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J&J, Bayer accused of hiding Xarelto’s dangers, face 18000 patient lawsuits

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.

RELATED: TRENDING LIFE & STYLE NEWS THIS HOUR[1]

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[2] 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.

References

  1. ^ RELATED: TRENDING LIFE & STYLE NEWS THIS HOUR (www.chicagotribune.com)
  2. ^ Food and Drug Administration (www.chicagotribune.com)

Saving the Lives of Maritime Passageways: The Coast Guard and Maritime Chokepoints

NAFAC Week[1]

By Victoria Castleberry

The need for security of international maritime trade has never been greater as over 90 percent of internationally traded goods are transported via maritime shipping and 70 percent of maritime shipped goods are containerized cargo.1 Most trade vessels are funneled through one or more of six strategic chokepoints around the world: the Suez and Panama Canals, Strait of Malacca, Strait of Bab el-Mandeb, Strait of Gibraltar, and the Strait of Hormuz.2 Perhaps the most unique of these chokepoints is the Strait of Hormuz, and the presence of six 110 Coast Guard Cutters in its vicinity. Coast Guard presence provides what no other U.S. asset can to this hostile region: provide security without an escalation of arms and the facilitation of transnational cooperation through various interagency programs. Expanding this model of strategic deterrence by increasing the U.S. Coast Guard s presence internationally, the United States will be capable of protecting our most precious passages, promote international cooperation, and give the U.S. an advantage in determining how the international maritime waterways are governed.

According to the Energy Information Administration, the Strait of Hormuz exports approximately 20 percent of the global oil market and a total of 35 percent of all sea-based trade.3 With such a valuable resource transported through a small area, the necessity of security for this strait is clearly essential to the international market. Unfortunately, tensions within the region are rising and the risk of port closure, piracy, and military interference are all real possibilities that the global market may face when transporting through this region.4 In an effort to counter potential mishaps the United States has already utilized the Coast Guard to provide an authoritative yet non-threatening presence in the Persian Gulf that over time has proven effective.

Currently the Coast Guard spearheads several programs in Patrol Forces Southwest Asia (PATFORCESWA).5 Programs in the region specialize in the training of Coast Guards from around the world to bolster international maritime security cooperation. These programs help to support Article 43 of the United Nations Convention on the Law of the Sea (UNCLOS) agreement which requires user and bordering states to cooperate for the necessity of navigation and safety for vessels transiting.6 This specific call to duty for the user and bordering states by UNCLOS is a mission set specialized by the Coast Guard. The Coast Guard is currently operating in Freedom of Navigation Operations, escorting of military vessels, hosts an International Port Security Liaison Officer program, and possesses a Middle East Training Team responsible for conducting operations in conjunction with foreign militaries.7

As previously stated, the Coast Guard currently offers programs which work toward international cooperation for maritime security. Programs offered in the Persian Gulf include the International Port Security Liaison Officer (IPSLO) program and the Middle East Training Team (METT). These programs act as partnerships between the U.S. Coast Guard and foreign militaries to build up and sustain their own Coast Guards, as well as improve their own port security to facilitate trade between all nations.8 The IPSLO program allows for a sound foundation from which countries can build their own domestic maritime security system. This foundation is built through the education and enforcement of the international codes.9 Other programs such as the METT regularly participate in theater security cooperation engagements with foreign navies and coast guards throughout the region. These teams focus on teaching other coast guards and navies proper procedure for LE boarding and smuggling interception.10 These are the programs which need support to protect maritime chokepoints globally.

