Wyeth, Inc. v. Weeks

• Court: Alabama Supreme Court
• Writing for the Court: BOLIN, Justice.
• Citation: Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014)
• Decision Date: 15 August 2014
• Docket Number: 1101397.
• Parties: WYETH, INC.,et al. v. Danny WEEKS and Vicki Weeks.

159 So.3d 649

WYETH, INC.

et al.

v.

Danny WEEKS and Vicki Weeks.

1101397.

Supreme Court of Alabama.

Aug. 15, 2014.

Kevin C. Newsom, Lindsey C. Boney IV, and Marc James Ayers of Bradley Arant Boult Cummings LLP, Birmingham; and Philip H. Butler and George R. Parker of Bradley Arant Boult Cummings LLP, Montgomery, for appellants Wyeth, Inc., and Pfizer, Inc.

Frederick George Helmsing, Jr., of McDowell, Knight, Roedder & Sledge, L.L.C., Mobile; Henninger S. Bullock and Andrew J. Calica of Mayer Brown LLP, New York, New York; and J. Gorman Houston, Jr., of Lightfoot, Franklin & White LLC, Birmingham, for appellant Schwarz Pharma, Inc.

W. Lewis Garrison, Jr., Christopher B. Hood, and William L. Bross of Heninger Garrison Davis, LLC, Birmingham, for appellees.

Chilton Davis Varner, Stephen B. Devereaux, Heather M. Howard, and Franklin P. Brannen of King & Spalding LLP, Atlanta, Georgia, for amicus curiae Product Liability Advisory Council, Inc., in support of the appellants.

F. Chadwick Morriss, Robert C. Brock, Michael X. Imbroscio, and Paul W. Schmidt of Covington & Burling LLP, Washington, D.C., for amicus curiae Pharmaceutical Research and Manufacturers of America, in support of the appellants.

Ed R. Haden of Balch & Bingham LLP, Birmingham, for amici curiae Chamber of Commerce of the United States of America and the Business Council of Alabama; and Robin S. Conrad and Kate Comerford Todd, National Chamber Litigation Center, Inc., Washington, D.C., for amicus curiae Chamber of Commerce of the United States of America, in support of the appellants.

Mary Massaron Ross and Karen E. Beach of Plunkett Cooney, Detroit, Michigan; and Henry M. Sneath, Chicago, Illinois, for amicus curiae DRI–The Voice of the Defense Bar; and Sharon Donaldson Stuart of Christian & Small, LLP, Birmingham, for amicus curiae Alabama Defense Lawyers Association, in support of the appellants.

Ralph D. Pittle, Medical Legal Consultants of Washington, Redmond, Washington; and Nancy Eady of Morris, Haynes & Hornsby, Alexander City, for amicus curiae The Conte Foundation, in support of the appellees.

Drayton Nabers, Jr., Lee E. Bains, Jr., Scott S. Brown, and Sarah Glover of Maynard, Cooper & Gale, P.C., Birmingham, for amicus curiae Business Council of Alabama, in support of the appellants' application for rehearing.

William H. Webster of Webster, Henry, Lyons, White, Bradwell & Black, P.C., Montgomery, for amicus curiae Alabama Defense Lawyers Association, in support of the appellants' application for rehearing.

Richard B. Garrett and D. Cameron Smith of Alabama Policy Institute, Mountain Brook, for amicus curiae Alabama Policy Institute, in support of the appellants' application for rehearing.

David G. Wirtes, Jr., of Cunningham Bounds, LLC, Mobile; and Louis M. Bograd, Center for Constitutional Litigation, P.C., Washington, DC, for amicus curiae American Association for Justice, in support of the appellees on application for rehearing.

On Application for Rehearing

BOLIN, Justice.

The opinion of January 11, 2013, is withdrawn, and the following is substituted therefor.

The United States District Court for the Middle District of Alabama, Southern Division (“the district court”), has certified to this Court the following question pursuant to Rule 18, Ala. R.App. P.:

“Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?”

Facts and Procedural History

In its certification to this Court, the district court provided the following background information:

“Plaintiffs Danny and Vicki Weeks filed this action against five current and former drug manufacturers for injuries that Mr. Weeks allegedly suffered as a result of his long-term use of the prescription drug product metoclopramide, which is the generic form of the brand-name drug Reglan.® The Weekses claim that two companies—Teva Pharmaceuticals USA and Actavis Elizabeth, LLC—manufactured and sold the generic metoclopramide that Mr. Weeks ingested.

