Mahoney v. Foundation Medicine, Inc.

CourtDistrict Court, D. Massachusetts
DecidedSeptember 20, 2018
Docket1:17-cv-11394
StatusUnknown

This text of Mahoney v. Foundation Medicine, Inc. (Mahoney v. Foundation Medicine, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mahoney v. Foundation Medicine, Inc., (D. Mass. 2018).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

) MARC F. MAHONEY, individually and on ) behalf of all others similarly situated, ) ) Plaintiff, ) ) v. ) Civil No. 17-11394-LTS ) FOUNDATION MEDICINE, INC., ) MICHAEL J. PELLINI, STEVEN KAFKA, ) JASON RYAN, VINCENT MILLER, and ) DAVID DALY, ) ) Defendants. ) )

ORDER ON MOTION TO DISMISS (DOC. NO. 26)

September 20, 2018

SOROKIN, J. Lead Plaintiff John A. Blair1 (“Plaintiff”), individually and on behalf of all others similarly situated,2 filed an Amended Class Action Complaint (the “Amended Complaint”) alleging violations of Section 10(b) of the Exchange Act, 15 U.S.C. § 78j(b), and Rule 10b–5, 17 C.F.R. § 240.10b–5, against all above-captioned Defendants (Count I), and violation of Section 20(a) of the Exchange Act, 15 U.S.C. § 78t(a), against Defendants Michael J. Pellini, Steven Kafka, Jason Ryan, Vincent Miller, and David Daly (the “individual Defendants”) (Count II). Doc. No. 19. Defendants move to dismiss the Amended Complaint in its entirety and with

1 Blair replaced former lead plaintiff Marc. F. Mahoney by order of this Court on October 20, 2017. Doc. No. 16. 2 Plaintiff brings this action on behalf of all persons or entities who purchased the publicly traded common stock of Defendant Foundation Medicine, Inc. (“Foundation” or “Company”) between February 26, 2014 and November 3, 2015 (the “Class Period”). Doc. No. 19 ¶ 1. prejudice. Doc. No. 26. After full briefing, a hearing was held on the motion on September 13, 2018. For the reasons that follow, the Court ALLOWS Defendants’ motion. I. BACKGROUND The Court recites facts alleged in the Amended Complaint, Doc. No. 19, which the Court

accepts as true, making all reasonable inferences in favor of the Plaintiff, for purposes of considering Defendants’ motion to dismiss. See Watterson v. Page, 987 F.2d 1, 3 (1st Cir. 1993). Defendant Foundation Medicine, Inc. (“Foundation”) develops, manufactures, and sells diagnostic tests that identify genomic mutations associated with cancer. Doc. No. 19 ¶¶ 2, 15. During the Class Period, Foundation offered two flagship products: FoundationOne, launched in June 2012, which detects genomic alterations in solid tumors, and FoundationOne Heme, launched in December 2013, which detects genomic alterations for patients with hematologic cancers. Id. ¶ 31-32. When the tests, which the company described as “the first commercially available comprehensive molecular information products for analysis of routine cancer specimens in a clinical setting,” id. ¶ 2, were launched, government insurance programs such as

Medicare did not cover Foundation’s tests, and private insurance only covered the tests to a limited extent. Id. ¶ 37. During the Class Period, individual Defendants, who served as Foundation officers and directors, made various statements about the company’s performance in press releases, public filings, and earnings calls. Throughout 2014, Foundation reported steadily increasing revenue and clinical test volumes. Foundation cited “the value that ordering physicians see in our approach” and “strong sales and volume increases.” Id. ¶ 43. Defendants explained throughout 2014 that Foundation’s sales trajectory involved initial uptake “from the major academic medical centers, the key opinion leaders” and a subsequent “migrat[ion] [of the tests] into the community setting” after the testing “became a little bit more well known” and “started to leak out into the community, often in a regional way around [the] leading academic medical centers[.]” Id. ¶¶ 49, 142. However, despite Foundation’s positive statements to investors throughout 2014,

community-based physicians were not adopting Foundation’s tests to the extent anticipated. Foundation suffered from “competitive noise” from single-marker and hotspot diagnostic tests as well as from new entrants to the market. Id. ¶ 55. Physicians were opting for single-market and hotspot tests that were less expensive and covered by both Medicare and private payors. Id. ¶ 81. Additionally, physicians found Foundation’s tests to be of limited utility, because few of the genes that the tests identified corresponded to a drug treatment and because the physicians lacked knowledge of how to interpret how to interpret the tests’ results. Id. ¶¶ 56-57. In February 2014, Foundation ceased its prior practice of reporting the specific number of physicians that ordered its tests, claiming to analysts on the earnings call that it “elected not to continue to just state … the number of overall physicians ordering the tests” because Foundation continued to “refine the

metrics that we will give the investor community.” Id. ¶¶ 57, 122. Despite these issues, in February 2015, reporting a number of tests performed in 2014 that was at the high end of Foundation’s forecasted range, id. ¶ 48, Pellini stated in a press release that growth rates for fourth quarter 2014 “highlight[ed] the broad adoption of our comprehensive genomic profiling approach.” Id. ¶ 191. The press release announced guidance for 2015, anticipating between 43,000 and 47,000 clinical tests and revenue between $105 and $115 million. Id. On a February 24, 2015, call discussing the 2014 results, Defendant Pellini made positive statements about the likelihood of obtaining Medicare reimbursement, stating that “we continue to believe it is a matter of when.” Id. ¶ 197. But beginning in May 2015, Foundation made a series of disclosures that tempered analysts’ and investors’ outlook. On May 11, 2015, Foundation announced a first quarter of 2015 clinical test volume of 7,854 tests. Id. ¶ 82. On the earnings call, Defendants said the test volume was due to “increased confusion in the marketplace,” making it “difficult for some oncologists

and pathologists to differentiate today between the various tumor profiling assays and to determine which test is most appropriate for a particular patient.” Id. ¶¶ 83. Defendant Daly cited “bold and misleading marketing statements from companies” that claimed to rival Foundation’s tests. Id. ¶ 214. Pellini pointed to new market entrants in next-generation sequencing-based testing and liquid biopsy-based testing. Id. ¶ 215. Daly noted the importance of the reorder rate among community-based physicians and Foundation’s focus “on ensuring the actionability of the results that we provide.” Id. ¶ 218. On the same call, Foundation also acknowledged a “slight decrease” in the average reimbursement per clinical test to $3,400. Id. ¶ 84. Ryan explained that “[s]ome level of volatility in this number is to be expected before we gain broader reimbursement coverage.” Id.

¶ 212. Foundation cited a January 23, 2015, draft local coverage determination issued by Palmetto GBA, LLC (“Palmetto”) as grounds for optimism. Id. ¶ 84. Palmetto, a Medicare Administrative Contractor (“MAC”) based in South Carolina, had issued a draft determination for “comprehensive genomic profiling” for non-smoker patients with stage IIIB or IV non-small cell lung cancer and who had already tested negative for certain genomic mutations. Id. ¶ 73. Because Palmetto enjoyed a reputation as having a leading role in molecular diagnostics coverage and reimbursement, id. ¶ 74, Foundation called its determination “an important step.” Id. ¶ 84. Moreover, Foundation maintained its 2015 guidance of expected revenue of between $105 and $115 million and expected clinical market tests (excluding those ordered by Foundation’s biopharmaceutical partners) of between 43,000 and 47,000 tests. Id. ¶ 85.

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