Joseph Boudreaux says taking Johnson & Johnson’s blood-thinning drug Xarelto was one of the biggest mistakes of his life. While Xarelto was supposed to help cut his stroke risk, Boudreaux says it instead caused internal bleeding that required a week-long hospital stay in the intensive-care unit, several blood transfusions and multiple heart procedures. “I don’t want anybody else to suffer like I have from that drug,” the part-time security guard says. Starting Monday, Boudreaux will get a chance to have jurors hold J&J and Bayer, which jointly developed Xarelto, responsible for the treatment’s potentially fatal side effects as his case in New Orleans becomes the first lawsuit targeting the medicine to go to trial.
The companies are facing more than 18,000 U.S. patient suits blaming the blood thinner for internal bleeding. The medicine also has been linked to at least 370 deaths, according to Food and Drug Administration reports. The drug is Bayer’s top-selling product, generating $3.24 billion in sales (3 billion euros) last year and $2.5 billion (2.3 billion euros) in 2015 for the Leverkusen, Germany based pharmaceutical company. Xarelto is J&J’s third-largest seller, bringing in $2.29 billion in 2016 as the New Brunswick, New Jersey, company seeks to replace revenue from its Remicade arthritis treatment, which lost patent protection a year ago. Boudreaux’s case is the first of four suits overseen by U.S. District Judge Eldon Fallon in New Orleans slated for trial over the next three months.
“The allegations made in the Xarelto lawsuits contradict years of data on the medicine and the FDA’s determination of its safety and efficacy,” said William Foster, a spokesman for J&J’s Janssen unit that sells the drug in the U.S.
Bayer officials contend that despite some patient complaints, Xarelto’s bleeding risks are fully outlined on the medicine’s warning label and well known by prescribing doctors. “Bayer stands behind the safety and efficacy of Xarelto, and will vigorously defend it,” spokeswoman Astrid Kranz said in an emailed statement. U.S. regulators approved Xarelto in 2011 to prevent blood clots in users undergoing knee and hip surgeries. The drug’s use has been extended to patients, such as Boudreaux, who suffer from irregular heartbeats and are at high risk of stroke. Xarelto belongs to a new class of drugs aimed at replacing Bristol-Myers Squibb Co.’s Coumadin, which has thinned patients’ blood since the 1960s. Other new thinners include Pradaxa made by Boehringer Ingelheim GmbH, a German company that paid $650 million in 2014 to settle thousands of suits claiming it hid the medicine’s bleeding risks.
J&J and Bayer are accused of falsely marketing Xarelto as more effective at preventing strokes than Coumadin and easier to use, because Xarelto patients didn’t need frequent tests to monitor blood-plasma levels. Lawyers for Boudreaux and other former Xarelto patients stress the drug has no antidote, so it puts some users at high risk for bleeding out if they suffer an injury. Coumadin’s blood-thinning effects can be stemmed.
“This trial is an important first step in gaining broader awareness of one of the most high-risk drug treatments in medicine today,” Andy Birchfield, one of Boudreaux’s lawyers, said in an email. J&J and Bayer officials should have warned consumers they could be tested to gauge their Xarelto bleed-out risk, patients’ attorneys claim. The companies “concealed their knowledge of Xarelto’s defects from physicians, the FDA, the public and the medical community,” Boudreaux’s lawyers said in the filing.
J&J and Bayer point to the FDA’s finding that Xarelto is “safe and effective” for patients seeking to avoid stroke-causing clots to buttress claims the drug doesn’t pose undue risks, according to court papers. The pharmaceutical makers also argue Boudreaux and other patients can’t prove doctors would have avoided prescribing the drug even if they’d had the kind of bleeding warnings sought by the plaintiffs, according to court filings. “Xarelto’s label is adequate as a matter of law,” the companies’ attorneys said. Boudreaux’s case serves as a bellwether to help decide the Xarelto claims’ strength, said David Logan, a mass-tort law professor at Roger Williams University in Rhode Island. Fallon will allow a number of such trials to see if jurors rule for patients and award damages, Williams said. “Once the results are in, the parties may feel more confident about whether to settle the remaining claims,” he said.
Xarelto cases filed in federal courts around the U.S. have been consolidated before Fallon while other suits are awaiting trials in state courts in Pennsylvania and Delaware. Fallon previously oversaw suits against Merck & Co. targeting its Vioxx painkiller that resulted in a $4.85 billion settlement.
“Judge Fallon has been through the process several times,” said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia. “He knows how to get suits to trial that will give the companies and plaintiffs a good feel for what these cases are worth.”
Bloomberg’s Della Hasselle contributed.
Health preparedness by state map April 2017. Source: Robert Wood Johnson Foundation
Vermont Business Magazine For the second year running, Vermont scored highest among the 50 states and District of Columbia in public health protection readiness, according to the new National Health Security Preparedness Index. The Index measures the nation’s ability to keep people safe and healthy in the event of epidemics, foodborne disease outbreaks, terrorism and other large-scale public health emergencies. Overall, Vermont scored 7.8 out of 10 points, compared to the national average of 6.8.
