PA Superior Court Reverses Risperdal Defense Verdict as Court Strikes Janssen Pharmaceuticals Only Favorable Jury Verdict

“Johnson & Johnson Hit With Another Trial Verdict Reversal”

By Mark York (November 17, 2017)

Mass Tort Nexus

 

 

 

 

 

 

(MASS TORT NEXUS) The Superior Court of Pennsylvania reversed the single defense verdict reached in favor of Janssen Pharmaceuticals, the manufacturer of anti-psychotic drug Risperdal. The reversal and order for a new trial stemmed from a 2015 trial that resulted in the one Risperdal defense verdict to date. The case is part of the mass tort docket for Risperdal cases in the Philadelphia County Court of Common Pleas, (see RISPERDAL Case No 296 PHILADELPHIA COURT OF COMMON PLEAS BRIEFCASE), where more than 6,000 Risperdal cases are pending.

The 22-page unanimous Superior Court decision by Judge Jack Panella, reversed the Janssen defense win in the Risperdal trial where plaintiff William Cirba filed suit against Janssen Pharmaceuticals and lost, as well the subsequent denial of Mr. Cirba’s request for a retrial based on “erroneous evidentiary rulings.”

The ruling ordered a new trial and will now be limited to the issues of causation and damages.

LAYPERSON AT TRIAL IS NOT AN EXPERT

The Superior Court stated the trial court made a reversible error at trial, by allowing physician’s assistant Michelle Baker’s testimony to be weighed on the same level as that of a medical expert. Ms. Baker was involved in the treatment of Mr. Cirba from 2005 to 2013, as a physician’s assistant.

During the Cirba trial, a videotaped deposition from Baker was played in which she stated an opinion that Cirba’s gynecomastia (the development of breast tissue) was the result of “extreme weight gain” rather than negative side effects from Risperdal. Cirba had been prescribed the drug to treat oppositional defiant disorder.

Cirba’s counsel objected that it was improper that Baker’s layperson testimony was considered equal to that of an expert, since she was not designated or qualified prior to trial – while the defense believed Baker’s deposition did not cross over into expert testimony and “constituted permissible lay opinion testimony, as it was rationally based on her perception of plaintiff during treatment.” Which the Superior Court has obviously disagreed with.

The jury returned a verdict in favor of Janssen in March 2015, although the jury at that time believed Janssen failed to properly warn Cirba’s physicians of gynecomastia risks associated with Risperdal, it stopped short of finding Janssen negligent in directly causing Cirba’s gynecomastia.

The Superior Court sided with the plaintiff in believing admitting Baker’s testimony was an attempt to enter the realm of expert knowledge.

Defendants’ experts opined that weight gain rather than Risperdal ingestion caused plaintiff to appear to have gynecomastia. Baker’s testimony, in which she opined that plaintiff’s weight gain, rather than his Risperdal usage, caused him to appear to have gynecomastia, was causation testimony offered by a witness who personally treated the plaintiff” Panella said.

Panella added Baker’s opinion was “offered without the proper vetting and safeguards surrounding expert testimony.”

“Further, this opinion was introduced into evidence due to the trial court’s improper application of the law, which is clearly an abuse of discretion. Therefore, we find that the trial court abused its discretion in denying plaintiff’s request for a new trial, limited to the issues of causation and damages,” the panel stated, in reversing the judgment and remanding the case for further proceedings.

SAME PANEL STRIKES RISPERDAL SOL CLAIMS

In a separate 18-page ruling also issued Nov. 13, the exact same three-judge panel upheld the trial court’s striking down of arguments that the statute of limitations in two Risperdal cases, featuring plaintiffs Jonathan Saksek and Joshua Winter, should have been tolled until 2013.

Saksek and Winter were prescribed Risperdal in 1997 and 1998, allegedly began developing gynecomastia in 1998 and 2002, respectively, but didn’t file suit until 2014. Both plaintiffs brought suit after seeing television advertising connected to Risperdal litigation in 2013.

The defense agreed with the trial court that the statute of limitations mandated the grant of summary judgment, but contended if the discovery rule applied, it would have only tolled the statute of limitations until October 2006, when Risperdal’s prescribing label was changed to include a warning about gynecomastia.

In January 2015, Judge Arnold New granted a defense motion for summary judgment and ruled an applicable statute of limitations applied to both Saksek and Winter’s cases, feeling that they should have known of Risperdal’s gynecomastia-related injury risks by June 30, 2009.

Both plaintiffs appealed, and the appeals were consolidated, but the higher court agreed with the trial court.

“Plaintiffs were aware of their injuries when they began experiencing unexplained weight gain – and breast growth – after starting Risperdal treatment in 1998 and 2002. However, from 1998 and 2002 until 2013, when plaintiffs were notified of the commercial claiming a link between gynecomastia and Risperdal, they did nothing to uncover the cause of their unexplained breast growth and weight gain. Plaintiff cannot hope to establish that they acted with reasonable diligence, when they admit that they failed to act at all,” Panella stated.

