There have been a number of recent noteworthy developments in the national litigation involving Xarelto. Currently, there are approximately 5,000 individual lawsuits pending in state and federal courts against the manufacturers of Xarelto. The largest concentration of state court cases is in Philadelphia, where nearly 600 individual lawsuits are pending. The state court litigation involves primarily those plaintiffs who are unable to participate in the MDL proceedings due to a lack of diversity jurisdiction, as the plaintiff resides in the same state where the drug manufacturer has a legal presence. The lawsuits that have been filed include a number of US and foreign drug companies, including Janssen Research & Development, LLC; Johnson & Johnson Pharmaceutical Research and Development, LLC; Johnson & Johnson Company; Janssen Ortho, LLC; Janssen Pharmaceuticals, Inc.; Janssen Pharmaceutica, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Bayer Corporation; Bayer Healthcare AG; Bayer Pharma AG; Bayer Healthcare LLC: and Bayer Healthcare Pharmaceuticals Inc.
It is anticipated that hundreds of additional cases will be filed in the coming months, especially since Xarelto remains on the market and patients and their prescribing doctors are unaware of the mounting safety concerns over the drug. Xarelto was approved by the FDA on July 1, 2011, and quickly became a “blockbuster” drug with sales in excess of $2 billion in 2013. The drug also is noteworthy for its meteoric rise on the list of drugs with the most reported adverse events to the Food & Drug Administration.
Judge Fallon, the Louisiana federal court judge who oversees MDL No. 2592, held a hearing in New Orleans in the national coordinated proceedings on January 22, 2016. At this court hearing, the judge heard arguments from the lawyers for both sides on a number of issues relating to the production of corporate documents, depositions of employees involved in the development and marketing of Xarelto, and selection of individual cases for future trials in the MDL.
Some of these same issues have been the subject of numerous meetings and hearings late last year as well. In particular, the Defendants’ privilege logs and the documents that have been requested by the plaintiffs but not yet produced by the drug manufacturers due to claims of some legal protection such as attorney-client confidentiality or trade secrets have been the subject of many of these meetings and the parties await rulings from the judge.
There was a dispute between the parties over the plaintiffs’ efforts to obtain the personnel files with regard to employees who were involved in the development, marketing, and oversight of Xarelto. On January 26, 2016, the MDL judge issued an order denying the plaintiffs’ requests for wholesale production of personnel files, but ruled that the plaintiffs could raise the issue again on a case-by-case basis with a showing of how the relevancy of those records would outweigh any privacy concerns of the employee. The plaintiffs sought these files in hopes of showing motive and bias of the employees in, allegedly, rushing Xarelto to market as well as any misconduct with regard to the performance of their duties in connection with the design, production, and sale of Xarelto.
The first depositions in the national litigation began in late 2015. It is anticipated that dozens of depositions of the Defendants’ employees and third parties will continue over the next few months. Judge Fallon has been asked to rule on a number of issues relating to the upcoming depositions, including notice requirements, duration of questioning, use of multiple video cameras, use of translators, receipt of documents in advance of the depositions, and other issues that (if let unresolved) have, historically, impeded the discovery process.
Millions of pages of documents have also been produced with more documents expected to be produced in the coming weeks. The FDA’s records relating to Xarelto were subpoenaed in April of 2015, and that production began in the fall of 2015.
The ROCKET AF clinical trial (also known as the Rivaroxaban Once Daily Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation study) served as the basis for the FDA’s approval of Xarelto back in 2011. In this MDL, the plaintiffs have made allegations that irregularities in managing participants in the study and analyzing the data. Plaintiffs further argue that if the study had been properly conducted that it would have shown that Xarelto was actually less safe and had less efficacy than Coumadin (warfarin), and presumably, the FDA would have refused to approval the drug for sale in the United States (resulting in the avoidance of perhaps thousands of injuries and deaths to patients).
In the course of this litigation, the plaintiffs have learned that participants in the ROCKET AF study were issued a blood monitoring device known as an INRatio, manufactured by HemoSense), to measure how thin their blood was while taking warfarin. The monitoring device was recalled by the FDA in September of 2015, and there are now concerns that the patients in the study who were reported in the original study as being well-controlled on their warfarin doses may have actually had their true INR levels misreported. The effectiveness of warfarin in the study patients is highly relevant since it is the comparator drug for the patients who were taking Xarelto. If the patients were not in fact well-controlled on their warfarin doses, then the risks of bleeding events seen in the warfarin population in the study may be artificially high when compared to the same risks in study participants who were taking Xarelto.
