Kerlinsky v. Sandoz, Inc. et al

Filing 83

Judge Michael A. Ponsor: MEMORANDUM AND ORDER entered. As follows: Defendant Sandozs Motion to Strike Plaintiffs Expert Disclosure (Dkt. No. 67 ) and Defendant USDVAs Motion to Strike Expert Disclosure (Dkt. No. 69 ) are hereby ALLOWED. Defendant S andozs Motion for Summary Judgment as to Causation (Dkt. No. 64) and Defendant USDVAs Motion for Summary Judgment (Dkt. No. 71 ) are hereby ALLOWED. Defendant Sandozs Motion for Judgment on the Pleadings (Dkt. No. 73 ) is hereby DENIED AS MOOT. The clerk will enter judgment for Defendants. The case may now be closed. See the attached order for complete details. (Lindsay, Maurice)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS

LOUIS KERLINSKY,
Plaintiff
v.
SANDOZ INC., ET AL.,
Defendants

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C.A. No. 09-cv-30136-MAP

MEMORANDUM AND ORDER REGARDING
DEFENDANT SANDOZ’S MOTION FOR SUMMARY JUDGMENT, DEFENDANT
SANDOZ’S MOTION TO STRIKE PLAINTIFF’S EXPERT DISCLOSURE,
DEFENDANT USDVA’S MOTION TO STRIKE EXPERT DISCLOSURE,
DEFENDANT USDVA’S MOTION FOR SUMMARY JUDGMENT, AND DEFENDANT
SANDOZ’S MOTION FOR JUDGMENT ON THE PLEADINGS
(Dkt. Nos. 64, 67, 69, 71, and 73)
May 9, 2011
PONSOR, D.J.
I. INTRODUCTION
Plaintiff Louis Kerlinsky, acting pro se, brings this
products liability suit against Defendants Sandoz, Inc.
(“Sandoz”) and the United States Department of Veteran’s
Affairs (“USDVA”)1 for personal injuries allegedly sustained

1

Although Plaintiff has named the United States
Department of Veterans Affairs as a defendant, the United
States of America is the only proper defendant in an action
under the Federal Tort Claims Act. See 28 U.S.C. §§ 2671 et
seq. Nonetheless, for the sake of clarity, the court will
use the abbreviation “USDVA.”

after taking medication manufactured by Defendant Sandoz and
prescribed by a hospital that Defendant USDVA operates.2
The sole remaining counts in the twelve-count complaint are
Counts 1 and 2 against Defendant Sandoz for, respectively,
breach of warranty and negligent failure to warn, and Count
6 against Defendant USDVA for negligent failure to obtain
informed consent.
Presently before this court are Defendant Sandoz’s
Motion for Summary Judgment as to Causation (Dkt. No. 64),
Defendant Sandoz’s Motion to Strike Plaintiff’s Expert
Disclosure (Dkt. No. 67), Defendant USDVA’s Motion to Strike
Expert Disclosure (Dkt. No. 69), Defendant USDVA’s Motion
for Summary Judgment (Dkt. No. 71), and Defendant Sandoz’s
Motion for Judgment on the Pleadings (Dkt. No. 73).

For the

reasons stated below, Defendants’ motions to strike expert
disclosure (Dkt. Nos. 67 & 69) and motions for summary
judgment (Dkt. Nos. 64 & 71) will be allowed.

Given these

rulings, Defendant Sandoz’s Motion for Judgment on the

2

Plaintiff originally included Main Line Hospitals,
Inc. d/b/a Lankenau Hospital as a defendant in this action,
but the court dismissed this party from the case on March
26, 2010. (Dkt. No. 29.)
2

Pleadings (Dkt. No. 73) will be denied as moot.
II.

FACTUAL BACKGROUND

The relevant facts, viewed in the light most favorable
to Plaintiff, are as follows.
Intermittently throughout 2005, Plaintiff visited an
outpatient clinic operated by Defendant USDVA in
Springfield, Massachusetts.

The clinic prescribed and

furnished to Plaintiff several medications, including
Terazosin HCL, Flovent, Felodipine, Allopurinel,
Finasteride, Aricept, Loratadine, aspirin, Lactase,
eardrops, multivitamins, suppositories, sertaline, nasal
spray, and carbonide peroxide.3

Of primary importance here

is the prescription of Terazosin HCL, a medicine
manufactured by Defendant Sandoz and prescribed to Plaintiff
by Defendant USDVA to treat high blood pressure and an
enlarged prostate gland.
On September 21, 2005, and again on October 21, 2005,
Defendant USDVA provided to Plaintiff ten pages of medical

3

Apart from Terazosin and Felodipine, the complaint is
silent as to which of these medications Plaintiff had
actually ingested in the days and hours prior to the event
in question.
3

literature, including the following description of
Terazosin:
It is used to treat high blood pressure
(hypertension) . . . symptoms of prostate
enlargement. Take the first dose at bedtime to
minimize the changes of getting dizzy or fainting.
PRECAUTIONS: To avoid dizziness or fainting get up
slowly from a lying or seated position especially
when you first start using this drug.
(Dkt. No. 1, Compl. ¶ 15.)

