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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$28 Million Xarelto Jury Verdict Reversed by Judge in Philadelphia Court

Defense gets fourth win in the four Xarelto bellwether trials

By Mark York (January 11, 2018)

 Xarelto Blood Thinner Developed by Bayer and Janssen

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The December 2017 Xarelto jury verdict of $27.8 million awarded to an Indiana couple, was overturned earlier this week, when the trial judge vacated the verdict. The plaintiffs had accused Bayer AG and Janssen Pharmaceuticals, Inc., a Johnson & Johnson subsidiary, of failing to warn of internal bleeding risks of their drug Xarelto.

Judge Michael Erdos, Philadelphia County Court of Common Pleas, heard arguments on January 9, 2018 in a motion hearing to reverse the December verdict, which was the first defense trial loss in litigation over the Xarelto blood thinner, and also the first trial outside the Xarelto MDL 2592, (see XARELTO MDL 2592 US District Court ED Louisiana briefcase) in front of Judge Eldon Fallon, US District Court of Louisiana.

Judge Erdos issued his ruling from the bench after the hearing on defense motions for a new trial or alternatively, for a judgement notwithstanding the verdict, and at the close of a full day of arguments stating, “a new trial is not necessary because plaintiff did not adequately demonstrate responsible cause,” and he then entered judgement for the defendants.

“J&J’s Janssen Pharmaceuticals Inc and Bayer, which jointly developed Xarelto, welcomed the decision and issued statements saying they will continue to defend against the allegations in all Xarelto litigation, with a total of more than 20,000 pending lawsuits now in both state and federal Xarelto dockets.

Bayer stated “Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”

The December 5, 2017 verdict came in a lawsuit filed by Lynn Hartman, who was prescribed Xarelto as treatment for an irregular heartbeat also known as atrial fibrillation, to prevent strokes. The testimony and opinions of Ms. Hartman’s treating physician and views on continued willingness to prescribe Xarelto, had a significant impact on the final ruling to overturn the verdict by Judge Erdos.

Hartman claimed she was prescribed the drug for a little more than a year, starting in February 2013, and was hospitalized with severe gastrointestinal bleeding in June 2014, at age 72, with the bleed attributed to taking Xarelto. The court record reflected that Ms. Hartman has since recovered from the hospitalization.

Lynn Hartman and her husband filed their complaint against the drugmakers in 2015, (see XARELTO Case No. 2349 Philadelphia Court of Common Pleas briefcase) with the six week trial starting the first week of November 2017, resulting in the jury awarding $1.8 million in compensatory damages and $26 million in punitive damages. This verdict was seen as a high note for plaintiff counsel in the Xarelto litigation, after three prior trial losses, in Xarelto MDL 2592 bellwether trials in Louisiana and Mississippi.

The Hartman trial is just one of about 21,400 against Bayer and Janssen pending in federal and state courts blaming injuries on Xarelto, and the first selected for trial from more than 1,400 Xarelto cases pending in the Complex Litigation docket of the Philadelphia court.

Plaintiff trial counsel Michael Weinkowitz, said the decision related to a “very narrow issue related to Mrs. Hartman’s prescribing physician.” He said he looked forward to trying the next series of Xarelto-related cases in Philadelphia. The post trial legal arguments were related to the “learned intermediary doctrine and proximate cause” and was raised by defense in post trial motions and aggressively argued, which plaintiff counsel was unable to overcome in the full day hearing.

The U.S. Food and Drug Administration approved Xarelto in 2011, to be prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms, often after implant surgeries.

Plaintiffs in the Hartman trial as well as in thousands of other Xarelto lawsuits, alleged that the drug was unreasonably dangerous and that Janssen (J&J) and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies and were aware of adverse events for a long period of time. These allegations will be argued aggressively by defense in all forthcoming trials, as the defendants do not seem to be willing to bend on their winning trial strategy.

Bayer and Janssen have defended Xarelto’s label stating that the label adequately warns of bleeding risks. After four trials verdicts, all in their favor, defense seems to be using an effective trial strategy that has worked in venues across the country.

The three bellwether trials in the Xarelto MDL 2592, all resulted in defense wins for Bayer and Janssen, with this Philadelphia trial shifting the focus from the federal Xarelto docket to the Philadelphia court and the Hartman trial. What impact the initial plaintiff’s trial win followed by the Judge Erdos reversal this week has on both Xarelto dockets remains to be seen.

