The Definitive Guide to Opioid Litigation

The Definitive Guide to the “Opioid Litigation”

If you believe your firm is not big enough to be involved in the “Opioid Litigation”, you are wrong. If you believe it is too late to get involved in the “Opioid Litigation”, you are so very wrong. The opioid lawsuits, filed mostly by government entities thus far, represent the tip of an extremely large iceberg. A vast number of entities both public and private, with potentially viable claims against opioid defendants, remain unrepresented. Recent actions by the FDA, the Surgeon General, and the DEA support potential product liability claims on behalf of individuals harmed by opioids. These mass litigations on behalf of individuals are in the inception phase. The total number of clients with claims in the “Opioid Litigation” could rival the Tobacco Litigation.

Mass Tort Nexus announces the upcoming release of “Volume 1 of the Definitive Guide to Opioid Litigation.”  A very limited number of  “pre-release”  copies will be provided to attendees of the October 18-20, Mass Torts Made Perfect Conference in Las Vegas.

To receive one of the limited “pre-release” copies at MTMP, contact Jenny Levine jenny@masstortnexus.com or (954) 520-4494.

Over the past two years, the research and technical divisions of Mass Tort Nexus have worked in conjunction with educational institutions, government entities and private organizations, to establish a comprehensive archive of documents, data and knowledge relevant to “The Opioid Litigation”.  Thus far, we have used our archive of documents as well as our databases to educate government entities, as well as private organizations that may have claims against the manufacturers, distributors and other co-conspirators that took part in causing the “Opioid Epidemic.”

Mass Tort Nexus also uses our document archive, data and our knowledge base to assist select law firms in identifying entities, both public and private, that have incurred the most significant financial damages related to opioids. After an entity client has been retained, Mass Tort Nexus then assists with establishing the direct connection between the actions of specific opioid defendants and the damages caused by those actions specific to given state, city, county or other entity.

Using “Big Data”  in the Opioid Litigation

Between 2013 and 2015,  68,177 doctors accepted a total of $46 million dollars in payments from opioid manufacturers. Using our collection of databases, Mass Tort Nexus can identify doctors in specific cities, counties and states that accepted payments from opioid Manufacturers. Mass Tort Nexus can then cross reference that data with the specific doctor’s opioid prescribing habits, as compared to the benchmark for their specialty.

Opioids “The Trillion Dollar Epidemic”

The damages caused by the Opioid defendants to government entities, as well as private business and individuals is in excess of 1 trillion dollars by our estimates. Although we have no expectation that the defendants will pay for all of the damage they have caused, Mass Tort Nexus intends to do its part to make sure the opioid defendants do not get off easy.

Only a Fraction of Government Entities Have Filed Claims

Of the 45,789 State, City, County, Territory and reservation governments that potentially have claims against opioid manufacturers, less than one percent have filed claims to date. Of course, not all government entities were damaged equally, some cities or counties may have suffered very little financial damage. Understanding how to identify and account for damages caused by opioids to a given city or other government entity is vital for the potential entity client, as well as the lawyers that represent them.

Mass Tort Nexus Definitive Guide to the Opioid Litigation First 6 Volumes

 

Volume 1

Volume 1:  The Definitive Guide to Opioid Litigation provides the history of the defendants bad acts, statistics related to which government entities (Cities, States and Counties) suffered the most significant financial damage directly related to the opioid defendants actions. Volume 1 also critiques entity complaints to date, as well as defense strategies employed related to those complaints. (Limited Pre-Release at October MTMP)

 

Volume 2

Volume 2: The Definitive Guide to Opioid Litigation provides guidance for identifying entity clients, both government and provide sector, with significant damages  related to the actions of the opioid clients. This volume also delves into how law firms undertake retaining these entity clients.

 

Volume 3

Volume 3: The Definitive Guide to Opioid Litigation takes the massive amount of statistical data, documents and other information most important to clients and their attorneys and summarizes the information for ease of use. Mass Tort Nexus has collected well over one million pages of documents and billions of data points related to the opioid litigation for our internal use, in our efforts to assist entity clients and law firms we work with directly. Although it would be impossible to provide all of these documents and data in a single resource, we hope that volume three of the guide provides a road map for those who wish to undertake the monumental task of collecting the data and documents needed to be in the best position possible, to represent any client they retain.

Volume 4

Volume 4: The Definitive Guide to the Opioid Litigation records the criminal convictions of opioid manufacturers, employees and executives that have occurred to date and makes some predictions of what may occur in the near future. Hint, unlike the three Purdue Pharma Executives that paid a $65 million dollar fine and agreed to probation to resolve criminal charges, future charges against opioid executives are likely to result in their receiving an all orange wardrobe.

On the record, admissions stemming from the criminal cases already prosecuted in addition to those to come will be very useful in the ongoing opioid civil litigations.

Volume 5

Volume 5: The Definitive Guide to the Opioid Litigation is intended to tie all of the pieces and players together referenced in Volumes 1-4.  The Mass Tort Nexus research staff has been amazed by the connections that they have uncovered between supposedly independent organization that contributed to the development of the “echo chamber” that was used to convince doctors that opioids were safe, despite the fact that over a thousand years of history indicated otherwise.