The literature also warned that

“lightheadedness or dizziness upon standing may occur,
especially after the first dose.”

(Id. ¶ 22.)

Plaintiff

alleges that the only warning on the vials of Terazosin HCL
prescribed to him was as follows: “May cause drowsiness.”
(Id. ¶ 17.)
On September 1, 2006, Plaintiff was visiting his
sister-in-law in Philadelphia, Pennsylvania.

At

approximately 5:00 p.m., Plaintiff ingested for the first
time one capsule of Terazosin HCL.

At approximately 7:00

p.m., Plaintiff’s heart stopped beating, and he stopped
breathing.

He was taken by ambulance to Lankenau Hospital

in Wynnewood, Pennsylvania.

Plaintiff was discharged from

the hospital four days later, on September 5, with
instructions to have a pacemaker surgically implanted in his
4

chest.

He incurred over $41,000 in medical bills as a

result of his hospital visit.
Between September 5 and September 8, Plaintiff was
examined and tested at Baystate Medical Center (“Baystate”)
in Springfield, Massachusetts, to determine whether he was a
good candidate for a pacemaker.

On September 8, Baystate

informed Plaintiff that he did not need a pacemaker.
Plaintiff alleges that the September 1, 2006, episode
was caused by Terazosin HCL and that Defendants failed to
adequately warn him of its possible side effects.

Plaintiff

demands $700,000 in damages.
III.

PROCEDURAL BACKGROUND

On March 26, 2010, this court adopted in part
Magistrate Judge Kenneth P. Neiman’s Report and
Recommendation concerning Defendants’ motions to dismiss.
(Dkt. No. 29.)

The court dismissed all counts against

Defendant Lankenau (eliminating Counts 9, 10, and 11 from
the complaint) as well as Counts 3, 4, and 5 against
Defendant Sandoz.

The court denied Defendant Sandoz’s

motion as to Counts 1 (breach of warranty) and 2
(negligence) insofar as those counts relied on a failure-to5

warn theory.

The court declined to adopt the Magistrate

Judge’s recommendation that Count 7 be dismissed sua sponte
along with the portions of Count 12 offering class action
allegations against Defendant USDVA.

However, on November

4, 2010, the court adopted a second report and
recommendation by Judge Neiman and allowed Defendant USDVA’s
motion to dismiss Counts 7, 8, and 12.

The court noted, in

its memorandum, that the quotations from case law relied
upon by Plaintiff to oppose the motion did not, in fact,
appear in the cases cited.

(Dkt. No. 51.)

At a scheduling conference less than a week following
the dismissal of Counts 7, 8, and 12, Judge Neiman pointed
out to Plaintiff that he had failed to comply with Federal
Rule 26 governing expert disclosure regarding the remaining
counts.

See Fed. R. Civ. P. 26(a)(2)(B).

Plaintiff had

submitted a letter purportedly written by his daughter, Dr.
Susan Kerlinsky, who practiced family medicine.4
68, Ex. 1, Kerlinsky Statement at 1.)

(Dkt. No.

The letter consisted,

in its entirety, of two sentences setting forth the author’s
4

As will be seen, at footnote six infra, it is far
from clear that Dr. Kerlinsky actually wrote the letter
attributed to her.
6

conclusion that Plaintiff’s injuries resulted from his use
of Terazosin.

(Id.)

At the conference, Judge Neiman

explained in detail the requirements of Rule 26 and gave
Plaintiff until December 31, 2010, to submit a revised
expert report.

(Dkt. No. 68, Ex. 3, Tr. 11/10/10, at 4-6.)

On December 13, 2010, Plaintiff submitted a
supplemental statement, again purportedly written by Dr.
Susan Kerlinsky.
Statement.)

(Dkt. No. 68, Ex. 2, Kerlinsky Supp.

He submitted no other statements or reports by

the December 31 deadline.

Defendants then filed the motions

currently pending in this case.

On January 26, 2011, Judge

Neiman allowed Defendants’ Joint Motion to Stay Discovery
Pending Disposition of Motions to Strike and Motions for
Summary Judgment (Dkt. No. 66).
IV.
A.

