United States District Court, D. Massachusetts
MEMORANDUM AND ORDER ON DEFENDANTS' MOTION TO
DENNIS SAYLOR IV UNITED STATES DISTRICT JUDGE
a claim of attorney misconduct, arising in a qui tam
action alleging the submission of false claims to Medicare.
The alleged false claims involve the off-label use of a
pharmaceutical called Namenda, which is approved by the FDA
for treatment of moderate to severe Alzheimer's disease.
Relator Timothy Leysock alleges that defendants Forest
Laboratories, Inc., and Forest Pharmaceuticals, Inc.,
illegally promoted the off-label use of Namenda to treat mild
forms of the disease, and that false claims were submitted to
Medicare as a result.
present dispute arises out of the conduct of counsel for
relator, the Milberg law firm, in investigating the case. As
set forth below, Milberg attorneys engaged in an elaborate
scheme of deceptive conduct in order to obtain information
from physicians about their prescribing practices, and in
some instances about their patients. In essence, Milberg
retained a physician and medical researcher, Dr. Mark Godec,
to conduct a survey of physicians concerning their
prescription of Namenda to Medicare patients. In order to
obtain the cooperation of the physicians, Dr. Godec falsely
represented that he was conducting a medical research study.
Dr. Godec, at Milberg's direction, conducted two
internet-based surveys as well as follow-up telephone
interviews. Among other things, the physicians were induced
to provide patient medical charts and other confidential
medical information to Dr. Godec. Information derived from
those surveys was then set out in the Second Amended
Complaint in this action, and was relied on by the Court in
denying defendant's motion to dismiss in 2014.
have now moved to dismiss the Second Amended Complaint as a
sanction for alleged violations of attorney ethical rules.
For the reasons stated below, that motion will be granted.
Laboratories, Inc., and its wholly owned subsidiary, Forest
Pharmaceuticals, Inc., are pharmaceutical companies. (2d Am.
Compl. ¶¶ 15, 16). (The two companies will be
referred to as a single entity for the sake of convenience.)
Forest produces and sells a drug called Namenda, which has
been approved by the Food and Drug Administration
(“FDA”) to treat moderate to severe
Alzheimer's disease. (Id. ¶ 1).
Leysock is a resident of Florida. (Id. ¶ 14).
From August 1996 until May 2012, he was employed by Forest as
a sales representative. (Id.). His sales territory
covered the counties of Palm Beach, Indian River, Martin, St.
Lucie, and Okeechobee in Florida. (Id.).
as relator, filed the original complaint in this action under
seal on July 24, 2012. That complaint alleged that Forest was
promoting the off-label use of two drugs-Savella and
Bystolic-and paying physicians kickbacks for prescribing
those drugs, all in violation of the False Claims Act, 31
U.S.C. § 3729 et seq. (Compl. ¶ 1-4, 12,
61). On October 2, 2012, Leysock amended the complaint to
include more specific factual allegations concerning
Forest's off-label promotion practices, and to add a
reference to Namenda. (1st Am. Compl. ¶¶ 75-78).
April 16, 2014, the United States declined to intervene. On
April 30, 2014, the Court unsealed the case. The same day,
Leysock filed a Second Amended Complaint. The Second Amended
Complaint focused only on the off-label promotion of Namenda;
it did not allege wrongdoing as to Savella or Bystolic. In
addition to factual allegations concerning improper off-label
promotion by Forest, it also alleged certain specific
instances of physicians prescribing Namenda for off-label use
to Medicare patients. (2d Am. Compl. ¶¶ 86-202).
particular, the Second Amended Complaint detailed the
practices of eight physicians who, allegedly, regularly
prescribe Namenda for mild Alzheimer's disease in
reliance on the off-label promotion by representatives of
Forest. (Id. ¶¶ 89-156). Those eight
physicians were identified by name and address.
(Id.). The complaint also identified eight patients,
one for each physician; although it did not identify the
patients by name, it included detailed patient information,
such as age, height, weight, dates of visits, diagnosis,
treatment plan, and prescriptions. (Id.). It then
identified 24 additional physicians, including their names
and addresses, and what purported to be information about
their Namenda prescribing practices. (Id.
¶¶ 157-202). Finally, it referred to “a
nationwide survey” of physicians in which
“approximately 60% stated they wrote off-label
prescriptions of Namenda and did so in reliance on
Forest's off-label promotion of the drug.”