Lieutenant Jared Korn, USCG, was the Operations Officer aboard USCGC Adak, one of the six cutters deployed to PATFORCESWA. When asked about situations experienced while deployed within the Persian Gulf region, LT Korn described instances where Iranian vessels would approach the cutter and eventually depart. LT Korn to explained that in whole, the U.S. Coast Guard is an internationally recognizable symbol for aid, security, and is notably less threatening than a grey-hulled naval vessel within the Persian Gulf region.11

The presence of the U.S. Coast Guard in the Persian Gulf has been an effective tool in deterrence of hostiles within the region. This model can and should be applied to the other strategic chokepoints around the world. In 2014 the Panama Canal was faced with 44 reported piracy attacks, the Suez Canal is similarly plagued with piracy, off the coast of Somalia pirates have collected ransoms for over 10,000 dollars.12 Other strategic chokepoints such as the Strait of Gibraltar, Strait of Malacca, and Strait of Bab el-Mandeb would also benefit from the presence of the U.S. Coast Guard within their regions. Although these regions are not experiencing as severe of a threat to their maritime trade route imminently, prevention-based presence could avoid severe consequences of trade shutdown in these strategic chokepoints. The best way to do this is to grow the U.S. Coast Guard s patrol craft fleet internationally as well as the training programs which aid in the diplomatic relations and sovereignty of nations security.

Although the solution of expanding the Coast Guard s mission internationally is possible, it does have two potential obstacles. The first obstacle is public perception, the second, asset availability. Public perception of law enforcement today is already at an all-time low. By allowing our only armed service with law enforcement capabilities to shift its mission internationally the United States runs the risk of the American people s perceptions shifting as well.13 The positive perception by the American people of the Coast Guard is at risk of being diminished due to the perception of war-like actions by our domestic maritime law enforcement. More clearly, however, is the logistics. As the smallest branch of the armed services the U.S. Coast Guard accomplishes its mission set with just a fraction of the assets, personnel, and budget as her Department of Defense counterparts. Expanding the mission set of the Coast Guard will only spread these resources more thin without congressional budgetary aid to gradually build up international forces overseas.

The solution to the problem of securing strategic maritime passageways is a complex one. The solution cannot escalate tensions, must facilitate international cooperation, be non-intrusive, and help bolster nations forces. In many of the strategic chokepoints around the world, tensions run high. The necessity for diplomatic operations makes the Coast Guard the best choice to accomplish this mission. Expanding the United States Coast Guard s assets and programs internationally will allow for these requirements to be met and give the United States a strategic advantage in the control of international maritime security.

Victoria Castleberry is a student at the Coast Guard Academy. She is a junior who studies government and focuses on security studies. She is the varsity coxswain for the women s crew team. She participates in the cadet musical and was recently a dancer in the musical Footloose. She has 2 dogs named Ezekiel (Zeke) and McCain (Mac) and grew up in Northern Virginia. She will be stationed in Puerto Rico on the USCGC Richard Dixon this summer. She hopes to become a Deck Watch Officer and drive big white boats somewhere south of the Mason-Dixon Line and attend law school.

Bibliography

Allen, Craig, Jr. White Hulls Must Prepare for Grey Zone Challenges. U.S. Naval Institute, November 2016: 365.

Castonguay, James. International Shipping: Globalization in Crisis. Witness Magizine. n.d. http://www.visionproject.org/images/img_magazine/pdfs/international_shipping.pdf (accessed March 28, 2017).

Katzman, Kenneth, Neelesh Nerurkar, Ronald O Rourke, R. Chuck Mason, and Michael Ratner. Iran s Threat to the Strait of Hormuz. Congressional Research Service, 2012: 1-23.

Korn, LT Jared, interview by Victoria Castleberry. Operations Officer CGC Adak Interview (March 29, 2017).

Rodrigue, Jean-Paul. Stragetic Maritime Passages. The Geography of Transport Systems. n.d. https://people.hofstra.edu/geotrans/eng/ch1en/appl1en/table_chokepoints_challenges.htm (accessed March 27, 2017).

US Coast Guard. United States Coast Guard. December 12, 2016. https://www.uscg.mil/lantarea/PATFORSWA/ (accessed March 30, 2017).

. United States Coast Guard. December 21, 2016. https://www.uscg.mil/d14/feact/Maritime_Security.asp (accessed March 31, 2017).

Williams, Colonel Robin L. Somalia Piracy: Challenges and Solutions. Academic Reseach Project, Carlisle Barraks: United States Army War College, 2013.