DISCUSSION

Defendants’ Motions to Strike Plaintiff’s Expert
Disclosure (Dkt. Nos. 67 & 69).
Defendants have filed separate motions seeking to

strike the supplemental expert statement of Dr. Kerlinsky
(Dkt. Nos. 67 & 69.), on the ground that it fails to comply
with the requirements of Fed. R. Civ. P. 26(a)(2)(B).

7

For

the reasons that follow, this court agrees.
Rule 26 requires that an expert report contain the
following: (1) a complete statement of all opinions the
witness will express and the basis and reasons for them; (2)
the facts or data considered by the witness in forming each
opinion; (3) any exhibits that will be used; (4) the
witness’s qualifications; (5) a list of all other cases in
which the witness testified as an expert in the previous
four years; and (6) a statement of the compensation to be
paid for his or her testimony.

See Fed. R. Civ. P.

26(a)(2)(B)(i)-(vi).
Here, Dr. Kerlinsky’s supplemental statement represents
only a slight improvement over her initial two-sentence
statement and still falls far short of the requirements of
Rule 26.

The most recent statement comprises three brief,

handwritten pages.

Given that the first page contains only

one sentence, which simply lists the requirements of Rule
26, the substance of the report is limited to two
handwritten pages.

This submission is deficient for several

reasons.
First, it does not contain a complete statement of all
8

opinions the witness will express and the basis and reasons
for them.

See Fed. R. Civ. P. 26(a)(2)(B)(i).

Dr.

Kerlinsky’s opinion is clear enough: “the 8 days of
hospitalization in 9-1-06 to 9-8-06 were a result of the
Terazosin [Plaintiff] took on 9-1-06 . . . .”

(Dkt. No.

68, Ex. 2, Kerlinsky Supp. Statement at 2.)

However, the

basis and reasons for that opinion are not.

The relevant

portion of Dr. Kerlinsky’s report reads:
The basis and reasons for my above opinions are my
education and experience including graduating from
Harvard College and N.Y.U. medical school and my
continuing education and studies including my
readings pertaining to Terazosin. The basis for
my opinion that the first dose of Terazosin
manufactured by Sandoz and prescribed by the VA
clinic in Spfld caused Louis Kerlinsky’s syncope,
loss of consciousness, heart stoppage and
breathing stoppage is that it is well known and
admitted by the VA in its literature on Terazosin
that a first dose of Terazosin can cause loss of
consciousness, heart stoppage and breathing
stoppage. There is no other reasonable cause for
the occurrence on 9-1-06 other than the first dose
of Terazosin.
(Dkt. No. 68, Ex. 2, Kerlinsky Supp. Statement at 2-3.)
As Defendants correctly note, an expert opinion on
medical causation must contain two elements -- general
causation, i.e., that the drug can cause the injury, and

9

specific causation, i.e., that the drug did cause the injury
in this case.

See In re Neurontin Mktg., Sales Practices,

and Prods. Liab. Lit., 612 F. Supp. 2d 116, 123 (D. Mass.
2009) (“In order to prevail in a pharmaceutical personal
injury case, a plaintiff must establish two types of
causation: general and specific.

General causation is

established by demonstrating, often through a review of
scientific and medical literature, that exposure to a
substance can cause a particular disease. . . .

Specific,

or individual, causation . . . is established by
demonstrating that a given exposure is the cause of an
individual’s disease.”) (internal quotation omitted).
As to general causation, Dr. Kerlinsky’s report states
that it is “well known” and “admitted by the VA in its
literature on Terazosin” that a causal link exists, but the
report does not identify any sources that the author relied
on as the basis for these statements.

Similarly, Dr.

Kerlinsky refers to her “readings pertaining to Terazosin”
without providing any specific references whatsoever.
As to specific causation, the report merely states that
“there is no other reasonable cause” for Plaintiff’s
10

syncope.
all.

This shorthand is tantamount to no explanation at

Obviously, many other factors might account for a

sudden loss of consciousness, including dehydration,
intoxication, shock, extreme fright, blunt force trauma, or
the various other medications Plaintiff alleges he was
prescribed by Defendant USDVA.
13.)

(See Dkt. No. 1, Compl. ¶

Dr. Kerlinsky’s report simply fails to explain what

led her to her ultimate conclusion in this case.
This deficiency extends to Dr. Kerlinsky’s opinion
regarding the issue of informed consent as well.

Dr.

