Brown v. Roche Laboratories, Inc. et al
Filing
162
ORDER AND OPINION granting 143 Defendants' Motion to Exclude Plaintiff's Expert; granting 144 Defendants' Motion for Summary Judgment; and denying as moot 160 Plaintiffs Motion for Leave to File an untimely Motion to Exclude Defendants Experts. Signed by Judge Julie E. Carnes on 6/6/13. (ddm)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF GEORGIA
ATLANTA DIVISION
DAWN BROWN,
Plaintiff,
CIVIL ACTION NO.
v.
1:06-cv-3074-JEC
ROCHE LABORATORIES, INC. and
HOFFMAN-LA ROCHE, INC.,
Defendants.
ORDER & OPINION
This case is before the Court on defendants’ Motion to Exclude
Plaintiff’s Expert [143], defendants’ Motion for Summary Judgment
[144], and plaintiff’s Motion for Leave to File an untimely Motion to
Exclude Defendants’ Experts [160]. The Court has reviewed the record
and the arguments of the parties and, for the reasons set out below,
concludes that defendants’ Motion to Exclude Plaintiff’s Expert [143]
should be GRANTED, defendants’ Motion for Summary Judgment [144]
should be GRANTED, and plaintiff’s Motion for Leave to File an
Untimely Motion to Exclude Defendants’ Experts [160] should be DENIED
as moot.
AO 72A
(Rev.8/82)
BACKGROUND
This is a pharmaceutical products liability case arising from
plaintiff’s use of the prescription antibiotics Bactrim and Rocephin
in 2004.
(Compl. [1].)
Plaintiff was prescribed and began taking
Bactrim on April 20, 2004 following a diagnosis of a sinus infection
by her primary care clinic, Kaiser Permanente Medical Center of
Gwinnett (“Kaiser”).
(Pl.’s Statement of Material Facts (“PSMF”)
[148] at 4.)
Plaintiff took Bactrim as prescribed for the next
fourteen days.
(Id.)
On May 3, 2004, plaintiff returned to Kaiser complaining of
fever, photophobia, headache, neck pain and blisters in her mouth and
throat.
(Defs.’ Statement of Material Facts (“DSMF”) [144] at ¶ 8.)
Based on her symptoms, Kaiser Dr. Puvi Seshiah feared that plaintiff
had developed bacterial meningitis.
(Id. at ¶ 9.)
He administered
two injections of Rocephin and transferred plaintiff to the Northside
Hospital Emergency Room.
(Id. at ¶ 10 and PSMF [148] at 5.)
Dr.
Seshiah was aware that plaintiff’s medical records indicated a
penicillin allergy, and that there is a possible cross-reactivity
between penicillins and Rocephin.
(DSMF [144] at ¶ 11.)
However,
Dr. Seshiah believed that any potential risk was heavily outweighed
by the benefits in treating her suspected meningitis. (Id. at ¶ 12.)
On May 4, 2004, plaintiff returned to Kaiser with worsening
symptoms.
(Id. at ¶ 13.)
At that time, plaintiff’s primary care
2
AO 72A
(Rev.8/82)
physician and consulting dermatologist agreed that plaintiff was
likely experiencing Stevens-Johnson Syndrome (“SJS”) rather than
bacterial meningitis.
(Id. at ¶ 14.)
SJS is a rare and life-
threatening drug reaction that causes blistering of the mucous
membranes and epidermal necrosis.
[1] at ¶ 32.)
(Defs.’ Br. [144] at 2 and Compl.
On May 5, 2004, plaintiff was admitted to Grady
Memorial Hospital with a confirmed diagnosis of SJS and an additional
diagnosis of Toxic Epidermal Necrolysis (“TEN”), a more severe form
of SJS.
(PSMF [148] at 5.)
Plaintiff subsequently filed this action in Fulton County State
Court against the manufacturers of Rocephin and Bactrim asserting
various product liability and other state law claims. (Compl. [1] at
¶¶ 4-12, 60-119.)
