Auto Safety Concerns Often Stay Secret

USA Today; February 25, 2013

Herman Ray Evans was killed when the tread separated on his 2001 Ford Explorer's tire, the vehicle rolled over into the median and he was ejected, according to the Daphne, Ala,. police crash report.

Evans was in one of at least 15 fatal tire-related crashes last year in Ford Explorers and Mercury Mountaineers, according to news reports. In Evans' crash, the police department did not find fault with the tiremaker or Ford Motor.

But from April 2002 through 2009, there were 375 similar deaths in mostly older-model Explorers and Mountaineers — nearly four times the number that led to the Ford/Firestone fiasco in 2000, according to an analysis of federal fatality data by the research firm Quality Control Systems. Still, neither the National Highway Traffic Safety Administration nor Ford Motor recalled the vehicles.

In a statement, Ford said it reviewed this issue with NHTSA and found the Explorer "has no unique tire issues." Ford says "numerous government safety agencies and independent organizations" have confirmed the Explorer's safety.

Although Ford is required to tell NHTSA about claims it receives about serious injuries and deaths in its vehicles — and NHTSA can investigate them — information about the probes and many of the injuries and deaths is only available to the public and news media through a Freedom of Information Act request. Even then, manufacturers can request the information they submit to the agency be kept confidential.

That's in sharp contrast to all the information posted on NHTSA's website about potential defects, injuries and deaths for the agency's official safety investigations. But informal investigations — where weeks or months can go by before potential problems are brought to the public's attention — are becoming more common. And that has ramifications for car buyers, who may not learn the vehicles they own or are considering buying have quietly raised safety concerns at NHTSA and among automakers.

Other examples:

• Hyundai recalled some of its Veracruz and Santa Fe SUVs in August 2011 because their air bags might not inflate in a crash. There was no public investigation or incidents, but in announcing the recall, Hyundai said it had been contacted by NHTSA about its nearly 8,000 warranty claims and 16 consumer complaints.

• Evenflo and NHTSA recalled more than 1 million Discovery child car seats in January 2008. But consumers didn't know the agency had been testing the seats for nearly a year because of concerns about how the seats fared in crash tests.

• And in November 2011, NHTSA announced it was opening a formal investigation of Chevrolet Volts — although it had been quietly testing Volts for six months after a car caught fire weeks after a crash test. The agency said it didn't consider that an investigation.

What these federal safety scenarios have in common is that they happened behind the scenes in what President Obama last week called "the most transparent administration in history" — even though questions about its transparency extend far beyond the halls of the U.S. Department of Transportation (DOT).

And they also involve an agency taken to task by Congress and DOT's Inspector General after the Ford/Firestone and the more recent Toyota sudden-acceleration cases. The issues: How NHTSA conducts its investigations of possible vehicle-related defects and how much information it publicly releases.

"It all goes back to the criticism for years: Where's the methodology? What are the thresholds? No one knows," says Sean Kane of Safety Research & Strategies. "It's a black art over there."

But NHTSA chief David Strickland disputes charges that his agency's methods are opaque and says if NHTSA isn't the most transparent agency in the federal government, it is certainly one of the most open.

"We definitely get information out to the consumer," he says.

The life cycle of a probe

Federal laws and regulations are both designed to prevent secrecy and written in ways that enable it.

Just what exactly signals the start of a formal public investigation falls into a gray area, both NHTSA critics and supporters agree. And that gives federal investigators considerable leeway when they want to work behind the scenes with the automakers they regulate.

The information that would be available to consumers and safety advocacy groups if early investigatory work were public includes testing, correspondence with manufacturers, injuries and deaths, says Allan Kam, a former NHTSA senior enforcement attorney.

On the other hand, delaying or deciding against starting a formal investigation can save automakers the bad press that comes from public probes — especially if they don't lead to a recall.

"Maybe the agency and the manufacturer know, but the public doesn't know and may want to provide input," Kam says.

NHTSA says the screening work it does to decide whether to open an investigation is sometimes confused with actually being an investigation. A public investigation is only opened when the agency has a reasonable belief a defect may have occurred, NHTSA says.

Strickland says NHTSA is able to do more pre-screening work these days, thanks to new data tools, "better technology and better exchanges with manufacturers." This non-public phase can last for months, depending on the complexity of the issue.

"Sometimes it's very fast; sometimes it lasts longer," he says.

But Kane, whose group does research for lawyers, engineering firms and the government, says he believes NHTSA carries this to an extreme so it can toil out of the harsh glare of public — and consumer advocate — scrutiny.

He calls NHTSA's work before it opened a formal probe of the Volt a "secret investigation" and questions how the agency could get a recall of the Evenflo car seat after doing the kind of testing usually considered part of a public investigation.

"If they can hide these kinds of investigations, there's more secrecy and it's less likely they're going to be accountable," Kane says.

To those in industry and government who suggest Kane pushes for public probes so the information is available to lawyers suing automakers, Kane notes, "The litigation isn't there unless people are killed or seriously injured."

The budget for NHTSA's Office of Defects Investigations nearly tripled in 2001, after all the news about Ford and Firestone injuries and deaths. Kane was instrumental in publicizing these issues after he uncovered what he calls a "secret recall" of tires by Firestone in Venezuela in 2000 that was then followed by a U.S. recall. In the past 20 years, the budget for the defects office has quadrupled.

Despite the increase and subsequent outcry over Toyota acceleration issues in 2009, the defects office has opened far fewer public investigations in each of the last three years than it had in nearly any of the previous 25 years.

"It seems logical to conclude that the reason there are fewer investigations is that they are doing more in the pre-investigation phase," says Kam, who worked in the defects office for 25 years until retiring in 2000.

Strickland says the agency shouldn't be judged by the number of public investigations it does: "The goal is to get recalls." In 2012, he notes, NHTSA defect investigations resulted in 134 vehicle recalls involving more than 9 million vehicles. That's the second highest number of recalls per investigation in the agency's history, he says.

