Hip Implant’s Risks Inadequately Assessed, DePuy Report Found in 2010


A review conducted internally by Johnson & Johnson soon after it recalled a troubled hip implant found that the company had not adequately assessed the device’s potential risks before it was used in more than 90,000 patients, court testimony on Thursday showed.


The engineering report, which was done in 2010, also found that Johnson & Johnson’s orthopedic unit had used inadequate or incorrect standards in trying to assess some of those risks before first selling the implant in 2003. The device at issue — the Articular Surface Replacement, or A.S.R. — proved to be among the most flawed orthopedic devices sold in recent decades.


The report was introduced on Thursday in Los Angeles Superior Court, in the first A.S.R.-related lawsuit to go to trial against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 similar lawsuits have been filed in the United States.


In videotaped testimony shown in court, Jimmy Smith, a compliance manager at DePuy, was asked about the report, and he said it indicated that company officials had not used appropriate engineering controls to try to anticipate the device’s problems.


“They did their job, but they could have done it better,” Mr. Smith said.


Separately, a DePuy engineer, Graham Isaac, testified on Thursday that before selling the A.S.R., the company only tested its performance on laboratory equipment at one angle of implantation.


Depending on the surgical technique and a patient’s build, orthopedic surgeons can implant the cup component of an artificial hip at a variety of angles. And because the A.S.R. had a design flaw, normal variance from the single angle at which DePuy had tested it made it more likely for the joint’s cup and ball components to strike each other, releasing metallic debris inside a patient.


DePuy conducted the post-mortem review of the A.S.R. in November 2010, just three months after it recalled the all-metal implant, but it never released the analysis. It also, apparently, did not conduct a similar review in response to the mounting number of complaints about the device that it received from doctors and others in 2008 and 2009.


Lorie Gawreluk, a spokeswoman for DePuy, said that she could not comment on any details of the lawsuit, but that the company believed that the evidence would show it acted appropriately. The trial’s proceedings were monitored over the Courtroom View Network.


The A.S.R. is projected to fail within five years in about 40 percent of patients who received the implant. That early failure rate, which is expected to grow over time, is many times higher than the failure rate for most hip replacements.


In the post-recall review in 2010, DePuy engineers examined the criteria and “controls,” or standards, that were used nearly a decade earlier when company officials tried to anticipate how the A.S.R. might perform. Because the version of the device that was sold in the United States was never clinically tested in patients, officials used the controls to assess the implant.


Among other things, DePuy officials failed to anticipate that the A.S.R. would have a high rate of wear as a patient moved, even though the control referenced in the device’s records demonstrated “that the product is more likely to experience contact between the head and rim” than competing implants.


In previously recorded testimony presented in court on Wednesday, DePuy’s president, Andrew Ekdahl, was shown an e-mail in which he was warned about the A.S.R.’s problems nearly three years before it was recalled.


Mr. Ekdahl and other DePuy executives have asserted that they acted properly and in a timely fashion to the device’s problems. The company spokeswoman, Ms. Gawreluk, said Mr. Ekdahl would not be made available for an interview.


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Former Peregrine CEO Wasendorf gets 50 years in prison









A U.S. judge on Thursday sentenced the founder of Peregrine Financial Group to 50 years in prison for looting hundreds of millions of dollars from the brokerage, saying his customers would probably never recover the money they lost.

Russell Wasendorf Sr., who had tried to kill himself just before the fraud was uncovered, received the maximum sentence allowed by law and was ordered to pay $215.5 million in restitution for his nearly 20-year scheme.

Wasendorf's fraud was revealed in 2012, triggering the collapse of the brokerage and further shaking investors' confidence in the U.S. futures industry, already rattled by the failure of larger rival M.F. Global.

"I'm very sorry for the financial and emotional damage I've caused to investors and employees of Peregrine Financial Group," Wasendorf said in a feeble voice at a sentencing hearing in Cedar Rapids, Iowa. "I feel I fully deserve whatever sentence I am given… My guilt is such I will accept that sentence."

Chief Judge Linda Reade of the U.S. District Court of the Northern District of Iowa said former Peregrine customers will probably never get all their money back.

Wasendorf, 64, admitted last July that he had bilked tens of thousands of clients over a period of nearly 20 years, faking bank statements and lying to federal regulators, employees and his closest family members.

As regulators closed in on the fraud, Wasendorf made a botched suicide attempt outside his $24-million headquarters in Cedar Falls, Iowa, which investigators say was financed with money siphoned from customers.

Peregrine Financial, known as PFGBest, quickly collapsed, and 24,000 former customers are still missing most of the money they had invested with the firm.

Wasendorf pleaded guilty in September to embezzling more than $100 million. Prosecutors said the amount stolen was more like $215 million.

"The lengthy prison sentence imposed today is just punishment for a con man who built a business on smoke and mirrors," said Acting U.S. Attorney Sean Berry.

PLEAS FOR LENIENCY

Supporters of the disgraced executive had asked Reade for leniency, arguing that Wasendorf is in frail health and that he had helped others even in the midst of his 20-year fraud.

