Johnson & Johnson settles Texas Risperdal case for $158 million

In the state's largest-ever Medicaid fraud recovery, Johnson & Johnson agreed Thursday to pay Texas $158 million to settle a lawsuit over its efforts to get the schizophrenia drug Risperdal on an approved list for the state's poorest patients.

Texas Attorney General Greg Abbott and a Pennsylvania whistleblower sued Janssen, a subsidiary of Johnson & Johnson, in 2004 over allegations the drug company used faulty research and trips, meals and other perks to convince Texas health officials to put Risperdal on the state's medication algorithm, which determined which drugs were dispensed at state-run hospitals and institutions.

“Today’s agreement sends a strong message that the state will pursue those who defraud Texas taxpayers,” Abbott said in a statement. “Johnson & Johnson’s scheme to profit from the Medicaid program by overstating the safety and effectiveness of an expensive drug and improperly influencing officials ended up costing taxpayers millions of dollars.”

In preceding medical trials, Risperdal — a drug which can lead to diabetes and excessive weight gain, especially for children — was found to be no better or safer than other generic versions, despite its significantly higher price tag.

Attorneys for the state of Texas argued Janssen marketed the powerful antipsychotic drug for use in children, even though the medication was approved only for the very narrow purpose of treating adult schizophrenia. The lawsuit also alleged the company offered trips and kickbacks to state health officials.

The whistleblower, Allen Jones, uncovered the details while working as an investigator at the Pennsylvania Office of the Inspector General. He was represented by Dallas attorney Tom Melsheimer and Austin attorney Tommy Jacks, both part of the firm Fish & Richardson.

“We are proud to have aided the courageous efforts of Allen Jones, a man who helped shine a light on the dark and corrupt practices that impacted taxpayers across Texas,” Melsheimer said. “He uncovered a terrible effort to push a mind-altering drug on children at the most vulnerable time in their lives.”

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source: Texas Tribune (Rich, 1/19)

Texas court begins trail of $1b Risperdal marketing suit

AUSTIN, Texas — Texas prosecutors want jurors to award the state $1 billion in a lawsuit that accuses Johnson & Johnson of overstating the safety of an anti-psychotic drug and influencing its use in the state's Medicaid program. The company, facing similar claims in other states, is promising to vigorously defend itself when both sides lay out their cases during opening statements Tuesday.

The lawsuit accuses Johnson & Johnson and several of its subsidiaries of fraud by making false or misleading statements about Risperdal and the drug's safety, cost effectiveness and superiority in the 1990s. Risperdal is a pill for schizophrenia and bipolar disorder.

The trial is expected to last two weeks.

The suit was originally filed in 2004 by whistle-blower Allen Jones, a former employee with the Office of Inspector General in Pennsylvania, and Texas later joined the case. Jones has said he learned of Johnson & Johnson's actions in Texas while investigating similar claims in Pennsylvania.

The suit is among dozens of pending state and federal cases alleging illegal marketing practices and kickbacks in an effort to boost Risperdal over competing drugs. And a verdict against the company wouldn't be the first.

Last year, a South Carolina judge ruled that Johnson & Johnson must pay a $327 million civil penalty after a jury found it guilty of overstating the safety and effectiveness of Risperdal. In 2010, a jury found that the company violated Louisiana's Medicaid Fraud Act and was fined about $258 million in damages.

Johnson & Johnson has denied the claims in Texas's lawsuit and said it follows U.S. Food and Drug Administration rules.

"We are committed to ethical business practices, and have policies in place to ensure that our products are only promoted for their FDA-approved indication. If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action," the New Brunswick, N.J.-based company and its subsidiaries said in a statement.

Jones' attorney and Texas Attorney General Greg Abbott's office, which is representing the state, declined comment before the trial began.

Risperdal and similar antipsychotic drugs have been linked to increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar.

Jones accuses several doctors who were state officials in Texas' mental health department of giving Risperdal preference over other antipsychotic drugs. One is accused of accepting honoraria from Johnson & Johnson to urge doctors in other states' Medicaid and mental health programs to use Risperdal.

The drug company and its subsidiaries are also accused of promoting misleading interpretations of research studies and paying millions of dollars - much of it to decision-makers - to influence the creation of state mental health medication guidelines favoring Risperdal.

The company also is accused of falsely saying the drug was safe to use with children and other populations when federal regulators had not approved its use with those groups.

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source: Seattle Times (AP, 1/10)

F.D.A. Orders Surgical Mesh Makers to Study Risks

The Food and Drug Administration issued an order on Wednesday requiring makers of implantable surgical mesh used to treat urinary incontinence in women to study its risks.

