Supreme Court to review lawsuits over flaws in generic drugs












(Reuters) – The Supreme Court on Friday agreed to consider whether generic drug manufacturers can be subjected to personal injury lawsuits that allege flaws in the design of drugs, even if federal law would not allow such cases to go forward.


The court agreed to review a bid by Mutual Pharmaceutical Co to overturn a $ 21 million jury award to Karen Bartlett, a New Hampshire woman who had taken its generic non-steroidal anti-inflammatory drug sulindac for shoulder pain.












Bartlett was left with permanent near-blindness and burn-like lesions on two-thirds of her body after suffering a rare hypersensitivity reaction associated with the drug, and sued Mutual for alleged design defects under New Hampshire law.


Mutual, an indirect unit of Japan’s Takeda Pharmaceutical Co, countered that federal law barred such claims because its drug had already been approved by the U.S. Food and Drug Administration, and federal law requires generic drugs to have the same design as their brand-name equivalents.


It cited the Supreme Court‘s June 2011 decision in Pliva Inc v. Mensing that federal law preempted state law claims based on alleged inadequate label warnings about potential side effects, given that federal regulations require brand-name and generic drugs to carry the same labels.


But in May, a unanimous three-judge panel of the 1st U.S. Circuit Court of Appeals in Boston refused to extend this ruling to design defect claims, and upheld Bartlett’s award.


In its appeal to the Supreme Court, Mutual said “scores” of federal and state courts had rejected the 1st Circuit’s “remarkable claim” that generic drug manufacturers could be liable under state law for refusing to stop selling their federally approved products.


Bartlett countered that the Supreme Court should not take the case, saying that lower courts were not divided over the issue, and that her award was based on New Hampshire law and that did not conflict with federal law.


The Generic Pharmaceutical Association submitted a brief in support of Mutual’s appeal. A decision by the Supreme Court is expected by the end of June.


The case is Mutual Pharmaceutical Co v. Bartlett, U.S. Supreme Court, No. 12-142.


(Reporting By Jonathan Stempel; Editing by Kevin Drawbaugh and Tim Dobbyn)


Medications/Drugs News Headlines – Yahoo! News


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Pelosi will try to force vote to extend tax rates

House Minority Leader Nancy Pelosi (Mark Wilson/Getty Images)


WASHINGTON—House Minority Leader Nancy Pelosi will try to force a vote on the House floor to extend current tax rates for the middle class next week if Republicans do not act, the California Democrat announced on Friday.


During a press conference on Capitol Hill, Pelosi called on House Republicans, who control the chamber, to hold another floor vote on whether to extend current tax rates for individuals who earn $200,000 or less and families making $250,000 or less. If they don't, Pelosi vowed to file a "discharge petition" that would force a vote if 218 House members sign it, which is unlikely.


The bill Pelosi wants to see put to a vote is identical to a measure passed in the Democrat-controlled Senate in July that extends the rates for middle-income earners for one year. House Republicans responded by rejecting the bill and passing their own measure that extends current tax rates for all income brackets.


"We're calling upon the Republican leadership in the House to bring this legislation to the floor next week. We believe that not doing that would be holding middle-income tax cuts hostage to tax cuts for the rich. Tax cuts for the rich, which do not create jobs, just increase the deficit, keeping mountains of debt for generations," Pelosi said. "To that end ... if it is not scheduled, then on Tuesday we will introduce a discharge petition."


Discharge petitions, which allow individual members of Congress to put a bill to a vote without committee or leadership approval, are rarely successful. In this case, Pelosi would need Republican support. But when asked if any Republicans had signaled that they would sign a discharge petition to force a vote, Pelosi responded, "No."


Pelosi said she wanted the bill passed so Congress will have more time to negotiate broader tax reform in 2013.


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Lohan arrested in NY, charged also for California car smash












NEW YORK/LOS ANGELES (Reuters) – Actress Lindsay Lohan was arrested outside a New York nightclub on an assault charge early Thursday, police said, while in California, she was charged with reckless driving and lying to police over a car crash in June.


