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.
The Chimney Hill chapter of the Daughters of the American Revolution held its March meeting recently at the Ada Arts and Heritage facility. Regent Myrtie Clarke and acting Chaplain Linda Hebert opened the meeting. The Pledge of Allegiance was led by Ruth Ann Taylor. Ruth Franks led The Star-Spangled Banner and was accompanied by Rita Floyd on the piano. Jean Kelley led the Oklahoma flag salute. The preamble to the U.S. Constitution was led by Carol Meyer, and the American Creed was led by Arletta Good. The president general s message was read by Myrtie Clarke. President General Ann Turner Dillon said one of her favorite issues of the year is the one dedicated to Women s History Month. She reported on several women who fostered the cause of women s rights. She also saluted the U.S. Mint, which is celebrating its 225th anniversary this year. She ended her message by wishing a happy spring to all.
The secretary s and treasurer s reports were e-mailed to members, and there are a few hard copies available at the meeting. A motion to accept the reports was made and seconded. The motion was approved. The registrar report was given by registrar Marian Paniague, who reported that there are three prospective members this month, which are Rena Scarbough, Binnie Wilson and Barbara Wilson. There was a member verified this month, Dana Hall Jordan, and there is also one name in review, Reta Boggs. The national defense report on the history of the U.S. Coast Guard was given by Carol Meyer. The Coast Guard is an amalgamation of five formally distinct federal services. On Aug. 7, 1789, the US Lighthouse Service was established under the control of the Treasury Department. On Aug. 4, 1790, Congress authorized the secretary of the Treasury, Alexander Hamilton, to create a maritime service to enforce custom laws and inspect vessels.
President Woodrow Wilson signed into law the Act to Create the Coast Guard on Jan. 28, 1915. By 1949 the Coast Guard was under the Navy Department, then the Treasury Department in 1946; then transferred to the newly formed Department of Transportation in 1967; then transferred to the newly created Department of Homeland Security on March 1, 2003. The Indian Minutes report from Mary Pfeffer detailed the Indian Youth of America (IYA), a non-profit charitable Indian service organization. It began in the summer of 1976 with an intertribal youth camp held on the Warm Springs Reservation in Oregon. IYA has branched out to serve Indian youth and families on both local and national levels through a number of programs and activities. IYA is dedicated to improving the quality of life for Native American children and serves these children through its resource center, scholarship assistance and sponsorship of students to leadership programs and sporting events, as well as the major focus on the Intertribal Summer Youth Camp Program. Camps are held in Arizona and South Dakota each summer, where campers experience a variety of cultural, educational, and recreational activities under the guidance of Indian counselors and staff. Special guests also share their songs, dances, stories, and cultural traditions. IYA was incorporated in 1978 and has its main office in Sioux City, Iowa. In the Conservation Minutes report, Janet Gibson reported on wildlife. She reported that some wild plants are wanted in our gardens and yards and some are not. She talked about redbud trees, holly bushes and butterfly plants, which are decorative and beneficial, but we do not like poison ivy and their family. She reminded us that it is time to plant the wanted varieties. She also talked about good wildlife, like rabbits and birds, but none of us want skunks in our yards and gardens.
The Veterans Report was given by Ruth Ann Taylor. Good news! We have raised enough money for two domino tables for the Sulphur Veteran Center. The tables will be ordered this week and should be at the center in about one month. The next visit to the center will be March 15th. The check for the tables will be presented to the center on this day. The programs section featured The Battle of Kings Mountain. Norma Reid from The Black Bead Chapter of DAR in Norman was the guest speaker. She has ties to Ada, being a graduate of Roff High School and East Central University, where she met her husband. She began by saying that Thomas Jefferson said the Battle of Kings Mountain changed the tide of the Revolutionary War. The Battle of Kings Mountain was between the patriot and the loyalist militias in South Carolina during the Southern campaign of the war. Kings Mountain is nine miles south of the present-day town of Kings Mountain, North Carolina. British Major Patrick Ferguson was ordered to raise a loyalist militia and protect the flank of Lord Cornwallis main force. The British gave the loyalists rifles and bayonets but not uniforms. Ferguson wrote a letter to patriot leader Isaac Shelby and other militia leaders to lay down their arms or he would lay waste to their country with fire and sword. In response the patriot leader Shelby, McDowell, and Campbell and others rallied an attack. Receiving intelligence on the upcoming attack Ferguson decided to stay on Kings Mountain. The battle began on Dec. 7, 1780, four and one half years into the war, and it lasted one hour. Patrick Ferguson rode his horse and blew a whistle for his men to attack the patriot forces coming up the mountain. He continued until he was shot and killed, after which his men surrendered. The loyalist forces had 225 men killed and 165 wounded while the patriot forces had 28 killed and 60 wounded. When the loyalist militia was destroyed, Cornwallis was forced to abandon his plan to invade North Carolina and retreated to South Carolina. In 1898, the Kings Mountain Chapter DAR launched a campaign to acquire the battlefield, and in 1931 Congress established The Kings Mountain National Military Park.