The agency says it has gotten better at screening for defects, now that it gets what's known as "early warning reports" from automakers who have had to disclose data including warranty claims and injury and death reports to the agency since the post-Ford/Firestone law known as the TREAD Act. NHTSA also says it combs online car chat rooms and other sources for information.

NHTSA guidelines set timetables for how long each stage of an investigation should take, Kam says. That, he says, encourages the agency "to do more in the pre-investigatory phase because the clock doesn't start ticking until the investigation is opened."

Cars, trucks and child seats

These early-warning reports can lead NHTSA to launch a variety of little-known probes, including "Death Incident Inquiries," "Comprehensive Inquiries" and "Aggregate Inquiries" — all activities that resemble typical investigations but are done out of the public eye.

Advocacy group Public Citizen as well as Quality Control Systems separately sued the Transportation Department to get it to release the death and injury data it gets from automakers, and NHTSA agreed to release this information starting in 2008.

But Randy Whitfield, the statistician who heads Quality Control Systems, says he often has to make a FOIA request to get it.

Clarence Ditlow, who successfully led efforts in the late 1970s to get the informal early stage of defect investigations made public, believes information about NHTSA's death investigations eventually will become more public, too: "We'll get there," he says.

Kam, who now runs a highway-safety consulting firm that does work for companies or attorneys with matters before NHTSA, agrees the death reports should be readily available public information.

But if NHTSA were to do that, "Consumers wouldn't have any idea what to trust when it comes to the safety of their vehicles. There are fatalities every single hour of every single day," Strickland says.

To read the complete article, please click here:

Samsung Hires British Judge Who Said Apple Lacked Integrity

Fortune; February 28, 2013

Remember the British case that Apple lost to Samsung last July in which the judge ordered Apple to publish a notice in newspapers and on its website correcting the impression left by the trial that Samsung's Galaxy tablets had copied the iPad? It's back in the news, with a twist. Apple (AAPL), you may recall, complied with the unusual order, but in such a passive aggressive way -- adding its own marketing spin to the court's language and quoting the judge as saying Samsung's devices were "not as cool" as the iPad -- that a judge in London's highest court threw the book at them. Sir Robin Jacob admonished Apple in the strongest terms, ordering it to pay Samsung's legal fees on an "indemnity basis" (i.e. all possible costs, including parking, phone calls, etc. from day one), and spelling out precisely where Apple, in the language it added, basically lied. "I hope," Sir Robin wrote at the end of his ruling, "that the lack of integrity involved in this incident is entirely atypical of Apple." Here's the twist: Samsung has hired him as an expert witness. "I'm sure that Samsung and Sir Robin Jacob wouldn't be doing this if there was any risk of this conduct violating the law," writes FOSS Patents' Florian Mueller, who stumbled across Sir Robin's name in the expert list in a separate case before the ITC. But, Mueller adds: "For someone so concerned with 'integrity,' it is utterly unusual to issue a high-profile and extreme ruling in favor of a particular party (Samsung in this case) only to be hired as an expert by that same party in another dispute." - See more at: - See more at:

BP Goes on Trial for Biggest U.S. Oil Spill

Thomson Reuters; February 25, 2013

A long-awaited trial over the biggest U.S. offshore oil spill began on Monday, with governments, businesses and individuals blaming BP Plc mostly for the 2010 disaster that killed 11 rig workers and spilled 4 million barrels of oil into the Gulf of Mexico.

"Not only was it within BP's power to prevent the tragedy, it was its responsibility," Mike Underhill, a U.S. Justice Department trial attorney, said at the trial over legal culpability for the blowout and spill.

The trial is being held with no jury before Judge Carl Barbier at federal court in New Orleans.

Lawyers for other plaintiffs also slammed BP executives, as did attorneys for two of the well owner's co-defendants, rig owner Transocean Ltd and cement services provider Halliburton Co. BP lawyer Mike Brock said the blame was shared by all three companies.

BP must show that its mistakes do not meet the legal definition of gross negligence required for the highest amount of damages. BP has already spent or committed $37 billion on cleanup, restoration, payouts, settlements and fines.

Beyond that, liabilities could stretch into the tens of billions of dollars if Barbier determines BP or the other defendants were grossly negligent. Oil came ashore from Texas to Florida, threatening livelihoods and state economies dependent on seafood and tourism, so the list of plaintiffs is long.

Most observers expect the case to be settled before the trial results in a verdict.

Underhill said that less than an hour before BP's long-troublesome Macondo well ruptured and caused an explosion, BP's top well site leader on the rig called an engineer in Houston to discuss a critical pressure test that indicated problems.

Company officials did not stop the operation and "11 souls had 47 minutes to live the rest of their lives," Underhill said.

Underhill said the accident could have been avoided if onshore engineer Mark Hafle and well site leader Don Vidrine on the rig had done their jobs. Vidrine faces separate criminal charges in the disaster, as does Robert Kaluza, the other highest-ranking supervisor aboard the rig before the disaster.

Jim Roy, an attorney for other plaintiffs suing BP, Transocean, Halliburton and others, said BP executives at the highest level felt pressure to push output to the limit.

"Production over protection. Profits over safety," said Roy, who represents plaintiffs who did not take part in an $8.5 billion settlement BP struck last year.

Roy also said Transocean opened the door to disaster with poor staff training and poor maintenance of seabed equipment, while Halliburton made substandard cement to plug the well.

Transocean's lawyer, Brad Brian, came out swinging against BP, saying rig workers trusted the company and died betrayed.

Brian noted BP employees had referred to Macondo as a "well from Hell" in emails, and the inaction following Vidrine and Hafle's 8-minute phone call showed they did what BP had done for two months in the face of a risky well: "They did nothing."

Halliburton's lawyer, Don Godwin, made similar arguments about BP but also said Transocean's rig crew should have shut in the well at the first sign of trouble. "Now is when they want to pass the buck and blame my client for their misdeeds," he said.

And David Beck, the lawyer for Cameron International , maker of the blowout preventer atop the well, said the structure works in tandem with other efforts to prevent disaster.

"It's a blowout preventer. It is not a blowout stopper," Beck said.

