Not allowing medical device companies to present information about the FDA’s analysis of their products in product liability cases against them results in unfair court trials, posits an article by Reuters.
In product liability cases against medical device companies, federal and state courts are frequently excluding from trial evidence of the FDA’s pre-market analysis and clearance of these products. This result may surprise medical device companies: they are among the most heavily regulated industries in the United States and spend extensive time and resources to ensure that they comply with FDA regulations before selling medical devices.
But these courts believe that evidence of FDA’s review is relevant but that juries may give it too much weight in a liability calculus. One court went so far as to threaten to sanction attorneys if they said “FDA” at trial.
Excluding evidence of the FDA’s review of a highly regulated product causes inequitable results at trial. This fundamental unfairness recently led a New Jersey appellate court to vacate two jury verdicts against medical device companies and to order new trials.
The juries were misled into believing that the companies were unreasonable for not doing premarket clinical testing in patients when the whole story (that was hidden from the juries) was that the FDA did not believe such testing was necessary.
Read more from Reuters.