Iqbal 'Plausibility' in Pharmaceutical and Medical Device Litigation
| Author | William M. Janssen |
| Position | Assistant Professor of Law, Charleston School of Law |
| Pages | 541-645 |
Iqbal “Plausibility” in Pharmaceutical and Medical
Device Litigation
William M. Janssen∗
Judicial opinions construing and interpreting the technicalities
of proper pleading may be bedside reading for the bench, the bar,
and civil procedure enthusiasts, but rarely for those outside the
legal circle. It is hardly the spice that energizes the cocktail party
circuit. Not true with the United States Supreme Court’s decision
in Ashcroft v. Iqbal, which examined the federal pleader’s burden
to avoid a dismissal.1 In fact, few decisions in recent memory have
attracted as much popular attention, analysis, and angry debate as
this opinion and its predecessor from two years earlier that it had
sought to clarify, Bell Atlantic Corp. v. Twombly.2 In tandem, these
two decisions represent the Court’s resolve that speculation of
wrongdoing will not be sufficient to unlock the doors to civil
litigation in federal court. Instead, as Iqbal made firm, a plaintiff is
now required to plead a claim that is factually “plausible” to avoid
dismissal.
As the furious debate unleashed by Iqbal ricochets among the
courts, practitioners, academics, and elected officials, assessing its
impact has become a leading order of the day. One sector worthy
of special attention in this pursuit is pharmaceutical and medical
device litigation. It has been estimated that products regulated by
the federal Food and Drug Administration account for
approximately one-quarter of the entire consumer economy in the
United States,3 an economic valuation once pegged at $1.5
Copyright 2011, by WILLIAM M. JANSSEN.
∗ Assistant Professor of Law, Charleston School of Law. The concept for
this Article originated with a chapter in Top 20 Food and Drug Cases 2009,
published by the Food and Drug Law Institute in April 2010. I thank both the
FDLI and John B. Reiss, Esquire for that opportunity. This Article was
improved through the generosity of time and wise counsel graciously offered by
six accomplished legal scholars: P rofessor Richard D. Freer, Professor David G.
Owen, Professor Sheila B. Scheuerman, Professor Craig R. Senn, Professor Jay
Tidmarsh, and Thomas E. Willging, Esquire. Finally, I thank William Gaskill,
Charles S. Propst, and Kristin D. Smith for their outstanding research assistance.
This Article is dedicated lovingly to the memory of my father, William Mathias
Janssen, who passed away just as it was being published.
3. See Richard Merrill, FDA Regulatory Requirements as Tort Standards,
12 J.L. & POL’Y 549, 557 (2004). Additionally, the federal government
estimates that, in 2009, the total national health expenditure (encompassing not
just pharmaceuticals and medical devices, but professional services as well) rose
to $2.5 trillion and represented a 17.3% share of the gross domestic product of
542 LOUISIANA LAW REVIEW [Vol. 71
trillion.4 The value of the world pharmaceutical marketplace alone
has been estimated to be $750 billion.5 Domestically, 18 of the
Fortune 500 companies in 2010 were in the pharmaceutical or
medical device industries,6 and 3 of the 30 companies comprising
the current Dow Jones Industrial Average were pharmaceutical
companies.7 Pharmaceutical and medicine manufacturing employs
hundreds of thousands of wage and salaried employees.8 By any
measure, the pharmaceutical and medical device marketplaces are
vast. What Iqbal means to this sector, therefore, may have a
relevance that far transcends the rarely dusty tomes of federal civil
procedure law. It may influence a very broad swath of federal
the United States. See Ctrs. for Medicare & Medicaid Servs., U.S. Dep’t of
Health & Human Servs., National Health Expenditure Projections 2009–2019,
CENTERS FOR MEDICARE & MEDICAID SERVICES, http://www.cms.hhs.gov/
NationalHealthExpendData/downloads/proj2009.pdf (last visited Aug. 2, 2010).
4. See Douglas A. Grimm, FDA, CLIA, or a “Reasonable Combination of
Both”: Toward Increased Regulatory Oversight of Genetic Testing, 41 U.S.F. L.
