Orange County and Santa Clara County Suits Against “Opiate Big Pharma” In California State Court Can Proceed

Ruling Rejects Opioid Manufacturers’ Arguments To Dismiss Deceptive Marketing Litigation

By Mark A. York (February 19, 2018)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) On February 13, 2018, the Orange County Superior Court rejected efforts by opioid manufacturers to dismiss a lawsuit brought by the Santa Clara County Counsel and the Orange County District Attorney on behalf of the People of the State of California. The lawsuit, filed in May 2014, alleges that the defendants—including opioid manufacturers Purdue Pharma L.P., Janssen Pharmaceuticals, Inc., Endo Health Solutions, Inc., and Actavis PLC—engaged in a deceptive marketing scheme that trivialized the risks of opioids, resulted in rampant over-prescribing, and led to a nationwide epidemic of opioid abuse and addiction.

“The court’s ruling puts an end to years of delay tactics by the defendants,” said Santa Clara County Counsel James R. Williams. “Now we will finally be able to move forward with the litigation and obtain key documents demonstrating the manufacturers’ misconduct. This is a critical step in addressing the opioid crisis that plagues California and the nation, and we will fight to hold opioid manufacturers accountable for their actions.”

STATE COURTS AHEAD OF FEDERAL OPIATE LITIGATION

In addition to the California counties suing in state court there are more than 200 counties from across the country as well as 30 major cities that have filed suits against opioid manufacturers in Opiate Prescription Multidistrict Litigation MDL 2804, pending in the US District Court of Northern Ohio in front of Judge Dan Polster, see Prescription Opiates MDL 2804 Briefcase. In addition to governmental entities, Judge Polster has also permitted unions and hospitals to join in the consolidated opioid litigation against Purdue Pharma, et al. The age of “Profits Before Patients” by Big Pharma may finally have started to come to an end, but it will not occur with very aggressive legal tactics and maneuvering by the opioid makers defense teams.

INSURERS ARE FIGHTING BACK

Earlier this year Travelers Insurance and St Paul Fire and Marine Insurance scored a legal victory when they were granted a declaratory judgment win related to defending Watson and it’s parent company Activis, Inc in the Orange County-Santa Clara County litigation, after the California Appellate Court declared the Traveller’s/St Paul  opioid coverage policy void due to the “Watson’s Deliberate Conduct” in relation to sales and marketing of opioid prescription drugs, which was determined to be improper. The decision also voided the Watson-Activis coverage in the City of Chicago vs. Watson et al, in Chicago federal court, see  California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense. This may be a trend for insurance carriers as they’ve filed other legal action to void coverage on behalf of opioid drug makers including Insys Therapeutics, Inc and defense of its Subsys fentanyl fast acting drug.

OPIOID RX DRUG MAKERS CHANGING TACTICS

The ruling comes the same week that Purdue Pharma, maker of the opioid OxyContin, announced that it will cut its salesforce in half and stop promoting opioids to doctors. The lawsuit brought by the Santa Clara County Counsel and the Orange County District Attorney was among the first lawsuits brought by government officials to hold opioid manufacturers responsible for their role in the opioids crisis. Manufacturers like Purdue now face pressure from hundreds of additional lawsuits nationwide.

The lawsuit was filed on May 21, 2014, against major opioid manufacturers. (People of the State of California v. Purdue Pharma, et al., Orange County Superior Court, Case No. 30-2014-00725287-CU-BT-CXC.) In 2015, defendants moved to stay the lawsuit, and the case was stayed until October 2016, when the court partially lifted the stay to consider defendants’ arguments that the case should be dismissed. The court has now lifted the stay entirely, and its ruling allows the lawsuit to go forward.