The manufacturer defendants jointly removed the
case to the Northern District of Georgia on the ground of diversity
jurisdiction.1
(Notice of Removal [1] at 2.)
Thereafter, plaintiff
abandoned her claims against the Bactrim defendants. (Pl.’s Mot. for
Voluntary Dismissal of Certain Defendants [119].)
After several delays, plaintiff and the remaining Rocephin
defendants completed fact and expert discovery in January, 2013.
(Am. Scheduling Order [132].)
Following discovery, defendants filed
1
Plaintiff is a Georgia resident and defendants are Delaware
and New Jersey corporations.
(Notice of Removal [1] at 4-5.)
Plaintiff seeks damages in excess of $75,000. (Id. at 5-7.) The
Court thus has jurisdiction over the case under 28 U.S.C. § 1332.
3
AO 72A
(Rev.8/82)
a Daubert motion to exclude plaintiff’s causation expert and a motion
for summary judgment.
Summ. J. [144].)
(Defs.’ Mot. to Exclude [143] and Mot. for
Both of those motions, as well as plaintiff’s
request for leave to file an untimely motion to exclude defendants’
experts, are now before the Court.
(Pl.’s Mot. for Leave [160].)
DISCUSSION
I.
DEFENDANTS’ DAUBERT MOTION
In support of her product liability claims, plaintiff seeks to
present the expert testimony of Dr. Manfred Wolff.
[118].)
caused
Dr. Wolff opines that:
plaintiff’s
concerning
SJS/TEN,
administration
patients was ineffective.
of
(Wolff Aff.
(1) the drug Rocephin most likely
and
the
(2)
Rocephin’s
drug
(Id. at 12.)
to
warning
label
penicillin-sensitive
Defendants contend that Dr.
Wolff is not qualified to render those opinions, and that his
opinions are not sufficiently reliable to meet the standards of
admissibility set forth in Rule 702 of the Federal Rules of Evidence
and Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).
In Daubert, the Supreme Court concluded that Rule 702 governs
the admissibility of scientific expert testimony.
at 588.
Daubert, 509 U.S.
Rule 702 states that a witness who is “qualified as an
expert” may provide opinion testimony if:
(a) the expert’s scientific, technical, or other
specialized knowledge will help the trier of
fact to understand the evidence or to determine
4
AO 72A
(Rev.8/82)
a fact in issue; (b) the testimony is based on
sufficient facts or data; (c) the testimony is
the product of reliable principles and methods;
and (d) the expert has reliably applied the
principles and methods to the facts of the case.
FED. R. EVID. 702.
Pursuant
to
Rule
702,
expert
testimony
is
admissible when: (1) the expert is qualified to testify competently,
(2) the expert’s methodology is reliable, and (3) the expert’s
testimony will assist the trier of fact to understand the evidence or
to determine a fact in issue in the case.
Guinn v. AstraZeneca
Pharm. LP, 602 F.3d 1245, 1252 (11th Cir. 2010).
See also Allison v.
McGhan Med. Corp., 184 F.3d 1300, 1309 (11th Cir. 1999)(applying
Daubert).
The Daubert Court emphasized the district court’s “gatekeeping”
role to ensure that expert testimony is relevant and reliable before
it is admitted as evidence.
Daubert, 509 U.S. at 589.
See also
Hudgens v. Bell Helicopters/Textron, 328 F.3d 1329, 1342 (11th Cir.
2003)(noting “the repeated emphasis the Supreme Court has placed upon
the district court’s ‘gatekeeping’ role in the determination of
whether expert evidence should be admitted”).
The overarching goal
of Daubert’s gatekeeping requirement is to ensure that an expert
“‘employs in the courtroom the same level of intellectual rigor that
characterizes the practice of an expert in the relevant field.’”
Kilpatrick v. Breg, Inc., 613 F.3d 1329, 1335 (11th Cir. 2010)(citing
Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152 (1999)).
