Washington v. Teva Pharmaceuticals USA, Inc. et al
ORDER granting 24 Motion to Dismiss for the reasons stated in the order. Washington is granted leave to file a motion to amend that attaches the proposed amended complaint within 14 days, otherwise the Court will fully dismiss the case at that time. Signed by District Judge Daniel P. Jordan III on February 7, 2013. (SP)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF MISSISSIPPI
PATRICIA WASHINGTON, ON BEHALF
OF AND AS MOTHER AND NEXT FRIEND
OF OLIVIA WASHINGTON, A MINOR
CIVIL ACTION NO. 3:12cv126-DPJ-FKB
MEDICIS PHARMACEUTICALS CORP., et al.
This pharmaceutical-injury case is before the Court on Defendant Medicis
Pharmaceuticals Corp.’s Motion to Dismiss . In general terms, Plaintiff asserts a productsliability claim against Medicis, the manufacturer of a brand-name pharmaceutical, although
Plaintiff ingested the generic equivalent of Medicis’s product. Having fully considered the
parties’ submissions and the relevant authorities, the Court finds that Mississippi law would not
recognize the causes of action alleged against the brand-name manufacturer. Medicis’s motion is
therefore granted, but Plaintiff is nonetheless afforded one additional opportunity to seek leave to
Facts and Procedural History
In summer 2010, Olivia Washington, a minor, was prescribed a generic minocycline-
hydrochloride-based drug, manufactured by Teva Pharmaceuticals USA, Inc., to treat her acne.
After she began using this generic minocycline, Washington experienced numerous adverse side
effects and was hospitalized as a result. Following a lengthy stint of observations, tests, and
preliminary diagnoses, Washington’s doctors diagnosed her with “Drug Hypersensitivity
Syndrome, or alternately Drug Reaction (or Rash) with Eosinophilia and Systemic Symptoms
(DRESS syndrome).” Pl.’s Am. Compl.  ¶ 8. Thereafter, the FDA updated the labeling
requirements for brand-name minocycline-based drugs, Minocin and Solodyn, to warn of the
heightened risk of DRESS syndrome in pediatric patients using minocycline.
On January 20, 2012, Washington, acting through her mother, filed suit against Teva in
the Circuit Court of Hinds County, Mississippi, for Teva’s alleged failure to warn against the risk
of DRESS syndrome from taking its generic minocycline. Teva removed the case to this Court
on the basis of diversity jurisdiction and moved to dismiss citing Pliva, Inc. v. Mensing, 131 S.
Ct. 2567 (2011), which held that federal law preempts failure-to-warn claims against generic
drug manufacturers. Washington opted to voluntarily dismiss Teva but moved to amend her
complaint to add new defendants.
Leave was granted, and on June 1, 2012, Washington amended her Complaint adding
Medicis (which manufactures Medicis) and Pfizer, Inc., (which manufacturers Minocin).1
Although Washington ingested the generic equivalent of Solodyn, the amended pleading alleges
that Medicis is nonetheless liable for both failure to warn and defective design. Medicis moved
to dismiss Washington’s claims against it on August 27, 2012, asserting that it cannot be held
liable for Washington’s injuries because it did not manufacture the drug she ingested. The
parties have fully briefed the motion and the Court is prepared to rule.
In considering a motion under Rule 12(b)(6), the “court accepts ‘all well-pleaded facts as
true, viewing them in the light most favorable to the plaintiff.’” Martin K. Eby Constr. Co. v.