States were rated on 139 measures from multiple data sources. Vermont was rated higher than the national average in five of six index domains and matched the national average in the other. The index results are not intended for ranking states, according to the report, because states face varying threats and should apply common preparedness principles in locally relevant ways. The Index tracks the nation s progress in preparing for, responding to, and recovering from disasters, disease outbreaks and other emergencies that pose risks to health and well-being. Because health security is a responsibility shared by many different stakeholders in government and society, the Index combines measures from more than 50 sources and multiple perspectives to offer a broad view of preparedness. The Index is issued by the Robert Woods Johnson Foundation in cooperation with the Association of State and Territorial Health Officials (ASTHO). The report shows strengths and challenges over time in health surveillance, incident and information management, countermeasure management, community planning and engagement, surge management, and Emergency Medical Services.
“The Health Department is working every day to protect and promote the health of Vermonters. Our strength as a state has been our ongoing planning and readiness to respond to public health threats in coordination with communities and key partners,” said Health Commissioner Mark Levine, MD.
Vermont’s strengths include health surveillance and epidemiological investigations, incident management and multi-agency coordination, and its focus on health promotion for children and other at-risk populations. Vermont also scored well in medical management, distribution and dispensing of medications, which was a key element of last year’s statewide emergency response exercise, Operation Vigilant Guard. Vermont has been actively working on making gains in the area of volunteer management, where the state scored 3.3 compared to a national average of 3.9, the state’s OnCall for Vermont is reaching more Vermonters than ever in an effort to recruit people with medical and non-medical backgrounds to join a Medical Reserve Corps unit (MRC) or to become an EMS provider. One such MRC volunteer has just received national recognition for her service. Deborah Carlson of St. Albans, a volunteer with the Northwest Vermont MRC, is one of two individuals out of 200,000 to be selected as National Outstanding MRC Public Health Volunteer.
Health Security Surveillance
NATIONAL CONFIDENCE INTERVAL: 7.7 – 8.1
Community Planning & Engagement
NATIONAL CONFIDENCE INTERVAL: 5.4 – 6.1
Incident & Information Management
NATIONAL CONFIDENCE INTERVAL: 7.9 – 8.4
NATIONAL CONFIDENCE INTERVAL: 4.9 – 5.6
NATIONAL CONFIDENCE INTERVAL: 6.8 – 7.2
Environmental & Occupational Health
NATIONAL CONFIDENCE INTERVAL: 6.4 – 7.5
An annual assessment of the nation s day-to-day preparedness for managing community health emergencies improved slightly over the last year though deep regional inequities remain. The Robert Wood Johnson Foundation (RWJF) released the results of the 2017 National Health Security Preparedness Index, which found the United States scored a 6.8 on a 10-point scale for preparedness a 1.5 percent improvement over the last year, and a 6.3 percent improvement since the Index began four years ago. The Preparedness Index analyzes measures such as hazard planning in public schools, monitoring food and water safety, wireless 9-1-1 capabilities, flu vaccination rates, and numbers of paramedics and hospitals to calculate a composite score that provides the most comprehensive picture of health security and preparedness available.
Improving health security and preparedness is important for all communities across the country. In our highly mobile country, national emergency preparedness depends on having high levels of protection in every state, city, and region, said Alonzo Plough, PhD, MPH, chief science officer and a vice president at RWJF. These data highlight where strengths and gaps in preparedness lie, and can inform approaches to improve health security throughout America.
Despite improvements in nearly two-thirds of states, significant inequities in preparedness exist across the nation: a gap of 32 percent separates the highest state (Vermont, 7.8) and the lowest state (Alaska, 5.9). Generally, states in the Deep South and Mountain West regions many of which face elevated risks of disasters and contain disproportionate numbers of low-income residents lag behind Northeast and Pacific Coast states.
Equal protection remains an elusive goal in health security, as rural and low-resource regions have fewer and weaker protections in place, said Glen Mays, PhD, MPH, who leads a team of researchers at the University of Kentucky in developing the Index. Closing the gaps in preparedness among states and regions remains a national priority. Eighteen states achieved preparedness levels that significantly exceed the national average in 2016, and 20 states are significantly below the national average. A total of 33 states increased their overall preparedness levels between 2015 and 2016, while 14 remained level and four states declined.
Health security and preparedness have wide-ranging impact in our communities, said Stephen C. Redd, MD, RADM, director of the U.S. Centers for Disease Control and Prevention (CDC s) Office of Public Health Preparedness and Response. The Index can help us see where investments are producing returns, and where more work is needed to build public health emergency response capacity. Originally developed by the CDC as a tool to drive dialogue to improve health security and preparedness, the Index remains a collaborative effort involving more than 30 organizations. State health officials, emergency management experts, business leaders, nonprofits, researchers, and others help shape the Index each year through its National Advisory Committee and expert workgroups.
The National Health Security Preparedness Index has launched a Preparedness Innovator Challenge to collect and spread best practices for using the Index to improve preparedness. Through July 31, users will submit their stories about how they used Index findings as a tool to focus efforts and, ultimately, improve health security in their communities.
Based on a model informed by experts in public health, emergency management, government, academia, health care, and other sectors, researchers collect, aggregate, and measure preparedness data from more than 50 sources. The final measures fall into six categories, each of which is assessed independently, and cover topics such as:
About the Robert Wood Johnson Foundation
For more than 40 years the Robert Wood Johnson Foundation has worked to improve health and health care. The Foundation is working with others to build a national Culture of Health enabling everyone in America to live longer, healthier lives. For more information, visit www.rwjf.org. Follow the Foundation on Twitter at www.rwjf.org/twitter or on Facebook at www.rwjf.org/facebook.
Source: Department of Health 4.21.2017
Late former Chief Minister of Tamil Nadu, J Jayalalithaa