12 Judges Will Try 20 AndroGel Trials In MDL 2545 Starting In Fall of 2018

“US District Court of Illinois Enacts A Real Rocket Docket In AndroGel MDL”

By Mark A. York (April 26, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Judge Matthew F. Kennelly, the Illinois federal judge overseeing AndroGel MDL 2545 also known as the Testosterone Replacement Therapy Multidistrict Litigation, has decided to go along with the 11 fellow district court judges who volunteered to try 20 bellwether trials involving AbbVie Inc.’s AndroGel between Oct. 2, 2018 and March 2019, see AndroGel MDL 2545 CMO No. 114 Re: Setting 20 Trials In Front of 12 Federal Judges, in the  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ilinois.

Judge Kennelly ordered the cases to be trial-ready by September 2018 and a second group by December.  He also told counsel that other judges in the district volunteered to assist him by trying cases throughout the fall and winter of 2018 and into the spring of 2019, with both sides agreeing to have the cases tried before different judges.  The judge said he will rule on all pretrial matters in the 20 cases, including summary judgments and in-limine motions, jury instructions and Daubert expert witness rulings, with each judge being given a trial-ready package of his rulings.

The judges who have agreed to hear trials in support of Judge Kennelly will be Chief Judge Ruben Castillo and Judges Virginia Kendall, Manish Shah, Rebecca Pallmeyer, Sara Ellis, John Lee, John Blakey, Robert Dow, Edmond Chang, Gary Feinerman and Jay Tharp.
Judge Kennelly said further trial dates after March 4 may be set by a future order.

AbbVie is facing more than 3,770 MDL Cases, see Mass Tort Nexus Briefcase Re: ANDROGEL-TESTOSTERONE-MDL-2545, which to date have resulted in plaintiffs bellwether trial verdicts in amounts ranging from $3 million up to $140 million with a single defense win. One main defendant, Eli Lilly chose to settle all their cases related the Axiron product line, see Eli-Lilly-Announces-Settlement-Of-All-Testosterone-Cases-in-MDL-2545. The Lilly action may have been a smart legal move, as the stacked up trials would be not only financially burdensome but would put major pressure on defense trial teams.

AbbVie declared 3,770 AndroGel claims in the MDL in its Nov. 11, 2017 10-Q report, and about 205 claims in various state courts, including more than 200 additional testosterone drug cases await judgment in Cook County Circuit Court, many involving Illinois plaintiffs. In one trial in the Cook County court,  involving a 66-year-old man who suffered a heart attack while taking AndroGel, resulted in a verdict in favor of AbbVie, but the man’s attorneys are seeking a new trial that will allow them to present evidence on the internal decision-making behind the company’s sales tactics. That evidence was not permitted in the initial trial.

PLAINTIFFS ARE AHEAD IN TRIAL VERDICTS

The first federal AndroGel case to go to trial in 2017 resulted in just a punitive damages award of $150 million, which was later vacated and a new trial ordered.  The retrial resulted in a $3.2 million verdict with compensatory and punitive damages. The second bellwether trial resulted in a $140.1 million verdict in 2017, with the third bellwether trial resulting in a verdict for the defense.

In the fall of 2017 Konrad bellwether trial, resulting in the punitive damage verdict of $150 million, which was the first case in the series of bellwether trials aimed at helping plaintiffs and manufacturers of AndroGel gauge the range of damages and define a legal strategy and settlement options, even though the large verdict was vacated, it sent a clear message to the parties.

With defense losing both of the initial bellwether trials doesn’t look good for the defense, see “ANDROGEL” JURY RETURNS $150 MILLION VERDICT IN 1st TESTOSTERONE TRIAL.  That jury’s decision to award punitive damages without granting compensatory damages was unusual and both sides continue to fight over the verdict’s validity in court, but shows that the plaintiffs seem to have viable claims at trial.

