FDA Fails to Cite Big Pharma Opioid Drug Makers for False Marketing and Advertisements

“PROFITS BEFORE PATIENTS REIGNS SUPREME AT FDA”

By Mark A. York (December 12, 2017)

Purdue Pharma and OxyContin Never Warned By FDA

 

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA)  In the midst of a national opioid crisis, the federal agency that monitors drug ads has issued a record low number of warning letters to pharmaceutical companies caught lying about their products.

The Food and Drug Administration has sent just three notice letters to drug makers busted for false marketing their medications to unknowing consumers, the lowest ever since the FDA historic decision to ease strict rules for drug ads in 1997. “It certainly raises questions,” said Dr. David Kessler, head of the FDA from late 1990 through 1996, who’s industry credentials would add weight to the issue of why the FDA is not doing more to monitor false marketing campaigns by Big Pharma and Opioid Drug makers in particular.

The FDA’s Office of Prescription Drug Promotion monitors all ads drug companies issue to make sure patients aren’t being scammed by false assertions or misleading marketing campaigns. Which now seems to be the norm, based on the hundreds of lawsuits filed against Opioid Drug Makers in the last 3 months, and recently consolidated into Opiate Prescription MDL 2804 see Opioid Crisis Briefcase-Mass Tort Nexus, where Big Pharma is being sued by states, cities and counties across the country. The primary claim in almost every suit is long term boardroom coordinated false marketing campaigns designed to push opioid drug prescriptions at any cost.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every years since the push to increase opioid prescriptions in every way possible became an accepted business model Big Pharma boardrooms across the counrty.

FDA PLEADS NO STAFF

But the agency has long struggled to keep track of the thousands of ads published each year, largely due to lack of staff.

There are approximately 60 FDA staffers responsible for keeping track of at least 75,000 ads and other promotional material published each year. Although in the age of electronic monitoring and hi-tech tracking of data it would seem that monitoring drugs such as Schedule 2 – 4 narcotics or other drugs that are considered high risk for abuse, the FDA could create a quarterly e-review or a flagging system when new campaigns are started by Big Pharma.

“It’s a very, very small unit,” a former high-ranking FDA official said. “It’s historically been underfunded.” Which seems to support the contention that Washington D.C lawmakers are in the pockets of Big Pharma and the hundreds of lobbyists they utilize to ensure a true lack of oversight in the pharmaceutical industry as a whole.

Additionally, many of the ads are submitted to the FDA for review at the same time they begin to run. So by the time the assessment is complete the ad has “already had a significant impact,” the FDA insider said. This policy flies in the face of the creation regulatory oversight based on the fact that when a problem or an issue with a product is discovered, the FDA, EPA or other agency should enforce the law and correct the problem. In the case of the FDA, that is not happening and Big Pharma is and has been aware of the lack of oversight for years.

Critics say the FDA needs to do more to stay on top of an industry with a history of trying to maximize profits by at times misleading consumers, which has recently been described as a policy of “patients before patients” which has resulted in the current Opioid Crisis that’s firmly in place across the United States.

The number of public admonishment letters has been at or close to single digits from 2014 until 2016 during the Obama administration, records show. The FDA sent out 11 of those caution missives in 2016, nine in 2015 and 2014, and 24 in 2013.

A SINGLE FDA WARNING IN 2016

This year, one of the warning letters was sent to Canadian drugmaker Cipher Pharmaceuticals, ordering it stop using deceptive promotional material to hawk its extended-release opioid ConZip.

The ad failed to note “any risk information” highlighting the potentially addictive nature of the powerful painkiller, the FDA letter issued Aug. 24 said. The promotional material was also misleading because it asserted other treatment options “are inadequate,” the oversight agency concluded.

“By omitting…serious and potentially fatal risks, the detail aid…creates a misleading impression about the drug’s safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse,” the FDA said.

The agency demanded that Cipher “immediately cease misbranding” the medication. The drug company responded by yanking the promotional material, the firm’s execs said in a statement issued after the warning letter was made public.

But that was the single caution letter issued to an overhyped painkiller by the FDA this year so far, records show. The other caution letters were sent to Amherst Pharmaceuticals for the insomnia drug Zolpimist, and to Orexigen Therapeutics Inc. for its weight loss drug Contrave.

There are many long term FDA and other senior DC officials who have for whatever reasons, chosen to defer reigning in Big Pharma sales and marketing abuses and now it appears the corrective action has been undertaken in federal courts across the country by mass tort lawyers in litigation which will apparently make the “Tobacco Litigation” of the 1980’s pale in financial comparison.

With the primary lawsuits recently consolidated by in the Multidistrict Litigation titled “National Prescription Opiate Litigation” Case No. MDL 2804, recently assigned to the US District Court, Northern District of Ohio.  With the key case heading including “prescription and opiate” which reflects the federal court recognizing that opiate prescriptions have become such a major issue the federal courts will now determine the penalties assessed against Big Pharma. The focus will be on the long term “sales and marketing campaigns” designed in corporate boardrooms of Fortune 100 companies, to increase corporate profits, while ignoring the known catastrophic increases in addictions and other inter-connected healthcare, economic and social upheavels caused by the flood of opioid drugs in the US market.

The FDA maintains that letters to drug companies are merely one tool the agency uses to keep the pharmaceutical industry in line.

“We have many efforts to encourage compliance by industry, including our work on guidance, by providing advice to companies on draft promotional materials, and outreach to our stakeholders,” FDA spokeswoman Stephanie Caccomo said. “The FDA’s priorities regarding prescription drug promotion are policy and guidance development, labeling reviews, core launch and TV ad reviews, training and communications and enforcement.” The key terms referred to by Ms. Caccamo are “guidance and by providing advice” from the FDA, when direct enforcement actions are required, as Big Pharma see the terms “guidance and advice” as harmless and not applicable to their efforts to increase sales and profits. In-house lawyers at Big Pharma have reviewed FDA enforcement failures and offered opinions to the boardrooms for years about the FDA not willing to enforce anything close to restrictions on opioid drug marketing and sale practices, all the while reaping the profits of the opioid crisis.