Washington has since voluntarily dismissed her claims against Pfizer. Order  Feb. 6,
Dallas Area Rapid Transit, 369 F.3d 464, 467 (5th Cir. 2004) (quoting Jones v. Greninger, 188
F.3d 322, 324 (5th Cir.1999)). To overcome a Rule 12(b)(6) motion, Plaintiff must plead
“enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly,
550 U.S. 544, 570 (2007). “Factual allegations must be enough to raise a right to relief above the
speculative level, on the assumption that all the allegations in the complaint are true (even if
doubtful in fact).” Id. at 555 (citations and footnote omitted). “A claim has facial plausibility
when the plaintiff pleads factual content that allows the court to draw the reasonable inference
that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678
(2009) (citing Twombly, 550 U.S. at 556). It follows that “where the well-pleaded facts do not
permit the court to infer more than the mere possibility of misconduct, the complaint has
alleged—but it has not ‘show[n]’—‘that the pleader is entitled to relief.’” Id. at 679 (quoting
Fed. R. Civ. P. 8(a)(2)). “This standard ‘simply calls for enough fact to raise a reasonable
expectation that discovery will reveal evidence of’ the necessary claims or elements.” In re S.
Scrap Material Co., 541 F.3d 584, 587 (5th Cir. 2008) (citing Twombly, 550 U.S. at 556).
In her Amended Complaint, Washington alleges that Medicis is liable because its brand-
name minocycline product, Solodyn, was defectively designed or included an insufficient
warning. Because jurisdiction is based on diversity of citizenship, the Court applies the
substantive law of the State of Mississippi. Scott v. Dorel Juvenile Grp., Inc., 456 F. App’x 450,
452 (5th Cir. 2012). And in Mississippi, the Mississippi Products Liability Act (MPLA)
normally provides the starting point for products-liability claims.
Washington brings no such claim, but an understanding of the MPLA is necessary to
evaluate the theories she does advance. Under the MPLA, “in any action for damages caused by
a product . . . [t]he manufacturer or seller of the product shall not be liable if the claimant does
not prove by the preponderance of the evidence that at the time the product left the control of the
manufacturer or seller” the product was defective in one of four specified ways, including failure
to warn and defective design. Miss. Code Ann. § 11-1-63(a). The wrinkle in this case is that
Medicis neither manufactured nor sold the generic minocycline-hydrochloride-based drug
Washington ingested. As such, it faces no liability under the MPLA. Lawson v. Honeywell Int’l,
Inc., 75 So. 3d 1024, 1029 (Miss. 2011) (affirming dismissal of MPLA claim because the act
does not cover mere designers of a product).
Washington apparently recognizes this obstacle and notes that this is not “a traditional
products liability case.” Pl.’s Resp.  at 1. She claims instead that Medicis “as innovator” of
Solodyn—a brand-name minocycline-based medication—breached its duties to customers who
later purchased generic forms of Solodyn from other manufacturers or sellers. Pl.’s Am. Compl.
 at 7. The so-called innovator theory of liability took root in Conte v. Wyeth, Inc., a case
decided by one of California’s many district courts of appeals. 85 Cal. Rptr. 3d 299, 313,
317–18 (Cal. Ct. App. 2008). In that case, the court held, “[W]e have no difficulty concluding
that [the brand-name drug maker] should reasonably perceive that there could be injurious
reliance on its product information by a patient taking generic [versions of the drug].” Id. at 313.
But as Washington correctly notes, the Mississippi Supreme Court has neither ruled on
the innovator theory of liability nor adopted the Conte decision. Thus, the Court “must make an
‘Erie-guess’, predicting how that court would rule.” Hodges v. Mack Trucks Inc., 474 F.3d 188,
199 (5th Cir. 2006) (citing Centennial Ins. Co. v. Ryder Truck Rental, Inc., 149 F.3d 378, 382
(5th Cir. 1998)). Courts consider several factors in making this prediction:
(1) decisions of the [Mississippi] Supreme Court in analogous cases, (2) the
rationales and analyses underlying [Mississippi] Supreme Court decisions on
related issues, (3) dicta by the [Mississippi] Supreme Court, (4) lower state court
decisions, (5) the general rule on the question, (6) the rulings of courts of other
states to which [Mississippi] courts look when formulating substantive law and
(7) other available sources, such as treatises and legal commentaries.
Id. (quoting Centennial Ins. Co., 149 F.3d at 382).
