DePuy Pinnacle Plaintiffs Request Cases Be Remanded For Trial in Hip Implant MDL 2244

Plaintiffs Request Remaining Pinnacle MDL 2244 Cases Be Remanded For Trial 

Mark A. York (February 9, 2018)

A DePuy Pinnacle Hip Implant Component

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Plaintiffs have asked U.S. District Court Judge Ed Kinkeade, Northern District of Texas, who’s hearing thousands of hip implant lawsuits in the DePuy Orthopaedics’ Pinnacle Hip MDL 2244, to remand their cases to the original court of filing for individual trial dates.

According to the February 5th motion filed with the U.S. District Court, plaintiffs request the Court begin an “orderly and efficient staggered remand process,” where both plaintiffs and defense would select 10 cases each for remand to federal courts in California, New York and Texas, for a total of 60 cases being set for trial starting in 2019.

There were further requests that the Court begin not only the remand process, but start phased MDL discovery as well in peripherally related cases alleging RICO, qui tam and other non-personal injuries as part of the metal-on-poly hip revision lawsuits currently pending in the multidistrict litigation.

DePuy Pinnacle Implants and Metallosis

DePuy Orthopaedics,  a subsidiary of Johnson & Johnson, have been named in more than 9,500 hip replacement lawsuits involving the metal-on-metal Pinnacle hip system, which utilizes the Ultamet liner, pending in the multidistrict litigation (see DEPUY MDL 2244 Pinnacle Hip Implant Briefcase) currently underway in the Northern District of Texas.

Plaintiffs allege that the metal-on-metal design within the Ultamet liner configuration can cause dangerous amounts of toxic metal debris to be released into the joint surround the hip, and into the blood stream resulting in metallosis, causing adverse local tissue reactions, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the DePuy hip implant components.

 DePuy/J&J Loses Bellwether Trials

So far, the Pinnacle hip MDL 2244 litigation has convened four bellwether trials related to the metal-on-metal implants with the trial in October 2014, ending with a verdict for DePuy and Johnson & Johnson, which to date, is the only defense win in this litigation.

In the second trial, plaintiffs were awarded a verdict of $500 million in March 2016, however, Judge Kinkeade ultimately reduced the award to $151 million, based on Texas statutes that limit punitive damages. The third bellwether trial ending in December 2016, resulted in a massive billion dollar verdict, when six Pinnacle recipients who were residents of California were awarded more than $1 billion, with 90 percent of the verdict being punitive in nature, meant to send a clear message to the defendants. California does not have a limit on punitive damages, but the judge reduced the award to $543 million, based on the US Supreme Court ruling limiting excessive punitive damages. The most recent trial resulted in the plaintiff being awarded $247 million in November 2017.

J&J Wants To Avoid More Massive Verdicts

J&J are simply using every legal tool available to them, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip  trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to its various medical device and pharmaceutical product lines.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials. Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure.  Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the Pinnacle hip system. The New York Times stated that the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

Artificial hips are designed to last for 15 years in the best of situations, often that is not the case with many implants failing after just 10 years, and in the case of design defects such as those alleged in Pinnacle devices and many other hip implants, onset of metallosis and other adverse conditions resulting, as well as the ever present implant mechanical breakdown, which cause life altering health problems for patients.

FDA Issues Pinnacle Warning

The U.S. Food & Drug Administration issued a warning in January 2013, stating that patients receiving metal-on-metal hip replacements were more likely to experience premature device failure compared to those who received other types of implants.

In November 2013, DePuy Orthopaedics announced a $2.5 billion settlement in the DePuy ASR Hip Impant MDL2197 ( MDL 2197 DePuy Orthopaedics, Inc. ASR Hip Implant Briefcase), related to the ASR line of metal-on-metal hip implant components. DePuy ended sales of the all-metal Pinnacle hip system that same year, purportedly due to “low clinician use”. However, the company has so far declined to settle the Pinnacle hip litigation.