US DEPT OF JUSTICE INDICTMENTS

While the FDA has failed, the US Department of Justice has launched a massive crackdown on opiate drug makers including indictments of company executives, sales & marketing personnel as well as the doctors and pharmacies that have enabled the flood of easy access narcotics into the US market for over 15 years. The question is “how and why” did the FDA drop the ball or was this an intentional lack of enforcement and oversight by the FDA and other agencies due to Big Pharma influence over Congressional members who would blunt any true oversight of drug companies.

US CONGRESS IS NOT HELPING

Perhaps a look at former US Representative Tom Price, will provide insight into how our lawmakers work within the healthcare industry. Rep. Price was appointed by President Trump to head the Department of Health and Human Services, which the FDA reports to, was forced to resign as HHS head due to various transgression within 6 months of being appointed, as well as leaks that while a sitting congressman he enacted a bill favoring a medical device makers extension of a multi-year government contract. Not only did Price enact the bill, he purchased stock in the company prior to the bill introduction and secured a massive profit on the stock price increase after the contract extension was announced. In normal business circles this is considered “insider trading” and is illegal, but when you’re one of those people in charge of creating the rules and regulations, there’s an apparent “get out of jail card” that comes with your congressional seat.

As long as the US Congress fails to correct the lack of oversight by the FDA and other regulatory agencies into what and how dangerous drugs and products are placed into the US marketplace, there will always be bad drugs entering the healthcare pipeline in the United States, with the now enduring default misnomer of “Profits Before Patients” firmly in place in boardrooms and within our government.

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JPML Approves Opiate Prescription MDL No. 2804: “Profits Before Patients” Exposed

JPML Approves Opiate Prescription MDL No. 2804

 

 

(Mass Tort Nexus) The U.S. Judicial Panel on Multidistrict Litigation, formally approved the “NATIONAL PRESCRIPTION OPIATE LITIGATION MDL No. 2804” earlier today see, JPML Transfer Order in MDL No. 2804, December 5, 2017.  Cases filed into MDL 2804 by counties, cities and other parties are expanding quickly as plaintiffs in more than 100 lawsuits against pharmaceutical companies related to the opioid epidemic were successful, when getting the MDL assigned to Judge Daniel Polster in the US District Court, Northern District of Ohio. While the manufacturers had argued for consolidation in corporate defense friendly New York, and various distributors supported consolidation in West Virginia. The location of this MDL in Ohio, which has been one of the hardest hit states by the “opioid crisis” may have far reaching implications toward the management and ultimate resolution of the onslaught of opioid claims.

Case plaintiffs are filing new claims across the country from Montana to New Mexico and into Wisconsin, where every county in the entire state of Wisconsin has filed suit against the opioid drug makers and distributors, see Mass Tort Nexus briefcase “OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION” for materials, including case dockets and information related to all areas of the opioid crisis across the country.

 Parties Vie For Strategic Positioning In Their Preferred Venues

On Sept. 25, 2017, 46 government plaintiffs filed a motion with the

panel seeking coordination or consolidation of their claims and 20

“substantially similar” lawsuits pending in 11 federal districts.

Among the common questions of fact that would justify MDL,

plaintiffs cited:

  • Whether, and to what extent, defendants promoted or allowed

the use of prescription opioids for purposes other than those

approved by the U.S. Food and Drug Administration.

  • Defendants’ knowledge of the actual or potential diversion of

prescription opioids into illicit channels.

  • The nature and adequacy of defendants’ internal controls and procedures for identifying suspicious orders for prescription opioids and reporting them to the authorities.

 Plaintiff Positions:

Pro-MDL plaintiffs had wanted to keep the docket in the hard hit Ohio or West Virginia courts, as the impact there has crossed all lines with no demographic not affected in one way or another by the opioid crisis.

Anti-MDL plaintiffs, including the city of Chicago and eight plaintiffs from West Virginia, opposed centralization, arguing their claims named

distributors or manufacturers, but not both, and the MDL would hinder their individual case interests, which was rejected by the panel, as Judge Charles Breyer of the Northern District of California noted repeatedly, the central factual issue for these claims is “what

did [the manufacturers and distributors] know and what did they do [with that knowledge]?” Plaintiff-specific questions, such as how many pills were shipped into a given community, could be answered in the context of MDL without hindering any individual plaintiff’s case.

 Drug Distributors:

The “big three” distributor defendants, McKesson Corporation, Cardinal Health Inc., and AmerisourceBergen Corporation, wanted the MDL before Judge David A. Faber in the Southern District of West Virginia, which already has a heavy MDL docket with the thousands of TVM cases, and the panel decided against another massive caseload being assigned to that venue.

Drug Manufacturers:

The manufacturers sought transfer to the federal district where they were first sued, in the Northern District of Illinois, where Judge Jorge Alonso is presiding over the lawsuit filed by the city of Chicago in June 2014.  As an alternative to the Illinois court, the manufacturers, with many being based in Connecticut, Pennsylvania, New York and New Jersey, argued for the U.S. District Court for the Southern District of New York, even though there is no opioid litigation pending against them there.

 MDL 2804 Impact on Opioid Crisis

Transferee courts often make crucial pretrial decisions regarding case management, the scope of discovery and class action certification.

The opioid claims have this far suffered from the lack of such coordination and guidance, and MDL 2804 would be making an important step in managing the ever growing case docket. Which has unique challenges including, opioid claims that are not brought by the injured individuals themselves. Instead, these claims have been filed b by government entities that allege they are out massive amounts of money and lost services after having treated or responded to the opioid epidemic for the last 15 years.

