Eliquis Plaintiffs Must Show Cause Why Their Cases Shouldn’t Be Dismissed from MDL

eliquis-internal-bleeding-lawsuitJudge Denise Cote of the U.S. District Court for the Southern District of New York, who is supervising the Eliquis MDL, ordered all plaintiffs to show cause by May 23 why her dismissal of one case should not be applied to all cases.

The case is In Re:  Eliquis [Apixaban] Products Liability Litigation, MDL 2754, No. 17-md-2754, Charlie Utts, et al. v. Bristol-Myers Squibb Company, et al., No. 16-5668, S.D. N.Y., 2017).

On May 8 the judge dismissed the Utts case, one of 49 cases brought against Bristol-Myers Squibb Company and Pfizer Inc. over their Eliquis anticoagulant, ruling that the plaintiff’s state-law claims were preempted by federal law.

On May 9, Judge Cote gave plaintiffs until May 23 to file amended complaints “and to show cause in a memorandum no longer than 20 pages why the amended complaint should not be dismissed based on the analysis in the May 8 Utts Opinion.”  Future lawsuits transferred into the MDL will have 14 days to provide the same information, the judge said.

The judge added that “it is unlikely that the plaintiffs in any of these actions will have a further opportunity to amend.”  She said the defendants will file a reply or replies by June 20, “at which point the motions to dismiss each action will be considered fully submitted.”

Gastrointestinal bleeding

Plaintiff Charlie Utts of California was diagnosed with atrial fibrillation and prescribed Eliquis by his doctor. After taking Eliquis, he suffered severe gastrointestinal bleeding and was hospitalized in July 2014 for about three weeks to undergo blood transfusions and several rounds of dialysis. He and his wife filed suit in 2016.

Eliquis — the brand name of the prescription medicine apixaban — is a blood-thinning medication used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis belongs to a class of drugs known as novel oral anticoagulants (“NOACs”). It does not have a known antidote or reversal agent. Unlike anticoagulant medications such as warfarin, NOACs, including Eliquis, do not require periodic blood testing or impose dietary restrictions on users.

The plaintiffs argued that despite there being no antidote for uncontrolled bleeding while taking Eliquis, the dosage recommendation was not individually tailored and that Bristol-Myers and Pfizer did not recommend constant monitoring of blood clotting times in patients.

Showing off her homework in an 85-page opinion, Judge Cote also rejected all nine scientific articles or documents cited by the plaintiffs to create a plausible claim that the Eliquis labeling fails to adequately warn of the risk of excessive bleeding. “The information contained in this literature does not constitute ‘newly acquired information’ under the FDA’s regulation,” the opinion says.

Well-Known to FDA

“These two complaints concern features of the design of the drug that were well known to the FDA [Food and Drug Administration] when it approved the drug,” Judge Cote wrote.

“Faced with the fact that, as of today, there is no research or clinical experience to suggest that any changes to the Eliquis label’s disclosures related to a risk of excessive bleeding are warranted, the plaintiffs argue vehemently that the motion to dismiss should be denied and that they should be permitted to conduct discovery to try to locate evidence in the defendants’ files that might support their failure to warn claims,” the judge continued.

“They emphasize that there is substantial ongoing litigation over the earlier drugs in the class of drugs to which Eliquis belongs,” the judge continued.  “But, the ability of other plaintiffs in other litigation over other drugs to survive a motion to dismiss does not relieve the plaintiffs of the requirements imposed by Rule 12(b)[Fed. R. Civ. P., 12(b)].  Accordingly, the claims in the [second amended complaint], which reduced to their essence are attacks on the design of this drug, will be dismissed.”

 

The Uttses are represented by Hunter J. Shkolnik and Nicholas Farnolo of Napoli Shkolnik in Melville, N.Y.

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Eliquis State-Law Claims Preempted, MDL Case Dismissed

eliquis-internal-bleeding-lawsuitA federal judge in New York dismissed one of 49 cases brought against Bristol-Myers Squibb Company and Pfizer Inc. over their Eliquis anticoagulant, ruling that the plaintiff’s state-law claims were preempted by federal law.

Granting a motion to dismiss, Judge Denise Cote threw out Utts et al v. Bristol-Myers Squibb Company et al, case number 1:16-cv-05668, in the U.S. District Court for the Southern District of New York, In Re: Eliquis (Apixaban) Products Liability Litigation, MDL No. 2754.

The court said that all the plaintiff’s claims — for failure to warn, design defect claims, warranty violations, fraud, and consumer protection claims — were preempted, adding that the Eliquis label is adequate as a matter of law.