In BP's opening statement, Brock said the misinterpretation of the pressure test was made along with Transocean. "It was a mistake made by several men with two companies," Brock said. "They should not have accepted it, but it was a mistake."



Louisiana continues to suffer from the oil spill, state Attorney General Buddy Caldwell said on Monday, with hundreds of miles of coastline still being polluted "less than 30 miles from the door of this courthouse."

Barbier, overseeing the trial, has deep Gulf Coast roots. Born in New Orleans in 1944, he went to Southeastern Louisiana University and Loyola University New Orleans School of Law. He had a private practice for years in New Orleans before President Bill Clinton tapped him for the federal bench in 1998.

The judge, who handled several high-profile cases stemming from Hurricane Katrina, had postponed the BP trial by more than a month. An army of media have descended on New Orleans to cover it, and the delay avoided a clash with the NFL Super Bowl on Feb. 3 or the Mardi Gras festival on Feb. 12.

The fact that the case has not yet settled surprises many. "I never thought that they intended to try this case and really cannot afford to do so because the exposure is too potentially catastrophic," said Blaine LeCesne, a professor at Loyola University College of Law in New Orleans.

The trial's first phase focuses on how much each company is to blame and the degree of negligence. Luther Strange, Alabama's attorney general, said he would seek to show BP, Transocean and Halliburton all acted with "gross negligence and willful misconduct" and therefore would owe his state punitive damages.

Simple negligence involves mistakes. Gross negligence involves reckless or willful disregard for human and environmental safety and is difficult to prove, experts say.

BP has consistently denied it was grossly negligent.

Any punitive damages would come on top of billions in potential fines under the Clean Water Act. The payout by BP so far included a record $4.5 billion in penalties, and a guilty plea to 14 criminal counts to resolve charges from the Justice Department and civil claims from U.S. securities regulators.

BP has sold assets to help cover its spill-related costs, including its older, smaller Gulf of Mexico operations.

The second phase of the trial, expected to start in September, will focus on the flow rate of the oil that spewed from the well. The third phase in 2014 will consider damages.

The case is In re: Oil Spill by the Oil Rig "Deepwater Horizon" in the Gulf of Mexico, on April 20, 2010, No. 10-md-02179, in the U.S. District Court, Eastern District of Louisiana.

Trayvon Martin’s Parents Ready to Let Jury Decide Fate of Son’s Killer

CNN; February 26, 2013

The final, violent moments in the life of their son, Trayvon Martin, no longer dominate the national news, as they once did. Tens of thousands no longer attend rallies demanding justice for the slain teenager; pundits no longer debate the case on every media platform imaginable. What once had been the big story has increasingly become yesterday's news.

But Sybrina Fulton and Tracy Martin haven't stopped fighting.

One year ago Tuesday, they were grieving and relatively anonymous parents, trying to come to grips with the sudden death of their 17-year-old son. But in time, they became celebrities of sorts in a world of gun violence and vigilante justice.

To their supporters, they were the faces and the voices of victims of racial profiling.

While the spotlight largely has faded since then, they say their commitment has not.

"We (want to) make sure that no other parents have to go through what we have gone through in the last year," Fulton told CNN's Piers Morgan on Monday night.

On February 26, 2012, her teenage son was walking back to the Sanford, Florida, home of his father's fiancee after picking up some Skittles and an iced tea at 7-Eleven. That's when, and where, then-28-year-old neighborhood watch volunteer George Zimmerman spotted him.

What happened the night Trayvon Martin died

What happened between then and when Zimmerman fatally shot the teen is subject to dispute, one that could be settled by a jury starting June 10, when Zimmerman is set to go on trial on a second-degree murder charge.

As the prosecution and defense lawyers battled in court in the weeks and months that followed, Trayvon Martin's parents became less visible on the national scene.

But they've still been active, said Fulton, including continuing to work on behalf of the Justice for Trayvon Martin Foundation, which they started.

They held a benefit dinner for the nonprofit organization, as well as a peace walk in Miami "to let teenagers know they have a right to walk in peace," she said Monday. On Tuesday, the anniversary of their son's death, they'll be in New York for a candlelight vigil.

Their efforts include continuing to speak out on issues. Among them is gun violence, a debate over which is brewing in Washington and nationwide after several grisly mass shootings, including one that left 20 children and 6 adults dead at a Connecticut elementary school last December.

"It's just too much senseless violence; it's overwhelming the homes right now," Tracy Martin said Monday, referring to the Newtown massacre as well as murders in places like Chicago. "We, as parents, certainly feel the pain."

Even as they continue to fight, Trayvon Martin's parents acknowledge that -- after months in the spotlight, trying to ramp up pressure on authorities to go after Zimmerman -- much about their son's case is now out of their hands.

Their lawyer, Benjamin Crump, on Monday asked rhetorically if Zimmerman is "not held accountable, what message does that send to the next child that's killed, unarmed, on the ground?"

Still, Sybrina Fulton said that, to a large extent, she and her ex-husband have gotten what they asked for. Zimmerman was arrested and, unless something unforeseen happens, he will stand trial.

"We just want to have that trial, and let the jury decide," she said. "And whatever decision comes out of that, we're going to accept that.

"We may not like it, but we're going to accept it."

The jury will have to decide between two starkly different versions of what happened that night.

Zimmerman told police that, after the two exchanged words, Martin went after him. According to his account, the teen, who didn't have any weapons on him, punched him, forced him to the ground, and slammed his head on the concrete. That's when Zimmerman shot Martin in self-defense, he claims.

Martin's family and supporters, though, have long had a different story.

One of the first to tell it was Tracy Martin, who initially addressed reporters last March 8, trying to raise the case's profile and hike pressure on authorities. He and, soon, others suggested Zimmerman had targeted his son, an African-American youth wearing a hooded sweatshirt, because of his race.

Timeline of events in the Trayvon Martin case

The parents' legion of supporters grew exponentially as the weeks wore on after the shooting, with no one charged. They created a petition on the website calling for Zimmerman's arrest. Within a week, it was the second most-popular petition in the website's history, with 877,110 signatures.