As Judge Vance noted throughout the hearing, “there are serious threshold issues” with the government entities’ standing to bring claims that do not apply to other plaintiff categories, such as individuals claiming wrongful death, which could lead to an inefficient MDL for non-government plaintiffs.

JPML Judge Refers to Future Individual Claims

Judge Vance stated, “Therefor the manner in which government entities can prove their damages will be a challenging topic for any MDL court, as will the consideration of how a settlement may be structured such that it does not impinge on the rights of recovery for the actual individuals who may later claim personal harm from opioids.” Which may be taking place sooner as opposed to later, as individual claims are being filed in a few courts across the country already.

 Settlement Ability Of Big Pharma

An additional consideration of the court is the pharmaceutical manufacturers being the primary target of opioid litigation, as the drug makers are alleged to have been involved in stoking the fires of the epidemic from the earliest days. Many of these companies have very large set aside cash reserves for just this type of legal development, which could give them increased leverage and ability to craft settlements in the MDL.  While distributor defendants, will face very different exposures, with resolution that may involve insurance interests, and some insurers have decided to decline coverage and spinning off a whole sub-set of insurance coverage lawsuits.

Healthcare Service Providers and Pharmacies Are Also Targets

Additional defendants in these claims now include pharmacies like CVS, Walgreens, etc, doctors and pain management clinics, all of which have settlement interests and exposures that differ from the others.  As opioid claims mount, reports have surfaced indicating that Purdue Pharma and other pharmaceutical defendants are eyeing settlement, at least at the state level.

RICO Claims Are In The Mix

Several entities have filed RICO claims against the drug makers and distributors alleging that the opioid crisis was developed and directed by boardroom decisions of some of the largest companies in the United States. How this affects the MDL direction will be worth watching.

The opioid plaintiff pool across the country now includes state and local governments, hospitals, labor unions and an ever growing number of individual plaintiffs as well, how Judge Polster decides to manage this extremely complex docket will be watched closely.

 Spin Off MDL’s As Needed

Judge Breyer offered one potential solution to multiple plaintiffs and defendants with divergent interests, which is allow the transferee court to create different “tracks” based on plaintiff category, spin off new MDLs as appropriate, or remand cases that have ceased to benefit from MDL 2804.

 A Conclusion Or A Reckoning

Now that MDL 2804 has been established, the pace of opioid litigation will quickly accelerate, with many new claims being filed daily as they have over the last 10 weeks, since the initial Motion to Consolidate was filed. With an MDL now looming over the entire pharmaceutical industry, the prescription opioid market will never be the same, as evidenced by criminal indictments of drug company executives and ongoing investigations that are taking place in many states. Perhaps now there will be an adjustment of the “profits before patients” policies that have been adopted by Big Pharma in this country, and drug makers will be forced to come to terms with the catastrophic damage they’ve caused by their flood of opioid drugs released across America over the last 15 years.

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JPML APPROVES “OPIATE PRESCRIPTION MDL 2804” AGAINST OPIOID MANUFACTURERS AND DISTRIBUTORS

The UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION  has formally approved the“NATIONAL PRESCRIPTION OPIATE LITIGATION, MDL No. 2804″ on December 5, 2017.

     Assigned to Judge Daniel Polster, US District Court Northern District of Ohio, who will oversee the litigation related to manufacturing, marketing, distribution and sales practices of prescription opioid drugs by Big Pharma drug makers and distributors.  

 

 

 

JPML Transfer Order in MDL No. 2804, December 5, 2017

UNITED STATES JUDICIAL PANEL

on

MULTIDISTRICT LITIGATION

IN RE: NATIONAL PRESCRIPTION OPIATE LITIGATION                                                                            MDL No. 2804

TRANSFER ORDER

Before the Panel:* Plaintiffs in 46 actions move under 28 U.S.C. § 1407 to centralize pretrial proceedings in the Southern District of Ohio or the Southern District of Illinois, but plaintiffs do not oppose centralization in the Southern District of West Virginia.  These cases concern the alleged improper marketing of and inappropriate distribution of various prescription opiate medications into cities, states and towns across the country.  Plaintiffs’ motion includes the 64 actions listed on Schedule A,1 which are pending in nine districts.  Since plaintiffs filed this motion, the parties have notified the Panel of 115 potentially related actions.2 

Responding plaintiffs’ positions on centralization vary considerably.  Plaintiffs in over 40 actions or potential tag-along actions support centralization.  Plaintiffs in fifteen actions or potential tag-along actions oppose centralization altogether or oppose transfer of their action.  In addition to opposing transfer, the State of West Virginia suggests that we delay transferring its case until the Southern District of West Virginia court decides its motion to remand to state court.  Third party payor plaintiffs in an Eastern District of Pennsylvania potential tag-along action (Philadelphia Teachers Health and Welfare Fund) oppose centralization of third party payor actions.  Western District of Washington plaintiff City of Everett opposes centralization and, alternatively, requests exclusion of its case.  Northern District of Illinois tagalong plaintiff City of Chicago asks the Panel to defer transfer of its action until document discovery is completed.

Defendants’ positions on centralization also vary considerably. The “Big Three” distributor defendants,3 which reportedly distribute over 80% of the drugs at issue and are defendants in most cases,

__________________________________________

* Judges Lewis A. Kaplan and Ellen Segal Huvelle did not participate in the decision of this matter.

1  Two actions included on plaintiffs’ motion to centralize were remanded to state court during the pendency of the motion.

