New FDA rule may offer drug makers more protection from lawsuits

NEW YORK Patients suing drug and medical device companies might find it more difficult under a new rule issued by the Food and Drug Administration Thursday.

The rule makes changing product warnings more difficult for the companies by strengthening standards under which they can make the changes without the FDA’s approval. Thus, it protects them from lawsuits by patients who allege that companies have failed to inform them of risks.

The agency originally proposed the rule in January, but it failed then after members of the House and Senate rejected it.