Protests drawing thousands of people sprung up nationwide demanding "Justice for Trayvon" and blasting local authorities' response. As their reason for not immediately arresting Zimmerman, police cited Florida's "stand your ground" law, which states that people who feel threatened don't have to retreat from danger and can use deadly force to protect themselves.

Zimmerman was charged on April 11, with a probable cause affidavit stating he "profiled" Martin and disregarded a 911 dispatcher's request that he wait for police.

The weeks that followed produced more news. For example, Zimmerman posted $150,000 bail, only to have it revoked after the judge said he'd mislead the court about his financial situation, including tens of thousands of dollars he'd raised online for his defense fund.

Woman Freed after ’05 Conviction Tossed: ‘Just glad to be Free’

Chicago Tribune; February 25, 2013

Nicole Harris, who has been locked up since the 2005 death of her son, walked out of an Illinois prison today after an appeals court threw out her murder conviction.

Harris emerged from Dwight Correctional Center in front of a gathering of news crews after being reunited with her other son.

"I'm just overwhelmed and I'm thankful that's it's going to be over and I just want to be home with my son," Harris told the assembled media.

"I'm just ready to get on with my life and hold my son."

The Chicago woman was 23 when a jury found her guilty of killing her 4-year-old son Jaquari in their Northwest Side apartment following her confession to authorities. But Harris has long maintained that her confession was false and the result of threats and manipulation by police.

She said today that she was able to make it through the past seven years knowing that "I'm innocent and the truth will come out."

"It was like at some point I just knew this isn't it, that this was not my final destination."

In a 90-page ruling last October that vacated her conviction, the 7th Circuit U.S. Court of Appeals said there were "many reasons" to question her confession.

The appeal judges also ruled that Diante, then 5, should have been allowed to testify.

Now 14, Diante was the first person to meet Harris when she was released into an outer room of the prison at about 11:30 a.m. today.  Diante walked in bearing a balloon that read, "It's your Day" and a teddy bear. Harris threw her arms around him, wept softly and kissed him.

When asked later what it was like to see her son at that time, she said, "There are no words."

At exactly noon, a prison official told Harris she was "free to go." She clutched hands with a close friend and walked out of the prison. She had been told to get her things together around 8:30 a.m. this morning, she told the media, and said that, at that time, "I was beyond anxious."

Jaquari had been found dead with an elastic bedsheet cord wrapped around his neck. Diante had told authorities that he was alone with Jaquari when he saw him wrap the cord around his neck while playing.

Prosecutors, who argued that Diante also said he was asleep when Jaquari died, accused Harris of strangling Jaquari with the cord because she was angry he would not stop crying.

Harris' release, which the state argued against, is not the end of legal battle. The state has appealed the October ruling, asking the U.S. Supreme Court to review the case. In addition, Cook County prosecutors could still move to retry her. A representative from the state's attorney's office said no decision on a retrial has been made.

For now, Harris said, "I just want to enjoy life."

"I'm just glad to be free. I'm just glad to be free.",0,5508782.story


Timeline of Gulf Oil Spill and Ensuing Legal Cases

ABC News, Associated Press; February 25, 2013

Timeline of the massive 2010 Gulf of Mexico oil spill, government response and ensuing legal cases:

— April 20, 2010: An explosion and fire on the BP-operated drilling rig Deepwater Horizon kill 11 workers about 50 miles off the Louisiana coast. The rig sinks less than two days later; crude oil begins gushing into the Gulf from the blown-out Macondo well about a mile below the Gulf surface. Before the well is capped, an estimated 200 million gallons of oil escape.

— April 29, 2010: President Barack Obama makes his first public statement about "the worsening oil spill." He pledges "every single available resource" to contain the slick, including Pentagon assistance if necessary. Oil from the well makes landfall near the mouth of the Mississippi River. Over several months, sensitive marshlands and fishing grounds across the northern Gulf coast are fouled.

— May 14, 2010: Then-BP CEO Tony Hayward says the amount of spilled oil is relatively small given the size of the Gulf. "The Gulf of Mexico is a very big ocean," he says. "The amount of volume of oil and dispersant we are putting into it is tiny in relation to the total water volume."

— May 28, 2010: Hayward says the "top kill" effort to plug the well with mud is progressing as planned and has a 60 to 70 percent chance of success. The next day the company announces the effort has failed.

— May 30, 2010: Hayward shocks Gulf residents when he says "I'd like my life back," an apparent reference to the intensity of dealing with the spill. He also disputes scientists' claims that there are large plumes of oil under the Gulf surface.

— June 16, 2010: BP agrees to put $20 billion into an escrow fund to settle economic injury claims by fishermen and various Gulf industries.

— June 22, 2010: A federal judge strikes down the Obama administration's six-month ban on deepwater drilling in the Gulf, saying the government rashly concluded that other rigs could be in immediate danger.

— July 1, 2010: Based on the high end of government estimates, the spill surpasses the 140-million-gallon mark. That eclipses the 1979 Ixtoc disaster in the southern Gulf and means the BP spill now ranks as the biggest offshore oil spill during peacetime.

— July 15, 2010: After 85 days, BP manages to stanch the leak with a massive cap. The cap holds until a more permanent solution is put into place.

— July 26, 2010: BP says Hayward, who is British, will step down on Oct. 1 and be succeeded by American Robert Dudley. BP said it planned to recommend Hayward for a non-executive board position at its joint venture in Russia.

— September 19, 2010: Federal officials say the well has been permanently sealed after workers drill a relief well into the damaged one and insert a cement plug.

— October 12, 2010: Obama's administration lifts the six-month moratorium on deepwater oil drilling in the Gulf. Interior Secretary Ken Salazar says new rules imposed after the BP spill have strengthened safety measures.

— December 15, 2010: The Justice Department files suit against BP and eight other companies over the accident, asking they be held liable for removal costs and damages caused by the explosion and spill.