2 These actions, and any other related actions, are potential tag-along actions.  See Panel Rules 1.1(h), 7.1 and 7.2. 3

3 AmerisourceBergen Drug Corp., AmerisourceBergen Corp., McKesson Corp., Cardinal Health 110, LLC, Cardinal Health, Inc., Cardinal Health 105, Inc., Cardinal Health 108, LLC, Cardinal Health 112, LLC, Cardinal Health 414, LLC, and Cardinal Health subsidiary The Harvard Drug  – 2 –

support centralization in the Southern District of West Virginia.  These defendants request that the Panel either delay issuing its transfer order or delay transfer of their cases until their motions to dismiss are decided.  Defendant distributor Miami-Luken also supports centralization in the Southern District of West Virginia.  Multiple manufacturer defendants4 support centralization in the Southern District of New York or the Northern District of Illinois; defendant Malinckrodt, LLC, takes no position on centralization but supports the same districts.  Teva defendants5 suggest centralization in the Eastern District of Pennsylvania or the manufacturers’ preferred districts.  Physician defendants6 in three Ohio actions, who are alleged to be “key opinion leaders” paid by manufacturing defendants, do not oppose centralization in the Southern District of Ohio. 

Defendants in several Southern District of West Virginia cases oppose centralization.  These defendants include several smaller distributor defendants or “closed” distributors that supply only their own stores.7  Many of these defendants specifically request exclusion of the claims against them from the MDL.  Also, manufacturer Pfizer, Inc., opposes centralization and requests that we exclude any claims against it from this MDL.8

The responding parties suggest a wide range of potential transferee districts, including: the Southern District of West Virginia, the Southern District of Illinois, the Northern District of Illinois, the Eastern

District of Missouri (in a brief submitted after the Panel’s hearing), the District of New Jersey, the Southern District of New York, the Southern District of Ohio, the Northern District of Ohio, the Eastern District of Pennsylvania, the Eastern District of Texas, the Western District of Washington and the Eastern District of Wisconsin.

After considering the argument of counsel, we find that the actions in this litigation involve common questions of fact, and that centralization in the Northern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. Plaintiffs in the actions before us are cities, counties and states that allege that: (1) manufacturers of prescription opioid medications overstated the benefits and downplayed the risks of the use of their opioids and aggressively marketed  (directly and through key opinion leaders) these drugs to physicians, and/or (2) distributors failed to monitor, detect, investigate, refuse and report suspicious orders of prescription opiates.  All actions involve common factual questions about, inter alia, the manufacturing and distributor defendants’ knowledge of and conduct regarding the alleged diversion of these prescription opiates, as well as the manufacturers’ alleged improper marketing of such drugs.  Both manufacturers and distributors are under an obligation under the Controlled Substances Act and similar state laws to prevent diversion of opiates and other controlled substances into illicit channels.  Plaintiffs assert that defendants have failed to adhere to those standards, which caused the diversion of opiates into their communities.  Plaintiffs variously bring claims for violation of RICO statutes, consumer protection laws, state analogues to the Controlled Substances Act, as well as common law claims such as public nuisance, negligence, negligent misrepresentation, fraud and unjust enrichment. 

______________________________________________________________

Group, L.L.C. 4

4 Actavis LLC, Actavis Pharma, Inc., Allergan PLC, Allergan Finance, LLC, Allergan plc f/k/a Actavis plc, Actavis Pharma Inc. f/k/a Watson Pharma Inc., Watson Pharmaceuticals, Inc. n/k/a Actavis, Inc., and Allergan PLC f/k/a Actavis PLS, Cephalon, Inc., Endo Health Solutions, Inc., Endo Pharmaceuticals, Inc., Janssen Pharmaceutica Inc., Johnson & Johnson, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Purdue Frederick Company Inc., Purdue Pharma Inc., Purdue Pharma L.P., Teva Pharmaceuticals Industries Ltd., Teva Pharmaceuticals USA, Inc., Watson Laboratories, Inc., Watson Pharmaceuticals, Inc., Janssen Pharmaceutica Inc. n/k/a Janssen Pharmaceuticals, Inc. 5

5 Teva Pharmaceutical Industries, Ltd., Teva Pharmaceuticals U.S.A, Inc., Cephalon, Inc., Watson Laboratories, Inc., Actavis LLC, and Actavis Pharma, Inc. 6

6 Scott Fishman, M.D., Perry Fine, M.D., Lynn Webster, M.D., and Russell Portenoy, M.D. 7

7 JM Smith Corp.; CVS Indiana, LLC and Omnicare Distribution Center, LLC; TopRx; Kroger Limited Partnership I, Kroger Limited Partnership II, SAJ Distributors (a Walgreens distributor for two months in 2012), Walgreen Eastern Co., Inc., and Rite Aid of Maryland, Inc.; Masters Pharmaceuticals and KeySource Medical; WalMart Stores East, LP. 8

8 Pfizer specifically requests that we exclude any potential future claims against it because of its minimal involvement in the opioid market.  At oral argument, counsel stated that Pfizer was not named as a defendant in any pending case.  In the absence of a case before us, the Panel will not address Pfizer’s argument.

 

 

The parties opposing transfer stress the uniqueness of the claims they bring (or the claims that are brought against them), and they argue that centralization of so many diverse claims against manufacturers and distributors will lead to inefficiencies that could slow the progress of all cases.  While we appreciate these arguments, we are not persuaded by them.  All of the actions can be expected to implicate common fact questions as to the allegedly improper marketing and widespread diversion of prescription opiates into states, counties and cities across the nation, and discovery likely will be voluminous.  Although individualized factual issues may arise in each action, such issues do not – especially at this early stage of litigation – negate the efficiencies to be gained by centralization.  The transferee judge might find it useful, for example, to establish different tracks for the different types of parties or claims.  The alternative of allowing the various cases to proceed independently across myriad districts raises a significant risk of inconsistent rulings and inefficient pretrial proceedings.  In our opinion, centralization will substantially reduce the risk of duplicative discovery, minimize the possibility of inconsistent pretrial obligations, and prevent conflicting rulings on pretrial motions.  Centralization will also allow a single transferee judge to coordinate with numerous cases pending in state courts.  Finally, we deny the requests to delay transfer pending rulings on various pretrial motions (e.g., motions to dismiss or to remand to state court) or until the completion of document discovery in City of Chicago

