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Glaxo Settles Cases With U.S. for $3 Billion

admin » 28 November 2011 » In Defective Products, FDA, Legal News, Mass Tort, Recall » No Comments

Glaxo Settles Cases With U.S. for $3 Billion

The British drug company GlaxoSmithKline said Thursday that it had agreed to pay $3 billion to settle United States government civil and criminal investigations into its sales practices for numerous drugs.

The settlement would be the largest yet in a wave of federal cases against pharmaceutical companies accused of illegal marketing, surpassing the previous record of $2.3 billion paid by Pfizer in 2009. In recent years, drug companies have been prime targets of federal fraud investigations, which have recovered tens of billions of dollars for Medicaid and Medicare.

The cases against GlaxoSmithKline include illegal marketing of Avandia, a diabetes drug that was severely restricted last year after it was linked to heart risks. Federal prosecutors said the company had paid doctors and manipulated medical research to promote the drug.

GlaxoSmithKline had already set aside cash for the settlement, which analysts said would remove legal uncertainty. The company’s stock rose 2.96 percent Thursday, to $44.55, near its 52-week high, amid a broader market advance of about 2 percent.

“This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today,” Andrew Witty, chief executive of GlaxoSmithKline, said in a statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently.”

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Drug Firms Told to Pay $162M in Hepatitis C Case

admin » 14 November 2011 » In FDA, Legal News, Mass Tort » No Comments

Drug Firms Told to Pay $162M in Hepatitis C Case

A Nevada jury on Monday ordered three pharmaceutical companies to pay $162.5 million in punitive damages in a lawsuit that accused them of negligently distributing large vials of an anesthetic to Las Vegas clinics at the center of a 2008 hepatitis C outbreak.

The damages awarded in Clark County District Court are on top of the $20.1 million in compensatory damages awarded to five plaintiffs Thursday after a jury found Teva Parenteral Medicines Inc., Baxter Healthcare Corp. and McKesson Corp. liable.

Plaintiffs’ lawyers had accused the companies of putting corporate profits ahead of patient safety, and of recklessly distributing 50 milliliter vials of the powerful anesthetic propofol to clinics where 10 or 20 milliliter doses were commonly needed for outpatient colonoscopy procedures. They had sought $600 million in punitive damages.

Teva attorney Mark Tully declined comment to reporters after the verdict was read, while photographers and news cameras snapped pictures of family members of the plaintiffs hugging each other and their lawyers.

“I’m glad this if over with. It’s not about the money,” said Anne Arnold, who was awarded $10 million in compensatory damages, plus a share of the punitive award.

“I don’t want anybody else to go through what I’m going through,” she said. “It’s hell.”

Philip Hymanson, attorney for Baxter and McKesson, told jurors the propofol was manufactured properly and delivered properly, and that clinic doctors and anesthesiologists were at fault if they misused it. Hymanson said there was no proof that happened.

The companies maintain the vials were properly marked with instructions and warnings, and that jurors weren’t allowed to hear that reusing syringes on multiple patients and not following proper sterilizing procedures could also have spread the incurable liver disease.

Teva was ordered to pay $89.4 million, while Baxter was told to pay $55.3 million and McKesson was ordered to pay $17.9 million.

Robert Eglet, an attorney for the plaintiffs, said the cases would continue until the companies change the vials it sells. He said the judgments should also urge the companies to settle cases that have not been resolved.

“They need to come to this community and they need to make this right and resolve this case with everyone,” he said. “But if not, we’re prepared to continue on.”

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Fatty Foods Addictive as Cocaine in Growing Body of Science

admin » 06 November 2011 » In Legal News, Mass Tort » No Comments

Fatty Foods Addictive as Cocaine in Growing Body of Science

Cupcakes may be addictive, just like cocaine.

A growing body of medical research at leading universities and government laboratories suggests that processed foods and sugary drinks made by the likes of PepsiCo Inc. and Kraft Foods Inc. (KFT) aren’t simply unhealthy. They can hijack the brain in ways that resemble addictions to cocaine, nicotine and other drugs.

“The data is so overwhelming the field has to accept it,” said Nora Volkow, director of the National Institute on Drug Abuse. “We are finding tremendous overlap between drugs in the brain and food in the brain.”

The idea that food may be addictive was barely on scientists’ radar a decade ago. Now the field is heating up. Lab studies have found sugary drinks and fatty foods can produce addictive behavior in animals. Brain scans of obese people and compulsive eaters, meanwhile, reveal disturbances in brain reward circuits similar to those experienced by drug abusers.

Twenty-eight scientific studies and papers on food addiction have been published this year, according to a National Library of Medicine database. As the evidence expands, the science of addiction could become a game changer for the $1 trillion food and beverage industries.

If fatty foods and snacks and drinks sweetened with sugar and high fructose corn syrup are proven to be addictive, food companies may face the most drawn-out consumer safety battle since the anti-smoking movement took on the tobacco industry a generation ago.
‘Fun-for-You’

“This could change the legal landscape,” said Kelly Brownell, director of Yale University’s Rudd Center for Food Policy & Obesity and a proponent of anti-obesity regulation. “People knew for a long time cigarettes were killing people, but it was only later they learned about nicotine and the intentional manipulation of it.”

Food company executives and lobbyists are quick to counter

that nothing has been proven, that nothing is wrong with what PepsiCo Chief Executive Officer Indra Nooyi calls “fun-for- you” foods, if eaten in moderation. In fact, the companies say they’re making big strides toward offering consumers a wide range of healthier snacking options. Nooyi, for one, is as well known for calling attention to PepsiCo’s progress offering healthier fare as she is for driving sales.
Coca-Cola Co. (KO), PepsiCo, Northfield, Illinois-based Kraft and Kellogg Co. of Battle Creek, Michigan, declined to grant interviews with their scientists.

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