(Id. ¶¶ 203-04).
Defendants' Motion to Dismiss
20, 2014, Forest moved to dismiss the Second Amended
Complaint for failure to state a claim upon which relief can
be granted. That motion was granted as to relator's
conspiracy claim, but otherwise denied. In denying the motion
as to the substantive FCA claims, the Court specifically
relied on the complaint's detailed allegations concerning
the practices of the eight physicians identified who
prescribed Namenda for off-label use. See United States
ex rel. Leysock v. Forest Lab., Inc., 55 F.Supp.3d 210,
218-19 (D. Mass. 2014). Among other things, the Court held
that those detailed allegations were sufficient to satisfy
the heightened pleading requirements of Fed.R.Civ.P. 9(b).
Id. at 219.
Defendants' Motion to Compel
February 8, 2016, Forest moved to compel the disclosure of
information and documents underlying those factual
allegations. Forest had learned that those allegations were
all derived from a survey conducted by Dr. Mark Godec, who
had apparently been retained by relator's counsel as an
investigator. (Def. Mem. in Supp. of Mot. to Compel at 6).
Relator had, apparently, not mentioned Dr. Godec in his
initial disclosures. He had also refused to provide discovery
related to Dr. Godec's study on the ground that it was
protected by the attorney work-product doctrine.
(Id. at 6-7). Forest requested leave to seek
third-party discovery from Dr. Godec, and moved to compel the
production of all information and documents underlying the
factual allegations in the Second Amended Complaint.
(Id. at 2).
opposing that motion, relator continued to contend that the
factual investigation underpinning the Second Amended
Complaint was protected by the attorney work-product
doctrine. Among other things, he stated that Dr. Godec
was retained to assist counsel's investigation in
anticipation of the filing of the SAC. . . . Dr. Godec, at
Relator's counsel's direction and under Relator's
counsel's supervision, conducted interviews of some
physicians to whom Defendants had marketed Namenda. During
those interviews, Dr. Godec asked questions prepared by, and
under the supervision of, Relator's counsel. Dr. Godec
took notes based on the interviews and disclosed the contents
of the interviews to Relator's counsel.
(Pl. Mem. in Opp. to Mot. to Compel at 3-4).
hearing on the motion to compel, relator agreed to produce
the information and documents relating to Dr. Godec's
research, and Dr. Godec was ultimately deposed.
Defendants' Second Motion to Dismiss
October 7, 2016, Forest moved to dismiss the Second Amended
Complaint as a sanction for unethical conduct of counsel,
based on the information provided by relator and the
deposition of Dr. Godec.
Mark Godec is a physician licensed in Maryland and Virginia.
(Godec Dep. at 317). He is also a former researcher at the
National Institutes of Health. (Id. at 312).
September 2013, the Milberg law firm retained Dr. Godec to
investigate Forest's off-label marketing and sales of
Namenda. (Id. at 16). The investigation was
conducted under the direction of attorneys at Milberg.
(Id. at 44). The attorneys at Milberg, not Dr.
Godec, developed the objectives for the investigation.
(Id. at 42-43, 81-82). During the investigation, Dr.
Godec spoke to attorneys at Milberg on a daily basis.
(Id. at 36).
Godec enlisted a company called Charter Oak Field Services to
assist him in the investigation. (Id. at 66).
Charter Oak is a marketing research and consulting agency
that conducts and facilitates market research in the
healthcare industry. (Id.; Hancock Decl. ¶ 1).
Among other things, Charter Oak has a proprietary database of
physicians, which was a necessary and important component of
the survey. (Hancock Decl. ¶ 1; see Godec Dep.
at 66-67, 87).
Godec told Charter Oak that “we were interested in
conducting a survey of physicians nationwide regarding
Namenda.” (Godec Dep. at 71). When speaking to
representatives of Charter Oak, he referred to the work as a
“study” or as “research.”
(Id. at 82, 83). He did not disclose to Charter Oak
that he had been retained by a law firm. (Hancock Decl.
¶ 3; Godec Dep. at 71-72). He did not disclose that the
information he intended to collect was to be used in a
lawsuit, rather than for medical research purposes. (Hancock
Decl. ¶ 3).
Oak helped create online surveys, solicit physician
participation in those surveys, collect the survey results,
and schedule follow-up telephone interviews with physicians.
