State attorney general sues drug company

Texas Attorney General Greg Abbott is pitted against one of the largest multinational pharmaceutical companies in a trial starting this week that could bring the state more than $1 billion - one of its largest potential awards since a multibillion-dollar tobacco settlement in 1998.

Abbott is charging that Johnson & Johnson Inc., its wholly owned subsidiary Janssen Pharmaceutical LLC and five other related companies defrauded the state in a "sophisticated marketing scheme" that caused the Texas Medicaid Program to pay too much for Janssen's schizophrenia drug Risperdal, the lawsuit says.

The state also questions the companies' marketing practices and alleges that the companies misled state health officials about the drug's effectiveness, the risk of side effects and its suitability for pediatric use.

The trial is scheduled to begin at 9 a.m. today in Judge John Dietz's 250th state District Court in Travis County.

The drug companies have denied the allegations in court documents and in a statement issued last week.

"Janssen is prepared to vigorously defend itself against these claims," the company said. "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."

Texas got involved with Risperdal litigation about six years ago, when Abbott's office joined a lawsuit filed by corporate whistle-blower Allen Jones, who is a former employee of the office of the inspector general of Pennsylvania.

Jones has questioned the process for how Risperdal was approved in Texas and how that information was used by other states in their approval processes.

Jones filed suit in 2004 after his investigation in Pennsylvania led him to examine the companies' track record in Texas. As a whistle-blower plaintiff, he alleged that the companies overcharged the states and overstated the drug's effectiveness.

Risperdal, approved by the FDA in 1993, was one of Johnson & Johnson's top-selling drugs. Sales dropped off when Risperdal got generic competition in June 2008. Originally, the drug was only approved for adults, but later the FDA allowed it for children and the elderly.

Texas' case alleges that the drug companies prevented state health officials from receiving "truthful information about the safety, efficacy, appropriate uses and cost-effectiveness of Risperdal."

Risperdal - which once brought Johnson & Johnson more than $3.4 billion in annual sales - 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, plus many more common but less-serious side effects. It also has been linked to lactation in some male patients, according to court documents.

The lawsuit says that Johnson & Johnson and its subsidiaries employed suspect tactics in order to sell Risperdal in the public sector, which promised to be especially lucrative. Eighty-five percent of Risperdal's revenue was projected to come from the public sector, because schizophrenic adults tend to be poor and uninsured.

"Understanding the need to obtain significant government buy-in to achieve their financial goals for Risperdal, defendants set their sights on a state with one of the largest Medicaid populations in the country - Texas," according to the filing by the state and Jones.

But getting a state like Texas to put a drug on a list of preferred medications - which the companies ultimately accomplished - can be a tremendous undertaking.

The lawsuit discusses the challenge for the companies to persuade decision-makers in Texas' public medical agencies to make the move - despite what it said was evidence that the drug is more expensive and no more effective than older medications, the state and Jones say in their lawsuit.

Johnson & Johnson and the related companies even created a special business unit called the Public Health Systems and Reimbursement Department designed to push the drug in the public sector, the lawsuit says.

The companies also had to navigate the Texas Medicaid Program's cost-savings measures , and to do so the companies employed a campaign that included misrepresentations about the drug's effectiveness and superiority over other drugs, the state alleges.

The state's case outlines allegations of kickbacks - "money going directly to key decision-makers," the lawsuit says - paid more than a decade ago to several doctors employed by the state's Health and Human Services Commission to give Risperdal preference over other antipsychotic drugs.

Jones' lawsuit claims that Risperdal became part of the treatment plan because of the drug companies' "improper influence" over Dr. Steven Shon, the former medical director for behavioral health at the Department of State Health Services. Shon had served as a paid Janssen consultant and traveled the country promoting the Texas plan. He denies the allegations in the lawsuit, however. And in 2006, he said: "I didn't personally benefit from this project."

Stephanie Goodman, a spokeswoman for the commission, said in an email last week that Shon resigned from the state in October 2006.

No state employees were named in the suit, but one of the doctors is accused of accepting an honorarium from Johnson & Johnson to fly around the country urging doctor colleagues in other states' Medicaid and mental-health programs to use Risperdal instead of other drugs, said Thomas Melsheimer, a Dallas lawyer who represents Jones and is co-counsel with the Texas attorney general in the case.