J&J Facing Many Legal Hurdles

Johnson & Johnson has been hit with numerous large jury verdicts across all areas of the J&J pharmaceutical and medical device operations, with plaintiff trial verdicts Risperdal, Ethicon TVM, Talcum Powder, Xarelto and other products, where recent combined trial verdicts have easily exceeded an additional $200 million. J&J and it’s subsidiaries are now facing more than 100 thousand lawsuits over it’s drug and medical device product lines, in both federal and state courts across the country. To complicate matters further for J&J, the recently started Opiate Prescription MDL 2804 (MDL 2804 Re: NATIONAL PRESCRIPTION OPIATE LITIGATION MDL 2804 Briefcase) names Johnson & Johnson as a defendant in suits filed by more than 400 cities, counties and states across the country.

 They Have Opioid MDL Issues Too

Perhaps J&J should look at settling some of the cases they’ve defended so aggressively over the last 5 years, such as the Pinnacle MDL 2244 to prepare for the Opioid Crisis litigation, which is now looking to displace Tobacco Litigation as far as size and scope as well as the massive multi-billion dollar settlements and years of ongoing litigation that came from lawsuits filed initially by governmental entities.

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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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JOHNSON & JOHNSON ACCUSED OF WITNESS TAMPERING IN TWO DIFFERENT TRIALS CURRENTLY UNDERWAY

Does Win At Any Cost Apply to J&J Legal Strategy Even At Trial?

By Mark York (November 7, 2017)

 

 

 

 

 

(Mass Tort Nexus)  Federal Judge Edward Kinkeade has requested the US Attorneys Office and the Federal Bureau of Investigations (FBI) open an investigation and question witnesses regarding potential witness tampering in a currently underway DePuy Pinnacle hip implant trial. The trial is taking place in the US District Court of Texas in Dallas. The trial is the third bellwether trial in Multidistrict Litigation No. 2244, where thousands of plaintiffs have filed suit in the DePuy Orthopaedics MDL 2244 Pinnacle Hip Implant Litigation. The last trial resulted in a massive initial verdict of $1 billion, subsequently reduced by Judge Kinkeade to just over $500 million.

DePuy, a subsidiary of Johnson and Johnson, has been sued along with J&J for their metal-on-metal Pinnacle hip devices, due to the release of cobalt and chromium metals into a patient’s body, resulting in the onset of metallosis, pseudotumors, and other adverse medical conditions which require surgery to remove the defective device, as well as ongoing treatment to address the related side effects.

As to J&J’s alleged witness tampering, Judge Kinkeade stated the potential witness tampering was “disturbing and disconcerting to me”. The issue revolves around interaction between am upcoming trial witness Dr. David Shein and a sales representative for DePuy. Dr Shein claims that during a surgical procedure he was warned of business ramifications,  in connection with his planned appearance as a witness during the DePuy Pinnacle trial.

Lead plaintiff trial attorney Mark Lanier noted:

“It is extremely concerning to me when there are requirements under the federal law, as well as state law, that witnesses not be tampered with, that—that it’s a serious felony, that it involves prison time, that it cuts to the core of who we are as a people and what our courts are about”

In the other witness tampering allegation during a current trial, J&J subsidiary Janssen Pharmaceuticals is accused of interfering with a treating physician and witness in the just started Xarelto trial in the Philadelphia Court of Common Pleas, see XARELTO Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation (PA State Court). This trial is the first state court Xarelto trial, where plaintiff Lynn Hartman filed suit against Janssen and Bayer over claims that Xarelto caused a major gastrointestinal bleed. The trial start was delayed by word that a meeting took place between a key witness, Dr. Timothy Aldridge, the plaintiff’s treating physician, and a Janssen sales representative.

Hartman’s lawyers said that scheduled testimony from Dr. Aldridge had essentially changed from indicating that Hartman had suffered a gastrointestinal bleed complicated by Xarelto, to denying whether he knew Hartman had suffered from a gastrointestinal bleed and being hostile to Hartman’s attorney.

Janssen claimed the meeting was routine, but opposing counsel claims that this contact, as well as the DePuy Pinnacle trial witness contact show a pattern of interference and a willingness of Johnson & Johnson employees to attempt to influence legal proceedings in ways that are often consider illegal.