UP TO $500 BILLION SETTLEMENT

The current “Opiate Prescription Litigation MDL 2804” is being compared to the 1998 Tobacco Litigation settlement where Big Tobacco paid a settlement of $200 billion to cities, states and other governmental entities. The Opioid Litigation is expected to reach settlement figures of 3 to 4 times that amount, projected to be at the $500 billion plus figure, due to the rampant corporate boardroom directed policies that flooded the US marketplace for the last 15 years. Corporate sales and marketing policies and lack of oversight, enabled hundreds of millions of opioid prescription drugs to reach all areas of the country, thereby causing in excess of 100 thousand deaths and unknown catastrophic economic damages in every corner of the United States.

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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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Xarelto Federal Court Hearing – Judge Fallon “Need to devise an end game for this MDL”

Xarelto MDL 2592 – Judge Fallon “I need to devise an end game for this MDL”

Are Settlement Talks Coming to Xarelto Litigation?

By Mark A. York (January 30, 2018)

 

XARELTO: A BAYER CORP. AND JANSSEN PHARMACEUTICALS JOINT EFFORT

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) 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.

Judge Fallon also referred to resolving any lingering discovery issues that remain in certain cases to avoid mounting discovery costs in getting those case resolved, while trying to put a time frame on the proposed process of winding down the Xarelto MDL.

The sprawling nationwide litigation has produced over 21,000 lawsuits since the federal MDL was created in 2014 in New Orleans, and the number of new cases filed each month remains the same at about 400 per month. Even more cases have been filed in state courts in Philadelphia and Los Angeles, with there being about 1200 cases in the Philadelphia Court of Common Pleas docket in front of Judge Arnold New.

Michael Weinkowitz, lead plaintiff counsel in the recent Philadelphia trial verdict of $29 million, awarded to plaintiff Lynn Hartman, provided an update to the court, including a discussion on the January 9, 2018 ruling that overturned the Hartman verdict in a contentious post trial hearing, where Judge Michael Erdos granted a defense Motion for Judgement Notwithstanding the Verdict. The Philadelphia court post-trial issues of attorney misconduct were also interjected into Judge Fallon’s courtroom by defense counsel, which seemed to be totally unwarranted and out of place in the MDL hearing, when Bayer defense counsel felt the need to advise the federal court of “allegations of trial misconduct” that were heard at the January 9th hearing, even though the Hartman verdict was overturned based on proximate cause issues, not in any way related to plaintiff attorney misconduct,” as defense counsel seemed to offer to the court.

CASE DEMOGRAPHICS

Jacob Woody, of Brown Greer’s MDL Centrality program provided current data as to case numbers and plaintiff demographics including 21,465 cases currently filed into the Xarelto MDL, averaging 450 new filings each month. As well as:

  • Texas, Florida and California having the most plaintiffs with over 1,000 each
  • Hawaii having the fewest at just fourteen
  • Plaintiff age groups: age 60 – 69 = 20%, age 70 – 79 = 30% and age 80 – 89 = 30%
  • 48% of plaintiffs allege a gastrointestinal bleed as the primary medical issue
  • The number of new case filings per month has remained steady for the last 3 years

PHILADELPHIA XARELTO DOCKET

While Judge Fallon is seeking an apparent end to the federal Xarelto MDL in New Orleans, Judge Arnold New in the Philadelphia Court of Common Pleas, has set a rather aggressive trial schedule in the Xarelto docket there, including trial start dates of March 19th, April 16th and June 11, 2018 with additional trials being set at “one to two trials per month for perpetuity” quoting Judge Fallon on his interaction with the Philadelphia court. The appeal of Judge Erdos’ January 9th reversal of the Lynn Hartman $29 million verdict was filed today as well, on January 30 2018 in the Superior Court of Pennsylvania.

PROBLEMS WITH XARELTO

The Food & Drug Administration (FDA) approved Xarelto in 2011 for prescriptions, written to patients suffering from a rhythmic heart disorder called atrial fibrillation and to prevent blood clots that can lead to heart attacks, strokes and pulmonary embolisms.

Plaintiffs and their counsel charge Xarelto’s manufacturers with failing to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.

Plaintiffs assert claims against Xarelto makers Bayer, Janssen and Johnson & Johnson of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud as well as violation of consumer protection laws where permitted by state statutes and loss of consortium when possible.