Their breasts were there, and had been there, for years. And then, in October 2006, the label on Risperdal changed, expressly linking usage of the drug to gynecomastia. Their breasts were clearly not temporary by 2006. Accordingly, by that date, ‘reasonable minds would not differ in finding that’ plaintiffs knew, or should have known, of their injuries and the cause of those injuries by this point,” Panella added.

RULING AFFECTS OTHER CASES

Kline commented on the Superior Court’s statute of limitations ruling, indicating it could be far-reaching beyond merely the instant cases.

“We believe [this] harsh ruling, which may bar the claims of thousands of claimants who could not possibly have known of their gynecomastia injury and its cause, is legally and factually wrong. We plan to appeal further, seeking to reopen the courthouse doors to them,” Kline said.

Janssen’s stated:  “We are pleased the Superior Court affirmed Judge New’s ruling on the application of statute of limitations.

MASS TORT DOCKET GROWING

More than 6,400 Risperdal lawsuits – most from out-of-state plaintiffs – will be handled in Philadelphia’s Complex Litigation Center. The CLC has several mass tort programs, including cases over Xarelto  (See Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation PA State Court) and asbestos, and the percentage of claims belonging to out-of-state plaintiffs has traditionally been in the high 80s. In 2016, the percentage for pharmaceutical lawsuits dropped to 74 percent.

However, in 2017, the most recent CLC stats show that figure has jumped to an unprecedented 94 percent.

Appeal Docket: Superior Court of Pennsylvania case 2451 EDA 2015 & 576 EDA 2015

Trial Docket: Philadelphia County Court of Common Pleas case 130301803, 140200183 & 140301170

 

 

 

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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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California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense: Will other insurers say no to opioid coverage?

Profits over Patients Continues”

Mark York (November 15, 2017)

Mass Tort Nexus

 

 

 

 

 

 

 

(MASS TORT NEXUS)  On November 6, 2017 California’s Court of Appeals, Fourth Appellate District, ruled that Travelers Property Casualty does not have a duty to defend or indemnify Watson Pharmaceuticals (Activis, Inc), in a long running opioid related lawsuit based in Orange County Superior Court, as well as a second opioid related suit in Chicago.

TRAVELERS FILES DECLARATORY COMPLAINT

Watson Pharmaceuticals aka Activis, Inc., along with several other opioid manufacturers, were sued by two California counties and the city of Chicago in 2014. The claimants were seeking redress for costs related to the opioid epidemic in their respective communities. Travelers denied Watson’s demand to pay for its defense and subsequently brought a lawsuit against the drug company. Travelers filed a Complaint for Declaratory Judgment requesting the court declare that insurance coverage or indemnification of Watson-Activis under policies issued to Watson.

The California Court of Appeal detailed in its 31-page ruling that the policy covers damages for bodily injuries caused by an accident, and that the actions of Watson-Activis were intentional and not subject to policy coverage.

OPINION CLEARLY DENIES COVERAGE

“The California action and the Chicago action do not create a potential liability for an accident because they are based, and can only be read as being based, on the deliberate and intentional conduct of Watson that produced injuries—including a resurgence in heroin use that were neither unexpected nor unforeseen,” Justice Richard Fybel wrote in the ruling.

WATSON CONDUCT IS EXCLUDED

“All of the injuries arose out of Watson’s products or the alleged statements and misrepresentations made about those products, and therefore fall within the product exclusions clause of the policies,” Fybel added.

“The takeaway is that the opioid crisis has gone into the realm of whether there is insurance coverage to pay for some of the costs being incurred by public entities,” commented Larry Golub, a lawyer and partner with Hinshaw & Culbertson who is unattached to the case.

“I think there is a potential for more cases,” Golub told Connecticut Law Tribune. “Big bucks are being spent to deal with the opioids crisis.”

This is the second time Travelers has won a ruling against Watson. In August 2016, the US Court of Appeals for the Eleventh Circuit ruled that the insurer did not have to defend Anda, a division of Watson Pharmaceuticals in a West Virginia federal court case over the “prescription drug abuse” crisis in that state. The court based its decision on the exclusions of the company’s insurance policy.

OPINION EXCERPT IN TRAVELERS vs. ANDA-WATSON

Background: Anda is a wholesale pharmaceutical distributor. The State of West Virginia has sued Anda and other pharmaceutical companies in West Virginia state court, requesting an injunction against their distribution practices and seeking compensation for expenses the state alleges it has incurred as a result of the proliferation of “Pill Mills” and the attendant “opioid epidemic.” Further stating “The judgment of the district court is affirmed, and the liability policy coverage for Anda and Watson in the West Virginia opioid suit is denied.”