 

Volume 6

Volume 6: The Definitive Guide to the Opioid Litigation  provides a comparison and contrast between three mass litigation’s with many similarities:

  1. The Tobacco Litigation
  2.  The BP Oil Spill Litigation
  3. The Opioid Litigation

 

 

 

 

 

 

 

 

 

 

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Opioid Manufacturers Break the “Don’t Kill White People Rule”

Government Inaction Turns to Obsession

The FDA, DEA, and the CDC, as well as numerous other government agencies have known for years that prescription opioids were killing people and took no significant action to confront the problem. Only after the CDC began correlating the data, that had always been at their disposal, did inaction turn into obsession and give birth to the Feds recognition of the opioid epidemic.  The word epidemic was not even in the government’s opioid lexicon, until it was discovered that opioids were killing white people at an alarming rate.

Although the correlation mentioned above is not likely to be made issue of in the “Opioid Litigation,” we found it interesting that the Feds discovery that Opioids were killing middle class, white suburban soccer moms, as well as other privileged white folks temporally coincided with the Feds sudden obsession with the problem noteworthy. Better late than never.

The Definitive Guide to the “Opioid Litigation”

Mass Tort Nexus will release the first volume of the “Definitive Guide to the Opioid Litigation” in October 2017. Contact Jenny Levine at jenny@masstortnexus.com to find out how to get a free copy of volume one. If your firm is interested in becoming involved in the Opioid Litigation, the guide should be your Bible, Koran, Torah etc. for the case.

The first volume is intended to provide plaintiff attorneys with a basic understanding of the multifaceted litigation, past, present and future. In reality, the term  “Opioid Litigation” is somewhat misleading, as it implies a far more limited scope to the “case” than is accurate.

Much attention has been given to the lawsuits filed on behalf of State, Federal and Local Governments against the makers of Opioid’s; however, these types of entity cases are only a fraction of those which can and should be filed.  Cases filed on behalf of individuals based on varied causes of actions should be far more numerous that those filed on behalf of entities. Firms of all sizes will be in a position to represent clients in the many niches that make up the “Opioid Litigation.”

  Back to the “Killing White People Rule”

“The wise do not take part in baseless conspiracy theories nor do they ignore reality regardless of the offense that may be given for its recognition. ”

John Ray

Circa 2017 🙂

 

Anyone who believes  that harming white people will not evoke action from our government far more quickly than harming non whites is ignoring history.

In the early 1930’s, the U.S. government conducted experiments on black men, which involved leading black men with Syphilis to believe they were being treated, when in fact they were being given a placebo. The government did not acknowledge or admit its actions for over 50 years. This is not a conspiracy theory, it is a fact.

This is Ancient History, Right?

More recently, one of  President Richard Nixon’s closest aides (and Watergate Co-Conspirator), years after being released from prison, admitted that Nixon created the “War on Drugs,”  in part to create an excuse to jail young black men. Every single President since Nixon has continued the war on drugs, resulting in a massive number of  black youth incarcerations, despite the fact that white people use illegal drugs at a higher rate than non whites.

 

 

The Reality 

Did the government’s realization that Opioids were killing white folks have an effect on turning inaction into obsession? Did the same factors turn an almost ignored problem into an epidemic?

The time line of the CDC getting around to correlating data, which had been at their disposal for almost 20 years, revealed a violation of the “Don’t Kill White People Rule.” The birth of the Feds obsession with the “Opioid Epidemic” would lead a wise man to conclude the two things are related.

 

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Actemra Research Suggest Congestive Heart Failure Warning Needed

A clinical study conducted by the maker of Actemra (tocilizumab), comparing the drug to its competitor, Enbrel (Etanercept), strongly indicates that a warning on the Actemra Label related to congestive heart failure is warranted.

In the study (see below) Hoffman La Roche compared Actemra to Enbrel. The goal of the study was to demonstrate that Actemra was not inferior to Enbrel.


 

The study demonstrated that patients using Enbrel suffered less adverse events in general however, for the purpose of this article one particular adverse event caught our attention.  The Hoffmann-La Roche study demonstrated that patients taking Actemra experienced congestive heart failure at essentially the same rate as those taking Enbrel with a statistically insignificant difference. One should also take into account that Hoffman-La Roche or those in their employ designed the rules of this “contest” as well as served as “referee”.

 

Whats the big deal?

The study conclusions become significant upon a review of the Black Box Warnings and Warnings and Precautions sections of Actemra and Enbrels FDA approved labels.  Enbrel  warns of Congestive Hearth Failure risks in the Warnings and Precautions section of their warning label and Acterma does not.  Given the fact that Hoffman La-Roache took it  upon themselves to stage this contest against Enbrel (with no input from the makers of Enbrel) and in the process discovered that their product carried essentially the same risk of Congestive Heart Failure (CHF) as Enbrel, Hoffman La-Roache would need to add the same warning related CHF in order not to be inferior to Enbrel.

Reasonably, if two competing drugs put patients at essentially the same risk of an AE and one drug warns potential users related to that AE and the other drug does not, the drug that does not warn is inferior. Given Hoffman La-Roache purpose was to prove non-inferiority to Enbrel, it would seem they may have achieved the opposite. Can theActemra Label be considered truthful and non misleading without a congestive heart failure warning given these facts or are they gaining an unfair advantage over Enbrel by withholding information from their warnings?

From out observations, it would appear that the study demonstrated higher risks for Actemra in most of the cardiac events observed. CHF caught our attention because Enbrel warns and Actemra does not.

Other important observations arose from the research conducted by Mass Tort Nexus specific to the study as well as the differences in the two product labels. Other observations will be covered in separate articles.

