FDA Defense Provision Removed From Senate Malpractice Reform Bill

The Senate sponsors of a medical malpractice reform bill have removed an earlier provision that would have shielded drugmakers from punitive damages if they followed all necessary FDA guidelines when seeking approval of their products.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act, introduced by Sens. Judd Gregg (R-N.H.) and John Ensign (R-Nev.), establishes strict criteria that plaintiffs must meet when seeking punitive damages from healthcare providers or medical product manufacturers.

What the HEALTH Act does not include is the provision in last session's bill that would have prohibited the award of punitive damages for products that comply with FDA standards. The current House version of the HEALTH Act, H.R. 534, introduced by Rep. Christopher Cox (R-Calif.), still contains the so-called FDA defense provision.

Such a provision could have shielded drugmaker Merck, which is facing billions of dollars in lawsuits after it abruptly pulled its arthritis drug Vioxx (rofecoxib) off the market last fall for safety reasons. Merck maintains it followed all required FDA regulations during the approval process for the drug.