Stewart v. Sanofi Aventis US LLC
MEMORANDUM OPINION. Signed by Judge Virginia Emerson Hopkins on 4/10/2014. (JLC)
2014 Apr-10 PM 02:52
U.S. DISTRICT COURT
N.D. OF ALABAMA
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
DANIEL STEWART, JR.,
SANOFI AVENTIS U.S., LLC,
) Case No.: 4:13-CV-539-VEH
Plaintiff Daniel Stewart, Jr. (“Mr. Stewart”) initiated this products liability
action in the Circuit Court of Etowah County, Alabama, on July 26, 2012. (Doc. 1 ¶
1). Defendant Sanofi Aventis U.S., LLC (“Sanofi”) removed the lawsuit to federal
court on March 21, 2013, on the basis of diversity jurisdiction. (Doc. 1 at 1, 4). The
case was reassigned to the undersigned on March 26, 2013. (Doc. 9). Sanofi filed an
amended removal petition on April 5, 2013. (Doc. 14).
In compliance with this court’s order requiring him to replead (Doc. 18),1 Mr.
Stewart filed an amended complaint (Doc. 19) on May 17, 2013. The amended
In that same order, the court explained why Indiana law applies to this dispute. (Doc. 18
pleading contains one count of a product liability failure to warn asserted under the
Indiana Product Liability Act (“IPLA”). (Doc. 19 at 12-13).
Pending before the court is Sanofi’s Motion for Judgment on the Pleadings
(Doc. 23) (the “Motion”) filed on September 6, 2013.2 Sanofi also filed copies of
several persuasive case authorities in support of its Motion on September 6, 2013.
(Doc. 25). Mr. Stewart opposed the Motion (Doc. 26) on September 27, 2013, and
Sanofi followed with its reply (Doc. 27) on October 4, 2013.
Based upon the allegations of Mr. Stewart’s amended pleading, he claims harm
and injuries as a result of ingesting Zolpidem, while he was attending a business
meeting in Columbus, Indiana, on October 3, 2011. (Doc. 19 ¶ 3). Zolpidem is a
generic form of the more commonly know prescription sleep aid called Ambien. (Id.
¶ 4). Sanofi manufacturers Ambien, but not Zolpidem. Id. Sanofi contends that as a
manufacturer of a name-brand drug, it is not liable under the IPLA for damages
allegedly caused by the use of another manufacturer’s generic-equivalent drug.
Because the court concludes that, accepting all of Mr. Stewart’s allegations as true,
Indiana law would not hold Sanofi liable to Mr. Stewart on a failure to warn theory,
the Motion is due to be granted.
The page references to Doc. 23 correspond with the court’s CM/ECF numbering system.
Rule 12(c) of the Federal Rules of Civil Procedure provides that “[a]fter the
pleadings are closed--but early enough not to delay trial--a party may move for
judgment on the pleadings.” Fed. R. Civ. P. 12(c). As the Eleventh Circuit has
explained the Rule 12(c) standard:
Judgment on the pleadings is appropriate when there are no material
facts in dispute, and judgment may be rendered by considering the
substance of the pleadings and any judicially noticed facts. See Bankers
Ins. Co. v. Florida Residential Property and Cas. Joint Underwriting
Ass'n, 137 F.3d 1293, 1295 (11th Cir.1998) (citing Hebert Abstract Co.
v. Touchstone Properties, Ltd., 914 F.2d 74, 76 (5th Cir.1990)); see also
Rule 12(c), Fed. R. Civ. P. When we review a judgment on the
pleadings, therefore, we accept the facts in the complaint as true and we
view them in the light most favorable to the nonmoving party. See
Ortega, 85 F.3d at 1524 (citing Swerdloff v. Miami Nat'l Bank, 584 F.2d
54, 57 (5th Cir. 1978)). The complaint may not be dismissed “ ‘unless
it appears beyond doubt that the plaintiff can prove no set of facts in
support of his claim which would entitle him to relief.’ ” Slagle, 102
F.3d at 497 (quoting Conley v. Gibson, 355 U.S. 41, 45–46, 78 S. Ct. 99,
101–02, 2 L. Ed. 2d 80 (1957) & citing Hartford Fire Ins. Co. v.
