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According to the Los Angeles Times, generic drugs are the nation’s most commonly used medications. In fact, roughly 80% of prescriptions prescribed by doctors are for generic drugs. Unfortunately for consumers, if a person suffers injury as the result of a defective generic drug, he or she is barred from suing the manufacturer for damages. In a 5-4 decision last Monday, the Supreme Court tossed out a $21 million jury verdict awarded to Karen Bartlett, a woman who is now legally blind and lost nearly two-thirds of her skin after taking the generic pain killer Sulindac to relieve shoulder pain.

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According to The New York Times, an animal study requested by Merck for its type 2 diabetes drug, Januvia, revealed worrisome changes in the pancreases of rats, leading to follow-up studies which now threaten the future of the lucrative diabetes drug, as well as all other drugs in its class.

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In addition to the gift ban laws discussed in our last series post, certain states require drug companies to adopt general compliance programs. Both Connecticut and California require drug companies to adopt such programs in accordance with the Office of Inspector General’s “Compliance Program Guidance for Pharmaceutical Manufacturers.” There are several elements in the guidance for manufacturers to consider when developing a compliance program, including:

• Written policies;
• Training program;
• Designation of a compliance officer and other appropriate bodies;
• Line of communication between all employees and compliance officer;
• Risk evaluation to monitor compliance;
• Policies for investigating noncompliance; and
• Development of policies to deal with employees and entities excluded from participation in federal healthcare programs.

This legal requirement is generally not burdensome for manufacturers thanks to the autonomous nature of the laws and the broad language of the guidance.
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