Teva Pharms. United States, Inc. v. Superior Court of Orange Cnty.

• Decision Date: 25 September 2013
• Docket Number: G047134
• Citation: 217 Cal.App.4th 96,158 Cal.Rptr.3d 150
• Parties: TEVA PHARMACEUTICALS USA, INC., et al., Petitioners, v. The SUPERIOR COURT of Orange County, Respondent; Olga Pikerie, Real Party in Interest.
• Court: California Court of Appeals Court of Appeals

217 Cal.App.4th 96

158 Cal.Rptr.3d 150

TEVA PHARMACEUTICALS USA, INC., et al., Petitioners,

v. The SUPERIOR COURT of Orange County, Respondent;Olga Pikerie, Real Party in Interest.

G047134

Court of Appeal, Fourth District, Division 3, California.

Filed June 13, 2013

Review Denied September 25, 2013

See 7 Witkin, Summary of Cal. Law (10th ed. 2005) Constitutional Law, § 19.

Original proceedings; petition for a writ of mandate/prohibition to challenge an order of the Superior Court of Orange County, Steven L. Perk, Judge. Petition denied. (Super.Ct. No. 30–2012–00535583)

Horvitz & Levy, Jon B. Eisenberg, Encino; Goodwin Procter, Steven A. Ellis, Los Angeles; and Michael D. Shumsky for Petitioners Teva Pharmaceuticals USA, Inc., Barr Pharmaceuticals LLC, and Barr Laboratories, Inc.

Shook, Hardy & Bacon, Irvine, Michelle M. Fujimoto and Eva M. Weiler, for Petitioner Mylan Pharmaceuticals, Inc.

The Yocca Law Firm, Irvine, Mark W. Yocca and Jared Glicksman for Petitioners Caraco Pharmaceutical Laboratories, Ltd., and Sun Pharmaceutical Industries, Inc.

Lewis Brisbois Bisgaard & Smith and Pamela M. Ferguson, San Francisco, for Petitioner NorthStar Rx LLC.

No appearance for Respondent.

Robinson CalcagnieRobinson Shapiro Davis, Mark P. Robinson, Jr., Newport Beach, Robert M. Partain, Los Angeles, Karen B. Menzies; Skikos, Crawford, Skikos & Joseph, San Francisco, Steven J. Skikos and Mark G. Crawford for Real Party in Interest.

OPINION

FYBEL, J.

Introduction

Plaintiff suffered injuries, allegedly as a result of ingesting a brand-name drug and its generic equivalents. She sued the manufacturers of both the brand-name drug and its generic equivalents. Although plaintiff asserts 11 separate causes of action, the gist of her claims against all defendants is the same—they failed to produce a safe product, failed to adequately warn plaintiff of the safety issues regarding the products, and failed to take other available steps within their control to warn plaintiff or protect her from injury.

The generic drug manufacturers demurred to plaintiff's complaint, arguing that, under the United States Supreme Court's decision in PLIVA, Inc. v. Mensing (2011) 564 U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (Mensing), all of plaintiff's claims were preempted by federal law. The trial court overruled the demurrer. Defendants filed a petition for a writ of mandate and/or prohibition. We issued an order to show cause, and now deny the petition.

In Mensing, the United States Supreme Court held that any claims that a generic drug manufacturer should have included stronger warning labels than those approved for use on the equivalent brand-name drug are preempted by federal law. The court explained that under federal law, the generic drug's label must be equivalent to—meaning it must match —the brand-name drug's label. The court also held that a state could not require a generic drug manufacturer to provide information on its label in addition to information required on the brand-name drug's label, as that would make it impossible for the generic drug manufacturer to comply with both its duty under federal law to match the brand-name label and any claimed duty under state law to do more. As a result of this impossibility, such a state requirement would be preempted by federal law.

In this case, in contrast, plaintiff alleged that the brand-name drug label was updated, but the generic drug manufacturers failed to update their products' labels accordingly. In other words, the generic drug labels did not match the brand-name drug label. Consequently, we conclude, plaintiff's claims in this regard are not preempted by federal law. Therefore, the trial court correctly overruled the demurrer.

Statement of Facts and Procedural History

Alendronate sodium is a generic version of the medication Fosamax, which is manufactured and sold by Merck Sharp & Dohme Corp. and Merck & Co., Inc. Merck's patent protection for Fosamax expired in 2008, at which time Teva Pharmaceuticals USA, Inc. (Teva), Barr Pharmaceuticals LLC (Barr), Barr Laboratories, Inc. (Barr Labs), Mylan Pharmaceuticals, Inc. (Mylan), Caraco Pharmaceutical Laboratories, Ltd. (Caraco), Sun Pharmaceutical Industries, Inc. (Sun), and NorthStar Rx LLC (NorthStar) (collectively, the Teva Defendants) began manufacturing and marketing alendronate sodium.