Will denial of insurance coverage become a trend in the exploding number od lawsuits filed against opioid manufactures, distributors and will Big Pharma finally be forced to admit the wholesale opioid abuse designed in the boardroom and placed into American commerce by any means necessary over the last 20+ years?

 

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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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Targeting Big Pharma and Their Opiate Marketing Campaigns

The Major Focus Across The USA is Now Big Pharma and Their Opiate Marketing Campaigns

Mark A. York (November 3, 2017)

(Mass Tort Nexus) A bipartisan group of states and their attorneys general have started massive joint investigations into the marketing and sales practices of drug companies that manufacture opioid painkillers. These drug makers are the largest in the country and are considered at the center of the current national addiction epidemic. This includes the executive suite and boardrooms of all opiate manufacturers, as the policy and direction for the massive growth in opiate prescriptions could not have gone unnoticed by executives at the opiate drug makers, for close to 15 years. Record earnings, bonuses and SEC filings all point to “boardroom knowledge” of ever increasing opiate focused sales efforts.

The state actions are now parallel to the “Motion for Consolidation in “The Opiate Prescription Litigation MDL 2804” , filed with the Joint Panel for Multidistrict Litigation. MDL 2804 is set for a Consolidation Motion Hearing before the JMPL panel in St. Louis,  MO on November 30, 2017, where numerous Midwest counties in Ohio, Kentucky and West Virginia as well as the city of Birmingham, Alabama joined together to file suit against the 3 largest distributors of opiates in the country, McKesson Corp., Cardinal Health and AmerisourceBergen Corporation. Also named in the suit are the primary Big Pharma opiate manufacturers including Purdue Pharma, J&J’s Janssen Pharmaceuticals, Endo, Teva and others as additional defendants.

Attorney Generals from Massachusetts, Tennessee, Texas, Illinois, New Jersey, Missouri and Pennsylvania have launched full investigations, following the lead of Ohio Attorney General Mike DeWine, who sued five drug manufacturers for misrepresenting the risks of opioids. Other states are also beginning the review of opioid manufacturers and will decide if they are joining the others in filing legal claims.

“We are looking into the role of marketing and how related corporate business practices might have played into increasing prescriptions and use of these powerful and addictive drugs,” District of Columbia Attorney General Karl Racine, a Democrat, said in a statement.

Its currently unclear exactly how many states are involved in the probe, though officials said a majority of attorneys general are part of the coalition. Among those leading the probe is Tennessee Attorney General Herbert Slatery, a Republican.

Officials did not specify which companies were under investigation, but suffice it to say, any company that made and marketed opioids products over the last 10 years will be scrutinized.

Opioid drugs, including prescription painkillers and heroin, killed more than 33,000 people in the United States in 2015, more than any year on record, according to the U.S. Centers for Disease Control and Prevention.

Separate lawsuits by attorneys general in Ohio, Tennessee, New Jersey and Mississippi, are pursuing opioid-related cases as of September 2017, with many more following suit very soon. They are have targeting Purdue Pharma LP, Johnson & Johnson(JNJ.N), Endo International Plc(ENDP.O), Teva Pharmaceutical Industries Ltd (TEVA.TA) and Allergan Plc(AGN.N) as well as leaving the door open to add additional defendants, based on the information revealed in the ongoing multi-state investigations.

New Jersey recently filed suit against Insys Therapeutics, Inc over marketing scheme for its Fentanyl product known as “Subsys”, and the massive off-label marketing campaign for uses other than FDA approved “cancer pain” treatments. The entire executive board of Insys was indicted in December 2016, along with many of its sales staff and numerous doctors across the country, with at least to physicians being sentenced to 20 years in prison by the US District Court in Alabama. See Insys Therapeutics, Inc Executives Indicted Over Fentanyl Sales Campaign.

Teva in a statement said on Thursday it is “committed to the appropriate promotion and use of opioids.” Representatives for the other companies did not immediately respond to requests for comment.

The companies have denied wrongdoing, saying the U.S. Food and Drug Administration approved their products as safe and effective and saying that they carried warning labels that disclosed their risks. The specific allegation focus more on “off label” and doctor targeting and marketing practices that repeatedly encouraged over-writing of opiate prescriptions for patients with minimal pain issues.

In announcing his office’s lawsuit in May 2017, Ohio Attorney General DeWine said the drug companies helped unleash the crisis by spending millions of dollars marketing and promoting such drugs as Purdue’s OxyContin, without consideration of the long term effects of the related addiction, which Purdue was absolutely aware of throughout the years of profits that now total billions of dollars.