The GI bleed issue which is the most common allegation in the Xarelto complaints is by no means the only medical issue to arise in litigation over the block-buster blood thinner, with claims of both hemorrhagic and ischemic strokes, sudden uncontrolled internal bleeding, lack of an antidote to stop traumatic bleeding events related to trauma as well as thousands of deaths related to taking Xarelto after being prescribed the drug by doctors.

Bayer and Janssen have aggressively defended the safety of Xarelto and proclaim the previous three defense verdicts in the Xarelto bellwether trails that took place in 2017, show that Xarelto is a safe drug. Medical and scientific data do not seem to support that position, but the 21,000 remaining lawsuits waiting to be returned to federal court dockets across the country may well force the defendants to rethink their legal strategy due to the catastrophic costs associated with defending and preparing cases for that number of potential trials.

XARELTO CALIFORNIA JCCP DOCKET

In January, California Superior Court Judge Kenneth R. Freeman in Los Angeles appointed the plaintiffs’ liaison counsel in the state’s Judicial Council Coordinated Proceedings (JCCP) for all Xarelto cases in the state courts, JCCP Case No. 4862. The California Xarelto docket is moving forward as cases filed there continue to increase monthly, with almost 300 cases currently pending in the California state courts. A recent status conference was held in December, when the parties agreed to submit plaintiff and defendant fact sheets.

XARELTO MDL 2592 FUTURE

Even though Judge Fallon has determined that there will be no more bellwether trials in his court as a sitting MDL judge, there are individual Xarelto cases that will remain in the US District Court of Louisiana docket that he may be ruling on. He will also have to address the various housekeeping and legal issues that will arise in winding down such a large MDL docket where the cases are still active and viable and both sides don’t seem to be looking toward a quick settlement at this point.

The thousands of cases being placed in front of federal judges across the country could possibly force the parties to come to the settlement table sooner as opposed to later, with a push here and there from individual courts, as already overloaded federal courts are probably not readily agreeable and inviting of this large a number of cases that are returning to home venues.

At this point the ball rests with defense counsel and their primary clients Bayer Pharma AG and Janssen Pharmaceuticals et al, and the corporate decision makers who are also facing the recently started Opiate Prescription Drug MDL 2804, which may require defense legal talent to switch from the Xarelto docket to the Opioid crisis litigation. The Opiate Prescription MDL may easily dwarf the prior Tobacco Litigation, to which it’s being compared. Big Pharma has some key decisions to make when it comes to where and how they will assign future resources and capital in defending past decisions in the manufacture and marketing of their prescription pharmaceuticals.

 

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Punitive Damages Now Allowed in Philadelphia Risperdal Suits Per Superior Court Ruling

Janssen Facing Over 6,400 Cases in Philadelphia Court of Common Pleas

By Mark A. York (January 18, 2017)

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Plaintiffs in the Risperdal litigation, may now seek punitive damages under a recent ruling by the Pennsylvania Superior Court.  Previously, plaintiffs were prevented from seeking punitive damages because the laws of New Jersey, applied to the Risperdal cases filed in the Philadelphia Court of Common Pleas, see Risperdal Re: Janssen: Philadelphia Court of Common Pleas. Johnson & Johnson is headquartered in New Jersey, with the courts previously applying those laws which barred punitive damages.

More than 6,000 Risperdal lawsuits in the Philadelphia docket allege Risperdal caused young men and boys to develop a condition called gynecomastia, where female breasts develop in male patients, with J&J’s Janssen Pharmaceuticals failing to warn about the risk.

The three-judge Superior Court panel ruled on January 9, 2018, that plaintiffs in the Philadelphia cases may apply the law of their home state to seek punitive damages, which opens up an entirely new legal avenue for plaintiffs.

Johnson & Johnson stated they were “disappointed in the ruling” and will be considering all options moving forward, while plaintiff counsel commented “This is something we’ve been right about from the beginning and maybe now, once and for all, J&J will recognize they’re facing punitive damages.”

