The Mass Tort Unit of Searcy Denney Scarola Barnhart & Shipley, led by veteran pharmaceutical and medical device lawyers Brenda Fulmer and C. Calvin Warriner, III, recently filed several more lawsuits against the manufacturers of Xarelto. The law firm has filed dozens of personal injury and wrongful death lawsuits against Bayer and Janssen Pharmaceuticals alleging that Xarelto is defective and has caused numerous serious and some fatal bleeding injuries to patients.
Searcy Denney Files Xarelto Lawsuits
One of the newly-filed lawsuits involves a Dade County, Florida resident who began taking Xarelto after being diagnosed with atrial fibrillation after failing aspirin therapy. The patient was placed on Xarelto in 2014. One of the allegations in the national Xarelto litigation effort is that prescribing doctors should have been warned by Xarelto’s manufacturers that this particular blood thinner should not be considered as first-line therapy in light of the reported increased incidence of bleeding injuries, the lack of an antidote to reverse the anti-clotting effects of Xarelto (which is available for Coumadin and Pradaxa), and the inability to determine which patients might be particularly susceptible to a bleeding episode while on Xarelto. This patient developed an acute upper GI bleed, the most common injury associated with Xarelto, after taking the drug for about a year. The patient developed significant hematuria (blood in urine), severe abdominal pain, and coffee-ground stool (a classic sign of bleeding in the gastrointestinal tract). The patient developed severe anemia which led to respiratory failure and significant abdominal bleeding which caused the bladder to rupture.
Searcy Denney’s pharmaceutical lawyers also filed a recent lawsuit on behalf of a Delray Beach, Florida patient who developed a GI bleed and bleeding in his brain after taking Xarelto for three years. This patient was prescribed Xarelto in 2012, shortly after this drug was approved by the FDA. At the time, there was a lot of hype over Xarelto and its ease of use over Coumadin, which requires regular blood monitoring of INR levels and dietary and medication restrictions. Patients were assured that Xarelto had the same safety profile as Coumadin, yet it would be easier to use and be less of a hassle, which was very compelling to young patients with busy lives. Unfortunately, since then, Xarelto has become one of the drugs with the highest number of adverse events reported to the FDA. In the pending Xarelto MDL litigation, the plaintiffs contend that Xarelto patients face a far greater risk of developing bleeding injuries than patients who ingest Coumadin and that representations in Xarelto’s warning label and marketing materials to the contrary were false.
The third recent lawsuit filing by our Mass Tort Unit involves a wrongful death claim on behalf of the surviving family members of a Pompano, Florida man who died in Broward County earlier this year due to an intracranial hemorrhage after ingesting Xarelto for a few months. Prior to starting Xarelto in 2016, the patient had taken Plavix and aspirin for several years for his atrial fibrillation. The primary use of Xarelto is in patients with this common heart arrhythmia who are at risk of developing blood clots and ischemic strokes from pooling of blood in the heart. Anticoagulant drugs (like Coumadin, warfarin, Xarelto, Pradaxa, and Eliquis) thin the blood and make patients less likely to develop blood clot-related injuries, including ischemic strokes where a clot blocks blood flow in the brain. Xarelto, however, has a propensity to cause hemorrhagic strokes, where there is bleeding in the brain (rather than a blockage).
Xarelto Lawsuits Consolidated into MDL
These individual lawsuits will become a part of MDL No. 2592, which are coordinated legal proceedings for Xarelto pending in New Orleans. Currently, there are more 18,000 individual lawsuits pending in these multi-district litigation proceedings. These cases include both personal injury and wrongful death claims, and most involve allegations that use of Xarelto led to the development of bleeding injuries in the GI tract or brain. Bleeding injuries have been reported after just a single dose of Xarelto. Judge Eldon Fallon is presiding over the national litigation and has extensive experience with supervising complex pharmaceutical cases. There are also nearly 1,500 cases pending in state court in Pennsylvania.