(Hancock Decl. ¶ 2; Godec Dep. at 66-67). Attorneys at
Milberg, however, designed the surveys and prepared the first
drafts. (Godec Dep. at 94-95). Although attorneys were
intimately involved in designing the survey, no attorney ever
communicated directly with anyone at Charter Oak.
(Id. at 72-73, 81-82).
Oak believed that Dr. Godec was conducting surveys to support
his own clinical practice or medical research. (Hancock Decl.
¶ 3). It would not have agreed to facilitate the surveys
had it known that the results would not be kept anonymous and
aggregated, or would not be used for research purposes.
(Id. ¶ 5). Likewise, it would not have done so
if it had known Dr. Godec had been retained by a law firm and
that the information he collected was to be used in a
lawsuit. (Id. ¶ 6).
Oak sent invitations to physicians soliciting their
participation in the online surveys. (Godec Dep. at 96;
Hancock Decl. ¶ 4). The invitations stated that the
survey was a “market research dementia study” and
asked physicians to complete “a brief survey regarding
Dementia and your treatment practices.” (Def. Ex. 13,
14; Hancock Decl. ¶ 4). The invitation stated: “As
always, we value your privacy. All responses will be
anonymous and aggregated. The data collected will only be
used for research purposes.” (Def. Exs. 13,
Dr. Godec approved the invitation before it was sent out.
(Hancock Decl. ¶ 4).
Milberg's direction, Dr. Godec conducted the first online
survey in October and November 2013. (Godec Dep. at 33).
Milberg attorneys decided how the survey was going to be
conducted and helped draft the survey questions.
(Id. at 94-95, 173).
first survey asked physicians generally about their off-label
use of Namenda, as well Forest's promotion of such uses.
(Id. at 173). Every physician who completed the
survey and agreed to participate was paid an
“honorarium” of $35. (Id. at 113-14).
Godec provided the results of the online surveys to attorneys
at Milberg. (Id. at 45-46). He followed up with
telephone interviews of the 40 physicians who completed the
first survey and who indicated a willingness to be
interviewed. (Id. at 105-06, 118-21, 285-86). He
worked from a script that he had prepared and that had been
approved by attorneys at Milberg. (Id. at 97-98,
124-25; Def. Ex. 15). Charter Oak contacted the physicians to
set up the interviews. (Godec Dep. at 99-100). In the
interviews, Dr. Godec referred to the survey as a
“Charter Oak” survey. (Id. at 102-03,
the telephone interviews, Dr. Godec told the physicians that
“we are studying drugs to treat patients with
dementia.” (Id. at 138-39). Among other
things, he asked the physicians whether they had used Namenda
to treat patients with mild Alzheimer's disease, and, if
so, whether they relied on information received from Forest,
or one of its representatives, when they did so.
(Id. at 141, 145; Def. Ex. 15). Dr. Godec also asked
about the “marketing channel(s)” by which the
physicians received information about Namenda from Forest, as
well as the particular communications about Namenda they had
received from Forest. (Godec Dep. at 205; Def. Ex. 15).
Godec provided the results of those interviews, which were in
the form of handwritten notes, to attorneys at Milberg.
(Godec Dep. at 45-46).
who provided “appropriate answers” to the
interview questions were then invited to participate in a
patient “chart review.” (Id. at 221-23,
240). Specifically, Dr. Godec solicited the
charts of patients with mild Alzheimer's disease who had
been treated with Namenda. (Id. at 224). Among other
things, the written solicitation stated that “[f]or
this study, we need a chart from a Medicare patient . . .
.” (Def. Ex. 17).
Godec told the physicians that “patient information
needed to be removed from the chart, ” or that
“[e]ach chart must be prepared to protect the
patient's identity (name, Social Security number,
identifying information removed).” (Godec Dep. at 224,
242, 247). However, at least some physicians were explicitly
told that it was “OK to leave date of birth” on
the charts. (Def. Ex. 17, 18, 19). Physicians who agreed to
provide patient charts were paid a $250
“honorarium” for the first chart and a $150
“honorarium” for a second chart, if a second
chart were requested. (Godec Dep. at 224, 240).
patient charts were sent directly to Dr. Godec, who then
reviewed them. (Godec Dep. at 65, 267). He then passed them
on to attorneys at Milberg. (Id. at 45, 65-66,
267). On occasion, he would ask ...