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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)

J&J, Bayer accused of hiding Xarelto’s dangers, face 18,000 patient …

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)

Tensions build before pipeline built in Massachusetts forest

SANDISFIELD, Mass. Amid drizzle and mist, the sound of nothing but toads and faint rippling water, the unmarked patrol cars pass slowly by, stop and watch, then move on until the next patrol comes. It continues like this on a gray morning as Tennessee Gas Pipeline Co. gets ready to start cutting trees here in Otis State Forest. Apart from one turkey, the only traffic this morning on Cold Spring Road is the host of Kinder Morgan s hired security to patrol the construction site for the company s 2-mile stretch of natural gas pipeline, part of its larger 13-mile Connecticut Expansion Project. Tennessee Gas is a subsidiary of Kinder Morgan.

The 24-inch pipes will go into a run next to two existing pipelines. But the corridor has to be expanded, and that involves cutting into state-owned forest protected by Article 97 of the Massachusetts Constitution, something the state fought before federal law forced it to give the company an easement. This and legal action by environmentalists delayed the project for about a year. But in mid-April the company got a green light when the Federal Energy Regulatory Commission issued it a notice to proceed with tree-cutting and construction, galvanizing the company s plans in a town with about 800 residents.

On April 19, however, U.S. Sens. Elizabeth Warren and Edward Markey of Massachusetts challenged FERC over the notice to proceed, saying the commission did not make the decision with necessary quorum, and it still has not officially heard important objections to the project raised by Sandisfield citizens in March 2016. Workers hired by Tennessee Gas are living at a home the company purchased next to a remote farm here, waiting for the signal to start work, said Sandisfield Select Board Chairwoman Alice Boyd. And Boyd said an even larger security plan is waiting in the wings. She said the town s fire and police chiefs have attended state meetings about how to manage public safety and emergencies related to the pipeline expansion. She said there are concerns about everything from protests to accidents.

Then the pipes add a new level of concern, she said. We ve had leaking pipes before. We are not set up to address this. It s very scary stuff.

Fire Chief Ralph Morrison told Boyd that Tennessee Gas has hired three Massachusetts State Police details for daylight hours and eight full-time security guards for around-the-clock coverage. The security patrols are nice enough when they ask why a reporter has pulled to the side of the road to take photographs; one said he was from Woburn, the other, from East Hartford, Conn. Just making sure there s no trouble, they both say. Sandisfield resident Susan Baxter is talking to one uniformed security officer who said he had stopped to use the portable toilet at Lower Spectacle Pond, which is across the road from one of the main pipeline access points.

Tennessee Gas is very nervous about protests here, Baxter said after he left. The only way for them to calm down is to communicate with them. (AP)

I live here I don t want anything bad to happen, she added. Baxter grew up in Sandisfield, moved away then came back. Baxter is an intervener, one of the residents holding the gas company s feet to the fire throughout the process, and one of those who requested that FERC rehear concerns ranging from environmental concerns to whether there is truly a demand for more natural gas.

My rights are being abused and I am unhappy, she said, noting that an existing pipeline built in the 1980s runs through her property and makes her nervous. The adjacent existing pipeline was installed in the 1950s.

These are two high pressure live pipelines, Baxter said. She said when the 1980s pipes were being installed, workers popped a hole in the other one, and the area had to be evacuated.

FERC allows interveners to object to a [pipeline approval] certificate, and this was not a legal notice to proceed, she said.

Stuart Burke pulls up and said he had come to fish for largemouth bass. The Westfield resident asks why so many signs and flags are marking the area. Baxter tells him about the pipeline, but said she won t say too much about what will happen at this pond.

I don t want to ruin your good time here, she adds. Burke appears stricken. I come here all the time to fish, he said. It s quiet here, and I m retired, so on a gray misty day I throw a line in the water. He said he doesn t mind the pipeline. But don t mess with this pond.

Tennessee Gas plans to draw water from what is considered a pristine pond to test the new pipes for leaks then release the water, where it will flow toward the Clam River. While the company has a number of conditions attached to local and state permits that require it to take care of these areas, residents and environmentalists are worried pipe chemicals will leach into wetlands and vernal pools. And Kathryn Eiseman of PipeLine Awareness Network said another concern is sending a large volume of warmed water into the cold water fisheries. Another unmarked patrol pulls up and parks near the pond. Inside are plain clothes officers. Soon a patrol with New Jersey plates drives slowly by.

This is way creepy, Baxter says of the unmarked patrols. They are very nice, but there s not a lot of communication, so citizens don t know what s going on.

Boyd said she was troubled by this, as well, and will ask Kinder Morgan if they will use marked security details. Kinder Morgan spokesman Richard Wheatley said he could not comment on this.

Because we take the safety of the public, our people and our assets very seriously, we do not comment on the specifics of our security efforts, he said in an email. Boyd has other worries, too.

A lot of people are coming here, she said of what will soon be an invasion of heavy equipment, cars and more security.

She s also worried about the town s roads and the town s budget. Tennessee Gas lawyers last year made a verbal agreement to give the town about $1 million for wear and tear to roads, and to reimburse the town s roughly $40,000 in legal fees it took to draft the agreement. After spending months negotiating in good faith the company never signed, she said.

Our town and townspeople are in a very susceptible position and our Select Board remains extremely concerned, she added.

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