Although all of the cases on the motion before us involve claims brought by political subdivisions, we have been notified of potential tag-along actions brought by individuals, consumers, hospitals and third party payors.  As reflected in our questions at oral argument, this litigation might evolve to include  – 4 –

additional categories of plaintiffs and defendants, as well as different types of claims.  We will address whether to include specific actions or claims through the conditional transfer order process.[1]

As this litigation progresses, it may become apparent that certain types of actions or claims could be more efficiently handled in the actions’ respective transferor courts.  Should the transferee judge deem remand of any claims or actions appropriate (or, relatedly, the subsequent exclusion of similar types of claims or actions from the centralized proceedings), then he may accomplish this by filing a suggestion of remand to the Panel.  See Panel Rule 10.1.  As always, we trust such matters to the sound judgment of the transferee judge.

Most parties acknowledge that any number of the proposed transferee districts would be suitable for this litigation that is nationwide in scope.  We are persuaded that the Northern District of Ohio is the appropriate transferee district for this litigation.  Ohio has a strong factual connection to this litigation, given that it has experienced a significant rise in the number of opioid-related overdoses in the past several years and expended significant sums in dealing with the effects of the opioid epidemic.  The Northern District of Ohio presents a geographically central and accessible forum that is relatively close to defendants’ various headquarters in New York, Connecticut, New Jersey and Pennsylvania.  Indeed, one of the Big Three distributor defendants, Cardinal Health, is based in Ohio.  Judge Dan A. Polster is an experienced transferee judge who presides over several opiate cases.  Judge Polster’s previous MDL experience, particularly MDL No. 1909 – In re: Gadolinium Contrast Dyes Products Liability Litigation, which involved several hundred cases, has provided him valuable insight into the management of complex, multidistrict litigation.  We have no doubt that Judge Polster will steer this litigation on a prudent course.

 

IT IS THEREFORE ORDERED that the actions listed on Schedule A and pending outside of the Northern District of Ohio are transferred to the Northern District of Ohio and, with the consent of that court, assigned to the Honorable Dan A. Polster for coordinated or consolidated  pretrial proceedings.

PANEL ON MULTIDISTRICT LITIGATION

  

Sarah S. Vance

Chair

Charles R. Breyer Marjorie O. Rendell
R. David Proctor Catherine D. Perry

__________________________________________________________________________________

IN RE: NATIONAL PRESCRIPTION

OPIATE LITIGATION                                                                            MDL No. 2804

SCHEDULE A

Northern District of Alabama

CITY OF BIRMINGHAM v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 2:17-01360

Eastern District of California

COUNTY OF SAN JOAQUIN, ET AL. v. PURDUE PHARMA, L.P., ET AL.,

C.A. No. 2:17-01485

Southern District of Illinois

PEOPLE OF THE STATE OF ILLINOIS, ET AL. v. PURDUE PHARMA LP, ET AL.,

C.A. No. 3:17-00616

PEOPLE OF THE STATE OF ILLINOIS, ET AL. v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 3:17-00856

PEOPLE OF STATE OF ILLINOIS, ET AL. v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00876

Eastern District of Kentucky

BOONE COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00157

PENDLETON COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00161

CAMPBELL COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00167

ANDERSON COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00070

FRANKLIN COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00071

SHELBY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00072

HENRY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 3:17-00073

BOYLE COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00367

FLEMING COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00368

– A2 –

Eastern District of Kentucky (cont.)

GARRARD COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00369

LINCOLN COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 5:17-00370

MADISON COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00371

NICHOLAS COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00373

BELL COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00246

HARLAN COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00247

KNOX COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00248

LESLIE COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00249

WHITLEY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00250

CLAY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00255

Western District of Kentucky

THE FISCAL COURT OF CUMBERLAND COUNTY v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 1:17-00163

LOUISVILLE/JEFFERSON COUNTY METRO GOVERNMENT v.

AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 3:17-00508

THE FISCAL COURT OF SPENCER COUNTY v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00557

THE FISCAL COURT OF UNION COUNTY v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 4:17-00120

THE FISCAL COURT OF CARLISLE COUNTY v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00136

Northern District of Ohio

CITY OF LORAIN v. PURDUE PHARMA L.P., ET AL., C.A. No. 1:17-01639

CITY OF PARMA v. PURDUE PHARMA L.P., ET AL., C.A. No. 1:17-01872

– A3 –

Southern District of Ohio

CLERMONT COUNTY BOARD OF COUNTY COMMISSIONERS v.

AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00662 BELMONT COUNTY BOARD OF COUNTY COMMISSIONERS v.

AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00663

BROWN COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00664

VINTON COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN CORPORATION, ET AL., C.A. No. 2:17-00665

JACKSON COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00680

SCIOTO COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00682

PIKE COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 2:17-00696

ROSS COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 2:17-00704

CITY OF CINCINNATI v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 2:17-00713

CITY OF PORTSMOUTH v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 2:17-00723

GALLIA COUNTY BOARD OF COMMISSIONERS v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00768

HOCKING COUNTY BOARD OF COMMISSIONERS v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00769

LAWRENCE COUNTY BOARD OF COMMISSIONERS v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00770

DAYTON v. PURDUE PHARMA LP, ET AL., C.A. No. 3:17-00229

Western District of Washington

CITY OF EVERETT v. PURDUE PHARMA LP, ET AL., C.A. No. 2:17-00209

CITY OF TACOMA v. PURDUE PHARMA, L.P., ET AL., C.A. No. 3:17-05737

Southern District of West Virginia

THE COUNTY COMMISSION OF MCDOWELL COUNTY v. MCKESSON CORPORATION,

ET AL., C.A. No. 1:17-00946

HONAKER v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 1:17-03364

THE COUNTY COMMISSION OF MERCER COUNTY v. WEST VIRGINIA BOARD OF

PHARMACY, C.A. No. 1:17-03716

– A4 Southern District of West Virginia (cont.)