California, 509 U.S. 764, 811, 113 S. Ct. 2891, 2916–17, 125 L. Ed. 2d
Hawthorne v. Mac Adjustment, Inc., 140 F.3d 1367, 1370 (11th Cir. 1998).
While the Indiana Supreme Court apparently has not yet addressed this specific
issue, a plain reading of the IPLA as well as several IPLA-related opinions from other
Indiana courts persuade this court that a plaintiff, such as Mr. Stewart, who allegedly
was injured by a prescription drug cannot state a claim for failure to warn under the
IPLA against the manufacturer of a brand name prescription drug, such as Sanofi,
when the allegations show that the plaintiff ingested solely a generic form of the drug.
Plain Language of the IPLA
The plain language of the IPLA does not support Mr. Stewart’s theory of
Sec. 1. Except as provided in section 3 of this chapter, a person who
sells, leases, or otherwise puts into the stream of commerce any product
in a defective condition unreasonably dangerous to any user or
consumer or to the user’s or consumer’s property is subject to liability
for physical harm caused by that product to the user or consumer or to
the user's or consumer’s property if:
(1) that user or consumer is in the class of persons that the
seller should reasonably foresee as being subject to the
harm caused by the defective condition;
(2) the seller is engaged in the business of selling the
(3) the product is expected to and does reach the user or
consumer without substantial alteration in the condition in
which the product is sold by the person sought to be held
liable under this article.
Ind. Code § 34-20-2-1.
As Sanofi correctly observes, “[t]he opening clause of Indiana Code §
34-20-2-1 requires that in order for a defendant to be held liable, it must have sold,
leased, or otherwise puts into the stream of commerce the product that caused the user
or consumer’s ‘physical harm.’” (Doc. 23 at 12). Because Sanofi is not alleged to be
responsible for manufacturing, selling, or otherwise putting Zolpidem into the stream
of commerce, it cannot be held liable to Mr. Stewart under the unambiguous wording
of the IPLA.
Sanofi has cited to several authorities in support of its Motion. The court finds
the following two cases to be particularly instructive and persuasive: Short v. Eli
Lilly and Co., No. 49D12-0601-CT-2187 decided on March 25, 2009, by the Superior
Court of Marion County, Indiana (Doc. 24-1); and the Seventh Circuit’s decision in
Williams v. REP Corp., 302 F.3d 660 (7th Cir. 2002).
In Short, the court was faced with the summary judgment issue of whether the
defendant could be held liable for the death of the plaintiff’s husband when the
evidence showed that he had only used a generic form of Prozac. (Doc. 24-1 at 14 ¶
44). After determining that the IPLA governed plaintiff’s claims, regardless of their
alleged nature, the court found that the brand name manufacturer of Prozac could not
be liable to the plaintiff because the statute “expressly limits liability to manufacturers
or sellers of the alleged injury-causing product.” (Id. ¶ 46).
The Short court further explained that innovator or original designer liability
[A] deviat[ion] from well-settled principles of Indiana law[,] . . .
fundamentally inconsistent with well-settled Indiana law and the most
basic tenets of products liability law[, and] . . . contrary to the
overwhelming weight of authority which has unanimously rejected such
an expansive theory of liability.
(Doc. 24-1 at 13 ¶ 39). This court agrees with Short.
Williams is also a summary judgment decision arising under the IPLA. 302
F.3d at 662. In affirming the district court’s order granting summary judgment in
favor of the defendant and rejecting an extension of products liability based upon
common ownership and/or corporate affiliation, the Seventh Circuit Court of Appeals
Mr. Williams submits that REP Corp. is subject to liability under
the Act notwithstanding the fact that it did not actually sell the machine
that injured him. He offers several arguments in support of his
contention. First, Mr. Williams contends that REP Corp. falls within the
Act’s definition of “manufacturer” and therefore may be liable under the
Act. The Act defines “manufacturer” to include “a seller who: ... (D) is
owned in whole or significant part by the manufacturer; or (E) owns in
whole or significant part the manufacturer.” Ind. Code Ann. §
33–1–1.5–2(3) (West 1996). The Act defines a “seller” in general terms
as “a person engaged in the business of selling or leasing a product ....”