“The Weekses concede that Mr. Weeks did not ingest any Reglan ® manufactured by the three brand-name defendants, Wyeth LLC, Pfizer Inc., and Schwarz Pharma, Inc. The Weekses nonetheless assert that the brand-name defendants are liable for Mr. Weeks's harm on fraud, misrepresentation, and/or suppression theories because they at different times manufactured or sold brand-name Reglan ® and purportedly either misrepresented or failed adequately to warn Mr. Weeks or his physician about the risks of using Reglan ® long-term. The brand-name defendants moved to dismiss the claims against them, arguing, among other things, (1) that the Weekses' claims, however pled, are in fact product liability claims that are barred for failure of ‘product identification’ and (2) that they had no duty to warn about the risks associated with ingestion of their competitors' generic products. The Weekses responded to the brand-name defendants' motion, and the defendants replied. On March 31, 2011, this Court granted in part and denied in part the brand-name defendants' motion, holding that the Weekses might be able to state a claim for relief under Alabama law if they could prove that the brand-name manufacturers had a duty to warn Mr. Weeks's physician about the risks associated with long-term use of brand-name Reglan ® and, further, that the Weekses, as third parties, had a right to enforce an alleged breach of that duty.

“Within the last year alone, federal district courts in this State have issued four decisions addressing the question whether brand-name Reglan ® manufacturers can be held liable on fraud, misrepresentation, and/or suppression theories for physical injuries allegedly caused by plaintiffs' ingestion of generic metoclopramide. The first two courts answered no; however, this Court held otherwise, thereby creating an intrastate split. Compare Simpson v. Wyeth, Inc., No. 7:10–CV–01771–HGD (N.D.Ala. Dec. 9, 2010) [not reported in F.Supp.2d], report and recommendation adopted (N.D.Ala. Jan. 4, 2011) [not reported in F.Supp.2d] (holding that a brand-name manufacturer has no duty under Alabama law to warn of the risks associated with a competitor's generic product); Mosley v. Wyeth, Inc., 719 F.Supp.2d 1340 (S.D.Ala.2010) (same), with Weeks v. Wyeth, Inc., No. 1:10–cv–602 (M.D.Ala. Mar. 31, 2011) [not reported in F.Supp.2d](denying brand-name manufacturers' motion to dismiss on the ground that the plaintiffs there had pleaded a claim ‘that defendants perpetrated a fraud on the physician’); see also Barnhill v. Teva Pharm. USA, Inc., No. Civ. 06–0282–CB–M (S.D.Ala. Apr. 24, 2007) [not reported in F.Supp.2d](holding that a brand-name manufacturer of the drug Keflex ® has no duty under Alabama law to warn of the risks associated with a competitor's generic product). Since this Court's decision, another district court in Alabama has followed the earlier decisions. See Overton v. Wyeth, Inc., No. CA 10–0491–KD–C (S.D.Ala. Mar. 15, 2011) [not reported in F.Supp.2d], report and recommendation adopted (S.D.Ala. Apr. 7, 2011)[not reported in F.Supp.2d].

“Certification is appropriate here to resolve the disagreement among the federal district courts within Alabama and to prevent both federal courts within the State and state courts around the country from having to ‘mak[e] unnecessary Erie guesses' about unsettled questions of Alabama law. Tobin v. Michigan Mut. Ins. Co., 398 F.3d 1267, 1274 (11th Cir.2005) ; see also, e.g., Lehman Bros. v. Schein, 416 U.S. 386, 391, 94 S.Ct. 1741, 40 L.Ed.2d 215 (1974) (noting that certification often ‘save[s] time, energy, and resources and helps build a cooperative judicial federalism’). ‘Because the only authoritative voice on Alabama law is the Alabama Supreme Court, it is axiomatic that that court is the best one to decide issues of Alabama law.’ Blue Cross & Blue Shield of Ala., Inc. v. Nielsen, 116 F.3d 1406, 1413 (11th Cir.1997).

“The question framed ... satisfies the requirements of Ala. R.App. P. 18(a) : first, it presents a pure question of Alabama law; second, it is ‘determinative’ of this case in the sense that a negative answer would require dismissal of the Weekses' claims against the brand-named defendants; and third, although two Alabama trial courts have addressed the question whether a brand-name manufacturer can ever be held liable for physical harm caused by a generic product and answered it in the negative,¹ the Alabama Supreme Court has never considered or resolved either that question or the subsidiary question whether a plaintiff claiming physical injury can prevail on fraud, misrepresentation, and/or suppression theories under these facts.

“Considerations of judicial efficiency likewise counsel certification. During the last year, the number of Reglan ®/metoclopramide cases nationwide ballooned from 250 to approximately 3500. Current estimates suggest that among the 3500 cases there are at least 250 Alabama-resident plaintiffs and that most (if not all) of these plaintiffs assert the fraud, misrepresentation, and/or suppression theories asserted here. The Alabama Supreme Court's definitive resolution of the question presented will therefore affect not only cases pending (or that might later arise) in this State, but also the scores of Alabama-resident cases pending in courts around the country—particularly in large consolidated actions pending in California, New Jersey, and Pennsylvania. Moreover, the question's significance extends well beyond the Reglan ® litigation—and for that matter, even beyond pharmaceutical litigation. It is likely to recur any time a brand-name manufacturer (of any product) is sued on fraud, misrepresentation, and/or suppression theories by a plaintiff who claims to have been injured while using a generic-equivalent product.

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