— January 12, 2011: A 380-page report from government-appointed National Oil Spill Commission finds that time- and money-saving decisions created an unreasonable amount of risk that triggered the Deepwater Horizon explosion.

To read the complete timeline, please click here:

Johnson & Johnson’s Regulatory Filing Indicates Two Government Probes

NewsInferno; February 22, 2013

In separate disclosures, Johnson & Johnson, stated that government investigations are underway concerning two of its medical device products. Johnson & Johnson is the world’s largest health care products manufacturer and the products in question have been making headlines in recent days.

The now-recalled DePuy Orthopaedics ASR hip device and the mesh Johnson & Johnson uses in hernia and transvaginal surgeries are both involved in the government probes, according to Bloomberg Businessweek. The DePuy ASR is being investigated over potential false claims accusations, while the way in which surgical mesh was marketed is being probed. DePuy Orthopaedics is a unit of Johnson & Johnson.

As we’ve long noted, both devices were approved through a fast-track process known as the 510(k), which means that a formal review for safety and efficacy was neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, the process has drawn increasing criticism.

The U.S. Justice Department requested documents on whether DePuy might have provided false claims to federal health care programs over its ASR XL hip devices, Johnson & Johnson stated in a regulatory filing. The filing, noted Bloomberg Businessweek, also indicated that the ASR hip devices were recalled in August 2010 and that a multi-state investigation is underway in California over the marketing of its surgical mesh.

Johnson & Johnson stated that it is “fully cooperating” with both the Justice Department’s civil division and the U.S. Attorney’s Office in Massachusetts after it received an informal request over the summer. The request involved the way in which the ASR hip devices were marketed and used, said Bloomberg Businessweek. “The government is investigating whether any person or entity submitted or caused to be submitted false claims or false statements affecting federal health-care programs in connection with the marketing and use of the ASR XL hip device,” said Johnson & Johnson in the filing. “The government has since made additional informal requests for the production of documents.”

Meanwhile, increasing adverse event report claims of hip device failure and the ultimate recall of 93,000 ASR hip devices prompted mounting lawsuits with more than 10,000 cases pending in the United States over the DePuy ASR. Claims include allegations that the device maker not only defectively designed the device, but also neglected to warn of its potential risks. At the time of the recall, noted Bloomberg Businessweek, Johnson & Johnson acknowledged that 12 percent of the devices failed in the United Kingdom. Since, reports of much higher failure rates have been reported. The first trial is now being heard in California state court.

Regarding its mesh devices, the attorney general of California contacted Johnson & Johnson this past October concerning an investigation into how hernia and urogynecological mesh were marketed, said Bloomberg Businessweek. That probe encompasses 42 states, said Johnson & Johnson.

As we’ve explained, transvaginal mesh is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Complication reports, mounting litigation, and concerns over the lack of clinical testing have raised questions about the devices’ safety, Johnson & Johnson now faces some 1,800 lawsuits over its Gynecare Prolift vaginal mesh implant; the case is being heard in state court in Atlantic City, New Jersey and the jury is in the midst of deliberations, said Bloomberg Businessweek.

Last July, the U.S. Food & Drug Administration said that the mesh has no clear advantage over non-mesh methods for treating POP and may actually present additional risks. The FDA went on to say that most POP cases can be successfully treated without the use of transvaginal mesh. In June, Johnson & Johnson told a judge that it will no longer sell four types of transvaginal mesh implants, including the Prolift, Prolift + M, TVT Secur, and Prosima. The company also asked that the FDA postpone post-market safety studies of the devices. Bloomberg Businessweek noted that Johnson & Johnson stated that it was ending worldwide sales of the device because of the products’ lack of commercial viability, not over any alleged safety or efficacy issues.

Nearly One-Third of Chemotherapy Used is Prescribed Off-Label

NewsInferno; February 20, 2013

Some one-third of the chemotherapy drugs used to treat cancer were never approved by federal regulators to fight the cancers they are used for, according to an emerging study.

Chemotherapy drugs, approved by the U.S. Food and Drug Administration (FDA) to fight specific cancers, are often prescribed off-label to treat other tumors for which the drugs are not approved, explained Reuters Health, As we’ve explained, physicians are free to prescribe drugs in a so-called “off-label” way, meaning that an approved medication may be prescribed for a non-approved purpose.

Chemotherapies are types of drugs used to destroy or slow down the growth of cancer cells, which rapidly increase and divide, explained WebMD. The drugs are also known to damage healthy and rapidly dividing cells such as those lining the mouth or intestines or that cause hair to grow. Chemotherapies are known to cause significant side effects.

Chemotherapy can, depending on the cancer type and its stage, cure or control cancer or ease it symptoms and can be used alone or in collaboration with surgery, radiation therapy, or biological therapy, WebMD noted. The type of chemotherapy used depends on the type of cancer involved; some drugs are used in the treatment of a broad array of cancers. While others are used for one or two specific cancers.

Researchers questioned of physicians have been prescribing chemotherapies—very costly and toxic drugs—for unapproved uses, said the study team, which was led by Rena Conti, an assistant professor of health policy and economics at the University of Chicago, said Reuters Health. “The main criticism of off-label prescribing has been the concern that it jeopardizes patient safety because the full risk-benefit ratio is often not completely understood,” wrote University of Toronto’s Dr. Monika Krzyzanowska, according to Reuters Health. Krzyzanowska published an editorial accompanying the study that appeared in the Journal of Clinical Oncology yesterday.

Despite this, said Conti, billions of dollars are spent on off-label chemotherapies and are wasted. “We don’t know what the outcomes are. We can’t make a judgment of whether the off-label use we document … is appropriate or inappropriate,” Conti said, wrote Reuters Health.

For the study, the team used a national prescription database from United States oncologists to estimate how the most commonly used intravenous or injected chemotherapies were used in 2010. The researchers discovered that 10 chemotherapies were patent-protected from competition and ranged from nearly 500,000 doses of Genentech’s Avastin (bevacizumab), which is approved to treat brain, colorectal, lung, and kidney cancers, to about 53,000 doses of Celegene’s Vidaza (azacitidine), which is used in the treatment of specific blood disorders, said Reuters Health. The study found that 70 percent of the doses were used for approved treatments; 30 percent were used off-label.

