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

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

By Mark A. York (April 26, 2018)

 

 

 

 

 

 

 

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

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

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

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

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

PLAINTIFFS ARE AHEAD IN TRIAL VERDICTS

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

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

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

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

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

ANDROGEL WAS A BLOCKBUSTER FROM FIRST RELEASE

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

HEART ATTACK AND STROKE RISK

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

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

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

FDA ISSUED A WARNING

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

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

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

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

 

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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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JPML Takes a Second Look at Proton Pump Inhibitor MDL 2757 at July 27, 2017 Hearings in Los Angeles

JPML Takes a Second Look at Proton Pump Inhibitor MDL 2757 at July 27, 2017 Hearings in Los Angeles

 The Judicial Panel on Multidistrict Litigation (JPML) has decided to revisit a possible Proton Pump Inhibitor (PPI) MDL consolidation (Nexium, Prevacid, et al) and will hear arguments July 27, 2017 at the Los Angeles Federal court on a new motion to centralize (PPI) drugs in a multidistrict litigation. The case is In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2757, JPML, where the case filings have significantly increased since the initial JPML hearing January 26, 2017 in Miami when U.S. District Judge Sarah Vance said at one point during the oral arguments “It just seems to me to be nightmarishly complex” as the primary defense counsel raised concern over the generic makers and related defense issues with so many co-defendants. The JPML ultimately denied the MDL 10 days later to the view that consolidation would be to cumbersome, however due to the large numbers of new suits and the refiling of a Motion to Consolidate, the Los Angeles hearings may have a different outcome.

The drugs at issue include Prilosec, Nexium, Protonix and Dexilant as well as potential the numerous generic manufacturers. The hearing order lists over 163 cases in 28 federal district courts and a decision will likely come in mid-August. Nevertheless, the judges may try to come up with ways to split up the cases into structures that might be simpler and more efficient or combine all parties. Ideas included single-product or single-defendant MDLs, separating out prescription-only users, or separating out patients who had only used products made and sold by AstraZeneca, which its attorney said is currently named in 100 cases.

Kidney injuries

In their May 31 motion, Motion to Consolidate Re: PPI Hearing Los Angeles July 27, 2017, the moving plaintiffs seek centralization before U.S. Judge David R. Herndon of the Southern District of Illinois.

The plaintiffs allege that PPIs cause kidney injuries including acute interstitial nephritis, chronic kidney disease and end-stage renal disease. Concerns that these drugs have harmful side effects for users’ kidneys were brought to the U.S. Food and Drug Administration by consumer advocacy group Public Citizen in 2011, and the agency required warnings about risks of acute interstitial nephritis on labels in 2014, according to the patients’ MDL brief.

More recent research led to stronger findings of a connection, including a scientific study published in January 2016 that said PPI use was independently linked to a 20 to 50 percent higher risk of chronic kidney disease. Plaintiffs have also brought allegations of renal failure being caused by the drugs. To date, more than 5,000 PPI cases are under investigation by Plaintiff’s counsel, and more could be added to that number as awareness of the association between PPI use and kidney damage continues to increase. While the drug class first received FDA approval in 1989, serious side effects prompted the FDA in 2014 to require all PPIs to display a warning label that called out the connection to acute interstitial nephritis. The Plaintiff’s brief also mentions several studies that have made a correlation between PPI use and kidney damage during the past 25 years, including a 1992 study by the University of Arizona Health Sciences Center, a 2006 study conducted at the Yale School of Medicine and a 2016 study from John Hopkins published in the Journal of the American Medical Association (JAMA).

The plaintiffs note that in January, the JPML denied centralization of PPI cases, but say later significant developments “warrant a second look at consolidation.”

The defendants are AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc. and Pfizer subsidiary Wyeth.  The defendants’ responses are due June 27.

The plaintiff attorneys are Christopher A. Seeger and Jeffrey Grand of Seeger Weiss in New York.