5
AO 72A
(Rev.8/82)
The
proponent
of
expert
testimony
bears
the
burden
of
demonstrating that the testimony meets each of the requirements of
Rule 702.
Hendrix ex rel. G.P. v. Evenflo Co., Inc., 609 F.3d 1183,
1194 (11th Cir. 2010).
See also McClain v. Metabolife Int’l, Inc.,
401 F.3d 1233, 1238 (11th Cir. 2005) (“[t]he burden of establishing
qualification, reliability, and helpfulness rests on the proponent of
the expert opinion”).
As discussed below, plaintiff has not met her
burden of showing that Dr. Wolff is qualified to render the opinions
offered
in
his
Affidavit,
or
that
his
opinions
are
reliable.
Accordingly, the Court GRANTS defendants’ motion to exclude [143].
A.
Dr. Wolff’s Qualifications
In support of his qualification as an expert, plaintiff refers
to Dr. Wolff’s Affidavit and CV indicating that he has a Ph.D. in
pharmaceutical chemistry and extensive research and patent experience
in the general area of pharmaceuticals.
Exclude [147] at 13.)
(Pl.’s Resp. to Mot. to
However, Dr. Wolff’s Affidavit and CV do not
reveal any particular expertise concerning the drugs at issue in this
case or their connection with SJS/TEN, as would be required to
support Dr. Wolff’s medical causation opinion. (Wolff Aff. [118] and
Ex. A.)
Nor is there any evidence that Dr. Wolff is sufficiently
knowledgeable about FDA regulatory practice and requirements to
render an expert opinion as to the efficacy of the Rocephin warning
label.
6
AO 72A
(Rev.8/82)
In fact, Dr. Wolff’s lack of experience in both areas is
apparent from his deposition testimony.
Dr. Wolff admitted during
his deposition that he has only a basic familiarity with Rocephin or
Bactrim, and that he has not conducted any research or published any
articles concerning either of those drugs.
(Wolff Dep. [143] at 11-
12.) Dr. Wolff further conceded that he done no research on SJS/TEN,
and has not been involved in any field work related to the treatment
of those conditions or the drugs alleged to cause them.
20, 24.)
(Id. at 19-
An important issue in this case is whether plaintiff’s
SJS/TEN was caused by the Rocephin that her doctor administered on
May 3, 2004, or instead by the course of Bactrim that she had just
completed on that date.
Remarkably, Dr. Wolff appeared to be
unaware, until he was presented with an article on the topic during
his deposition, that Bactrim has a much higher relative risk than
Rocephin for the onset of SJS/TEN.
As
to
his
regulatory
(Id. at 75-76.)
training
and
experience,
Dr.
Wolff
acknowledged in his deposition that he has never consulted with the
FDA regarding the content of a drug package insert.
(Id. at 58.)
Although he vaguely recalled contributing to the parts of an insert
that describe the chemical and pharmacological properties of a drug,
he admitted that he has no experience drafting insert warnings. (Id.
at 58-59.)
done
by
According to Dr. Wolff, that type of drafting would be
the
“regulatory
affairs”
7
AO 72A
(Rev.8/82)
division
of
a
pharmaceutical
company.
(Wolff Dep. at 58.)
Dr. Wolff conceded that he has no
training or practical experience in “regulatory affairs.”
(Id. at
58-60.)
That Dr. Wolff has a Ph.D. and experience in the general area of
pharmaceutical chemistry is insufficient, in and of itself, to
qualify him as either a medical causation or a labeling expert in
this case.
See United States v. Brown, 415 F.3d 1257, 1269 (11th
Cir. 2005)(upholding the district court’s refusal to qualify an
expert with a Ph.D. in plant pathology because he had only worked
with the substance at issue in the case on “isolated projects”) and
In re Trasylol Prod. Liab. Litig., No. 08-MD-01928, 2011 WL 7109297,
at *6 (S.D. Fla. Apr. 27, 2011)(the plaintiff’s doctor was “not an
expert on FDA regulations and labeling” and was therefore “not
qualified to opine on this subject”). Based on his CV and deposition
testimony, the Court finds that Dr. Wolff is not qualified to render
either of the opinions that are asserted in his expert Affidavit.