See the Black Box and Warnings and Precautions sections of the labels for both drugs below.  We believe these to be the most current versions.

 

 

 

 

 

 

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Actemra Adverse Events

Actemra Emerging Mass Tort Litigation Preliminary Adverse Event Reports

The following article addresses reports related to adverse events and  medical conditions potentially related to the use of the Rheumatoid arthritis drug Actemra. The article will cover a report published by STAT which identified 5 major adverse events (AEs)  and medical conditions  (MCs) potentially caused by Actemra. We will also cover a larger number  serious AEs and MCs potentially related to the use of Actemra identified by Mass Tort Nexus using our proprietary adverse event indicator algorithm.

The AEs and MCs identified by Stat as well as Mass Tort Nexus only include those arguably not warned of on the product label in the Unitied States.

The report  from Stat was recently published in June 2017. The stat report linked Actemra to the following AEs and MCs:

  • Heart Attack
  • Stroke
  • Heart Failure
  • Interstitial Lung Disease
  • Pancreatitis

The Mass Tort Nexus (MTN) investigation has thus far identified the following AEs and MCs potentially linked to Actemra.  It should be noted that the MTN report is based on a partially automated process in addition to traditional research as a result, the MTN investigation into any medical device or drug is essentially always ongoing. The following is MTNs list:

  • Interstitial lung disease
  • Death
  • Stroke
  • Myocardial infarction, Congestive Heart Failure and other Cardiac Disorders
  • Acute Myelomonocytic Leukemia
  • Bone marrow failure
  • Synovitis
  • Increase in required knee replacements resulting from synovitis
  • Demyelinating Disorders such as Multiple Sclerosis and Guillain-Barre syndrome
  • Psoriasis
  • Psoriatic arthritis
  • Pancreatic cancer
  • Malignancies

The remainder of this article will briefly define the conditions (not commonly known) we have identified as being potentially caused by the use of Actemra as well as our reasoning for the inclusion of theses AEs and MCs on our current list.

Interstitial lung disease

Interstitial lung disease describes a wide range of disorders which result in progressive scarring of the tissues of the lungs. Common among all of these disorders is decreased profusion (inability to breathe).

Mass Tort Nexus included Interstitial lung disease in our findings primarily based on the extremely large number of adverse event reports which have been filed with the FDA as well as  regulatory agencies in other countries.

It should be noted that Interstitial lung disease is a common co-morbidity factor in RA patients. Although early indications lead us to believe that the use of Actemra increases the risk of Interstitial lung disease above the baseline for RA patients in general, our research into this matter is ongoing.

Death

Although it is unclear why Actemra users experience a higher death rate than RA patients using other therapies, there is a strong indication that death does in fact occur more frequently in the Acterma user group. This conclusion was based on adverse event reports which have been filed with the FDA as well as  regulatory agencies in other countries as well as other factors.

Myocardial Infarction, Congestive Heart Failure and other Cardiac Disorders

The inclusion of MI, CHF and Cardiac Disorders in general was based in part on the drug manufacturers on Clinical Research used to gain FDA approval as well as case reports from sources world wide. This research is also supported by adverse event reporting data.

Acute Myelomonocytic Leukemia

Acute myelomonocytic leukemiais a form of acute myeloid leukemia that involves a proliferation of CFU-GM myeloblasts and monoblasts. Acute myeloblastic leukemia  is a group of malignant bone marrow neoplasms of myeloid precursors of white blood cells.

The inclusion of Acute myelomonocytic leukemiais is based on adverse event report reviews and case reports as well as other published literature deemed reliable.

Synovitis and Increased Knee Replacements

Synovitis describes inflammation of the synovial membrane. This membrane lines joints cavities, known as synovial joints.

Our inclusion of Synovitis and Increased Knee Replacements on this list was a result of adverse event report reviews as well as other data that we believe demonstrates a correlation between the use of Actemra and Synovitis leading to an increased number of knee replacements.

Bone Marrow Failure

Bone marrow failure occurs in individuals who produce an insufficient number of red blood cells, white blood cells or platelets.

Our inclusion of Bone Marrow Failure on this list is based on our adverse event report reviews as well as other indicators. Our inclusion on this list is also based on the significance of the disorder itself. Bone Marrow Failure can lead to a vast number of secondary conditions, may of which are fatal. If further research demonstrates that Actemra causes bone marrow failure (not simply is correlated to bone marrow failure), the significance for existing Actemra users as well as future potential Actemra users could actually be life or death.

Psoriasis and  Psoriatic arthritis

It is worth noting that other drugs such as Humira, also approved to treat RA are additionally approved for the treatment of Psoriasis. In the case of Actemra, there is some indication from case studies, adverse event report reviews as well as published articles from authoritative sources that Actemra may increase the risk of developing psoriasis. This may explain why Roche has not sought approval (as is the case with many RA drugs) for the treatment of Psoriasis given that the market for Psoriasis treatments is exponentially larger than the market for RA treatments.

The inclusion of  Psoriatic arthritis on our list is based solely on the well established fact that a significant percentage of patients that develop Psoriasis will eventually develop Psoriatic arthritis as a secondary condition.

Demyelinating Disorders such as Multiple Sclerosis and Guillain-Barre syndrome

Demyelinating disorders include  any condition that results in damage to the protective covering (myelin sheath) that surrounds nerve fibers in your brain and spinal cord. Damage to the myelin sheath results in the slowing of nerve impulses and can lead to a number of neurological problems.