 

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

 

 

 

 

 

 

 

 

By Mark York, Mass Tort Nexus Media

(December 21, 2017)

New Jersey Supreme Court Review Reinstatement Of Accutane Experts

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

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

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

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

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

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

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

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

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

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

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

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

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

Pennsylvania Appeals Court Affirms $29.6M Remitted Zimmer Knee Judgment

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

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

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

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

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

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

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$29 Million XARELTO Jury Verdict Against Bayer AG, Janssen Pharmaceuticals (Johnson & Johnson) in Philadelphia

XARELTO TRIAL VERDICT FOR PLAINTIFF: BAYER AND JANSSEN PHARMACEUTICALS (J&J) LOSE  $29 MIILLION IN XARELTO TRIAL VERDICT BY PHILADELPHIA JURY

  

 

 

 

 

A state court jury in Philadelphia delivered a first-of-its-kind verdict on Tuesday as it awarded $29 million in damages against a pair of Johnson & Johnson and Bayer AG units after finding the companies had provided inadequate warnings about the risks of bleeding associated with the blood thinner Xarelto,(see XARELTO Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation (PA State Court).  In the first bellwether trial outside the Xarelto Federal MDL 2592, plaintiff counsel scored a win in a $29 million verdict, when plaintiff Lynn Hartman showed that Xarelto caused severe bleeding after she was prescribed the drug by her doctor. The 3 prior federal court trials in the Xarelto MDL 2592 docket (see XARELTO MDL 2592 US District Court ED Louisiana) were all won by the defense and this trial was watched closely by both legal and drug industry observers to see if the 3-0 defense win streak continued. Now that Ms. Hartman has shown that the Xarelto prescription caused her internal bleeding, with no warnings by manufacturers Bayer and J&J, the remaining 22,000 Xarelto cases pending in courts across the country will begin preparations for a legal battle that to date has gone in favor of defense counsel.

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WEEKLY MDL UPDATE by MASS TORT NEXUS for Week of November 13, 2017

The week in mass torts around the country:

By Mark York, Mass Tort Nexus (November 16, 2017)

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MASS TORT NEXUS

 Verdicts on November 16, 2017: 

J&J gets hit hard again, in a $247 million Pinnacle hip implant verdict, DePuy Orthopaedics Pinnacle Implant MDL 2244, in bellwether trial of 3:15-cv-03489 Alicea et al v. DePuy Orthopaedics Inc et al. (DePuy Pinnacle Hip Implant MDL 2244 Briefcase)

Drug maker Auxilium won a defense verdict in their Testim product bellwether trial, where plaintiffs claimed it caused a heart attack in a verdict reached in the US District Court Northern District of Illinois, Judge Kennelly, in MDL 2545 Testosterone Replacement Therapy. (Testosterone Therapy MDL 2545 USDC ND Illinois)

Johnson & Johnson Wins a Defense Verdict in Los Angeles Court Talcum Powder Mesothelioma Trial, Jury Finds J&J Not Liable in Tina Herford et al. v. Johnson & Johnson Case number BC646315, consolidated in LAOSD Asbestos Cases, case number JCCP4674, in the Superior Court of the State of California, County of Los Angeles.  (J&J Talcum Powder Cancer Litigation Briefcase)

Senator Bob Menendez  judge declares a mistrial in New Jersey federal court trial, after a hung jury cannot agree unanimously on charges. Question is- Are the Senator and his doctor friend in Florida, just that-were they just friends or was there active bribery taking place?

Recent Case Updates:

>Plaintiff in DePuy Pinnacle Hip Implant Trial Asks Texas Jury For A Hundred Million + In Punitive Damages

At the close of arguments in the latest DePuy MDL 2244 trial on Monday November 13, 2017, six New York plaintiffs asked a Texas federal jury to hit Johnson & Johnson and it’s DePuy subsidiary, with at least a nine-figure punitive damages award. Attorneys asked that J&J and DePuy be punished for making and marketing their Pinnacle model hip implants, an alleged defective line of metal-on-metal hip implants, that have caused many thousands of injuries to unsuspecting patients. If this jury follows suit on prior Pinnacle bellwether jury awards, then J&J and DePuy should be ready for a massive verdict, as the last jury awarded California plaintiffs over one billion dollars in December 2016, sending a clear message that the company’s Pinnacle design and subsequent marketing policies have failed.

