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)


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S&P 500 posts second week of gains












NEW YORK (Reuters) – The S&P 500 wrapped up its second positive week in a row on Friday, although it ended the day flat as politicians remain at odds about how to avoid the so-called fiscal cliff.


Based on the latest available data, the Dow Jones industrial average <.DJI> rose 3.22 points, or 0.02 percent, to finish unofficially at 13,025.04. The Standard & Poor’s 500 Index <.SPX> inched up just 0.30 of a point, or 0.02 percent, to end unofficially at 1,416.25. But the Nasdaq Composite Index <.IXIC> dipped 1.79 points, or 0.06 percent, to close unofficially at 3,010.24.












For the week, the Dow rose 0.1 percent, the S&P 500 gained 0.5 percent and the Nasdaq climbed 1.5 percent.


For the month of November, though, the Dow slipped 0.5 percent, while the S&P 500 gained 0.3 percent and the Nasdaq jumped 1.1 percent.


(Reporting by Caroline Valetkevitch; Editing by Jan Paschal)


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Oliver Stone, Benicio del Toro visit Puerto Rico












SAN JUAN, Puerto Rico (AP) — Benicio Del Toro didn’t wait long to collect on a favor that Oliver Stone owed him for working extra hours on the set of his most recent movie, “Savages”, released this year.


The favor? A trip to Del Toro‘s native Puerto Rico, which Stone hadn’t visited since the early 1960s.












“I told him, you owe me one,” Del Toro said with a smile as he recalled the conversation during a press conference Friday in the U.S. territory, where he and Stone are helping raise money for one of the island’s largest art museums.


Del Toro, wearing jeans, a black jacket and a black T-shirt emblazoned with the name of local reggaeton singer Tego Calderon, waved to the press as he was introduced.


“Hello, greetings. Is this a press conference?” he quipped as he and Stone awaited questions.


Both men praised each other’s work, saying they would like to work with each other again.


“I deeply admire him as an actor, the way he thinks, the way he expresses himself,” Stone said. “Of all the actors I’ve worked with, he’s the most interesting.”


Stone said Del Toro always delivers surprises while acting, even when it’s as something as subtle as certain gestures between dialogue.


“I think Benicio is the master of keeping you watching,” he said.


Stone said he enjoys meeting up with Del Toro off-set because he’s one of the few actors in Hollywood who can talk about something other than movies.


“He is very interested in the world around him,” Stone said, adding that the conversations sometimes center around politics and other topics.


Del Toro declined to answer when asked what he thought about Puerto Rico’s referendum earlier this month, which aimed to determine the future of the island’s political status. He said the results did not seem to point to a clear-cut outcome.


Del Toro then said he would like the island’s movie business to grow, especially in a way that would encourage learning.


“I’m talking about movies in an educational sense, as a way to discover other parts of the world,” he said. “Create a film class. You’ll see, kids won’t skip it.”


Del Toro also shared his thoughts on being a father after having a daughter with Kimberly Stewart in August 2011.


He said the girl is learning how to swim and is discovering the world around her.


“She has her own personality,” Del Toro said. “She’s not her mother. She’s not me.”


Both Del Toro and Stone are expected to remain in Puerto Rico through the weekend to raise money for the Art Museum of Puerto Rico, which is hosting its annual movie festival and will honor Stone’s movies.


Museum curator Juan Carlos Lopez Quintero said the money raised will be used to enhance the museum’s permanent collection, especially with Puerto Rican paintings from the 19th century and early 20th century.


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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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)


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US growth rate revised up to 2.7%













The US economy grew at an annualised rate of 2.7% in the third quarter of the year, revised data has suggested.












The figure is significantly higher than the 2% initial estimate that the Commerce Department released just before the presidential election.


Much of the growth was due to companies rebuilding their inventories, and is not expected to be sustained.


The first estimate itself had beaten analysts’ expectations, and fuelled the suspicions of some Republicans.


The growth rate for the second quarter was confirmed at 1.3%.


Housing rebound


The revised data confirmed that a 9.5% jump in spending by the federal government during the quarter – compared with a 0.2% decline the previous quarter – played an important role in the pick-up in growth.


What the first estimate had failed to pick up was the scale of restocking by private-sector businesses.


This inventory build-up effect – which typically provides a temporary boost to economic activity early on in the recovery from a recession – added 0.77 percentage points to the pick-up in the overall growth rate in the third quarter, the Commerce Department said.


Other factors that boosted growth included the continued rise in consumer spending, stronger exports, and a slight rebound in homebuilding activity from historically low levels.


There were also some negative factors in the data, including further cuts in state and local government spending, and a fall in construction of commercial property.


Developments in the US housing market are being watched closely by economists, as they are likely to determine the durability of the recovery.