Jones' legal team also charged that the company perfected its marketing skills in Texas before reaching out to the other states in which it pushed for expanded Risperdal prescriptions.

Other states have already successfully sued Johnson & Johnson and its subsidiaries in Risperdal-related cases.

In October 2010, Louisiana got a ruling to receive $258 million from the drugmaker for violating the state's Medicaid Fraud Act.

And in June of last year, a judge in South Carolina issued an order for the defendants to pay $327 million, plus $73 million for the state's legal expenses, for misrepresentation of possible side effects of Risperdal.

Attorneys for South Carolina told The Associated Press that it was the biggest verdict in the country over the marketing of Risperdal.

By comparison, Melsheimer has said that he is seeking more than $1 billion against the companies, based on the large number of Texans who were prescribed the drug.

Texas' largest legal award came in 1998, when it won a $17.3 billion settlement from five tobacco manufacturers after suing to recover the state's cost of treating ill smokers.

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source: Austin American Statesman (Eaton, 1/8)

Deaths linked to cantaloupe could reach 16 or more; deadliest outbreak in more than a decade

WASHINGTON — Health officials say as many as 16 people have died from possible listeria illnesses traced to Colorado cantaloupes, the deadliest food outbreak in more than a decade.

The Centers for Disease Control and Prevention said Tuesday that 72 illnesses, including 13 deaths, are linked to the tainted fruit. State and local officials say they are investigating three additional deaths that may be connected.

The death toll released by the CDC Tuesday — including newly confirmed deaths in Kansas, Missouri, Nebraska and Texas — surpassed the number of deaths linked to an outbreak of salmonella in peanuts almost three years ago. Nine people died in that outbreak.

The CDC said Tuesday that they have confirmed two deaths in Texas and one death each in in Kansas, Missouri and Nebraska. Last week the CDC reported two deaths in Colorado, four deaths in New Mexico, one in Oklahoma and one in Maryland.

New Mexico officials said Tuesday they are investigating a fifth death, while health authorities in Kansas and Wyoming said they too are investigating additional deaths possibly linked to the tainted fruit.

Listeria is more deadly than well-known pathogens like salmonella and E. coli, though those outbreaks generally cause many more illnesses. Twenty-one people died in an outbreak of listeria poisoning in 1998 traced to contaminated hot dogs and possibly deli meats made by Bil Mar Foods, a subsidiary of Sara Lee Corp. Another large listeria outbreak in 1985 killed 52 people and was linked to Mexican-style soft cheese.

Listeria generally only sickens the elderly, pregnant women and others with compromised immune systems. The CDC said the median age of those sickened is 78 and that one in five who contract the disease can die.

Dr. Robert Tauxe of the CDC says the number of illnesses and deaths will probably grow in coming weeks because the symptoms of listeria don’t always show up right away. It can take four weeks or more for a person to fall ill after eating food contaminated with listeria.

“That long incubation period is a real problem,” Tauxe said. “People who ate a contaminated food two weeks ago or even a week ago could still be falling sick weeks later.”

CDC reported the 72 illnesses and deaths in 18 states. Cases of listeria were reported in California, Colorado, Florida, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, Nebraska, New Mexico, North Dakota, Oklahoma, Texas, Virginia, West Virginia, Wisconsin, and Wyoming. The most illnesses were reported in Colorado, which has seen 15 sickened. Fourteen illnesses were reported in Texas, 10 in New Mexico and eight in Oklahoma.

The outbreak has been traced to Jensen Farms in Holly, Colo., which recalled the tainted cantaloupes earlier this month. The Food and Drug Administration said state health officials had found listeria in cantaloupes taken from grocery stores in the state and from a victim’s home that were grown at Jensen Farms. Matching strains of the disease were found on equipment and cantaloupe samples at Jensen Farms’ packing facility in Granada, Colo.

FDA, which investigates the cause of foodborne outbreaks, has not released any additional details on how the contamination may have happened. The agency says its investigation is ongoing.

The Rocky Ford-brand cantaloupes from Jensen Farms were shipped from July 29 through Sept. 10 to Arkansas, Arizona, California, Colorado, Idaho, Illinois, Kansas, Minnesota, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, and Wyoming.

The recalled cantaloupe may be labeled “Colorado Grown,” ‘’Distributed by Frontera Produce,” ‘’Jensenfarms.com” or “Sweet Rocky Fords.” Not all of the recalled cantaloupes are labeled with a sticker, the FDA said.