1. Castonguay, James. International Shipping: Globalization in Crisis. Witness Magizine. n.d. http://www.visionproject.org/images/img_magazine/pdfs/international_shipping.pdf (accessed March 28, 2017).

2. Rodrigue, Jean-Paul. Stragetic Maritime Passages. The Geography of Transport Systems. n.d. https://people.hofstra.edu/geotrans/eng/ch1en/appl1en/table_chokepoints_challenges.htm (accessed March 27, 2017).

3. Katzman, Kenneth, Neelesh Nerurkar, Ronald O Rourke, R. Chuck Mason, and Michael Ratner. Iran s Threat to the Strait of Hormuz. Congressional Research Service, 2012: 1-23.

4. ibid.

5. US Coast Guard. United States Coast Guard. December 12, 2016. https://www.uscg.mil/lantarea/PATFORSWA/ (accessed March 30, 2017).

6. United Nations. United Nations Convention on the Law of the Sea, Part III Straits Used for International Navigation (n.d.).

7. US Coast Guard. United States Coast Guard. December 12, 2016. _______https://www.uscg.mil/lantarea/PATFORSWA/ (accessed March 30, 2017).

-United States Coast Guard. December 21, 2016. https://www.uscg.mil/d14/feact/Maritime_Security.asp (accessed March 31, 2017).

8. United States Coast Guard. Maritime Security

9. United States Coast Guard. Maritime Security

10. ibid.

11. ibid.

12. Williams, Colonel Robin L. Somalia Piracy: Challenges and Solutions. Academic Reseach Project, Carlisle Barraks: United States Army War College, 2013.

Featured Image: ASTORIA, Ore. Two Coast Guard 47-foot motor lifeboat crews comprised of members from smallboat stations throughout the Thirteenth District train in the surf at Umpqua River near Winchester Bay, Ore. (Coast Guard photo by Petty Officer First Class Shawn Eggert)

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References

  1. ^ NAFAC Week (cimsec.org)

Malcolm Turnbull wants to draw New Delhi into security relationship

Malcolm Turnbull has a lot of interesting friends. Among them is acclaimed Scottish author and historian William Dalrymple. The pair first met in Sydney several years ago and, most recently, caught up on Monday night in New Delhi for a post-dinner drink. Dalrymple, among his myriad achievements has written authoritatively on Afghanistan and India, and spends most of each year living on a little farm outside the Indian capital.

He and Turnbull caught up at the end of a long day for the PM that included a bilateral meeting and train ride with Indian Prime Minister Narendra Modi, and a meeting with Gautam Adani and his executives over the proposed giant coal mine for Queensland’s Galilee Basin[1].

Malcolm Turnbull Wants To Draw New Delhi Into Security Relationship

Malcolm Turnbull Wants To Draw New Delhi Into Security Relationship

David Rowe

Turnbull is very well read and has a fierce grasp of history, be it European, Middle Eastern or subcontinental. He and Dalrymple talked at length about the Raj and other matters historical, such as India’s period of non-alignment and the stop-start nature of the relationship with Australia in the decades after independence. Moreover, the Prime Minister sought the perspective of a man whose opinion he respects on the increasingly dynamic India today under Modi. It’s what prime ministers should do. Educate themselves as widely as possible.

Similarly, on Tuesday morning, before flying to Mumbai, Turnbull, away from the media, held a round-table discussion with four of India’s foremost foreign policy, political and security experts. These were Shiv Menon, a former Indian Foreign Ministry head, former national security adviser and now a Brookings Institution fellow. Also there was Dr Pratap Mehta, one of India’s foremost constitutional experts, policy analyst and commentators, Ashok Malik, a journalist and columnist, and Shyam Saran, former foreign secretary and diplomat.

Heavy engagement

While most of the pubic discourse this week concerned energy[2], trade[3] and education, ever present, both official and otherwise, was regional security and its twin challenges of China and North Korea. India, which Turnbull badged on the eve of his visit as alongside China, “a land of immense opportunity for Australia”[4], does not view herself as secondary to China. She aims to be at least as powerful, prosperous and influential, even more so.

