Journal of Philosophy, Science & Law
8, November 5, 2008
NEJM, Drug Companies, and
The Conflict Underlying Levine
Charlene L. Smith*
* Professor Law, Shepard Broad Law Center, Nova
new under the sun.”
Product manufacturers, drug companies, and
even tug boat owners want to set their own standards when it comes to the
products they make or the work they do. Additionally, they want those standards to protect them from tort
liability. Even in the 1930’s, a tug
boat company tried to argue that the custom of the industry at that time should
protect them from liability. Most tug
boats did not have radios on board to warn them of imminent storms.
Thus, they argued, they would not be liable
for barges that sunk in a storm since the custom or standard did not include
having radios on board for warning purposes. However, Judge Learned Hand thought otherwise. He told the tug boat owners that when the
risks of potential losses were high and the costs to prevent the harm were low,
then the industry was not allowed to determine for themselves what was
the world has changed, especially with regard to food and drugs. Instead of Judge Hand, the Food and Drug
Administration (“FDA”) supposedly looks after the consumers and protects them
from unsafe drugs.
The FDA attempts to be the standard bearer in
this particular industry. The promise by
the FDA, however, has not been fulfilled because it has been captured by the
very people they are assigned to regulate.
Furthermore, the FDA does not have the
manpower to thoroughly investigate the drugs or their potential adverse affects
after the drug is marketed.
Related to these two flaws in the regulatory
system, the New England Journal of Medicine (“NEJM”) has written a laudable
amicus Supreme Court brief in support of plaintiff, Diana Levine, who was
seriously harmed by a drug approved by the FDA.
NEJM’s brief largely focuses on the policy
reasons why the petitioner Wyeth’s claims are not based in fact.
This editorial is related only to the NEJM’s counter-policy arguments.
NEJM’s brief illustrates, what happened to Ms. Levine, a musician living in
Vermont, is exactly why the FDA’s rules and regulations should not be the
accepted standard. Briefly, Ms. Levine
went to a health center because she had a migraine headache and was nauseous.
The health care center administered Phenergan
by an intro-muscular injection.
The nausea continued which prompted the staff
to give her a second intravenous injection using what is called an “IV
push.” The second injection hit an
The drug instructions clearly said that the
drip system was the preferred way to give the drug.
Additionally, Wyeth, the drug manufacturer,
had sent the FDA new warnings stemming from reports which emphasized that
inadvertent intra-arterial injections led to gangrene.
The FDA did nothing about the new warnings
and Wyeth did nothing about it either even though they were fully aware of the
danger associated with it.
As a result of the injections, Ms. Levine’s
arm became infected with gangrene and had to be amputated.
Ms. Levine settled with the Health Care
Center and sued Wyeth.
A Vermont jury found for Ms. Levine.
Wyeth appealed to the Supreme Court of
Vermont which affirmed the jury’s decision.
Wyeth then appealed to the United States
Supreme Court arguing that despite the fact that the drug company did nothing
after telling the FDA about the potential hazards, that the original FDA
approved warning gave them immunity because complying with FDA requirements
pre-empts any state tort law and therefore they were shielded from tort
counter points NEJM makes in its brief are laudable because they unravel every
policy argument that Wyeth attempts to use. For instance, according to Wyeth, the FDA creates the standard and that
standard reflects the health and safety needs of the American public. Since the drug company was in compliance with
the standard, according to Wyeth, they should be immune from tort liability law
suits. NEJM correctly argued that the
FDA largely relies upon drug companies through self-reporting to warn them
about dangerous effects of the drugs after marketing. However, the drug companies are slow to
clearly demonstrates that the FDA’s past history of monitoring drugs is marred
with failures. Their brief gives
examples of those failures by explaining what happened with regard to
Redux/Pondimin, Vioxx, and Trasylol drugs.
One cause of the FDA’s failure is that the
drug companies fail to inform the FDA in a timely fashion.
