16 states against C.R. Bard, Inc., makers of the defective Bard IVC Filter — into a multidistrict litigation docket in Arizona.

The class action charges that Bard executives:

  • Promoted its defective blood clot filters starting in 2004 despite immediate and many reports of patient deaths.
  • Lied to the government about the widespread extent of patient deaths and adverse events.
  • Lied to its own sales force about the dangers of the medical device to preserve its market share and to boost its stock price.
  • Repeatedly introduced new models that had the same design and manufacturing defects as the older models.
  • Used a regulatory shortcut to bypass the FDA’s more rigorous approval process for new devices, and obtained “clearance” under Section 510(k) of the Medical Device Amendments to the Food, Drug, and Cosmetic Act

Tragically, it took the FDA 10 years to issue a safety communication stating on May 6, 2014 that “the risk of having an IVC filter in place is expected to outweigh the benefits.” Later that year the FDA started a nine-month investigation and issued two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC-filters facilities.

US District Judge David G. Campbell, acting on a stipulation by the parties on June 22, 2016, ordered that the case be heard together with hundreds of other cases in In Re Bard IVC Filters Product Liability Litigation, MDL 2641.

The case is Maria E. Barraza v. C.R. Bard, Inc., and Bard Peripheral Vascular, Inc., Case 2:16-cv-01374-DGC. The lead attorneys are Ramon R. Lopez of Lopez McHugh in Newport Beach, CA, and Wendy R. Fleishman of Lieff Cabraser Heimann & Bernstein of New York.

In a Master Answer, Bard denies that there is any factual or legal basis for relief.

Medical monitoring

The plaintiffs are seeking an injunction to create a court-supervised medical monitoring fund for plaintiffs. It would pay for:

  1. A notice campaign to all class members informing them of the availability and necessity of the medical motoring protocol
  2. A “catheter venography” to be performed on every class member who still has a Bard IVC filter installed by an interventional radiologist who will consult with the class member’s physician within 60 days to decide if retrieval is clinically necessary.

Also the plaintiffs seek +$5 million in damages for negligent design and manufacture, and fraudulent concealment of dangers Bard was aware of.

The lawsuit outlines the history of IVC filters that Bard rolled out:

  • Recovery Filter System, launched in 2004
  • G2 Filter System (permanent), launched in 2005
  • G2 Express System (removable), launched in 2008
  • Eclipse Filter System, launched in 2010
  • G2X System, launched in 2011
  • Meridian Filter System, launched in 2011
  • Denali Filter, launched in 2013

“The design of the Meridian is based on the Eclipse filter, which, in turn, is based entirely on the G2 filter, which, in turn, is based on the Recovery Filter,” the complaint says. All the “IVC filters were fracturing, perforating, migrating, and/or tilting in the patients in which they were implanted.”

“These devices are potential ticking time bombs implanted in unsuspecting patients.” An IVC filter is designed purportedly to filter or “catch” blood clots that travel from the lower portions of the body to the heart and lungs.

Patient injuries include:

  • Death
  • Hemorrhage
  • Cardiac/pericardial tamponade (pressure caused by a collection of blood in the area around the heart)
  • Cardiac arrhythmia and other symptoms similar to myocardial infarction
  • Severe and persistent pain
  • Perforations of tissue, vessels and organs

FDA shortcut

Read our shocking report: How did IVC Filters Obtain FDA Approval without Proving they were Safe and Effective

To rush the devices to the market, Bard repeatedly used the Section 510(k) shortcut to get a “clearance,” from the FDA, claiming the filter was substantially similar to its existing device. A 510(k) review is completed in an average of 20 hours by the FDA.

Bard avoided the more rigorous “premarket approval” (PMA) process, which must include data sufficient to demonstrate that the IVC Filters is safe and effective. The FDA takes 1,200 hours to complete a PMA review.

Section 510(k) notification requires little information, rarely elicits a negative response from the FDA, and gets processed quickly.

Once placed on the market, Bard immediately became aware of numerous confirmed events where its Recovery filter fractured, migrated, or perforated the inferior vena cava, caused blood clots, and caused serious injury, including death. About a month after the full-scale launch of the Recovery filter, on February 9, 2004, Bard received notice of the first death associated with this filter.

On July 9, 2004, a Bard safety analysis found that the Recovery filter had a reported failure rate that was 28 times higher than all other IVC filters.  Peer-reviewed medical literature found that among 363 patients implanted with the Recovery filter and 658 patients implanted with the G2 filter, the devices experienced fracture rates of 40% and 37.5%, respectively, after five and a half years.

A review of the FDA MAUDE database from 2004 through 2008 shows that Bard IVC Filters are responsible for the following percentages of all IVC filter adverse event reports:

  • 50% of all adverse events
  • 64% of all occurrences of migration of the IVC Filters
  • 69% of all occurrences of vena cava wall perforation
  • 70% of all occurrences of filter fracture.

Cover-up campaign

Instead of pulling the Recovery filter off the market, Bard started a coverup. By April of 2004, at least three deaths had been reported to Bard. The company concealed this information from doctors and patients and hired the public relations firm Hill & Knowlton to address anticipated publicity that could affect stock prices and sales.

Bard lied to its own sales force to keep pushing the IVC filters. By December 2004, Bard’s own internal safety procedure deemed the Recovery filter not reasonably safe for human use. Yet the company gave mandatory scripts to its Bard IVC filter sales force, which required salespeople to falsely tell physicians that the Recovery filter was safe because it had the same reported failure rates as all other filters, according to the complaint.

Meanwhile Bard gave false information to the FDA’s MAUDE adverse-events database. The FDA discovered that Bard had reported multiple serious injuries and a death as non-injurious “malfunctions.”

FDA finally acts

In 2010, the FDA issued an advisory to physicians and clinicians noting that it had received 921 device adverse event reports involving IVC filters. But the FDA said only that it was “concerned” about the retrievable IVC filters. It recommended that physicians consider removing the filter as soon as protection from a pulmonary embolism is no longer needed.

In 2014, the FDA issued Bard two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC filter facilities. An audit showed that Bard had underreported 274 out of 939 adverse events.

Finally, on May 6, 2014, the FDA issued an updated safety communication about IVC filters. The FDA reported that “the risk of having an IVC filter in place is expected to outweigh the benefits.”

Accordingly, the plaintiffs’ proposed Medical Monitoring Protocol aims to reduce complications by aiding in the detection and remediation of any malfunction and also generally provides awareness of the issue so it can be investigated. Without this protocol, many if not most patients implanted with these IVC Filters will not even be aware of the serious risk they are in.

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