Starting with clues from within Mississippi, Washington believes the innovator theory is
at least consistent with the Mississippi Supreme Court’s decision in Lawson v. Honeywell
International, Inc. 75 So. 3d 1024. There, the plaintiff was involved in a single-car accident and
claimed that her seatbelt failed. Id. at 1026. In addition to suing the vehicle’s manufacturer, the
plaintiff sued Honeywell, claiming that it designed a defective seatbelt and sold the design to the
manufacturer. Id. After the trial court dismissed the case as preempted by the MPLA, the
Mississippi Supreme Court was asked to consider whether the MPLA precluded a common-law
negligence claim against Honeywell as the designer of the seatbelt. Id. The court concluded that
“[b]ecause the statute applies only to manufacturers and sellers, a person or entity other than the
manufacturer or seller—who negligently designs a product—may be held liable for common-law
negligence or under any other available theory of liability.” Id. at 1029–30.
Though Lawson reversed dismissal of a negligence claim against a product designer, it
stopped well short of endorsing innovator liability as adopted in Conte. Unlike innovator
liability, the designer in Lawson allegedly designed a defective part and sold it directly to the
manufacturer of the vehicle plaintiff was driving when the accident occurred. Thus, there existed
a direct foreseeable link between the design and the subject product. Cf. Craig v. Pfizer, Inc.,
No. 3:10-00227, 2010 WL 2649545, at *4 n.3 (W.D. La. May 26, 2010) (noting similar designer
liability under Texas law does “not extend liability to designers or manufacturers that did not
design, manufacture, or sell the specific product that caused the plaintiff’s injuries.” (citing
Firestone Steel Prods. Co. v. Barajas, 927 S.W.2d 608, 615–16 (Tex. 1996))). Conte, on the
other hand, goes much further concluding that the “duty of care in disseminating product
information” extends to patients injured by generic drugs manufactured by companies with no
connection to the alleged innovator. 85 Cal. Rptr. 3d at 315. Lawson appears to be
At least one other federal court has distinguished Lawson in this exact context. In
Gardley–Starks v. Pfizer, Inc., the court rejected products-liability claims against a brand-name
pharmaceutical manufacturer when the plaintiff took the generic equivalent. — F. Supp. 2d —,
No. 4:10-CV-099-SA-JMV, 2013 WL 139900, at *5 (N.D. Miss. Jan. 10, 2013). There, Judge
Sharion Aycock first noted that the “court in Lawson was careful to limit its holding to
non-manufacturing, non-selling designers of a product” whereas the brand-name defendants both
manufactured and sold their products. Id. at *4. The court then held that “Mississippi law,
consistent with the vast majority of courts to consider this issue, would not recognize a cause of
action—however styled—against a brand manufacturer for injuries caused by use of its
competitors’ generic product.” Id. at *5. This Court agrees that Lawson is distinguishable and
that Mississippi has yet to recognize innovator liability.
Because Mississippi has not spoken on this issue, the Court looks to the general rule on
the question. Hodges, 474 F.3d at 199. And “‘[a]bsent evidence to the contrary we presume that
the Mississippi courts would adopt the prevailing rule if called upon to do so.’” Centennial Ins.
Co., 149 F.3d at 382 (quoting Jackson v. Johns-Manville Sales Corp., 781 F.2d 394, 398 (5th
Cir. 1986) (en banc)). This rule is consistent with the Fifth Circuit’s “long[-]followed . . .
principle that we will not create ‘innovative theories of recovery or defense’ under local law, but
will rather merely apply it ‘as it currently exists.’” Barfield v. Madison Cnty., 212 F.3d 269, 272
(5th Cir. 2000) (quoting Johnson v. Sawyer, 47 F.3d 716, 729 (5th Cir. 1995) (en banc)).
Conte’s innovator theory is certainly “innovative.” The majority rule on this point comes
from Foster v. American Home Products Corp., where the Fourth Circuit held under Maryland
law that a brand-name drug maker may not be liable on the basis of negligent misrepresentation
for injuries caused by a generic drug. 29 F.3d 165, 168 (4th Cir. 1994). Conte broke from this
rule, and in doing so recognized “that in declining to follow Foster we depart from the majority
of courts to have wrestled with this particular issue.” 85 Cal. Rptr. 3d at 317 (citations omitted).