Now that there is a threat of punitive damages, J&J will have to determine long term case strategy, as the punitive awards against J&J in 2016 – 2017 in other mass torts amounted to over eight hundred million dollars, and plaintiffs’ attorneys hope J&J will consider settling the remaining cases.

Plaintiffs have filed more than 6,400 product liability cases resulting from the use of anti-psychotic drug Risperdal in the complex litigation docket of the Philadelphia Court of Common Pleas. Plaintiff lead counsel, Tom Kline of Kline & Specter in Philadelphia, says “stakes in these cases will be raised now that the prospect of punitive damages is in play.”

On Jan. 8, Superior Court Judges Jack A. Panella, Alice Beck Dubow and Kate Ford Elliott ruled that plaintiffs in the Philadelphia-based Risperdal litigation may apply the respective laws of their home states to attempt to obtain punitive damages from Janssen Pharmaceuticals, the developer of Risperdal and a subsidiary of Johnson & Johnson.

“This is a pivotal decision in the Risperdal litigation. The Court found that the trial evidence justified the verdict in plaintiff’s favor. In addition, the stakes in any mass tort are raised when punitive damages are recoverable. This thoughtful and thorough opinion will now provide guidance for the entire litigation moving forward,” Kline said.

J&J and Janssen official statement is “We are disappointed in the Court’s ruling and will consider our options going forward. Contrary to the impression plaintiffs’ attorneys have attempted to create over the course of this litigation, Risperdal (risperidone) is an important FDA-approved medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions,” there was no comment released by Janssen defense counsel.

Currently, most of the 6,400 lawsuits based in the Philadelphia Risperdal docket have been filed by out-of-state plaintiffs, who assert Risperdal causes young males to contract gynecomastia, or the development of female breast tissue, and that Johnson & Johnson failed to adequately warn of these side effects from the drug.

The Superior Court’s new ruling applies across-the-board, as even plaintiffs who have previously received jury verdicts in Risperdal litigation, can now petition the court for new trials or request hearings to enhance verdict awards by adding punitive damages. One prior jury verdict was for more than $70 million and plaintiffs can now request additional punitive damages be awarded.

Before this ruling, seeking of punitive damages in Risperdal cases was prohibited according to New Jersey state law – because Johnson & Johnson is headquartered there.

The ruling on Risperdal punitive damages started when Johnson & Johnson appealed the Stange vs. Janssen Pharmaceuticals verdict; where Wisconsin plaintiff Timothy Stange asserted an inadequate warning of developing gynecomastia from taking Risperdal.

Mr. Stange used Risperdal for three years during his childhood, for treatment of Tourette’s syndrome, and at the close of the trial, a Philadelphia jury awarded him $500,000, and the recent Superior Court ruling has now upheld plaintiff arguments that an inadequate warning of the gynecomastia risks directly caused his injuries.

According to reports from the Philadelphia Court of Common Pleas, of the suits filed in the first 3 months of 2017, about 80 percent of cases in the Complex Litigation docket, came from out-of-state plaintiffs. With this recent ruling, it would seem logical that the number of Risperdal lawsuits filed in the Philadelphia court, may increase dramatically as the potential verdict award amounts have just risen to unknown numbers at this point.

One explanation for the surge in Risperdal filings can be directed toward defendants Johnson & Johnson, when they decided to cancel tolling agreements on thousands of cases. Knowing this strategy would increase the number of cases filed and the burden on the Court.

Tolling agreements pause the statute of limitations to file a lawsuit, and J&J actions seem to indicate that they wanted more lawsuits, not less, with J&J deciding to cancel the agreement after the $77 million verdict.

To date, eight Risperdal case have gone to trial in Philadelphia, with four juries ruling in favor of the plaintiffs, and J&J getting the other four cases dismissed.

The first case to trial, filed by Austin Pledger of Alabama was heard in 2012, with the jury siding with Pledger, finding J&J and Janssen failed to warn the drug could cause gynecomastia, and the jury awarded $2.5 million to Mr. Pledger.