Lohan, 26, was arrested shortly after 4:00 a.m. (0900 GMT) on a third-degree misdemeanor assault charge after punching another woman in the face at a club in Manhattan’s Chelsea neighborhood, New York police said.












The charges in California were more serious, and could result in the “Mean Girls” actress having her probation revoked and being sent back to jail.


Lohan’s publicist and attorney did not return calls for comment on Thursday.


Lohan, who has been to rehab, jail and court numerous times since a 2007 arrest for drunk driving and cocaine possession, is currently on informal probation, following her January 2011 conviction for stealing a gold necklace from a California jewelry store.


A Los Angeles judge had lifted her formal probation in March but told her to comply with all laws and stay out of trouble.


Police in the beach city of Santa Monica said Lohan was formally charged on Thursday with reckless driving and lying to police after telling them she was not driving the Porsche that smashed into a truck on a busy highway. No one was seriously injured in the collision.


Lohan was also charged with obstructing an officer in his duty. A court date has not been set, Santa Monica police said in a statement.


In New York, Lohan was accused of punching a 28-year-old unidentified woman multiple times in the face, said New York Police Sergeant John Buthorn. The victim sustained “minor, minor injuries,” he said.


The actress was released from police custody later on Thursday morning.


The two incidents come during a rough week for the former child star, once one of the most promising young actresses in Hollywood.


Her most recent performance, as screen legend Elizabeth Taylor in the TV movie “Liz & Dick,” was panned by critics. Cable TV channel Lifetime said Monday that a modest 3.5 million Americans watched the film, which premiered last weekend.


Lohan’s recent visits to New York have been peppered with run-ins with police and public spats.


Last month, police were called to the Long Island home of Lohan’s mother, Dina Lohan, after a loud argument, though no arrests were made. In September, Lohan was arrested in Manhattan after a pedestrian told police her car had struck him in an alley, but charges were not filed.


(Reporting by Colleen Jenkins in New York and Jill Serjeant in Los Angeles; Editing by Xavier Briand and Bernadette Baum)


Celebrity News Headlines – Yahoo! News


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FDA approves Exelixis’ cabozantinib for thyroid cancer












WASHINGTON (Reuters) – The U.S. Food and Drug Administration on Thursday approved Exelixis Inc‘s cabozantinib as a treatment for medullary thyroid cancer that has spread to other parts of the body.


Cabozantinib, the company’s lead product candidate, is an oral drug designed to limit blood supply to tumors as well as block two segments of a pathway used by cancer cells to grow and spread.












The FDA announcement came shortly after the close of stock market trading in New York, where Exelixis shares eased slightly on the day at $ 5.24 per share.


The regulatory agency noted that cabozantinib is the second drug approved to treat medullary thyroid cancer in the past two years. The other drug, Caprelsa, is marketed by AstraZeneca Pharmaceuticals.


Medullary thyroid cancer, which is rare and difficult to treat, develops in cells that make a hormone called calcitonin, which helps maintain a healthy level of calcium in the blood. It can occur spontaneously or in families that are genetically prone.


The National Cancer Institute estimates that 56,460 Americans will be diagnosed with thyroid cancer and 1,780 will die from the disease in 2012. About 4 percent of thyroid cancers are medullary thyroid cancer.


The FDA completed its review of cabozantinib in six months under the agency’s priority review program.


San Francisco-based Exelixis is also studying the drug as a treatment for a number of different tumor types, including prostate cancer.


(Reporting by David Morgan; Editing by Gary Hill and Marguerita Choy)


Health News Headlines – Yahoo! News


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U.N. recognizes state of Palestine

UNITED NATIONS (AP) — The United Nations voted overwhelmingly Thursday to recognize a Palestinian state, a long-sought victory for the Palestinians but an embarrassing diplomatic defeat for the United States.

The resolution upgrading the Palestinians' status to a nonmember observer state at the United Nations was approved by a more than two-thirds majority of the 193-member world body — a vote of 138-9, with 41 abstentions.

A Palestinian flag was quickly unfurled on the floor of the General Assembly, behind the Palestinian delegation.