Our inclusion of Demyelinating Disorders is based on a Dear Health Care Provider Letter sent to health care providers in 2013, warning of several conditions potentially related to or caused by the use of Actemra. All but two of these conditions have been added to the Actemra Label with the exclusion of Demyelinating Disorders and malignancies.  Indications from our review of adverse event reports also justifies Demyelinating Disorders inclusion in this list.

Malignancies

A malignancy is simply the presences of a cancerous tumor.

Our reason for inclusion of Malignancies in this list is in part based on the Dear Health Care Provider Letter referenced above for the same reasons we included Demyelinating Disorders. There is also support for AEs related to Cancer and Actemra in the review of adverse events, case reports and other reliable literature.

Pancreatitis and Pancreatic Cancer

Our inclusion of Pancreatitis in this list is based on a review of adverse event reports, case reports as well as literature from sources deemed to be reliable.

Our inclusion of pancreatic cancer in this list is based on the well established fact that patients that suffer from Pancreatitis are at an increased risk for pancreatic cancer. Although the number of patients that develop pancreatic cancer secondary to pancreatitis is relatively small, the fact that pancreatic cancer is generally fatal, we feel its inclusion on this list is warranted.

Correlation vs Causation

It is important to note that neither the Stat Report nor the information reported in this article are sufficient to indicate that Actemra causes any of the AEs or MCs listed.  The report and this article observe correlations.  Discovering correlation is a necessary step towards determining causation however, correlation alone does not prove causation.

Even if Actemra does cause every AE and MC listed in the Stat Report and this article, the evidence to prove this causation may never come into existence.  The drug maker has little incentive to fund clinical studies to prove their product causes an adverse event. Developing proof of causation for any AE or MC is largely dependent unintended  outcomes of studies the drug maker may still have motive to publish or information developed by the FDA or FDA equivalents in other countries.

In our opinion, to date,  the strongest causation evidence exists for the following AEs and MCs:

Heart Disorders, including Congestive Heart Failure and Myocardial Infarction.

Demyelinating Disorders

Malignancies

Pancreatitis

As our investigations continue, we are highly likely to find additional evidence related to the AEs and MCs listed as well as others. We expect to be publishing information related to Actemra for the next several years.

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No Cause for Panic in Defense Verdict in the First Xarelto Bellwether Trial

John Ray
“The decisions made in the boardroom of pharmaceutical companies with regard to settling mass litigation cases often have very little to do with the ‘legal’ aspects of the case, and although bellwether trials results are not insignificant, they are not as significant as one might assume.”

Within minutes of the defense verdict being handed down in the first Xarelto bellwether trial, (Boudreaux vs Bayer et.al., Case No. 2:14-cv-02720) the phone lines at Mass Tort Nexus began ringing like a Salvation Army donation site at Christmas.

The primary inquiry was the same: “What effect does the Boudreaux defense verdict have on the overall prospects of the Xarelto litigation?”

Our website www.masstortnexus.com already contained all of the pretrial documents for the Boudreaux case and we ordered an expedited copy of the Boudreaux transcript so that our researchers could get the complete picture and start an autopsy of the case.

If you are a Mass Tort Nexus subscriber you may obtain all documents, including the 1,600+ page transcript from the Boudreaux bellwether trial here.

Before going further, it is important to say to any plaintiff lawyer representing clients in the Xarelto litigation who may be freaking out due to the defense verdict in the first bellwether trial: put the cap back on the Xanax.

In fact, the plaintiff may well lose the second bellwether trial as well, because it appears that the Dr. St. James, the prescribing physician in the Orr case (the second Xarelto bellwether trial set for May 30, Joseph Orr, Jr., Case No. 2:15-cv-03708), is likely to testify in a very similar manner to Dr. Wong, (the prescribing physician in the Boudreaux bellwether case).

Regardless, keep your feet firmly planted on the rail of that bridge you may be thinking of jumping off of. Panic would be extremely premature.

Mass Tort Nexus became aware of how Dr. Wong and Dr. St. James were likely to testify as a result of the motion for summary judgment based on the learned intermediary doctrine filed by the defense revealing deposition testimony of Dr. Wong and Dr. St. James. Both prescribing physicians testified as if someone had given them a script entitled “How a prescribing physician should testify to support a learned intermediary doctrine defense.”

The defense motion for summary judgment was denied as under Louisiana’s version of the learned intermediary doctrine, because the relevant issues are considered matters for a jury to decide under Louisiana Law.  Louisiana law applied because both the Boudreaux and the Orr case state of “original jurisdiction” was Louisiana. This had nothing to do with the fact that the MDL is consolidated in Louisiana nor will Louisiana law apply to cases where other states would be the state of “original jurisdiction.”

The Answer to the $64,000 Question

The simple answer to the question, regarding the defense verdict in the first Xarelto bellwether, is that the Boudreaux verdict has no direct impact on any other case other than the case brought on behalf of Joseph Boudreaux.

As to the indirect impact Boudreaux verdict on the overall Xarelto litigation, the analysis must be broadened.

First, the fact that defense based its entire strategy on the learned intermediary doctrine, could be somewhat telling about the defendants and their counsel’s belief that they would prevail under other defense theories. The learned intermediary doctrine is considered by many to be a defense of last resort. When possible, the goal of defendants in pharmaceutical and medical device cases should be to obtain dismissal of every single plaintiff’s case in a mass litigation via preemption or other universal case-killer legal theory. This goal will never be achieved through the learned intermediary doctrine defense.