In unsuccessful legal maneuvering, J&J requested a gag order to prevent the public from knowing about the DePuy trial witness tampering issue, but the judge denied their request. Prior verdicts against DePuy for Pinnacle Hip Implant cases included jury awards of $1.4 billion and $498 million in the two prior bellwether trials. The Xarelto trial tampering issue is still being reviewed by the court.

 

 

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Johnson & Johnson and DePuy Pinnacle Hip Implant Trial Continued Until September 18th Based on Appeal

Johnson & Johnson and DePuy Orthopaedics Latest “Pinnacle Hip Implant Trial” Continued Until September 18th Based on Fifth Circuit Appeal 

  • By Mark A. York (September 15, 2017)

  • Mass Tort Nexus

 

 

 

 

 

The latest bellwether trial in the  DePuy Pinnacle MDL 2244 (see DePuy Pinnacle Hip Implant MDL 2244 Briefcase) litigation has been postponed until September 18th, based on the U.S. Court of Appeals for the Fifth Circuit ruling, just days before the trial was to start, where they cited “grave error” by the sitting US District Court judge, in requesting a trial delay. The trial start date was September 5th, where eight plaintiffs from New York were part of the DePuy Pinnacle MDL 2255 multidistrict litigation, who are now facing jurisdictional issues based on the June 2017 SCOTUS “Plavix Ruling” that restricts jurisdiction over plaintiffs who are residents of another state, SCOTUS Plavix Jurisdictional Ruling Strikes Non-Resident CA Plaintiffs. The Plavix ruling forced thousands of non-California residents to determine if and where they can refile their claims against Bristol-Myers Squibb. DePuy Orthopaedics and it’s parent Johnson & Johnson (J&J) are asserting the Plavix ruling by stating that the New York residents are not subject to jurisdiction of the US District Court ND Texas and the trial should be stopped. This seems to fly in the face of the justification of certain tenants of the Joint Panel on Multidistrict Litigation rules of procedure, which assigned the DePuy Pinnacle Hip Implant cases to the Texas court to consolidate the many thousands of cases across the country.

 J&J Wants To Avoid More Massive Trial Verdicts

J&J are simply using evry legal tool available, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip Implant trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to it’s various other medical device and pharmaceutical product lines.

Appeals Panel Denies Writ of Mandamus Petition

On August 23rd, the Fifth Circuit panel denied Johnson & Johnson’s and DePuy Orthopaedics’ petition for writ of mandamus, which sought to halt the upcoming trial. However, two of the three panel members found that the judge proceeding over the consolidated DePuy Pinnacle litigation in Texas had allowed certain trials to take place before him which a “judicial error” including the one that as scheduled to begin yesterday where plaintiffs were New York residents. On September 1st, U.S. District Court Judge Ed Kinkeade of the Northern District of Texas issued an Order delaying the next DePuy Pinnacle hip replacement trial until September 18, 2017.

DePuy Pinnacle Hip Verdicts

The multidistrict litigation underway in the Northern District of Texas, DePuy Pinnacle MDL 2244, currently involves more than 9,000 hip replacement lawsuits related to the metal-on-metal version of DePuy Orthopedics’ Pinnacle hip system that utilizes the Ultamet liner. Plaintiffs claim that this configuration is defectively designed, as it sheds toxic metals into the joint surround the hip, as well as the blood stream, causing adverse local tissue reactions, metallosis, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the joint.

As of August 2017, MDL 2244 Pinnacle hip litigation has convened three bellwether trials. The first concluded in October 2014, with a verdict for DePuy and Johnson & Johnson.

In March 2016, five plaintiffs were awarded a total of $500 million at the close of the second DePuy Pinnacle trial, where the judge overseeing the case reduced the award to $151 million, in order to comply with Texas law governing punitive damages.

The largest hip implant trial verdict anywhere to date was in the DePuy MDL’s third bellwether trial which ended December 2, 2016, where six Pinnacle implant recipients, who were California residents, were awarded more than $1 billion in punitive damages, see $1 billion DePuy Hip Implant Verdict in MDL 2244, with the judgment later reduced to $543 million, by Judge Kinkeade.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials.  Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure.  Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the device named in Pinnacle hip replacement lawsuits. According to The New York Times, the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

 

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PA Court Allows Strict Liability Manufacturing Defect Claims Against Stryker

Stryker Gamma 3 Nail System
Stryker Gamma 3 Nail System

A federal judge, ruling on Pennsylvania law, allowed a strict liability manufacturing defect claim to proceed against Howmedica Osteonics Corp. and Stryker Corporation for the complete failure of their hip and leg prosthetic device.