Australia, understandably, spent much of the Howard government years building relations with China that enabled it to cash in on that country’s meteoric economic rise. At the same time, India, which is nowhere near advanced in its development, was overlooked. That changed under Kevin Rudd and his efforts were carried on by Julia Gillard, Tony Abbott and, now, Turnbull. Abbott reached high with plans for a Free Trade Agreement. Australia now seeks to engage heavily with India, both in economic and security terms. A comprehensive Free Trade Agreement will struggle to ever be realised because of various complexities with India’s economy, particularly its heavy levels of protection. But around this concerted efforts are being made in education, energy and services.

In recognition that a more imaginative approach was needed, Turnbull on Tuesday night in Mumbai commissioned an India Economic Strategy, headed by former ambassador to India and foreign affairs secretary Peter Varghese, to explore other ways to cash in on India’s rapid rise. Varghese, sources said, was never keen on the idea of an FTA with India if only because of the level of difficulty. As Turnbull pushes the engines to full steam ahead this week, he learned in his discussions that one challenge to overcome is old-school thinking. This is a belief among some in India that Canberra cannot escalate the relationship with Delhi without damaging it with another close partner China. As if it were some zero-sum game. Therefore, there is a level of suspicion about how strong the relationship with India can become and how serious Australia is.

That needs to be dealt with and Australia has the perfect template. John Howard listed as one of his three greatest achievements while in office the ability to elevate the relationships with Beijing and Washington at the same time. Turnbull needs New Delhi to know the relationship with India can also be lifted to the same dizzy heights without cost elsewhere. Regional security is a big part of the push. This week, Turnbull and Modi spoke of the need to uphold the rule of law in the region, which is standard code for ensuring China acts like a responsible international citizen and not a bully in the South China Sea. As India grows, her old enmity with Pakistan remains but her role is much bigger now than a longstanding feud with a neighbour.

Broadening bonds

India, alongside the US and Japan, becomes an increasingly important part of the regional jigsaw and Turnbull spent much of this week reinforcing the mutual interest of each nation in keeping peaceful a region Australia now refers to as the Indo-Pacific, not the Asia-Pacific.

“The strategic interests of our two nations are clearly converging,” Turnbull said in a speech to the National Defence College in New Delhi.

“Co-operation on regional stability sits squarely in the interests of both our nations. Our top five trading partners, for example, are all located in the Indo-Pacific and, like India we depend heavily on the oceans for our trade.

“Today more than ever, our economies rely on the maintenance of free and secure trade routes across the Indo-Pacific.

“One of the more significant regional challenges we face, of course, is competing maritime claims in the South China Sea.”

It is essentially advancing the quadrilateral security pact initiated by Japan in 2007 with the support of Australia and the US. At another speech on Sunday night, which was supposed to be about education, Turnbull said bonding over cricket, culture and food was fine but the relationship really needed to be taken to a new level. He said events over the past 20 years China’s rise had resulted in “a sea change in our interest in each other”.

“As India began to look east, Australia too was broadening its horizons, strategically and economically looking west as well as north and reframing our context as the Indo-Pacific rather than the Asia-Pacific.”

“As Prime Minister I am determined to broaden the bonds between our two great nations and establish the strong compact our relationship deserves. One in which Canberra and New Delhi are able to see eye to eye on the major issues confronting our region and the world.”

Given the rapidly moving events in the region, expect to hear more and more about our new friend to the north.

Phillip Coorey is The Australian Financial Review‘s chief political correspondent, and accompanied the Prime Minister’s delegation to India this week.

References

  1. ^ a meeting with Gautam Adani and his executives over the proposed giant coal mine for Queensland’s Galilee Basin (www.afr.com)
  2. ^ energy (www.afr.com)
  3. ^ trade (www.afr.com)
  4. ^ “a land of immense opportunity for Australia” (www.afr.com)
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