Not ‘newly acquired information’

Showing off her homework in an 85-page opinion, Judge Cote also rejected all nine scientific articles or documents cited by the plaintiffs to create a plausible claim that the Eliquis labeling fails to adequately warn of the risk of excessive bleeding. “The information contained in this literature does not constitute ‘newly acquired information’ under the FDA’s regulation,” the opinion says. “Accordingly, the plaintiffs’ claims are preempted because federal law would not have permitted the defendants to make any change to the Eliquis label.”

“The risk of excessive bleeding from this blood thinner and the lack of an antidote were clearly disclosed to the Food & Drug Administration (“FDA”) when it approved the drug, and are prominently disclosed to medical practitioners and patients on the FDA-approved labeling for the drug,” the judge says.

Charlie Utts of California was diagnosed with atrial fibrillation and prescribed Eliquis by his doctor. After taking Eliquis, he suffered severe gastrointestinal bleeding and was hospitalized in July 2014 for about three weeks to undergo blood transfusions and several rounds of dialysis. He and his wife filed suit in 2016.

Eliquis — the brand name of the prescription medicine apixaban — is a blood-thinning medication used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis belongs to a class of drugs known as novel oral anticoagulants (“NOACs”). It does not have a known antidote or reversal agent. Unlike anticoagulant medications such as warfarin, NOACs, including Eliquis, do not require periodic blood testing or impose dietary restrictions on users.

Eliquis was approved by the FDA in 2012. The judge said the Eliquis label warns about the risk of serious bleeding five times, and warns that there is no specific antidote two times.

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Attorneys Mistakenly Turn Down Xarelto Cases When Death Certificate Omits Internal Bleeding

John Ray has been a leading consultant to the Mass Tort industry for over a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.
John Ray has been a leading consultant to the Mass Tort industry for over a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.

By John Ray.

Even as Xarelto litigation grows ahead of the first bellwether trial in federal court MDL No. 2592, some plaintiff attorneys are mistakenly turning down cases if the death certificate does not specifically mention internal bleeding or ischemic stroke.

In our consulting practice at Mass Tort Nexus we are often asked if the cause of death listed on a death certificate does not mention bleeding or ischemic stroke deal — is that a fatal obstacle to filing a wrongful death case related to Xarelto, Pradaxa or Eliquis?

The simple answer is, possibly but often not.

Many mass tort lawyers see the upcoming bellwether trials on April 24 and May 30 as an opportune time to start or expand a Xarelto product liability practice. So far 15,611 cases lawsuits have been filed before US District Judge Eldon E. Fallon in Louisiana, up from 10,769 cases in September 2016. 

The federal lawsuits stem from allegations that the anticoagulant Xarelto could cause uncontrollable bleeding and hemorrhagic strokes. They accuse the drug’s manufacturers — Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals — of failing to warn about Xarelto’s potential risks. 

In parallel state court litigation in Pennsylvania, Judge Arnold L. New in the Philadelphia Court of Common Pleas amended the master and short form complaint to allow for Ischemic Stroke Claims to be made in that court.

What a death certificate is — and isn’t

A  death certificate is document that serves primarily as a public record of an individual’s death. These records are often used in a variety of statistical analysis.

The cause of death (COD) noted on a death certificate is not intended to be an expansive diagnostic review of all medical events that led to the death. In some cases, the person who issued the death certificate may not even be a medical practitioner.

In reviewing blood-thinners Xarelto, Pradaxa and Eliquis cases, the COD listed on the death certificate may not mention bleeding or any other condition known to directly occur as a result of using these drugs however,  this does not necessarily mean that it cannot be determined by a preponderance of the evidence that the given anticoagulant did not cause or contribute to the death.

Example: The cause of death on a death certificate may list heart attack, myocardial infarction or cardiac insult as well as other terms that fall under the more general term “heart attack.”

Should one automatically assume that the death, under this circumstance, cannot be attributed to the use of Xarelto, Pradaxa or Eliquis?  No!

Bleeding can cause heart attack

Do not allow the cause of death listed on a death certificate be the final determining factor in whether you continue to pursue a wrongful death action.

There is ample evidence in the medical literature “heart attacks” can be secondary to bleeding events. Heart attacks can be caused by sudden significant increases and decreases in blood pressure as well as the heart being deprived of oxygen, delivered by adequate blood flow.

If the death certificate lists any form of “heart attack” as the cause of death, further investigation is warranted to determine whether the use of any of the aforementioned drugs could have reasonably caused or contributed to the heart attack.

  • A significant bleed within two or three weeks before the heart attack resulting in death will have more likely than not caused or contributed to the heart attack.
  • A significant bleed can lead to permanent heart damage and can cause or contribute to a heart attack months or even years after the bleeding event. Obviously, the less time there is between the bleeding event and the heart attack makes for a less difficult argument.

It should be noted that in cases where the patient had a history of heart attacks or conditions which are known to lead to heart attacks such as late stage diabetes, for example, may make it more difficult to prevail in your argument.

