Some local pharmacies offer compounding services to meet special needs of patients. However, some pharmacies are acting as miniature drug companies replicating products already available on the market to compete with large pharmaceutical companies. This has created an element of risk that is talked about in this Editorial from the New York Times which calls on Congress to enact legislation to give increased regulatory power to the F.D.A. This health risk is responsible for repeated incidents such as the recent outbreak of meningitis and thousands who were exposure to tainted steroids. Read … [Read more...]
Victory for Big Pharma: Texas Adopts “Learned Intermediary” Rule
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...]
Tort Reform has not Increased the Number of Doctors in Texas
Anew 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 measurably … [Read more...]
DuPuy / J&J Hip Recall Abroad
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
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
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...]
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...]