Kerlinsky’s report states that “[t]he VA clinic was required
by good accepted medical practise [sic] to inform its
patients of the possible affects [sic] of the medication it
prescribed and to obtain its patients’ informed consent” and
concludes that such failure “constitutes substandard medical
treatment.”
at 3.)

(Dkt. No. 68, Ex. 2, Kerlinsky Supp. Statement

Again, Dr. Kerlinsky offers only conclusory

statements that fail to explain how she formed her opinions.
Second, and relatedly, Dr. Kerlinsky’s report does not
disclose the facts or data she considered in arriving at her
conclusions.

See Fed. R. Civ. P. 26(a)(2)(B)(ii).
11

Significantly, the report does not state that the author has
reviewed the pharmaceutical information provided to
Plaintiff by Defendants or even her father’s medical
records.

Other than the excerpt quoted above, the only

reference to facts or data underlying her opinion is the
following statement: “the other information considered by me
in forming my opinions is my general knowledge of medicine
and the practise [sic] of medicine.”
Kerlinsky Supp. Statement at 3.)

(Dkt. No. 68, Ex. 2,

The report does not give

any indication of what this “general knowledge” might
include.
Third, the report does not adequately describe Dr.
Kerlinsky’s qualifications.
26(a)(2)(B)(iv).

See Fed. R. Civ. P.

The report states, “My qualifications are

my education and experience.

I am licensed to practise

[sic] medicine in New York state.”
Kerlinsky Supp. Statement at 3.)

(Dkt. No. 68, Ex. 2,
The report does not

explain whether Dr. Kerlinsky has treated patients with
medical conditions like Plaintiff’s, has studied fields of
medicine related to this case (e.g., cardiology,
pulmonology), has participated in any relevant training or
12

clinical work, or has any familiarity with the drug
Terazosin.

Plaintiff’s short, vague statement is flatly

insufficient to comply with Rule 26.5

See Adams v. J.

Meyers Builders, Inc., 671 F. Supp. 2d 262, 268 (D.N.H.
2009) (excluding expert where report “failed to give [the
expert’s] qualifications apart from the brief references to
[the expert’s] ‘38 years of experience’ and his ‘client
list’”).
In sum, even after being warned that his submissions
were deficient, Plaintiff failed to provide adequate expert
disclosure pursuant to Rule 26.

For the reasons noted, Dr.

Kerlinsky’s supplemental statement does not provide with any
reasonable degree of specificity the basis and reasons for
her opinions, the facts or data underlying her opinions, or
her qualifications.

Under such circumstances, striking the

expert report is the proper remedy.

See Santiago-Diaz v.

Laboratorio Clinico y de Referencia del Este, 456 F.3d 272,

5

It is worth noting that Dr. Kerlinsky in fact appears
entirely unqualified to offer an expert opinion in this
case. She practices family medicine, and, as noted,
Plaintiff has failed to point to any relevant experience
that would qualify her to render an opinion as to medical
causation in a pharmaceutical products liability action.
13

274 (1st Cir. 2006) (affirming the trial court’s grant of
summary judgment and noting that the plaintiff’s expert’s
one-page statement, which consisted only of two “conclusory”
paragraphs, “did not by any stretch of the most fertile
imagination meet the criteria set by the Civil Rules for
expert witness reports”); Flebotte v. Dow Jones & Co., Inc.,
No. 97-30117-FHF, 2001 WL 35988081, at *2 (D. Mass. Feb. 7,
2001) (striking an expert report where it failed to identify
any diagnostic tools as the basis for the proposed medical
causation opinion, and, instead, “merely indicate[d] that
[the expert] formulated his opinion based on his
conversations with [the plaintiff] during treatment
sessions”).

Consequently, the court will strike Dr.

Kerlinsky’s expert report and preclude her from testifying.6
6

Defendants have raised one additional independent
basis for excluding Dr. Kerlinsky’s expert testimony.
Defendants observe that Dr. Kerlinsky’s entire supplemental
statement, including her signature, appears to be in the
same handwriting as all other documents authored and signed
by her father, Plaintiff Louis Kerlinsky. (See Dkt. No. 68,
Ex. 2, Kerlinsky Rep. at 2-5.) Given that the proposed
expert may not have participated in the drafting of the
expert report, Dr. Kerlinsky’s report could be stricken on
these grounds alone. See Fed. R. Civ. P. 26(a)(2)(B)
(requiring that expert reports be “prepared and signed by
the witness”); see also Flebotte v. Dow Jones & Co., Inc.,
No. 97-30117-FHF, 2000 WL 35539238, at *2 (D. Mass. Dec. 6,
14

B.

