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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Noisy city: Cacophony in Caracas sparks complaints












CARACAS, Venezuela (AP) — This metropolis of 6 million people may be one of the world’s most intense, overwhelming cities, with tremendous levels of crime, traffic and social strife. The sounds of Caracas‘ streets live up to its reputation.


Stand on any downtown corner, and the cacophony can be overpowering: Deafening horns blast from oncoming buses, traffic police shrilly blow their whistles and sirens shriek atop ambulances stuck in bumper-to-bumper traffic.












Air horns routinely used by bus drivers are so powerful they make pedestrians on crosswalks recoil, and can even leave their ears ringing. Loud salsa music blares from the windows of buses, trucks with old mufflers rumble past belching exhaust, and “moto-taxis” weave through traffic beeping high-pitched horns.


Growing numbers of Venezuelans are saying they’re fed up with the noise that they say is getting worse, and the numbers of complaints to the authorities have risen in recent years.


One affluent district, Chacao, put up signs along a main avenue reading: “A honk won’t make the traffic light change.”


“The noise is terrible. Sometimes it seems like it’s never going to end,” said Jose Santander, a street vendor who stands in the middle of a highway selling fried pork rinds and potato chips to commuters in traffic.


Prosecutor General Luisa Ortega recently told a news conference that officials have started “putting an increased emphasis on promoting peaceful coexistence” by punishing misdemeanors such as violations of anti-noise regulations and other minor crimes. That effort has translated into hundreds of noise-related cases in recent years.


Some violators are ordered to perform community service. For instance, two young musicians who were recently caught playing loud music near a subway station were sentenced to 120 hours of community service giving music lessons to students in public schools.


Others caught playing loud music on the street have been charged with disturbing the peace after complaints from neighbors. Fines can run as high as 9,000 bolivars, or $ 2,093.


On the streets of their capital, however, Venezuelans have grown used to living loudly. The noisescape adds to a general sense of anarchy, with many drivers ignoring red lights and blocking intersections along potholed streets strewn with trash.


“This is something that everybody does. Nobody should be complaining,” said Gregorio Hernandez, a 23-year-old college student, as he listened to Latin rock songs booming from his car stereo on a Saturday night in downtown Caracas. “We’re just having fun. We’re not hurting anybody.”


Adding to the mess is the country’s notoriously divisive politics, which regularly fill the streets with marches and demonstrations.


On many days, the shouts of protesters streaming through downtown can be heard from blocks away, demanding pay hikes or unpaid benefits.


And the sporadic crackling of gunfire in the slums can be confused for firecrackers tossed by boisterous partygoers.


It’s difficult to rank the world’s noisiest cities because many, including Venezuela’s capital, don’t take measurements of sound pollution, said Victor Rastelli, a mechanical engineering professor and sound pollution expert at Simon Bolivar University in Caracas. But Rastelli said he suspects Caracas is right up there among the noisiest, along with Sao Paulo, Mexico City and Mumbai.


Excessive noise can be more than simply an annoyance, Rastelli said. “This is a public health problem.”


Dr. Carmen Mijares, an audiologist at a private Caracas hospital, said she treats at least a dozen patients every month for hearing damage caused by prolonged exposure to loud noises.


“Many of them work in bars or night clubs, and their maladies usually include temporary hearing loss and headaches,” Mijares said. For others, she said, the day-to-day noise of traffic, car horns and loud music can exacerbate stress and sleeping disorders.


Several cities have successfully reduced noise pollution, said Stephen Stansfeld, a London psychiatry professor and coordinator of the European Network on Noise and Health.


One of the most noteworthy initiatives, Stansfeld said, was in Copenhagen, Denmark, where officials used sound walls, noise-reducing asphalt and other infrastructure as well as public awareness campaigns to fight noise pollution.


But such high-tech solutions seem like a remote possibility in Caracas, where streets are literally falling apart and aging overpasses regularly lack portions of their guard rails. Prosecutors, angry neighbors and others hoping to fight the noise will have to persuade Venezuelans to do nothing less than change their loud behavior.


For Carlos Pinto, however, making noise is practically a political right.


The 26-year-old law student and his friends danced at a recent street party to house music booming from woofers in his car’s open trunk, with neon lights on the speakers that pulsed to the beat.


When asked about the noise, he answered: “We will be heard.”


___


AP freelance video journalist Ricardo Nunes contributed to this report.