Wasendorf, wearing an orange sweatshirt, looked gaunt in court after spending six months in isolation in a county jail.

He has been sick in jail, and doctors found a tumor on or near his pancreas, according to testimony from his pastor, Linda Livingston of Ascension Lutheran Church. Wasendorf's mother died of pancreatic cancer, but it is unknown whether Wasendorf's tumor is cancerous, she said.

U.S. prosecutors said the large loss, the sophisticated nature of the crime, and the sheer number of victims justified Wasendorf spending the rest of his life behind bars.

"The defendant spent like he was the richest man in the world," Assistant U.S. Attorney Peter Deegan said in court.

Peregrine's collapse dealt a blow to confidence in the U.S futures industry, already reeling from $1.6 billion hole in customer pockets left when giant brokerage MF Global failed nine months earlier.

Futures traders had never before suffered such large losses as a result of a brokerage failure.

Despite his misdeeds, Wasendorf "did do some positive things for the community," said former U.S. Congressman David Nagle from Iowa, who spoke up for the fallen CEO in court.

Nagle, who helped Wasendorf win zoning approval for Peregrine's environmentally-friendly headquarters, asked the judge for leniency.

"Who wants to defend the magnitude of the crimes Mr. Wasendorf committed?" he said. "But good people do bad things."

Wasendorf was well known for donating to local charities before his empire came crashing down.

However, he built his reputation for generosity using money stolen from his customers, Judge Reade said, adding that the donations likely lessened Wasendorf's feelings of guilt.

Peregrine customers "unwittingly funded the charities, but it was Mr. Wasendorf who took the credit," she said.

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$11K reward offered in slaying of girl 'destined for great things'









With outrage over his daughter's death spreading from City Hall to the White House, Nathaniel Pendleton made a public plea Wednesday for someone to step forward and bring the 15-year-old's killer to justice.

"They took the light of my life," Pendleton said at a news conference, where a $11,000 reward was announced for information about Tuesday's slaying of Hadiya Pendleton. "This guy, whoever he was, the gunman, man, you took the light of my life. Just look at yourself and just know that you took a bright person, an innocent person, a non-violent person."

Shaking his head and collecting himself, he continued, "This kid didn't like violence at all, didn't even like to fight, avoided a fight, moved away from anything that was not positive. She was a majorette, just came back from the inauguration. She was destined for great things and you stripped that from her."

Hadiya, who last week performed at President Barack Obama's inaugural festivities, was killed when a gunman opened fire on a group of students at Harsh Park, just blocks from King College Prep and about a mile from Obama's home in Kenwood on the South Side.

Presidential spokeman Jay Carney, asked about Hadiya's death Wednesday, said it was a “terrible tragedy” any time a young person is struck down “with so much of their life ahead of them.”

“The president and first lady's thoughts and prayers are with the family of Hadiya Pendleton,” he said. “All of our thoughts and prayers are with her family.”

Carney, asked about a petition urging President Barack Obama to attend Pendleton’s funeral, said he was not aware of the petition and had no scheduling announcements to make.

When asked if Obama had reached out to Pendleton’s family, Carney said he had no communications to share with reporters.

Carney also said that when Obama talks about gun violence in America he is not talking only about Newtown (Conn.) or Aurora (Colo.) or Oak Creek (Wis.) or Virginia Tech, but to shootings in Chicago and other parts of the country.

He added that while "we may not be able to prevent every act of gun violence. . .we need to take action to reduce gun violence” and “make sure that we’re doing everything we can in a responsible way to reduce this violence, to protect our children, including Hadiya Pendleton and others.”

Hadiya's death also came up at a news conference by Mayor Rahm Emanuel as a particularly violent January in Chicago draws to a close.

Emanuel called Hadiya "what is best in our city" and urged anyone with information about the slaying to come forward.

"If anybody has any information, you are not a snitch, you're a citizen," the mayor said. "You're a good citizen in good standing if you help."

The mayor said he talked this morning with Police Superintendent Garry McCarthy, "going over what we need to do, what differences we have to do, what other tactics we have to adopt." He did not say what plans he and McCarthy discussed.

Later, McCarthy appeared with Hadiya's father at a news conference at Harsh Park to announce the reward.

"The fact is, at this point, we have very little to go on. The fact is that somebody knows something," he said, surrounded by family members and community leaders.

The Rev. Michael Pfleger, pastor of St. Sabina Church on the South Side, said the reward will be "a bounty out on the head of a killer before you kill somebody else.

"Your butt needs to be in jail," he said. "Somebody knows. . .right now, sitting in their home some young person knows, some young friend of theirs knows, some parent knows, some adult knows. Where are you?"

Pfleger compared Hadiya's slaying to the mass murder of school children in Newtown, Conn. "We should be just as outraged," he said.

Hadiya was hanging out with her volleyball team at Harsh Park after taking exams Tuesday afternoon. About a dozen teens had taken shelter under a canopy during a rainstorm when a boy or man jumped a fence in the park, ran toward them and opened fire around 2:20 p.m., police said.