Id. § 33–1–1.5–2(5). At the time the district court entered summary
judgment for REP Corp., the evidence before the court indicated that
“REP France” was the manufacturer of the machine and that REP Corp.
was a wholly owned subsidiary of “REP France.” Even if REP Corp.
could be considered a “seller” under the statute’s generic definition, and
therefore a “manufacturer” because it is owned by “REP France,” there
is still no evidence that REP Corp. sold, leased or otherwise put into the
stream of commerce the allegedly defective machine as required by Ind.
Code § 33–1–1.5–3(a). It was later disclosed that REP International
manufactured the machine and did not own REP Corp. This
development does not change the basic analysis. REP, the parent
corporation, owns REP International and REP Corp. Yet, REP Corp. still
cannot be said to have sold, leased or otherwise placed the machine in
the stream of commerce.
Williams, 302 F.3d at 663 (emphasis added).
The court acknowledges that the Supreme Court of Alabama (against the great
majority of those courts which have examined the theory) has issued a decision on a
certified question that has not yet been released for publication, which embraces a
type of innovator liability, see Wyeth, Inc. v. Weeks, No. 1101397, 2013 WL 135753,
(Ala. Jan. 11, 2013).3 However, Justice Murdock issued a lengthy dissenting opinion,
As the Supreme Court of Alabama concluded its opinion in Weeks:
We answer the question as follows: Under Alabama law, a brand-name drug
company may be held liable for fraud or misrepresentation (by misstatement or
omission), based on statements it made in connection with the manufacture of a
brand-name prescription drug, by a plaintiff claiming physical injury caused by a
generic drug manufactured by a different company. . . .
FDA regulations provide that a generic-drug manufacturer’s labeling for a
prescription drug must be exactly the same as the brand-name-drug manufacturer's
labeling. The Supreme Court in PLIVA held that it would have been impossible for
the generic-drug manufacturers to change their warning labels without violating the
federal requirement that the warning on a generic drug must match the warning on
the brand-name version, preempting failure-to-warn claims against generic
In the context of inadequate warnings by the brand-name manufacturer placed
on a prescription drug manufactured by a generic-drug manufacturer, it is not
fundamentally unfair to hold the brand-name manufacturer liable for warnings on a
product it did not produce because the manufacturing process is irrelevant to
2013 WL 135753, at *20-37, on February 4, 2013, and the direct history in Weeks
reflects that a rehearing was granted on June 13, 2013. Consequently, whether the
reasoning and holding in Weeks will ultimately stand is debatable.
Moreover, even if Weeks is unchanged after reargument, the court sees nothing
in Mr. Stewart’s opposition to the Motion which convinces this court that the
Supreme Court of Indiana will be persuaded to follow Weeks, especially as that
opinion, consistent with Alabama law, is predominantly common-law driven in its
analysis while, in sharp contrast and as illustrated above, Indiana products liability
law is statutorily driven.
In sum, consistent with the plain language of the IPLA and persuasively guided
by Short, Williams, and the plethora of other decisions cited by Sanofi, the court
concludes that Mr. Stewart cannot maintain a failure to warn theory under the IPLA
against Sanofi under the particular factual allegations of his case.
misrepresentation theories based, not on manufacturing defects in the product itself,
but on information and warning deficiencies, when those alleged misrepresentations
were drafted by the brand-name manufacturer and merely repeated by the generic
Weeks, 2013 WL 135753, at *19.
Accordingly, the Motion is due to be granted. The court will enter a separate
order dismissing this action with prejudice.
DONE and ORDERED this the 10th day of April, 2014.
VIRGINIA EMERSON HOPKINS
United States District Judge
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