METALLSOIS DAMAGE

Closing arguments wrapped up on the two-month bellwether trial, where plaintiffs claimed they suffered “metallosis” which caused tissue damage and negative reactions to the Pinnacle Ultamet line of metal-on-metal hip implants made by J&J’s DePuy Orthopaedics Inc. unit. Depending on the jury verdict, perhaps J&J will consider coming to the settlement table if another massive verdict is awarded, or they may continue the aggressive “we’ve done no wrong stance” resulting in more plaintiff verdicts in the future..

 >Travelers Insurance Wins Declaratory Judgment Suit Over Defense Coverage In Orange County and Chicago Opioid Lawsuits:

“California Appeals court says Watson not covered”

Watson Pharma, Inc. and it’s parent Activis, Inc. were denied insurance coverage in a November 6, 2017 ruling by the California State Court of Appeals in the 2014 Declaratory Judgment action filed by Travelers Insurance in an Orange County, CA court where Travelers successfully asserted claims that they were not required to defend or indemnify Watson in the underlying opioid based litigation filed by Santa Clara and Orange County against opioid manufacturers, due to Watson’s “intentional bad conduct” in their business practices related to sales and marketing of it’s opioid products. The Appeals Court also excluded Watson’s coverage in a similar opioid lawsuit against them in a Chicago, Illinois federal case where the City of Chicago filed similar claims against Watson over opioid marketing abuses in 2014. Perhaps other insurance carrier will take notice and look closer at denying policy coverage for many other opioid manufacturers who have been sued across the country in cases with almost the exact claims as those alleged by Santa Clara County and the City of Chicago.

>NEW XARELTO TRIAL:

Former FDA Commissioner Testifies in Philadelphia Xarelto Trial-

“Xarelto Warnings Are Inadequate”

— Former head of the Food and Drug Administration, Commissioner David Kessler testified during the first state court trial in Philadelphia, telling the jury on Tuesday that “warning labels for the blood thinner Xarelto failed to provide adequate information to doctors and consumers about the risk of bleeding that some patients could face when using the drug”.

David Kessler, FDA Commissioner under President George H.W. Bush and President Bill Clinton, told jurors that Bayer AG and Johnson & Johnson’s warning labels for the medication understated the risk of significant bleeding events that had been seen in television and print ads across the country for years, and failed to disclose the true risks associated with prescribing the blockbuster drug. This trial, expected to take six weeks, is the first state court bellwether trial for the blood thinner Xarelto, in the Philadelphia Court of Common Pleas, the prior trials took place in federal courts in Louisiana and Mississippi where the defense prevailed in all 3 trials earlier this year. Those trials were all bellwether trials, as part of the Xarelto MDL 2592 in front of Judge Eldon Fallon, US District Court, ED Louisiana. Will the change of venue to Pennsylvania State Court have a different outcome than the three prior Xeralto trial losses?

>Luzerene County, Pennsylvania Files RICO Suit Over Opioid Marketing Against Drug Makers

Luzerne County in Northeast Pennsylvania has filed a federal RICO based lawsuit accusing pharmaceutical companies including Purdue, Pharma, Endo, Janssen and Teva of violating the Racketeer Influenced and Corrupt Organizations Act by illegally marketing highly addictive painkillers that have contributed to a costly national opioid epidemic. The suit filed in US district Court of Pennsylvania by Luzerne County is one of many cases opioid drugmakers and distributors are facing as state and local governments seek to recoup costs they’ve incurred in the increased marketing and prescribing of opioid painkillers, and the resultant spikes in addiction and overdose.

OPIOID MARKETING ABUSES

“The manufacturers aggressively pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction,” the complaint, which was filed on Wednesday, said. “These pharmaceutical companies … turned patients into drug addicts for their own corporate profit.”
“The lawsuit accused the drugmakers of using false and deceptive marketing practices over the course of the last two decades, including pushing the opioid painkillers for treatment of chronic pain, to boost prescriptions for the drugs

COMMON CLAIMS AGAINST ALL OPIOiD MAKERS

Among the companies’ primary claims, cited by Luzerne county and others, evidence the manufacturers intentionally misled consumers, was that the drugs were not addictive when prescribed to treat legitimate pain. This is one of the key claims used by all parties filing suit against the opioid manufacturers, across the entire country.

Case heading is: Luzerne County v. Purdue Pharma LP et al., case number 3:17-cv-2043, in the U.S. District Court for the Middle District of Pennsylvania.