Hadiya was wounded in the back and a 16-year-old boy -- also a student at King -- was shot in the leg, police said. The attacker got into a white Nissan auto and fled, police said. No arrests have been reported.

Today, Hadiya's family was inside their South Side home exchanging stories about her quirks and sense of humor.

Ten-year-old Nathaniel Pendleton Jr. recalled the way his big sister would often greet him with a few gentle slaps on his cheeks whenever she came home from school.

"She said it was with love," he said.

Nathaniel etched "I miss you" and "I love you" on his arm Wednesday. "It's very painful to see your big sister get slaughtered," the soft-spoken Nathaniel said, tearing up as he went through photos of his big sister on his phone.


His father said he would miss Hadiya's bright smile the most. He said the family had been saving up for her upcoming trip to Paris and was excited to see her go abroad.

"I just knew she wanted to go and I knew it was a very good opportunity for her. . .to get cultured," Pendleton Sr. said.

The father said he didn't get a chance to speak to his daughter on the day she died. He was headed to Hadiya's godfather's house when he learned of the shooting.

Pendleton said he did not fear for his daughter's safety around the school.

"She had good energy, very good energy," he said. "And the thing is. . .You don't expect good energy to attract bad energy. Never in a million years I thought I would get this call."


Kimiko Pettis, Hadiya's 32-year-old aunt, laughed when she talked about her niece's goofy personality. "We really miss her," Pettis said. "She was a remarkable young lady and such a great asset to our family."

Hadiya was a busy but lighthearted teen, always trying to get a laugh from her family. Just Tuesday, she put on what she thought was a "fabulous outfit" and make-up before school.

"She popped out of the bathroom saying. 'I'm ready!' " Pettis said, throwing her arms in the air.

Pettis said her niece loved Coldplay and Maroon 5. "You could not find any urban music on her phone," Pettis said with a laugh. "And she had two left feet."

Last year, Hadiya traveled with her school band to perform at Marti Gras in New Orleans, Pettis said. Last week, she had performed at Obama’s inauguration festivities. This year's travel plans included Dublin and Paris with the band, her aunt said, a trip she was very much looking forward to.

Though only a sophomore, Hadiya had aspirations to become a pharmacist or a journalist, Pettis said. Because she couldn't decide, family encouraged her to do both with a possible double major. She had interest in attending Northwestern University, her aunt said.

Hadiya was such a whirlwind of activity, relatives would jokingly tell her to slow down.

"There were a lot of good opportunities that were coming her way. She was just taking them all,” said Lakeisha Stewart, 37, Hadiya’s godmother. "She was the kid who you had to say, ‘Slow down, you can’t do everything.' "

Just last week, at the inauguration, Hadiya sent her godparents a text and a photo of her and her teammates in Washington, D.C., Stewart said.  She had not gotten the chance to talk to Hadiya about the details of the trip since she returned from the East Coast.

Hadiya’s parents made sure she stayed involved in school, said her godfather, Damon Stewart, 36, an attorney and Chicago police officer. He said she was in the wrong place at the wrong time.

“Her life was dominated by her activities and the things she was into,” he said.

“I’ve known this little girl her entire life," added Lakeisha Stewart. "I can’t think of a moment that this child did anything wrong. She always strived to do the right thing."

At King today, Bria Carter and two friends said the halls of the school were unusually quiet as students mourned Hadiya’s death.

"People are crying at school," said Carter, 17, a friend of Hadiya. "Those who knew her are so hurt.

"She was an amazing person -- always positive," Carter said. "She was one of those people everyone loved. She was the sweetest thing."

Brothers Addison and Zion Morgan said many of their classmates took to social media Tuesday night to express their emotions.

"Based off of the tweets, everyone is surprised and shocked by this," said senior Addison Morgan, 17.

Freshman Zion Morgan, 15, said he was in a U.S. History class with Hadiya.  "She was always smiling," Zion Morgan said. "She would always raise her hand in class."

School Principal Shontae Higginbottom said Hadiya was well-loved at the school, and students and staff are devastated.

"This is a great loss to us, she was a wonderful student. She was well-loved by her friends, well-adored by her teachers. We are going to miss her. Our hearts are so heavy, we have to stop the violence, we have to save our children," said Higginbottom.








Relatives of the girl said she was in an anti-gang violence video while she was attending the Carter G. Woodson Elementary School.


At the park, neighbors along the well-maintained North Kenwood block could not remember any trouble there before.

The small park's bright blue and orange playground equipment is often used by toddlers down the street, a neighbor said, but otherwise remains quiet.

A neighbor, who declined to be named, lives next door to the park and said it's a "perfect neighborhood."

Teens and older children are not often visitors of the park, he said. The block is filled with "Harvard attorneys," "business owners" and other executives, the neighbor said. "No one knows about our block," he said. "It's a quiet place."