When analyzing whether the bleeding event may have caused or contributed to the cause of death listed on the death certificate, it is important to understand a basic fact:

Bleeding is never the actual cause of death — events secondary to bleeding are the actual cause of death.

This statement can be difficult to wrap one’s head around as the term “bled to death” is so commonly used and is not inaccurate in the broadest sense. However, from a physiological perspective the true cause of death is always secondary to loss of blood. If insufficient blood volume exists vital organs that are highly dependent on oxygen and fluid volume can quickly fail resulting in death.

The takeaway from this article is: Do not allow the cause of death listed on a death certificate be the determining factor in whether you continue to pursue a wrongful death action.

Once you have a death certificate in hand, review the cause of death listed on the death certificate. After ascertaining the COD listed on the death certificate, as a first step simply Google “Can Bleeding Result in (insert cause of death listed).”

If the cause of death listed a condition that can be attributed to bleeding, then further review of the patient’s pre-death medical records is warranted to determine if there is a strong argument that the bleeding event caused or contributed to the condition listed on the death certificate.

Two Cautions

Late-stage cancers, particularly pancreatic and liver cancer, often result in bleeding regardless of whether the patient is receiving anticoagulant therapy or not. If the cause of death listed is a type of cancer that has a high mortality rate in late stages, then is would be far more difficult to argue that it was more likely than not that the anticoagulant caused the death versus the cancer.

In some cases, the cause of death may be listed as “natural causes” or even “old age.” Although no one dies of natural causes or old age, if such terms are listed as the COD, it may be more difficult, although not impossible, to show that the death was caused by the use of the anticoagulant. To demonstrate that the anticoagulant more likely than not caused or contributed to the death, medical records demonstrating a circumstance that would almost certainly lead to death would be needed.

This article is not intended to be medical or legal advice. Our goal is to provide issues to consider when evaluating Xarelto, Pradaxa and Eliquis cases as well as other cases in which the content of this article may apply.

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JPMDL Consolidates Eliquis Product Liability Litigation into New MDL in NY

eliquis-5mg-60slblThe Judicial Panel on Multidistrict Litigation created new MDL No. 2754 to hear product liability litigation against Bristol-Myers Squibb Company, Pfizer Inc. and McKesson Corporation charging that blood-thinner Eliquis (apixaban) causes severe and fatal bleeding.

There is a total of 53 actions pending in 17 districts raising substantially the same factual and legal issues concerning plaintiffs’ alleged injuries arising from Eliquis and over a dozen involved plaintiffs’ firms. Moreover, the parties unanimously agree that there is a strong likelihood of additional federal actions and also report a significant number of state court actions.

US District Judge Denise L. Cote in Southern District of New York will supervise the cases. The defendants requested the MDL, and the plaintiffs argued unsuccessfully to continue informal coordination.

“We find that, on this record, informal coordination is not an efficient alternative to centralization,” the JDMDL said. “In addition to the unsuccessful efforts to coordinate discovery informally, it is clear that the number of involved counsel, the large number of actions and districts, and the complexity of the factual issues pose significant obstacles to informal coordination.”

Insufficient testing

All the actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding and related injuries as a result of taking Eliquis (apixaban), that defendants did not conduct sufficient testing of the drug, and that defendants’ warnings and instructions as to the alleged risks, including the unavailability of a reversal agent to counteract bleeding, were inadequate. Issues concerning the design, testing, manufacture, regulatory approval, labeling, and marketing of Eliquis thus are common to all actions.

Eliquis is an oral anti-coagulant first put on the market in Europe in 2012 and then approved by the FDA in 2014 for use in the United States. The clinical trials are alleged to have documented adverse effects including severe internal bleeding and other severe adverse symptoms including at least one death caused by Eliquis, which went unreported. Bristol-Myers and Pfizer chose to place Eliquis on the market while failing to disclose this critical information as required.

Currently the claims in the MDL include wrongful death as well as ongoing severe medical injuries. Eliquis is another in the line of recent blood thinner products including Pradaxa and Xarelto that have been the subject of Multi-District Litigations, including drug maker Boehringer Ingelheim’s $650 million settlement in 2014 to settle the Pradaxa MDL.  The recent Eliquis lawsuits center on patients who have died from internal bleeding or suffered other critical life-altering injuries, including Deborah Herschell who’s husband died after using Eliquis in June 2015 and Oliver Becker who suffered from atrial fibrillation (AFib) and also died after being prescribed Eliquis.

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Bristol-Meyers and Pfizer Seek MDL for Eliquis Blood-Thinner Litigation

eliquis-5mg-60slblBristol-Meyers Squibb Company and Pfizer Inc. have filed a motion to create new MDL No. 2757 in New York to hear Eliquis (Apixaban) products liability litigation. The US Judicial Panel on Multidistrict Litigation (JPMDL) will hear the motion Jan. 26 in Miami.