Real independence, however, remains an elusive dream until the Palestinians negotiate a peace deal with the Israelis, who warned that the General Assembly action will only delay a lasting solution. Israel still controls the West Bank, east Jerusalem and access to Gaza, and it accused the Palestinians of bypassing negotiations with the campaign to upgrade their U.N. status.

The United States immediately criticized the historic vote. "Today's unfortunate and counterproductive resolution places further obstacles in the path peace," U.N. Ambassador Susan Rice said.

Israeli Prime Minister Benjamin Netanyahu called the speech by Palestinian President Mahmoud Abbas to the General Assembly shortly before the vote "defamatory and venomous," saying it was "full of mendacious propaganda" against Israel.

Abbas had told the General Assembly that it was "being asked today to issue the birth certificate of Palestine." Abbas said the vote is the last chance to save the two-state solution.

After the vote, Netanyahu said the UN move violated past agreements between Israel and the Palestinians and that Israel would act accordingly, without elaborating what steps it might take.

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Rapper PSY wants Tom Cruise to go ‘Gangnam Style’












BANGKOK (AP) — The South Korean rapper behind YouTube’s most-viewed video ever has set what might be a “Mission: Impossible” for himself.


Asked which celebrity he would like to see go “Gangnam Style,” the singer PSY told The Associated Press: “Tom Cruise!”












Surrounded by screaming fans, he then chuckled at the idea of the American movie star doing his now famous horse-riding dance.


PSY’s comments Wednesday in Bangkok were his first public remarks since his viral smash video — with 838 million views — surpassed Justin Bieber‘s “Baby,” which until Saturday held the record with 803 million views.


“It’s amazing,” PSY told a news conference, saying he never set out to become an international star. “I made this video just for Korea, actually. And when I released this song — wow.”


The video has spawned hundreds of parodies and tribute videos and earned him a spotlight alongside a variety of superstars.


Earlier this month, Madonna invited PSY onstage and they danced to his song at one of her New York City concerts. MC Hammer introduced the Korean star at the American Music Awards as, “My Homeboy PSY!”


Even President Barack Obama is talking about him. Asked on Election Day if he could do the dance, Obama replied: “I think I can do that move,” but then concluded he might “do it privately for Michelle,” the first lady.


PSY was in Thailand to give a free concert Wednesday night organized as a tribute to the country’s revered King Bhumibol Adulyadej, who turns 85 next month. He paid respects to the king at a Bangkok shopping mall, signing his name in an autograph book placed beside a giant poster of the king. He then gave an outdoor press conference, as screaming fans nearby performed the pop star’s dance.


Determined not to be a one-hit wonder, PSY said he plans to release a worldwide album in March with dance moves that he thinks his international fans will like.


“I think I have plenty of dance moves left,” he said, in his trademark sunglasses and dark suit. “But I’m really concerned about the (next) music video.”


“How can I beat ‘Gangnam Style’?” he asked, smiling. “How can I beat 850 million views?”


___


Associated Press writer Thanyarat Doksone contributed to this report.


Asia News Headlines – Yahoo! News


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A Minute With: Pop star Ke$ha on new album “Warrior”












LOS ANGELES (Reuters) – Pop star Ke$ ha made a name for herself with infectious dance-pop hits but the singer-songwriter is stepping out of her Auto-Tune comfort zone on “Warrior”, out this week.


Ke$ ha, 25, stormed the charts with hit songs about drinking, partying and having a good time, such as “TiK ToK” and “Your Love is my Drug” from her 2010 platinum-selling album “Animal”.












Ke$ ha talked with Reuters about the pressures of following up the success of her first album and responding to her critics.


Q: Did you feel additional pressure while working on this album after the success of your debut, “Animal”?


A: “Everybody keeps asking me about pressure, and I think a lot of other people maybe are feeling pressure about this record, but I just want to make a good record. If I sat around trying to make a number one record, I’d just be too consumed with that. I just want to make an awesome, kick-ass record that I love and that my fans love.”


Q: Was there anything that you weren’t happy with on the first album and that you wanted to change for the second?