>Opioid Litigation Roundup: An Overview Of Recently Filed Cases and MDL 2804

In addition to the many counties and other communities from across the country that have filed lawsuits against opioid manufacturers in MDL 2802, set for a JPML consolidation hearing November 30, 2017 a new group of plaintiffs have joined the increasing pool of parties filing suit against Big Pharma opioid manufacturers and their distributors. Unions are now joining in the suits alleging that the business practices of the opioid makers and distributors caused catastrophic healthcare and related labor problems everywhere in the country over the last 15 years. Locals from the Electrical Workers; Commercial Food Service and Teamsters are now plaintiffs in the MDL 2804, which if approved at the upcoming JPML hearings in St Louis, will probably cause a flood of additional filings by unions across the country.

State attorneys general, a Native American tribe and individual consumers are among the ever increasing pool of plaintiffs who’ve brought lawsuits against drugmakers, pharmacies and distributors allegedly responsible for epidemic levels of opioid abuse. As word spreads among the network of local governments, and discussion take place about the municipal opioid lawsuits being filed, there will be a flood of new complaints filed, that will match or exceed the number of cases filed in the massive “Tobacco Litigation” which is quickly gaining comparison as the opioid case filings are looking to be comparable in size and probably exceed the tobacco litigation in damages.

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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 Loses Again In First California Talc-Cancer Trial As Jury Awards Plaintiff $417 million

J&J’s Loses Again In First California Talc-Cancer Trial As Jury Award Plaintiffs $417 million

  • Los Angeles jurors decide Johnson & Johnson failed to warn about risks
  • The Eva Echeverria trial is first of 300 cases in California alleging ovarian cancer

“Eva Echeverria v. Johnson & Johnson, number BC628228, in the Superior Court of California for Los Angeles County”

Johnson & Johnson (J&J) found out earlier today, August 21, 2017 that California is no friendlier than Missouri when fighting allegations that its talc powder causes ovarian cancer in women, as a Los Angeles Superior Court awards plaintiff Eva Echeverria $417 million after 3 days of deliberations.

J&J has lost four out of five recent talc cases that went to trial in St. Louis, and is the first trial before a jury in Los Angeles, and is the first case to go to a state-court jury outside Missouri and one of more than 300 similar cases pending in California. This trial follows the US Supreme Court ruling in June 2017 that made it harder for mass tort lawyers to try cases in St. Louis and other cities that have been a destination of choice for litigation against companies that do business nationwide.

The jury verdict shows that J&J is liable for failing to warn Eva Echeverria, 62, about the alleged cancer risks of using its talcum products, which she started using when was 11. She was diagnosed with ovarian cancer in 2007. The Monday morning verdict followed last Wednesday’s closing arguments, with the California jury deliberations coinciding with J&J’s jury trial in the Xarelto blood thinner Mississippi federal trial, which resulted in a defense verdict for J&J on August 18, 2017.  J&J was hoping the Mississippi Xarelto jury verdict was a precursor to the California Talc verdict, which it was not. Ms. Echeverria’s case was chosen as the first bellwether trial due to the onset of final stage ovarian cancer and her failing health, with doubts in some circles that she may not have survived until the trial start.

There are more than 4,800  Talc claims in federal and state U.S. courts accusing J&J, the world’s largest health-care company, of ignoring studies linking its baby powder and Shower to Shower talc products to ovarian cancer and failing to warn customers about the risk, with cases pending in Missouri, New Jersey and California.

In June, the Missouri judge halted the Talc trial there mid-trial in St. Louis, following a U.S. Supreme Court decision, earlier in the day limiting out-of-state plaintiffs joining lawsuits in state court, in the Bristol-Myers (Plavix) state court jurisdictional ruling, Bristol Myers California Plavix Ruling.  Up to then, J&J had been hit with verdicts as high as $110 million by Missouri juries, a favored location for Talc litigation, totaling more than $300 million and J&J, a New Brunswick, New Jersey-based company is appealing these verdicts.

J&J claims the plaintiffs’ allegations aren’t supported by scientific evidence, pointing to a New Jersey state court decision last year tossing out two cases set for trial, due to lack of expert witness supporting evidence.  That judge found evidence linking talc to ovarian cancer was inadequate, however, J&J just happens to be a New jersey based corporation.

The case is Eva Echeverria v. Johnson & Johnson, BC628228, Los Angeles County Superior Court.