B.
Dr. Wolff’s Reliability
In addition, Dr. Wolff’s medical causation opinion is not
sufficiently reliable to be admitted under Rule 702 and the standards
of Daubert.
Even a “‘supremely qualified expert cannot waltz into
the courtroom and render opinions unless those opinions are based on
some recognized scientific method.’”
McDowell v. Brown, 392 F.3d
1283, 1298 (11th Cir. 2004)(citing Clark v. Takata Corp., 192 F.3d
8
AO 72A
(Rev.8/82)
750, 759 (7th Cir. 1999)).
To fulfill its gatekeeper obligation
under Daubert, the Court must ensure that scientific evidence is “the
product of reliable principles and methods” and “must screen out
‘expert’ testimony that is not sufficiently . . . trustworthy for the
factfinder to consider.”
Brown, 415 F.3d at 1266-67.
The Supreme Court has identified several non-exclusive factors
that a court may consider when evaluating the reliability of an
expert opinion, including:
(1) whether the opinion can be and has
been empirically tested, (2) whether the opinion has been subjected
to peer review and publication, (3) the known or potential error rate
of the opinion, and (4) whether the opinion is generally accepted in
the field.
Daubert, 509 U.S. at 593-95.
The pertinence of these
factors in any given case “depends on the nature of the issue, the
expert’s particular expertise, and the subject of his testimony.”
Brown, 415 F.3d at 1268 (citing Kumho Tire, 526 U.S. at 150).
The
Supreme Court has emphasized that the factors should be applied
flexibly.
Kumho Tire, 526 U.S. at 141.
None of the reliability factors instill confidence in Dr.
Wolff’s causation opinion.
Dr. Wolff admitted during his deposition
that plaintiff had been exposed to both Rocephin and Bactrim during
the relevant time frame, and that either drug can cause SJS/TEN.
(Wolff Dep. at 63, 76.) In his Affidavit, Dr. Wolff summarily stated
that Rocephin was likely the precipitating factor in plaintiff’s
9
AO 72A
(Rev.8/82)
case.
(Wolff Aff. [118] at 12.)
However, there is no indication
that Dr. Wolff tested his opinion or estimated its potential error
rate.
(Wolff Dep. at 24, 62-63.)
Neither did he publish the opinion
or otherwise subject it to peer review.
(Id. at 12.)
As to general
acceptance in the field, the only available evidence suggests that
Bactrim is more likely to cause SJS/TEN than Rocephin.
(Id. at 76.)
In addition, it is evident that Dr. Wolff ignored or dismissed
highly relevant and unfavorable evidence in reaching his causation
opinion.
Immediately after she finished her two-week course of
Bactrim and prior to being prescribed Rocephin, plaintiff returned to
her doctor complaining of fever, photophobia, headache, neck pain and
blisters in her mouth and throat.
(DSMF [144] at ¶ 8.)
These
symptoms are well-known early indicators of SJS, and they were
exhibited by plaintiff during the typical one to four-week latency
period for the onset of SJS after exposure to a precipitating drug.
(Defs.’ Mot. to Exclude [143] at Ex. F.)
The record evidence thus
suggests that plaintiff was already suffering from the initial
symptoms of SJS when she ingested Rocephin, and that her SJS was most
likely caused by Bactrim.
Yet, Dr. Wolff did not rule out or
meaningfully address that possibility in reaching his causation
opinion.
(Wolff Aff. [118] and Wolff Dep. at 40-45.)
Daubert’s reliability inquiry is focused on the methodology
underlying an expert’s opinions.
Kilpatrick, 613 F.3d at 1341.
10
AO 72A
(Rev.8/82)
Dr.
Wolff’s “methodology” consists solely of pointing out a supposed
temporal relationship between plaintiff’s ingestion of Rocephin and
the onset of her SJS/TEN symptoms.