The third bellwether trial against Janssen Pharmaceuticals (a division of Johnson & Johnson) and Bayer Corporation began on August 7, 2017, at a federal courthouse in the Southern District of Mississippi in Jackson. This case involves Dora Mingo, a 69-year-old retired schoolteacher from Summit, Mississippi who developed deep vein thrombosis (a “DVT”) in January of 2015, after undergoing hip implant surgery earlier that month. She developed by the DVT while she was on the blood thinner Lovenox following her hip surgery, so a hospital doctor prescribed Xarelto 15 mg to be taken twice a day for 21 days and then a 20-mg dose to be taken daily after that. After taking Xarelto for only a few weeks, Ms. Mingo’s blood work showed significant abnormalities in her hemoglobin and hematocrit levels, and she was instructed to go to the ER immediately. At the hospital, she was diagnosed with severe anemia and testing showed that she had an acute upper GI bleed for which she received blood transfusions and underwent a procedure to clip a bleeding ulcer. She was hospitalized for two days for the Xarelto-induced bleed and associated anemia.
The Xarelto defendants sought to dismiss her lawsuit and prevent the jury trial from proceeding in July and contended that Ms. Mingo was unable to prove that Xarelto was defective under Mississippi’s product liability law which requires that the plaintiff prove that the product was unreasonably dangerous to consumer and that she was injured by the drug. Further, Bayer and Janssen contended that Ms. Mingo’s case should be dismissed as they do not believe that she can fulfill her burden to prove that the Xarelto that she ingested failed to function as expected and that there was a feasible alternative medication available that she could have taken and avoided the risk of developing the upper GI bleed and anemia. In the Xarelto MDL litigation, the plaintiffs contend that there are safer alternative blood thinners available, including Coumadin or warfarin (which have been prescribed for decades) as well as other modern blood thinners, including Eliquis (which has a different dosing regimen) and Pradaxa (which reportedly now has an antidote available). The plaintiffs have also argued that manufacturers should warn that patients be given a blood test (known as an anti-Factor Xa assay, which is being used in Europe to identify high-risk patients) prior to use of the newer blood thinners to confirm that the patient will tolerate the drug.
The biggest challenge in meeting the plaintiff’s burden of proof is that the FDA has not determined that Xarelto is unreasonably dangerous (and, in fact, has promoted the safety of the drug). The plaintiff also has a burden in proving that the risk of a GI bleed is higher with Xarelto than with the other blood thinners, as the studies on this issue are conflicting and all blood thinners can cause GI bleeding events. The FDA originally approved Xarelto (also known as rivaroxaban) in 2011 for blood clot and stroke prevention in patients with atrial fibrillation and those who have undergone orthopedic surgeries.
Request for Summary Judgment from Defendants Denied
On July 21, 2017, Judge Fallon denied the defendants’ request for a summary judgment dismissing the lawsuit under Mississippi’s product liability statute, finding that there were disputed fact issues that prevented the claims from being dismissed prior to trial. It is likely that these same issues will be raised during the course of the trial after evidence and testimony on the existence of a product defect is presented to the Mississippi federal court jury. Additional motions to dismiss the case on the basis of federal court preemption and claims that federal law prevented Xarelto’s manufacturers from enhancing the safety warnings for the blood thinner have also been denied by the MDL judge. Judge Fallon also considered and rejected motions from both parties to exclude their opponents’ expert opinions on the risks associated with other anti-coagulants, unapproved dosing and monitoring regimens, and whether Ms. Mingo’s injuries were caused by her short-term use of Xarelto.
Judge Fallon is expected to preside over a fourth Xarelto bellwether trial, the Henry case, in Texas federal court later this year. The first two MDL bellwether trials were tried before juries in New Orleans and both resulted in verdicts in favor of the drug’s manufacturers. Appeals are pending regarding these trial losses by the plaintiffs.