The move comes after years of reports of serious injuries linked to the devices, including infections, pain and other complications. It follows a recommendation in September by an F.D.A. advisory panel that the agency require such studies.

The move Wednesday by the agency is similar to one it took last year when it ordered producers of all-metal artificial hips to undertake patient studies. The mesh products and the hips belong to a class of implantable devices that manufacturers do not have to study in patients before they are marketed or closely follow in patients afterward.

Female incontinence is often caused by two conditions. One is called pelvic organ prolapse, in which muscles that support organs like the bladder weaken, allowing them to descend and press against the vaginal wall. The other, stress urinary incontinence, is also caused by muscle weakening.

In 2008, the F.D.A. issued a warning that the use of vaginal mesh was associated with complications but said at the time that such problems were rare. However, from 2008 to 2010 there was a fivefold increase in adverse event reports related to the use of vaginal mesh to treat pelvic organ prolapse, said Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices.

Dr. Maisel emphasized that the order Wednesday did not cover all uses of surgical mesh to treat incontinence. He added that the safety of such devices when surgically implanted through the abdomen was “well established.”

The top producers of vaginal mesh include Boston Scientific, C. R. Bard, Ethicon and W. L. Gore & Associates.

In 2010, about 185,000 women underwent procedures in which mesh was implanted vaginally to treat urinary incontinence.

That same year, researchers reported in a medical journal that about 15 percent of the women treated with vaginal mesh experienced potential complications. The study, which appeared in the journal Obstetrics and Gynecology, also concluded that mesh did not provide greater benefits than the traditional surgical treatment in which a patient’s own ligaments are used to strengthen the vaginal wall.

Dr. Maisel said he expects that mesh manufacturers, once studies are started, will follow patients for about three years to determine the frequency and severity of complications.

Over the last year, the F.D.A. has increasingly used its authority to order manufacturers to conduct emergency studies. But the effectiveness of that procedure in preventing patient injuries is questionable because by the time the agency acts, a device has been on the market for years and been implanted in hundreds of thousands of patients.

Also, while the F.D.A. in May ordered makers of all-metal hips to conduct postmarket studies of their risks, the agency and company officials are still discussing study designs, Dr. Maisel said.

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source: New York Times (Meier, 1/4)


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Texas A&M Football Player Killed in Crash With 18-Wheeler

HOUSTON –  Texas A&M University was Thursday mourning the loss of an Aggie football player, 22-year-old Joseph Villavisencio.

Villavisencio was killed in a head-on collision on Highway 39, south of Normangee -- about 115 miles north of Houston Thursday according to an A&M statement cited by myFOXhouston.com.

The senior offensive lineman was on his way home to Jacksonville, Texas, when according to witnesses, he swerved to avoid a buzzard on the roadway and went directly into the path of an oncoming 18-wheeler.

"Villavisencio played his freshman season in 2008 earning his first career start on the offensive line in a 49-35 A&M victory against Iowa State in Ames, Iowa," the A&M statement read.

During his Jacksonville High School years, he earned second team all-state honors from the Associated Press and the Texas Sports Writers Association.  A senior radiological health engineering major, Villavisencio is survived by his sister, mother and father.  The driver of the 18-wheeler was not hurt, KBTX-TV reported.

If you or a loved one has been injured in an accident involving an 18 Wheeler, you should know your rights.  Contact The Texas Injury Lawyer David Cole for a free consultation.

SOURCE: Read more: http://www.foxnews.com/us/2011/12/23/texas-am-football-player-killed-in-crash-with-18-wheeler/#ixzz1hkqGJzFO

Earlier, more comprehensive Honda recall could have avoided near fatal injury

TOKYO — Georgia college student Kristy Williams was almost killed when a metal piece flew out of an air bag in her 2001 Honda Civic — a traumatic accident her lawyer says might have been avoided had there been an earlier, more comprehensive recall.

Williams had even arranged to get her air bag fixed. But the appointment was a week too late.

The recalls at Honda Motor Co. for defective air bags that may inflate with too much pressure and send pieces of metal and plastic flying now affect some 2 million vehicles around the world.

Tragically for Williams, although recalls for air bags began in November 2008, her vehicle wasn’t included until last year’s batch.

The Tokyo-based automaker has now issued five recalls for defective air bags — the latest just this month for 304,000 vehicles globally, including the popular Accord, Civic, Odyssey, Pilot, CR-V and other models manufactured in 2001 and 2002.