(Wolff Dep. at 33-34.)
Even a
strong temporal connection is “generally not a reliable indicator of
a causal relationship.”
so
in
this
case,
Guinn, 602 F.3d at 1254. Especially is that
where
the
undisputed
evidence
suggests
plaintiff’s SJS symptoms preceded her ingestion of Rocephin.
that
Given
the obvious lack of both a sound methodology and evidentiary support
in the record, and in consideration of the applicable reliability
factors, the Court finds that Dr. Wolff’s opinions “lack the indicia
of reliability necessary to survive a Daubert inquiry and challenge
under Rule 702.”
II.
McClain, 401 F.3d at 1240.
DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT
Defendants
contend
that
without
Dr.
Wolff’s
testimony,
plaintiff’s product liability claims fail as a matter of law.
(Defs.’ Mot. for Summ. J. [144].) The parties agree that plaintiff’s
claims are governed by Georgia law.
See Grupo Televisa, S.A. v.
Telemundo Commc’n Grp., Inc., 485 F.3d 1233, 1240 (11th Cir. 2007)(a
federal court sitting in diversity applies the conflicts rules of its
forum state to determine which state law applies) and Bullard v. MRA
Holding, LLC, -- S.E.2d --, No. S12Q2087, 2013 WL 1247976, at *2 (Ga.
Mar. 28, 2013)(“for over 100 years, the state of Georgia has followed
the doctrine of lex loci delicti in tort cases”).
11
AO 72A
(Rev.8/82)
According to
defendants, plaintiff cannot maintain a product liability action
under Georgia law without supporting expert testimony.
[144] at 10.)
(Defs.’ Br.
Defendants also argue that (1) plaintiff’s failure to
warn claim is barred by the learned intermediary doctrine and (2) any
remaining state law claims are either derivative of the product
liability claims or otherwise baseless.
A.
(Id. at 13-22.)
Summary Judgment Standard
Summary
judgment
is
appropriate
when
the
“pleadings,
depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any, show that there is no genuine
issue as to any material fact and that the moving party is entitled
to a judgment as a matter of law.”
materiality
is
determined
by
the
FED. R. CIV. P. 56(c).
controlling
substantive
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
is genuine when the evidence is such that
return a verdict for the nonmovant.
A fact’s
law.
An issue
a reasonable jury could
Id. at 249-50.
Summary judgment is not properly viewed as a device that the
trial court may, in its discretion, implement in lieu of a trial on
the merits. Instead, Rule 56 of the Federal Rules of Civil Procedure
mandates the entry of summary judgment against a party who fails to
make a showing sufficient to establish the existence of every element
essential to that party’s case on which that party will bear the
burden of proof at trial.
Celotex Corp. v. Catrett, 477 U.S. 317,
12
AO 72A
(Rev.8/82)
322 (1986).
In such a situation, there can be no genuine issue as to
any material fact, as a complete failure of proof concerning an
essential element of the non-moving party’s case necessarily renders
all other facts immaterial.
Id. at 322-23 (quoting FED. R. CIV. P.
56(c)).
The movant bears the initial responsibility of asserting the
basis for his motion.
Id. at 323.
However, the movant is not
required to negate his opponent’s claim.
The movant may discharge
his burden by merely “‘showing’--that is, pointing out to the
district court--that there is an absence of evidence to support the
non[-]moving party’s case.”
Id. at 325.
After the movant has
carried his burden, the non-moving party is then required to “go
beyond the pleading” and present competent evidence designating
“‘specific facts showing that there is a genuine issue for trial.’”
Id. at 324.
While the court is to view all evidence and factual
inferences in a light most favorable to the non-moving party, Samples
v. City of Atlanta, 846 F.2d 1328, 1330 (11th Cir. 1988), “the mere
existence of some alleged factual dispute between the parties will
not
defeat
an
otherwise
properly
supported
motion
for
summary
judgment; the requirement is that there be no genuine issue of
material fact.”