REV. 107, 113–14 & n.54 (2006) (citing Eve E. Slater, Today’s FDA, 352 NEW
ENG. J. MED. 293, 293 (2005)). Further discrimination within that regulatory
category is elusive. As the agency’s authorizing statute confirms, the FDA’s
regulatory net encompasses food, cosmetics, and biologics (and, now, tobacco),
in addition to pharmaceuticals and medical devices. See Federal Food, Drug, &
5. See IMS Health Lowers 2009 Global Pharmaceutical Market Forecast to
2.5–3.5 Percent Growth, BUS. WIRE (Apr. 22, 2009), http://www.allbusiness.com/
economy-economic-indicators/economic-conditions-recovery/12305880-1.html.
6. The 12 pharmaceutical companies with this distinction (with their
Fortune 500 rank) were: Johnson & Johnson (33); Pfizer (40); Abbott
Laboratories (75); Merck (85); Eli Lilly (112); Bristol-Myers Squibb (114);
Amgen (159); Gilead Sciences (324); Mylan (412); Genzyme (458); Allergan
(459); and Biogen Idec (471). See FORTUNE, May 3, 2010, at F-39, available at
http://money.cnn.com/magazines/fortune/fortune500/2010/industries/21/index.
html. The six medical device companies with this distinction (with their Fortune
500 rank) were: Medtronic (160); Baxter International (185); Boston Scientific
(279); Becton Dickinson (312); Stryker (333); and St. Jude Medical (445). See
FORTUNE, May 3, 2010, at F-38, available at http://money.cnn.com/magazines/
fortune/fortune500/2010/industries/195/index.html.
7. These companies were Johnson & Johnson, Merck, and Pfizer. See Dow
Jones Industrial Average—Components, DOW JONES AVERAGES, http://www.
djaverages.com/?view=industrial&page=components (requires registration) (last
visited July 2, 2010).
8. In 2008, for example, the Department of Labor counted almost 300,000
such employees in the pharmaceutical and medicines manufacturing industries.
See Bureau of Labor Statistics, U.S. Dep’t of Labor, Career Guide to Industries:
Pharmaceutical and Medicine Manufacturers, BUREAU LAB. STAT., http://www.
bls.gov/oco/cg/cgs009.htm (last modified Dec. 17, 2009). Interestingly,
approximately 87% of these positions were “in establishments that employed
more than 100 workers.” Id.
2011] IQBAL “PLAUSIBILITY” 543
litigation that encompasses an equally broad (and critical)
dimension of the nation’s life.
It is not this Article’s goal to condemn or applaud Iqbal or the
pleading choices the Supreme Court made in deciding it. That
effort has been undertaken by many others, and their formidable
scholarship has already ably crystallized that debate. Instead, this
Article’s objective is narrower—to assess whether Iqbal matters in
pharmaceutical and medical device litigation and, if so, how and to
what degree.
This Article begins with context. Part I introduces the legal
landscape onto which Iqbal emerged. Part II retells the story of
Iqbal, describing the facts of the decision, followed by the
substance of the Supreme Court’s ruling. Part III reviews the
message of Iqbal and the clarification it aspired to supply to
federal pleaders and the courts. Part IV discusses the legal and
non-legal reactions to the decision, including legislative proposals
to overturn Iqbal. Part V surveys a few of the existing analytical
and statistical studies seeking to divine the significance of Iqbal
generally, over the full inventory of federal cases. Part VI probes
the meaning of Iqbal in the specific context of pharmaceutical and
medical device litigation, beginning with a description of the
methodology used in this Article to make that assessment,
proceeding to the results of this Article’s analysis of Iqbal’s effect
in the 264 pharmaceutical and device opinions released during a
period of more than 15 months since Iqbal was decided, and
closing with a sampling of noteworthy judicial uses of the decision
in this context. This Article finds that Iqbal has not had a
dramatically recalibrating effect throughout pharmaceutical and
medical device litigation: nearly 80% of the time, Iqbal did not
drive the outcome of dismissal motions. But this Article also finds
that summary pronouncements that brush Iqbal aside as entirely
inconsequential may be just as incorrect: 20% is still a big number.
However, a focused inspection of those cases where Iqbal seemed
to make a difference reveals a pattern of their reducing incidence,
no obviously explainable geographic concentrations, a frequent
grant of amendment opportunities, and the presence of a possible,
though modest, “information asymmetry.” This Article also finds
that, in large measure, whatever Iqbal significance there seems to
be within this pharmaceutical and medical device cohort cannot be
verified; the apparent Iqbal difference might just be a new label for
the prevailing “no-conclusions” pleading paradigm that has long
reigned nationally among the lower federal courts.
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