After two more verdicts of $500,000 and $1.75 million were awarded to plaintiffs, in 2016 a Philadelphia jury handed a landmark verdict of $70 million to Andrew Yount of Tennessee, with. Judge Paula Patrick adding nearly $7 million in additional damages over intentional delays during the legal proceedings.

With the new rules regarding punitive damage,  including permitting retroactive claims by successful plaintiffs to now request punitives, Johnson & Johnson/Janssen Pharmaceuticals may need to rethink their long term case strategy, as having a punitive sword hanging over the 6,400 plus remaining cases, should cause defense counsel to re-evaluate their position sooner versus later.

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New York City sues Big Pharma over opioids – joining Chicago, Seattle, Milwaukee and other major cities

New York City Joins Chicago, Seattle, Milwaukee in Suing Opioid Industry Players

“PROFITS OVER PATIENTS BY BIG PHARMA CONTINUES”

 

MAJOR CITIES SUE BIG PHARMA OVER OPIOIDS

 

                                           

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) New York City has filed a lawsuit against pharmaceutical companies that make or distribute prescription opioids, on Tuesday the complaint was filed in New York state court, Superior Court of Manhattan, which is a break from other Opioid lawsuits filed by cities, who filed into federal court, see OPIOID-CRISIS: MDL-2804-OPIATE-PRESCRIPTION-LITIGATION. The primary claims state that the opiate drug companies fueled the deadly epidemic now afflicting the most populous U.S. city, joining Chicago, Seattle, Milwaukee and other major cities across the country in holding Big Pharma drug makers accountable for the opioid crisis.

New York Mayor Bill de Blasio stated the lawsuit seeks $500 million in  damages to help fight the crisis, which kills more people in the city annually than homicides and car accidents combined, which at last count was more than 1,100 from opioid-induced overdoses in 2016.

He also clarified “Big Pharma helped to fuel this epidemic by deceptively peddling these dangerous drugs and hooking millions of Americans in exchange for profit,” making his point clear as to where responsibility for the opioid crisis rests.

Named defendants include manufacturers Allergan Plc (AGN.N), Endo International Plc (ENDP.O), Johnson & Johnson (JNJ.N), Purdue Pharma LP and Teva Pharmaceutical Industries Ltd (TEVA.TA), and distributors AmerisourceBergen Corp (ABC.N), Cardinal Health Inc (CAH.N) and McKesson Corp (MCK.N), sourced from Reuters.

 

All were accused in the city’s complaint of creating a public nuisance, and the distributors were cited for negligence. The same allegations have been asserted in other complaints, including RICO claims by many plaintiffs who assert the companies conspired and created the opioid crisis by developing questionable opioid marketing plans, including offering financial incentives and making payments directly to doctors and others to write opiate prescriptions.

Allergan, Endo, J&J, Purdue, Teva, AmerisourceBergen and McKesson have all stated that they historically emphasized the importance of using opioids safely, in their business operations

BIG PHARMA OFF-LABEL DRUG ABUSES

Endo, J&J and Purdue denied the city’s allegations, with McKesson and Cardinal Health not immediately responding to requests for comment. All companies listed in the complaint have repeatedly been cited, fined and entered into consent decrees with the federal and state governments regarding questionable marketing practices related to prescription drugs. Often these fines have totaled hundreds of millions of dollars and never admit liability, simply agreeing to stop the cited activity, which as reflected in the hundreds of opioid based complaint recently filed, the agreement to cease and desist in “off label” or inappropriate drug marketing efforts has not been applied to the opiate prescription industry.

New York City, with over 4 million residents, has joined a long list of U.S. states and municipalities suing drug companies over opioid abuse, often referring to the drug makers “off label” use, where sales reps have continuously pushed an agenda of the opiates being “non-addictive” and part of proper healthcare.