Anderson, 477 U.S. at 247-48 (1986).
13
AO 72A
(Rev.8/82)
B.
Product Liability Claims
In Counts I and II of the complaint, plaintiff asserts product
liability
claims
liability.
based
(Compl.
[1]
on
theories
at
¶¶
of
negligence
60-84.)
Whether
and
strict
proceeding
in
negligence or strict liability, “[t]he sine qua non of a product[]
liability claim . . . is a defect in the product.”
Corp., 292 Ga. App. 234, 235 (2008).
Boswell v. OHD
Plaintiff also must prove that
there is a causal connection between the alleged defect and her
injury.
Id.
Disregarding
Dr.
Wolff’s
testimony,
there
is
insufficient evidence to create a material issue of fact as to either
of these essential elements.
The Court thus GRANTS defendants’
motion for summary judgment [144] as to Counts I and II.
1.
Evidence of a Defect
Plaintiff vaguely states in her response that the Rocephin she
received in May, 2004 was “not of merchantable quality, nor fit for
[its] intended use.”
(Pl.’s Resp. [148] at 6.)
However, plaintiff
does not present any evidence of a defect in the “merchantability” or
“fitness” of Rocephin generally or of the specific dose of Rocephin
that she received. In fact, even Dr. Wolff recognized that there was
no evidence that Rocephin is defectively designed or that the
particular batch of Rocephin that plaintiff ingested was defectively
manufactured.
(Wolff Dep. at 77-78.)
14
AO 72A
(Rev.8/82)
The only potential defect that Dr. Wolff identified concerns the
Rocephin label.
(Id.)
According to Dr. Wolff, the label “does not
clarify to the medical practitioner . . . the cautionary procedures
that
need
to
appropriate
patient.”
to
be
followed
administer
prior
to
Rocephin
(Wolff Aff. [118] at 12.)
determining
to
a
whether
it
is
penicillin-sensitive
Given Dr. Wolff’s testimony,
and the lack of evidence to establish any other kind of defect, it
appears that plaintiff’s product liability claim is based solely on
a failure to warn theory.
See Daniels v. Bucyrus-Erie Corp., 237 Ga.
App. 828, 829-30 (1999)(describing the difference between failure to
warn and design and manufacturing defect claims).
During the relevant time period, the Rocephin label contained
the following statement:
WARNINGS: BEFORE THERAPY WITH ROCEPHIN® IS
INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO
DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS
HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS,
PENICILLINS OR OTHER DRUGS. THIS PRODUCT SHOULD
BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE
PATIENTS.
ANTIBIOTICS SHOULD BE ADMINISTERED
WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED
SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS.
(Wolff Aff. [118] at ¶ 16.) Dr. Wolff’s conclusion that this warning
is somehow “vague” or “ambiguous” is questionable.
But
in
any
experience
case,
to
Dr.
render
Wolff
an
is
expert
not
opinion
Rocephin’s FDA-mandated warning label.
15
AO 72A
(Rev.8/82)
qualified
as
to
(Id. at ¶ 17.)
by
the
education
or
efficacy
of
Accord In re Trasylol Prod.
Liab. Litig., 2011 WL 7109297, at *6 (disqualifying a doctor who was
“not an expert on FDA regulations and labeling”). Plaintiff does not
offer any other evidence to support her claim that the Rocephin
warning label is inadequate.
2.
Causation
Neither does plaintiff offer any evidence other than Dr. Wolff’s
conclusory and unsubstantiated opinion to establish causation.
To
prevail on her product liability claim, plaintiff must establish both
general and specific causation.
Toole v. Georgia-Pacific, LLC, No.
A10A2179, 2011 WL 7938847, at *8 (Ga. App. Jan. 19, 2011).
Butler
v.
Union
Carbide
Corp.,
310
Ga.
App.
21,
(distinguishing between general and specific causation).