KANAWHA COUNTY COMMISSION v. RITE AID OF MARYLAND, INC., ET AL.,

C.A. No. 2:17-01666

FAYETTE COUNTY COMMISSION v. CARDINAL HEALTH, INC., ET AL.,

C.A. No. 2:17-01957

BOONE COUNTY COMMISSION v. AMERISOURCEBERGEN DRUG CORPORATION,

ET AL., C.A. No. 2:17-02028

LOGAN COUNTY COMMISSION v. CARDINAL HEALTH, INC., ET AL.,

C.A. No. 2:17-02296

THE COUNTY COMMISSION OF LINCOLN COUNTY v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 2:17-03366

LIVINGGOOD v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 2:17-03369

SPARKS v. WEST VIRGINIA BOARD OF PHARMACY, C.A. No. 2:17-03372

CARLTON, ET AL. v. WEST VIRGINIA BOARD OF PHARMACY, ET AL.,

C.A. No. 2:17-03532

STATE OF WEST VIRGINIA, ET AL. v. MCKESSON CORPORATION, C.A. No. 2:17-03555 BARKER v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 2:17-03715

THE CITY OF HUNTINGTON v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 3:17-01362

CABELL COUNTY COMMISSION v. AMERISOURCEBERGEN DRUG CORPORATION, ET

AL., C.A. No. 3:17-01665

WAYNE COUNTY COMMISSION v. RITE AID OF MARYLAND, INC., ET AL.,

C.A. No. 3:17-01962

WYOMING COUNTY COMMISSION v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-02311

 

[1]  Eastern District of Pennsylvania Philadelphia Teachers Health and Welfare Fund third party payor plaintiff opposed centralization of such claims, stating that it intends to file a motion for centralization of third party payor claims.  We will address that motion, if it is filed, in due course.

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WEEKLY MDL and MASS TORT UPDATE by MASS TORT NEXUS for Week of November 27, 2017

By Mark A. York (November 30, 2017)

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This week in mass torts around the country:

Opioid Crisis: See Mass Tort Nexus Briefcase Re: OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION

> Superseding indictments of Insys Therapeutics Executives Unsealed in USDC of Massachusetts

BOSTON — A federal indictment against seven high-ranking officers of opioid maker Insys Therapeutics Inc. was unsealed Oct. 26 in a Massachusetts federal court charging the men with racketeering, mail fraud and conspiracy for a scheme to pay kickbacks to doctors for, and to fraudulently induce health insurers into approving, off-label prescriptions for the company’s addictive Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

>Doctor Pleads Guilty To Opioid Health Care Fraud, Taking Kickbacks From Insys

PROVIDENCE, R.I. — A Rhode Island doctor on Oct. 25 pleaded guilty to health care fraud and taking kickbacks for prescribing the opioid Subsys to unqualified patients (United States of America v. Jerrold N. Rosenberg, No. 17-9, D. R.I.).

 > Opioid Distributors Support MDL While Municipalities Oppose

WASHINGTON, D.C. — The “Big Three” national drug distributors on Oct. 20 told a federal judicial panel that they support centralization of more than 60 opioid lawsuits filed against them by various cities and counties (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, JPML).

Related Mass Tort Nexus Opiod Articles:

>California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense: Will other insurers say no to opioid coverage? Nov 15, 2017

>Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA Nov 3, 2017

For more Mass Tort Nexus Opiod Crisis Information See: Mass Tort Nexus Newsletters and MDL Updates

IVC FILTERS:

Cook Medical IVC: See Mass Tort Nexus Briefcase Re: Cook Medical IVC Filter MDL 2570

>First Cook IVC Bellwether Trial Starts in USDC SD of Indiana

INDIANAPOLIS — The first bellwether trial in the Cook Medical Inc. inferior vena cava (IVC) filter multidistrict litigation got under way on Oct. 23 in Indianapolis federal court (In re:  Cook Medical, Inc., IVC Filters Litigation, MDL Docket No. 2570, No. 14-ml-2570, Elizabeth Jane Hill v. Cook Medical, Inc., No. 14-6016, S.D. Ind., Indianapolis Div.).

Cordis IVC Filters: See Cordis IVC Filter Litigation Alameda County, California Superior Court

>Cordis IVC Filter Plaintiffs Tell Supreme Court Trial Proposal Is No ‘Mass Action’

WASHINGTON, D.C. — Plaintiffs in an inferior vena cava (IVC) filter case on Oct. 18 told the U.S. Supreme Court that their suggestion of individual bellwether trials does not convert their actions into a mass action under the Class Action Fairness Act (CAFA), 119 Stat. 4 (Cordis Corporation v. Jerry Dunson, et al., No. 17-257, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4013).

Taxotere: See Taxotere MDL 2740 (US District Court Eastern District of Louisiana)

>Taxotere MDL Judge Denies Statute of Limitations Motion by Sanofi

NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere multidistrict litigation on Oct. 27 denied without prejudice a motion by defendant Sanofi-Aventis U.S. LLC to dismiss claims barred by applicable statutes of limitations (In Re:  Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740, No. 16-md-2740, E.D. La.).

Pelvic Mesh: Boston Scientific TVM Litigation MDL 2362

>Exclusion of 510(k) Defense in Boston Scientific Pelvic Mesh Case:

ATLANTA — The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017 U.S. App. LEXIS 20432).

