Derr v. RA Medical Systems, Inc.

District Court, S.D. California·Decided March 24, 2021·No. 3:19-cv-01079·Unknown

Opinion

ERVIN DERR and PETER CASE NO. 19cv1079-LAB-AHG SHOEMAKER, individually and on behalf of others similarly situated, ORDER:

Plaintiffs, 1) GRANTING IN PART vs. REQUESTS FOR JUDICIAL NOTICE; RA MEDICAL SYSTEMS, INC., et al. 2) GRANTING IN PART Defendants. MOTIONS TO DISMISS [Dkt. 29; Dkt. 30]; and 3) GRANTING MOTION FOR LEAVE TO FILE SUR- REPLY [Dkt. 40].

Plaintiffs Ervin Derr and Peter Shoemaker brought this action against Defendants Ra Medical Systems, Inc. (“Ra”), Andrew Jackson, Richard Heymann, Maurice Buchbinder, Martin Colombatto, Richard Mejia, Jr. (collectively, the “Ra Defendants”), Dean Irwin, Melissa Burstein, and Martin Burstein (collectively with the Ra Defendants, “Defendants”), alleging violations of the securities laws. Ra is a medical device manufacturer that sells in vascular blockages. Plaintiffs allege, generally, that Defendants made a series of false or misleading statements, beginning with the Registration Statement issued in connection with Ra’s IPO, that tended to gloss over known problems with the DABRA system, Ra’s internal financial reporting, and Ra’s sales training programs. When the allegedly omitted problems came to light, the value of Ra’s stock collapsed, harming shareholders who had purchased shares in Ra without knowing of the challenges the company faced. Based on these allegations, Plaintiffs seek to recover for violations of Section 11 of the Securities Exchange Act of 1933, 15 U.S.C. § 77k, and Sections 10(b), 15, and 20a(a) of the Securities Exchange Act of 1934.15 U.S.C. §§ 78j, 78o, 78t. Irwin, Melissa Burstein, and Martin Burstein filed a motion to dismiss the Amended Complaint, and the Ra Defendants followed suit with a motion of their own. Plaintiffs, they argue, lack standing under Sections 11 and 15 because they can’t trace their shares to the IPO and fail to allege any false or misleading statements as necessary to state claims under Sections 10(b) and 20(a). Plaintiffs sought leave to file a sur-reply. The Court finds a valid reason for additional briefing, and so it GRANTS Plaintiffs leave to file the sur-reply. (Dkt. 40.) Because the Court finds that Plaintiffs haven’t alleged facts to support standing under Sections 11 and 15, it GRANTS IN PART both motions to dismiss. (Dkt. 29; Dkt. 30.) The Amended Complaint alleges viable claims against Ra, Irwin, and Jackson under Section 10(b) and against Irwin and Jackson under Section 20, though, so the motions are DENIED IN PART as to those claims. The Court summarizes the Amended Complaint’s allegations as follows. Ra’s sole business is manufacturing and selling the DABRA system, which the disease, a form of peripheral artery disease. That sort of procedure is commonly known as an atherectomy, but the FDA considers “atherectomy” to encompass a wider range of procedures. Accordingly, the DABRA system’s approval for channel ablation in occlusive peripheral vascular disease not not translate to approval for use in atherectomies. (See id. ¶ 99.) Irwin, Ra’s co- founder, served as its CEO, Chief Technology Officer, Co-President, and Board Chairman until August 12, 2019. Melissa Burstein, Irwin’s wife, is Ra’s other co-founder and served as an Executive Vice President and director until March 2019, then solely as Vice President from April 2019 through November 1, 2019. Martin Burstein, Jackson, Heymann, Buchbinder, Colombatto, Mejia, Saad, and Enquist are each directors of Ra. Ra initiated a device recall in February 2018. It explained to the FDA, “Lasers/Catheters did not calibrate during set-up prior to use.” (Dkt. 29-23 at 1.) Ra stated that it addressed the issue by sending service technicians to customer facilities to service affected lasers beginning on February 15, 2018. Five months later, on July 16, 2018, Ra filed an S-1 Registration Statement with the SEC in preparation for its initial public offering. It made its final amendment to that Statement on September 24, 2018. Ra then went public on September 27, 2018, at a price of $17.00 per share. Derr purchased 500 shares of Ra stock at $7.30 on February 6, 2019. Beginning on February 8, 2019, Shoemaker purchased 615 shares of Ra stock in February 2019, paying between $6.93 and $7.28 per share.1 In August 2019, Ra made a series of announcements that had a deleterious effect on its stock price. It announced that it had terminated Irwin and that its Audit Committee was investigating allegations made in an anonymous complaint. (Dkt. 21 ¶ 133.) It announced, too, that “[i]n the fourth 1 Shoemaker purchased another 150 shares in November 2019, after joining quarter of 2018 and first quarter of 2019, [it] experienced inconsistencies in its DABRA catheter manufacturing process.” (Id. ¶ 133.) Following equipment upgrades and process modifications, it stated that it believed the problem had been solved, but “[t]he percentage of catheters that fail to calibrate at customer sites . . . began to increase after decreasing during April and May 2019.” (Id.) Ra reported in September 2019 that it had initiated a voluntary recall of the catheters in the DABRA system “due to a change in product labeling.” (Id. ¶ 141.) The catheters, which had been labeled with expiration dates twelve months after manufacturing, were now being labeled with a two-month expiration period. (Id.) A month after that, on October 31, 2019, the Audit Committee issued a report. It found that: (1) the DABRA system frequently failed to calibrate and occasionally overheated; (2) Ra’s explanations regarding fourth quarter 2018 and first quarter 2019 sales “created a risk of confusion” because they didn’t explicitly disclose these issues; (3) Ra had failed to make timely Medical Device Reports concerning issues with the DABRA system to the FDA; (4) Ra had “engaged in systematic efforts to replace product held by customers,” but failed to document these efforts as a recall; (5) Ra had failed to properly document “certain payments to physicians,” including $300,000 paid to three individuals; and (6) Ra had instructed its salespeople to “characterize DABRA as performing atherectomy and to encourage doctors to seek reimbursement using atherectomy codes.” (Id. ¶ 144.) That failure to document payments to physicians was subsequently revealed to arise from a series of deficiencies in its internal controls aggregating to a material weakness. (Id. ¶ 151.) A Rule 12(b)(6) motion to dismiss is a preliminary evaluation of a party’s pleading, intended to “test[] the legal sufficiency of [the] claim.” Navarro v. claims at such an early stage, only state them sufficiently. See, e.g., Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 563 n. 8 (complaint “may not be dismissed based on . . . assessment that the plaintiff will fail to . . . prove his claim”). A Rule 12(b)(6) motion to dismiss calls for a preliminary evaluation of a party’s pleading and tests only whether the pleading provides “a short and plain statement of the claim showing that the pleader is entitled to relief, in order to give the defendant fair notice of what the claim is and the grounds upon which it rests.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007) (internal marks and citation omitted). The required short and plain statement “does not need detailed factual allegations,” only “factual allegations . . . enough to raise a right to relief above the speculative level . . . on the assumption that all the allegations in the complaint are true.” Id. (internal marks and citations omitted). The Court must make all reasonable inferences that can be made in the plaintiff’s favor. Dahlia v. Rodriguez,

Derr v. RA Medical Systems, Inc., (S.D. Cal. 2021).

Derr v. RA Medical Systems, Inc. (Derr v. RA Medical Systems, Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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