Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-alnd-4_13-cv-00539/USCOURTS-alnd-4_13-cv-00539-1/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1441 Petition for Removal- Product Liability

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IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF ALABAMA

MIDDLE DIVISION

DANIEL STEWART, JR.,

Plaintiff,

v.

SANOFI AVENTIS U.S., LLC, 

Defendant.

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Case No.: 4:13-CV-539-VEH

 

MEMORANDUM OPINION

I. Introduction

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), Mr. 1

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 1

at 5-7).

FILED

 2014 Apr-10 PM 02:52

U.S. DISTRICT COURT

N.D. OF ALABAMA

Case 4:13-cv-00539-VEH Document 28 Filed 04/10/14 Page 1 of 9
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. Sanofi also filed copies of 2

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. 2

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II. Standard

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

612 (1993)).

Hawthorne v. Mac Adjustment, Inc., 140 F.3d 1367, 1370 (11th Cir. 1998).

III. Analysis

While the Indiana Supreme Court apparently has not yet addressed thisspecific

issue, a plain reading of the IPLA as well asseveral IPLA-related opinionsfromother

Indiana courts persuade this court that a plaintiff, such as Mr. Stewart, who allegedly

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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 formofthe drug.

A. Plain Language of the IPLA

The plain language of the IPLA does not support Mr. Stewart’s theory of

liability.

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

product; and 

(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,

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leased, or otherwise putsinto the streamof 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 Zolpideminto the stream

of commerce, it cannot be held liable to Mr. Stewart under the unambiguous wording

of the IPLA.

B. Persuasive Authorities

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 “expresslylimits liability tomanufacturers

or sellers of the alleged injury-causing product.” (Id. ¶ 46). 

The Short court further explained that innovator or original designer liability

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was:

[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 authoritywhich 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 SeventhCircuitCourt of Appeals

reasoned:

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 contendsthat 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

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stream of commerce the allegedly defective machine asrequired 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). However, Justice Murdock issued a lengthy dissenting opinion, 3

 As the Supreme Court of Alabama concluded its opinion in Weeks:

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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

manufacturers.

In the context ofinadequatewarnings bythe 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

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Case 4:13-cv-00539-VEH Document 28 Filed 04/10/14 Page 7 of 9
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 Weeksis 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 ofthe 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

manufacturer.

Weeks, 2013 WL 135753, at *19.

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IV. Conclusion

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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