Big Pharma had a major victory on June 8th, when the Texas Supreme Court handed down its ruling in Centocor, Inc. v. Hamilton. The Court held that "When a drug manufacturer properly warns a prescribing physician of the dangerous propensities of its product, the manufacturer is excused from warning each patient who receives the drug. The doctor stands as a learned intermediary between the manufacturer and the ultimate consumer." Further, "A prescription drug manufacturer fulfills its duty to warn end users of its product’s risks by providing adequate warnings to the intermediaries who … [Read more...]
Depakote Maker to pay $1.5 Billion to Settle Criminal and Civil Investigations
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 fine and … [Read more...]
The Risks of Using Generic Drugs
by Sarah Hoffman, 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 common … [Read more...]
Cancer Risk linked to Diabetes Treatment
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 SpringerLyle … [Read more...]
Tragedy Brought on by Tainted Fruit
By Moni Basu, CNN William Beach was one of those people who fixated on certain foods. He would eat the same thing voraciously for a few days, and then, when he tired of the same tastes, he moved onto something else. In August, when summer’s heat seemed unending in Mustang, Okla., Beach took to savoring fried chicken -- and soft, sweet cantaloupe. Beach was elderly -- 87 -- but after eating the fruit, his health declined rather suddenly and before anyone in his family knew what was wrong, he was dead. He is among 15 people who died from Listeria monocytogenes in what the Centers for Disease … [Read more...]
Hip Implant Complaints Increase, While Dangers Are Reviewed
By BARRY MEIER and JANET ROBERTS of the New York Times Published: August 22, 2011 The federal government has received a surge in complaints in recent months about failed hip replacements, suggesting that serious problems persist with some types of artificial hips even as researchers scramble to evaluate the health dangers. An analysis of federal data by The New York Times indicates that the Food and Drug Administration has received more than 5,000 reports since January about several widely used devices known as metal-on-metal hips, more than the agency had received about those devices in the … [Read more...]
Voluntary Recall Of Slimming Capsules
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
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 oral … [Read more...]
J&J recalling more Tylenol from closed plant
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
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 succession of some of … [Read more...]