See also
25
(2011)
That is,
plaintiff must prove both that Rocephin “is capable of causing”
SJS/TEN in the general population and that Rocephin in fact caused
plaintiff’s SJS/TEN.
Id. at 25.
General causation is not a problem
here because defendants do not dispute that Rocephin is capable of
causing SJS/TEN.
(Defs.’ Br. [144] and Mot. to Exclude [143] at 19-
20.) But having excluded Dr. Wolff’s testimony, there is no evidence
from which a jury could rationally conclude that Rocephin caused
plaintiff’s SJS/TEN in this particular case.
As discussed above, it is undisputed that plaintiff had just
completed a two-week course of Bactrim when she ingested Rocephin.
(DSMF [144] at ¶ 7.)
Bactrim is known to be associated with SJS/TEN
16
AO 72A
(Rev.8/82)
and in fact has a higher relative risk for the onset of SJS/TEN than
Rocephin.
(Defs.’
Mot.
to
Exclude
[143]
at
19
and
Ex.
D.)
Plaintiff’s medical records indicate that she was likely experiencing
the initial symptoms of SJS when she returned to the Kaiser Clinic
and was prescribed Rocephin.
Under
the
(DSMF [144] at ¶ 8.)
circumstances,
that
Rocephin
caused
plaintiff’s
SJS/TEN “is not a natural inference that a juror could make through
human experience.”
Allison, 184 F.3d at 1320 (applying Georgia
product liability law).
Expert testimony is therefore essential to
establish causation in this case.
Id.
See also Wilson v. Taser
Int’l, Inc., 303 Fed. App’x 708, 715 (11th Cir. 2008)(“In product
liability cases, proof of causation generally requires reliable
expert testimony”(citing Rodrigues v. Georgia-Pacific Corp., 290 Ga.
App. 442 (2008)).
Again, the only expert testimony plaintiff
proffers is the excluded opinion of Dr. Wolff.
In addition, and as an alternative ground for summary judgment,
any inference of causation on plaintiff’s failure to warn claim is
precluded by the learned intermediary doctrine.
intermediary
doctrine,
a
manufacturer
has
a
Under the learned
duty
to
warn
the
patient’s doctor of the dangers associated with a prescription drug
rather than the patient herself.
Talton v. Arnall Golden Gregory,
LLP, 276 Ga. App. 21, 27 (2005).
The doctor acts as a learned
intermediary between the patient and the manufacturer, the rationale
17
AO 72A
(Rev.8/82)
being that the doctor is in the best position to warn the patient of
any medical risks associated with the drug.
Id.
To invoke the protection of the learned intermediary doctrine,
a manufacturer ordinarily must provide an adequate warning of the
alleged risk to the plaintiff’s doctor.
Id.
However, where the
doctor has actual knowledge of the risk and would have taken the same
course of action even with the warning that plaintiff claims should
have been provided, the learned intermediary doctrine bars recovery.
Wheat v. Sofamor, S.N.C., 46 F. Supp. 2d 1351, 1363-64 (N.D. Ga.
1999)(Story, J.).
See also Ellis v. C.R. Bard, Inc., 311 F.3d 1272,
1283 (11th Cir. 2002)(under Georgia law, the learned intermediary
doctrine applies where the doctor is independently aware of the risks
or the risks are well-known to the medical community).
In such a
case, the learned intermediary doctrine breaks any causal link
between the alleged failure to warn and the plaintiff’s injury.
Wheat, 46 F. Supp. 2d at 1363-64.
Plaintiff claims that she was injured as a result of defendants’
failure to provide an adequate warning concerning the administration
of Rocephin to penicillin-sensitive patients.
23-25.)
(Pl.’s Resp. [148] at
It is undisputed that plaintiff’s prescribing physician Dr.
Seshia was aware both of plaintiff’s reported penicillin sensitivity
and
of
Rocephin.
the
possible
cross-reactivity
(DSMF [144] at ¶ 11.)