The lawsuit said the drug companies disseminated misleading statements about the risks and benefits of opioids as part of a marketing scheme aimed at persuading doctors and patients that drugs should be used for chronic rather than short-term pain.  Pain centers and medical practices across the country started writing an ever increasing number of high dose opioid prescriptions for what would be considered low to mid-level pain treatment.

Similar lawsuits have been filed by local governments, including those in several California counties, as well as the cities of Chicago, Illinois and Dayton, Ohio, three Tennessee district attorneys, and nine New York counties have also filed individual suits.

It is unknown at this time, if all of the legal actions filed by governmental entities across the country will be consolidated into MDL 2804, which may be the most effective way to manage the soon to be massive number of legal claims against Big Pharma and their long term opiate profit centers. Municipalities across the country seeking to recoup the enormous financial losses brought on by the opioid crisis.

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Chicago Asks Federal Judge For Janssen Employee Marketing Records In Opioid Lawsuit

By Mark A. York (November 3, 2017)

 

 

 

 

 

 

 

 

Chicago Is Now Three Years Into it’s Suit Against Opioid Drug Manufacturers

(Mass Tort Nexus)  In the case of City of Chicago v. Purdue Pharma LP et al., Case No. 1:14-cv-04361 U.S. District Court for the Northern District of Illinois, the City of Chicago has requested the judge order Janssen Pharmaceuticals to turn over records of 10 employees that contain information related to the city’s claims that the drug company and others marketed opioids inappropriately.

In a motion to compel Janssen to produce the documents, Chicago said that Janssen Pharmaceuticals Inc. should include the employee related documents who were responsible for its opioid marketing, as the custodians of electronically stored information that can be searched for the relevant documents. So far, Janssen has refused to offer up the records or the employees in discovery requests, with Chicago stating “the company’s reasons are baseless” in the heavily redacted filing. Their claim that the custodians are ‘duplicative’ finds no support in Janssen’s own documents,” Chicago stated in the pleadings.

SUIT CLAIMS JANSSEN MISLED DOCTORS

Chicago sued Janssen Pharmaceuticals, Purdue Pharma LP, Teva Pharmaceuticals Industries Ltd., and other opioid manufacturers in 2014, saying they misled doctors and the public about the addictive nature of opioids and pushed prescriptions despite known dangers of addiction. As a result, the city claims that it paid for thousands of medically unnecessary prescriptions for city employees.

Janssen argues that including these employees would be “duplicative,” but it’s unlikely that employees working in the same area would carry out the same tasks in a way that would make their documents the same, the city said.

“Janssen has complained of the yet unproven ‘burden’ of searching the files of additional custodians,” the city said. “Janssen offers no specifics in support of this argument.”
Janssen hasn’t declared the size or scope of the additional data in the electronic files, nor has it shared with the city any costs for searching through more employees’ information, the searches are generally standard and it’s probable all the requested data has been collected in some format, Janssen is just playing hardball in giving it up.
“It merely argues that it has collected ‘nearly a terabyte’ of data from unspecified sources and therefore refuses to collect and search anymore,” this is not a valid argument as the collection of massive amounts of data in complex litigation is standard practice and the process is very well defined in cases of this type.
“Chicago has identified more than 125 parties whose files it will search for responsive electronically stored information. Janssen has agreed to search only 17 custodians,” according to the city “In contrast, the Endo defendants have agreed to search 62 ESI custodians and the Actavis defendants have agreed to search 43 ESI custodians.”

LOCAL GOVERNMENTS IN OPIOID MDL

The city’s suit is one of a number filed by municipalities over the ongoing opioid epidemic, there is now a Motion to Consolidate the “Opiate Prescription Litigation as MDL 2804” (see OPIOID CRISIS: MDL 2804 OPIATE PRESCRIPTION LITIGATION) pending before the Joint Panel on Multidistrict Litigation, set for November 30th in St. Louis. In addition, the Cherokee Nation tribe gas filed against the drug makers, and at least one class action was filed on behalf of individuals in Arkansas, which has been placed on hold pending the outcome of the JPML motion hearing in St. Louis on November 30th.

More than 40 state attorneys general have also launched a joint investigation into at least half a dozen opiate drugmakers and distributors and many are close to moving forward in not only civil claims but looking very closely at potential criminal charges. The state AGs’ probe initially focused on OxyContin maker Purdue Pharma, now widened to include other opioid drugmakers and distributors such as Endo, Allergen, McKesson and Teva.

CRIMINAL INVESTIGATIONS

The US Department of Justice is now pursuing criminal charges against select opioid drug manufacturers in Massachusetts, where Insys Therapeutics, Inc. is under indictment. In a surprise move, the US Attorney’s office in Connecticut has opened a criminal review of Oxycontin maker, Purdue Pharma, LP, and it’s opioid drug marketing practices.