Unlike many pathogens, listeria bacteria can grow at room temperatures and even refrigerator temperatures. The FDA and CDC recommend anyone who may have one of the contaminated cantaloupes throw it out immediately and clean and sanitize any surfaces it may have touched.

About 800 cases of listeria are found in the United States each year, according to CDC, and there usually are three or four outbreaks. Most of these are traced to deli meat and soft cheeses, where listeria is most common.

Produce has rarely been the culprit, but federal investigators say they have seen more produce-related listeria illnesses in the past two years. It was found in sprouts in 2009 and celery in 2010.

While most healthy adults can consume listeria with no ill effects, it can kill the elderly and those with compromised immune systems. It is also dangerous to pregnant women because it easily passes through to the fetus. Dr. Tauxe of the CDC said the type of listeria linked to the cantaloupes is not one that is commonly associated with pregnancy-associated illnesses, however. State and federal health authorities have not definitively linked any miscarriages, stillbirths or infant illnesses to the current outbreak.

Symptoms of listeria include fever and muscle aches, often with other gastrointestinal symptoms. Victims often become incapacitated and unable to speak.

Debbie Frederick said her mother knew something was wrong when her father, 87-year-old William Thomas Beach, collapsed at his home in Mustang, Okla. and couldn’t get up. He died a few days later, on Sept. 1. The family later learned his death was linked to eating the cantaloupe and sued Jensen Farms.

“First you just kind of go into shock,” said Frederick. “Then it settles in that he would still be alive if this hadn’t happened. It’s a life, for what?”



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Online:

CDC on cantaloupe outbreak: http://www.cdc.gov/nczved/divisions/dfbmd/diseases/listeriosis/092111.html

FDA on cantaloupe recall: http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm272372.htm

Center for Science and the Public Interest, “Super Safe Your Kitchen”: http://www.cspinet.org/new/pdf/safekitchen.pdf

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Associated Press writers Jamie Stengle in Dallas, Josh Funk in Omaha, Neb., Maria Sudekum Fisher in Kansas City, Mo., Susan Montoya in Albuquerque, N.M. and Ben Neary in Cheyenne, Wyo. contributed to this report.


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source: Washington Post (Jalonick, 9/28)

2 in Texas get sick from melons

Health officials have issued a warning for cantaloupes from a revered melon-producing area of Colorado amid a bacteria outbreak blamed for four deaths in the state and New Mexico, troubling farmers who depend on sales of the fruit.

The warning from the Centers for Disease Control and Prevention came after numerous cases of a strain of Listeria were reported in six states, including at least 11 from Colorado, 10 from New Mexico, two from Texas, and one each from Indiana, Nebraska and Oklahoma.

The agency said it was the first Listeria outbreak linked to cantaloupe in the United States. The U.S. Food & Drug Administration said it had not recalled the melons while it worked to locate the source.

Rocky Ford cantaloupes, named for a region along the old Santa Fe Trail about 130 miles southeast of Denver, are prized for their above-average sugar content.

"This is really silly. You can get Listeria any place. I eat those melons every day," said Kent Lusk, a fifth-generation cantaloupe farmer from Rocky Ford.

Colorado Agriculture Commissioner John Salazar said the contamination might not be the cantaloupes, but a truck or other source. But several Colorado grocery chains pulled their supplies as a precaution, and New Mexico issued a voluntary recall. State Environmental Health Bureau inspectors were collecting cantaloupe samples from grocery stores and distributors across New Mexico for laboratory analysis.

Listeriosis is a serious infection usually caused by eating food contaminated with the bacterium Listeria monocytogenes. The disease primarily affects older adults, pregnant women, newborns and adults with weakened immune systems.

Colorado health director Chris Urbina said people who are at high risk included people 60 and older, those with weakened immune systems from transplants and people with chronic diseases. Symptoms can include fever, muscle aches, diarrhea, headache, stiff neck, confusion and convulsions. Listeriosis can cause miscarriages and stillbirths.

The CDC warning advised people with cantaloupes at home to see if they came from the Rocky Ford region, and if so, not to eat the melons if they're in a vulnerable group. Health authorities asked people throwing out Rocky Ford cantaloupes to put them in a sealed plastic bag before putting them in the trash.

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source: Houston Chronicle (AP, 9/14)