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J&J, Bayer Accused of Hiding Blood-Thinning Drug’s Flaws

Joseph Boudreaux says taking Johnson & Johnson[1] s blood-thinning drug Xarelto was one of the biggest mistakes of his life. While Xarelto[2] 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. On Monday, Boudreaux urged a New Orleans jury to hold J&J and Bayer AG[3], which jointly developed Xarelto, responsible for the treatment s potentially fatal side effects, in 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[4], according to U.S. Food and Drug Administration reports.

Top Seller

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.

J&J, Bayer Accused Of Hiding Blood-Thinning Drug's Flaws

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 says that while there are 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.[5] s Coumadin, which has thinned patients blood since the 1960s. Other new thinners include Pradaxa made by Boehringer Ingelheim GmbH[6], a German company that paid $650 million[7] in 2014 to settle thousands of suits claiming it hid the medicine s bleeding risks.

No Antidote

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 blood tests. 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. J&J and Bayer officials should have warned consumers they could be tested to gauge their Xarelto bleed-out risk, patients attorneys claim. Financial concerns ruled out such disclosures, Brian Barr[8], one of Boudreaux s lawyers, told jurors in open statements Monday. The test that would identify people at high risk was inconsistent with the marketing plan they came up with, he said. The business plan came first.

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. They also say millions of users have taken the drug without suffering bleeding side effects. 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. The companies also dispute the validity of the safety test designed to gauge Xarelto users bleeding risks, saying in court filings that the test didn t provide useful information to doctors. We don t believe it s a safety test because it doesn t work with this particular drug,” Beth Wilkinson[9], a lawyer for both companies, said in opening statements Monday.

Bellwether Case

The most important business stories of the day. Get Bloomberg’s daily newsletter. Boudreaux s case serves as a bellwether to help decide the strength of the Xarelto claims, said David Logan, a mass-tort law professor at Roger Williams University[10] 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[11].

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.

The cases are Boudreaux v. Janssen, 14-cv-2720, U.S. District Court, Eastern District of Louisiana, and In RE Xarelto Products Liability Litigation, 14-MD-2592, U.S. District Court, Eastern District of Louisiana (New Orleans).

References

  1. ^ Company Overview (www.bloomberg.com)
  2. ^ Drug s Web Site (www.xarelto-us.com)
  3. ^ Company Overview (www.bloomberg.com)
  4. ^ Web Site With FDA Side-Effect Data (www.ismp.org)
  5. ^ Company Overview (www.bloomberg.com)
  6. ^ Company Overview (www.bloomberg.com)
  7. ^ Boehringer Pays $650 Million to Settle Blood-Thinner Suits (2) (www.bloomberg.com)
  8. ^ Lawyer s Web Site (www.levinlaw.com)
  9. ^ Lawyer s Web Site (wilkinsonwalsh.com)
  10. ^ Company Overview (www.bloomberg.com)
  11. ^ Merck to Pay $4.85 Billion to Resolve Vioxx Claims (Update4) (www.bloomberg.com)

Shepherd announces commencement speakers

SHEPHERDSTOWN, W.Va. Fred T. White, senior director of business development at ABS Consulting, will deliver the baccalaureate commencement address during Shepherd University s 144th Commencement on Saturday, May 6. He will be awarded an honorary Doctor of Business degree during the ceremony. Also honored during the baccalaureate commencement will be Shepherd alumnus Michael A. Smith, president of the Shepherd University Foundation, who will be awarded the President s Award for his service to the university.

Admission to the baccalaureate commencement ceremony, which begins at 1:50 p.m. in the Butcher Center arena, is by ticket only. Earlier in the day, Shepherd University alumnus Dr. John E. Adams, assistant vice president emeritus for student affairs, will deliver the graduate commencement address at the graduate ceremony at 11 a.m. in the Frank Center Theater. Adams will be awarded an honorary Doctor of Pedagogy degree during the ceremony. This marks the first year for a separate commencement ceremony for master s degree recipients.

Admission to the graduate ceremony is by ticket only. Baccalaureate Ceremony: 1:50 p.m., Butcher Center

White has been associated with ABS Consulting since 2009. The firm provides compliance services, optimization of asset performance, and advanced engineering support and management systems for a variety of sectors including marine; offshore; oil, gas and chemical; government; and power. Recent projects include work with the Department of Homeland Security, the U.S. Coast Guard, and Kingdom of Saudi Arabia.

Previously, White served as the vice president for business development at Universal Systems and Technology, working with Homeland Security, South Carolina chemical companies, South Carolina State Ports Authority and the Coast Guard. White received an M.S. in instructional technology from Florida State University and a B.S. in management from the U.S. Coast Guard Academy. During his career with the Coast Guard, he served as an anti-submarine warfare officer on the USCG Cutter Jarvis, among other posts.

