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.


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.


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



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, 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 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.


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 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.


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



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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Two Reasons That More Attorneys File Xarelto Claims in Philadelphia Court

Pa Court of Common Pleas Xarelto Litigation
Court of Common Pleas Xarelto Litigation

Approximately 1,100 claims have been docketed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation to date, and the number of claims before Judge Arnold New is increasing. We believe the increase Xarelto being filed  can be attributed to two primary factors.

  1. Judge Arnold New in PTO 10 ordered that the Master Complaint in the Xarelto Pa. Court Consolidation be amended to allow for Ischemic Stroke claims in addition to bleeding related claims. Judge Eldon Fallon, overseeing the Xarelto Federal MDL 2592  is not considering allowing Ischemic Stroke claims to be brought in Xarelto MDL 2592 . Our impression from reading a status conference transcript from Judge Fallon’s court is that he does not think it is necessary to change the allowed claims in the Xarelto MDL he presides over because these claims can be filed in Judge News court.
  2. An issue arose over whether “total lack of diversity” existed during the Bellwether Selection process in Xarelto MDL  2592 where the defendants attempted to eliminate claims filed in certain states from the Bellwether Pool. Although the defendants’ efforts failed, the issue may be brought up again in individual cases. Some attorneys are filing cases from states in which a total lack of diversity issue exists in the Philadelphia Consolidation in an effort to eliminate the potential issue.  The States in question are: California, Delaware, Indiana, New Jersey and Pennsylvania.

Because many firms that are not members of the Pennsylvania bar may need to file Xarelto Claims in the Philadelphia Court Consolidation, we have compiled a list of firms that are in a position to act as local counsel or co-counsel for filing in the Xarelto Pa. Consolidation. Our criteria for compiling this list was :

  1. The attorney must be a member of the Pennsylvania Bar.
  2. The attorney or firm must have filed a significant number of cases in the Pa. Xarelto Consolidation.

Potential Local Counsel and Co-Counsel Firms For Pa. Court Xarelto Litigation 

(713)583-5388 – FAX


(850)916-7449 – FAX

PO BOX 30049
(215)689-4315 – FAX
SUITE 2801
(215)923-9302 – FAX
(215)592-4663 – FAX
Napoli Shkolnik  PLLC
10,000 LINCOLN DR. E.
(856)985-7408 – FAX
MEDIA PA 19063
(610)565-9531 – FAX

Heather  D’ONOFRIO 
(215)923-1057 – FAX

(267)335-2245 – FAX
(212)344-5461 – FAX


Ferrer, Poirot, Wansbrough
(214)526-6026 – FAX

3102 OAK LAWN AVENUE, #1100
(214)520-1181 – FAX

130 N 18TH ST., STE 1600
(215)875-7722 – FAX

(302)622-7100 – FAX


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Caseload Growing in Philadelphia Against Rex and Argon in IVC Filter Litigation

Option Elite IVC Filter Litigation Rex Medical L.P., the designer of the Option and Option Elite IVC Filters as well as the distributor of these products, Argon Medical, face a growing number of lawsuits related to injuries that plaintiffs’ complaints allege were caused by these devices. (See a detailed list of complaints and attorneys below.)

We believe the majority, if not all, claims against Rex and Argon have been filed in the Philadelphia Court of Common Pleas. Plaintiffs claim that jurisdiction is proper in the Philadelphia Court of Common Pleas under Pennsylvania Law partially due to the Pennsylvania citizenship of Rex Medical.

Although attorneys practicing in the IVC Filter litigation are well aware of the Bard  IVC Filter Litigation and Cook IVC Filter Federal Multidistrict Litigation, far less has been published about the Rex and Argon Medical IVC Filter Litigation underway in Philadelphia.

Pennsylvania allows for consolidation of common claims brought by plaintiffs against the same defendant. Although these consolidations are not Federal MDLs, they function much in the same manner.

Claims may be brought by plaintiffs against defendants in these consolidated litigations without regard to the plaintiff’s citizenship, so long as the plaintiff’s citizenship is within the United States.

Numerous medical device and pharmaceutical consolidated litigations have been heard in the Philadelphia Court of Common Pleas including the Risperdal Product Liability Litigation as well as a consolidated Xarelto Product Liability Litigation which is currently on going, while a Federal MDL also exists related to the same basic issues.

Currently, Judge Arnold New has designated the cases against Rex/Argon to the “Complex Litigation” track. Although the cases have yet to be consolidated for adjudication in the MDL-like process, we expect this to occur as more cases are filed in the Pa. Court of Common Pleas.

Judge New oversees all consolidated litigation in the Court of Common Pleas.


Plaintiffs Cases Filed Against Rex Medical and Argon Medical

Philadelphia Court of Common Pleas

Click on the Case Description to Access all documents including complaints for individual plaintiff cases:

Case Description

Date Filed

Case ID

Plaintiff Residence



DURBIN VS REX MEDICAL  17-Oct-16 161002290 California Option Efficacy


STOKAN VS REX MEDICAL  10-Oct-16 161001150 Arizona Option




DUGAS VS REX MEDICAL 9-Sep-16 160900897 Texas Option Fracture


HARRIS VS REX MEDICAL 14-Jun-16 160601343 Georgia Option Injury


MILLER VS REX MEDICAL 14-Jun-16 160601344 Louisiana Option Injury


CASEMAN VS REX MEDICAL 7-Mar-16 160300207 Ohio Option Irretrievable


MONPLAISIR VS REX MEDICAL  3-Oct-16 161000070 Florida Option Injury


AMOUR-WEST VS REX MEDICAL 13-Oct-16 161001566 Tennessee Option Injury


STRODE VS REX MEDICAL  6-Sep-16 160900127 Tennesse Option Injury


TURNER VS REX MEDICAL 5-Aug-16 160800773 Mississippi Option Fracture


THOMAS VS REX MEDICAL 8-Apr-16 160400816 Colorado Option




 Attorneys Filing Cases Against Rex Medical and Argon Medical

Philadelphia Court of Common Pleas




Stewart J. Eisenberg
Spruce Street Philadelphia, PA 19103

Villari Brandes & Giannone P.C.
Peter M Villari
Nicole T. Matteo
8 Tower Bridge
Suite 400
161 Washington Street
Conshohocken, PA 19428
(610) 832-8050

Terri Anne Benedetto

SUITE 2801
William B. Curtis
12225 Greenville Ave
Suite 750 Dallas, TX 75243
Ben C. Martin
3710 Rawlins Street, Suite 1230
Dallas, Texas 75219


Tim K. Goss
2905 Sackett St.
Houston, Texas 77098

David P. Matthews
Lizy Santiago
3031 Allen Street, Suite 200
Lopez McHugh, LLP


James J. McHugh, Jr
Carrie R. Capouellez
214 Flynn Avenue Moorestown
NJ 08057
(856) 273-8500

Wagstaff & Cartmell, LLP


Thomas P. Cartmell
David C. DeGreeff
4740 Grand Ave.
Suite 300
Kansas City, MO 64112
(816) 701-1100

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