___


Christopher Toothaker on Twitter: http://twitter.com/ctoothaker


Latin America News Headlines – Yahoo! News


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Sony sells over half a million PlayStation 3 consoles over Black Friday week












Both Microsoft (MSFT) and Nintendo (NTDOY) had a big week of console sales during Black Friday’s week of shopping madness in the U.S. So how did Sony (SNE) do in comparison? Sony Computer Entertainment of America president and CEO Jack Tretton announced on Thursday that the company sold 525,000 PlayStation 3 consoles and 160,000 PS Vita handhelds during the Black Friday week. Overall PlayStation sales of hardware, software and accessories are up 9% over the same period last year. Tretton was also happy to reveal that subscriptions to its PlayStation Plus grew 259% since last year with customer satisfaction flying high at 95% after Sony added the Instant Game Collection to the service earlier this year.


Sony’s PlayStation 3 and PS Vita sales were largely bolstered by $ 199.99 bundles packaged with free games that the company pushed to retails on Black Friday. The sell-out of the bundles within minutes at retailers such as Amazon (AMZN) is a good indicator that there is huge demand for a sub-$ 200 PlayStation 3. Currently, the lowest-priced PS3 is a second-gen 160GB slim model with an MSRP of $ 249.99. The redesigned third-gen PS3s start at $ 269.99 with a 250GB hard drive.












In terms of which home console did the best over Black Friday, it looks like the Xbox 360′s 750,000 consoles took first place, while Sony came in second with 525,000 PS3s and Nintendo came in third with 400,000 Wii U systems.


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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 U.N. General Assembly has voted by a more than two-thirds majority to recognize the state of Palestine.

The resolution upgrading the Palestinians' status to a nonmember observer state at the United Nations was approved by the 193-member world body late Thursday by a vote of 138-9 with 41 abstentions.

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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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Microsoft CEO defends its innovation record, financial results












BELLEVUE, Washington (Reuters) – Microsoft Corp Chief Executive Steve Ballmer defended his company’s record on innovation and financial performance at the annual shareholders’ meeting, but conceded that he should have moved faster to get into the booming tablet market dominated by Apple Inc‘s iPad.


Bill Gates, co-founder and now chairman of the world’s largest software company, was one of the first to champion tablet-sized devices more than 10 years ago, but Microsoft failed to come up with a product that worked as well as the iPad. Gates was silent throughout the meeting, attended by about 450 shareholders.












“We’re innovating on the seam between software and hardware,” said Ballmer, asked why his company had fallen behind rival Apple. “Maybe we should have done that earlier.”


A month ago, Microsoft launched the Surface tablet – its first own-brand computer – but has not revealed sales figures.


In the tablet market, “we see nothing but a sea of upside,” Ballmer said, an acknowledgement that until now Microsoft has effectively had zero presence in the tablet market.


“I feel pretty good about our level of innovation,” he added.


Ballmer said smartphones running Microsoft’s new Windows software were selling four times as much as they did at this time last year. Microsoft has never given sales numbers of Windows phones, primarily made by Nokia, Samsung and HTC.


Windows currently has 2 to 4 percent of the global smartphone market, according to various independent data providers. Its overall market share will not likely grow in proportion to its own sales, given that sales of other smartphones – mostly running Google’s Android system – are also growing quickly.


Ballmer, flanked by Gates and Chief Financial Officer Peter Klein, was asked by several shareholders to explain Microsoft’s lackluster share price, which has been stuck for a decade, and has been outperformed by Apple and Google Inc stock in recent years.


“I understand your comment,” he told one shareholder. He went on to explain that Microsoft had “done a phenomenal job of driving product volumes” and was focusing on profiting from that growth.


He suggested that whether investors recognized that value at any given time was out of his hands.


“The stock market‘s kind of a funny thing,” he said, adding that Microsoft had handed back $ 10 billion in dividends and share buybacks to investors in the last fiscal year.


Several shareholders at the meeting in Bellevue, an upscale suburb of Seattle, complimented the executives on how they had grown and managed the company.


Microsoft’s shares rose almost 18 percent during fiscal 2012, which ended in June of this year, compared with a 3 percent rise in the Standard & Poor’s 500.


Despite such fluctuations, Microsoft’s shares stand around the same level they did 10 years ago.


To see a graphic on U.S. tech share price performance, 1990 to present, click on http://link.reuters.com/rug53t


(Reporting by Bill Rigby; Editing by Gary Hill)


Wireless 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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