Hsingching Hsu v. Puma Biotechnology, Inc.

213 F. Supp. 3d 1275, 2016 U.S. Dist. LEXIS 136527
CourtDistrict Court, C.D. California
DecidedSeptember 30, 2016
DocketCASE NO. SACV 15-0865 AG (JCGx)
StatusPublished
Cited by16 cases

This text of 213 F. Supp. 3d 1275 (Hsingching Hsu v. Puma Biotechnology, Inc.) is published on Counsel Stack Legal Research, covering District Court, C.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Hsingching Hsu v. Puma Biotechnology, Inc., 213 F. Supp. 3d 1275, 2016 U.S. Dist. LEXIS 136527 (C.D. Cal. 2016).

Opinion

ORDER DENYING MOTION TO DISMISS

Andrew J. Guilford, United States District Judge

Lead Plaintiff Norfolk County Council, as administering authority of the Norfolk Pension Fund, and others filed this lawsuit under the Securities Exchange Act of 1934 (“Exchange Act”) and Securities and Exchange Commission Rule 10b-5. Defendants Puma Biotechnology, Inc., Alan H. Auerbach, and Charles R. Eyler (collectively, “Puma”) filed a motion to dismiss the case (“Motion to Dismiss”) under Federal Rule of Civil Procedure 9(b) (“Rule 9(b)”), Federal Rule of Civil Procedure 12(b)(6) (“Rule 12(b)(6)”), and the Private Securities Litigation Reform Act (“PSLRA”).

The Court DENIES the Motion to Dismiss.

1. BACKGROUND

In 2013—the most recent year numbers are available—232,924 people in the Unit[1278]*1278ed States were diagnosed with breast cancer. Breast Cancer Statistics, Centers for Disease Control ánd Prevention, http:// www.cdc.gov/cancer/breast/statistics/index. htm (last visited September 30, 2016). That year, 41,324 people in the United States died from breast cancer. Id. The disease is the most common cancer among women in our country. See id. And as they often do, statistics fail to give us the right measure of heartbreak. Breast cancer radically reshapes the lives of our mothers and daughters, sons and fathers, brothers and sisters, husbands and wives, friends and family, every day of every year, in every corner of every country. The disease’s impact far too often includes (but never ends with) the loss of those who we love most.

Some of the science behind this sickness is relevant here. In particular, this case revolves around statements about a potential treatment for a subset of breast cancers that are called HER2-positive breast cancers. A fourth or fifth of breast cancer patients are HER2-positive: they have cells that make too many copies of a cell surface receptor called human epidermal growth factor receptor 2, or HER2 for short. These HER2 receptors promote cell division and proliferation, which results in HER2-positive breast cancer spreading more aggressively than other types of breast cancer. There are drugs that combat overexpression of the HER2 gene, but most patients develop resistance to them after a year. So up until now, there generally haven’t been any drugs that patients with HER2-positive breast cancer can use after a year on the existing drugs.

Puma hoped to change this. It’s a pharmaceutical company that acquires and develops new drugs. Puma has focused its efforts almost entirely on drug PB272, also called neratinib. Neratinib is an “extended adjuvant treatment.” “Extended” refers to neratinib’s viability as a long-term treatment beyond the year window that existing drugs cover. “Adjuvant therapy” means that neratinib is a therapy given after an initial treatment (such as surgery) to help suppress further formation of cancerous tumors. Neratinib is supposed to irreversibly bind to the HER2 receptor, and eventually slow down or stop out-of-control cell growth.

There was a clinical trial of neratinib called the ExteNET trial. This case concerns Puma’s statements about the results of that trial. In short, Norfolk County Council and other investors accuse Puma and its executives of making false or misleading statements about the ExteNET trial results, and accordingly filed this putative class action.

The alleged misstatements are basically about two things. First, there’s the DFS rate. The success of the ExteNET neratin-ib trial was primarily measured by the percentage of disease free survival (“DFS”) among patients taking neratinib versus those taking a placebo. Norfolk County Council says Puma lied to or misled investors and others about the absolute DFS rates coming out of the ExteNET trial and the improvement in DFS between the neratinib group and the placebo group. Second, there are the Kaplan-Meier curves. These are used to identify trends in DFS rates over time—here, for example, between the neratinib group and the placebo group. What’s the DFS difference between the two groups after two years? Four years? Eight years? The Kaplan-Meier curves would tell you. A widening difference between the neratinib group and the placebo group over time could suggest that the drug is effective. Norfolk County Council says Puma lied to or misled investors and others about whether that the gap was widening over time, when it was really narrowing.

[1279]*1279Finally, there’s a money side to medicine too, of course. A few figures are relevant here. During a public offering, Puma sold $218.5 million in Puma stock. Defendants Auerbach and Eyler—both Puma executives—earned more than $23 million in performance-based compensation. If nera-tinib makes it to the market, it’s expected to cost $6,500 a month, or $78,000 a year.

2. LEGAL STANDARD

A court will grant a motion to dismiss if the complaint does not allege claims upon which relief can be granted. Fed. R. Civ. P. 12(b)(6). A complaint must contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). A claim to relief must be plausible on its face. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal., 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009).

Securities fraud claims like the ones in this case require more. Specifically, they “must satisfy the heightened pleading requirements of both Federal Rule of Civil Procedure 9(b) and the [PSLRA].” In re Rigel Pharm., Inc. Sec. Litig., 697 F.3d 869, 876 (9th Cir.2012). Rule 9(b) “requires particularized allegations of the circumstances constituting fraud, including identifying the statements at issue and setting forth what is false or misleading ... about the statement and why the statements were false or misleading at the time they were made.” Id. The PSLRA requires “plaintiffs to state with particularity both the facts constituting the alleged violation and the facts evidencing” that the defendants had the required state of mind. Id.

In analyzing the complaint’s sufficiency, a court must “accept[] all factual allegations in the complaint as true and constru[e] them in the light most favorable to the nonmoving party.” Skilstaf, Inc. v. CVS Caremark Corp., 669 F.3d 1005, 1014 (9th Cir. 2012).

3. WHAT (ELSE) SHOULD THE COURT CONSIDER?

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Cite This Page — Counsel Stack

Bluebook (online)
213 F. Supp. 3d 1275, 2016 U.S. Dist. LEXIS 136527, Counsel Stack Legal Research, https://law.counselstack.com/opinion/hsingching-hsu-v-puma-biotechnology-inc-cacd-2016.