RECOMMENDED FOR FULL-TEXT PUBLICATION
Pursuant to Sixth Circuit Rule 206
File Name: 11a0271p.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
_________________
X
-
No. 09-5460
Plaintiff-Appellant, --
LALA SMITH,
-
Nos. 09-5460/5466/5509
v.
,
>
-
-
WYETH, INC.; AMERICAN HOME PRODUCTS
-
CORPORATION; PLIVA, INC.; and SCHWARZ
-
PHARMA, INC.,
Defendants-Appellees. -
-
-
-
No. 09-5466
-
ALICE WILSON,
Plaintiff-Appellant, -
-
-
v.
-
-
PLIVA, INC.; BARR PHARMACEUTICALS, INC.;
WYETH, INC.; and SCHWARZ PHARMA, INC., -
Defendants-Appellees. -
-
-
-
No. 09-5509
DENNIS MORRIS, -
Plaintiff-Appellant, -
-
-
v.
-
-
PLIVA, INC.; SCHWARZ PHARMA, INC.; TEVA
-
-
PHARMACEUTICALS, USA, INC.; and UDL
Defendants-Appellees. -
LABORATORIES, INC.,
-
N
Appeal from the United States District Court
for the Western District of Kentucky at Paducah, Louisville, and Bowling Green.
No. 07-00018—Thomas B. Russell, Chief District Judge.
Argued: June 9, 2010
Decided and Filed: September 22, 2011
Before: DAUGHTREY, GILMAN, and SUTTON, Circuit Judges.
1
Nos. 09-5460/5466/5509 Smith, et al. v. Wyeth, Inc., et al. Page 2
_________________
COUNSEL
ARGUED: Louis M. Bograd, CENTER FOR CONSTITUTIONAL LITIGATION,
P.C., Washington, D.C., Claire Patricia Mary Prestel, TRIAL LAWYERS FOR PUBLIC
JUSTICE, Washington, D.C., for Appellants. Jeffrey R. Pilkington, DAVIS GRAHAM
& STUBBS LLP, Denver, Colorado, Joseph P. Thomas, ULMER & BERNE LLP,
Cincinnati, Ohio, for Appellees. ON BRIEF: Louis M. Bograd, CENTER FOR
CONSTITUTIONAL LITIGATION, P.C., Washington, D.C., Claire Patricia Mary
Prestel, TRIAL LAWYERS FOR PUBLIC JUSTICE, Washington, D.C., Daniel J.
McGlynn, McGLYNN, GLISSON & MOUTON, Baton Rouge, Louisiana, Jeffrey A.
Roberts, ROBERTS LAW OFFICE, Murray, Kentucky, for Appellants. Jeffrey R.
Pilkington, Andrew M. Low, DAVIS GRAHAM & STUBBS LLP, Denver, Colorado,
Joseph P. Thomas, Linda E. Maichl, ULMER & BERNE LLP, Cincinnati, Ohio, Richard
H.C. Clay, DINSMORE & SHOHL LLP, Emily Fritts Whitty, MORRIS & PLAYER,
Louisville, Kentucky, Henninger S. Bullock, Andrew J. Calica, MAYER BROWN LLP,
New York, New York, for Appellees. Robert E. O’Malley, SEGAL McCAMBRIDGE
SINGER & MAHONEY, LTD., Chicago, Illinois, Benjamin S. Kingsley, Douglas N.