Ruth Ann Taylor the Kiamichi County district director has visited seven of the nine chapters in our district and plans on visiting the other two soon. She gave a program on Martha Washington to three of the chapters. She reported that at our district conference in April, we will be doing basket giveaways, and that Tammy Hinton of the McAlester chapter has taken care of our basket this year. Regent Myrtie Clarke thanked the chapter for their donation to the Oklahoma Heart Association. Elaina Bearden announced that the eighth-grade essay winner from our chapter won State. The sixth-grade and 10th grade essay writers won third at the state level, and the fifth grade essay writer placed fourth at state.
The door prize was won by Ruth Ann Taylor. Hostesses for the March meeting are Jean Kelley, Arletta Good, Erna Leach, Marian Paniagua and Linda Leach. Members present: Janet Barrett, Elaine Bearden, Tommie Beddow, Beth Buxton, Myrtie Clarke, Rita Floyd, Mary Ann Frame, Ruth Franks, Joyce Gentry, Janet Gibson, Sue Gonyon, Arletta Good, Linda Gebert, Lou Ann Hoover, Kathy Howry, Jean Kelley, Erna Leach, Ann Maxwell, Marian Paniaguia, Mary Pfeffer, Jerry Wages, and Elizabeth Witherow.
Guests are Norma Reid, Anita Renells and Binnie Wilson.
Kaspersky Lab has launched a new partner program in Africa, aimed at managed service providers (MSPs) that already offer security services or would like to add them to their current portfolio. According to the cybersecurity firm the program is designed to help MSP’s expand their client base, particularly within the SMB market and also satisfy the demand from customers looking to outsource IT functions including security. Riaan Badenhorst, Managing Director, Kaspersky Lab Africa says: “Kaspersky Lab’s MSP Program was created specifically to meet the needs of partners who want to grow their managed service offerings in cybersecurity without additional administrative overheads or resources. The program is based on the world’s most tested, most awarded multi-layered security solutions. It allows MSP partners to secure the complete customer infrastructure, from mobile devices and desktops to physical and virtual servers, with our comprehensive portfolio that can be delivered both on-premises or from the cloud.”
MSPs that sign up to the new program and meet specific criteria, are eligible for what the company calls “special privileges and benefits” including exclusive access to volume based pricing with a separate MSP price list, monthly licensing, as well as product and security training and certification, among others.
MSP looking to engage the program must be a provider of managed services, must purchase licenses from a distributor affiliated with Kaspersky Lab and must provide first line support to customers.
The company also states that managed service providers can choose between cloud and on-premise models.
Networks Unlimited supports non-profit organisation in the improvement of literacy and numeracy Published on 25 April 2017
Company says it is reorganising its commercial operations to accelerate growth, drive efficiency.
A new Kaspersky partner program for security services providers Published on 25 April 2017
Global cybersecurity firm says the offering will help MSPs meet demand for IT security services and attract new customers in SMB markets.
- ^ Networks Unlimited supports non-profit organisation in the improvement of literacy and numeracy (www.itwebafrica.com)
- ^ Airtel Nigeria appoints new VP for mobile money (www.itwebafrica.com)
- ^ A new Kaspersky partner program for security services providers (www.itwebafrica.com)