And since that departure, Conte has gained little traction. As one court recently noted while
rejecting the Conte position: “Fifty-five decisions from twenty-two states have rejected
arguments similar to those put forward by the plaintiffs. . . . These courts have all concluded that
a brand name defendant owes no duty of care to consumers of the generic bioequivalents of its
product.” In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig., 856 F. Supp. 2d 904, 912
(E.D. Ky. 2012) (citations omitted) (collecting cases); see also Demahy v. Schwarz Pharma, Inc.,
702 F.3d 177, 184 (5th Cir. 2012) (“We do not view Mensing as overruling Foster . . . .”); Smith
v. Wyeth, Inc., 657 F.3d 420, 424 (6th Cir. 2011) (“As have the majority of courts to address this
question, we reject the argument that a name-brand drug manufacturer owes a duty of care to
individuals who have never taken the drug actually manufactured by that company.”). But see
Wyeth, Inc. v. Weeks, 2013 WL 135753, at *19 (Ala. Jan. 11, 2013) (“Under Alabama law, a
brand-name drug company may be held liable for fraud or misrepresentation . . . , 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.”). Indeed, Medicis cites numerous cases that have either followed the reasoning in
Foster or rejected the rationale in Conte, or both. See Def.’s Mem.  App. A & B.
The last relevant Erie consideration is the decisions of other courts to which Mississippi
looks when formulating substantive law. Hodges, 474 F.3d at 199. In that regard, Mississippi
often looks to federal courts that have interpreted Mississippi law, and as stated, Gardley–Starks
rejected a nearly identical claim. — F. Supp. 2d —, 2013 WL 139900, at *5. Gardley–Starks
relies in part on two post-Lawson opinions that likewise rejected innovator-liability claims
against brand-name manufacturers under Mississippi law. Id. at *4–5 (citing In re Darvocet, 856
F. Supp. 2d at 906–09; Lashley v. Pfizer, Inc., 877 F. Supp. 2d 466 (S.D. Miss. 2012)). Given
these rulings under Mississippi law, the prevailing rule nationally, and the absence of
countervailing Mississippi authority, the Court finds that the Mississippi Supreme Court would
reject the holding in Conte.
Having found that Washington’s current claims should be dismissed, the Court must
consider the request for leave to amend “to bring the common-law negligence claim based upon
defective design as articulated in Lawson.” Pl.’s Resp.  at 8. Although Washington’s ability
to amend and pursue a claim against Medicis under Lawson is not yet apparent, courts should not
dismiss cases “without granting leave to amend, unless the defect is simply incurable or the
plaintiff has failed to plead with particularity after being afforded repeated opportunities to do
so.” Hart v. Bayer Corp., 199 F.3d 239, 248 n.6 (5th Cir. 2000) (citation omitted). And
although this would be a second amended complaint, it would be the first amendment as to any
averments regarding Medicis. Leave will therefore be granted, but Washington is cautioned that
the amended complaint may not rely on the innovator theory of liability and must instead aver a
theory that Lawson would recognize.
With the United States Supreme Court’s Mensing decision, plaintiffs injured by generic
medications are precluded from pursuing failure-to-warn claims against generic manufacturers,
yet most states have not adopted innovator liability against brand-name manufacturers. While
this may present a potential “catch 22,” the Court can see valid policy arguments on both sides of
the issue. Regardless, it is not an issue this Court can remedy because it lacks authority to certify
the question and is charged with applying the law “as it currently exists.” Barfield, 212 F.3d at
272 (citation and quotations omitted). Based on that law, the Court follows the other federal
district courts that have rejected similar claims and grants Medicis’s Motion to Dismiss .
Washington is hereby granted leave to file a motion to amend that attaches the proposed
amended complaint within 14 days, otherwise the Court will fully dismiss the case at that time.
The Court has considered all of the parties’ arguments. Those not addressed would not change
SO ORDERED AND ADJUDGED this the 7th day of February, 2013.
s/ Daniel P. Jordan III
UNITED STATES DISTRICT JUDGE
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