In Re Boston Scientific Corporation Securities Litigation

604 F. Supp. 2d 275, 2009 U.S. Dist. LEXIS 21640, 2009 WL 723490
CourtDistrict Court, D. Massachusetts
DecidedMarch 10, 2009
DocketCivil Action 05-cv-11934-DPW
StatusPublished
Cited by17 cases

This text of 604 F. Supp. 2d 275 (In Re Boston Scientific Corporation Securities Litigation) 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
In Re Boston Scientific Corporation Securities Litigation, 604 F. Supp. 2d 275, 2009 U.S. Dist. LEXIS 21640, 2009 WL 723490 (D. Mass. 2009).

Opinion

*276 MEMORANDUM AND ORDER

DOUGLAS P. WOODLOCK, District Judge.

The Public Employees’ Retirement System of Mississippi (“PERS”) as Lead Plaintiff seeks to pursue this consolidated securities fraud action as a class action against defendants Boston Scientific Corporation (“Boston Scientific”) and several of its corporate executives. PERS alleges that defendants violated §§ 10(b) and 20(a) of the Securities Exchange Act of 1934, 15 U.S.C. §§ 78j(b) and 78t(a), by knowingly withholding material information from the marketplace. Specifically, PERS alleges that defendants made misleading statements about a Boston Scientific medical product that was eventually recalled, thereby causing Boston Scientific’s securities to be inflated artificially, allowing individual defendants wrongfully to enrich themselves, and harming investors.

PERS has moved to certify a class of plaintiffs comprising all those who acquired Boston Scientific equity securities between November 20, 2003 and July 15, 2004, inclusive (“the Class Period”). Defendants have opposed the motion for certification, arguing that PERS has failed to show that questions of law or fact common to the class predominate over questions affecting only individual members. I informed counsel at the hearing in this matter on February 25, 2009 I was disposed to grant the motion to certify the proposed class. For the reasons discussed more fully below, I now formally do so.

I. BACKGROUND

A. The Parties

Defendant Boston Scientific is a publicly traded manufacturer of medical devices based in Natick, Massachusetts. Individual defendants Peter M. Nicholas, James R. Tobin, Lawrence C. Best, Paul A. LaViolette, Fredericus A. Colen, Stephen D. Moreci, Paul W. Sandman, James H. Taylor, Jr., and Robert G. MacLean are corporate executives of Boston Scientific. Lead Plaintiff PERS is a Mississippi pension fund that purchased Boston Scientific stock during the Class Period.

*277 B. Factual Allegations 1

In 2001, Boston Scientific decided to produce a new drug-eluting coronary stent called the TAXUS Express Paclitaxel-Eluting Monorail Coronary Stent System (“the TAXUS stent”). Coronary stents are tubes implanted in a patient’s arteries to facilitate blood flow. The TAXUS stent was based on the platform of Boston Scientific’s bare metal Express2 stent. Unlike bare metal stents, drug-eluting stents (also called “coated” or “medicated” stents) slowly release drugs into a patient’s arteries to ease complications associated with stent implantation. Both the Express2 stent and the TAXUS stent were designed to be implanted by means of a balloon dilation catheter, which uses a tiny balloon to inflate a patient’s artery before the stent is inserted.

The TAXUS stent debuted in Europe in January 2003. According to PERS, Boston Scientific faced “tremendous pressure” to introduce the TAXUS stent to the United States, because the company was losing market share to a rival stent producer. To increase anticipation for the U.S. release of the TAXUS stent, defendants provided a “drum roll” for the investment community leading up to its FDA approval, publicly announcing every positive step and downplaying any bad news. For example, defendants delayed disclosing to the market a Major Deficiency letter Boston Scientific received from the FDA in September 2003.

During the course of 2003, Boston Scientific received approximately 30 complaints from physicians in Europe and other countries regarding the TAXUS stent. These doctors reported that in some cases the balloon used to implant the stent would deflate too slowly or would not deflate at all, leading to complications for the patient. According to PERS, Boston Scientific soon determined that these “no deflate” incidents were attributable to a manufacturing problem with the TAXUS stent known as “focal necking” or “focal neckdown.” Focal neckdown occurs when the balloon and catheter are welded together too tightly, thereby impeding deflation of the balloon after implantation.

In May 2003, Boston Scientific officers had “detailed discussions” about “the scope of any potential recall” as a result of the focal neckdown problem. By June 2003, the company considered the “no deflate” issue to be “urgent.” During this time, Boston Scientific began “corrective action efforts” in several of its facilities, retraining operators who assembled the stents and conducting tests to predict when particular batches of inventory would be susceptible to focal neckdown.

According to PERS, despite Boston Scientific’s discovery of the root cause of the “no deflate” problem, the company decided to defer making any necessary manufacturing fixes to the TAXUS stent until after receiving FDA approval, so as not to risk delaying its anticipated U.S. launch. In the meantime, Boston Scientific continued to expand its inventory of TAXUS stents by producing stents according to the original, flawed manufacturing process.

On November 20, 2003, the TAXUS stent reached a major milestone in the FDA approval process, receiving “panel approval” from a group of doctors. Boston Scientific immediately issued a press release announcing this achievement. The press release did not, however, disclose defendants’ knowledge of the “no deflate” complaints from international physicians *278 nor their knowledge of the need for a manufacturing fix to solve the focal neck-down problem. 2

On March 4, 2004, the FDA approved the TAXUS stent for marketing and distribution in the United States. Shortly after the launch of the product in the United States, U.S. doctors began reporting “no deflate” incidents. In Boston Scientific’s Form 10-Q for the First Quarter of 2004— filed May 7, 2004 — the company acknowledged that it was “reviewing a limited number of reports related to balloon withdrawal difficulty during TAXUS angioplasty procedures,” but the company did not disclose or discuss the possibility of a future manufacturing change. During the company’s First Quarter earnings call with analysts, Boston Scientific downplayed the “no deflate” issue, emphasizing that there was “an extremely low complaint rate” and attributing the problem to doctor unfamiliarity with the device rather than to the stent’s manufacturing process.

On April 4, 2004, approximately one month after the U.S. launch, Boston Scientific submitted its proposed manufacturing fix to the FDA. On May 5, 2004, the FDA approved the change.

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