The Supreme Court’s decision in Wyeth v. Levine that held that federal law does not preempt state-law claims with regard to drug warning labels. This decision returned the right to seek justice when an individual has been injured by a pharmaceutical product. The same right should be returned to those injured by a medical device that had been approved by the FDA .
An earlier decision, Reigal V. Medtronic, had held that manufacturers of class III medical devices that have been approved by the Food and Drug Administration’s (FDA) pre-market approval process were essentially immune from liability. The immunity could apply even in instances when a company knew a device was defective and dangerous, and had even been recalled.
“From peanut butter to unsterile syringes, we know the FDA alone cannot adequately police all drugs and medical devices on the market,” said Linda Lipsen, Senior Vice President of Public Affairs for the American Association for Justice. “That is why it is essential the civil justice system provide an added check and balance to strong federal regulations and oversight authority. “ If you or someone in your family has been injured by a fault medical device, seek the assistance of a qualified medical device attorney.
The Food and Drug Administration’s (FDA) advisory panel is meeting April 8 to determine if AstraZeneca can market Seroquel XR to patients for major depression and anxiety disorders, extending the market share to approximately 20 million more patients. The drug is currently approved for schizophrenia and bipolar disorder.
Unfortunately for consumers, this decision might be made without the full benefit of knowing what AstraZeneca knows about their drug and its potential side effects. Court documents, which the company refuses to make public, contain unpublished clinical trial information and internal conclusions by the company on the increased risk of weight gain and diabetes which were not previously shared with the FDA.
Sealed court records are hiding the dangers of prescription drugs and Seroquel is the latest example of how companies use secrecy agreements to hide product risks and mislead consumers into thinking they are safe,” said American Association for Justice Senior Vice President of Public Affairs Linda Lipsen. “Companies that are unable to hide behind secrecy agreements would be motivated to fix or recall product dangers, preventing consumers from suffering unnecessary injury or death.”
In a decision just released, the Supreme Court has upheld a 6.8 million dollar verdict for Diane Levine, (Levine v. Wyeth) and at the same time took a step in the right direction for making pharmaceutical drugs safer for all.
The plainiff, Diane Levine, was given a given “push injection” of the drug Pheneragen, manufactured by Wyeth. She developed complications from an apparent mistake in the injection, and ultimately had to have her forearm amputated.
Although Levine won at the state level, Wyeth, appealed arguing that a 2006 regulation of the Food and Drug Administration should mean that such cases are barred at the state level. Read more about preemption.
