The North Carolina Senate this week began consideration of House Bill 542: “Tort Reform for Citizens and Businesses.”
At the heart of this measure is product-liability protection for pharmaceutical companies if an FDA-approved drug causes harm to the public.
There are exceptions: if the drug is sold after the FDA withdraws its approval and orders the drug off the market, or if the drug-maker intentionally misled the FDA in order to receive approval.
What this bill doesn’t do is protect citizens from the marketing department at places like Bayer Pharmaceuticals, makers of the oral contraceptive Yaz.
Yaz contains a progestin hormone that may cause potassium levels in the body to become dangerously high, leading to strokes, heart attacks or blood clots.
Attorneys in a Wisconsin class-action suit against Bayer indicate that packaging did not sufficiently warn women about these risks.
Advertisements suggested that Yaz would cure PMS conditions and acne, even though it had only been approved as an oral contraceptive and as treatment for PMDD, a severe form of PMS but with different symptoms of PMS.
The FDA forced Bayer to correct the misleading advertisement and labeling.
House Bill 542 is indeed tort reform, but if approved, it’s a cure for businesses but bad medicine for citizens.