The law firm of Searcy Denney, with offices in West Palm Beach and Tallahassee, represents more than 50 clients in their mass tort product liability lawsuits against the manufacturers of Xarelto. The firm has a dedicated Mass Tort Unit that focuses solely on drug and medical device claims. The timeframe for filing of lawsuit over a defective drug can be short, so please do not delay in contacting a lawyer if you or a loved one have suffered a gastrointestinal bleed, bleeding in the brain, or other injury associated with the use of Xarelto.
Almost half a million pacemakers implanted in patients with heart disease have been recalled because of a scary and shocking scenario: The life-saving devices could be tampered with remotely by computer hackers – pacemaker hacking is becoming a possibility.
The U.S. Food and Drug Administration released a safety alert in August of 2017 about potential pacemaker hacking, stating the potential for personal harm. The safety alert, titled “Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication – Firmware Update to Address Cybersecurity Vulnerabilities,” immediately grabbed headlines.
Pacemaker Hacking Fears Stoked by FDA
“White hat hackers have previously pointed out the risks with connected medical devices,” according to an article in Fortune titled “465,000 Pacemakers Recalled on Hacking Fears.” “In its announcement, the FDA noted that this vulnerability could allow third parties to rapidly drain the pacemaker’s battery or adjust the operation of the device.”
Josh Corman, director of the Atlantic Council’s Cyber Statecraft Initiative, which focuses on the public impact of cybersecurity vulnerabilities, said the threats involving such medical devices are real.
“Corman says people should not have a crisis of confidence that imperils future medical breakthroughs, despite the reality that nothing is unhackable,” CNN Money reports in an article titled “Over half a million hackable pacemakers can now be fixed.” “Instead, he says, it’s important to determine what connectivity is actually needed, and balance it with acceptable risks.”
The fix actually is easy and takes no more than three minutes, although it will require everyone affected to make an appointment with his or her doctor. The corrective action is a firmware update.
“The FDA and Abbott do NOT recommend prophylactic removal and replacement of affected devices,” the FDA states in the safety alert. “Print or digitally store the programmed device settings and the diagnostic data in case of loss during the update.
After the update, confirm that the device maintains its functionality, is not in backup mode, and that the programmed parameters have not changed.”
The FDA stated that no injuries have been reported yet but made clear the danger of that happening in the future.
“Many medical devices – including St. Jude Medical’s implantable cardiac pacemakers – contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits,” the safety alert states. “As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.”
Pacemaker Hacking Scenarios Explained
The scary and shocking scenario might play out like this: A computer hacker gains access to an implanted pacemaker and changes its programmed data, resulting in improper pacing – making the heart beat too fast or too slow – depleting the battery in the process. While the FDA’s safety alert is limited to pacemakers, there is no reason bad actors are unable to gain access to other devices connected to the Internet. The firmware of these devices forms the basis of their operating systems.
Included in the recall list are the Accent DR RF, Accent MRI, Accent SR RF, Allure Quadra RF, Allure RF, Anthem RF, Assurity, Assurity MRI and Quadra Allure MP RF.
“All industries need to be constantly vigilant against unauthorized access,” Robert Ford, Abbott’s executive vice president of medical devices, said in a press release titled “Abbott Issues New Updates for Implanted Cardiac Devices.” “This isn’t a static process, which is why we’re working with others in the healthcare sector to ensure we’re proactively addressing common topics to further advance the security of devices and systems.”
The topic of hacking and health care is not a new one. In 2013, former Vice President Dick Cheney revealed on CBS’ 60 Minutes he disabled a feature on his defibrillator that enabled it to be connected to Wi-Fi out of fear of being assassinated by terrorists. Also in 2013, the FDA and the Industrial Control Systems Cyber Emergency Response Team, which works to reduce the risks surrounding 16 critical-infrastructure sectors in the United States, came out with dual studies not only on pacemakers and defibrillators but on drug-infusion pumps, patient monitors and ventilators, as well – all containing passwords. A blog later published the findings.