Plaintiff Gary A. Smith had a Stryker Gamma 3 Nail System implanted on March 2, 2015. X-ray images taken on Sept. 30, 2015, showed that the Stryker nail had broken. As a result on April 26, 2016, Smith had to undergo a left total hip replacement, which became infected causing more medical consequences.

He filed strict liability, negligence, breach of implied warranty claims under Pennsylvania law. Gary A. Smith v. Howmedica Ostonics and Stryker Corporation, No. 17-1174, US District Court for Eastern District of Pennsylvania (April 27, 2017).

“In the absence of a controlling decision by the Pennsylvania Supreme Court, a federal court applying that state’s substantive law must predict how Pennsylvania’s highest court would decide this case,” Judge Wendy Beetlestone wrote.

“This Court predicts that the Pennsylvania Supreme Court would not bar strict liability claims asserting a manufacturing defect against medical device manufacturers under Comment k” to Section 402A of the Restatement (Second) of Torts.

Stryker is a defendant in other litigation including:

Other claims fail

The court, however, dismissed the plaintiffs’ claims for:

  • Strict liability claims asserting a design defect against medical device manufacturers.
  • Negligent failure to warn and to recall against medical device manufacturers.
  • Breach of implied warranty of merchantability.

A strict liability claim generally requires proof “(1) that the product was defective, (2) that the defect existed when it left the hands of the defendant, and (3) that the defect caused the harm.”

“Here, the plaintiffs have plausibly alleged a manufacturing defect strict liability claim. The existence of a manufacturing defect is satisfied by the allegation that the Stryker Gamma 3 Nail System broke down after it was implanted into Mr. Smith, where it was subjected to normal and anticipated use, and that there were no reasonable secondary causes,” the judge said.

“That it existed at the time it left Defendants’ control is plausibly suggested by the allegation that the product was manufactured and shipped by Defendants to Grand View Hospital, where it was ultimately implanted into Mr. Smith.”

“And causation follows from the allegation that the failure of the Stryker Gamma 3 Nail System necessitated a subsequent surgery to remove it, as well as a total hip replacement, which gave rise to a secondary infection. Therefore, the motion to dismiss the strict liability claim insofar as it asserts a manufacturing defect will be denied,” the judge said.

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Judge Awards $2 Million to Zimmer Hip Implant Plaintiff

Joseph Osborne, Jr., of Osborne & Associates in Boca Raton, Fla
Joseph Osborne, Jr., of Osborne & Associates in Boca Raton, FL.

Medical device manufacturer Zimmer Inc. has been ordered to pay more than $2 million to a New Mexico man for a defective Zimmer hip implant with an “unreasonably dangerous design,” following a two-week bench trial.

“This is the first case we know of that has gone to trial in the country, and a growing number of these are going to court,” said Joseph Osborne, Jr., of Osborne & Associates in Boca Raton, Fla., who represents medical device plaintiffs around the country. Osborne tried the case with Randi McGinn and Allegra Carpenter of McGinn, Carpenter, Montoya & Love, P.A., of Albuquerque, N.M.

The product in question is Zimmer’s dual modular hip implant, the M/L Taper Hip Prosthesis with Kinectiv Technology (“MLTK”) and a cobalt-chromium head.

In a 27-page decision, New Mexico Judge Nan G. Nash ruled that the defective design and insufficient testing caused likely permanent harm to the plaintiff, resulting in “metallosis,” or a buildup of cobalt debris harming the hip joint and contaminating blood.

“It is never appropriate to design a hip implant system that would create an unreasonable risk of injury to the health or safety of a patient,” Nash wrote, ruling for the patient on grounds of strict products liability.

The case is McDonald v. Zimmer Inc. and Zimmer Holdings, Case No. D-202-CV-201304060, Second Judicial District, New Mexico County for Bernalillo.