 

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What Trump and the New Commissioner mean for the FDA

Trump FDA deregulation
President Trump claims that 75% to 80% of all governmental regulations are unnecessary.

By Joseph DiNardo, Esq. and Erin Delaney, Esq.

There is much uncertainty throughout the pharmaceutical industry as a new U.S. Food and Drug Administration (FDA) Commissioner is chosen and steps are taken to deregulate government agencies.

President Donald Trump has stated one of his goals is to speed up the drug approval process to lower drug prices, promote competition, benefit small start-ups and bring innovative new treatments to market faster.

However, many industry leaders are concerned that dramatically speeding up the current approval process could put patients at risk. This, in turn, could subject manufacturers to costly litigations.

CEO of Pfizer favors deregulation

The high cost of obtaining approval for a new drug, estimated at $2.6 billion, has been blamed for hindering pharmaceutical start-ups from entering the market. As a result, certain pharmaceutical executives, like the CEO of Pfizer Inc., have publicly favored deregulation, claiming it will help create more competition and lower drug prices.

Others in the pharmaceutical industry disagree, opining that current FDA rules and regulations provide a level playing field for both small and large companies. Lowering the bar for drug approvals, they contend, would allow the wealthiest pharmaceutical companies to inundate the market with countless new drugs and associated advertising, eclipsing any potential advances of smaller companies.

President Trump, who has stated that 75% to 80% of all governmental regulations are unnecessary, issued an executive order on January 30, 2017, aimed at significantly reducing them. The order requires all executive government agencies identify at least two regulations to be repealed for each newly-proposed regulation.

There are 40 MDLS where plaintiffs allege the drug companies engaged in false and misleading marketing and sales practices, including Vioxx, Tylenol, Celexa, Lipitor, Avandia and Plavix.

FDA may not be affected

While not immune to the executive order, the FDA, which regulates food, drugs, medical devices, blood donations, vaccines, biologic products, animal and veterinary products, cosmetics and tobacco products, may not be markedly affected by it. Many FDA regulations deal with process and merely codify or interpret the law. Accordingly, even if certain agency regulations were repealed, congressional mandates, including statutory safety and efficacy standards under the Food, Drug and Cosmetic Act (FDCA), would not change.

Further, a number of regulations are no longer applicable and could be repealed without consequence. Arguably, some existing regulations could even increase protection and transparency for the public if rescinded.

It is not the executive order that has the industry buzzing, however, but rather the potential actions of the new FDA commissioner under the Trump administration, who is likely to share the President’s goal of streamlining the FDA’s drug approval process to decrease the amount of time it takes for new drugs and medical devices to get to market. In an attempt to restructure and quicken the process, the commissioner may choose to institute various levels of approvals, focusing on biomarkers and short-term surrogate endpoints.

Although legislation is in place that requires substantial evidence of a drug’s efficacy prior to it being sold in the marketplace, some suggest if the new commissioner were so inclined, the commissioner need only to interpret existing regulations loosely to weaken the efficacy standard.

12 years from lab to patient

Under the current system, it takes a new drug, on average, 12 years to make it from a research lab to the patient. The FDA’s role is minimal throughout the preclinical research stage, which can take one to six years, but increases if the drug is successful and the FDA approves the commencement of human trials.

Phase one allows researchers to test the drug for the first time in a small group of healthy volunteers, identifying side effects and basic product characteristics, adjusting dosages and evaluating safety. Phase two involves evaluating

Phase two involves evaluating efficacy and short-term side effects for different dosages within a larger randomized or controlled group of people, often measuring biomarkers or laboratory results rather than clinical outcomes. Phase three, a large clinical trial, uses a group of people more similar to those to whom the product would be marketed to determine a risk/benefit ratio. Each phase takes about one to two-and-a-half years.

Ninety percent of the drugs and biologics that proceed through clinical trials fail, whether it’s due to safety or efficacy. If a drug completes phase three of the trials, the manufacturer will file a New Drug Application with the FDA, getting a response, on average, in about 12 months for standard review and eight months for priority review.

