Lewert v. Boiron, Inc.

• Decision Date: 12 May 2016
• Docket Number: Case No.: CV 11–10803–AB (JPRx)
• Citation: 212 F.Supp.3d 917
• Parties: Christopher LEWERT v. BOIRON, INC. and Boiron, USA, Inc.
• Court: U.S. District Court — Central District of California

212 F.Supp.3d 917

Christopher LEWERT

v.BOIRON, INC. and Boiron, USA, Inc.

Case No.: CV 11–10803–AB (JPRx)

United States District Court, C.D. California.

Signed May 12, 2016

Elaine A. Ryan, Bonnett Fairbourn Friedman and Balint PC, Phoenix, AZ, Anna Faircloth, Jeff S. Westerman, Kenneth A. Remson, Westerman Law Corp., Los Angeles, CA, Manfred Patrick Muecke, Patricia N. Syverson, Bonnett Fairbourn Friedman and Balint PC, San Diego, CA, Max A. Stein, Nada Djordjevic, Boodell and Domanskis LLC, Chicago, IL, Stewart M. Weltman, Siprut PC, Chicago, IL, for Christopher Lewert.

Amy Waterman Byrd, Orrick Herrington and Sutcliffe, Los Angeles, CA, Christina Guerola Sarchio, Orrick Herrington and Sutcliffe LLP, Washington, DC, Elliott S. Henry, Raija J. Horstman, Valerie M. Goo, Orrick Herrington and Sutcliffe LLP, Los Angeles, CA, Thomas S. McConville, Orrick Herrington and Sutcliffe LLP, Irvine, CA, for Boiron, Inc. and Boiron USA Inc.

Proceedings: [In Chambers] ORDER DENYING Motions for Summary Judgment (Dkt. Nos. 242, 244), DENYING Defendants' Motion to Strike (Dkt. No. 273), and DENYING in part and GRANTING in part Plaintiff's Motion to Strike (Dkt. No. 272)

Present: The Honorable ANDRÉ BIROTTE JR., United States District Judge

Before the Court are Plaintiff's Motion for Partial Summary Judgment ("Pl.'s MSJ"), filed October 13, 2015 (Dkt. No. 242); Plaintiff's Motion to Strike Certain Expert Opinions Submitted by Defendants ("Pl.'s Motion to Strike"), filed November 16, 2015 (Dkt. No. 272); Defendants' Motion for Summary Judgment ("Defs.' MSJ"), filed October 13, 2015 (Dkt. No. 244); and Defendants' Motion to Strike Plaintiff's Expert ("Defs.' Motion to Strike"), filed November 16, 2015 (Dkt. No. 273).¹ The parties timely filed their respective Oppositions to these Motions on November 9, 2015 and November 23, 2015 and timely filed their respective Replies on November 30, 2015. Dkt. Nos. 265, 267, 282, 286, 293, 294, 295, 297. After this matter was transferred to this Court's calendar on December 14, 2015 (Dkt. No. 317), the Court heard oral argument on March 28, 2016 and took the matter under submission. Dkt. No. 324. For the following reasons, the Court DENIES the parties' Motions for Summary Judgment, DENIES Defendants' Motion to Strike, and DENIES in part and GRANTS in part Plaintiff's Motion to Strike.

I. BACKGROUND

The crux of the parties' dispute is whether Defendants' products, Oscillococcinum and Children's Oscillococcinum (the "Products" or "Oscillo"), provide relief for flu-like symptoms as promised on the Products' packaging. 2d Am. Compl. ("SAC") ¶ 1, Dkt. No. 128; Pl.'s MSJ at 1; Defs.' MSJ at 1. Oscillo is a homeopathic drug labeled as containing the active ingredient Anas Barbariae Hepatis et Cordis extractum 200ck HPUS ("Anas Barbariae"), derived from crushed and incubated duck hearts and livers and the inactive ingredients sucrose and lactose. SAC ¶ 2; Pl.'s MSJ at 2; Defs' Separate Statement of Genuine Issues of Material Fact ("Defs.' SGD") Nos. 4–6, 11. It is undisputed that the Anas Barbariae is incorporated into Oscillo by mixing 1 ml of a solution with the starting material with 99 ml of a solvent such as water and then repeating this dilution process 200 times according to a method of manufacturing known as the Korsakovian method (thus explaining the number "200CK" in the active ingredient title). SAC ¶ 4; Defs.' SGD Nos. 23–26. After the 200CK dilutions are completed, the final solution is then "impregnated" onto sugar granules made from sucrose and lactose. Defs.' SGD No. 47.

Plaintiff alleges in this class action that Defendants are liable for violations of California's Unfair Competition Law ("UCL"), codified at California Business and Professions section 17200, and California's Consumer Legal Remedies Act ("CLRA"), codified at California Civil Code section 1750, because Plaintiff purchased Oscillo in reliance on Defendants' affirmative representations on its label that Oscillo would relieve Plaintiff's flu-like symptoms and taking Oscillo did not relieve Plaintiff's symptoms as represented. SAC ¶¶ 21–48, 56–78.

