An American company producing pharmaceutical equipment has agreed to plead guilty to committing what the Lancet (23 October 1993) has termed “the largest case of health fraud ever handled by the Food and Drug Administration”.

CR Bard plans to make a $61 million settlement to survivors and families of those using its heart products. One person died and 22 others had emergency heart surgery following breakages of angioplasty catheters and other equipment.

The FDA has charged that CR Bard failed to disclose design changes on its heart products and tested the new catheters in patients without their knowledge or consent.

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Written by What Doctors Don't Tell You

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