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...]
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...]
AstraZeneca and Seroquel Suits
from Bloomberg.Com AstraZeneca Said to Pay $150 Million to Settle About 6,000 Seroquel Suits AstraZeneca Plc agreed to pay $150 million to settle more lawsuits claiming its antipsychotic drug Seroquel causes diabetes, pushing the amount the drugmaker has paid to resolve cases over the medicine to almost $350 million, people familiar with the accords said. AstraZeneca, the U.K.’s second-biggest drugmaker, will resolve about 6,000 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, two people familiar with the settlements said. They spoke on … [Read more...]