Letter, Sharon Swingle, UNITED STATES DEPARTMENT OF JUSTICE, Washington,
D. C., for Amici Curiae.
_________________
OPINION
_________________
MARTHA CRAIG DAUGHTREY, Circuit Judge. Plaintiffs Lala Smith, Alice
Wilson, and Dennis Morris developed tardive dyskinesia as a result of their use of
generic metoclopramide, a drug prescribed for the treatment of gastroesophageal reflux
disease. They filed individual actions against various manufacturers of generic
metoclopramide, alleging that the defendants failed to include adequate information on
product labels concerning the risks of taking the drug long-term and seeking damages
under Kentucky state law for failure to warn. They also named as parties Wyeth, Inc.,
and Schwarz Pharma, Inc., the manufacturers of the name-brand form of
metoclopramide, sold as Reglan, alleging fraud and tortious misrepresentation. The
district court dismissed the plaintiffs’ claims against the generic defendants on federal
preemption grounds, finding a conflict between their tort claims and the federal
regulation of generic drugs. The district court also dismissed the plaintiffs’ action
Nos. 09-5460/5466/5509 Smith, et al. v. Wyeth, Inc., et al. Page 3
against the name-brand defendants because the plaintiffs did not allege that they had
ingested Reglan, a threshold requirement for a products-liability action under Kentucky
law. We find no error with regard to either ruling and affirm.
FACTUAL AND PROCEDURAL BACKGROUND
All three plaintiffs were originally prescribed Reglan to treat gastroesophageal
reflux. The active ingredient in Reglan is metoclopramide, which is also available in
generic form. Reglan, the name-brand form of metoclopramide, was manufactured by
defendant Wyeth from 1989 to 2001 and by defendant Schwarz from 2001 to 2005
(collectively, the name-brand defendants). Kentucky, where the plaintiffs reside, has a
generic-substitution law requiring pharmacies to fill prescriptions with a lower-priced,
therapeutically-equivalent generic drug unless the doctor or the purchaser explicitly
instructs otherwise. See KY. REV. STAT. § 217.822(1) (2010). As a result, the plaintiffs’
pharmacies filled their prescriptions for Reglan with generic metoclopramide1
manufactured and distributed by defendants Pliva, Barr Pharmaceuticals, Actavis, Teva
Pharmaceuticals, UDL Laboratories, and Morton Grove Pharmaceuticals (collectively,
the generic defendants). As a result of their long-term consumption of metoclopramide,
all three plaintiffs allegedly developed tardive dyskinesia, a severe neurological disorder
that resembles Parkinson’s disease.
Plaintiffs Wilson and Morris filed suit against the generic and name-brand
defendants in federal court in 2007. Plaintiff Smith initially sued the same defendants
in Kentucky state court, and the defendants removed the case to the federal district court
in which the other suits were pending. Against the generic defendants, the plaintiffs
asserted state-law failure-to-warn claims; against the name-brand defendants, they
asserted state-law fraud, fraudulent concealment, and negligent misrepresentation,
alleging that Reglan’s label and corresponding entry in the Physician’s Desk Reference
1
Although Smith and Wilson claim to have consumed only generic metoclopramide, plaintiff
Morris does assert that he consumed some Reglan manufactured by Wyeth (but not Schwarz), a fact that
Wyeth did not contest before the district court. Morris, however, has voluntarily dismissed his claims
against Wyeth.
Nos. 09-5460/5466/5509 Smith, et al. v. Wyeth, Inc., et al. Page 4
falsely and misleadingly represented the risks associated with long-term use of
metoclopramide.
The district court initially issued orders granting summary judgment to the name-
brand defendants, dismissing the plaintiffs’ claims, and holding that Kentucky law does
not permit a cause of action for misrepresentation about a product against anyone other
than the product’s manufacturer or distributor. Subsequently, the district court granted
summary judgment to the generic defendants on federal preemption grounds. After
denying motions for reconsideration, the district court issued orders dismissing all claims
and entered final judgment in favor of the defendants. This appeal followed.
DISCUSSION
Federal Preemption
On appeal, the plaintiffs contend that the district court erred in concluding that
their state-law failure-to-warn claims against the generic defendants were preempted by
federal law. Their arguments must fail, however, given the recent decision of the
Supreme Court in Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011), issued on June 23,
2011. Just as in the present case, the plaintiffs in Mensing alleged that their long-term
use of generic metoclopramide caused tardive dyskinesia, and they predicated the
manufacturers’ liability under state law on the failure to provide adequate warnings on
the product’s label. The Supreme Court held unequivocally, however, that federal law
preempts state laws that impose on generic-drug manufacturers the duty to change a
drug’s label, thus barring the plaintiffs’ state-law tort claims. The plain language of the
Pliva decision compels the same result here.