He has received the U.S. Coast Guard Legion of Merit, U.S. Coast Guard Meritorious Service Medal (three times), U.S. Coast Guard Commendation Medal (three times), U.S. Coast Guard Achievement Medal, and U.S. Navy Achievement Medal. Smith is the vice president of Valley Proteins Inc., a family-owned business in Winchester, Va., founded by Smith s grandfather more than 60 years ago. The company s focus is on creating renewable resources for animal feed and contributing to a cleaner environment by developing clean-energy bio fuel. Smith earned a B.S. degree in business from Shepherd in 1989 and was a member of Tau Kappa Epsilon fraternity, serving as the group s fundraising chair.

Smith is the fifth president of the Shepherd University Foundation, a 501(c)(3) nonprofit organization incorporated in 1961 that serves as the fundraising arm of Shepherd University. Smith has endowed two funds with the Shepherd University Foundation in support of Shepherd University: the Gerald F. Smith Memorial Scholarship in honor of his father and the Edward L. Snyder Chair for Business honoring his grandfather. In July 2016, Smith supported Shepherd s efforts to create a School of Business by issuing a $250,000 challenge grant in support of revitalizing the business program, the first challenge grant at this financial level for Shepherd.

The challenge was met by donors, and more than $650,000 was raised for the project. Graduate Ceremony: 11 a.m., Frank Center Theater

Graduate ceremony speaker Dr. John E. Quincy Adams, a resident of Shepherdstown, began his career at Shepherd in 1971 with the position of residence director/admission counselor in Thacher Hall. Over the next 40 years, he assumed several titles including retention specialist, housing director, director of counseling and career services, director of Washington Gateway, assistant and associate dean of student affairs, assistant vice president for student affairs and dean of students, and interim vice president for student affairs.

In 2013, he finished his Shepherd career as a university professor. His accomplishments during his long career at Shepherd include creating the Career Development Center, acquiring a $570,000 cooperative education federal grant, implementing the Washington Gateway Program. He also served as team writer for the College Student Development and Administration curriculum and proposal.

In 2012, he received Shepherd s Distinguished Graduate Faculty Award.

Woman forced to strip by airport security and show surgery scars after dramatic transformation thanks to 17-stone …

passportly

Fionna Murray had seven operations to remove sagging skin after going from 26 stone to 13st in four years

A WOMAN who shed half her weight had to show passport inspectors surgery scars as they did not believe the photo was of her. Fionna Murray has had seven operations to remove sagging skin after going from 26 stone to 13st in four years.

Woman Forced To Strip By Airport Security And Show Surgery Scars After Dramatic Transformation Thanks To 17-stone ...

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Fionna Murray had to show passport inspectors surgery scars as they did not believe her passport photo was of her

After the latest op she was forced to strip from the waist up in a room at Izmir airport[1] in Turkey while trying to return home to Deptford, South East London. Fionna, 28, said: I felt violated and victimised.

I was distraught. It was an invasion of my personal space.

Woman Forced To Strip By Airport Security And Show Surgery Scars After Dramatic Transformation Thanks To 17-stone ...

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Fionna shed an astonishing amount of weight, going from 26 stone to 13st in just four years

I didn t know these people and I was just trying to go home.

They must have thought I was using a stolen passport[2].

I felt horrible. I felt like they were laughing at me.

Woman Forced To Strip By Airport Security And Show Surgery Scars After Dramatic Transformation Thanks To 17-stone ...

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Following the weight loss, Fionna Fionna Murray had to have seven operations to remove sagging skin

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Woman Forced To Strip By Airport Security And Show Surgery Scars After Dramatic Transformation Thanks To 17-stone ...

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After security refused to believe the passport picture, above, was her, Fionna said: I felt violated and victimised Woman Forced To Strip By Airport Security And Show Surgery Scars After Dramatic Transformation Thanks To 17-stone ...

News Group Newspapers Ltd

Fionna was forced to strip from the waist up in a room at Izmir airport in Turkey while trying to return home to Deptford

Fiona continued: I removed my top and they could see the bandages on my arms from the skin removal surgery.

They never apologised. In the end they just said, come on let s go, your flight is about to leave.

I felt like they dragged out a process and were abusing their power. The whole ordeal was so unnecessary.

Woman Forced To Strip By Airport Security And Show Surgery Scars After Dramatic Transformation Thanks To 17-stone ...

News Group Newspapers Ltd

Fionna added: My weight loss journey has seen me come a long way and these people were questioning me as a person

Fionna has used the 2013 passport twice before in Turkey as well as for holidays to the USA, Germany and Italy. Airport officials did not respond to requests for comment.

She added: My weight loss journey has seen me come a long way and these people were questioning me as a person.

I didn t think the passport picture looked too different from me facially.

References

  1. ^ airport (www.thesun.co.uk)
  2. ^ passport (www.thesun.co.uk)
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