“We look forward to fully responding to this latest motion once we have the opportunity to review it with counsel,” stated Janssen, “We recognize opioid abuse is a serious public health issue that must be addressed. At the same time, we firmly believe the allegations in these lawsuits are both legally and factually unfounded

As the legal heat is turned up across the country on opioid drug manufactures, it remains to be seen how they will react to what is being termed as a repeat of the legal strategy followed in the massive and financially damaging “Tobacco Litigation.”

 

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States Across The Country Are Targeting Big Pharma and Their Opiate Marketing Campaigns

Is Big Pharma The Target of Litigation Modeled After Tobacco Litigation?  

Mark A. York,  October 6, 2017

 

 

 

 

 

 

 

(Mass Tort Nexus) A bipartisan group of states and their attorneys general have started massive joint investigations into the marketing and sales practices of drug companies that manufacture opioid painkillers. These drug makers are the largest in the country and are considered at the center of the current national addiction epidemic. This includes the executive suite and boardrooms of all opiate manufacturers, as the policy and direction for the massive growth in opiate prescriptions could not have gone unnoticed by executives at the opiate drug makers, for close to 15 years. Record earnings, bonuses and SEC filings all point to “boardroom knowledge” of ever increasing opiate focused sales efforts.

Opiate Rx MDL 2804 Parallels State Claims

The state actions are now parallel to the September 25, 2017 filing of a “Motion for Consolidation in “The Opiate Prescription Litigation MDL 2804”, with the Joint Panel for Multidistrict Litigation. MDL 2804, where numerous Midwest counties in Ohio, Kentucky and West Virginia as well as the city of Birmingham, Alabama joined together to file suit against the 3 largest distributors of opiates in the country, McKesson Corp., Cardinal Health and AmerisourceBergen Corporation. Also named in the suit are the primary Big Pharma opiate manufacturers including Purdue Pharma, J&J’s Janssen Pharmaceuticals, Endo, Teva and others as additional defendants.

Attorney Generals from Massachusetts, Tennessee, Texas, Illinois, New Jersey, Missouri and Pennsylvania have launched full investigations, following the lead of Ohio Attorney General Mike DeWine, who sued five drug manufacturers for misrepresenting the risks of opioids. Other states are also beginning the review of opioid manufacturers and will decide if they are joining the others in filing legal claims.

“We are looking into the role of marketing and how related corporate business practices might have played into increasing prescriptions and use of these powerful and addictive drugs,” District of Columbia Attorney General Karl Racine, a Democrat, said in a statement.

Its currently unclear exactly how many states are involved in the probe, though officials said a majority of attorneys general are part of the coalition. Among those leading the probe is Tennessee Attorney General Herbert Slatery, a Republican.

Officials did not specify which companies were under investigation, but suffice it to say, any company that made and marketed opioids products over the last 10 years will be scrutinized.

Opioid drugs, including prescription painkillers and heroin, killed more than 33,000 people in the United States in 2015, more than any year on record, according to the U.S. Centers for Disease Control and Prevention.

Separate lawsuits by attorneys general in Ohio, Tennessee, New Jersey and Mississippi, are pursuing opioid-related cases as of September 2017, with many more following suit very soon. They are have targeting Purdue Pharma LP, Johnson & Johnson(JNJ.N), Endo International Plc(ENDP.O), Teva Pharmaceutical Industries Ltd (TEVA.TA) and Allergan Plc(AGN.N) as well as leaving the door open to add additional defendants, based on the information revealed in the ongoing multi-state investigations.

New Jersey Files Against Insys Therapeutics

New Jersey recently filed suit against Insys Therapeutics, Inc over marketing scheme for its Fentanyl product known as “Subsys”, and the massive off-label marketing campaign for uses other than FDA approved “cancer pain” treatments. The entire executive board of Insys was indicted in December 2016, along with many of its sales staff and numerous doctors across the country, with at least to physicians being sentenced to 20 years in prison by the US District Court in Alabama. See Insys Therapeutics, Inc Executives Indicted Over Fentanyl Sales Campaign.

Teva in a statement said on Thursday it is “committed to the appropriate promotion and use of opioids.” Representatives for the other companies did not immediately respond to requests for comment.

The companies have denied wrongdoing, saying the U.S. Food and Drug Administration approved their products as safe and effective and saying that they carried warning labels that disclosed their risks. The specific allegation focus more on “off label” and doctor targeting and marketing practices that repeatedly encouraged over-writing of opiate prescriptions for patients with minimal pain issues.

Ohio Filed First

In announcing his office’s lawsuit in May 2017, Ohio Attorney General DeWine said the drug companies helped unleash the crisis by spending millions of dollars marketing and promoting such drugs as Purdue’s OxyContin, without consideration of the long term effects of the related addiction, which Purdue was absolutely aware of throughout the years of profits that now total billions of dollars.