“Pacemaker programmers do not authenticate to pacemaker devices,” the blog, titled “Understanding Pacemaker Systems Cybersecurity,” states. “Any pacemaker programmer can reprogram any pacemaker from the same manufacturer. This shows one of the areas where patient care influenced cybersecurity posture.”
Patients and physicians are urged to contact Abbott’s customer hotline for technical support. The number is 800‐722‐3774 and patients can call with questions regarding the firmware update. They additionally are urged to report any adverse events via the FDA’s MedWatch Online Voluntary Reporting Form.
Medtronic, one of the world’s largest medical-device makers, already has been the focus of high-profile litigation that resulted in an $8.45 million settlement. The Dublin, Ireland, company whose operational headquarters are in Fridley, Minnesota, is now the focus of more high-profile litigation involving thousands of Medtronic Infuse cases that could result in $300 million in payouts.
All of the cases surround the Infuse Bone Graft product. Infuse Bone Graft, when used correctly, is surgically implanted in an area of the body where bone growth is lacking. It consists of a naturally occurring protein carried via a sponge, which releases the protein in stages so it can be absorbed properly.
“Using Infuse Bone Graft eliminates the need for a second surgery to harvest, or remove surgically, bone from your body (“autogenous” bone) for placement at the surgery site,” the Medtronic Web site states. “Autogenous bone harvest has the risk of pain, complications, longer surgical time, and more anesthesia.”
Problems with Medtronic Infuse Bone Graft Explained
Problem is, Infuse Bone Graft has not been used correctly, according to the plethora of plaintiffs who have suffered debilitating and permanent injuries as a result. In some cases, patients said they were unaware they were going to receive the product.
Medtronic’s Headquarters in Fridley, Minnesota. By Group29 – Own photo, CC BY-SA 3.0, Wikipedia.
“Many of the injured patients allege in their lawsuits that they found out about the use of Infuse only after their surgery ended with complications,” reports the StarTribune in an article titled “Medtronic says it’s close to resolving Infuse lawsuits.” “Some say Medtronic sales reps were present in the operating rooms during their surgeries.”
That allegation was the root of the problem in the first case, where two men being treated at the University of California Los Angeles said their doctors were getting kickbacks from Medtronic.
“Patients Ralph Weiss and Jerome Lew alleged that hundreds of thousands of dollars in Medtronic consulting, grants and royalty payments to UCLA surgeon Jeffrey Wang created conflicts of interest that led to risky treatments about which they were not informed,” the StarTribune reports in another article titled “Patients who received Medtronic’s Infuse product to get $8.45 million in settlements.” “They said they were not told that they were receiving Infuse or that it was being inserted into mechanical devices with which it had never been tested for safety.”
In addition to the sponge, there is another carrier for Infuse Bone Graft – the LT-Cage Device. Small, hollow and thimble-like, it is used for spinal fusion.
“Today there is a clinically studied, proven alternative to taking bone graft from the patient,” according to Medtronic. “A potential advantage to having spinal-fusion surgery using the Infuse Bone Graft and LT-Cage Device is that it removes the need to collect bone from your hip.”
Weiss and Lew both experienced extra spinal bone growth that led to nerve damage. Weiss had lumbar surgery, while Lew’s condition prompted Wang to insert the LT-Cage Device into Lew’s neck even though the U.S. Food & Drug Administration warned that could cause nerve damage.
“The following is a list of potential adverse events which may occur with oral maxillofacial surgery using the INFUSE® Bone Graft:” reads a document on the FDA’s Web site. “Some of these adverse events may have been previously reported in the adverse events table below or have been reported to the manufacturer.”
Off-Label Use of Medtronic Infuse Bone Graft Exacerbates Problems
“Ectopic and/or exuberant bone formation” is listed as a risk in addition to nerve damage. Other potential adverse events include allergic reaction, death, fetal-development complications, itching, scar formation, tissue damage and antibodies to certain types of collagen.