PLAVIX: See Mass Tort Nexus Briefcase Re: PLAVIX MDL 2418 USDC NEW JERSEY

>Plaintiff Loses Plavix Case on Summary Judgment Over Late “Learned Intermediary” Declaration

TRENTON, N.J. — The judge overseeing the Plavix multidistrict litigation on Oct. 26 granted summary judgment in a case after ruling that the plaintiff’s “eleventh hour” declaration by one treating physician did not overcome California’s learned intermediary defense for defendants Bristol-Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. Inc. (In Re:  Plavix Products Liability Litigation, MDL Docket No. 2418, No. 13-4518, D. N.J., 2017 U.S. Dist. LEXIS 177588).

Abilify MDL 2734: Mass Tort Nexus Briefcase Re: Abilify MDL 2734

 >Abilify MDL Judge Orders Defendants To Name Settlement Counsel

PENSACOLA, Fla. — The Florida federal judge overseeing the Abilify multidistrict litigation on Oct. 25 ordered the defendants to engage settlement counsel for monthly settlement conferences (In Re:  Abilify [Aripiprazole] Products Liability Litigation, MDL Docket No. 2734, No. 16-md-2734, N.D. Fla., Pensacola Div.).

Mirena IUD: Related-Federal Court Reopens Mirena IUD Product Liability MDL Nov 3, 2016

>2nd Circuit Affirms Exclusion Of Mirena MDL Experts, Termination Of Litigation

NEW YORK — The Second Circuit U.S. Court of Appeals on Oct. 24 affirmed the exclusion of general causation experts in the Mirena multidistrict litigation and a court order terminating the MDL before any trials were held (In Re:  Mirena IUD Products Liability Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals, Inc., Nos. 16-2890 and 16-3012, 2nd Cir., 2017 U.S. App. LEXIS 20875).

Hip ImplantsSee Mass Tort Nexus Briefcase Re: Wright Medical, Inc. MDL 2329 Conserve Hip Implant Litigation

>Wright Medical Settles Remaining Wright Hip Cases; Judge Closes MDL 2329

ATLANTA — Wright Medical Technology Inc. and plaintiffs in a multidistrict litigation have entered two additional agreements settling the remainder of the litigation, a Georgia federal judge said Oct. 18 (In Re:  Wright Medical Technology, Inc., Conserve Hip Implant Products Liability, MDL Docket No. 2329, No. 12-md-2329, N.D. Ga., Atlanta Div

Testosterone Replacement Therapy: See Mass Tort Nexus Briefcase Re: TESTOSTERONE MDL 2545 (AndroGel)

>Testosterone Bellwether Out and Pre-emption Denied

CHICAGO — An Illinois multidistrict litigation judge on Oct. 23 granted summary judgment in one of two testosterone replacement therapy bellwether cases but denied preemption in the second case (In Re:  Testosterone Replacement Therapy Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ill., Eastern Div., 2017 U.S. Dist. LEXIS 176522).

 

>AbbVie, AndroGel Plaintiff Spar Over Mixed Verdict In 1st Bellwether Trial Verdict

CHICAGO — AbbVie on Oct. 25 urged the judge overseeing the testosterone replacement therapy multidistrict litigation to not disturb a bellwether trial verdict where a jury awarded $0 compensatory damages (In Re:  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Jesse Mitchell v. AbbVie, No. 14-9178, N.D. Ill.).

Fosamax MDL 1789: See Mass Tort Nexus Briefcase Re: MDL 1789 Fosamax Products Liability Litigation USDC New Jersey

>Fosamax Femur Plaintiffs Urge Supreme Court To Deny Preemption Review

WASHINGTON, D.C. — Counsel for more than 500 Fosamax femur fracture plaintiffs on Oct. 25 urged the U.S. Supreme Court to deny certiorari to Merck Sharp & Dohme Corp., arguing that their claims are not preempted by “clear evidence” that the Food and Drug Administration would have rejected stronger warnings for the osteoporosis drug (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4064

 

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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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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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Insys Therapeutics, Inc. Founder and Billionaire John Kapoor, Indicted For Bribing Doctors to Prescribe Fentanyl

Is this the start of indictments against senior executives at Big Pharma opioid manufacturers”

By Mark A. York (October 27, 2017)

(Mass Tort Nexus)

The founder of Insys Therapeutics, Inc., Johnathon N. Kapoor was arrested Thursday October 26, 2017 and charged with leading a massive conspiracy across the United States to pay bribes and use fraudulent sales methods in the illegal distribution of Subsys, a fentanyl spray intended for cancer patients. The Insys boardroom orchestrated an “off label” marketing campaign of “Subsys” which is a fast-acting sublingual fentanyl product, resulting in indictments against all members of the pre-2017 Insys executive board, as well as mid level managers and sales representatives across the country.

 

 

 

 

 

 

 

 

Dr. John N. Kapoor, 74, of Phoenix, Arizona, the former Chairman-CEO of Insys and still a member of its board, was indicted on federal charges of racketeering, conspiracy to commit fraud and conspiracy to violate the Anti-Kickback law. The racketeering and fraud charges carry prison sentences of up to 20 years, while the kickback charge can bring up to five years as well as millions of dollars in fines and asset forfeitures

Prosecutors allege the company paid hundreds of thousands of dollars to doctors in exchange for prescribing a sublingual spray called Subsys that contained the powerful and synthetic opioid fentanyl which is highly addictive. Three top prescribers have already been convicted of taking bribes from Insys, along with several sales and marketing representatives having entered plea deals in federal courts across the country.

In various media reports, former sales rep Patty Nixon, turned whistleblower, explained how the company lured doctors into prescribing the drug for patients who didn’t need it, known as “off-label” marketing. She stated “It was absolutely genius, it was wrong, but it was genius.”

“What I did, I was instructed to do, I was trained to do,” Nixon, who was fired by Insys after becoming adverse to the company sales activity, “she felt guilty about lying on the job” and decided to not return to work. “It was wrong, but it was genius.”