There have been 20 accidents related to the problems, including two deaths in the U.S. in 2009, according to Honda.

“This is a serious, basic problem,” Williams’ attorney Leigh May said in a telephone interview.

Honda should have made the recalls encompassing, and her client might not have gotten hurt if it had, she said.

“It’s so terrible. Air bags are supposed to be there to protect you. And, if the air bag is a mechanism of your injury, that’s just not right,” May told The Associated Press.

Honda and Williams settled for an amount that cannot be disclosed as a condition of their agreement, May said.

On April 2 last year, Williams was stopped at a traffic light when the driver and passenger air bags deployed without there being a crash.

Flying shrapnel severed her neck artery. She was in intensive care for two weeks, required several surgeries and suffered strokes. Luckily, she survived.

“It was really hard to get things together when I was released from the hospital. However, I am a determined individual and put my mind to finishing school,” Williams, 25, said in an email.

“I want others to be aware of the consequences of not getting the recall seen about ASAP,” she said.

Atlanta-based Butler, Wooten & Fryhofer, where May is a partner, is among a handful of U.S. law firms that won in suing Honda over the air bags.

May said it was unclear what Honda knew when, and why all the vehicles weren’t recalled the first time as the problem air bags came from one supplier, Takata Corp.

Honda spokesman Hajime Kaneko confirmed the recalled air bags came from the one supplier. Takata declined comment.

As it played out, the recalls grew almost piecemeal, from the first recall in 2008, to include more models in two separate recalls in 2009, and again last year, and then this month.

Kaneko said Honda had earlier thought the causes were different, such as the use of incorrect material in the chemical used to deploy the air bags and excessive moisture in the inflator propellant, which is part of what inflates the air bag.

But Honda found, under its fourth recall, that the cause was a defect during the production of the chemical, which had led to all the problems, Kaneko said. The latest recall came about because the company had not fully accounted for all the vehicles requiring recall, he said.

Honda, a reputed pioneer in air-bag technology, had expanded the recall to account for a possibly defective stamping machine during production.

“I can only say we are extremely sorry,” said Kaneko. “It is our responsibility we failed to identify a problem part in our products.”

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source: Washington Post (Kageyama, 12/20)

Novartis Confirms Patient Died After Starting Gilenya (fingolimod)

Novartis AG (NOVN) said a multiple sclerosis patient died on Nov. 23 after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease.

Whether Gilenya played a role in the patient’s death can’t be excluded or confirmed, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today in an e-mailed statement. The death is the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug, Althoff said.

Gilenya was approved in the U.S. last year and cleared for sale in Europe in March. It’s among the products Novartis is depending on to boost sales as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan. It’s not clear yet how a single death might affect doctors’ cost-benefit analysis of the drug, Tim Anderson, an analyst for Sanford C. Bernstein Ltd., wrote in a note to investors today.

“In the case of MS drugs, there is often significant safety baggage of different sorts,” Anderson wrote. He rates Novartis’s shares “outperform” and estimates that by 2015 Gilenya sales will reach $1.4 billion, about 2 percent of the Swiss company’s revenue.

The exact cause of the death hasn’t been established, Novartis said. Sudden death “smacks of being cardiovascular in nature,” Anderson wrote, adding that the possibility of a temporary slowdown in heart rate after patients start treatment with Gilenya is part of the reason for a recommendation for monitoring in a doctor’s office after treatment begins.

The patient who died had begun treatment on Nov. 22 and had been monitored “without incident” for six hours after taking the first dose, Althoff said.

Novartis said it has sent details of the case to the U.S. Food and Drug Administration and other regulatory authorities.

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source: Bloomberg.com (Kresge, 12/13)



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Three Dallas Police Officers Injured in 2 Traffic Accidents

Video KDAF TV - Three Dallas Police Officers Injured in 2 Traffic Accidents

Three DPD officers were sent to the hospital after they were involved in two differnt traffic accidents early Friday morning.

The first accident occurred around 2:00 am in the east-bound lanes of LBJ Freeway after a vehicle lost control and hit the center lane barrier. Two police squad cars were parked on the highway working the accident when an 18-wheeler jack-knifed into the vehicles. Two officers were transported to Parkland Hospital with unknown injuries.

Within an hour, a second similar accident occurred when another DPD vehicle was rear-ended by a car that was unable to stop on the slick road. The impact caused the squad car's gasoline tank to rupture, closing the freeway for HAZMAT clean up. One officer was taken to Parkland hospital for observation and the driver of the vehicle was uninjured.

Source - KDAF TV The cw33.com