Hadiya's godmother agreed. “It amazed me when I found out what park it was," she said. "Nothing I have ever heard ever goes on over there.”

The shooting occurred about a mile from Obama's Kenwood home, but Emanuel said the circumstances do not carry symbolic significance.

"It's not the mile from a house. Wherever it happens in the city of Chicago is where I consider it," the mayor said while talking to reporters at a news conference about a West Humboldt Park company building new seats for CTA buses.

"While you may say it's a mile from the president's house, my view is, it's in the city of Chicago, regardless of where it happens," Emanuel added.

Ald. Will Burns, 4th, appearing with McCarthy, noted that the community and King Prep have steadily improved over the last 20 years.

"King High School went from being one of the worst high schools in the city of Chicago to being a selective enrollment high school," he said. "These young people were going to one of the best schools in the city of Chicago and they were spending their time in a park, which is what parks are there for, for young people to enjoy themselves and recreate and do something positive."

"This is not my community, these are not the people I know and love," he said referring to the killer. "No gang controls this ward."


Tribune reporters Carlos Sadovi and Christi Parsons contributed.


Chicagobreaking@tribune.com


Twitter: @ChicagoBreaking





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Rape trial of teenaged football players to be open to public: Ohio judge






(Reuters) – The controversial trial of two high school football players accused of raping a classmate will remain open to the public and will not be relocated to another town, an Ohio judge ruled on Wednesday.


Prosecutors and an attorney representing the accuser had sought a closed trial, arguing that public access to the juvenile trial would subject the accuser to unwanted publicity and make potential witnesses reluctant to testify.






Visiting Hamilton County Judge Tom Lipps said the presence of the media would prevent inaccurate reporting and enhance public confidence in the juvenile justice system, according to his written ruling, a copy of which was seen by Reuters.


“An open hearing is especially valuable where rumors, mischaracterizations and opinions unsupported by facts have reportedly been repeated in social media postings and other published outlets,” Lipps wrote. “An open hearing will diminish the influence of such postings and publications.”


Prosecutors have accused Ma’Lik Richmond and Trent Mays, both 16, of raping a classmate at a party attended by many teammates last August in Steubenville, a close-knit city of 19,000 near the Pennsylvania border.


The case attracted national attention after the hacker activist group Anonymous publicized a picture of two young men carrying a girl by her wrists and ankles and released a video showing other young men joking about the alleged assault.


Richmond’s lawyer, Walter Madison, said previously on CNN that his client was one of the young men in the photograph – which he said was taken out of context – but does not appear in the video. A lawyer for Mays has not publicly commented on the postings.


Community leaders have accused authorities of protecting the school’s popular football program by not charging more players who could have prevented the alleged attack.


Lipps also ruled on Wednesday that the trial will remain in Steubenville. He set a trial date for March 13.


Reuters generally does not identify people who say they have been victims of sex crimes.


(Editing by Paul Thomasch, Bernard Orr)


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Final cut: The gems and stars left off the Oscars list






(Reuters) – If I could remove any word from Oscar conversations, it would be “snubbed.” It’s catchy and makes good headline fodder, but it implies that a cabal of Academy members sat in a room and consciously decided to ostracize this actor or that moviemaker. These ballots are filled out by 6,000 to 7,000 voters, ranging from visual effects experts to screenwriters to studio chiefs. I can’t envision secret meetings to decide the fate of each candidate.


Jamie Foxx (“Django Unchained”) and veteran French star Jean-Louis Trintignant were both considered serious contenders for a Best Actor nomination; neither made the final cut, even though Trintignant’s co-star in “Amour,” Emmanuelle Riva, was nominated for Best Actress. At one point, the gifted John Hawkes was touted as a shoo-in for his brilliant performance in “The Sessions.” But I’ve learned never to use the word “shoo-in” where the Oscars are concerned.






There were fewer surprises in the Best Actress category, although some pundits had predicted Helen Mirren for “Hitchcock,” Marion Cotillard for the French import “Rust and Bone” and Rachel Weisz, who won the New York Film Critics’ award, for “The Deep Blue Sea.” As it happens, they took a collective backseat to the youngest female ever nominated in this category, 9-year-old Quvenzhané Wallis (“Beasts of the Southern Wild”) and the oldest, 82-year-old Riva.


The always-crowded Supporting Actor and Actress rosters excluded such prominent figures as Nicole Kidman, Leonardo DiCaprio, Samuel L. Jackson and Maggie Smith, while admitting Philip Seymour Hoffman for what is clearly a leading role in “The Master.”


But the biggest buzz concerns this year’s Best Director lineup. Experienced Oscar watchers could see this brewing, as the current Oscar setup has a built-in dilemma. To understand it, one need only do the math: With the Academy of Motion Picture Arts and Sciences now enabling nine films to compete for Best Picture — in fact, they allow as many as 10 — but retaining only five slots for Best Director, at least four world-class filmmakers are guaranteed to be left out in the cold. How those four happened to be Kathryn Bigelow, Ben Affleck, Tom Hooper and Quentin Tarantino this year is anybody’s guess.


