The Next Step in Drug Product Liability

The pharmaceutical industry’s efforts to uproot the ancient right of compensation of persons injured by a “negligent Apothecary” came to an abrupt end in the Supreme Court on Wednesday, March 4, 2009 in the Phenergan case Wyeth  v. Levine.  In a 6-3 decision the Court brushed aside the Bush-Administration FDA’s efforts to protect pharmaceutical manufacturers from liability. 

Justice John Paul  Stevens wrote for the Court:

“Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.”

My most concise statement on the preemption issue was probably from the floor at the November 2008 Product Liability symposium at Brooklyn Law School which you can hear by following this link (at minute 66.30):

“ It is very rare that the FDA requires any particular warning - what it actually does is permit the use of a warning proposed by a manufacturer who is in general in a far superior position to determine the facts regarding risks and benefit.  And so the principal actor... is the designer, manufacturer,  and marketer.  That is the principal source of expertise, not the FDA, which the National Academy of Sciences/Institute of Medicine, in its report  The Future of Drug Safety,  has described as scientifically incompetent and demoralized, and funded by the regulated industry.” 

Having endured the slings, slights, barbs, and arrows of academics bending like reeds in the winds from the right, I won’t pass up the opportunity to say “I told you so”.  And I have in journals from Yale to UCLA, and the University of Texas.  And, of course, in McDarby v. Merck  in which I was on the brief.  It is the only appellate decision to comprehensively review (and find sufficent) the plaintiffs’ evidence in a Vioxx case.  

You can hear my  summation of the issues in the Vioxx cases at minute 1:20.20 of the video below - a panel discussion at NYU in February 2009 (pre-Levine) at which the tilt to the right on preemption was strong.  Only Ben Zipursky of Fordham stated a clear defense of the principle of recourse for wrongs.  

Allison Zieve of Public Citizen and Richard Daynard of the Tobacco Product Liability Project, like me, spoke strongly but from the floor.

The Next Step: Product Stewardship

A duty to study real-world use of drugs!

The next step in drug product liability law should be what I have called “product stewardship”.  It is based on recognition that FDA permission to market is not the end of study but rather the beginning of the next stage of drug development: the mass, poorly controlled human experiment stage.

Product stewardship obligates medical product makers to systematically and actively follow their products' use, to continue testing as they market, and to provide meaningful comparisons of the effectiveness of actual treatment choices. Like physicians discussing surgery with patients, medical product makers must compare their products' risks and benefits - based on real-world data - both to competing products of the same class, and to recognized competing   therapeutic options, including those the manufacturer's product does not serve. See my article Punctuated Equilibrium.

for the entire NYU preemption Symposium, including the afternoon litigation panel with leading plaintiffs' lawyers Elizabeth Cabraser, Richard, Daynard, and Allison Zieve go here