Normally, periods of recovery in the US economy are led by residential construction, as building firms quickly get back to work on a backlog of projects as soon as the recession is over.


But this time round, the recession was in large part caused by the bursting of a housing market bubble, that left behind a glut of unsold homes, bankrupted many homebuilding firms, and saw the sharpest and most sustained collapse in homebuilding activity in recorded US history.


Further evidence that the housing market may be on the mend was provided by the National Association of Realtors on Thursday.


Its index of pending home sales – which tracks sales that have been agreed but not completed, and provides an early indicator of market activity – rose 5.2% to 104.8 in October, its highest level in five years, despite subdued activity in the north east due to the impact of storm Sandy.


Data controversy


Some Republicans had expressed incredulity at a string of unexpectedly strong economic figures released in October, in the run-up to the presidential elections.


The initial growth estimate followed jobs figures that showed the unemployment rate falling in September from 8.1% to 7.8% – its lowest rate since January 2009, and well below market expectations.


The positive jobs data came shortly after Mr Obama put in a poor performance during the first of the three presidential debates, and prompted some Republican supporters to call foul.


However, the latest growth estimate strengthens the evidence that the US economy genuinely enjoyed a rebound over the summer.


Meanwhile, weekly data on the number of people claiming unemployment benefits, also released on Thursday, added to the picture of recovery.


The number of claimants fell 23,000 to a seasonally adjusted 393,000 – the second such fall in as many weeks, suggesting that a sharp run-up in the number of claimants in parts of the US struck by storm Sandy four weeks ago may prove to be temporary.


The claimant count had been averaging about 375,000 before the storm struck, and peaked at 451,000.


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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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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)


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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.


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Tunisia secures more loans as protests hit deprived town












TUNIS (Reuters) – Tunisia, struggling to ease economic difficulties that have provoked unrest since its democratic revolution, said on Wednesday it had secured more international lending to cover its 2013 spending.


Tunisia’s new, elected Islamist-led government has sought to revive the economy in the face of a decline in trade with the crisis-hit euro zone and disputes between secularists and hardline Salafi Islamists over the future direction of the North African Arab state.












At least 200 people were injured when Tunisians demanding jobs clashed with police on Tuesday and Wednesday in the city of Siliana in a region on the edge of the Sahara desert that has long complained of economic deprivation.


The state news agency TAP said Tunis had clinched a $ 500 million loan from the African Development Bank, after the World Bank approved a $ 500 million loan on Tuesday, and a government minister told Reuters finances were now in order for 2013.


“Next year our public expenditure is essentially covered, thanks also to lines of credit for a total of $ 1 billion from the World Bank and the African Development Bank,” Investment Minister Riad Bettaieb said on the sidelines of a meeting with a European Union business delegation.


“So we are not planning to ask for further international support from the International Monetary Fund (IMF),” he said.


But he said Tunisia could ask the IMF for a standby credit line worth $ 2.5 billion for 2014 and beyond. “We are considering asking the IMF for a precautionary line of credit to give a guarantee for our financing needs … around $ 2.5 billion.”


The loans, the World Bank’s second since the “Arab Spring” uprising that toppled autocrat Zain al-Abidine Ben Ali in January 2011, aim to support economic recovery by improving the business and financial sectors and reforming social services.


BLINDED BY BIRDSHOT


In Siliana on Wednesday, police fired tear gas and rubber bullets to disperse crowds who rallied for a second day.


A medic from Siliana Hospital who did not wish to named said more than 200 people had been injured in the clashes. A journalist from France 24 television told Reuters he and a colleague had been hospitalized for wounds from birdshot apparently fired by riot police.


State media said 17 people had been blinded by birdshot wounds to the eyes. Residents blocked the entrances to the city, setting tyres alight on roads.


Many protesters called for the resignation of local officials, saying the authorities had failed to release development funds for their region.


Iyed Dahmani, a politician from the Republican Party in the town, said the national guard – an interior ministry-run security force – had deployed tanks to help restore order.


Interior Minister Ali Larayed appeared on state television to call for calm. “I ask people in Siliana to calm down, to protest calmly and accept dialogue,” he said, accusing leftist politicians of inflaming the situation.


But state TV also showed Prime Minister Hamadi Jebali saying he would not remove the unpopular governor of the region: “I won’t accept sacking him; he will stay in place.”


Jebali has accused both Salafis and liberal elites of harming Tunisia’s economy and image through their conflict with each other. His Ennahda party has tried to present itself as a middle way between liberals and Salafis.


The protests are the fiercest since hardline Salafi Islamists attacked the U.S. embassy in Tunis in September over an anti-Islam film made in California. That violence left four people dead.


(Writing by Andrew Hammond)


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