The lawsuit said the drug companies disseminated misleading statements about the risks and benefits of opioids as part of a marketing scheme aimed at persuading doctors and patients that drugs should be used for chronic rather than short-term pain.  Pain centers and medical practices across the country started writing an ever increasing number of high dose opioid prescriptions for what would be considered low to mid-level pain treatment.

Similar lawsuits have been filed by local governments, including those in several California counties, as well as the cities of Chicago, Illinois and Dayton, Ohio, three Tennessee district attorneys, and nine New York counties have also filed individual suits.

It is unknown at this time, if all of the legal actions filed by governmental entities across the country will be consolidated into MDL 2804, which may be the most effective way to manage the soon to be massive number of legal claims against Big Pharma and their long term opiate profit centers. Municipalities across the country seeking to recoup the enormous financial losses brought on by the opioid crisis.

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“NATIONAL PRESCRIPTION OPIATE LITIGATION MDL No. 2804”

Transfer Motion Accepted by JPML On September 29, 2017

By Mark A. York

Mass Tort Nexus (September 29, 2017)

 

 

 

 

 

 

 

The  Motion to Transfer and Consolidate MDL No. 2804, now known as “National Prescription Opiate Litigation”, was accepted by the JPML on September 29, 2017 see “JPML Motion to Consolidate Prescription Opiate Litigation as MDL 2804”, with the apparent motion hearing date being November 30, 2017 at the Joint Panel on Multidistrict Litigation hearings in St Louis, Missouri. The consolidation motion was filed by Hill, Peterson, Carper, Bee & Dietzler, based in Charleston, WV. The filing is the long expected result of the ongoing “Opioid Crisis” which has seemingly overtaken many aspects of day to day life in America, with a particular emphasis on rural America. The many small towns and counties have seen unheard of increases in overdose deaths and 911 calls for drug overdoses, which have depleted budgets and caused ever mounting levels of grief for stricken families as well as tension in government council meetings everywhere, when attempting to address the crisis.

The consolidation filing is followed in the Mass Tort Nexus briefcase, “National Prescription Opiate Litigation MDL”,as the motion directly cites the nation’s three largest wholesalers of opiod drugs, McKesson Corporation, AmerisourceBergen Corporation and Cardinal Health, Inc. as well as naming primary drug makers Purdue Pharma, Teva, Cephalon, Janssen, Endo, Actavis and Mallinckrodt as defendants in certain actions. Opiate drug makers and their executives are now firmly in the sights of not only mass tort lawyers, but facing the full force of criminal investigation by the US Department of Justice in every state, as indictments have already been handed down in several federal venues. The MDL filing contains complaints that specifically reference RICO claims in many of the 66 federal actions cited in the motion, to be transferred into the JPML venue.

The pharmaceutical industry already faces dozens of lawsuits brought by cities, counties and states — including Ohio, Missouri and Oklahoma. Some are trying to recoup the costs incurred from the surge in emergency response from spikes in opioid-related overdoses. The strategy is reminiscent of the successful litigation brought by states and municipalities three decades ago against tobacco companies.

The opioid drug industry expanded in the 1990s in response to the medical community’s push to better treat pain and chronic pain.

A primary focus is the how and why of , millions of opioid users became addicted to opioids, or heroin, after being prescribed the medication by doctors and the apparent failure of corporate executives to address the ever mounting evidence in light of the enormous profits, year in and year out.

Many doctors, in turn, said they were assured by the drugmakers that the opioids were less addictive or even not addictive, which in the civil matters will be a point of very high contention and potentially a focus of US DOJ investigators.

Some states have obtained consent decrees and financial penalties from drug makers, including Illinois, “My investigations have shown that drug companies pressure physicians into prescribing powerful, addictive drugs without regard for the law or patients’ well-being,” said Illinois Attorney General Lisa Madigan, who is also party to the new investigation.

SHOTS – HEALTH NEWS

Intent On Reversing Its Opioid Epidemic, A State Limits Prescriptions

Now, many state prosecutors say they will examine whether the industry was complicit in creating the epidemic and whether it should now be responsible for helping pay for the damage caused to many communities.

Allergan said it was “working cooperatively” with the attorneys generals on their requests for information. The other companies being investigated did not immediately issue statements, and industry lobbying group PhRMA didn’t respond to a request for comment.

The number of opioid prescriptions has declined in recent years, after federal regulators placed new limits on the drugs. That reduced the amount of opioids prescribed by 18 percent in 2015, from a peak in 2010, according to the Centers for Disease Control and Prevention.

Still, as the state attorneys general and other community leaders note, the slowdown in prescriptions has been offset by greater demand for cheaper alternatives such as heroin.

“For millions of Americans, their personal battle with opioid addiction did not start in a back alley with a tourniquet and syringe,” Schneiderman said. “They got hooked on medicine they were prescribed for pain or that they found in a medicine cabinet.”