Nevertheless, according to 2016 data, the majority of new drugs are approved through an expedited approval process. The approval process has also already been shortened for certain drugs and medical devices by the 21st Century Cures Act, which was signed by President Barack Obama last year.

Safety and efficacy

Some experts argue that safety and efficacy go hand-in-hand; side effects that would never be approved for an over-the-counter drug may be approved for a drug that treats a life-threatening illness if it were proven to be an effective treatment. The type, nature, length and size of clinical trials are already becoming increasingly flexible, allowing deviations from the typical structure on a case-by-case basis in consideration of factors such as whether the condition is widespread, rare, chronic, short-term or life-threatening, the frequency of the symptoms, and the toxicity of the drug on test subjects.

For instance, the FDA may approve orphan drugs, which treat diseases that typically affect less than 200,000 people, based on only one positive clinical trial and/or on surrogate endpoints, while mass-market drugs typically require two to three trials to prove safety and efficacy. In doing so, the FDA provides patients access to a drug, often where there was a previously unmet medical need, while the company continues to study its clinical benefits.

Even so, the FDA maintains that “a randomized, controlled, clinical trial… of a size and duration that reflect the product and target condition remains the gold standard for determining whether there is an acceptable benefit/ risk profile for drugs and biologics.” A neurologist at the Mayo Clinic told Business Insider he commends the idea of speeding up the development of new treatments, but worries that in doing so patients could be exposed to “costly, ineffective and potentially dangerous drugs.” Likewise, the CEO of Ovid Therapeutics Inc., a pharmaceutical company that develops drugs for rare diseases, told Reuters, “any change at the FDA that allows drugs to be tried out on patients without clinical evidence is a damaging approach.”

In a January 2017 FDA evaluation of 22 case studies with divergent results, early clinical studies were promising. Should the commissioner decide to base approval on initial safety reports or on surrogate endpoints, these drugs could have been approved. However, “[p]hase 3 studies did not confirm phase 2 findings of effectiveness in 14 cases, safety in 1 case, and both safety and effectiveness in 7 cases… In two cases, the phase 3 studies showed that the experimental product increased the frequency of the problem it intended to prevent.” The side effects of these drugs in phase three trials ranged from mere uselessness to serious adverse events, including death.

Testing requirement

Further, removing the requirement of extensive clinical testing could mean that courts will see more lawsuits and multidistrict litigations similar to those currently filed against 3M involving its Bair Hugger Forced Air Warming device. In that litigation, it is alleged that the company knew of the threat of contaminants due to the device, and the risk of infection, but failed to warn of the risk. The plaintiffs further allege that 3M continued to market its product as safe for use during surgeries and attempted to “conceal and discredit peer-reviewed scientific studies that undermined their ability to market the Bair Hugger.” Notably, the FDA approved the Bair Hugger device for use in 1987 under Section 510(k) of the FDCA, which is an expedited process that allows for less clinical testing if a substantially similar device is already on the market.

It is also unclear how rules and regulations that promote a quicker approval process will affect the doctrine of federal preemption. Just like Bayer Corp. has done with some success in suits alleging injuries sustained from the implantation of Essure Permanent Birth Control, a manufacturer’s defense often rests on the fact that the FDA approved the drug or device’s design, manufacturing method, labels, warnings and instructions for use prior to its release into the market.

This defense has held up in the past, especially for devices approved in the premarket approval process, based on the FDCA’s statutory requirements for safety and effectiveness, with defendants arguing the FDA subjected their product to the “highest level of scrutiny that exists in the federal regulatory system.” If the statutory requirements for a new drug’s approval are weakened, this defense may prove futile for pharmaceutical companies in future litigations to the advantage of plaintiffs.