A: “I just wanted to make sure my entire personality was presented more accurately. I feel like people really got to know the super-wild side of me but then sometimes a more vulnerable side. I didn’t really feel comfortable expressing it. So this time I kind of forced myself to express a little bit more vulnerability, less Auto-Tune, less vocal trickery. It’s a little more raw.”


Q: You received a lot of criticism for your use of Auto-Tune, masking your true singing voice. Was that a valid criticism for you, when many others use it?


A: “I remember having this conversation with my producer, and him saying, ‘We’re using a lot of vocal tricks,’ and I said, ‘People will get to know me as my career goes on, I just want it to sound really weird and cool and clubby right now, and super electronic.’ I made a conscious decision to use Auto-Tune for effect, as ear candy, and vocoders and chop up my words.


“This time around, I have heard so many different people say I can’t sing, it’s quite frankly irritating, so I … made a five-song acoustic EP (‘Deconstructed’, out on December 4) that’s kind of like my middle finger to all those people that said I couldn’t sing, and there’s more of my voice on this record. You know, haters are going to hate, you just have to do what you want to do.”


Q: Talk us through some of the collaborations on “Warrior”. There’s quite a variety, such as with Iggy Pop and Ben Folds.


A: “Ben Folds is a friend of mine. He gave me a giant glitter grand piano that’s in my house, so that one was natural. The Flaming Lips was probably surprising for a lot of people because we’re two super-different genres of music but we had the most fun and we made so many songs, it was super insane. We’re like best friends, we text everyday now, so that kind of came naturally. The one that I really have been working on for years was a collaboration with Iggy Pop. He’s one of my favorite musicians and artists of all time, so that was super exciting for me, because I respect him so much.”


Q: You’ve written tracks for Kelly Clarkson and Britney Spears, and you’ve written all the songs for “Warrior”. What did you want to bring out in your lyrics this time round?


A: “I definitely wanted to maintain the irreverence, because that’s why my fans like me. It’s because I’m super honest, not always PG rated … but I didn’t want to let the haters somehow cramp my style or get the best of me, so I maintain my irreverence … I also really wanted to show the other side of my personality, which kind of is more nerve-wracking to show people, being a real person and the vulnerable side of my personality and voice. So there are tracks on this record that are super vulnerable and were hard even to write. I had to force myself to sit down and write these songs.”


Q: You’ve carved a distinctive image and also just launched your latest collaboration with Baby-G watches. How do you want to evolve your career in the future?


A: “I think that with this record, I really wanted to show that there are no rules or boundaries in art, at all, like I sing and I can use crazy Auto-Tune vocoders and I can rap and I can do a song with Iggy Pop. You can do all these things that make sense. You don’t have to just be one thing, like, you don’t adhere to any sort of stereotype or any boundaries or any rules, so for me it’s really fun to break down these boundaries.”


Q: You came in at the forefront of the electronic dance music explosion in the pop charts two years ago. Why do you think EDM is doing so well?


A: “Dancing is one of the ways we, as adult human beings, still get to play and it’s socially acceptable. Little kids play all the time, but as we grow up, we’re supposed to just not play anymore, so our version of that is going out and dancing, and I think it’s one way people are still visceral and animal-like.”


(Reporting by Piya Sinha-Roy; Editing by Jill Serjeant and Dale Hudson)


Music News Headlines – Yahoo! News


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Some women overwhelmed by cancer treatment options












NEW YORK (Reuters Health) – More than one in five women with early-stage breast cancer in a new study said they were given too much responsibility for treatment-related decisions – and those patients were more likely to end up regretting the choices they made.


The findings don’t mean women should not be fully informed about their treatment options, researchers said, but rather that doctors may need to find new strategies to communicate with patients, especially those who are less educated.












“Some women may feel overwhelmed or burdened by treatment choices, particularly if they are not also given the tools to understand and weigh the benefits and harms of these choices,” researchers led by Jennifer Livaudais wrote in the Journal of General Internal Medicine.


Her team from the Mount Sinai School of Medicine in New York surveyed 368 women who had just had surgery for early-stage breast cancer at one of eight New York City hospitals, and again six months later.


The majority said they typically had trouble understanding medical information and less than one-third knew the possible benefits of surgery, radiation and chemotherapy, Livaudais and her colleagues found.