Only members of the director’s branch get to nominate directors; that’s an elite group of fewer than 400 people. The same constituency didn’t cite Affleck for his terrific movie “The Town” a few years ago but did support Bigelow and Hooper, who went on to win for “The Hurt Locker” and “The King’s Speech,” respectively. They were early boosters of Tarantino, who won an Oscar for Best Screenplay for “Pulp Fiction” in 1994 and was nominated for Best Director for his last film, “Inglorious Basterds.” It may be true that they’ve undervalued Ben Affleck, but there is no logic to the omission of the three other Best Picture directors.


What’s more, the Academy’s director lineup doesn’t coincide with that of the Directors Guild of America, which historically, and almost invariably, has forecast the Oscar winner. But that was before the Academy opened up the Best Picture category beyond its traditional five slots, so now all bets are off. (For the record, this year’s DGA nominees are Affleck, Bigelow, Hooper, Ang Lee and Steven Spielberg.)


WHAT ABOUT ‘TED’?


Every round of Oscar nominations brings its share of surprises and disappointments. Many people I know were counting on Judi Dench to be up for Best Supporting Actress, which would have made her the first person to be singled out for a performance in a James Bond movie in that series’ 50-year history. There was also great enthusiasm for Javier Bardem‘s performance as the movie’s colorfully sinister villain. Both Dench and Bardem are former winners, so the Academy actors’ branch clearly appreciates them … just not enough to make this year’s finals. Even so, “Skyfall” earned a record five nominations, including one for Thomas Newman’s rousing music score and one for cinematographer Roger Deakins, who has been nominated 10 times and never taken home one of those gold statuettes. (It’s the first time around for Adele, who sang and co-wrote the movie’s theme song.)


Over the course of the year, a handful of other films elicited critical notice that might have led to Oscar recognition: Richard Linklater’s “Bernie” offered Jack Black an unusually juicy part as a real-life Texas character who may or may not have murdered his older female companion. Novelist Stephen Chbosky’s adaptation of his best-selling book “The Perks of Being a Wallflower” earned warm reviews for its deeply felt look at high school outcasts. Co-star Ezra Miller has been singled out in particular amid a talented young cast. Two of the best performances of the year were given by Jake Gyllenhaal and Michael Peña in David Ayer’s vibrant L.A. cop drama “End of Watch,” but their work has been largely overlooked. Fortunately, Peña is in the running for an Independent Spirit Award as Best Supporting Actor.


Christopher Nolan loyalists are still miffed that the filmmaker has been nominated for two of his screenplays (“Memento” and “Inception”) but never recognized as Best Director — and that the finale in his Batman trilogy, “The Dark Knight Rises,” did not earn a Best Picture nod this year.


Omissions don’t come only in the boldface categories that attract the lion’s share of attention. It’s understandable that “The Hobbit: An Unexpected Journey,” “Life of Pi,” Marvel’s “The Avengers,” “Prometheus” and “Snow White and the Huntsman” are competing for Best Achievement in Visual Effects. But if you stop and think about it, was there a more convincing or persuasive use of “movie magic” this year than a teddy bear come to life sharing the screen with Mark Wahlberg in Seth MacFarlane’s “Ted”? To me, that’s the most amazing kind of trickery, because you’re forced to believe what your brain tells you can’t be true. Yet “Ted” didn’t even make the Academy’s short list before the final five contenders were chosen.


For my money, there is one 2012 release that has truly been robbed. It happens to be a box-office blockbuster, which offers its creators (and backers) some consolation, I’m sure. Still, “The Avengers” is the best comic book superhero movie of this, or possibly, any year, in large part because of Joss Whedon’s sensationally smart, funny screenplay. There is none of the self-seriousness that mars “The Dark Knight Rises” or the hollowness of earlier Marvel efforts like “Thor.” It doesn’t run out of steam like “Captain America” or simply repeat itself like “Iron Man 2.”


Whedon pulls off the formidable feat of assembling an all-star cast of characters and giving each a purpose. He takes a two-dimensional villain from “Thor” and makes him truly menacing. He breathes new life into the lumbering Hulk. He makes us care about all these characters and gives them a cause worth fighting (and rooting) for. On top of that, he infuses his screenplay with a welcome dose of humor, including some of the funniest moments ever found in an ostensibly serious superhero saga. (Here’s a sample exchange. Bruce Banner: I don’t think we should be focusing on Loki. That guy’s brain is a bag full of cats. You can smell crazy on him. Thor: Have a care how you speak! Loki is beyond reason, but he is of Asgard and he is my brother! Natasha Romanoff: He killed 80 people in two days. Thor: He’s adopted.)


Moviegoers around the world loved the result, and even critics sang its praises. But aside from a nomination for its excellent visual effects, the movie was shut out. Normally, this wouldn’t be shocking, as the Academy tends to shun popcorn movies except in the technical categories, but “The Avengers” is no ordinary popcorn movie.