OPIATES: A PUBLIC HEALTH EMERGENCY

The national opioid crisis incited President Trump to designate the it as a national public health emergency in November 2107, and the administration extended the emergency as of January 19, 2018. Although it should be noted that President Trump has not applied any federal funding to the now official “public health emergency” thereby leaving the state and local governments to push forward in the efforts to combat the opioid crisis on their own.

Opioids, including prescription painkillers and heroin, played a role in 42,249 U.S. deaths in 2016, up 28 percent from 2015 and 47 percent from 2014, according to the U.S. Centers for Disease Control and Prevention.

The complaint filed in state court in Manhattan, New York accused manufacturers of having for two decades misled consumers into believing that prescription opioids were safe to treat chronic non-cancer pain, with minimal risk of addiction.

The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

MILLIONS OF PILLS PRESCRIBED

Almost 2.75 million opioid prescriptions were filled in New York City each year from 2014 to 2016. Which is a very high number for a major city, but not nearly the millions of opiate prescriptions written in the more rural regions of Ohio, West Virginia and Kentucky, where the number of opiates prescribed equaled 100 plus pills per month for every resident in these state, with West Virginia numbers being 780 million painkillers in six years.

As more and more cities, states and counties files suits against the opiate drug industry as a whole, there will be a appoint where Big pharm will have to decide whether to admit it’s fault in the opioid crisis, or simply continue to evade responsibility and leave the process up to lawyers and the courts to simply assign a financial penalty for the alleged corporate opioid abuses.

The case docket information is: City of New York v Purdue Pharma LP et al, New York State Supreme Court, New York County, No. 450133/2018.

 

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FDA Delays “Off-Label” Intended Use Rule Change For Drugs

“Trump Lets Big Pharma Off The Hook”

By Mark. A. York (January 23, 2018)

Trump Removes FDA Rules

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Just as Big Pharma was looking at 2017 victories related to off-label marketing of drugs for unintended uses, drug makers were expecting some loosening of the regulatory shackles. Then the FDA rolled out a new rule on that subject, that wasn’t in Big Pharma’s bests interests, sending the drug industry into a lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials in their camp, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

Trump stops FDA enforcement rule change: January 12, 2018 Food and Drug Administration Press Release: FDA Delays Change to “Off-Label” Drug Use Enforcement Rules

This seems to be further evidence of the Trump administration permitting private corporations to control what goes on behind the scenes in federal regulatory agencies these days. The same loosening of enforcement rules has been seen in the EPA as well as in Energy oversight enforcement authority. Whatever else you might think about the ramped up Trump vs. Obama administration mindset, this delay is an example of the new FDA leadership doing what is in the best interests of those they are supposed to be regulating, the drug makers, and not in the interests of the US consumers.

To put this into perspective, consider the current “Opioid Crisis” gripping the entire country, where “off-label” marketing of opiates for the last 20 years by drug makers, has resulted in thousands of deaths each year, unknown financial losses and the related social impact felt in every state across the country. Another result is the Opiate Prescription Litigation MDL 2804, (see OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION) where litigation started when hundreds of counties, states and cities and other entities impacted by the catastrophic expense related to combatting the opiate healthcare crisis fought back. The various parties have filed lawsuits against opioid drug makers and distributors, demanding repayment of the billions of dollars spent on addressing the massive costs related to opioid abuse, primarily due to opioid based prescription drugs flooding the country.

As the Obama administration ended on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was meant to enable additional enforcement and control over drug makers rampant “off -label” marketing of drugs for purposes that were never FDA approved. This was an attempt by the FDA to have the ability to punish off-label promotions, where previously the process was a two-step regulatory review, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. These regulations have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.

In a 2015 proposed rule, the FDA referred to striking the language from regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use, which would have further enabled Big Pharma drug marketing abuses to go unchecked. But then, the FDA’s January 9, 2017 proposal reversed course, stating that retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard. This would have enable the FDA to begin oversight and enforcement of practices such as the blatant and wide open “off-label” marketing of opioid prescription drugs that started in the mid-1990’s and never stopped.

