In Re Cipro Cases I and II

17 Cal. Rptr. 3d 1, 121 Cal. App. 4th 402, 2004 Daily Journal DAR 9609, 2004 Cal. Daily Op. Serv. 7104, 2004 Cal. App. LEXIS 1286
CourtCalifornia Court of Appeal
DecidedJuly 21, 2004
DocketD043543
StatusPublished
Cited by26 cases

This text of 17 Cal. Rptr. 3d 1 (In Re Cipro Cases I and II) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Cipro Cases I and II, 17 Cal. Rptr. 3d 1, 121 Cal. App. 4th 402, 2004 Daily Journal DAR 9609, 2004 Cal. Daily Op. Serv. 7104, 2004 Cal. App. LEXIS 1286 (Cal. Ct. App. 2004).

Opinion

*406 Opinion

AARON, J.

Petitioners Bayer Corporation, Barr Laboratories, Inc., The Rugby Group, Inc., Watson Pharmaceutics, Inc., and Hoechst Marion Roussel, Inc., seek a writ of mandate directing the superior court to vacate its order granting class certification in a coordinated proceeding against them for alleged violations of the Cartwright Act (Bus. & Prof. Code, § 16720 et seq.), the Unfair Competition Law (Bus. & Prof. Code, § 17200 et seq.), and the common law. We conclude that the trial court did not abuse its discretion in certifying the class. We nevertheless grant relief because the class as defined by the trial court is overbroad to the extent it includes purchasers of Cipro who paid a flat copayment when they would have paid for a generic substitute under their health insurance.

I

FACTUAL AND PROCEDURAL BACKGROUND

A. Allegations of Class Action Complaint

This matter arises out of a series of cases filed in various counties in California, which have been coordinated in the Superior Court of San Diego County pursuant to Code of Civil Procedure section 404 et seq. The following facts are taken from the consolidated second amended complaint filed in the coordinated proceeding.

Cipro is the brand name for ciprofloxacin hydrochloride (ciprofloxacin), an antibiotic prescribed for the treatment of various infections. Cipro is manufactured and marketed by Bayer AG and its subsidiary Bayer Corporation (collectively referred to as Bayer). In 1987, Bayer obtained a patent on ciprofloxacin known as the “444 patent.” Cipro is the best selling antibiotic in the world. Cipro was the first Bayer product to post over $1 billion in annual sales in the United States.

In 1991, Barr Laboratories, Inc. (Barr) applied for approval from the federal Food and Drug Administration (FDA) to market a generic version of Cipro. As authorized by the federal Hatch-Waxman Act (21 U.S.C. § 355), Barr challenged the validity of Bayer’s 444 patent. In January 1992, Bayer brought a patent infringement suit against Barr in federal court, which triggered a 30-month waiting period for FDA approval of Barr’s application under the Hatch-Waxman Act. In its answer to Bayer’s complaint, Barr asserted that the 444 patent was invalid and unenforceable.

According to the complaint, Bayer’s internal studies estimated that a generic version of Cipro could capture 70 percent of the market within *407 the first six months of marketing and 90 percent within the first full year of generic competition. Based on Barr’s predictions, Bayer stood to lose at least $750 million in annual revenues within a few years after the introduction of generic competition.

Bayer settled the patent litigation in January 1997 and entered into several interrelated agreements (the Cipro Agreements) with Barr and two other entities affiliated with Barr-Hoechst Marion Roussel, Inc. (HMR) and The Rugby Group, Inc. (Rugby). Under the terms of these agreements, Barr acknowledged the validity of the 444 patent. Barr, HMR, and Rugby agreed to refrain from selling or marketing a generic version of Cipro. In exchange, Bayer paid Barr and HMR a lump sum of $49.1 million and agreed that it would either license and supply Cipro to Barr and HMR for resale, or make additional quarterly payments to Barr and HMR. As of the filing of the complaint, Bayer had opted to pay a total of $398 million in quarterly payments to Barr and HMR.

The complaint alleges that, in the absence of the Cipro Agreements, Barr would have begun manufacturing, marketing, and selling generic ciprofloxacin in the United States market no later than January 1997. According to the complaint, the purpose of the Cipro Agreements was to allocate the entire United States market for ciprofloxacin to Bayer for at least six years, to restrain competition in the market, and to grant Bayer an unlawful monopoly with the concomitant ability to charge supracompetitive prices for Cipro.

The complaint alleges causes of action for per se violation of the Cartwright Act (Bus. & Prof. Code, § 16720 et seq.), unfair competition in violation of the Unfair Competition Law (Bus. & Prof. Code, § 17200 et seq.), and the common law tort of monopolization.

The named plaintiffs are individual residents and not-for-profit entities in California, each of whom allegedly purchased Cipro indirectly from Bayer. The complaint alleges that the named plaintiffs are suing on behalf of themselves and a class of California individuals and entities “who indirectly purchased, paid and/or reimbursed for Cipro intended for consumption by themselves, their families, or their members, participants, employees or insureds (the ‘Class’) during the period from January 8, 1997 through such time in the future as the effects of Defendants’ illegal conduct, as alleged herein, have ceased (the ‘Class Period’).” According to the complaint, the named plaintiffs and the class members paid substantially more for Cipro than they would have had to pay in a competitive market.

B. Class Certification Motion

In December 2002, plaintiffs filed a motion for certification of the class described in the complaint. The motion was supported by a declaration *408 of economist Raymond S. Hartman, as well as declarations of the named plaintiffs. According to Hartman, he had “analyzed whether the indirect end-payer purchasers of Cipro in California were impacted as a Class and damaged economically as a result of the alleged antitrust violations and other unlawful conduct among Defendants.” Based on his economic analysis, Hartman concluded that the purchasers of Cipro had been damaged economically, for two reasons: “First, all scientific evidence indicates that over time consumers switch in large numbers from a branded drug to its lower-priced bioequivalent generic once that generic becomes available. Second, existing evidence suggests that branded prices would have been lower once the generic entered.”

Hartman also analyzed “whether class-wide analysis is feasible and is the most efficient and effective way of analyzing impact and measuring damages.” He concluded that it was. According to Hartman, there exists a “standard formulaic methodology” to calculate both the amount of overcharges to the class as a whole and the monetary remedies available under Business and Professions Code section 17200. Hartman described the formula in detail in his declaration and explained that the formula was widely used and accepted in scientific analysis of the penetration of generic drugs into the market.

Defendants opposed the motion for class certification and submitted evidence in opposition to the Hartman declaration, including expert declarations from economists Gregory K. Bell and James Hughes. The defense experts asserted that there was no method for determining the impact on the class or for measuring damages to its individual members through common proof. In the opinions of the defense experts, the individual circumstances of the putative class members were too varied to permit an assessment of their claims on a classwide basis.

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17 Cal. Rptr. 3d 1, 121 Cal. App. 4th 402, 2004 Daily Journal DAR 9609, 2004 Cal. Daily Op. Serv. 7104, 2004 Cal. App. LEXIS 1286, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-cipro-cases-i-and-ii-calctapp-2004.