The researchers also reviewed off-label chemotherapies use and how those uses were supported by the National Comprehensive Care Network (NCCN), which publishes its own cancer care guidelines, said Reuters Health. The team learned that 14 percent of chemotherapies were prescribed off label and supported by the NCCN’s expert opinion; 10 percent were prescribed with no NCCN or FDA support. This is significant because, as Conti explained to Reuters Health, physicians will follow guidelines from expert organizations when insufficient data is available for the federal regulator to make a decision; for instance, when treating rare diseases that are challenging to research in a clinical trial, said Reuters Health.

Conti and her colleagues noted that some researchers have criticized NCCN recommendations, given both potential delays in releasing guidelines based on current data and possible conflicts of interests, Reuters Health explained. Of the $12 billion spent on chemotherapies in 2010, $4.5 billion was spent on off-label chemotherapies and $2.5 billion was spent on non-NCCN-supported uses.

“To me it’s a little troubling that so many drugs are given in areas where there is not a lot of data to back it up,” Dr. Nancy Keating, a cancer researcher not involved with the research, told Reuters Health. “The tricky thing is patients with cancer and their doctors are looking for anything with a benefit. So I think they’re sometimes willing to try things where there isn’t as much data as you would like,” said Keating, who is from Boston’s Harvard Medical School and Brigham and Women’s Hospital.

Conti said the research did not conclude if patients prescribed on-label chemotherapy fared better than those receiving off-label chemotherapy. “What our study basically does is highlight this proportion of use that is off-label and endorsed by expert opinion, or off-label and not endorsed by expert opinion,” Conti told Reuters Health. Conti pointed out that the study also revealed that the use of chemotherapies is driven by FDA approval and expert opinion, while treatments prescribed with no expert or FDA backing, may be over a lack of available treatments, said Reuters Health.

U.S. Justices Agree to Weigh Defendant’s Self-incrimination Claim

Thomson Reuters; February 25, 2013

The U.S. Supreme Court agreed on Monday to consider whether a criminal defendant's right against self-incrimination is violated when a psychiatrist who examined him testifies about his mental state.

Scott Cheever was sentenced to death for killing Greenwood County, Kansas, Sheriff Matthew Samuels while officers sought to enforce a warrant for his arrest in January 2005.

Cheever's defense was that he was intoxicated after using methamphetamine and therefore incapable of the premeditation necessary for him to be convicted of murder and attempted murder.

The legal question is whether Cheever's Fifth Amendment right against self-incrimination was violated when the state called a psychiatrist who had examined Cheever to testify in order to rebut the claim that the defendant was incapable of rational thought.

The psychiatrist's testimony was based in part on what Cheever had said to him during the evaluation. The Kansas Supreme Court ruled in Cheever's favor.

Oral argument and a decision are expected in the U.S. Supreme Court's next term, which begins in October and runs until June 2014.

The case is Kansas v. Cheever, U.S. Supreme Court, No. 12-609.

Supreme Court to Hear Claim over Withdrawn Guilty Plea

Thomson Reuters; February 25, 2013

The U.S. Supreme Court agreed on Monday to consider whether a lower court erred in throwing out a murder conviction of a transgender man accused of killing his wealthy uncle so he could use money from the estate for a sex-change operation.

Vonlee Titlow claimed his trial lawyer was constitutionally ineffective by giving him bad advice in urging that he withdraw his guilty plea to the lesser charge of manslaughter and go to trial over the August 2000 death of his uncle, Donald Rogers.

Prosecutors said Titlow agreed to help his aunt, Billie Rogers, kill his uncle so she could inherit Donald Rogers' estate and ultimately pass some of the money to him.

The manslaughter plea could have subjected Titlow to a seven- to 15-year prison term, but Titlow was later convicted by an Oakland County, Michigan, state court jury of second-degree murder and sentenced to 20 to 40 years in prison.

On May 22, the 6th U.S. Circuit Court of Appeals threw out the conviction, saying Titlow's trial lawyer did not investigate the case. The court said that had the lawyer done so properly he would, or should, have recommended that Titlow not withdraw his plea.

It cited a 2012 Supreme Court precedent, Lafler v. Cooper, which held that the right of criminal defendants under the Sixth Amendment to the U.S. Constitution to effective assistance of counsel extended to the plea bargaining process.

Nineteen U.S. states supported Michigan's appeal.

Oral argument and a decision are expected in the court's next term, which runs from October 2013 to June 2014.

The case is Burt v. Titlow, U.S. Supreme Court, No. 12-414.

Pharma Execs Shape Industry Response to Litigation – Study

Thomson Reuters; February 25, 2013

Pharmaceutical executives play an important, but often unseen role in how their companies react to product liability lawsuits, says a new paper from the RAND Institute for Civil Justice, a centrist research and policy think tank.

The paper, released last week, argues that drug industry executives who evaluate legal liability and choose how to respond to a lawsuit play a large role in determining the economic impact of pharmaceutical product liability litigation.

Dr. Steven Garber, the author of "Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals," said most people assume that court decisions lead directly to positive or negative outcomes. For example, the business community might conclude that a large payout in a mass tort case would chill innovation in similar product areas, while consumer advocates might believe that such a payout would enhance compliance with regulations.

Litigation itself does not cause those outcomes, howevever; instead, it informs executives' decisions on how the company should proceed, Garber says. Judges might consider how their rulings will affect not just the plaintiff in question, but other pharmaceutical executives at other companies.

In conducting the study, Garber analyzed half a dozen mass tort claims that resulted in large payouts by defendants to try to get inside the heads of company executives.

"If we want to understand how liability affects those outcomes, we need to analyze carefully how we expect company decisionmakers to respond to legal decisions," said Garber.

Hunter Shkolnik, a senior partner at Napoli Bern Ripka Shkolnik, LLP who has represented plaintiffs in mass tort claims against pharmaceutical companies, said litigation was an important tool in keeping pharmaceutical companies compliant with the law.