Then again, if the Oscars followed a predictable path — mine or anyone else’s — they wouldn’t be the Oscars. The final surprises will be unveiled on February 24.


Film critic and historian Leonard Maltin is perhaps best known for his annual paperback reference book, “Leonard Maltin’s Movie Guide.” He hosts “Maltin on Movies” for Reelz, introduces films on Comcast and teaches as the University of Southern California School for Cinematic Arts. He has written many books on film and holds court at www.leonardmaltin.com.


(Editing by Kathy Jones, Arlene Getz and Douglas Royalty)


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During Trial, New Details Emerge on DuPuy Hip





When Johnson & Johnson announced the appointment in 2011 of an executive to head the troubled orthopedics division whose badly flawed artificial hip had been recalled, the company billed the move as a fresh start.




But that same executive, it turns out, had supervised the implant’s introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.


In addition, the executive also held a senior marketing position at a time when Johnson & Johnson decided not to tell officials outside the United States that American regulators had refused to allow sale of a version of the artificial hip in this country.


The details about the involvement of the executive, Andrew Ekdahl, with the all-metal hip implant emerged Wednesday in Los Angeles Superior Court during the trial of a patient lawsuit against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 lawsuits have been filed against DePuy in connection with the device — the Articular Surface Replacement, or A.S.R. — and the Los Angeles case is the first to go to trial.


The information about the depth of Mr. Ekdahl’s involvement with the implant may raise questions about DePuy’s ability to put the A.S.R. episode behind it.


Asked in an e-mail why the company had promoted Mr. Ekdahl, a DePuy spokeswoman, Lorie Gawreluk, said the company “seeks the most accomplished and competent people for the job.”


On Wednesday, portions of Mr. Ekdahl’s videotaped testimony were shown to jurors in the Los Angeles case. Other top DePuy marketing executives who played roles in the A.S.R. development are expected to testify in coming days. Mr. Ekdahl, when pressed in the taped questioning on whether DePuy had recalled the A.S.R. because it was unsafe, repeatedly responded that the company had recalled it “because it did not meet the clinical standards we wanted in the marketplace.”


Before the device’s recall in mid-2010, Mr. Ekdahl and those executives all publicly asserted that the device was performing extremely well. But internal documents that have become public as a result of litigation conflict with such statements.


In late 2008, for example, a surgeon who served as one of DePuy’s top consultants told Mr. Ekdahl and two other DePuy marketing officials that he was concerned about the cup component of the A.S.R. and believed it should be “redesigned.” At the time, DePuy was aggressively promoting the device in the United States as a breakthrough and it was being implanted into thousands of patients.


“My thoughts would be that DePuy should at least de-emphasize the A.S.R. cup while the clinical results are studied,” that consultant, Dr. William Griffin, wrote.


A spokesman for Dr. Griffin said he was not available for comment.


The A.S.R., whose cup and ball components were both made of metal, was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use here in standard hip replacement that used the same cup component as the resurfacing device. Only the standard A.S.R. was sold in the United States; both versions were sold outside the country.


Before the device recall in mid-2010, about 93,000 patients worldwide received an A.S.R., about a third of them in this country. Internal DePuy projections estimate that it will fail in 40 percent of those patients within five years; a rate eight times higher than for many other hip devices.


Mr. Ekdahl testified via tape Wednesday that he had been placed in charge of the 2005 introduction of the standard version of the A.S.R. in this country. Within three years, he and other DePuy executives were receiving reports that the device was failing prematurely at higher than expected rates, apparently because of problems related to the cup’s design, documents disclosed during the trial indicate.


Along with other DePuy executives, he also participated in a meeting that resulted in a proposal to redesign the A.S.R. cup. But that plan was dropped, apparently because sales of the implant had not justified the expense, DePuy documents indicate.


In the face of growing complaints from surgeons about the A.S.R., DePuy officials maintained that the problems were related to how surgeons were implanting the cup, not from any design flaw. But in early 2009, a DePuy executive wrote to Mr. Ekdahl and other marketing officials that the early failures of the A.S.R. resurfacing device and the A.S.R. traditional implant, known as the XL, were most likely design-related.


“The issue seen with A.S.R. and XL today, over five years post-launch, are most likely linked to the inherent design of the product and that is something we should recognize,” that executive, Raphael Pascaud wrote in March 2009.


Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant.


The F.D.A. also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.


DePuy never disclosed the F.D.A. ruling to regulators in other countries where it was still marketing the resurfacing version of the implant.


During a part of that period, Mr. Ekdahl was overseeing sales in Europe and other regions for DePuy. When The Times article appeared last year, he issued a statement, saying that any implication that the F.D.A. had determined there were safety issues with the A.S.R. was “simply untrue.” “This was purely a business decision,” Mr. Ekdahl stated at that time.


This article has been revised to reflect the following correction:

Correction: January 30, 2013

An earlier version of this article, in the summary, described the start of the DePuy trial incorrectly. It began last week, not this week.