18
AO 72A
(Rev.8/82)
between
penicillins
and
He nevertheless administered
Rocephin to plaintiff because he believed that any risk associated
with the drug was heavily outweighed by the benefits of treating what
he suspected was bacterial meningitis, a potentially fatal condition.
(Id. at ¶ 12.)
Given Dr. Seshia’s actual knowledge of the risk
presented by Rocephin and his considered decision to prescribe the
drug
in
spite
of
the
risk,
the
learned
intermediary
doctrine
precludes a finding of causation and bars plaintiff’s recovery in
this case.
Wheat, 46 F. Supp. 2d at 1363-64 and Ellis, 311 F.3d at
1283.
C.
Remaining Claims
1.
Breach of Warranty and Misrepresentation
In Counts III, IV and V, plaintiff asserts claims for breach of
warranty and fraudulent and negligent misrepresentation. (Compl. [1]
at ¶¶ 85-119.)
Based on the arguments presented in plaintiff’s
response brief, these Counts appear to be merely a reframing of
plaintiff’s failure to warn claim. (Pl.’s Resp. [148] at 23-27.) To
the extent that is the case, summary judgment on Counts III, IV and
V is GRANTED for the reasons discussed above.
In the interest of caution, the Court also notes that plaintiff
has not produced any evidence to support a stand-alone breach of
warranty or misrepresentation claim.
Plaintiff fails to allege or
prove privity, a required element of a breach of warranty claim under
Georgia law.
See Cobb Cnty. Sch. Dist. v. MAT Factory, Inc., 215 Ga.
19
AO 72A
(Rev.8/82)
App. 697, 702 (1994)(applying the privity requirement) and Bryant v.
Hoffmann-La Roche, Inc., 262 Ga. App. 401, 411 (2003)(affirming
summary judgment in favor of the defendant pharmaceutical company on
an implied warranty claim, citing a lack of privity).
Plaintiff’s
allegations concerning fraudulent and negligent misrepresentation are
similarly lacking as to the essential elements of either claim, and
do not come close to meeting the special pleading requirements of
Federal Rule 9(b).
See Thompson v. Floyd, 310 Ga. App. 674, 683
(2011)(describing the elements of a claim for fraud under Georgia
law) and FED. R. CIV. P. 9(b)(requiring a plaintiff to “state with
particularity the circumstances constituting fraud”).
For these
additional reasons, defendants’ motion for summary judgment [144] is
GRANTED as to Counts III, IV and V of the complaint.
2.
Damages, Punitive Damages, and Joint Liability
In Counts VI, VII and VIII, plaintiff asserts claims titled
“Joint and Several Liability,” “Plaintiff’s Damages” and “Punitive
Damages.”
(Compl. [1] at ¶¶ 120-125.)
These claims are derivative
of plaintiff’s substantive claims. See Racette v. Bank of Am., N.A.,
318 Ga. App. 171, 181 (2012)(“An award of . . . punitive damages is
derivative of a plaintiff’s substantive claims”) and Lilliston v.
Regions Bank, 288 Ga. App. 241, 246 (2007)(holding that plaintiff’s
claim for damages was properly dismissed as derivative of the
substantive tort claims in the case). In light of the Court’s ruling
20
AO 72A
(Rev.8/82)
on plaintiff’s product liability and other substantive state law
claims, defendants’ motion for summary judgment [144] is GRANTED as
to Counts VI, VII and VIII.
CONCLUSION
For the foregoing reasons, the Court GRANTS defendants’ Motion
to Exclude Plaintiff’s Expert [143], GRANTS defendants’ Motion for
Summary Judgment [144], and DENIES as moot plaintiff’s Motion for
Leave to File an untimely Motion to Exclude Defendants’ Experts
[160].
The clerk is directed to CLOSE this case.
SO ORDERED, this 6th day of June, 2013.
/s/ Julie E. Carnes
JULIE E. CARNES
CHIEF UNITED STATES DISTRICT JUDGE
21
AO 72A
(Rev.8/82)
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?