Carnes et al v. Eli Lilly and Company

Filing 29

OPINION and ORDER granting 24 Motion for Summary Judgment. Signed by Honorable Cameron McGowan Currie on 12/16/2013.(cbru, )

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF SOUTH CAROLINA
ROCK HILL DIVISION

Clayton Carnes and Linda Carnes (h/w),

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)
Plaintiffs,
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v.
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Eli Lilly and Company, an Indiana
)
Corporation,
)
)
)
Defendant.
)
___________________________________ )

C/A NO. 0:13-591-CMC

OPINION and ORDER

This matter is before the court on motion for summary judgment filed by Defendant Eli Lilly
and Company (“Eli Lilly”). Dkt. No. 24. For reasons stated below, the court grants Defendant’s
motion for summary judgment.
BACKGROUND
While serving his country in December 2004, Plaintiff Clayton “Scott” Carnes suffered
significant spinal cord injury as a result of a helicopter crash while attempting to rescue fellow
soldiers in Iraq. As a result, Mr. Carnes is wheelchair bound, has significant physical limitations,
and suffers from chronic pain. Since 2008, Mr. Carnes has received treatment at Palmetto TriCounty Medical in Lancaster, South Carolina. In summer 2011, Mr. Carnes reported to Dr. Knight,
a physician at Palmetto Tri-County Medical, that he wanted to stop taking Lyrica. Dkt. No. 27-2 at
130; 162-163 (Carnes Dep. 129: 17-25; 161:21-162:10). At that time, Dr. Knight prescribed 60 mg
daily of Cymbalta, manufactured by Defendant Eli Lilly. Dkt. No. 27-6 at 62 (Knight. Dep. 61:5-8).
Mr. Carnes took Cymbalta under the care of Dr. Knight through December 2011, when Dr. Knight
1

left Palmetto Tri-County Medical. Id. at 64:10-15. Dr. Anupama Singaraju took over Mr. Carnes’
care upon Dr. Knight’s departure. Carnes Dep. 165:17-19.
At Mr. Carnes’ first visit with Dr. Singaraju in March 2012, Mr. Carnes complained about
weight gain, which he attributed to Cymbalta. Dkt. No. 27-7 at 15-17 (Singaraju Dep. 14:1-17:13).
Mr. Carnes informed Dr. Singaraju that he wanted to switch to a different medication. Id. at 17:1416. As a result, Dr. Singaraju reduced his Cymbalta dosage to 30 mg daily.1 Id. at 26:15-21. Dr.
Singaraju testified she decided to use the tapering off method to avoid potential side effects from
stopping Cymbalta suddenly. Id. at 26:25-27:10; 31:3-12. At Mr. Carnes’ next visit in June 2012,
Dr. Singaraju directed Mr. Carnes to stop Cymbalta and restart Lyrica. Id. at 45:12-24; 50:7-52:12.
Mr. Carnes alleges he experienced “severe and dangerous withdrawal symptoms” when he
discontinued Cymbalta, including “sharp, painful zaps of electricity shooting from one side of his
head to the other,” “nightmares,” and “anger.” Complaint ¶ 35. Mr. Carnes testified that he
continues to experience “shakes . . . like a dog getting wet and . . . shaking,” which he attributes to
Cymbalta. Carnes Dep. 187:7-13.