In a statement related to the Kapoor indictment, Nixon said, “I wasn’t sure this day would ever come. It is a great day for justice. A great day for the victims. Dr. Kapoor is an evil man. I give a lot of credit to all the prosecutors and all the people who worked on bringing him to justice. It’s what needs to be done.”

She said that if requested to testify against Kapoor, “I absolutely will.”

 

 

 

 

 

 

 

 

Subsys is 100 times stronger than morphine, and was approved by the FDA to treat patients with cancer who had “breakthrough” pain, that is pain which other narcotics are not addressing. This was soon seen as not the way Insys Therapeutics wanted to market Subsys and they developed a very direct and highly profitable marketing campaign that placed “profits over patients” and contributed to the current opioid crisis across the USA.  They Insys executive suite quickly ramped up a sales and marketing campaign that reached from Alabama to Alaska, two states where the Subsys sales skyrocketed, all based on the company sales efforts

The role of the sales staff was to make sure Subsys got into the hands of as many patients as possible, whether they had cancer or not, and this included using illegal and unethical methods of getting doctors to write massive numbers of Subsys prescriptions for questionable pain complaints.

Related: By Mass Tort Nexus- “THE OPIOID CRISIS IN AMERICA” – How Insys Theraputics, Inc. Sold Stock And Killed Americans At The Same Time With The Help Of Doctors

THE REIMBURSEMENT UNIT FRAUD

“My job responsibilities were to contact insurance companies on behalf of the patients and the doctors to get the medication approved and paid for by their insurance company,” along with several others.

Subsys is not cheap prescription, a 30-day supply costs anywhere from $3,000 to $30,000 and the fraudulent scheme depended upon insurance approval.That was Nixon’s job, along with the other employees in the Reimbursement Unit, who were tasked with the role of misleading insurers into believing the drug was “medically necessary.”

“I would say, ‘Hi, this is Patty. I’m calling from Dr. Smith’s office. I’m calling to request prior authorization for a medication called Subsys,” taken form the Unit’s management created insurance approval script.

The Unit staff would often pretend they were calling from the office of a cancer doctor to increase the chances of approval, as well as using specific diagnosis codes, likely to be approved, whether the patient had the condition or not.

The Reimbursement Unit role at Insys, was making sure that patients got approval for Subsys, which includes fentanyl, from insurance companies. “The unit job responsibilities were to contact insurance companies on behalf of the patients and the doctors to get the medication approved and paid for by their insurance company,” said Patty Nixon.

“We told complete bold-faced lies” as part of the part of the ongoing fraudulent Insys business model.

CHRONIC PAIN LEADS TO DEATH

One of the patient who was prescribed Subsys was Sarah Fuller, who was prescribed the drug even though she didn’t have cancer. In her case, it was chronic neck and back pain from two car accidents. And when her doctor prescribed Subsys, an Insys sales rep was sitting in the room with them.  Within a month, Fuller’s prescription was tripled. And 14 months after she started using the drug, she was found dead on a bedroom floor.

What killed her? “Well, technically fentanyl,” Fuller’s mother said. “But a drug company who couldn’t care less about a human life. And, apparently, a doctor who didn’t either.” Sarah’s Cherry Hill, New Jersey physician, Dr. Vivienne Matalon, had her medical license suspended over the “off-label” prescribing that resulted in the death of Sarah Fuller, but denies responsibility for her death.

Sadly, Fuller is not alone, FDA reports of adverse events and possible related complications include hundreds of deaths.

Attorney Richard Hollawell who represents the Fuller’s family, is suing everyone involved in marketing and prescribing Subsys to Sarah, and said, “This is serious stuff that we’re dealing with … People need to finally be held accountable.”

Insys has denied any responsibility and insists it shouldn’t be blamed for how doctors prescribe their products. The corporation is not currently facing criminal charges and is still selling Subsys — some $240 million worth of Subsys just last year. But the company is under investigation by various states across the country regarding how the “off-label” marketing campaign came to be the company business model..

KAPOOR ADDED TO PRIOR INSYS INDICTMENTS

Dr. Kapoor will appear in federal court in Phoenix Thursday, and will have to appear in federal court in Boston, where the indictments originated, at a later date. The indictment, unsealed today in Boston, also includes additional allegations against several former Insys executives and managers who were initially indicted in December 2016.

“In the midst of a nationwide opioid epidemic that has reached crisis proportions, Mr. Kapoor and his company stand accused of bribing doctors to overprescribe a potent opioid and committing fraud on insurance companies solely for profit,” said Acting United States Attorney William D. Weinreb of Massachusetts. “Today’s arrest and charges reflect our ongoing efforts to attack the opioid crisis from all angles. We must hold the industry and its leadership accountable.”

Subsys, a fentanyl sublingual spray from Insys Therapeutics

“As alleged, these executives created a corporate culture at Insys that utilized deception and bribery as an acceptable business practice, deceiving patients, and conspiring with doctors and insurers,” said Harold H. Shaw, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division. “The allegations of selling a highly addictive opioid cancer pain drug to patients who did not have cancer, make them no better than street-level drug dealers.”

Brian Kelly, a lawyer for Kapoor, said, “My client is innocent and he intends to fight these charges vigorously.”

In response to an early 2017 investigation, Insys stated that charges against individuals discussed in the media related to “previously disclosed investigations and litigation and  Insys continues to cooperate with all relevant authorities in its ongoing investigations, including our federal investigation which began in and around December 2013.”

“We are committed to complying with laws and regulations that govern the promotion of our products and all other business practices. We continue to emphasize ethical behavior within our organization and pursue opportunities to illustrate that our company’s mission is to put patients first.”

The October 26, 2017 indictments were the first naming John Kapoor, but also include enhanced charges against the entire executive board of Insys Therapeutics, Inc. who were already facing long prison sentences and financial penalties in one of the most far reaching and aggressive US Department of Justice investigations into the root cause of the “Opioid Crisis” that is gripping all areas of the United States.

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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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