Kentucky Products Liability Law
On appeal, the plaintiffs also argue that the district court erred in granting the
name-brand defendants’ motion for summary judgment on their state-law claims. The
district court first concluded that plaintiffs’ tort claims were subject to Kentucky’s
Products Liability Act, KY. REV. STAT. §§ 411.300 - 411.350 (2010). The court then
held that the claims could not succeed because the plaintiffs alleged that generic
Nos. 09-5460/5466/5509 Smith, et al. v. Wyeth, Inc., et al. Page 5
metoclopramide, not the defendants’ name-brand product Reglan, caused their injuries.
As a result, the action against the name-brand defendants was dismissed.
We review the district court’s dismissal de novo, construing the complaint in the
plaintiffs’ favor and taking all well-pleaded allegations in the complaint as true. See
Beaudry v. TeleCheck Servs., Inc., 579 F.3d 702, 704 (6th Cir. 2009). The Kentucky
Products Liability Act, a codification of preexisting common-law principles, defines a
“product liability action” as “any action brought for or on account of personal injury,
death or property damage caused by or resulting from the manufacture, construction,
design, formulation . . . warning, instructing, marketing, advertising, packaging or
labeling of any product.” KY. REV. STAT. § 411.300(1) (2010). As the Kentucky
Supreme Court has held, “[t]he [Products Liability Act] applies to all damage claims
arising from the use of products, regardless of the legal theory advanced.” Mosanto Co.
v. Reed, 950 S.W.2d 811, 814 (Ky. 1997). We conclude that the district court correctly
applied the Act here.
A threshold requirement of any products-liability claim is that the plaintiff assert
that the defendant’s product caused the plaintiff’s injury. See Holbrook v. Rose,
458 S.W.2d 155, 157 (Ky. 1970). The plaintiffs in this case concede that they had
consumed only generic versions of metoclopramide and not Reglan. As the district court
observed, adopting their theory of liability would require the court to attribute any
deficiency in a name-brand manufacturer’s labeling and marketing of its products to
products manufactured by its generic competitors. Such a theory, however, fails to
satisfy the threshold requirement of a products-liability action – that the defendant’s
product have injured the plaintiff. As the district court stated, “Just because a company
is in the same business as a tortfeasor, the company is not automatically liable for the
harm caused by the tortfeasor’s product.”
The plaintiffs’ argument – that the name-brand defendants’ liability stems from
the fact that the regulatory structure governing name-brand and generic drugs makes it
foreseeable that patients and their physicians will rely on the name-brand labels to use
and prescribe generic drugs – has been rejected by all but one of the courts that have
Nos. 09-5460/5466/5509 Smith, et al. v. Wyeth, Inc., et al. Page 6
considered it. The leading case is Foster v. American Home Products Corp., 29 F.3d 165
(4th Cir. 1994), in which the court held that the manufacturer of a name-brand drug has
no duty to patients who ingested only a generic version of the drug manufactured by the
name-brand drug company’s competitors. See also Colacicco v. Apotex, Inc., 432 F.
Supp. 2d 514, 540-41 (E.D. Pa. 2006) (collecting cases), rev’d on other grounds, 521
F.3d 253 (3d Cir. 2008). But see Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 313 (Cal.
Ct. App. 2008) (“[W]e have no difficulty concluding that [the name-brand defendant]
should reasonably perceive that there could be injurious reliance on its product
information by a patient taking generic metoclopramide.”). 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. Moreover, and most significantly, the plaintiffs have
not convinced us that the state courts of Kentucky would adopt their vicarious-liability
argument under the Kentucky Products Liability Act.
CONCLUSION
For the reasons set out above, we AFFIRM the judgment of the district court.