Bioethics: July 2008 Archives
In a startling reversal of his own ruling, Chief Judge David Hamilton of the Southern District of Indiana issued a 28 page Opinion reversing his preemption ruling in an
from its earlier stance."
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
Alan Milstein
The connection between Mirapex and compulsive gambling first came to light in July 2005 when doctors at the Mayo Clinic reported the results of a study suggesting a link between dopamine agonist drugs like Mirapex and compulsive gambling.
Researchers have long known that certain drugs can cause adverse reactions that can change a person's behavior by initiating destructive thoughts which lead to destructive behavior. It will be interesting to see if a court and jury will accept the theory that a prescription drug is responsible for behavior such as a gambling addiction.
Alan Milstein
Representative Henry Waxman has introduced a bill to essentially overrule the recent court rulings such as Riegel v Medtronic holding that civil claims against medical device manufacturers are pre-empted by FDA action. The Medical Device Safety Act of 2008 would reinstate tort liability in state civil actions alleging negligent design of such devices or the failure to warn of their dangerous propensity. Such a bill would be a welcome relief to consumers seeking just compensation for their injuries.