Such off-label use of a medical device is acceptable, according to the FDA. In response to the question of whether the FDA requires and Institutional Review Board to approve off-label use, the agency states, “No, when a physician uses a legally marketed device outside its labeling to treat a patient and no research is being done, IRB review is not required. Note: Although not required by FDA, an IRB may still decide on its own initiative to review such use.”
The $8.45 million settlement was split between Weiss and Lew. Their doctor, Jeffrey Wang, is believed to have received $300,000 in consulting fees, grants and royalties from Medtronic beginning in 2000, and at one point appeared as an endorser on the company’s Web site.
“Substantially all” of the thousands of other cases that stem from the product’s misuse have reached agreements, says Mark Reilly, managing editor of the Minneapolis / St. Paul Business Journal, in an article titled “Medtronic could soon settle thousands of Infuse lawsuits.”
Reilly notes that Medtronic will pay $22 million to 950 plaintiffs, already paid $85 million to settle a shareholder lawsuit and paid another $40 million to the U.S. Department of Justice.
“In all the settlements, Medtronic denied wrongdoing,” Reilly says.
In April of 2016, the Judicial Panel on Multidistrict Litigation, a panel who determines whether to coordinate federal court lawsuits into multidistrict litigation (MDL), centralized lawsuits involving men who developed melanoma after ingesting Viagra. This MDL was established in San Francisco federal court before Judge Seeborg and styled as In Re: Viagra (Sildenafil Citrate) Products Liability Litigation. Recently, Judge Seeborg expanded the MDL proceedings to include claims against Eli Lilly & Company, after patients who ingested Cialis (a drug similar to Viagra) also developed melanoma. To date, hundreds of individual personal injury and wrongful death lawsuits have been filed by patients alleging that Viagra and/or Cialis were defectively designed, inadequately tested, and improperly marketed, as the manufacturers did not properly inform the patients or their prescribing physicians that the use of the drug could cause or promote the growth of melanoma cancer cells.
The discovery efforts concerning both drugs are now moving on nearly-parallel tracks and are progressing smoothly, especially with Judge Seeborg’s recent rulings.
Judge Seeborg entered a scheduling order, which governs the progress of the case by setting certain deadlines for each of the parties involved. This specific order imposed a timetable requiring the parties to complete key parts of the general and scientific liability discovery by certain dates.
What Does Judge Seeborg’s Scheduling Order Mean for the Parties?
Both defendants have been producing documents relating to the development of the drugs, clinical studies before and after FDA approval, interactions with the FDA and other drug regulators, how the drugs were marketed, monitoring of safety issues, etc. Per Judge Seeborg’s order, the Plaintiffs Steering Committee is only allowed to conduct 14 depositions of key fact witnesses from the two international drug manufacturers. Considering the complexity of the case and the length of time that both Cialis and Viagra have been on the market, the permitted amount of depositions seems exceptionally low, but the plaintiffs are hopeful that Judge Seeborg will allow additional depositions in the future. Nonetheless, the depositions of Pfizer’s fact witnesses relating to Viagra must be completed by October 30, 2017 and Eli Lilly’s fact witness depositions must be completed by January 15, 2018.
The plaintiffs have also been limited to a total of 12 general causation experts – 6 for Viagra and 6 for Cialis. These experts are scientists who will be hired by the plaintiffs to provide expert witness opinions to substantiate the plaintiffs’ case and to satisfy the high thresholds required for admissibility of expert witness testimony in federal court. These experts will cover subjects including how the drugs cause cancer, whether the risks of melanoma are higher n patient who have ingested ED drugs, how much of an exposure to the ED drugs is required in order to cause an increased risk of melanoma, why the cancer link should have been discovered sooner by the manufacturers, whether the rugs were properly tested before being sold to patients, the adequacy of the drug manufacturers’’ systems to detect potential safety issues, and whether the drugs were ethically and honestly marketed by the Defendants. The plaintiffs’ experts must prepare and file their extensive reports by February of 2018. Thereafter, the experts will testify in depositions regarding their opinions. The Defendants’ experts will likewise be required to file their extensive reports by April 2, 2018, and the depositions of those experts must be completed by August 15, 2018.