According to the Defendants, researchers at Duke have reportedly reanalyzed the data from the original clinical trial following the INR device recall and have reached the same conclusions with regard to the safety and efficacy of Xarelto. Those results have not yet been published, and are part of the evidence sought by the plaintiffs from Duke and the Defendants in this litigation. Duke has also refused to produce the critical evidence thus far by arguing that production of the data re-analyses would infringe on pending proceedings before drug regulators in the European Union as well as Duke’s internal, peer-review process for scientific publications. A committee meeting of the European Medicines Agency (the equivalent of the FDA in the EU) regarding Xarelto and the reanalysis of ROCKET AF data is scheduled for January 25-28, 2016. Judge Fallon is expected to rule on these critical discovery issues in the coming weeks.
A motion has been filed by the Defendants requesting permission to have direct communications with the plaintiffs’ physicians. This ex parte contact is something that is opposed by the plaintiffs due to concerns about patient confidentiality and the potential for undue influence of the physicians. In most jurisdictions, Defendants are not permitted to speak directly with a plaintiff’s physician without either a court order, specific consent from the patient, or within the context of a deposition. It is expected that Judge Fallon will hear further argument on this very important issue at the hearing scheduled for February 23, 2016.
In the near future, Judge Fallon will release the list of the 40 cases that have been selected as a part of the first MDL bellwether trial pool. Of the 40 cases that will be selected for case-specific discovery and potential selection for the first trials in the MDL, 20 will be requested by the parties and 20 will be selected randomly by the judge. The cases selected must also involve fatal or non-fatal GI bleeds, rectal bleeds, or brain bleed (also known as a hemorrhagic stroke) and include plaintiffs from various age groups and indications for use of Xarelto (i.e., patients with atrial fibrillation who took the drug for stroke prevention versus patients who took Xarelto for prevention or treatment of a deep vein thrombosis or pulmonary emboli). Most of the plaintiffs will also be chosen from the states of Louisiana, Texas, and Mississippi. The trials are still expected to occur in February through March of 2017.
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There have been a number of recent noteworthy developments in the national litigation involving Xarelto. Currently, there are approximately 5,000 individual lawsuits pending in state and federal courts against the manufacturers of Xarelto. The largest concentration of state court cases is in Philadelphia, where nearly 600 individual lawsuits are pending. The state court litigation involves primarily those plaintiffs who are unable to participate in the MDL proceedings due to a lack of diversity jurisdiction, as the plaintiff resides in the same state where the drug manufacturer has a legal presence. The lawsuits that have been filed include a number of US and foreign drug companies, including Janssen Research & Development, LLC; Johnson & Johnson Pharmaceutical Research and Development, LLC; Johnson & Johnson Company; Janssen Ortho, LLC; Janssen Pharmaceuticals, Inc.; Janssen Pharmaceutica, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Bayer Corporation; Bayer Healthcare AG; Bayer Pharma AG; Bayer Healthcare LLC: and Bayer Healthcare Pharmaceuticals Inc.
It is anticipated that hundreds of additional cases will be filed in the coming months, especially since Xarelto remains on the market and patients and their prescribing doctors are unaware of the mounting safety concerns over the drug. Xarelto was approved by the FDA on July 1, 2011, and quickly became a “blockbuster” drug with sales in excess of $2 billion in 2013. The drug also is noteworthy for its meteoric rise on the list of drugs with the most reported adverse events to the Food & Drug Administration.
Judge Fallon, the Louisiana federal court judge who oversees MDL No. 2592, held a hearing in New Orleans in the national coordinated proceedings on January 22, 2016. At this court hearing, the judge heard arguments from the lawyers for both sides on a number of issues relating to the production of corporate documents, depositions of employees involved in the development and marketing of Xarelto, and selection of individual cases for future trials in the MDL.
Some of these same issues have been the subject of numerous meetings and hearings late last year as well. In particular, the Defendants’ privilege logs and the documents that have been requested by the plaintiffs but not yet produced by the drug manufacturers due to claims of some legal protection such as attorney-client confidentiality or trade secrets have been the subject of many of these meetings and the parties await rulings from the judge.