40 MDLs

Congruently, there are currently 40 multidistrict litigations pending with the Judicial Panel on Multidistrict Litigation in which plaintiffs allege the defendants engaged in false and misleading marketing and sales practices, including those for Vioxx, Tylenol, Celexa, Lipitor, Avandia and Plavix, to name a few. Allowing a pharmaceutical company to advertise a drug for potentially ineffective uses without proper testing could open the floodgates of similar litigation should the drug fail to work, or worse, cause fatalities, while costing patients hundreds of thousands of dollars per year. For example, Sarepta Therapeutic’s orphan drug, Exondys 51, which the FDA approved for use in September 2016 based on surrogate endpoints, runs patients about $300,000 per year with little to no insurance coverage, but it has not yet been proven effective.

Industry heads such as the CEO of Alnylam Pharma and the head of research and development at Merck and Co Inc. have also expressed concern about how a manufacturer must be able to show insurers and physicians alike through a risk/benefit profile that their drug has value, rather than leaving them to make such a determination on their own. Further, even if deregulation lowers costs to pharmaceutical companies, there have been no assurances that these reduced costs will be passed on to patients. A first-to-market advantage will not do pharmaceutical companies much good if the product is too expensive for patients to afford and insurance companies are not willing to cover the cost.

If current pre-market clinical requirements are reduced, it could arguably endanger patients, who are often the most vulnerable. It may also make it more difficult for pharmaceutical companies to differentiate effective products from new, less effective — or ineffective — treatments flooding an easy-to-enter market. On the other hand, greater flexibility could allow for innovative new products to enter the market faster and reach those waiting on new therapies or a cure. Until the right balance has been struck, the industry may be in for a bumpy, litigation-filled ride.

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All Eyes on 3rd Circuit in Zoloft Expert Appeal

Nicholas P. Jewell
Nicholas P. Jewell

Will Nicholas Jewell, a renowned Ph.D. biostatistician, get his chance to testify in In re Zoloft Products Liability Litigation? More than 300 mothers in 45 states who charge that the antidepressant caused heart defects in their newborns hope he will.

It’s up to the Third US Circuit Court of Appeals, which will decide whether US District Judge Cynthia M. Rufe of the Eastern District of Pennsylvania erroneously excluded him as a causation expert last April. The judge also granted summary judgment to defendant Pfizer and effectively wiped out the caseload in MDL 2342.

Judge is “armchair scientist”

Calling the judge an “armchair scientist,” the plaintiffs argue that the court “superimposed its own standard of sound science,” and disregarded Jewell’s 40 years of experience.

The case is Jennifer Adams v. Wolters Kluwer, No. 16-2247 in the Third Circuit. Leading the effort to revive the litigation are plaintiff attorneys Mark P. Robinson, Jr. of Robinson Calcagnie, Inc. in Newport Beach, CA, Dianne M. Nast of Nastlaw LLC in Philadelphia, PA, and David C. Frederick, Derek T. Ho and Hilary P. Gerzhoy of Kellogg, Huber, Hansen, Todd, Evans & Figel, PLLC in Washington, D.C.

Jewell is highly qualified:

  • He has been a professor of biostatistics (the statistical design and analysis of studies that investigate risk factors for disease) for nearly four decades, first at Princeton University.
  • For the last 33 years, he has been a professor at the University of California (Berkeley).
  • He authored a widely used textbook, Statistics for Epidemiology, and 160 peer-reviewed articles on biostatistics.
  • He is also the editor of the Journal of the American Statistical Association, the country’s preeminent peer-reviewed statistics journal.

Zoloft triples the risk

Jewell reviewed multiple peer-reviewed epidemiological studies involving hundreds of thousands of women, and concluded that taking Zoloft (sertraline) during pregnancy can as much as triple the risk for having babies with serious, life-altering heart defects.

He employed a “weight of the evidence” methodology using established criteria developed by English epidemiologist Sir Austin Bradford Hill. This methodology has been generally accepted in the scientific community for decades.

However Judge Rufe ruled that a causation opinion must be supported by “repeated, consistent, statistically significant human epidemiological findings.”

In fact, four published peer-reviewed studies did find a statistically significant increased risk of cardiac birth defects with Zoloft use during pregnancy.