Separately, Zimmer is facing 466 lawsuits in MDL 2158 supervised by U.S. District Judge Susan D Wigenton in federal court in New Jersey. IN RE: Zimmer Durom Hip Cup Products Liability Litigation.

Two corrective surgeries

In February 2010, Michael Brian McDonald, an Albuquerque economist then in his sixties, was suffering right hip pain that was preventing him from his usual tennis and golf. That June, McDonald received the MTLK implant.

Initial recovery went well, but by May 2011, McDonald suffered from hip and groin pain and loss of flexibility, resulting in two corrective surgeries that October and November, during which the doctor implanted two new prostheses and replaced the cobalt-chromium head with a ceramic head.

After a lengthy recovery, McDonald sued and the case went to bench trial before Judge Nash December 12-23, 2016, in the Second Judicial District Court in Albuquerque.

In her March 31 ruling, Judge Nash wrote that the ordeal has forced McDonald to a permanent course of antibiotics, an end to golf and tennis, and the likelihood of a recurrent infection.

“It is more probable than not that Plaintiff will need a third, more complicated revision surgery in the future,” Nash wrote. “This surgery will cost approximately $250,000 and will involve removal of all of the implant components for a period of 2-3 months to try and kill the infection, during which Plaintiff will be wheelchair bound. If the infection can be successfully eradicated, another hip prosthesis will be implanted, necessitating the same type of physical therapy and recovery period as the first two revision surgeries.”

Product defect

The judge traced the product defect to Zimmer’s testing its components in isolation, but not their interactions together, which would have determined their potential harm.

“In designing the MLTK, Defendants knew that the use of dissimilar metals can result in a higher potential for corrosion and that wear debris from a junction of two dissimilar metals had been documented to be toxic and harmful to the human body,” she wrote.

In determining the damages of $2.027 million, Judge Nash apportioned it into $1 million for past and future pain and suffering, $480,000 for lost enjoyment of life, and the rest for past and future medical expenses, lost household services, and out-of-pocket expenses.

 

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11th Circuit Upholds $2.1 Million Verdict by Initially-Confused Jury in Wright Hip Case

The 11th US Circuit Court of Appeals upheld a $2.1 million judgment, excusing the initial confusion by a jury in the first bellwether trial in a multidistrict litigation involving over 500 cases about the Wright Medical Conserve “metal-on-metal” hip replacement device.

U.S. District Judge William S. Duffey Jr. of the Northern District of Georgia corrected the jury form, re-charged the jury, and ordered it to continue deliberating until it reached a final verdict on November 25, 2015, in Robyn Christiansen, v. Wright Medical Technology Inc., Case No. 16-12162.

Wright today faces 585 lawsuits over its metal-on-metal hip replacement in Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation.

A crunching sound

Christiansen received a Wright Conserve Hip Implant System in 2006. Six years later, she “felt and heard a crunching sound and then felt immediate, severe pain in her right hip and groin” while doing yoga. She was diagnosed with a loose and displaced acetabular cup, and forced to undergo revision surgery. During the procedure, her surgeon discovered “a metallosis reaction” in the joint around the implant.

At the trial, the jury initially filled out Question 1A incorrectly on the jury verdict form saying that the hip device was not defectively designed. Then it inconsistently awarded $662,500 in compensatory damages and $2.5 million in punitive damages. The judge told the jury to go back into the jury room and “please carefully read the instructions.”

Minutes later the jury returned and said it did not understand the verdict sheet. This time the judge added to the verdict sheet instructions: “If you answered NO to Question 1A, stop [regarding defective design]. Do not complete the remainder of the form.”

Half a day later the jury said one juror was refusing to deliberate. The judge interviewed the recalcitrant juror in open court, decided that the juror was unwilling to follow the instructions, and dismissed him or her. The seven remaining jurors returned to the jury room and reached the final verdict in 30 minutes:

  • The hip device was defectively designed and unreasonably dangerous.
  • It caused the plaintiff’s harm.
  • Wright did not meet its burden to prove that the device could not be made safe.
  • Wright made a negligent misrepresentation about the device.
  • Wright’s conduct was “willful and malicious,” “intentionally fraudulent,” or “manifested a knowing and reckless indifference towards, and a disregard of, the rights of others, including Ms. Christiansen.”
  • $1.1 million in compensatory damages.
  • $10 million in punitive damages, which the judge later reduced to $1.1 million.