Fosamax and alendronate sodium belong to the class of drugs known as bisphosphonates; they are indicated for the treatment and prevention of osteoporosis. Olga Pikerie was prescribed and took Fosamax and/or alendronate sodium from 2006 to 2011. Pikerie's complaint alleged prolonged use of Fosamax and/or alendronate sodium might cause fractures of the femur due to suppression of bone turnover. In April 2011, allegedly as a result of using Fosamax and/or alendronate sodium, Pikerie suffered a left femur fracture.

In April 2011, lawsuits against the manufacturers of Fosamax and alendronate sodium were coordinated before the Orange County Superior Court. By agreement of the parties, a test case complaint was filed in January 2012, on behalf of Pikerie, to raise and resolve the issue of federal preemption. Pikerie's complaint asserted causes of action for strict liability, negligence, breach of express and implied warranties, deceit by concealment, negligent misrepresentation, fraud, violation of Business and Professions Code sections 17200 and 17500, and violation of Civil Code section 1750 et seq.

Teva, Barr, and Barr Labs demurred to the complaint. Caraco, Sun, and NorthStar joined in the demurrer.¹ Following briefing and a hearing, the trial court overruled the demurrer. The court concluded the allegations that the Teva Defendants failed to make timely labeling changes and breached a duty to communicate to the public and to health care professionals were sufficient to state causes of action, which would not be preempted by the Supreme Court's opinion in Mensing, supra, 564 U.S. ––––, 131 S.Ct. 2567. The court granted the motions by Caraco, Sun, and NorthStar to join the demurrer. The court also filed an order pursuant to Code of Civil Procedure section 166.1, in which it certified and found: “In overruling the Demurrer, the Court issued a ruling on a controlling question of law relating to federal preemption as to which there are substantial grounds for difference of opinion; and [¶] ... Appellate resolution of the controlling question of law relating to federal preemption may materially advance the conclusion of the litigation.”

Discussion

I.Standard of Review

In ruling on a demurrer, the “allegations [of the complaint] must be liberally construed, with a view to substantial justice between the parties.” (Code Civ. Proc., § 452; Rickley v. Goodfriend (2013) 212 Cal.App.4th 1136, 1141–1142, 151 Cal.Rptr.3d 683 [court must liberally construe complaint, and draw all reasonable inferences in favor of its allegations].)

“ ‘The standard of review for an order overruling a demurrer is de novo. The reviewing court accepts as true all facts properly pleaded in the complaint in order to determine whether the demurrer should be overruled. [Citation.]’ [Citation.]” (Boy Scouts of America National Foundation v. Superior Court (2012) 206 Cal.App.4th 428, 438, 141 Cal.Rptr.3d 819.)

II.Federal Laws and Regulations Regarding Drug Labeling

This case involves questions arising out of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 United States Code section 301 et seq. The United States Food and Drug Administration (FDA) regulates the manufacture, sale, and labeling of prescription drug products under the FDCA. (21 U.S.C. § 355(a).) Before marketing a new drug, a drug manufacturer must obtain FDA approval, by proving the drug is safe and effective, and that the proposed label for the drug is accurate and adequate. (21 U.S.C. § 355(b)(1); see Mensing, supra, 564 U.S. at p. ––––, 131 S.Ct. at p. 2574.) In order to meet this burden, the manufacturer of a new, brand-name drug must perform lengthy, expensive testing on its product. (21 U.S.C. § 355(b)(1); see Mensing, supra, at p. ––––, 131 S.Ct. at p. 2574.)

Manufacturers of generic drugs, however, may avoid the clinical testing process and obtain FDA approval to market their products by filing an abbreviated new drug application (ANDA), showing the generic drug is equivalent to the brand-name drug, or reference listed drug (RLD), in active ingredients, safety, and efficacy (21 U.S.C. § 355(j)(2)(A)(ii) & (iv); 21 C.F.R. § 314.94 (2013)), and that the labeling for the generic drug is the same as the labeling for the RLD (21 U.S.C. § 355(j)(2)(A)(v); 21 C.F.R. § 314.94(a)(8) (2013)). The 1984 legislation by which the United States Congress authorized this simplified process for approval of generic drugs, the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub.L. No. 98–417 (Sept. 24, 1984) 98 Stat. 1585), is commonly referred to as the “Hatch–Waxman Amendments.”

The labeling on or within any prescription drug package must provide sufficient information, including, but not limited to, “any relevant hazards, contraindications, side effects, and precautions,” to allow physicians and pharmacists to “use the drug safely and for the purposes for which it is intended.” (21 C.F.R. § 201.100(c)(1) (2013).) Specifically, the FDA requires that drug labels “describe serious adverse reactions and potential safety hazards [and] limitations in use imposed by them.” (21 C.F.R. § 201.80(e) (2013).)

Certain changes to an approved drug label require the drug manufacturer to submit a prior approval supplement to the FDA. (21 C.F.R. § 314.70(b) (2013).) Other changes may be made by the manufacturer without FDA approval, upon submission of a “Changes Being Effected” (CBE) supplement. (21 C.F.R. § 314.70(c) (2013).) A CBE supplement is permitted for “[c]hanges in the labeling to reflect newly acquired information ... to accomplish any of the following: [¶] (A) To add or strengthen a contraindication, warning,...