Plaintiff now argues in his Motion for Summary Judgment (and Opposition to Defendants' Motion for Summary Judgment) that Oscillo's labeling is false as a matter of law because, as found by Plaintiff's expert Dr. Siavash Kurdistani, the active ingredient in Oscillo has been diluted to essentially zero and thus cannot possibly work to relieve flu-like symptoms. Pl.'s MSJ at 8–11; Pl.'s Reply in support of MSJ at 5–12; Pl.'s Opp. to Defs.' MSJ at 16–20. Defendants respond and argue in their Motion for Summary Judgment (and Opposition to Plaintiff's Motion for Summary Judgment) that, to the contrary, Plaintiff cannot meet his burden to prove Oscillo is ineffective because Dr. Kurdistani is unqualified to offer an opinion in this case and because, even if he were qualified, Dr. Kurdistani's work shows only that Oscillo is highly diluted, while Defendants have presented their own expert testimony and studies to show that Oscillo is still effective to relieve flu-like symptoms despite its dilution. Defs.' MSJ at 16–18; Defs.' Reply in support of MSJ at 2–11; Defs.' Opp. to Pl.'s MSJ at 7–13. Defendants also argue that, regardless of the parties' evidence concerning Oscillo, Plaintiff's claims are barred by the doctrines of implied preemption and primary jurisdiction because the Federal Drug Administration ("FDA") and Federal Trade Commission ("FTC") are currently considering whether to revise their regulations on homeopathic drugs. Defs.' MSJ at 11–15.

The parties' Motions to Strike follow in line with the parties' primary arguments in the Motions for Summary Judgment. Plaintiff moves to strike from the record and exclude at trial portions of Defendants' expert testimony as well as declarations from physicians providing anecdotal testimony of Oscillo's effects on the grounds that such evidence is unreliable. Pl.'s Mot. to Strike at 3–20. Defendants in turn move to strike from the record and exclude at trial Dr. Kurdistani's expert opinions on the grounds that Dr. Kurdistani is unqualified to offer the opinions he offers and that his testimony is unreliable and biased. Defs.' Mot. to Strike at 3–19.

II. IMPLIED PREEMPTION / PRIMARY JURISDICTION

Before turning to the merits of the parties' arguments concerning Oscillo, the Court must first address the threshold question raised in Defendants' MSJ regarding whether Plaintiff's claims are barred by the doctrines of implied preemption and primary jurisdiction. In August 2013, the Court denied Defendants' Motion for Judgment on the Pleadings on the issues of implied preemption and primary jurisdiction, concluding that Plaintiff's state law claims did not seek to impose any requirements in conflict with federal law (thus excluding the possibility of implied preemption) and recognizing that, although the FDA has regulatory authority over homeopathic drugs and special expertise, Defendants had failed to demonstrate that Plaintiff's claims turned on any particular technical issue that required resolution by the agency. Dkt. No. 78 ("August 2013 Order") at 17–19. Defendants now argue, however, that "significant developments in the Federal government's handling of homeopathy" require the Court to postpone adjudication of the action. Defs.' MSJ at 11–14. Defendants' arguments are not persuasive.

First, as it concerns implied preemption, a plaintiff's state law claims are impliedly preempted by federal statute "when compliance with both state and federal law is impossible, or when the state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Capital Cities Cable, Inc. v. Crisp , 467 U.S. 691, 698–99, 104 S.Ct. 2694, 81 L.Ed.2d 580 (1984) (citations and internal quotations omitted) as cited in Defs.' MSJ at 12 and August 2013 Order at 17.² Defendants argue that implied preemption should apply because "[i]n this case, both the FDA and the FTC are actively evaluating current policies regarding the level of substantiation of safety and efficacy required to be able to advertise and sell homeopathic drugs...." Defs.' MSJ at 13. But on their face, such developments are insufficient to justify implied preemption. Just as the Court found in its August 2013 Order, there is still no indication that Plaintiff's claims seek to impose requirements in conflict with federal law. The state law underlying Plaintiff's claims only requires truthful statements on Oscillo's label, and Defendants have offered no evidence to suggest that federal law requires the opposite or even that, after the current phase of evaluation, federal law may be changed to require the opposite. Indeed, as the Court previously recognized, "Given that Plaintiff's state law claims merely seek to impose requirements that are identical to what federal law already requires, to wit, truthful indications of use on Oscillo's label, it is difficult to imagine under these circumstances how the state law conflicts with, or poses an obstacle to federal law." August 2013 Order at 18.

Defendants have offered no new arguments to warrant departing from this holding.

Second, as it concerns primary jurisdiction, Defendants argue that since August 2013, the FDA and the FTC have begun "actively evaluating" their current regulations concerning homeopathic drugs, but Defendants have failed to identify any potential changes in either agency's regulations that would impact whether Oscillo's current label misleads consumers—the question raised by Plaintiffs' claims. "The primary jurisdiction doctrine allows courts to stay proceedings or to dismiss a complaint without prejudice pending the resolution of an issue within the special competence of an administrative agency ... [and] is to be used only if a claim involves an issue of first impression or a particularly complicated issue Congress has committed to a regulatory agency , and if protection of the integrity of a...