The learned intermediary doctrine provides that a manufacturer of a product has fulfilled his duty of care when he provides all the necessary information to a “learned intermediary” who then interacts with the consumer of a product.

Although most states have codified some version of the doctrine and the reasoning behind it has been applied in individual cases in all 50 States, it is safe to say that not all states have applied the doctrine in the same manner.

More important is that the learned intermediary doctrine defense is entirely dependent on the testimony of the individual prescribing physician in any given plaintiff’s case. To prevail with the learned intermediary doctrine defense, the prescribing physician must testify, very specifically, in one of two manners:

  1. That the doctor was aware of all the risks associated with the drug and continued to believe that the benefits outweighed the risks with regard to the individual plaintiff (patient).
  2. That any risk not known at the time the doctor prescribed the drug, if known, would not have changed her decision with regard to prescribing the drug for the individual plaintiff patient.

16,285 additional complaints

Plaintiffs and their counsel can safely assume that many of the prescribing physicians for the 39 remaining scheduled Xarelto bellwether cases will not all testify in a manner supporting a learned intermediary doctrine defense. Beyond the 39 bellwether cases, defense has 16,285 (and climbing) additional complaints to contend with. Are all the prescribing physicians in the other 17,000 plus complaints going to fiddle to the music of the learned intermediary doctrine defense? Not bloody likely.

In the Xarelto bellwether trial selection, Judge Eldon Fallon allowed the defense to pick 10 cases, allowed the plaintiffs to pick 10 cases and Judge Fallon selected the remaining 20 cases himself. Plaintiffs are not facing a situation where defense was able to load the bellwether selection with cases in which the individual prescribing physicians gave depositions or otherwise indicated that they would eventually testify by the script the defendants need to prevail under a learned intermediary defense.

In cases where the prescribing physician cannot be counted on to follow the defendants’ learned intermediary doctrine script, the defendant and counsel will be forced to base their arguments on the merits of the case. Without the learned intermediary doctrine knockout, the merits of the Xarelto case favor defense looking as if it was in a fight with Joe Frazier followed by a fight with Mike Tyson.

Putting aside the foregoing, a review of past MDL pharmaceutical product liability bellwether verdicts in which defense has prevailed in the first trial and often in the majority of the bellwether cases may allow some plaintiff lawyers to put the first Xarelto bellwether defense verdict in perspective and take comfort.

39 bellwethers to go

Note: If the prescribing physician takes the stand wearing a Rolex with the defendants’ logo inscribed on the back, no matter how good the case or counsel may be, the plaintiff is probably not going to fare well. Fortunately, in the Xarelto litigation, there are 39 more bellwether trials to go.

If the defense does not settle those 39 cases, there will likely be more bellwethers scheduled. If Judge Fallon at some point determines that the litigation is not going to result in settlement, he could remand all remaining cases for trial.

The only other possible outcome is for the defense to find a way to get all Xarelto cases dismissed on a creative legal theory (which does not exist in the Xarelto case). It is safe to say, we are past the point where all Xarelto cases will be universally dismissed under any legal theory.

Anyone who has attended the Four Days to Mass Tort Success Course has heard me say, “The decisions made in the boardroom of pharmaceutical companies with regard to settling mass litigation cases often have very little to do with the ‘legal’ aspects of the case and although bellwether trials results are not insignificant, they are not as significant as one might assume.”

What is the likely future of the Xarelto bellwether trials? The defense will win some, the plaintiffs will win some and in the final analysis, these wins and losses will not be the primary factor in the defendant’s decision to settle the case. We apologize to anyone who was under the false impression that Big Pharma makes any decision that is not based on the bottom line, including their decision to put dangerous products on the market in the first place. Ultimately it is unlikely that a scenario will appear where the math for the defendant will not favor mass settlement.

Below is a sampling of cases where the first bellwether trial resulted in a defense verdict or the majority of bellwether trials resulted in defense verdicts and yet, the litigation ended in mass settlement.

Bellwether Defense Wins and Settlements

Vioxx MDL 1657

Of the six bellwether trials that occurred in the Vioxx MDL the first bellwether trial ended in a defense verdict. The other five bellwether trials ended in three more defense verdicts, one trial ended in a hung jury and the plaintiffs won only one of the six bellwether trials. Ten additional trials occurred outside of the MDL. Of the total 16 trials that occurred in the Vioxx product liability litigation, 11 resulted in defense verdicts.

The defendant ultimately agreed to settle the vast majority of Vioxx cases for an estimated $4.8 billion.

72 Defense firms participated in the Vioxx product liability defense. According to documents filed on behalf of these firms, the total hours billed for all firms was 350,000 hours. Using a blended rate including averages for partners, associates and other personnel of $475 per hour. The defendant’s legal fees were about $165,550,000.

If you are doing the math, inclusive of the legal fees paid for the defendant’s legal fees in the MDL and the 16 Vioxx trials, the defendant spent on average $10,343,750 per tried case. Winning does not feel that great when your own lawyers dip their hands deeper into your pocket than the opposition.

MDL 1355 Propulsid

The first bellwether trial resulted in a defense verdict. The second and third bellwether trials resulted in defense motions for summary judgment being granted.