Wright wanted judgment

On appeal Wright argued that the court failed to grant it judgment as a matter of law based on the jury’s first verdict sheet.

The 11th Circuit rejected the idea, because under Rule 49 of the Federal Rules of Civil Procedure the district court has authority enter judgment, order further deliberations, or order a new trial.

“From a review of the record, the district court acted in a neutral and non-biased manner in acknowledging and addressing the inconsistent verdict,” the appeals court said.

In November 2016 Wright agreed to settle 1,292 claims in consolidated litigation in Georgia federal court and California state court for $240 million, putting an end to the majority of the suits over the implants.

Patients who had revision surgery within eight years of their original Conserve, Lineage or Dynasty hip implant are eligible for the settlement.

  • Those implanted with the Conserve Cup —  the device with the most frequent failures — can receive $170,000.
  • Those who had the metal-liner Dynasty and Lineage devices can recoup $120,000, according to a statement from the plaintiffs’ leadership counsel.

Meanwhile, Wright also faces 74 lawsuits involving fractures of its Profemur long titanium modular neck hip device. It has been marketed by MicroPort Orthopedics, Inc. of Arlington, TN, since 2013.

On June 21, 2016, MicroPort recalled its Conserve Shell, Dynasty® Metal Liner, Procotyl® Metal Liner and Lineage® Metal Liner because of “an increasing overall trend in revisions from 2009 to present, and it was found that there was a specific hazard/harm for “suspected tissue reaction to metal debris.” The potential for a patient reaction when implanted with Metal on Metal THA is a known risk for this product technology. The typical impairment of tissue reaction is reversed by revision surgery to remove the old device and replace it with a new device.”

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Admitting Hip Replacements Cause Metallosis, Smith & Nephew Issues Urgent Recall

Smith & Nephew Modular SMF hip implant
Smith & Nephew Modular SMF hip implant

Admitting for the first time that its Modular SMF and Modular REDAPT femoral replacement hip systems cause toxic metallosis in patients, Smith & Nephew has issued an urgent field safety notice recalling thousands of the defective medical devices.

The recall affects 6,266 SMF and REDAPT hip systems in commerce, plus 13,671 modular neck hip prostheses in commerce — shipped from October 2008 through July 2016.

Based in Memphis, TN, Smith & Nephew has sold the Modular SMF and REDAPT implants for almost a decade. In its letter to doctors, the company admitted that “Smith & Nephew considers that patients implanted with the modular neck hip prostheses may be at greater risk of revision surgery than with comparable monolithic products.”

Metal-Related Adverse Events

The letter states, “We observed a rate of complaints higher than comparable monolithic hip prostheses. Metal-related complaints are trending upward year-on-year with an overall complaint rate (number of complaints/total implantations) of 0.527% for Modular SMF and 0.25% for Modular REDAPT Revision Femoral Hip Systems. Overall, the metal-related Adverse Events accounted for the highest category of complaints in both products.

“For patients that exhibit these symptoms, physicians may consider additional clinical follow-up which includes the following:

  • Cobalt/Chromium metal-ion level measurements in whole blood – metal ion levels in excess of 7ppb may indicate the potential for soft tissue reaction; and
  • Where appropriate and subject to the clinician’s assessment, further active evaluation of the potential soft tissue reactions either through ultrasound or cross-sectional imaging might be indicated.”

Hip litigation

In related litigation, plaintiffs who were injured by Smith & Nephew’s Birmingham Hip Resurfacing (“BHR”) system and R3 metal-on-metal liner (“R3”) have filed a motion with the Judicial Panel on Multidistrict Litigation to create new MDL No. 2775 in the US District Court for the District of Maryland.

The plaintiffs allege that the BHR and R3 devices have caused toxic levels of cobalt and chromium in the bodies of patients implanted with the devices, and caused other symptoms including metallosis, pain, adverse local tissue reaction, pseudotumor, bone and tissue necrosis, and other symptoms leading to revision surgery.