This litigation currently consists of 34 related actions filed in 13 different federal districts. The companies propose the cases be consolidated in the Southern District of New York, where judges are handling 27 MDLs, notably two prominent product liability MDLs for Rezulin and Fosamax.

The plaintiffs allege that they suffered various bleeding-related injuries as a result of taking Eliquis after their physicians prescribed it, and charge that the defendants failed to warn adequately about the risk of bleeding and that the defendants should not have sold Eliquis without precautions for blood monitoring or an additional drug to reverse its anticoagulant effect.

As safe as aspirin?

Eliquis thins the blood, prevents the formation of blood clots, and significantly decreases the risk of stroke in patients with atrial fibrillation and certain other conditions. Atrial fibrillation is a common arrhythmia (abnormal heart beat) that causes blood clots to form in the heart. Eliquis was designed to replace warfarin.

The companies claim that Eliquis “is no less safe than a daily aspirin.” The FDA approved Eliqius in December 2012. The Eliquis label carries a warning that the medication “can cause serious, potentially fatal bleeding,” that there “is no established way to reverse the anticoagulant effect of apixaban,” and that “[a] specific antidote for Eliquis is not available.”

The first lawsuit was filed August 4, 2015, and plaintiff’s counsel have promised they intend to file many more cases.

For example, the complaint in Charlie Utts and Ciara Utts  v. Bristol-Myers Squibb Company and Pfizer Inc.Case 1:16-cv-05668-DLC (S.D.N.Y) alleges that the companies:

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

The companies requested the MDL be set in New York because their headquarters, witnesses and documents are there. Almost half of the lawsuits have been filed in New York. The JPMDL has centralized product liability litigation for other anticoagulants including Pradaxa and Xarelto. The Pradaxa litigation culminated in 2014, while the Xarelto MDL has been ongoing for nearly two years.

Attorneys Loren H. Brown of New York and Matthew A. Holian of Boston, both with DLA Piper, filed the motion.

 

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Pharma and Med Device Companies Pay Doctors $2 Billion for “Consulting”

bribe doctor kickbackEven though it is illegal to pay kickbacks to doctors, pharmaceutical and medical device companies are paying $2 billion in general payments to 618,000 physicians each year, in addition to another $600 million a year to teaching hospitals, according to a ProPublica database.

General payments cover promotional speaking, consulting, meals, travel, gifts and royalties, but not research, as shown in its Dollars for Docs database.

The 10 drugs for which companies spent the most in payments to physicians in 2015 — many of which are targets of mass tort litigation —  were:

  1. Blood thinner Xarelto ($28.4 million).  In Re: Xarelto Products Liability Litigation in Philadelphia, hundreds of plaintiffs charge that the blood-thinning drug caused gastrointestinal bleeding, hemorrhagic strokes or death.
  2. Rheumatoid arthritis drug Humira ($24.9 million)
  3. Diabetes drug Invokana ($20.9 million). The Judicial Panel for Multidistrict Litigation (JPMDL) has created new MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in New Jersey.
  4. Hepatitis C drug Viekira ($19.2 million)
  5. Blood thinner Eliquis ($18.8 million). Bristol-Meyers Squibb Company and Pfizer Inc. have filed a motion to create new MDL No. 2757 in New York to hear Eliquis (Apixaban) products liability litigation.
  6. Diabetes drug Bydureon ($18.5 million)
  7. Testosterone drug Androgel ($15.3 million). US District Judge Matthew F. Kennelly has set June 5, 2017, for the start of first of six AbbVie bellwether trials in MDL 2545, in the Testosterone Replacement Therapy Products Liability Litigation in the Northern District of Illinois.
  8. Thyroid drug Synthroid ($14.7 million)
  9. Synthetic hormone Lupron ($14.3 million)
  10. Diabetes drug Victoza ($11.9 million).

“We’ve shown that physicians who receive payments from the industry tend to prescribe more brand-name drugs than those who don’t. Several academic studies later had similar findings. We also recently reported that companies continue to work with thousands of doctors who have received disciplinary sanctions against their licenses,” ProPublica states.

The disclosures included in Dollars for Docs were required under the Physician Payments Sunshine Act, a part of the 2010 Affordable Care Act.

For example, Janssen has paid $106 million to 141,294 doctors in connection with Xarelto, Invokana, Risperdal and many other drugs. From August 2013 to December 2015, Janssen paid:

Richard Aguilar
Internal Medicine
Huntington, CA
$345K
Gregory Mitchell
Specialist
Annapolis, MD
$290K
Bruce Bode
Endocrinology, Diabetes & Metabolism
Atlanta, GA
$286K

 

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

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

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

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

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

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

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

Bogus Aristotle Study

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

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

According to the complaint, the companies:

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

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