Plaintiffs across the country allege AndroGel has caused heart attacks, strokes and other injuries, and the company was aware of the increase in adverse events while marketing “off-label” use. AbbVie has defended the drug and responded that its marketing of AndroGel adhered strictly to uses approved by the Food and Drug Administration and they have remained in full compliance with all FDA standards.

Konrad, 56, had been using AndroGel for two months in 2010 when he suffered a heart attack, from which he has since recovered. In court pleadings, the company contended that Konrad’s heart attack was caused by other factors, which are are not related to being prescribed AndroGel, such as obesity and high blood pressure. It also said it made no misrepresentations about AndroGel’s safety, which now two juries have disagreed with to the tune of $290 million.

ANDROGEL WAS A BLOCKBUSTER FROM FIRST RELEASE

AbbVie’s AndroGel is one of the more dominant testosterone treatments In the ever growing Low-T market, with sales of $675 million in 2016, and was declared a blockbuster drug and moved earnings and shares higher as soon as AndroGel hit the market. However, there were concerns about the drug safety as far back as 2012 and the FDA took notice not long thereafter. In 2014, the FDA convened an advisory committee to consider the adverse cardiovascular outcomes associated with testosterone replacement therapy, and the committee recommended changing the product warning labels, the FDA then required AbbVie to add a warning about cardiovascular risk to AndroGel’s label in May 2015.

HEART ATTACK AND STROKE RISK

Testosterone replacement drugs are approved to treat certain low-testosterone conditions in men. Plaintiffs allege that manufacturers invented a condition called “low-t” and marketed it for the treatment of the normal aging process and to restore strength and virility. Instead, the plaintiffs say testosterone drugs cause heart attacks and strokes.

AbbVie and predecessor Abbott Laboratories Inc. make AndroGel, a topical gel, AbbVie has owned AndroGel for only part of the drug’s history. Abbott Laboratories acquired AndroGel in 2010, and AbbVie was spun off from the company three years later.

Other defendants included Eli Lilly and Co. which makes Axiron, also a topical gel, and as previously mentioned has chosen to settle all claims in the litigation.. Endo Pharmaceuticals Inc. makes Aveed and Delatestryl, both injection drugs, and Fortesta, a topical gel. Actavis plc makes AndroDerm, an adhesive skin patch. Auxilium Pharmaceuticals Inc. makes Testim, a gel. Pfizer Inc. and Pharmacia Inc. make Depo-Testosterone, an injection drug.

FDA ISSUED A WARNING

As listed in the Chicago Tribune article of March 4, 2015, see Testosterone drugs overused per FDA warning. Testosterone injections were first approved in the 1950s for men who had been diagnosed with hypogonadism, a form of abnormally low testosterone caused by disorders of the testicles, brain and other hormone-related organs. The But current labeling on the drugs is vague enough that companies have been able to promote them to millions of otherwise healthy men who simply have lower-than-normal levels of testosterone.

The FDA began reviewing the safety of testosterone drugs in January 2014 after two federal studies associated them with increased rates of heart attack, stroke and other serious problems. But other studies associated testosterone replacement with longevity.”The benefits and safety of this use have not been established,” the FDA said in a statement released in March 2015.

While men’s testosterone levels naturally decline after age 40, experts disagree on whether that drop actually leads to the issues like decreased energy and lower bone density. Additionally, testosterone levels change by the hour and are affected by a range of environmental factors, such as stress and sexual arousal.

How this unusual judicial move goes over at the trialsl remains to be seen, but there is a distinct message being sent by the courts, that failure to engage in serious settlement talks will result in cases being set for trial. Perhaps other courts across the country should try accelerating MDL case dockets to trial via such unexpected rulings, thereby resulting in more years long case dockets being cleaned up. Who this may benefit remains to be seen, as there will be 20 trial verdicts coming sooner as opposed to later , to answer questions such as this.

