Cross posted from The Pop Tort by Andy Hoffman
As we count down the days before the U.S. Supreme Court hears arguments in the big “preemption” case, 
Wyeth v. Levine, the news has been filled with compelling evidence that granting drug companies complete immunity from lawsuits is a truly terrible idea. Here are a few samples…
Citing a new report by the Government Accountability Office (GAO), the Wall Street Journal reported today that the Food and Drug Administration (FDA) “is failing to keep accurate data about foreign drug facilities it is supposed to oversee and often doesn't follow up warning letters with inspections.”
A new study out of the Netherlands found that “Nearly one in four recently approved products in a relatively new class of medicines needed some type of regulatory action because of safety issues that arose after they came on the market,” according to the USA Today.
Meanwhile, the Journal of the American Medical Association (JAMA), in anticipation of Wyeth, has written an editorial forcefully condemning blanket immunity for drug and medical device manufacturers. Here’s an excerpt.
“Given the current imperfect process for approval and the flawed
postmarketing surveillance system, the drug and device regulation
process is at best an inexact and incomplete science. Until these
deficiencies in the system are remedied, some patients inevitably will
continue to experience harm from the use of newly marketed products as
well as from use of other approved medications. Just as with other
consumer products that cause harms, consumers (ie, patients) who are
injured by defective medical devices or by pharmaceutical products with
inadequate warnings of potential harms may have to resort to legal
action as recourse for their injuries…Litigation and state tort law
‘provides a system of civil justice designed to compensate patients,
deter unreasonably hazardous conduct, and encourage innovation in
product design, packaging, labeling, and advertising.”
“Thus, tort law serves in effect as a way to close regulatory gaps in
the FDA premarketing approval process and to provide a mechanism for
postmarketing surveillance. Moreover, litigation has been a rich source
of information about how drug and device manufacturing companies
behave, such as with off-label promotion, guest and ghost authorship,
and reporting of safety findings. Without the information revealed by
the public release of documents in tort liability actions, many of
these behaviors would remain unknown, some drug manufacturers’
judgments about safety issues would be hidden from view, review, or
oversight, and the FDA would not be able to uncover them either…”