For instance, Merck knew as far back as 1997
that Vioxx “resulted in systemic reduction of a critical component to the human
body’s defense mechanism against heart attacks.”
It was not until 2002 that the FDA finally
insisted that Merck issue a precaution.
And to further exacerbate the problem, it was
not until 2004 that Merck finally withdrew the drug from the market.
NEJM’s amicus brief shows the same striking
pattern for the other drugs.
also clings to the idea that over-warning about drugs hazards will scare sick
people away from taking the drug. However, NEJM correctly observes that no empirical data exists which demonstrates
this hypothesis and in the meantime, the public’s health is jeopardized.
The drug companies are essentially playing
doctor by making decisions for and on the behalf of patients.
the policy arguments, as the NEJM correctly notes, satisfy the scrutiny
requirements. The antidote is a “robust”
state tort system.
Since many drug problems come to light only
after the drug is marketed
and the FDA cannot compel drug companies to reveal internal documents that
track reports made by doctors and users regarding side effects, torts suits are
an effective remedy.
During these suits, state courts can provide
the stop gap via the discovery process or a court subpoena.
What is hidden from the FDA comes to light
during this important stage of the trial. Further, potential high tort damages provide an incentive to ensure that
drug companies warn the public.
As the FDA’s budget decreases, so does needed
oversight and investigation. The tort liability system gives the FDA a powerful
tool in which to poke the drug companies into warning the consumers.
Finally, the FDA has no independent power to
make those who have been seriously harmed whole.
Hurrah for the independence of the NEJM
for making a case for the consuming public.
thanks to David Haas, class of 2009, for his help.
See generally Levine v. Wyeth, 944 A.2d 179 (Vt. 2006); Brief for New
England Journal of Medicine Editors and Authors as Amici Curiae Supporting
Respondents, Wyeth v. Levine, No. 06-1249 (U.S. filed August 14, 2008)
(Hereinafter Brief for New England Journal of Medicine Editors and Authors);
Brief for the United States as Amicus Curiae Supporting Petitioner, Wyeth v.
Levine, No. 06-1249 (U.S. filed June 2008) (Hereinafter Brief for the United
The quotation is “…adapted from the Book of Ecclesiastes; the author
complains frequently in the book about the monotony of life.” E. D. Hirsch, Jr. et al., The New
Dictionary of Cultural Literacy (3d ed. 2002), available at http://www.bartleby.com/59/1/nothingnewun.html (last visited October 29, 2008).
The T.J.Hooper, 60 F.2d 737 (2nd Cir. 1932).
Vale Krenik, “No One Can Serve Two Masters”: A Separation of Powers
Solution for Conflicts of Interest Within The Department of Health and Human
Services, 12 Tex. Wesleyan L.
Rev. 585, 620 (2006). See Marcia Angell, M.D., The Truth About The Drug Companies 211–12 (2004). Dr. Angell was the NEJM’s
Executive Editor between 1988 and 1999 and its Editor-In-Chief between 1999 and
U.S. Gov’t Accountability Office,
Testimony, Fed. Oversight of Food Safety: FDA’s Food Protection Plan Proposes Positive First Steps, But Capacity
to Carry Them Out Is Critical 2 (2008), available at http://www.gao.gov/new.items/d08435t.pdf (last visited October 29, 2008); U.S.
Gov’t Accountability Office, Testimony, Fed. Oversight of Food Safety: FDA Has Provided Few Details on The Resources
and Strategies Needed to Implement Its Food Protection Plan 2–3 (2008), available
at http://www.gao.gov/new.items/d08909t.pdf (last visited October 29, 2008).
See generally Brief for New England Journal of Medicine Editors and
Authors, supra note 1.
Levine v. Wyeth, 944 A.2d 178, 182 (Vt. 2006).
Brief for the United States, supra note 1, at 7.
Brief of New England Journal of Medicine Editors and Authors, supra note
1, at 12–30.