Supreme Court blocks bid to sue Merck over Fosamax bone fractures

dkfielding/iStock(WASHINGTON) — A unanimous Supreme Court has blocked, for now, a class-action lawsuit against pharmaceutical giant Merck over “atypical femoral fractures” caused by osteoporosis drug Fosamax.

More than 500 Fosamax users from 45 states contend the company failed to warn them or their doctors of the danger, despite early evidence suggesting the increase potential for spontaneous bone breaks without any previous stress.

Merck, which does not dispute the risk and has included a warning with prescriptions since 2010, argued it cannot be held liable for damages in state courts because the Food and Drug Administration in 2009 rejected a proposed warning to patients.

“When the FDA exercises this authority, it makes careful judgments about what warnings should appear on a drug’s label for the safety of consumers,” Justice Stephen Breyer writes in the court’s opinion.

“For that reason, we have previously held that ‘clear evidence’ that the FDA would not have approved a change to the drug’s label preempts a claim, grounded in state law, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug,” he wrote.

The case was returned to a lower court for further proceedings.

The justices clarified that it should be left to a judge, not a jury, to decide the preemption question in class-action drug-harm suits, as occurred in this case. But they left the door open for patients to challenge drug companies on the facts surrounding information provided to the FDA — up front — ahead of a labeling decision.

Patient advocates have said a decision siding with Merck in the case would embolden drug manufacturers to provide insufficient and misleading information to FDA, in effect insulating themselves from potential legal liability. “It’s the pharmaceutical company’s job to write the drug label,” said Medshadow’s Sue Robotti.

Manufacturers are required by law to inform patients of potential adverse reactions to their drugs as soon as reasonable evidence exists. But the FDA has ultimate authority to approve or reject the wording that appears on drug labels.

In a 2008 application to the FDA, Merck proposed revising the warning language for Fosamax, describing a heightened risk of “stress fractures.”

One year later, the FDA rejected that draft language, saying the warning was “not warranted and is not adequately supported by the available literature” and asked for revised language.

Merck said the FDA’s conclusion, based on available evidence at the time, means the company cannot be held liable for failing to warn consumers as required under state law because the federal government wouldn’t allow it.

On Monday, the Supreme Court agreed.

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Measles cases continue to climb but not as rapidly as before

SOURCE: Centers for Disease Control as of May 17, 2019. (ABC News)(NEW YORK) — The number of measles cases in the U.S. continues to climb but at a slightly slower rate than previous weeks.

The Centers for Disease Control and Prevention said there have been 880 cases in the U.S. since January.

The number of measles cases in 2019 has already blown past the reported cases in recent years.

In early May, there were 60 new cases in a week, and in late April, that number jumped to 78 cases in one week. There were 71 new cases the week before that.

The latest numbers through May 17 show that there was an increase of 41 cases from the prior report.

Oklahoma reported its first measles diagnosis, bringing the total to 24 states with reported cases.

The majority of the reported cases are in New York. New York City health officials say there have been a total of 498 confirmed cases in Brooklyn and Queens since the outbreak there began in September. There have been been 231 confirmed cases as of May 17 in New York’s Rockland County.

Washington state was home to a significant outbreak earlier in 2019 and there have been a total of 78 cases in the state this year.

In California, there have been 45 reported cases in four outbreaks.

The CDC said the majority of people who got measles were unvaccinated.

Measles was eliminated in the country in 2000 but the CDC notes that measles is still common in many parts of the world and travel is one reason why it has returned to the U.S.

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Paralyzed man completes 3,100-mile cross-country journey from California to Washington, DC

ABC News(WASHINGTON) — Janne Kouri, who was paralyzed in 2006, has accomplished what most able-bodied people will never do. He completed a 3,100-mile ride across the country, from California to Washington, D.C.

Kouri completed the ride to raise money and awareness for people living with paralysis. He used a specialized power chair and was surrounded by family and friends on his two-month journey.