There was a dispute between the parties over the plaintiffs’ efforts to obtain the personnel files with regard to employees who were involved in the development, marketing, and oversight of Xarelto. On January 26, 2016, the MDL judge issued an order denying the plaintiffs’ requests for wholesale production of personnel files, but ruled that the plaintiffs could raise the issue again on a case-by-case basis with a showing of how the relevancy of those records would outweigh any privacy concerns of the employee. The plaintiffs sought these files in hopes of showing motive and bias of the employees in, allegedly, rushing Xarelto to market as well as any misconduct with regard to the performance of their duties in connection with the design, production, and sale of Xarelto.
The first depositions in the national litigation began in late 2015. It is anticipated that dozens of depositions of the Defendants’ employees and third parties will continue over the next few months. Judge Fallon has been asked to rule on a number of issues relating to the upcoming depositions, including notice requirements, duration of questioning, use of multiple video cameras, use of translators, receipt of documents in advance of the depositions, and other issues that (if let unresolved) have, historically, impeded the discovery process.
Millions of pages of documents have also been produced with more documents expected to be produced in the coming weeks. The FDA’s records relating to Xarelto were subpoenaed in April of 2015, and that production began in the fall of 2015.
The ROCKET AF clinical trial (also known as the Rivaroxaban Once Daily Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation study) served as the basis for the FDA’s approval of Xarelto back in 2011. In this MDL, the plaintiffs have made allegations that irregularities in managing participants in the study and analyzing the data. Plaintiffs further argue that if the study had been properly conducted that it would have shown that Xarelto was actually less safe and had less efficacy than Coumadin (warfarin), and presumably, the FDA would have refused to approval the drug for sale in the United States (resulting in the avoidance of perhaps thousands of injuries and deaths to patients).
In the course of this litigation, the plaintiffs have learned that participants in the ROCKET AF study were issued a blood monitoring device known as an INRatio, manufactured by HemoSense), to measure how thin their blood was while taking warfarin. The monitoring device was recalled by the FDA in September of 2015, and there are now concerns that the patients in the study who were reported in the original study as being well-controlled on their warfarin doses may have actually had their true INR levels misreported. The effectiveness of warfarin in the study patients is highly relevant since it is the comparator drug for the patients who were taking Xarelto. If the patients were not in fact well-controlled on their warfarin doses, then the risks of bleeding events seen in the warfarin population in the study may be artificially high when compared to the same risks in study participants who were taking Xarelto.
According to the Defendants, researchers at Duke have reportedly reanalyzed the data from the original clinical trial following the INR device recall and have reached the same conclusions with regard to the safety and efficacy of Xarelto. Those results have not yet been published, and are part of the evidence sought by the plaintiffs from Duke and the Defendants in this litigation. Duke has also refused to produce the critical evidence thus far by arguing that production of the data re-analyses would infringe on pending proceedings before drug regulators in the European Union as well as Duke’s internal, peer-review process for scientific publications. A committee meeting of the European Medicines Agency (the equivalent of the FDA in the EU) regarding Xarelto and the reanalysis of ROCKET AF data is scheduled for January 25-28, 2016. Judge Fallon is expected to rule on these critical discovery issues in the coming weeks.
A motion has been filed by the Defendants requesting permission to have direct communications with the plaintiffs’ physicians. This ex parte contact is something that is opposed by the plaintiffs due to concerns about patient confidentiality and the potential for undue influence of the physicians. In most jurisdictions, Defendants are not permitted to speak directly with a plaintiff’s physician without either a court order, specific consent from the patient, or within the context of a deposition. It is expected that Judge Fallon will hear further argument on this very important issue at the hearing scheduled for February 23, 2016.
In the near future, Judge Fallon will release the list of the 40 cases that have been selected as a part of the first MDL bellwether trial pool. Of the 40 cases that will be selected for case-specific discovery and potential selection for the first trials in the MDL, 20 will be requested by the parties and 20 will be selected randomly by the judge. The cases selected must also involve fatal or non-fatal GI bleeds, rectal bleeds, or brain bleed (also known as a hemorrhagic stroke) and include plaintiffs from various age groups and indications for use of Xarelto (i.e., patients with atrial fibrillation who took the drug for stroke prevention versus patients who took Xarelto for prevention or treatment of a deep vein thrombosis or pulmonary emboli). Most of the plaintiffs will also be chosen from the states of Louisiana, Texas, and Mississippi. The trials are still expected to occur in February through March of 2017.