 

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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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Jury Finds AbbVie Misrepresented Risks of AndroGel and Awards $140 Million in Second Low-T Bellwether Trial

“AbbVie, Inc. Misrepresented Risks of AndroGel and Jury Awards $140 Million in 2nd AndroGel Low-T Trial”

By Mark A. York (October 17, 2017

Mass Tort Nexus

 

 

 

 

 

 

 

 

 

 

 

AbbVie loses again, a jury in Chicago ordered AbbVie, Inc. to pay more than $140 million on October 5, 2017 to a man who claimed the company misrepresented the risks of its testosterone replacement drug AndroGel prescribed for Low-T, causing him to suffer a heart attack. This is the second major loss for AbbVie in the AndroGel related MDL 2545, (Testosterone Replacement Therapy MDL 2545 Briefcase) in front of Judge Matthew Kennelly, US District Court ND Illinois, this verdict follows the July 24, 2017 verdict of $150 million in the first trial.

The verdict, handed down in federal court in Chicago, came in a lawsuit filed by Tennessee resident Jeffrey Konrad and his wife, the suit was filed in 2015. It is the second verdict against AbbVie to come out of more than 6,000 additional lawsuits against AbbVie and other companies consolidated in the Chicago court in front of Judge Kennelly. Kennelly is a long-term judge, who’s not prone to judicial errors or permitting either side in cases to stray outside the fairly conservative courtroom standards Kennelly is known for, which also relates directly to any AbbVie appeals and post-trial maneuvering.

Chicago-based AbbVie said in a statement “We are disappointed with today’s verdict and we intend to appeal,” With thousands more cases pending, AbbVie may need to look at changing legal strategy or to begin thinking settlement. The juries have stated that the company misled consumers via fraudulent misrepresentation in the “off-label” marketing campaign, which included urging men to their testosterone levels checked.

This verdict was comprised of $140 million in punitive damages, intended to deter the defendant and others from engaging in similar behavior, and $140,000 in compensatory damages, sending a message to not only AbbVie, but other Big Pharma drug makers, that consumers are now becoming aware of manipulation of prescription drug use behind the scenes via marketing campaigns including massive television advertisements.

SECOND BELLWETHER LOSS FOR ABBVIE

Konrad’s case is part of a series of bellwether trials aimed at helping plaintiffs and manufacturers of AndroGel gauge the range of damages and define a legal strategy and settlement options., losing both of the initial bellwether trials doesn’t look good for the defense, see “ANDROGEL” JURY RETURNS $150 MILLION VERDICT IN 1st TESTOSTERONE TRIAL.  That jury’s decision to award punitive damages without granting compensatory damages was unusual and both sides continue to fight over the verdict’s validity in court, but shows that the plaintiffs seem to have viable claims at trial.

Plaintiffs across the country allege AndroGel has caused heart attacks, strokes and other injuries, and the company was aware of the increase in adverse events while marketing “off-label” use. AbbVie has defended the drug and responded that its marketing of AndroGel adhered strictly to uses approved by the Food and Drug Administration and they have remained in full compliance with all FDA standards.

Konrad, 56, had been using AndroGel for two months in 2010 when he suffered a heart attack, from which he has since recovered. In court pleadings, the company contended that Konrad’s heart attack was caused by other factors, which are are not related to being prescribed AndroGel, such as obesity and high blood pressure. It also said it made no misrepresentations about AndroGel’s safety, which now two juries have disagreed with to the tune of $290 million.

ANDROGEL WAS A BLOCKBUSTER FROM FIRST RELEASE

AbbVie’s AndroGel is one of the more dominant testosterone treatments In the ever growing Low-T market, with sales of $675 million in 2016, and was declared a blockbuster drug and moved earnings and shares higher as soon as AndroGel hit the market. However, there were concerns about the drug safety as far back as 2012 and the FDA took notice not long thereafter. In 2014, the FDA convened an advisory committee to consider the adverse cardiovascular outcomes associated with testosterone replacement therapy, and the committee recommended changing the product warning labels, the FDA then required AbbVie to add a warning about cardiovascular risk to AndroGel’s label in May 2015.

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