One of those friends was ABC News correspondent Will Reeve, whose own father, the late Christopher Reeve, was paralyzed in a horse riding accident in 1995.

“People used to tell my dad, ‘You were meant for this to happen to you,'” Reeve recalled. “And he was like, ‘What do you mean? I had a life. I had plans and now they’ve completely changed.'”

When Reeve asked Kouri if he has found himself equipped to handle all he has been through, Kouri replied, “Definitely.”

“I knew it happened for a reason,” Kouri said of the 2006 accident that left him instantly paralyzed when he dove into a sandbar in the Pacific Ocean.

Kouri said his “reason” is NextStep Fitness, the Los Angeles-based non-profit organization he founded in 2008 to make rehabilitation and fitness available to individuals living with paralysis. Today there are seven NextStep Fitness gyms across the country and there are plans to expand.

“Insurance on average only covers 36 days of rehab for people, and then you’re sent home with access to nothing,” Kouri said.

NextStep is a member of the Christopher and Dana Reeve Foundation NeuroRecovery Network (NRN), a network of rehabilitation centers founded by Will Reeve’s late parents.

Kouri’s own commitment to exercise and physical therapy has brought him personal returns, too. In May 2009, Kouri took his first steps in three years with the assistance of a walker.

At the time of his accident, Kouri, a former star defensive tackle for Georgetown University’s football team, was told he would never walk again.

“What I love and miss and I’m so grateful in that moment is just how tall he is,” said Kouri’s wife, Susan, who was his girlfriend at the time of his accident. “I forget that most days and it’s just great to see him in that way, to see him standing and see him be as large in stature as he is in his heart.”

Kouri said his greatest physical milestone recently has been his ability to ride across the country. The ride raised over $350,000 for people living with paralysis.

He has another major goal planned for 2021, he told Reeve, but has not yet revealed the details.

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Whoopi Goldberg’s doctors reveal she had a 1 in 3 chance of dying during pneumonia battle

ABC(NEW YORK) — The View co-host Whoopi Goldberg was joined by her doctors, Dr. Jorge Rodriguez and Dr. Martin Greenberg, on Monday morning to share the story of how close she was to death’s door during her battle with double pneumonia and sepsis earlier this year.

Goldberg said that she had felt “sick for a while” since at least November 2018, and it “kept going” until Donald Trump’s State of the Union Address.

“This can’t be the only reason I’m feeling sick,” Goldberg said she thought to herself while watching the president on television.

Eventually Goldberg got on the phone with her primary physician, Dr. Jorge Rodriguez, who said he could “barely understand what she was saying” during their conversation, because her teeth were chattering from her uncontrollable shivering.

“She was gasping for air” prior to going to the hospital, Dr. Rodriguez said.

When Goldberg told her doctor she was unable to walk and wanted to go to sleep, Dr. Rodriguez knew “it sounded very serious,” he said.

“She couldn’t breathe,” the doctor said. “Her teeth were chattering, she was obviously in what we call rigors,” which he described as an episode of shaking chills.

Every episode of ABC’s award-winning talk show “The View” is now available as a podcast! Listen and subscribe for free on Apple Podcasts, Google Podcasts, TuneIn, Spotify, Stitcher or the ABC News app.

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Report: Timberwolves finalizing deal with interim coach Ryan Saunders

Sports News Report: Timberwolves finalizing deal with interim coach Ryan Saunders https://linewsradio.com/report-timberwolves-finalizing-deal-with-interim-coach-ryan-saunders/ http://abcnewsradioonline.com/sports-news/

Tar_Heel_Rob/iStock(NEW YORK) — It appears interim coach Ryan Saunders may be staying put with the Minnesota Timberwolves.

League sources tell ESPN Saunders is close to completing a multiyear deal, which could be finalized as early as Monday, to become the team’s head coach. ESPN reports Saunders, 32, is working on putting his staff together.

Saunders stepped in to lead Minnesota after the Timberwolves fired coach Tom Thibodeau in January.

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Posted On 20 May 2019
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