Modular femoral stems have been a big problem in orthopedics for years. Stryker Orthopedics had to recall two of its modular stems in 2012 because of very high failure rates. A total of 1,807 cases have been filed in MDL 2441 against Stryker before Sr. US District JudgeDonovan W. Frank in Minnesota.

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Bellwether Mediation in Mass Tort Litigation Promotes Settlements

Professor Adam Zimmerman, Loyola Law School, Los Angeles
Professor Adam Zimmerman, Loyola Law School, Los Angeles

Adam Zimmerman, Professor of Law, Loyola Law School, has published his new article “Bellwether Settlements” to SSRN.  The abstract is below:

This article examines the use of bellwether mediation in mass litigation. Bellwether mediations are different from “bellwether trials,” a practice where parties choose a representative sample of cases for trial to decide how to resolve a much larger number of similar cases. In bellwether mediations, the parties instead rely on a representative sample of settlement outcomes overseen by judges and court-appointed mediators.

The hope behind bellwether mediation is that different settlement outcomes, not trials, will offer the parties crucial building blocks to forge a comprehensive global resolution. In so doing, the process attempts to:

  1. Yield important information about claims, remedies, and strategies that parties often would not share in preparation for a high-stakes trial.
  2. Avoid outlier or clustering verdicts that threaten a global resolution for all the claims.
  3. Build trust among counsel in ways that do not usually occur until much later in the litigation process.

“Information-forcing” role

The embrace of such “bellwether settlements” raises new questions about the roles of the judge and jury in mass litigation. What function do courts serve when large cases push judges outside their traditional roles as adjudicators of adverse claims, supervisors of controlled fact-finding, and interpreters of law?

This article argues that, as in other areas of aggregate litigation, courts can play a vital “information-forcing” role in bellwether settlement practice. Even in a system dominated by settlement, judges can help parties set ground rules, open lines of communication, and, in the process, make more reasoned trade-offs. In so doing, courts protect the procedural, substantive, and rule-of-law values that aggregate settlements may threaten.

Following is the introduction:

A curious thing happened in a Bergen County court in New Jersey. In a case involving thousands of people with defective hip implants, the parties reached a $1 billion global settlement in record time through an unprecedented series of “bellwether settlements.”

For years, courts have relied on “bellwether trials” to resolve large numbers of similar lawsuits. In a bellwether trial, the parties select a small group of cases for jury trial out of a larger pool of similar claims. Steering committees of plaintiff and defense lawyers then use information gleaned from those trials to resolve the remaining cases. Bellwether trials have been used in many high-profile cases—most famously in the Vioxx litigation— and, most recently, in General Motors’s litigation over its defective ignition switches. As multidistrict proceedings begin to take up a larger portion of the federal docket, the use of bellwether trials will only grow.

But instead of bellwether trials, the Bergen County court organized a system of bellwether mediations. In a bellwether mediations, no jury decides the merits or value of the case. Rather, the parties—supervised by the court—rely on a structured sample of mediated settlements involving representative plaintiffs. The different settlement outcomes, much like a series of bellwether trials, are intended to offer the parties crucial “building blocks” of information to globally resolve the remaining cases.

Judge Brian R. Martinotti, the New Jersey state court judge designated to handle the selected cases, was incredibly successful. Following forty representative mediations, the parties resolved more than 2,000 lawsuits in New Jersey state court and a similar number of pending lawsuits in a parallel federal multidistrict litigation in Minnesota—all in one fell swoop. In the end, over 95 percent of the potential plaintiffs accepted settlement offers based on the global agreement.

The court’s complete embrace of a bellwether settlement scheme raises new questions for juries and judges. What do bellwether settlements mean when the procedures and outcomes lack any connection with a jury trial? By dispensing with the jury entirely, the parties arguably give up procedures that are thought to (1) encourage vigorous advocacy before neutral fact-finders, (2) promote fidelity to law by ensuring that settlements correspond to the merits of the dispute, and (3) provide a democratic bulwark against unelected judges who may harbor biases about what makes for a fair outcome.

Zimmerman, Adam S., The Bellwether Settlement (March 15, 2017). Fordham Law Review, Vol. 85 (forthcoming 2017). Available at SSRN.

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