Further, the plaintiffs argue that the judge’s doubt about Jewell’s methodology usurps the role of the jury, and that questions about his analysis are properly left to cross-examination and trial.

For 30 years, the scientific community has been aware that serotonin reuptake inhibitiors (SSRIs), including Zoloft, are potential teratogens (i.e., agents that affect the development of eggs, sperm, or embryos and therefore increase the risk of birth defects).

In 1988, a Pfizer report warned that “[s]ertraline should not be administered to pregnant or lactating females.” In 1995, the Food and Drug Administration sent a letter to Pfizer that it was “necessary to change the pregnancy category of Zoloft® from B to C” (drugs that have caused or may be suspected of causing, harmful effects on the human fetus).

The four studies that the court disregarded include:

Colvin (2011). Lyn Colvin, et al., Dispensing Patterns and Pregnancy Outcomes for Women Dispensed Selective Serotonin Reuptake Inhibitors in Pregnancy, 91 Birth Defects Res. A Clin. Mol. Teratol. 142 (2011), a study including 123,405 pregnancies from 2002 to 2005 in Western Australia, found a positive association between Zoloft exposure and cardiovascular defects.

Ban (2014). Lu Ban, et al., Maternal depression, antidepressant prescriptions, and congenital anomaly risk in offspring: a population-based cohort study, 121 BJOG 1471 (2014), a study including 349,127 births from 1990 to 2009 in the U.K., found a positive association between Zoloft exposure and cardiovascular defects.

Huybrechts (2014). Krista F. Huybrechts, et al., Antidepressant Use in Pregnancy and the Risk of Cardiac Defects, 370 N. Engl. J. Med. 2397 (2014), a study that included 949,504 U.S. pregnancies from 2000 to 2007, found a positive association between Zoloft exposure and cardiac malformations.

Furu (2015). Kari Furu, et al., Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design, 350 British Med. J. 1798 (2015), a study that included 2.3 million births in Denmark, Finland, Iceland, Norway, and Sweden from 1996 to 2010, found a positive association between Zoloft exposure and all cardiac defects.

“Under the correct legal standard, Dr. Jewell’s analysis easily clears Rule 702’s bar for admissibility,” the plaintiffs argue.

 

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Defendants File Motion to Create New MDL for Eliquis Mass Tort Litigation

eliquis-5mg-60slblBristol-Myers Squibb and Pfizer have filed a motion to create a new MDL 2754 consolidating mass tort litigation in US District Court for the Southern District of New York concerning bleeding-related injuries allegedly caused by Eliquis blood thinner.

The companies are facing 34 related actions filed in 13 different federal courts. Plaintiffs’ counsel have promised that they intend to file many more cases in the near future.

Starting in 2015, plaintiffs began filing lawsuits alleging the defendants failed to warn adequately about the risk of bleeding, and that the defendants should not have sold Eliquis without precautions for blood monitoring or an additional drug to reverse its anticoagulant effect.

Eliquis (also known by its molecular name apixaban) is an anticoagulant medication that thins the blood, prevents the formation of blood clots, and decreases the risk of stroke in patients with atrial fibrillation and certain other conditions. Atrial fibrillation is a common arrhythmia (abnormal heart beat) that causes blood clots to form in the heart, and that is known to be associated with a very high risk of stroke.

The companies claim that the drug is “no less safe than a daily aspirin.” It was approved by the FDA in 2012 and carries a warning that it increases the risk of bleeding that there is no antidote for Eliquis.

The companies requested the New York federal court because they have headquarters there and because half of the actions have been filed there. The court has previously handled 158 MDLs and now is handling 27 MDLs including product liability cases against prescription drugs Rezulin (MDL 1348) and Fosamax (MDL 1789).

Bogus Aristotle Study

Plaintiffs allege that approval of Eliquis was based in large part on clinical trials known as Aristotle, which was conducted under the supervision and control of the defendants, in various countries, including China.