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Dora Mingo vs Janssen and Bayer (Xarelto) Trial Update: Plaintiff Closes Her Case on August 16, 2017

(Dora Mingo vs. Janssen Research & Development, LLC et al. Case No. 2:15-cv-03469)

 DEFENDANTS’ MOTION FOR JUDGMENT AS A MATTER OF LAW AT THE CLOSE OF PLAINTIFF’S CASE-IN-CHIEF

The third Xarelto MDL 2592, bellwether trial is proceeding in US District Court of Mississippi in front of MDL Judge Eldon Fallon, where plaintiff Dora Mingo resides, see Xarelto MDL 2592 Mass Tort Nexus Briefcase.  At the close of plaintiff’s case-in-chief on August 16, 2017 defendants Janssen Research & Development and Bayer Pharma AG, et al, moved the Court for judgment as a matter of law on Plaintiff’s design-defect and failure-to-warn-or-instruct claims under the Mississippi Product Liability Act (“MPLA”) see, Defendants Motion for Judgment as a Matter of Law.

Plaintiff have asserted two causes of action under Miss. Code Ann. § 11-1-63. Plaintiff first asserts that Xarelto is defectively designed because it was brought to market without an  accompanying rivaroxaban-specific anti-Factor Xa assay. Plaintiff also claims that Xarelto is unreasonably dangerous due to inadequate warning or instruction because Defendants failed to instruct physicians to use Neoplastin PT at the initiation of therapy to identify patients at an increased risk of bleeding.

Defendants state in their assertions that they are entitled to judgment as a matter of law on Plaintiff’s design-defect claim because an adjunct rivaroxaban-specific anti-Factor Xa assay to be used with Xarelto is not an alternative anticoagulant design and is therefore not a feasible alternative design under the MPLA.3 See Elliot v. El Paso Corp., 181 So. 3d 263, 273 (Miss. 2015); Clark v. Brass Eagle,Inc., 866 So. 2d 456, 461 (Miss. 2004). In their second assertion, they claim they are entitled to a trial win on Plaintiff’s design-defect claim because Plaintiff has presented no evidence that Xarelto failed to function as expected. See Austin v. Will-Burt Co., 361 F.3d 862, 872 (5th Cir. 2004).

Defendants further plead, they are entitled to judgment as a matter of law on Plaintiff’s design-defect claim because Plaintiff has made clear that her design-defect claim is based on a theory that Xarelto should have had a different design at the time it was released to the market (Trial Transcript. 141:19–142:11, 144:1–17), and the Court’s preemption decision so requires. See Order & Reasons on Defs.’ Preemption MSJs (Doc. 7110), at 11 (plaintiff’s “pre-market design-defect claims under the MPLA are not preempted”).

Defendants also include in their request for judgment, plaintiffs abandonment of various claims that were not presented at trial or withdrawn before trial, including the “failure to include the Rocket AF trial data” on participant bleeding rates and that Xarelto was designed without a reversal agent.

Mass Tort Nexus will provide additional Dora Mingo trial updates as they become available.

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Xarelto Bellwether Trial #2 also Ends with Defense Verdict

A federal jury in Louisiana found that Janssen Pharmaceuticals Inc. and Bayer Corp., makers of blood thinner Xarelto, adequately warned about the risk of unstoppable bleeding and that it did not cause the plaintiff to suffer a stroke that killed her.

The case was Joseph Orr Jr. v. Janssen Pharmaceuticals, Inc., et al., No. 15-3708, E.D. LA. Some 17,097 cases are pending before US District Judge Eldon E. Fallon in MDL 2592, IN RE: Xarelto (Rivaroxaban) Products Liability Litigation.

It was a weak case to begin with. The plaintiff Sharyn Orr, was a 67-year-old grandmother who had a host of medical problems. See No Cause for Panic in Defense Verdict in the First Xarelto Bellwether Trial.

The jury returned itsverdict on June 12 in the second bellwether trial in the Xarelto multidistrict litigation.

Plaintiff Sharyn Orr took Xarelto to prevent blood clots due to atrial fibrillation.  She died after suffering a stroke in 2015.  Her husband and children filed the acting, charging that Janssen and Bayer failed to adequately warn that it could cause uncontrolled brain bleeding.

The manufacturers argued successfully that the Xarelto label sufficiently addressed the risk of uncontrolled bleeding.