“Governmental entities across the country are now joining together and stating “We are taking this action today because our communities and homes have been broken and families torn apart by this epidemic,” and this known danger was ignored by opioid drug makers, “This epidemic has claimed victims from all walks of life, and both the financial and emotional costs to our citizens.”

Primary allegations include “That the manufacturing companies pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction, while the distributors breached their legal duties to monitor, detect, investigate, refuse and report suspicious orders of prescription opioids:, which is applicable to all afflicted communities across the country.

From the extensive research by Mass Tort Nexus to date, it appears that this is just the tip of the litigation iceberg that will be brought against all levels of opiate pharmaceutical manufactures and affiliated distributors in the USA. Based on US Dept. of Justice criminal filings, the executive boardrooms are not exempt from indictments and criminal charges,  as well as the many doctors, sale and marketing professionals and others who helped facilitate the current opioid crisis, which directly results in related civil and mass tort actions against all involved.

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AS EXPECTED A “NATIONAL PRESCRIPTION OPIATE LITIGATION MDL FILING” IS ON THE JPML DOCKET

Transfer Motion Filed To Create New Opioid Rx Multidistrict Litigation

By Mark A. York

Mass Tort nexus (September 28, 2017)

A Motion to Transfer and Consolidate the “National Prescription Opiate Litigation”, was filed on September 25, 2017 see “JPML Motion to Consolidate Prescription Opiate Litigation”, with the Joint Panel on Multidistrict Litigation. An MDL number designation has not been assigned as of Thursday the 28th, but the filing and designation are under JPML review.  The motion was filed by Hill, Peterson, Carper, Bee & Dietzler, based in Charleston, WV. The filing is the long expected result of the ongoing “Opioid Crisis” which has seemingly overtaken many aspects of day to day life in America, with a particular emphasis on rural America. The many small towns and counties have seen unheard of increases in overdose deaths and 911 calls for drug overdoses, which have depleted budgets and caused ever mounting levels of grief for stricken families as well as tension in government council meetings everywhere, when attempting to address the crisis.

The consolidation filing is followed in the Mass Tort Nexus briefcase, “National Prescription Opiate Litigation MDL”,as the motion directly cites the nation’s three largest wholesalers of opioId drugs, McKesson Corporation, AmerisourceBergen Corporation and Cardinal Health, Inc. as well as naming primary drug makers Purdue Pharma, Teva, Cephalon, Janssen, Endo, Actavis and Mallinckrodt as defendants in certain actions. Opiate drug makers and their executives are now firmly in the sights of not only mass tort lawyers, but facing the full force of criminal investigation by the US Department of Justice in every state, as indictments have already been handed down in several federal venues. The MDL filing contains complaints that specifically reference RICO claims in many of the 66 federal actions cited in the motion, to be transferred into the JPML venue.

STATES HAVE FILED SUIT ALREADY

The pharmaceutical industry already faces dozens of lawsuits brought by cities, counties and states — including Ohio, Missouri and Oklahoma. Some are trying to recoup the costs incurred from the surge in emergency response from spikes in opioid-related overdoses. The strategy is reminiscent of the successful litigation brought by states and municipalities three decades ago against tobacco companies.  The common understanding is that the “Opiate Rx Litigation MDL” and related lawsuits across the country, may equal or surpass the tobacco litigation in both scope and financial penalties paid by drug makers.

The opioid drug industry expanded in the 1990s in response to the medical community’s push to better treat pain and chronic pain.

A primary focus is the how and why millions of opioid users became addicted to opioids, or heroin, after being prescribed the medication by doctors and the apparent failure of corporate executives to address the ever mounting evidence in light of the enormous profits, year in and year out.

WARNINGS TO DOCTORS INADEQUATE

Many doctors, in turn, said they were assured by the drugmakers that the opioids were less addictive or even not addictive, which in the civil matters will be a point of very high contention and potentially a focus of US DOJ investigators.

Some states have obtained consent decrees and financial penalties from drug makers, including Illinois, “My investigations have shown that drug companies pressure physicians into prescribing powerful, addictive drugs without regard for the law or patients’ well-being,” said Illinois Attorney General Lisa Madigan, who is also party to the new investigation.

 

 

 

 

 

 

 

 

 

Intent On Reversing Its Opioid Epidemic, A State Limits Prescriptions

Now, many state prosecutors say they will examine whether the industry as a whole, was complicit in creating the epidemic and whether it should now be responsible for helping pay for the damage caused to many communities.

Allergan said it was “working cooperatively” with the attorneys generals on their requests for information. The other companies being investigated did not immediately issue statements, and industry lobbying group PhRMA didn’t respond to a request for comment.