Lack of both “health literacy” and knowledge about treatment benefits was common among the 21 percent of women who said they had too much responsibility for decision-making – as well as among the seven percent who felt they didn’t have enough responsibility.


Women who were poor, non-white or didn’t finish high school were also more likely to feel that they had either too much or too little say in their treatment.


Close to two-thirds of women on both ends of the spectrum had some regret about their original treatment decisions six months down the line. That compared to one-third of women who originally said they had a “reasonable amount” of decision-making responsibility.


One in eight women will be diagnosed with breast cancer at some point in her life, according to the National Cancer Institute, with a higher risk among those with certain genetic mutations.


Dr. Steven Katz, who has studied cancer-related decision-making at the University of Michigan in Ann Arbor, said that compared to past years, doctors now have better ways to tailor treatment to individual patients. But that also means treatment options are based on more convoluted information.


“The treatments are linked in complicated ways, and the information that doctors draw on to make recommendations has increasingly become more and more complex,” Katz, who wasn’t involved in the new research, told Reuters Health.


He said that for patients trying to make the best treatment choices, the smartest thing they can do is have a team of doctors – an experienced surgeon, a medical oncologist, a radiation oncologist and a plastic surgeon – all working on their case and sharing ideas.


“Of course if they have strong preferences for retaining a breast and having radiation yes (or) no, those are really important decisions for a patient to think about,” Katz said.


“There are very strong reasons to engage women at the very highest level regarding those values and preferences.”


“The purpose (of the study) was not to say women shouldn’t be provided with these treatment options, but that the information really needs to be tailored better,” Livaudais, who is now at the University of California, San Francisco, told Reuters Health.


She recommended doctors ask each patient how much responsibility she feels comfortable taking going into treatment.


“Some patients prefer… for the information to be presented in simpler terms, or for the physician to recommend something to them,” Livaudais said.


SOURCE: http://bit.ly/11d6IlW Journal of General Internal Medicine, November 2012.


Diseases/Conditions News Headlines – Yahoo! News


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Behind the curtain of the Great and Powerful Grover Norquist

(Michael D'Antuono/www.artandresponse.com)


WASHINGTON—If aliens landed in Washington, D.C. right now, they might assume in their search for a terrestrial leader that a bespectacled man called "Grover Norquist" controlled the planet's most powerful nation. They might also conclude that this person had magical powers.


The misunderstanding wouldn't necessarily be their fault.


Grover Fever has swept the nation's capital this week, shortly after thousands of politicos waddled back into the city after a Thanksgiving break. After years of notoriety in Washington but near obscurity elsewhere, Norquist is becoming a household name around the dinner table.


"The Colbert Report" recently devoted a feature to Norquist, portraying the 56-year-old Harvard graduate as an omniscient creature whose power knows no bounds. Norquist has been all over cable news shows and the subject of lengthy profiles in prestigious newspapers and magazines. Outside Washington's Metro stations this week, hawkers handed out free tabloid dailies bearing the image of his face. Politico devoted an entire hour to him at a newsmakers breakfast on Wednesday morning.


His name is on the lips of top Democrats in Congress who blame him for single-handedly bringing the United States of America to an immediate standstill. Norquist is "one obstacle standing between Congress and compromise," Democratic Senate Majority Leader Harry Reid exclaimed from the Senate floor on Tuesday morning.


His crime? Norquist has persuaded more than 1,000 politicians to sign a pledge never to raise taxes through his organization, Americans for Tax Reform (ATR). But with Congress now debating how to avoid the so-called fiscal cliff—a series of tax increases and spending cuts scheduled to kick in Jan. 1 if a budget deal isn't reached with President Barack Obama—some Republicans appear to be wiggling away from Norquist's grip.


A few GOP lawmakers have voiced a willingness to eliminate deductions within the tax code, which, without offsetting tax cuts elsewhere, would technically violate the pledge. One of the possible pledge violators, Republican Rep. Peter King of New York, called Norquist a "low-life" and said his wife would "knock his head off" after Norquist compared the taxpayer pledge to King's marriage vows.


