Houston v. United States of America et al

Filing 71

MEMORANDUM Opinion and Order. The Court grants Qualitest's motion to dismiss 13 and dismisses with prejudice the claims plaintiff asserts against it. Signed by the Honorable Jorge L. Alonso on 4/20/2015. Notice mailed by judge's staff (ntf, )

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT ILLINOIS
EASTERN DIVISION
MICHAEL HOUSTON,
Plaintiff,
v.
UNITED STATES OF AMERICA and
QUALITEST PHARMACEUTICAL,
INC.,
Defendants.

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No. 14 C 1042
Judge Jorge L. Alonso

MEMORANDUM OPINION AND ORDER
In 2011, plaintiff took Allopurinol, a generic drug manufactured by Qualitest, for treatment of
gout. (Compl. ¶¶ 6, 40-41.) After taking the medication as prescribed, plaintiff developed StevensJohnson Syndrome (“SJS”), a serious disorder that produces severe skin rashes and can cause
blindness. (Id. ¶¶ 7-10, 13.) Plaintiff brings state-law claims alleging that Qualitest defectively
designed Allopurinol (Count VI (First), Count VII, Count XI, and Count XII), failed to warn that the
drug was dangerous (Counts VI (Second) and VIII), and failed to ensure that the drug performed as
described and was fit for its intended purpose (Counts IX and X). Qualitest asks the Court to dismiss
these claims as preempted by the federal Food, Cosmetic and Drug Act.
Under the Supremacy Clause of the Constitution, federal law is “the supreme Law of the Land”
notwithstanding any state laws to the contrary. U.S. Const. art. IV, cl. 2. “Accordingly, it has long
been settled that state laws that conflict with federal law are without effect.” Mutual Pharm. Co., Inc.
v. Bartlett, 133 S. Ct. 2466, 2471 (2013) (quotation omitted). Thus, if “it is impossible for a private
party to comply with both state and federal [law],” the state law is preempted. Id. (quotation omitted).

Qualitest contends that the Federal Food, Drug, and Cosmetic Act preempts plaintiff’s claims
against it. That statute and the regulations promulgated under it require a generic drug to be
bioequivalent to the brand-name drug, to have the same active ingredients, route of administration,
dosage form, and strength of the brand-name drug, and to have the same labeling as the brand-name
drug. 21 U.S.C. § 355(j)(2)(A)(ii)-(v). Moreover, once a generic drug is approved by the FDA, the
manufacturer is prohibited from changing the drug’s formulation or labeling. Bartlett, 133 S. Ct. at
2471.
This so-called “duty of sameness,” PLIVA v. Mensing, 131 S. Ct. 2567, 2575 (2011),1 that
federal law imposes on Qualitest directly conflicts with its duties under state law, which as relevant
here, are: (1) to design [a] reasonably safe product[],” Calles v. Scripto-Tokai Corp., 864 N.E.2d 249,
264 (Ill. 2007) (Counts VI (First), VII, XI, and XII); (2) “to warn of a product’s dangerous
propensities,” Kirk v. Michael Reese Hospital & Medical Center, 513 N.E.2d 387, 391 (Ill. 1987);
Connick v. Suzuki Motor Co., 675 N.E.2d 584, 593 (Ill. 1996) (Counts VI (Second) and VIII); and (3)
to ensure that goods perform as described and are fit for the purpose for which they are sold, 810 Ill.
Comp. Stat. §§ 5/2-313, 315; Berry v. G.D. Searle & Co., 309 N.E.2d 550, 554-55 (Ill. 1974) (holding
that prescription of drugs is a sale subject to the UCC) (Counts IX and X). Qualitest can only abide
by these state-law duties if it changes the design or labeling of Allopurinol, steps that federal law
prohibits it from taking. Because it is impossible for Qualitest to comply with both federal and state
law, plaintiff’s state-law claims are preempted. See Bartlett, 133 S. Ct. at 2470 (holding that “state-law
design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted” (quotation

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Unlike the claims in Mensing, plaintiff’s claims arose after the enactment of the Food and
Drug Administration Amendments Act of 2007 (“FDAAA”). That statute did not, however, alter
or eliminate the duty of sameness. See FDAAA, Pub. L. No. 110-85, 121 Stat. 823 (2007).

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omitted); Mensing, 131 S. Ct. 2567, 2577 (2011) (holding that federal law preempted state failure-towarn claims against generic drug manufacturers because “[i]t was not lawful under federal law for the
Manufacturers to do what state law required of them,” i.e., “to use a different, stronger label” than the
one approved by the FDA). Therefore, the Court grants Qualitest’s motion to dismiss [13] and
dismisses with prejudice the claims plaintiff asserts against it.
SO ORDERED.

ENTERED: April 20, 2015

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HON. JORGE L. ALONSO
United States District Judge

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