"Companies are making decisions about drugs through marketing, and how much they can make with it. They are not thinking at all about their risks," Shkolnik said.

John Beisner, co-head of the co-head of the Mass Torts and Insurance Litigation Group at Skadden, Arps, Slate, Meagher & Flom LLP, said litigation by nature is an inefficient way to influence pharmaceutical executives.

"Whoever's making those decisions, if they're simply trying to guess what litigation will arise down the road, that's not very effective regulation because it's so hard to predict, especially when most of the individuals who are bringing the litigation are profit driven," Beisner said. "It's much more efficient to tell someone in advance, 'Here's what you should do or not do,' rather than after the fact."

Shkolnik said few pharmaceutical companies viewed litigatoin as a deterrent.

"It's not the fear of it that changes them, it's the actual lawsuit that changes them. Had they done the right thing with these drugs, they wouldn't have had these billion dollar lawsuits."

Without the threat of product liability suits, Shkolnik said, "There is no one guarding the henhouse."

To Practice Law, Apprentice First

The New York Times, February 17, 2013

THE American Bar Association, which sets the standards for accrediting law schools, met recently in Dallas at a time of existential crisis for legal education. The job market for law school graduates is collapsing; some schools have been misleading, or even fraudulent, in reporting admissions and employment data; tuition and student debt have reached record levels. Some question legal education itself: What is its mission? What value does it add?

Those are legitimate questions. But to answer them for legal education, we also need to ask them of the profession.

Consider this: Nearly half of those who graduated from law school in 2011 did not quickly find full-time, long-term work as lawyers. Yet the need for legal representation has never been greater. In New Jersey, where I teach law, 99 percent of the 172,000 defendants in landlord-tenant disputes last year lacked legal counsel.

Nationwide, judges decry not a surplus of lawyers, but a lack of competent representation for those who aren’t rich individuals and corporations.

Lawyers cost too much in part because of rates established during the economic bubbles of the past 15 years. No less than in the dot-com or real-estate or derivatives markets, the cost of legal services became unsustainable. The recession worsened, but did not cause, the predicament now: a mountain of student debt and dearth of legal jobs, even as there is a crying need for legal services.

Legal education has not so much failed the profession as mirrored it. Law schools have trained students for a profession that has left a huge part of the public unable to afford representation — especially the middle class — and at a cost that perpetuates the problem.

There is a way out. Law schools and the legal profession could restore a vibrant job market by making representation easier to obtain. In doing so, they would revive their historic commitment to the balance between acquiring wealth and promoting civic virtue.

The New York State courts took a step in that direction recently by requiring pro bono service as a condition for admission to the bar. That is laudable, but many law schools already encourage or require pro bono service. That proposal doesn’t address the deeper problem: the disconnect between cost and need.

That disconnect relates to how lawyers are hired. Big firms have been hiring a few graduates from a few select schools, and paying them exorbitantly. The result: These law-firm associates provide services, like document review or memo drafting, at rates that their competence and experience don’t merit. In a recession, clients resist paying the rates; now, firms resist hiring new lawyers.

Let’s scrap this system. We need, at its entry level, the equivalent of a medical residency. Law school graduates would practice for two years or so, under experienced supervision, at reduced hourly rates; repaying their debts could be suspended, as it is for medical residents.

Law firms would be able to hire more lawyers, at the lower rates, and give talented graduates of less prestigious institutions a chance to shine. The firms, at the end of the residencies, could then select whom to keep. Even for those who don’t make the cut, the residency will have provided valuable experience. The law firms should be required, under this proposal, to offer stipends to help those residents who don’t make the cut but have debt burdens.

In theory, there would be no restriction on the types of matters residents could undertake. At Rutgers, where I teach, students in clinics work on commercial transactions as well as criminal cases. Many states restrict the activities of law students; but residents, as new lawyers, would be able to litigate and give legal advice without restriction.

This scheme would reduce the cost of legal services; rates would vary according to the attorneys’ experience levels and the clients’ abilities to pay.

Every form of legal practice could benefit, not just pro bono work. The largest firms would use the legal residents on large institutional matters and use the savings to lower hourly rates for clients. Large and small firms could afford to serve people who can’t afford legal services but don’t qualify for pro bono aid: the middle class. (Many of the indigent already qualify for free representation.)

Schools are already experimenting: Mine is about to start a postgraduate, nonprofit law clinic/firm staffed by recent graduates, under supervision, to represent lower-middle-class clients.

The greatest benefit, however, would be the recovery of an ethic of legal practice that has been greatly diminished. At its best, law protects the vulnerable, safeguards liberty and serves the public. By embracing a residency model, the profession can rebalance the tension between profit and service.

John J. Farmer Jr., a former attorney general of New Jersey and senior counsel to the 9/11 Commission, is the dean of Rutgers School of Law in Newark.

Lawsuits Begin Over Carnival Cruise Ordeal

NewsInferno; February 18, 2013

Less than 24 hours after the Carnival Triumph cruise ship docked in Mobile, Alabama, a Texas woman has filed a lawsuit against Carnival Cruise Line over the “horrifying” conditions on the ship.

Cassie Terry of Brazoria County, Texas, is suing the cruise line for physical and emotional harm, The Washington Times reports. An engine-room fire disabled the ship on February 10 and it took four days to tow the Triumph back to Mobile. Without power, there was no air conditioning or ventilation and water pressure was inadequate for toilets and showers to function. Toilets overflowed and, Miss Terry said, she and fellow passengers had to wade through human feces in passageways. Many passengers slept in makeshift tents on the ship’s decks to escape the darkness, stench, and squalid conditions inside the ship.

The lawsuit alleges that the “Plaintiff was forced to endure unbearable and horrendous odors on the filthy and disabled vessel, and wade through human feces in order to reach food lines where the wait was counted in hours, only to receive rations of spoiled food,” according to The Los Angeles Times.

Gerry Cahill, Carnival’s CEO went aboard the ship on Thursday to apologize to the passengers. Carnival said every passenger will receive a full refund for this cruise, discounts on a future cruise, and $500 in compensation.


