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Critical Care Diagnostics, Inc. v. American Association for Clinical Chemistry, Inc.

United States District Court, S.D. California

February 18, 2014



M. JAMES LORENZ, District Judge.

Defendants Nader Rifai ("Rifai"), and American Association for Clinical Chemistry, Inc. ("AACC") each move to strike plaintiff's complaint under California Code of Civil Procedure § 425.16, known as the Anti-SLAPP[1] statute. The motions have been fully briefed and are considered without oral argument.


This action concerns a peer-reviewed scientific research article concerning heart disease entitled "Soluble ST2 Is Associated with All-Cause and Cardiovascular Mortality in a Population-Based Cohert: The Dallas Heart Study" ("the Article"). The Article was published by

the American Association for Clinical Chemistry ("AACC") in its peer-reviewed scientific journal, CLINICAL CHEMISTRY ("Journal"), which reported on the defendant authors' research regarding ST2 in asymptomatic patients. The article was published on AACC's website in December 2012, and in its March 2013 print edition. The AACC is an international scientific/medical society of clinical laboratory professionals, physicians, research scientists and other individuals involved with clinical chemistry and related disciplines. Defendant Nader Rifai, Ph.D., is the Editor-in-Chief of CLINICAL CHEMISTRY ("Journal"). As a peer-reviewed journal, independent professionals, namely scientists and scholars, review the journal's articles and research prior to publication. Comp., ¶ 16. Defendants Lu Q. Chen, James A. De Lemos, Sandeep R. Das, Colby R. Ayers and Anand Rohatgi ("Author Defendants")[2] are the credited authors of the Article. Comp., ¶¶ 4-8.

Plaintiff Critical Care Diagnostics, Inc. is a biomarker[3] company that focuses on cardiovascular diseases. It holds patent rights to an assay, Presage ® ST2 Assay, which the FDA approved for application to patients already diagnosed with and experiencing existing heart problems. ST2 can be a significant predictor of mortality due to cardiovascular disease in such a population. The Article at issue purports to describe one such test to measure ST2 - the Alere ST2 assay, and not the Presage ® ST2 Assay. However, the Article is not an evaluation of commercially available assays, approved FDA assays, or plaintiff or plaintiff's product. Instead, the Article focuses on ST2 research using an assay other than plaintiff's assay to be applied to the general asymptomatic population. The Alere ST2 assay is not FDA approved at this time.

The Journal has a regular policy and procedure for the review of articles it publishes. As Editor-in-Chief, defendant Rifai, reviews manuscripts for subject matter only. Then an associate editor reviews the manuscript and assigns it to two peer reviewers. After further review by the Deputy Editor, James C. Boyd, M.D., a manuscript is accepted for publication. Dr. Boyd's approval is the final approval required for publication.

Plaintiff contends that the Article contains false statements that were known to Rifai and the AACC publisher defendant because of prior studies and articles. Specifically, plaintiff points to what it alleges are three factually untrue statements:

- The Article states "to our knowledge, no prior study has evaluated sST2 as a cardiac biomarker in the general population." (Article at 537.) Plaintiff contend that a proper literature search would have revealed that two prior articles had performed such an evaluation.

- The Article states that plaintiff's Presage Assay was less sensitive at detecting ST2 than the Alere assay which was used in the study. (Article at 537.) Plaintiff asserts that the Presage Assay measures ST2 in 100% of the population and therefore, is more sensitive than the Alere assay.

- The Article states that "[t]he development of more sensitive assays is needed to fully explore the potential role of this biomarker for population screening." (Article at 544.) Plaintiff states that the "Presage Assay was a more sensitive assay' which had already been developed and utilized in exploring the potential role of the sST2 biomarker. (Opp. at 7-8. (emphasis in original.))

According to plaintiff, defendants "deliberately chose to make false statements which cast the Preage Assay in a negative light." Id. at 9. Also, plaintiff asserts that the publisher defendant allowed the author defendants to misstate their financial relationship with Alere.

Finally, plaintiff contends that after the print publication of the Article, it suffered at least one specific lost distribution deal with the SMS Gruppen Danmark company in Denmark, which was to be the Danish distributor of the Presage Assay. (Geliebter Decl. ¶8.)


California Civil Procedure Code §425.16 was enacted "to provide for the early dismissal of unmeritorious claims filed to interfere with the valid exercise of the constitutional rights of freedom of speech and petition for the redress of grievances." Club Members for an Honest Election v. Sierra Club, 45 Cal.4th 309, 315 (2008). Section 425.16 thus allows a court to strike any cause of action that arises from the defendant's exercise of his or her constitutionally protected free speech rights or petition for redress of grievances. §425.16 (b)(1); see also Flatley v. Mauro, 39 Cal.4th 299, 311-312 (2006). In ruling on a special motion to strike brought under § 425.16, the trial court must engage in a two-step process that involves shifting burdens. First, the court must determine whether defendant has made a threshold showing that the challenged cause of action "arises from" a protected activity. Second, if the defendant makes this showing, the trial court must determine whether the plaintiff has established a probability of prevailing on the claim. Jarrow Formulas, Inc. v. LaMarche, 31 Cal.4th 728, 733 (2003). "Reasonable probability' in the anti-SLAPP statute has a specialized meaning" and "requires only a minimum level of legal sufficiency and triability.'" Mindys Cosmetics, Inc. v. Dakar, 611 F.3d 590, 598 (9th Cir. 2010) (quoting Linder v. Thrifty Oil Co., 23 Cal.4th 429, 438 n. 5 (2000)). In order to satisfy this burden, the plaintiff "must demonstrate that the complaint is both legally sufficient and supported by a sufficient prima facie showing of facts to sustain a favorable judgment if the evidence submitted by the plaintiff is credited." Wilson v. Parker, Covert & Chidester, 28 Cal.4th 811, 821(2002); see also Metabolife Int'l, Inc. v. Wornick, 264 F.3d 832, 840 (9th Cir. 2001). "The plaintiff's showing of facts must consist of evidence that would be admissible at trial.'" Stewart v. Rolling Stone LLC, 181 Cal.App.4th 664, 679 (2010). "[D]eclarations that lack foundation or personal knowledge, or that are argumentative, speculative, impermissible opinion, hearsay, or conclusory are to be disregarded." Gilbert v. Sykes, 147 Cal.App.4th 13, 26 (2007).

Each challenged basis for liability must be examined individually to determine if the plaintiff has demonstrated a probability of prevailing, and if the plaintiff has failed to do so, then only that basis must be stricken from the plaintiff's pleading. Navellier v. Sletten, 29 Cal.4th 82, 89 (2002).


As noted above, both Dr. Rafai and the AACC move to strike plaintiff's entire complaint under the anti-SLAPP statute. Plaintiff has included causes of action for libel per se, libel per quod, trade libel, and violation ...

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