Depakote Maker to pay $1.5 Billion to Settle Criminal and Civil Investigations

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Last week, the Department of Justice Announced a record $1.5 Billion settlement with Abbott Laboratories over their mislabeling of the drug Depakote. "Global Health Care Company Abbott Laboratories Inc. has pleaded guilty and agreed to pay $1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Justice Department announced today.  The resolution – the second largest payment by a drug company – includes a criminal … [Read more...]

Tort Reform has not Increased the Number of Doctors in Texas

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A new study by  David A. Hyman, Charles Silver, and Bernard Black shows that Texas Tort Reform measures have not increased the number of doctors in Texas since 2003. "Does state tort reform affect physician supply? Tort reformers certainly believe so. Before Texas adopted tort reform in 2003, proponents claimed that physicians were deserting Texas in droves. After tort reform was enacted, proponents claimed there had been a dramatic increase in physicians moving to Texas due to the improved liability climate. We find no evidence to support either claim. Physician supply was not … [Read more...]

DuPuy / J&J Hip Recall Abroad

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The following article by Mark Hollmer at FierceMedicalDevices.Com reports how the Johnson & Johnson (Dupuy Orthopaedics) hip implant is being treated in courts and by regulatory agencies in the U.K, Australia and New Zealand. Read below. Johnson & Johnson  is facing more bad news over its metal-on-metal artificial hip implant products, this time in New Zealand and Australia. Both countries' regulatory agencies issued a recall of the MITCH TRH hip components made by J&J's Finsbury Orthopaedics unit. In New Zealand, the problem involves a loosening and movement of part of … [Read more...]

J&J Faces Fines Drug Case

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Arkansas is added to the growing list of states penalizing Johnson & Johnson based on allegations of misrepresentation of effectiveness and/or potential dangers of usage of pharmaceutical designed for the treatment of psychosis, schizophrenia and bipolar disorder. Read about this  in the article by Katie Thomas of The New York Times. A judge in Arkansas ordered Johnson & Johnson and a subsidiary to pay more than $1.2 billion in fines on Wednesday, a day after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic … [Read more...]

The Risks of Using Generic Drugs

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by Sarah Taylor, SpringerLyle ••• In June of 2011, the United States Supreme Court decided an important issue regarding the warning labels on prescription drugs in Pliva, Inc. et al v. Mensing.  Mensing was a prescription drug failure-to-warn-case.  It dealt with prescription drug companies’ failure to put accurate warnings on their drug labels, leading to patients taking dangerous drugs that they otherwise would not have taken. In Mensing, the Court held that name-brand manufacturers of prescription drugs have an obligation, both under the federal regulations and under state … [Read more...]

Cancer Risk linked to Diabetes Treatment

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By Frank Lyle “Actos” is the brand name for a drug (pioglitazone) used to treat adult onset, Type-II diabetes. In June of 2011, The Food and Drug Administration (FDA) informed the public that this drug may increase the risk of bladder cancer. The FDA required new warnings to be placed on the medication’s label sold under the names Actos, Actoplus Met and Duetact. The drug has already been pulled off the market in France and Germany. It has been estimated that more than 2 million patients filled prescriptions for the drug between January 2010 and October 2010. Our attorneys at … [Read more...]

Voluntary Recall Of Slimming Capsules

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from the U.S. Food and Drug Administration website**: Intercharm Inc. Issues A Nationwide Voluntary Recall Of Slim Forte Slimming Capsules Lot 20100604 And Lot 20100928, Slim Forte Slimming Coffee Lot 20100903, And Meizitang Botanical Slimming Softgel Exp. 12.23.2011 Weight Loss Capsules Found To Contain Sibutramine Contact: Intercharm Inc. 323-876-7441 FOR IMMEDIATE RELEASE - July 25, 2011 - Intercharm Inc., is recalling Slimforte Slimming Capsules, Slimforte Slimming Coffee, and Botanical Slimming Soft Gel to the consumer/user level. FDA laboratory analyses found the products to contain … [Read more...]

FDA Reports Cancer Risk from Osteoporosis Drugs

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An FDA Safety Alert issued today warns that taking oral osteoporosis drugs (“bisphosphonates”) may cause an increased risk of esophageal cancer.  This category of drugs includes Fosamax, Actonel, Boniva, Atelvia, Didronel, and Skelid. Esophageal cancer and other esophageal problems have been reported in connection with use of the drugs, and the FDA is reviewing data from published studies to determine whether a link exists. The FDA posted the following recommendation in its Safety Alert: “Patients should talk with their healthcare professional about the benefits and risks of taking … [Read more...]

J&J recalling more Tylenol from closed plant

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Reported in Reuters by Lewis Krauskopf -- Johnson & Johnson said it was recalling more than 700,000 bottles or packages of Tylenol and other consumer medicines made at a now-closed plant, the latest in a litany of recalls by the company. J&J's McNeil Consumer Healthcare unit recalled one lot of Tylenol 8 Hour Extended Release Caplets, or 34,056 bottles, from retailers, the company said. The company cited a musty odor that has prompted many other J&J recalls. The product was made at its Fort Washington, Pennsylvania plant before J&J closed the facility in April … [Read more...]

Johnson & Johnson Recalls Hip Implants

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By NATASHA SINGER The New York Times Published: August 26, 2010 More than two years after the Food and Drug Administration began receiving complaints about the failure of a hip replacement implant made by the DePuy Orthopaedics unit of Johnson & Johnson, the company said Thursday that it was recalling two kinds of hip implants. DePuy said that it had made the decision to withdraw the products because many patients required a second hip replacement after the company’s implants had failed. The news compounded problems for Johnson & Johnson, which has recalled a … [Read more...]