The plaintiff attorneys were Thomas C. Wicker III, James A. Watkins and Vincent E. Odom of Capitelli & Wicker in New Orleans and Albert J. Nicaud of Nicaud & Sunseri in Metairie, Louisiana.

Bayer is represented by Susan M. Sharko, an attorney with Drinker, Biddle & Reath in Florham Park, N.J.

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Witness: Xarelto is “The Worst” of All Anticoagulents

Frank W. Smart, MD
Frank W. Smart, MD, testified that Xarelto should have an FDA Black Box Warning — the strongest warning.

In damning testimony against drugmakers Janssen Pharmaceuticals and Bayer, an expert cardiologist testified at the second Xarelto bellwether trial that of all the anticoagulants, Xarelto is “the worst.”

“So Xarelto, of all the new oral anticoagulants, is the worst. And that’s well established in the medical literature and even by the FDA. The FDA said that Xarelto was equal to Coumadin. The other drugs which would be apixaban or Eliquis, dabigatran or Pradaxa and edoxaban or Savaysa are in one shape or form superior either in anticoagulation effect or in bleeding or in both,” testified Frank W. Smart, MD, a board-certified doctor in cardiology at LSU School of Medicine.

The case is  In Re: Xarelto (Rivaroxaban) Products Liability LitigationJoseph Orr v. Janssen Research, Case No. 2:15-CV-3708, before US District Judge Eldon Fallon in the Eastern District of Louisiana. Plaintiff attorney Anthony Birchfield, Jr. of Beasley Allen Crow Methvin Portis & Miles in Montgomery, AL, led the direct examination.

Dr. Smart’s  opinion was based on his own research plus internal company e-mails from drug manufacturers Janssen Pharmaceuticals and Bayer, and transcripts of FDA reviewers’ opinions FDA where the Xarelto was discussed.

Stops precribing Xarelto

Xarelto is a NOAC or new oral anticoagulant. Instead of blocking clotting factor Vitamin K, Xarelto is an inhibitor of Factor Xa, and it too stops the prothrombin-to-thrombin conversion and thins a person’s blood.

“I read an article that was in one of the Canadian journals that was very impressive to me, and I started transitioning people off of Xarelto at that time and have completely abandoned the use of it,” he testified. “It was a twice-a-day drug crammed into a once-a-day prescription, and I thought that that was a poor idea. I still think it’s a poor idea.”

“A practicing cardiologist sees people six, seven days a week “and they don’t have time. They don’t physically have time to chase down information like this.”

“Coumadin has a black box warning that says: Bleeding is an issue. You really need to focus on this. Be careful. Monitor it, and then things like that. Xarelto, I believe, should have a black box warning as well because all the literature and the FDA said that there’s no difference,” he testified.

An FDA Black Box Warning is the strongest warning that the US Food and Drug Administration (FDA) puts on a drug. For example, addictive opioids have black box warnings.

After reading FDA transcripts, Smart said, “The conclusion seemed to be that if the FDA had had their druthers, the company would have tested a twice-a-day dose, but they went on to say that they didn’t have the capacity to force the company into doing that, and the only thing that they could do was to consider the information that had been presented to them at the once-a-day dose.

Xarelto worst drug in its class

The ROCKET-AF trial of Xarelto on 7,000 patients with atrial fibrillation (Afib) found that “Xarelto was the worst in the class of these drugs. It was never shown to be superior to warfarin for either stroke or bleeding. But Eliquis, or apixaban, was shown to be superior for both,” Smart testified.

Q. (by attorney Anthony Birchfield) So when we look at these drugs, if we look at Eliquis.  Eliquis in the clinical trial, is it shown to be superior in both safety and efficacy?

A. (by Dr. Smart) Yes, sir. To warfarin.

Q. So Eliquis is superior to them both. And then, when we look at Pradaxa compared to warfarin, was Pradaxa — was it superior to either — in either safety or efficacy?

A. Yes, sir. It was superior in safety.

Q. What about efficacy?

A. Equal.

Q. And then, when we look at Xarelto was Xarelto superior in safety?

A. No, sir.

Q. Was it superior in efficacy?

A. No, sir.

“I think, again, playing Monday morning quarterback, I think had Eliquis been released at the time, there was no way that Xarelto would have been approved,” by the FDA, Smart testified.

“It’s worst in class among the NOACs. That’s pretty accepted. I mean, it’s a four-horse race, and they are the fourth horse. This adds concern that the approval was maybe less grounded in great science.”

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