“Defendants, as a means of cutting costs, chose incompetent and untrustworthy agents in China to conduct the Aristotle study Defendants’ agents committed fraud in their conduct of the Aristotle study, by concealing side effects which occurred in test users of Eliquis; a death which went unreported (whereas one purpose of the study was to study the rate of death in Eliquis users compared to others in Coumadin); loss of subjects to follow-up; major dispensing errors including indicating that certain subjects were getting Eliquis when they were not; poor overall quality control; and changing and falsifying records, including records disappearing just before the FDA made a site visit, reportedly on the order of an employee of BMS,” states the complaint in Charlie Utts and Ciara Utts  v. Bristol-Myers Squibb Company and Pfizer Inc.Case 1:16-cv-05668-DLC (S.D.N.Y).

According to the complaint, the companies:

  • Failed to provide adequate warnings about the increased risk of gastrointestinal bleeds in those taking Eliquis, especially, in those patients with a history of gastrointestinal issues and upset;
  • Failed to provide adequate warnings about the increased risk of suffering a bleeding event, requiring blood transfusions in those taking Eliquis;
  • Failed to provide adequate warnings about the need to assess renal functioning before starting a patient on Eliquis and to continue testing and monitoring of renal functioning periodically while the patient is on Eliquis.
  • Failed to provide adequate warnings about the need to assess hepaticfunctioning prior to starting a patient on Eliquis and to continue testing and monitoring of hepatic functioning periodically while the patient is on Eliquis.

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Pfizer’s Lyrica Linked to Major Birth Defects

LyricaA drug commonly used to treat pain, epilepsy, anxiety and other brain health disorders may be associated with an increased risk of major birth defects, according to a study published in the May 18, 2016, online issue of Neurology®, the medical journal of the American Academy of Neurology.

The drug pregabalin is approved by the FDA to treat epilepsy, fibromyalgia and neuropathic pain, such as pain from diabetic neuropathy or pain after shingles or spinal cord injury. It is also used for generalized anxiety disorder and other mental health issues. This is called off-label prescribing.

Lyrica, made by Pfizer, has been the target of extensive litigation. In 2009, for example, parent company Pfizer agreed to pay $2.3 billion to the Department of Justice for illegally promoting sales of a Lyrica dosage. This charge revolved around the fact that manufacturers urged doctors to prescribe Lyrica for so-called “off-label” use.

The study collected information in seven countries from 164 women who took pregabalin during a pregnancy and 656 pregnant women who were not taking any anti-seizure drugs. The women or their practitioners were then contacted again after their expected date of delivery.

Birth defects 3X more likely

Pregnancies of the women who took pregabalin during the first trimester of pregnancy were three times more likely to result in major birth defects than those of the women who did not take anti-seizure drugs. Seven of the 116 pregnancies in women taking anti-seizure drugs, or 6 percent, had major birth defects, compared to 12 of 580 pregnancies, or 2 percent, in women who did not take the drug. Birth defects due to chromosomal abnormalities were not included in these results.

The major birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs. The women taking pregabalin were six times more likely to have a pregnancy with a major defect in the central nervous system than women who were not taking the drug, with four CNS defects out of 125 pregnancies, or 3.2 percent, compared to three CNS defects out of 570 pregnancies, or 0.5 percent.

Of the women taking pregabalin, 115 were taking it to treat neuropathic pain, 39 were taking it for psychiatric disorders, including depression, anxiety, bipolar disorder and psychosis, five were taking it for epilepsy and one was taking it for restless leg syndrome.

A total of 77 percent of the women started taking pregabalin before they became pregnant. The women in the study stopped taking the drug at an average of six weeks into their pregnancies. Of the women taking pregabalin, 22, or 13 percent, were also taking another anti-seizure drug.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects and because the study was small and the results need to be confirmed with larger studies, but these results do signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy,” said study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland.

Winterfeld said, “Pregabalin should be prescribed for women of child-bearing age only after making sure that the benefits of the drug outweigh the risks and after counseling them about using effective birth control. In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted.”

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