UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
_______________________________________
:
RICHARD BAYLESS, RONALD BRAUMAN, : Civil Action
M. JAY HARNAGE, RICHARD A. STILZ, : No. [97cv11989]
GEORGE E. LAMOTHE and KEN ST. CYR, : [filed Sep. 2, 1997]
on behalf of themselves :
and all others similarly situated, :
Plaintiff, : :
v. : :
PLC SYSTEMS, INC., :
ROBERT C. RUDKO, and :
MAX LEE HIBBS, : :
Defendants. :
_______________________________________ : :
CLASS ACTION COMPLAINT
Plaintiffs by their attorneys, allege the following upon information and belief after due
investigation by his counsel (except for those allegations pertaining to plaintiffs, which
are based on personal knowledge). The investigation included, among other things,
thorough review and analysis of (a) public statements of PLC and the individual
defendants, (b) analysts' reports, (c) wire service releases, (d) articles in newspapers and
periodicals, and (e) interviews by counsel with various experts who assisted in the
preparation of the Complaint including experts in critical care medicine and Food and
Drug Administration procedures.
NATURE OF THE ACTION
1. This is a class action on behalf of a class (the "Class") consisting of plaintiffs and all
other persons or entities who purchased the common stock or traded in options of PLC
Systems, Inc. ("PLC" or the "Company") during the period from August 15, 1996,
through July 25, 1997, inclusive (the "Class Period") and were damaged thereby, to
recover damages caused to the Class by defendants' violations of the federal securities
laws and the common law.
JURISDICTION AND VENUE
SNIPPETS:
Plaintiffs by their attorneys, allege the following upon information and belief after due
The investigation included, among other things, thorough review and analysis of public
This is a class action on behalf of a class consisting of plaintiffs and all other persons or
It is in the business of developing medical devices to provide patients suffering from
Because of their executive, managerial, and directorial positions with PLC, defendants Rudko
CLASS ACTION ALLEGATIONS
Excluded from the Class are the defendants, members of their immediate families, and any
New medical devices can be marketed in the United States for general use only if they have
Clinical studies are performed pursuant to a protocol, which is a written submission to the
After the conclusion of such a controlled study, the applicant provides complete data on the
The sponsor must demonstrate both that patients treated with the device have better results
For determination of efficacy, the FDA is especially concerned with "hard endpoints," and
If a device does not demonstrate statistically significant results according to its preset
Beginning before the beginning of the Class Period, PLC Systems was engaged in the
The primary endpoint was improved myocardial perfusion, or blood flow into the heart, and a
Defendants' False and Misleading Statements
TMR Group is 63% Lower Than in Medical Therapy Group
The study also provided a direct comparison of the mortality rate associated with TMR and
All of the foregoing statements and the press release taken as a whole were materially
Patients Previously Randomized to Medical Management
This data has been submitted to the Food and Drug Administration as a post-filing PreMarket
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