But Norquist is like a bearded Lernaean Hydra, which grows only more powerful the more you attack it. The evidence? A majority of Republicans have not publicly joined the rogue moderates, reinforcing the narrative that they remain under Norquist's binding spell.


But Norquist isn't necessarily the most powerful conservative activist in town. And many conservatives don't always move in lockstep with him, which is clear in the current debate over the fiscal cliff.


While there is a consensus among Republicans against increasing marginal tax rates for the sake of a deal, the disagreement lies in whether to eliminate deductions and close loopholes in the tax code.


Norquist insists that eliminating the loopholes without offsetting them by tax cuts would violate the pledge, but others say the deductions violate conservative principles by inserting the hand of government into the market.


"We look at things differently than Grover does," Chris Chocola, president of the free-market group the Club for Growth, told Yahoo News. "We have always been advocates of lowering the marginal rate, broadening the base, eliminating what we think are market-distorting tax credits and loopholes."


Chocola said the approach would produce benefits that could please both parties: It would force companies that manipulate the system of loopholes to pay more in taxes and increase revenue by growing the economy.


Matt Kibbe, who heads the tea party organizing network FreedomWorks, agreed that any deal that scrapped the thousands of tax code loopholes would be progress.


"An ideal tax code doesn't choose favorites, and it shouldn't matter that you have a great lobbyist in Washington, D.C.," Kibbe said. "I think all conservatives generally support fundamental tax reform—they don't like the idea that GE gets a special credit for green energy or that some other company gets different treatment from anyone else."


Despite the differences, Norquist remains the man in the spotlight. He seems to be enjoying every minute of it, using the opportunity to promote his organization and raising his own profile.


On Wednesday, Norquist presided over a gathering of conservative activists who piled into a massive conference room at ATR's Washington office. The hump-day confab, known as "The Wednesday Meeting," puts what Hillary Clinton famously called "the vast right-wing conspiracy" in one room for an hour and a half every week.


The meeting is strictly off the record, but reporters can attend if they agree not to disclose details of the discussion.


On each chair in the room, representatives stacked press releases, pamphlets and articles promoting their organizations. From ATR, everyone received a full-page, color picture of former Republican President George H.W. Bush, whose bid for a second term was foiled after he agreed to raise taxes. It was a warning to anyone who might be thinking of breaking the pledge.


This week's meeting was standing-room only, and Norquist, wearing a headset microphone, was in his element, roaring through presentations. Seated at the head of the table, he called on activists, think-tankers and members of Congress to share how they are promoting the conservative movement.


Despite his image as a puppeteer who controls the strings of Republican lawmakers, Norquist is not so much the Secret Master of the GOP as he is the Grand Facilitator of the coalitions that hold it together.


In the meantime, he doesn't seem to mind the confusion.


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Rugby-England add flyhalf Burns to squad for All Blacks’ test












LONDON, Nov 27 (Reuters) – England called up uncapped Gloucester flyhalf Freddie Burns on Tuesday to their squad for Saturday’s test against New Zealand in place of the injured Toby Flood.


Flood sustained ligament damage to a big toe during the 16-15 loss to South Africa at Twickenham last Saturday.












Owen Farrell, whose last start was in the first test in South Africa this year, is set to replace Flood in the starting XV against the world champions.


Lock Courtney Lawes, who missed England’s first three tests of the November series because of a knee injury, has also been included in the 23-man squad. Two other locks, Mouritz Botha and Tom Palmer, have been omitted.


After beating Fiji in their opening match, England have lost to Australia and the Springboks and now face a daunting match against the All Blacks who are unbeaten in 20 tests since the start of their victorious World Cup campaign last year.


“For those in Saturday’s squad the message is clear – last week we went toe to toe with the second best team in the world and felt we should have won,” England head coach Stuart Lancaster said in a statement.


“Now we have a chance to take on the number one side in front of a passionate Twickenham crowd, who have been fantastic throughout the Internationals, and it is a challenge we will meet head on.” (Reporting by John Mehaffey; Editing by Ken Ferris)


Australia / Antarctica News Headlines – Yahoo! News


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