The defendant Johnson & Johnson ultimately settled with the majority of the plaintiffs in the Propulsid litigation for an estimated $100 million.

Prempro Product Liability Litigation

The first bellwether trial resulted in a defense verdict. The defendant went on to win the majority of the 15 bellwether trials.

Ultimately the defendant settled the vast majority of the plaintiffs’ cases for about $1 billion.

NuvaRing Litigation Product Liability Litigation MDL 1964

Defense summary judgment granted in all Group I bellwether cases. The defendant agreed to settle the majority of NuvaRing cases for approximately $100 million.

Traysol Product Liability Litigation MDL 1928

The first two bellwether trials were dismissed on a defense motion for summary judgment. The defendant Bayer ultimately settled the Traysol Litigation for an average of approximately $400,000 per plaintiff.

Actos Product Liability Litigation MDL 2299

The first three bellwether trials resulted in plaintiff’s verdicts with jury awards of $6.5 million, $1.76 million and $2.05 million. The fourth bellwether trial resulted in a defense verdict. Takeda settled Actos cases for a total of approximately $2.4 billion.

Fen-Phen Product Liability Litigation MDL 1023

Despite having prevailed in many bellwether trials including Weston v. Wyeth, No. 03-CV-679878 (Jasper Co., Mo., Cir. Ct. 2006). Geers v. Wyeth, No. MO-03-CA-107-H (W.D. Texas 2006), Townley v. Wyeth, Nos. 0402-03094 and 0402-03171 (Philadelphia Co., Pa., Ct. C.P. 2006), Smith v. American Home Products, No. 97-55545 as well as others — Wyeth ultimately settled the Fen-Phen Litigation for approximately $2.74 billion.

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Holding Brand Name Drug Makers Liable for Generic Versions

Today, nearly 8 in 10 prescriptions filled in the US are for generic drugs, according to the FDA. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent.

But who is liable when a generic drug makes sells a bioequivalent drug to a patient who suffers a personal injury from taking it?

Two US Supreme Court cases insulate the generic makers from responsibility, so long as they included the branded drug maker’s warnings. But now courts in California, Vermont, and Illinois have accepted the notion of “innovator liability,” imposing liability on the branded drug maker for injuries caused by a generic drug equivalent.

Research shows that generics work just as well as brand-name drugs. A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand-name heart drugs worked any better than generic heart drugs. See JAMA. 2008;300(21)2514-2526.

The FDA says that any generic drug modeled after a single, brand name drug must perform about the same in the body as the brand-name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product.

Immunizing generic drug makers

California, Vermont, and Illinois state law rulings impose liability on the original drug company innovator for injuries caused by a generic drug equivalent.

Two notorious US Supreme Courts rulings have immunized generic drug makers from liability in product liability and failure to warn claims.

  • PLIVA, Inc. v. Mensing, 564 U.S. 604  (2011), holds that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state-law tort claim alleging a failure to provide adequate warning labels.
  • Mutual Pharmaceutical Co. v. Bartlett, 570 US 2468 (2013), holds that generic drug manufacturers cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug.

However, in California, Vermont, and Illinois, these rulings did not protect branded manufacturers from innovator liability claims, because the companies controlled the text of the warning labels.

Plaintiffs argue that the physicians “reasonably and foreseeably” relied on the representations of branded manufacturers when prescribing a generic drug, because physicians understood that generics are bioequivalent to and have the same labeling as branded drugs.

In the event that the branded manufacturer made misrepresentations or engaged in other unlawful activities such as “off-label” marketing, plaintiffs further argue that physicians relied on the branded manufacturers’ misrepresentations, understood that generics are bioequivalent to the branded product, and prescribed the generic based on the branded manufacturers misrepresentations.  

Innovator liability

Only California, Vermont, and Illinois state law rulings impose liability on the original drug company innovator for injuries caused by a generic drug equivalent.

California

Conte v. Wyeth, 168 Cal.App.4th 89, 85 Cal.Rptr.3d 299 (2008), involved a user of generic metoclopramide who brought an action against Wyeth, the manufacturer of Reglan, the name-brand form of metoclopramide, for fraud, fraud by concealment, and negligent misrepresentation.

The court of appeals held that Wyeth’s common-law duty to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent.

In T.H. v. Novartis Pharmaceuticals Corp., 199 Cal. Rptr.3d 768 (Cal. App. 2016), the court of appeals imposed innovator liability in perpetuity − for injuries occurring even after an innovator manufacturer had sold all rights and left the relevant market altogether.

Note: This decision is currently under appeal. If Novartis wins this appeal Conte would not be overturned, innovator liability would simply end at the point (if) the brand manufacturer discontinued the marketing of the brand drug.

Vermont

Vermont chose to recognize innovator liability in Kellogg v. Wyeth, 762 F. Supp.2d 694 (D. Vt. 2010). The plaintiff filed suit against the brand name and generic manufacturers of metoclopramide for strict product liability, breach of express and implied warranties, negligent misrepresentation, fraud and fraud by concealment.  

A federal court interpreted state law, imposing a duty on Wyeth because it was “fair” to do so, and there is no reason, under Vermont law, to limit defendant’s duty of care to physicians by the pharmacist’s choice of a generic bioequivalent.

Illinois

Dolin v. SmithKlineBeecham Corp., 62 F. Supp.3d 705, was a wrongful death action against SmithKline Beecham Corporation involving a man who committed suicide after taking paroxetine, the generic version of Paxil.