The number of opioid prescriptions has declined in recent years, after federal regulators placed new limits on the drugs. That reduced the amount of opioids prescribed by 18 percent in 2015, from a peak in 2010, according to the Centers for Disease Control and Prevention.

Still, as the state attorneys general and other community leaders note, the slowdown in prescriptions has been offset by greater demand for cheaper alternatives such as heroin, now recognized by medical industry leaders, substance abuse professionals, law enforcement and now mass tort lawyers, as a primary direct result of the massive opioid prescription writing campaign for so many years.

ADDICTIONS STARTED WITH A PRESCRIPTION

“For millions of Americans, their personal battle with opioid addiction did not start in a back alley with a tourniquet and syringe,” industry leaders are stating “They got hooked on medicine they were prescribed for pain or that they found in a medicine cabinet.”

“Governmental entities across the country are now joining together and stating “We are taking this action today because our communities and homes have been broken and families torn apart by this epidemic,” and this known danger was ignored by opioid drug makers, “This epidemic has claimed victims from all walks of life, and both the financial and emotional costs to our citizens.”

Primary allegations include “That the manufacturing companies pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction, while the distributors breached their legal duties to monitor, detect, investigate, refuse and report suspicious orders of prescription opioid, which is applicable to all afflicted communities across the country.

From the extensive research by Mass Tort Nexus to date, it appears that this is just the tip of the litigation iceberg that will be brought against all levels of opiate pharmaceutical manufacturers and affiliated distributors in the USA. Based on US Dept. of Justice criminal filings, the executive suites and boardrooms are not exempt from indictments and criminal charges,  as well as the many doctors, sale and marketing professionals and others who helped facilitate the current opioid crisis, which directly results in related civil and mass tort actions against all involved.

Read More

XARELTO in Philadelphia Court: Will The BMSQ “California Plavix” SCOTUS Ruling Affect Out of State Plaintiffs?

XARELTO in Philadelphia Court of Common Pleas: Will The “California Plavix” Supreme Court Ruling Affect Out of State Plaintiffs?

By Mark A. York

Mass Tort Nexus (September 26, 2017)

 

 

 

 

 

Bayer, which has a headquarters in Pennsylvania, recently used a June 2017 U.S. Supreme Court decision on out of state plaintiffs and court jurisdictions to dismiss dozens of lawsuits from a Missouri federal court in the “Essure” birth control litigation. It remains to be seen if Bayer will use the same strategy in other jurisdictions, like Philadelphia, where the Xarelto blood thinner cases are piling up, see XARELTO Case No. 2349 in Philadelphia Court of Common Pleas Briefcase.

Thousands of out-of-state plaintiffs flocked to Philadelphia recently to file lawsuits over prescription drugs, but a recent U.S. Supreme Court decision might deter that practice in the future, see  June 19, 2017 Bristol-Myers v. Superior Court of California (Plavix Jurisdiction).

The many claimants who have brought their lawsuits in Philadelphia will have to see if pharmaceutical companies like Bayer, Johnson & Johnson and others who are facing many thousands of other claims from out-of-state plaintiffs, will rely on the June 19th U.S. Supreme Court ruling that states an out-of-state plaintiff couldn’t file suit in California, due to a lack of jurisdiction.

The Supreme Court justices ruled 8-1 in favor of Bristol Myers-Squibb after the company argued plaintiffs living outside California who alleged injury from BMS’s blood thinner Plavix, should not be able to sue the company in that state.

The Supreme Court ruled that, essentially the “all inclusive view of personal jurisdiction by non-resident plaintiffs has come to an end.” Plavix was not designed or made in California, and the company is headquartered in New York. The ruling may simply force thousands of pending cases across the country to be refiled in other venues, as plaintiff firms are not likely to simply withdraw the cases as massive losses, without having their day in one court or another.

A non-residents plaintiff can file suit in the Philadelphia County Court of Common Pleas, if the defendant is either incorporated in Pennsylvania, or has a principal place of business in Pennsylvania, which limits the legal options for Bayer, based on their corporate headquarters in the state.

Two of the biggest mass tort programs in the Philadelphia Complex Litigation Center docket are the Risperdal litigation, which is produced by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) and allegedly causes males to develop breasts, Janssen has been hit with several large multi-million dollar verdicts in Risperdal trials. The other is Xarelto, a blood-thinner made by Bayer and Johnson & Johnson that allegedly causes uncontrolled bleeding events, and the makers failed to warn of the dangers. The Xarelto MDL 2592 in US district Court ED Louisiana . see Xarelto MDL 2592 Mass Tort Nexus Briefcase, where close to twenty thousand additional Xarelto cases are pending.

Bayer will be having a much harder time using the BMS Plavix decision to dismiss non-resident plaintiffs from the Philadelphia courtroom, given it’s headquarters in Pittsburgh, Pennsylvania.

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