The Daubert Challenge
Following the completion of the expert witness depositions, both sides will file briefs requesting the MDL judge to strike, or remove, expert witness testimony that they believe does not meet the rigorous standards required for admissibility at trial in federal court. The judge may decide to strike all, some, or none of the expert testimony. In making that determination, the MDL judge will focus on the methods used by the experts in arriving at their opinions. If the judge determines that the experts for both the plaintiffs and defendants have relied upon accepted scientific procedures, even if they have reached differing opinions, the testimony will be admissible and the responsibility of determining which testimony is most credible and reliable will be left for a jury to decide in future trials. This process is known as a Daubert challenge and must be completed by November 19, 2018.
Bellwether Trial Plan for Viagra & Cialis MDL
Judge Seeborg has also ordered the parties to present him with a bellwether trial plan, a plan for selecting the first Viagra and/or Cialis cases to be tried in the MDL, by May 1, 2018. Once Judge Seeborg selects the cases to be prepared for trial, case-specific depositions and expert witness discovery will be completed. These trial preparation efforts will be coordinated with the general liability and expert witness discovery discussed above. The purpose of the bellwether trial process is to complete a trial or trials of individual cases that are representative of many of the cases that are pending in the MDL, such that the parties will receive feedback as to the value of the cases, the likelihood of prevailing, etc. In preparing the bellwether cases for trial, the MDL judge will make several rulings relating to legal issues and will also decide on the admissibility of evidence and case-specific expert witness testimony (which must also endure the Daubert challenge, similar to the generic expert witness testimony). In this part of a case, the judge will evaluate whether the plaintiff’s treating doctors and expert witnesses have properly followed scientific and medical methodology in determining that Cialis or Viagra were the legal cause of the plaintiff’s melanoma (as opposed to other causes).
Once the bellwether trial process is complete and Judge Seeborg is ready to dismantle the MDL, it is likely that he will remand each individual case back to its respective local federal court jurisdiction for trial settings. Since the first MDL trials will not occur until 2019, it is doubtful that the remaining cases will be set for trials until late 2019 or, more likely, 2020 and later.
But, for now, the judge and the parties will remain heavily focused on completing the generic liability discovery and the generic expert witness discovery, which must be completed prior to preparing for the first bellwether trials and potential trials in the future.
The FDA announced a recall of Zimmer Biomet’s SpF PLUS Mini and SpF XL IIb implantable spinal fusion stimulators. This is due to the high levels of potentially harmful chemicals that are potentially harmful to tissues and organs (cytotoxicity). The recall of the implantable device affects certain serial numbers that were manufactured between Oct. 11, 2016 and Jan. 18, 2017 and distributed between March 28, 2017 and April 6, 2017. This discovery was made during a routine monitoring procedure. The cytotoxicity can cause chronic infections, long-term hospitalization due to revision surgeries, paralysis, and death. On April 20th, Zimmer Biomet released an urgent Medical Device Removal notification to all of its customers to seek medical treatment to quarantine the devices.
Though not the same device, this is what a spinal fusion stimulator can look like.
Spinal Fusion Stimulator Failed Cytotoxicity Tests
“A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body,” said the FDA. “A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient.” The FDA has labelled this as a Class 1 recall which is the most serious classification of recall. This severity of classification is only reserved for products that could be linked to serious complications or death.
These devices are used during spinal fusion surgery. They increase the possibility of permanently connecting two or more bones of the spine together. They are implanted in patients backs and provide constant electrical stimulation to the surgical site. This assists in fusing the vertebrae bones.
Zimmer Biomet will apparently schedule a time for removal of the quarantined devices from medical facilities by one of their sales representatives. Surgeons who extract these devices should conduct normal clinical monitoring for 3-6 months postoperatively for implanted patients. Hopefully the spinal fusion simulators were recalled in time to avoid adverse health effects in patients. However, with 100,000 of these devices already implanted in patients, that may not be the case.