Instead of putting a check on Big Pharma abuses, we have the Trump administration placing a hold on new regulations, and delaying the “intended use” regulation change to March 19, 2018, so that comments could be received and considered, and thereby enabling the Big Pharma “lobby machine” to become fully engaged across all DC circles, ensuring that the FDA changes are effectively put to rest.

The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations on “off-label” drug use, when describing the types of evidence that may be considered in determining a medical product’s intended uses.  The FDA will receive comments on this proposal through February 5, 2018.

Here is the official FDA publication of January 16, 2018:

The Federal Register:  https://www.federalregister.gov/documents/2018/01/16/2018-00555/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or

 

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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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Attorney General Opiate Investigations in New York, Texas, Missouri and Other States Move Forward

Amid Opioid Crisis: Investigations by AG’s in Texas, New York and Other States Demand Drug Company Documents

By Mark A. York (December 19, 2017)

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) As communities nationwide grapple with opioid addiction, Texas and a coalition of 40 other states have served investigative subpoenas and other requests to eight companies that manufacture or distribute prescription painkillers, Texas Attorney General Ken Paxton recently announced. This is just one of at least 14 other states that are conducting investigation into opiate drug companies and their recent business practices.

It’s the latest development in an investigation unveiled in June. Paxton and his counterparts are trying to determine whether opioid manufacturers played a role in creating or prolonging what has become a national epidemic. The attorneys general served investigative subpoenas to drugmakers Endo Pharmaceuticals, Janssen Pharmaceuticals, Teva Pharmaceuticals’ Cephalon, Allergan and their related entities, and they served a supplemental subpoena to Purdue Pharma, Paxton’s office said. The states also sent “information demand letters” to three opioid distributers: AmerisourceBergen, Cardinal Health, and McKesson.  These actions are completely apart from the many civil lawsuits filed against the same opiate drug makers under investigation, the civil suits have been filed by more than 400 counties, cities and states in “Opiate Prescription Litigation MDL 2804” recently consolidated in the United States District Court of Ohio, see NATIONAL PRESCRIPTION OPIATE LITIGATION MDL 2804 BRIEFCASE.

“The goal of this phase of our investigation is to collect enough information so that the multi-state coalition can effectively evaluate whether manufacturers and distributors engaged in unlawful practices in the marketing, sale, and distribution of opioids,” Paxton said in a statement. “We’ll determine an appropriate course of action once it’s determined what role these companies may have played in creating or prolonging the opioid crisis.”

Caitlin Carroll, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, said Tuesday she could not comment on the investigation of individual companies, but she pointed to policies her group supports to “prevent and deter abuse.”

An Allergan spokesman said that company was “working cooperatively with the state attorneys general,” but he downplayed the company’s share of the opioid market and said it didn’t aggressively promote such drugs.

“Allergan’s two branded opioid products — Norco and Kadian — account for less than 0.08 percent of all opioid products prescribed in 2016 in the U.S.,” the spokesman, Mark Marmur, said. “These products came to Allergan through legacy acquisitions and have not been promoted since 2012, in the case of Kadian, and since 2003, in the case of Norco.”

Cardinal Health also released a lengthy statement in which the company said: “We look forward to working with the attorneys general.”

Opioids are a family of drugs including prescription painkillers like hydrocodone, as well as illicit drugs like heroin.

Prescription and illegal opioids account for more than 60 percent of overdose deaths in the United States, a toll that has quadrupled over the past two decades, according to the U.S. Centers for Disease Control. Drug overdose deaths in 2015 far outnumbered deaths from auto accidents or guns.

Texas saw 1,186 opioid-related deaths in 2015, while the nation as a whole had 33,000 such deaths that year. Researchers have flagged opioids as one possible factor in Texas’ staggering rise in women’s deaths during and shortly after pregnancy.

In teaming up to probe drug companies, some experts suggest the states are following a playbook similar to one used during the 1990s to sue tobacco companies for their role in fueling a costly health crisis — an effort that resulted in a settlement yielding more than $15 billion for Texas alone.

 

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