Reactions to Wyeth v. Levine

Steve Klearman
Attorney
(866) 735-1102 Ext 535
Posted by Steve KlearmanMarch 10, 2009 3:22 PM
Tags: None

A USA Today editorial opined that the Wyeth v. Levine decision opened a new door for plaintiff's rights. During the Bush administration manufacturers were able to avoid lawsuits for defective products as long as the product met federal regulations. The Wyeth decision, however, opens the door for plaintiffs to sue manufacturers despite compliance with federal standards. The editorial argues that the courts will have to strike a balance to protect the interests of both consumers and companies. "States should allow suits but set a high burden of proof on the plaintiffs."

Bert Rein's article in USA Today sets forth an opposing view. He argues that the decision actually creates uncertainty for patients and doctors. He emphasizes that the FDA was created because decisions regarding the risks and benefits of prescription drugs and medical devices should be left up to the experts. Allowing a jury to make these decisions based on an isolated catastrophic event places the interests of one individual over the health interests of the public as a whole.

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Matt
Posted by Matt
March 11, 2009 11:04 AM

Why did Wyeth get sued for the mistake caused by the needle in the Levine case? Regardless of the drug used, practically any IV fluid including basic saline can create this condition called an "infiltration" when IV medication is not infused into the vein as intended. Diana Levine's true damage (injury) was more a result of the needle for having punctured the artery. Wyeth's drug nor any drug impoperly delivered could cause similar damage. This method of delivery led to the accident, infection and then resulting amputation.

This will simply force drug makers to specify, central line delivery for all IV delivered medications and exempt them from any such errors. Central lines and specifically the longer PICC lines are fail safe for the delivery of medication but are time consuming and carry certain risks in their insertion as well.

Basically the drug companies will be more specific in their DFUs to say "Central Line Delivery Only" and any such instance as the Levine case is clearly a gross "off label" use of the drug as intended.

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