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BlackBerry 10 launches after long wait









Research In Motion Ltd unveiled the long-delayed line of smartphones it hopes will put it on the comeback trail on Wednesday but it disappointed investors by saying U.S. sales of its all-new BlackBerry 10 will start only in March.

Chief Executive Thorsten Heins also announced that RIM was abandoning the name it has used since its inception in 1985 to take the name of its signature product, signaling his hopes for a fresh start for the company that pioneered on-your-hip email.






"From this point forward, RIM becomes BlackBerry," Heins said at the New York launch. "It is one brand; it is one promise."

RIM, which is already starting to call itself BlackBerry, had initially planned to launch the new BlackBerry 10 smartphones in 2011. But it pushed the date back twice as it struggled to work with a new operating system.

Ahead of Wednesday's announcements, analysts had said that any launch after February would be a black mark for the Canadian company.

"The biggest disappointment was the delay in the U.S., that it will take so long before the devices get going there," said Eric Jackson, founder and managing Partner at Ironfire Capital LLC in New York.

Heins said the delays reflected the need for U.S. carrier testing, although carrier AT&T offered few clues on what that meant.

"We are very enthusiastic about the devices. We will announce pricing, availability, and other information at a later date. Beyond that, nothing to add," said spokesman Mark Siegel.

RIM launched its first BlackBerry back in 1999 as a way for busy executives to stay in touch with their clients and their offices, and the Canadian company quickly cornered the market for secure corporate and government email.

But its star faded as competition rose. The BlackBerry is now a far-behind also-ran in the race for market share, with a 3.4 percent global showing in the fourth quarter, down from 20 percent three years before. Its North American market share is even worse: a mere 2 percent in the fourth quarter.

RIM shares tumbled along with the company's market share, and the stock is down 90 percent from its 2008 peak.

The shares fell as much as 8 percent on Wednesday, although they are still more than twice the level of their September 2012 low, reflecting ever-louder buzz about the new devices.

TOUCH COMPETITION

The new BlackBerry 10 phones will compete with Apple's iPhone and devices using Google's Android technology, both of which have soared above the BlackBerry in a competitive market.

The BlackBerry 10 devices boast fast browsers, new features, smart cameras and, unlike previous BlackBerry models, enter the market primed with a large application library, including services such as Skype and the popular game Angry Birds.

The BlackBerry Z10 touchscreen device, in black or white, will be the first to hit the market, with a country-by-country roll-out that starts in Britain on Thursday.

A Q10 model, equipped with small "qwerty" keyboard that RIM made into its trademark, will launch globally in April.

The Z10 device won a lukewarm review from Wall Street Journal tech blogger Walt Mossberg, who complained of missing or lagging features and a shortage of apps.

But David Pogue, who writes for The New York Times, apologized for describing BlackBerry as doomed in the past. The Z10 touchscreen device was "lovely, fast and efficient, bristling with fresh, useful ideas," he said.

Announcements about pricing so far have been in line with expectations. U.S. carrier Verizon Wireless said the phone would cost $199 for a two-year contract, while Canada's Rogers Communications is quoting C$149 ($150) for certain three-year plans.

GLITZY LAUNCH

RIM picked a range of venues for its global launch parties, including Dubai's $650-a-night Armani Hotel, which occupies six floors of the Burj Khalifa, the world's tallest tower.

The New York event took place in a sprawling basketball facility on the Lower East Side of Manhattan, just north of the Manhattan Bridge. The BlackBerry has been "Re-designed. Re-engineered. Re-invented," RIM said.

RIM, which is splurging on a Superbowl ad to promote its new phones, also introduced Grammy-winning singer-songwriter Alicia Keys as its global creative director.

"I was in a long-term relationship with BlackBerry, and then I started to notice some new, kind of hotter, attractive, sexier phones at the gym, and I kind of broke up with you for something that had a little more bling," Keys said at the New York launch.

"But I always missed the way you organized my life, and the way you were there for me at my job, and so I started to have two phones - I was kind of playing the field. But then … you added a lot more features … and now, we're exclusively dating again, and I'm very happy."

RIMM Chart

RIMM data by YCharts





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Teen girl killed, boy wounded in shooting near high school









After taking their exams, Hadiya Pendleton and a group of others decided to hang out at a park on Tuesday just blocks away from their high school on the South Side.


But the trip ended in tragedy when the 15-year-old King College Prep student was fatally shot in the back and a 16-year-old boy was wounded in the leg, and remained in serious condition Tuesday night, authorities said. Police said Pendleton was not believed to be the target of the shooting, but that most of those who were in the park were gang members, and that those in the group did not stay on scene to help after the shootings.


The shooting occurred around 2:20 p.m. in the 4500 block of South Oakenwald Avenue, police said.








Pendleton was a sophomore at King high school, friends said. The boy also is a student at King, they said, though Pendleton's relatives said they were not sure what school he attended.


One of the teens was taken in serious to critical condition to Comer Children's Hospital, according to Chicago Fire Department spokesman Will Knight.


