Finally, A Sensible Preemption Decision

In a startling reversal of his own ruling, Chief Judge David Hamilton of the Southern District of Indiana issued a 28 page

The Judge rightly concluded that "drug manufacturers
have the authority to strengthen warnings without the advance permission of
the FDA"  and that “failure to warn litigation can serve to reinforce the FDA's
regulations, which already place the obligation to strengthen the warnings
on a drug's label squarely on the shoulders of the drug's manufacturer."
          The Judge relied in part on a recent law review article by former FDA Commissioner, David Kessler, in which he noted the recent change in position by the FDA under the watch of a Chief counsel with significant ties to BigPharma. Mr. Kessler wrote: "The most fundamental problem is that drugs are approved on the basis of
clinical testing that cannot, and is not designed to, uncover risks that are
relatively rare or have long latency periods. Legislation cannot solve this
problem ... Top-down surveillance is no substitute for failure to warn
litigation, which provides the FDA, doctors, and patients with information
about new risks that is otherwise unavailable to the agency."
              The Indiana case involved a 55 year-old Catholic priest with no history of suicidal ideation who took his life 22 days after being put on Paxil.

Alan Milstein