A federal court interpreted Illinois law to impose a duty of reasonable conduct upon GSK. The plaintiff’s common law negligence and negligent misrepresentation claims survived summary judgment.

Note: Under Illinois law a product liability claim under an innovator liability theory would likely fail where as a negligence claim would survive.

Innovator Liability and Zofran

In an unusual move, Judge Dennis Sailor presiding over MDL 2657, has approved two master complaints, one for branded drug use and a separate Master Complaint for plaintiffs that wish to pursue GSK under innovator liability theories.

Judge Sailor is overseeing 364 lawsuits in MDL 2657 in federal court in Massachusetts, IN RE: Zofran (Ondansetron) Products Liability Litigation.

The most significant difference in the Zofran Brand Master Complaint and the Zofran Generic Master Complaint is in paragraph 101 of the generic master complaint:

101. Defendants knew or should have known that consumers such as Plaintiffs would foreseeably use the generic bioequivalent of Zofran and rely upon representations and omissions of Defendants as the holders of the NDA for Zofran.

Although the Master Complaint does not contain language that limits its use to claims governed by the laws of the three “innovator liability states,” the defense is free to argue these claims based on the laws of the state of original jurisdiction.  For states that do not have settled caselaw related to innovator liability, it is likely that the defense will prevail in most cases.  

Mensing and Bartlett both turned on an “impossibility preemption argument,” in that is not possible for a generic manufacturer to legally alter the warning label. The generic label most conform exactly to brand label.

What if the brand drug manufacturer also makes a generic version of its own drug?  Obviously, the brand manufacturer would control both the brand label as well as the generic label under this circumstance and the impossibility preemption reasoning of Mensing and Bartlett would not apply.

Novartis purchased GlaxoSmithKline’s oncology division in March of 2015. Along with Glaxo’s cancer business came the right to sell Zofran. Novartis also owns Sandoz, which manufacturers a generic version of Zofran. Therefore there is a strong argument that Mensing and Bartlett do not provide protection for Zofran Generics made by Sandoz after May 2015.

 

 

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FDA Recommends Against the Use of Ovarian Cancer Screening Test

Ovarian-CancerOn September 7, 2016 the FDA issued a letter to physicians as well as the public recommending against the use of screening tests for Ovarian Cancer. Below are excerpts from the FDA recommendation:

“The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer. Based on currently available information, the FDA recommends against using currently offered tests to screen for ovarian cancer.”

“Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results. However, over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer. For example, recently, Abcodia Incorporated began marketing the Risk of Ovarian Cancer Algorithm (ROCA) test in the United States, with claims that the ROCA test can screen for and detect ovarian cancer before symptoms appear and increase the chance for survival. Yet, available data do not support its claims.”

“Some women may receive test results that suggest ovarian cancer even though no cancer is present (a false­ positive). These women may undergo additional medical tests and/or unnecessary surgery, and may experience complications related to both. Or, test results may not show ovarian cancer even though cancer is present (a false­ negative), which may lead women to delay or not seek surgery or other treatments for ovarian cancer.”

How many women Have Been Harmed by Inaccurate Test?

Ovarian Cancer Test Kits have been added to the Mass Tort Nexus Watch List for Emerging Litigations for 2017. This topic will be discussed at the November 11th-14th 2016  Mass Tort Nexus “Four Days to Mass Tort Success Course . ”

 

 

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MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation

Ethicon PhysiomeshEthicon, a division of Johnson and Johnson, issued an urgent field safety notice on May 25, 2016 related to its hernia repair product Ethicon Physiomesh Flexible Composite Mesh.

The notice included a recall of existing stock currently held by health care facilities for all variations (product codes) of the Physiomesh Product Line.

  • On the same day, Health Canada, (the Canadian FDA) issued a recall of the Physiomesh products as well.
  • The Australian Therapeutic Goods administration followed suit in June issuing a hazard alert.

The recall of “on the shelf” products should serve to prevent future hernia repair patients from being implanted with Physiomesh however, this recall does not help those already implanted with the defective hernia mesh product.

We estimate that as many as 300,000 individuals may have been implanted with Physiomesh since the product was approved by the FDA via the 510k process in 2010.

MDL Motion Expected

A large number of lawsuits are expected to be filed resulting from injuries alleged to be caused by Ethicon Physiomesh. It is probable that, as more cases are filed, a motion to consolidate will be filed before the Judicial Panel on Multidistrict Litigation (JPML). Given the fact that Ethicon has recalled the Physiomesh product line, this litigation may move rapidly.  It is possible that an MDL could be formed as early as 2017.

The emerging litigation related to injuries caused by Physiomesh will be discussed in the November 11th – November 14th Four Days to Mass Tort Success Course  in Fort Lauderdale. We will continue to update our subscribers on this emerging litigation. If you are not already a subscriber to the Mass Tort Nexus App, please sign up today at this link: Sign Up

Current litigation

Matthew Huff filed a complaint (See Huff vs Ethicon) in the Southern District of Illinois in April 2016.  The Huff complaint alleges that after being implanted with Physiomesh he was hospitalized beause of an infection in and around the mesh, which caused two abdominal abscesses and an intestinal fistula. These complications from the Physiomesh implant required extensive surgery.

