Xarelto — National Drug Litigation
November has proven to be a very busy month for Searcy Denney and its Xarelto clients, with the firm filing several new individual lawsuits on behalf of its clients besides participating in the national discovery efforts. Here, I summarize the new complaints filed recently on behalf of injured or deceased Xarelto users and their loved ones:
- A wrongful death lawsuit was filed against the manufacturers of Xarelto on behalf of a Naples woman who died after suffering an intracranial hemorrhage caused by the anti-coagulant. The case is being prosecuted by her loving husband on behalf of her estate and survivors. Prior to use of Xarelto, she was an avid golfer and enjoyed an active retirement in Southwest Florida.
- A lawsuit for the premature death of an Orlando husband was filed on behalf of his surviving wife and adult children. This patient was prescribed Xarelto for stroke prevention with the promise that the drug would be easier to take than Coumadin. Unfortunately, the decedent suffered a catastrophic Xarelto-induced gastrointestinal bleed, which led to chest pain, kidney failure, elevated blood pressure, fluid in his lungs, respiratory failure, and uncontrolled bleeding.
- A personal injury lawsuit was initiated of a 71 year-old Boca Raton woman who suffered a GI bleed after ingesting Xarelto. This has been associated with the use of Xarelto. This plaintiff had to be hospitalized for anemia and active bleeding and required multiple blood transfusions due to her Xarelto-induced bleed.
- A wrongful death claim was filed on behalf of the survivors of a 67 year-old Stuart, Florida woman who died after Xarelto caused a subdural hematoma and extensive bleeding in her brain. This patient took Xarelto for slight more than a year for atrial flutter, which is where the heart does not beat normally and is the most common reason for the prescription of Xarelto and other drugs in the same class hoping to reduce a patient’s risk of potential stroke from the abnormal heart rhythm.
- A personal injury case was filed in the MDL in New Orleans on behalf of a 65 year-old retiree who resides in Melbourne, Florida. This plaintiff was prescribed Xarelto to prevent strokes in light of his previous diagnosis of atrial fibrillation. He only ingested Xarelto for about six weeks prior to suffering a catastrophic bleeding episode with associated kidney damage. Many of the clients injured by Xarelto have ingested the blood thinner for only a few days or weeks prior to the injury. This is a central issue in the Xarelto litigation, as the plaintiffs contend that the drug manufacturer should warn patients and prescribing physicians of the need for routine blood monitoring of patients before starting Xarelto and while on the drug to determine whether the patient metabolizes the drug consistently. There are many clients who cannot consistently process Xarelto, especially those with underlying kidney issues, such that they are either receive too little of the drug (so the drug is not adequately protecting them from having a stroke) or too much of the drug (which leads to GI bleeds, brain bleeds, and other life-threatening harms). The reality, however, is that no one would want to take Xarelto or other drugs in this class if frequent testing were required (which is counter to the primary selling point of this drug as a “no testing/no hassle” drug), especially because the effectiveness of Xarelto is equivalent to that of Coumadin, especially in light of the lack of an antidote for Xarelto and that the anti-coagulant effects of warfarin can be easily reversed. Much of the discovery that is ongoing at this point in time will focus on the drug manufacturers’ failure to provide adequate information about the need for ongoing patient monitoring and their decision to put profits before safety.
- A complaint for personal injuries was filed in MDL 2592 on behalf of a Tennessee woman who spent three weeks in the hospital following bleeding in her brain caused by Xarelto, and drug she had ingested for only six months. This individual lawsuit was also brought on behalf of her husband, to whom she has been married for over 50 years for his loss of support, consortium, companionship and other damages relating to his wife’s brain injury and resulting disability, memory loss, and inability to regain the active life she enjoyed prior to the Xarelto-induced left temporal lobe hematoma.
- A lawsuit was filed against Bayer, Janssens and other entities involved in the sale and development of Xarelto on behalf of a Jacksonville, Florida man who developed a GI bleed after taking Xarelto for less than a week. Xarelto had been prescribed for the prevention of a DVT following minor knee surgery, which is an FDA approved use of the drug. Because of his Xarelto-induced injury, he was hospitalized for several days in Central Florida and required blood transfusions to counter the anemia caused by the gastrointestinal bleed caused by rivaroxaban.
- A personal injury lawsuit was also filed on behalf of a Gainesville woman prescribed Xarelto to prevent a deep vein thrombosis. Again, as is common with Xarelto plaintiffs, she ingested the drug for only a few weeks before requiring hospitalization for bleeding in her stomach and gastrointestinal tract caused by Xarelto.
The national litigation over Xarelto continues to move at a rapid pace. On November 20, 2015, Judge Fallon, the federal judge based in New Orleans who oversees the national litigation, held his monthly status conference to discuss developments in the cases pending against the manufacturers of Xarelto, one of the most popular blood thinners on the market linked to an excessive number of patient injuries and deaths due to gastrointestinal bleeding, hemorrhagic strokes, intracranial bleeding, cardiac tamponade, and other life-threatening bleeding events.
Xarelto is also known as rivaroxaban, and is the second drug approved by the FDA in the class of drugs known as direct thrombin inhibitors and direct factor Xa inhibitors. Xarelto was developed by German pharmaceutical giant Bayer, and is jointly marketed in the United States with Janssen Pharmaceuticals, a division of Johnson & Johnson. Other drugs in this class include Pradaxa (which was the subject of a confidential settlement in 2014 resolving 4,000 individual lawsuits) and Eliquis (also known as apixaban and marketed by Bristol-Myers Squibb).