Defendants’ Motions for Summary Judgment (Dkt. Nos. 64
& 71).
Both Defendant Sandoz and Defendant USDVA have filed

motions for summary judgment on the counts remaining in the
complaint: Count 1 alleging breach of warranty against
Defendant Sandoz, Count 2 alleging negligent failure to warn
against Defendant Sandoz, and Count 6 alleging negligent
failure to obtain informed consent against Defendant USDVA.
(Dkt. Nos. 64 & 71).

In these motions, Defendants argue

that if the report of Plaintiff’s sole expert, Dr.
Kerlinsky, is stricken, the court should grant summary
judgment for Defendants due to Plaintiff’s inability to
establish a key element of his case: causation.
Defendants correctly observe that the issue of medical
causation requires expert analysis.

See, e.g., Case of

Canavan, 733 N.E.2d 1042, 1051 (Mass. 2000) (“Because
understanding medical causation is beyond the . . .

2000) (noting that “it is generally accepted that [Rule
26(a)(2)(B)] requires the expert to substantially
participate in the preparation of his report”) (citation and
quotation marks omitted). However, because several other
grounds exist for excluding this testimony, the court need
not anchor its holding on the disturbing possibility that
the expert statement was fabricated.
15

knowledge of the ordinary layman . . . proof of it must rest
upon expert medical testimony.”) (citation and quotation
marks omitted); Polaino v. Bayer Corp., l22 F. Supp. 2d 63,
71(D. Mass. 2000) (allowing defendants’ motions to strike
expert testimony and granting summary judgment for
defendants on plaintiff’s product liability claims because
“without such testimony, plaintiff can prove neither a
design defect nor causation”).

This rule applies with equal

force to cases involving informed consent.

See Harnish v.

Children’s Hosp. Med. Ctr., 439 N.E.2d 240, 243 (Mass. 1982)
(“What the physician should know [and should convey to the
patient] involves professional expertise and can ordinarily
be proved only through the testimony of experts.”) (citing
Haggerty v. McCarthy, 181 N.E.2d 562, 566 (Mass. 1962)).
In opposition to these motions, Plaintiff does not
address the above case law but instead cites two cases that
do not touch upon the issue presently before the court.

See

Wyeth v. Levine, 129 S. Ct. 1187, 1204 (2009) (holding that
state law failure-to-warn claims against manufacturer of
antihistamine were not preempted by federal law); Hayes v.
Ariens Co., 462 N.E.2d 273, 277 (Mass. 1984) (holding that
16

jury’s verdict for plaintiff on theory of negligence was
inconsistent with its finding that manufacturer did not
breach warranty of merchantability and noting that “the
vendor is presumed to have been fully informed at the time
of the sale of all risks”).7
Given that Plaintiff’s sole expert will not be allowed
to testify, Plaintiff cannot prove causation with respect to
any of the remaining counts.8

Accordingly, the court will

allow Defendants’ motions for summary judgment (Dkt. Nos. 64
& 71).
C.

Defendant Sandoz’s Motion for Judgment on the Pleadings
(Dkt. No. 73).
Given the above rulings, the court will deny as moot

Defendant Sandoz’s Motion for Judgment on the Pleadings

7

Hayes was later abrogated by Vassallo v. Baxter
Healthcare Corp., 696 N.E.2d 909, 922-23 (Mass. 1998), which
held that a manufacturer cannot be found liable for failure
to warn about risks not reasonably foreseeable at time of
sale.
8

Plaintiff’s complaint also refers to letters authored
by two physicians allegedly linking Plaintiff’s syncope to
his use of Terazosin HCL. (See Dkt. No. 1, Compl. ¶¶ 25,
26.) However, Plaintiff did not produce these documents to
the court in opposition to the pending motions. More
importantly, Plaintiff has not presented expert reports on
behalf of either of these individuals.
17

(Dkt. No. 73).
V.

CONCLUSION

For the foregoing reasons, Defendant Sandoz’s Motion to
Strike Plaintiff’s Expert Disclosure (Dkt. No. 67) and
Defendant USDVA’s Motion to Strike Expert Disclosure (Dkt.
No. 69) are hereby ALLOWED.

Defendant Sandoz’s Motion for

Summary Judgment as to Causation (Dkt. No. 64) and Defendant
USDVA’s Motion for Summary Judgment (Dkt. No. 71) are hereby
ALLOWED.

Defendant Sandoz’s Motion for Judgment on the

Pleadings (Dkt. No. 73) is hereby DENIED AS MOOT.
will enter judgment for Defendants.

The clerk

The case may now be

closed.
It is So Ordered.
/s/ Michael A. Ponsor
MICHAEL A. PONSOR
U. S. District Judge

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