The other victim also was taken to Comer and police at first believed both victims' conditions had stabilized by a little after 3 p.m., said Chicago Police News Affairs Officer Veejay Zala.


At Comer this evening, a group of young people sat and stood inside the entrance to the hospital's emergency room, along with the principal of King high school.


Many hugged as they brushed tears from their eyes and consoled each other and Pendleton's parents.


"She was awesome," one girl said of Pendleton outside the hospital's ER.


Friends of the slain girl said King was dismissed early today because of exams, and students went to the park on Oakenwald--something they don't usually do.


Friends said the girl was a majorette and a volleyball player, a friendly and sweet presence at King, one of the top 10 CPS selective enrollment schools.


Neighbors said students from King do hang out at Harsh Park, 4458-70 S. Oakenwald Ave., and that students were there this afternoon before the shooting took place. A group of 10 to 12 teens at the park had taken shelter under a canopy there during a rainstorm when a boy or man jumped a fence in the park, ran toward the group and opened fire, police said in a statement this evening.


The attacker then got into an auto and left the area, police said.


Neighbors reported hearing shots about 2:20 p.m.


Desiree Sanders said she heard six gunshots and called 911 after a neighbor told her that some teens had been shot. Neighbors told her as many as 10 young people had been hanging out at the small park, and most scattered after the shooting, though a few stayed behind with the victims.


Those in the group were not cooperating with police, however, and investigators had no detailed descriptions yet of either the attacker or the vehicle in which he left. Central Area detectives were investigating, and they had no one in custody as of about 8:20 p.m.


Police crime data show no serious crimes happened in the 4400 or 4500 blocks of South Oakenwald Avenue Dec. 19 to Jan. 20.


“It’s a great neighborhood. Nothing like this has happened since I’ve been here,” on the block, said Roxanne Hubbard, who has lived in the neighborhood for 19 years.


As a matter of policy, Chicago Board of Education officials refuse to confirm whether any child is a student at Chicago Public Schools because a policy on student identification passed by the board several years ago has never been implemented.


Tribune reporter Liam Ford contributed.


jmdelgado@tribune.com





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BlackBerry 10 said to be inadequate for helping RIM overcome its ‘demons’






After hitting a seven-year low of $ 6.22 this past summer, shares of Research in Motion (RIMM) have rebounded and climbed more than 100% in the past six months. The company that was previously written off by Wall Street investors has seen a significant boost in recent months as anticipation grows for its BlackBerry 10 operating system. But while a number of analysts have voiced their support for RIM, not everyone is convinced.


[More from BGR: Apple’s 128GB iPad shows the world exactly what Apple does best]






Jan Dawson of Ovum explained, per Benzinga, that RIM continues to “face the twin demons of consumer-driven buying power and a chronic inability to appeal to mature market consumers,” and he believes BlackBerry 10 won’t change this. The analyst said that due to a strong user base of 79 million subscribers and profitability still in the black, the company will remain for years to come. He was quick to note, however, that its glory days are in the past and “it is only a matter of time before it reaches a natural end.”


[More from BGR: Apple unveils new 128GB iPad]


Dawson previously wrote that RIM’s strategy seems to be focused on building the best devices for current BlackBerry users “rather than something that will necessarily win converts from other platforms.”


“The points of differentiation RIM has focused on in teasers for the new platform confirm this – better multitasking, productivity, email, contacts and calendar applications and so on, rather than a better gaming, content consumption or social networking experience,” he said.


Shares of RIM are down more than 6% on Monday, a day before the company is set to unveil its BlackBerry 10 operating system.


This article was originally published on BGR.com


Gadgets News Headlines – Yahoo! News




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Justin Timberlake’s new album ’20/20′ is due out in March






(Reuters) – Singer-turned-actor Justin Timberlake has set a March date for his comeback album – his first in more than six years.


RCA Records said on Tuesday “The 20/20 Experience,” the former N’Sync boy band member’s follow-up to 2006′s “FutureSex/LoveSounds” and only his third album ever, would be released on March 19.






In recent years, Timberlake, 31, has focused more on films and business ventures ranging from restaurants to a clothing line, and reviving social networking site Myspace, of which he is part owner. He remarked in a recent video that creating music involved “physical torture” for him.


“Suit & Tie,” the first single off his forthcoming album, fell short of sales expectations for its first week. The song, featuring rapper Jay-Z, sold 314,000 downloads last week. Industry experts had expected about 350,000 downloads.


Top menswear designer Tom Ford collaborated with Timberlake, designing suits worn in the “Suit & Tie” video as well as styling the production and the release’s artwork.


Timberlake will perform his first concert in five years during a private Super Bowl-weekend event in New Orleans on February 2 at an invitation-only concert.


Timberlake posted on Twitter about the forthcoming game, saying among other things: “This is gonna be a GREAT Super Bowl!” and “Oh wait … I don’t have tickets. Dammit! Anybody know anybody?? LOL!”


(Reporting by Chris Michaud; Editing by Jill Serjeant and Philip Barbara)


Music News Headlines – Yahoo! News





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