At the November hearing in the MDL No. 2592, Judge Fallon was informed there are now over 4,000 individual lawsuits pending in the consolidated federal court proceedings and various state court venues (with nearly 500 individual plaintiffs having sued in state court in Philadelphia, Pennsylvania). We anticipate that several thousand additional lawsuits will be filed in the coming months.
At this November hearing, Judge Fallon again reminded the lawyers and all plaintiffs with pending cases of the judge’s previous orders regarding preservation of evidence. In particular, Pretrial Order #1 requires all parties to preserve medical records, medical bills, letters, diaries, notes, internet searches, marketing materials, and several other paper and electronic documents and files relating to the use of Xarelto. The MDL judge also made further orders (Pretrial Order #15 and Pretrial Order #15B) regarding preservation of electronic evidence, including emails, text messages, voicemails, etc. The next status conference hearings before Judge Fallon are scheduled for December 21, 2015, and January 22, 2016.
At the November of 2015 hearing, Judge Fallon heard arguments from both the plaintiffs and the defendants regarding the plan for selecting the cases that might be included in the first bellwether trials in the MDL. The judge had stated in the past that the plaintiffs whose cases would be eligible to include in these first trials would hail from Louisiana, Mississippi, and Texas, which comprises only about 15% of the plaintiffs who have sued in the MDL proceedings so far. The judge also indicated that half of the cases in the bellwether trial pool would be selected randomly, a process vehemently opposed by the plaintiffs for fear that such a process would cause cases being tried that were not representative of the thousands of pending cases.
The goal of a bellwether trial process in MDL proceedings is to, hopefully, try individual cases that are similar enough to many other pending cases, such that the results will be helpful in predicting the outcome of several pending claims. The parties and Judge Fallon, however, noted that it is not uncommon in a bellwether trial selection process for both sides to want to choose the cases strongest for their side, which, also, may cause cases being tried that are not truly representative either. In particular, the Xarelto plaintiffs were seeking to change the selection process to include a broader range of potential claims that might be more representative of the injuries suffered by all plaintiffs who have cases pending in the MDL. Judge Fallon noted the plaintiffs’ concerns, and within a few hours of conclusion entered an order that represented a compromise that allows the plaintiffs to include a few additional plaintiffs hailing from other states but still retains the plan to select some of the bellwether trial cases randomly.
The first trial in the MDL proceedings is scheduled to begin in February of 2017, and Judge Fallon will preside over that jury trial. It is likely that approximately 40 individual cases will be prepared for this first trial, and that the ultimate case to go to trial will be selected by Judge Fallon in the latter half of 2016. Subsequent trials are scheduled to occur in March, April, and May of 2017. Judge Fallon has clarified that he intends to remand the cases he does not personally try back to local jurisdictions for individual trial settings once these four initial MDL jury trials are completed. The prospect of the remand and transfer of thousands of individual cases back to various jurisdictions around the country is more daunting for the Defendants than the Plaintiffs, and often leads to global settlements. There are no settlement negotiations at this time, nor would any be anticipated until much closer to trial when the strengths and weaknesses of the cases (for both plaintiffs and defendants) are known.
In mid-November, Brenda Fulmer of Searcy Denney had the pleasure of attending a meeting in St. Louis along with lawyers from across the country who are involved in the review of all of the documents that are being produced in the national litigation. So far, about 2.2 million pages of documents have been produced. These documents have been reviewed electronically using sophisticated linguistic software and targeted searches. I am now working with the other lawyers to review those documents that have been identified by the electronic search engines as being the most relevant to critical liability and scientific issues in the litigation. This 2.2 million pages of documents is only the first round of production, and it is likely that we will ultimately receive well in excess of 10 million documents between Janssens Pharmaceutica and Bayer, including a number of documents in foreign languages. We are hopeful to complete the review of all of the documents over the next few months, as depositions will begin in early 2016.
The Plaintiffs are also seeking the production of relevant documents from the Food & Drug Administration as well as Duke Clinical Research Institute, relating to the clinical studies on which the FDA approval of Xarelto was based. It is likely that the Plaintiffs will also conduct depositions of a number of third party witnesses with regard to liability and scientific issues that are pertinent to Xarelto. Some progress has been made with regard to obtaining this critical evidence from these third parties, but the production remains incomplete. Sadly, injured plaintiffs have historically had a very difficult time in obtaining evidence and testimony from the FDA, even in the face of allegations of fraud with regard to clinical trials and serious patient safety issues.
Additional Research Sources:
MDL web site – http://www.laed.uscourts.gov/xarelto/
MDL PTO #1 – http://www.laed.uscourts.gov/xarelto/orders/pto1.pdf
MDL PTO#15 – http://www.laed.uscourts.gov/xarelto/Orders/PTO15.pdf
MDL PTO #15B – http://www.laed.uscourts.gov/xarelto/Orders/PTO15B.pdf
FDA approval history of Xarelto on drugs.com – http://www.drugs.com/history/xarelto.html
What is a GI Bleed – https://www.nlm.nih.gov/medlineplus/ency/article/003133.htm
What is an intracranial hemorrhage – http://emedicine.medscape.com/article/1163977-overview