Merck to Pay $688M to Settle Vytorin Lawsuits

NewsInferno; February 18, 2013

After reportedly reaching an agreement in principle, Merck has reached a settlement in which it will pay $688 million to resolve two class-action lawsuits over its cholesterol drug, Vytorin (ezetimibe/simvastatin).

Merck said it reached the agreement in principle with plaintiffs who alleged that drug makers Merck and Schering-Plough put off releasing the details of unfavorable clinical trial results, specifically from the ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) trial, said Cardiovascular Business.

ENHANCE involved 720 patients who were diagnosed with heterozygous familial hypercholesterolemia and who either received ezetimibe/simvastatin 10/80 mg or simvastatin 80 mg alone over a two-year period.

According to Cardiovascular Business, the plaintiffs were a group of investors who purchased securities issued by Merck and Schering-Plough between December 2006 and March 2008. The plaintiffs claim they suffered losses when the ENHANCE trial results were published in early 2008.

The lawsuits are pending in the U.S. District Court for the District of New Jersey against Merck and Schering-Plough, as well as some current and former officers and directors, said Cardiovascular Business. Merck and Schering-Plough jointly marketed Vytorin.

Under the proposal, Merck will pay $215 million to resolve the securities class action against the Merck defendants and $473 million to resolve the securities class action against the Schering-Plough defendants, said Cardiovascular Business, citing the proposed agreement. The agreement, which is subject to court approval, contains no admission of liability or wrongdoing.

Merck recorded a pre-tax and after-tax charge of $493 million, an anticipation of insurance recoveries and in connection with the settlement, Cardiovascular Business reported.

Meanwhile, we previously wrote that people who use statins such as Vytorin to lower their cholesterol may face a higher risk of developing age-related cataracts, according to a study published late last year in Optometry and Vision Science. According to the study, the association between statins and cataracts may be equal to the association with Type 2 diabetes, a known risk factor for age-relegated cataracts. That’s significant, because statin use is generally higher among Type 2 diabetics, compared to the general population. Statins, which are used to lower blood cholesterol levels, rank among the best selling drugs in the world.

Prior to that, we wrote that the U.S. Food & Drug Administration (FDA) warned that statins, including Vytorin, cannot only raise blood sugar levels, but may cause memory loss. The labels for the drugs were updated to include information about these possible statin side effects.


Study: Hip Implants Likelier to Fail in Women

NewsInferno; February 19, 2013

Hip implant failure rates are greater in women than men, according to a recent study conducted at the Southern California Permanente Research Group in San Diego, California.

The research revealed that hip implant failure rates were 29 percent higher in women than men based on information from a large United States registry study, said MedPage Today. The team controlled for factors such as device type and adjusted for age, body mass index, diabetes status, degree of presurgical symptom severity, implant fixation method, device category, and femoral head size, MedPage Today said. Study results appear online in JAMA Internal Medicine.

The team, led by Maria C.S. Inacia, MS, followed 35,140 patients who were undergoing primary total hip arthroplasty for a median period of three years. The failure rate in women was 2.3 percent, said MedPage Today, compared to a 1.9 percent failure rate seen in men, said Inacia. The risk was greatest in so-called “aseptic” revision surgeries.

Larger femoral head sizes caused more problems in women. In head sizes of 36 mm or greater, the adjusted failure rate in women, when compared to men, was 1.49; differences in revision rates involving smaller head sizes were not found to be significant after adjustments, MedPage Today explained. Increased risks in women also appeared to be concentrated in metal-on-metal implants. In fact, the risk was doubled for women when these metal devices were involved.

Data for the current study was derived from the Kaiser Permanente system’s registry of total joint replacements from 2001 to 2010; procedures were conducted at 46 hospitals in California, Hawaii, Oregon, Washington, and Colorado by 319 different surgeons, said MedPage Today. The registry is the largest of its type in the U.S., according to the study’s authors, and includes data on surgeons’ and hospitals’ arthroplasty procedure volumes; patients and the type of implants they received (cemented, uncemented, or hybrid); and the implant bearing surface (metal-on-metal, metal or ceramic on highly crosslinked polyethylene, or ceramic-on-ceramic. The researchers put the DePuy metal-on-metal hip resurfacing monoblock device in a category of its own, MedPage Today noted. Patients undergoing unilateral procedures—procedures on one hip—were included and more than half (58 percent) of the 35,140 procedures were conducted on women with a mean age of 65.7; the male mean age was 63.8, MedPage Today added.

We previously wrote that women who have received DePuy Orthopaedics’ recalled ASR Hip Resurfacing System and ASR XL Acetabular System may be at highest risk for premature failure of their implant. That’s because ASR hip implants with femoral head sizes below 50 mm have the highest failure rate, according to data from the National Joint Registry of England and Wales. The DePuy hip implants with smaller femoral heads are more likely to have been implanted in female patients.

DePuy Orthopaedics is a unit of Johnson & Johnson and the DePuy ASR is at the center of a lawsuit brought by Loren Kransky against Johnson & Johnson over the device. Kransky’s is the first of some 10,000 similar cases that have been filed.

In August 2010, DePuy issued a worldwide recall of its ASR XL Acetabular System (a hip socket used in traditional hip replacement) and the ASR Hip Resurfacing System (a partial hip replacement that involves placing a metal cap on the ball of the femur). The recall was issued after data from the National Joint Registry of England and Wales revealed unexpectedly high revision rates within five years of original implantation. Traditionally, hip implants are expected to last 15 years or so.

The recall followed a warning DePuy issued in March 2010 in which the device maker warned doctors that recently analyzed data from Australia suggested that the ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patient. According to the letter, patients of small stature, a group that typically includes women and patients with weak bones, faced the highest risk of device failure.

The DePuy ASR metal-on-metal hip implant is made of chromium and cobalt and many of the complaints involve allegations that normal wear causes the device’s metal components to rub against one another and shed into patients’ bodies and bloodstreams, leading to serious injuries.