Buy this domain.
High Court Rules Generic Drug Companies Not Liable Under State Law | cialis online

High Court Rules Generic Drug Companies Not Liable Under State Law

AddThis Social Bookmark Button

In a 5-4 vote, the U.S. Supreme Court overturned a U.S. appeals court decision which allowed generic drug companies to be sued under state law over allegations that they failed to provide adequate label warnings.

The justices were presented with the interesting issue of whether makers of generic drugs, whose products must mimic the warning labels of the corresponding brand-name drugs and who cannot alter those labels, should also be sued under state law for failing to warn users about the risks posed by their products,” reported the New York Times.

Justice Clarence Thomas agreed with the majority, concluding that “federal drug regulations applicable to generic drug manufacturers directly conflicted with, and thus pre-empt state claims.”

A similar issue was decided in Wyeth v. Levine, when the Court addressed whether federal law pre-empts state law in personal injury claims against drug manufacturers. The high court held that federal law did not preempt the plaintiff’s state claim; thus, allowing makers of brand-name drugs to be sued under state law for failing to adequately warn consumers.

In the present case, the companies relied on the fact that federal law requires generic drugs to have the same labels as their brand-name equivalent. They argued federal law barred such lawsuits since the U.S. Food and Drug Administration (FDA) approved the drugs; therefore, making it illegal for the companies to alter drug labels.

Unlike generic drug companies, brand-name drug makers are permitted to sometimes change the labels on their products without FDA permission, says the Times.

The high court recognized this issue and agreed the generic drug makers “had no choice but to use the same drug labels as the brand manufacturer,” reported Reuters.

The lawsuit was brought by women who took the generic equivalent of Reglan. The plaintiffs claimed defendants, Teva Pharmaceutical, UDL Laboratories and Actavis Inc., failed to warn consumers of increased risks of developing a neurological movement disorder, reported Reuters.

When the plaintiffs started taking the drug, the FDA approved label said that ‘“therapy longer than 12 weeks has not been evaluated and cannot be recommended;’” however, in 2004, it was changed to say therapy should not exceed 12 weeks. In 2009, the FDA ordered that a specific warning about the movement disorder be added to Reglan and its generic brand equivalent, metoclopramide.

« »

Leave a Reply

You must be logged in to post a comment.




Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!

Whistle Blower

Stand up and say what you think is right. See something, say something.