Joanne Quinn filed a complaint (See Quinn vs Ethicon) in the Middle District of Florida in September 2016. The Quinn complaint alleges that the implanted Physiomesh did not improve her condition and in fact resulted in further complications including bowel obstruction. Quinn alleges that due to complications related to Physiomesh she was required to undergo a significant surgical procedure in an attempt to correct the complications allegedly caused by Phsyiomesh.

Shortly after the FDA approved Physiomesh, surgeons and other medical providers began filing adverse event reports, by the end of 2012 an estimated 90 adverse event reports had been filed related to Physiomesh. Today an estimated 650 Adverse Event Reports have been filed in the FDA’s Maude Adverse event reporting System since Physiomesh Composite Mesh was approved by the FDA in 2010 via the 510k market approval pathway. Despite this alarming number of adverse event reports, the FDA took no action prior to the manufacturer’s recall of all Physiomesh Products in May.

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Second Wave of Plaintiffs in Hip Litigations Stryker LFIT V40 Recall

Zimmer-ML-Taper-Hip-Replacement-Device-Recall

 

The emergence of a second wave of plaintiffs for hip implant cases which have already been litigated or are currently being litigated will now likely be joined by plaintiffs with injuries related to the LVIT v40 Femoral Head component recall. The recent  surge in new plaintiffs for existing hip replacement litigation’s is likely due to the fact that those individuals who received their recalled or defective hip implant in the two year period prior to the problems with these devices becoming known, are just now experiencing the adverse events associated with these devices.

Urgent medical device recall

Stryker Corporation issued  an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

The urgent medical device recall notification was related to LFIT V4o Femoral Heads manufactured prior to 2011, and therefore it is highly unlikely that any of the recalled devices would still be in the stockroom of any surgical center or other medical providers. The recall obviously affects devices that are already implanted in hip replacement patients and therefore can not simply be packaged up and sent back to the manufacturer.

Health Canada  issued a similar recall several days before the voluntary recall was issued by Stryker in the United States.  The notice from the Canadian Equivalent of the FDA noted that:

“Stryker has received higher than expected complaints of taper lock failure for specific lots of certain sizes of  LFIT Anatomic COCR V40TM Femoral Heads manufactured prior to 2011.”

The taper lock is the part of the hip implant component that connects the femoral head to the femoral neck. Failure of the taper lock can result in a complete loss of movement, severe pain, instability of the entire joint,bone fracture, dislocation as well as other significant problems. Surgery will generally be required to repair any complications resulting from taper lock failure. In some cases, surgery will not repair the complication and the patient may be left permanently disabled.

Emerging LFIT V40 Litigation

The newly-released information related to the defective nature of the LFIT V40 may give rise to a large number of new hip implant lawsuits to accompany those which have already been filed over the past few years, many having been consolidated into Multidistrict Litigations (MDL) as well as State Court Litigations. A number of lawsuits which include allegations related to the LFIT V40 component have already been filed in the New Jersey Stryker Hip State Court Consolidation.

In July 2016 Annah Marie Gidora (See Gidora vs Howmedica) filed a complaint in the Southern District of New York related to the LFIT V40 Femoral Head implanted in conjunction with a Stryker Accolade. She alleges that the device is prone to fail before its expected life. As a result of the device failure Giordia alleges that she suffered a debilitating loss of mobility as well as other injuries resulting in significant pain and suffering.

The LFIT V4o recall complicates and already complicated assortment of problems related to hip implants and litigation’s related to these defective products.  The LFIT V40 recall and litigation will be discussed at the November 11th- 14th Four Days to Mass Tort Success Course in Fort Lauderdale.  To view other topics that will be discussed by our speaker panel visit this link: November Speaker Panel.

 

 

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Viibryd linked to Acute Pancreatitis and Sleep Paralysis

ViibrydViibryd, manufactured by Forest Laboratories was approved by the FDA in 2011 for the treatment of major depressive disorder (MDD) in adults.

  • After reviewing an FDA Letter to Forest Labs written on September 6, 2016, we believe new warnings will shortly be added to the Viibryd label related to a link between the drug and acute pancreatitis.
  • Additionally we expect to see new warnings related to sleep paralysis also added to the Viibryd label and prescribing information.

Although this drug affects serotonin, it functions slightly different from most SSRIs because it also acts as a partial antagonist of the 5­HT1A receptor.  Approved in 2011, Viibryd quickly became the third-most prescribed antidepressant by 2014, according to Mental Health Daily. Cymbalta and Prestiq being the two antidepressants prescribed more often that Viibryd.

Although sleep paralysis is a serious condition and which cause psychological harm in the most severe cases, the condition is generally not severe. Sleep paralysis is a condition in which a person is awake but can not move or speak. Generally, sleep paralysis occurs upon waking and last less than one minute.

However acute pancreatitis can lead to serious injury and even death. Pancreatitis, especially if it reoccurs, can lead to pancreatic cancer, which is almost uniformly fatal.

Added to Mass Tort Nexus Watch List

To the best of our knowledge no lawsuits have been filed related to these newly discovered conditions linked to Viibryd however, we expect that when the new warnings are added, it may lead to investigations by law firms and education campaigns directed toward  users of Viibryd. The result of these investigations and public education campaigns are likely to lead to Viibryd lawsuits being filed.

The potential Viibryd Litigation will be discussed at the November 11th -14th Four Days to Mass Tort Nexus Course in Fort Lauderdale. For Information on other topics that will be discussed by our panel at the November Course visit this link:  Panel Discussions

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