1

As explained above, Dr. Singaraju testified that she reduced Mr. Carnes’ dosage to 30 mg
daily at his first visit with her in March 2012. She also testified that in Mr. Carnes’ medical records,
it simultaneously included both 30 mg and 60 mg of Cymbalta, which she agreed was an error.
Singaraju Dep. 47:10-13. Defendant states that, although “Dr. Singaraju reduced Mr. Carnes’
Cymbalta dosage to 30 mg [,]. . . it appears that Mr. Carnes continued to be dispensed a 60 mg dose.”
Dkt. No. 24-1 at 7. Plaintiffs do not address the dosage issue in their opposition brief and do not
argue that there is any disputed fact concerning this discrepancy. In Plaintiffs’ opposition brief,
Plaintiffs merely state that Dr. Singaraju continued to prescribe Cymbalta until the summer of 2012,
at which point Plaintiffs suggest that Mr. Carnes decided to terminate Cymbalta. Dkt. No. 27-1 at
5 (“Plaintiff came under the care and treatment of Dr. Anupama Singaraju [a female physician], who
prescribed Cymbalta for Plaintiff until the summer of 2012, when he ultimately discontinued use of
the drug and began experiencing the symptomatology that is the subject of this suit.”) (emphasis
added).
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On March 5, 2013, Mr. Carnes and his wife Linda Carnes (“Plaintiffs”) filed this Complaint
alleging claims under various product liability theories, including defective design, negligence,
failure to warn, strict liability, negligent misrepresentation, fraud, breach of express warranty, breach
of implied warranty of merchantability, and violation of the South Carolina Unfair Trade Practices
Act (“SCUTPA”). Dkt. No. 1 (Compl.). Plaintiffs allege that Defendant “overstated the efficacy
of Cymbalta and understated, downplayed, and/or failed altogether to state the true withdrawal side
effects associated with Cymbalta.” Compl. ¶ 14. At all relevant times, the Cymbalta label provided
the following information about discontinuation:
“Discontinuation symptoms have been systematically evaluated in patients taking
duloxetine [Cymbalta]. Following abrupt or tapered discontinuation in placebocontrolled clinical trials, the following symptoms occurred at a rate greater than or
equal to 1% and at a significantly higher rate in duloxetine-treated patients compared
to those discontinuing from placebo: dizziness, nausea, headache, fatigue,
paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety,
hyperhidrosis and vertigo . . . .”
Id. at ¶ 15. An article published in 2005 states that Defendant’s Cymbalta clinical trials show that
44.3% of Cymbalta patients suffered from “discontinuation” symptoms, far above the 1% reported
in the product label. Id. at ¶ 17. Those clinical trials also showed that “9.6% of Cymbalta users
suffered severe withdrawal side effects.” Id. at ¶ 18. A 2012 report by the Institute for Safe
Medication Practices indicates that “withdrawal symptoms were reported in 44-50% of patients
abruptly discontinuing duloxetine at the end of clinical studies for depression, and more than half
of this total did not resolve within a week or two.” Id. at 27.
Dr. Knight and Dr. Singaraju testified that they were unaware of the clinical trials or articles
cited above prior to prescribing Cymbalta to Mr. Carnes. Had Dr. Knight known that Defendant’s
data showed that 44% of patients taking Cymbalta experienced withdrawal symptoms, he would
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have been “more aggressive” in counseling his patients about Cymbalta. Knight Dep. 100:3-5. Mr.
Carnes testified he would not have taken Cymbalta had he been warned about the risk of withdrawal
symptoms. Carnes Dep. 205:24-207:11. Dr. Knight also testified that, had he had this additional
information concerning Cymbalta’s withdrawal risk, he still would have prescribed Cymbalta to Mr.
Carnes in the summer of 2011. Knight Dep. 115:1-17. Dr. Singaraju testified that, had she been
provided this additional information, her decision still would have been to taper Mr. Carnes off of
Cymbalta. Singaraju Dep. 132:22-133:24.
On September 9, 2013, Defendant filed a motion for summary judgment based on the learned
intermediary doctrine. Dkt. No. 24. Plaintiffs responded on October 3, 2013 (Dkt. No. 27), to which
Defendant replied on October 15, 2013 (Dkt. No. 28).
STANDARD
A. Summary Judgment
Summary judgment should be granted if “the movant shows that there is no genuine dispute
as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P.
56(a). It is well established that summary judgment should be granted “only when it is clear that
there is no dispute concerning either the facts of the controversy or the inferences to be drawn from
those facts.” Pulliam Inv. Co. v. Cameo Properties, 810 F.2d 1282, 1286 (4th Cir. 1987).
The party moving for summary judgment has the burden of showing the absence of a genuine
issue of material fact, and the court must view the evidence before it and the inferences to be drawn
therefrom in the light most favorable to the nonmoving party. United States v. Diebold, Inc., 369
U.S. 654, 655 (1962).
Rule 56(c)(1) provides as follows:

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(1)
A party asserting that a fact cannot be or is genuinely disputed must support
the assertion by:
(A)

citing to particular parts of materials in the record, including
depositions, documents, electronically stored information, affidavits
or declarations, stipulations . . . , admissions, interrogatory answers
or other materials; or

(b)

showing that the materials cited do not establish the absence or
presence of a genuine dispute, or that an adverse party cannot produce
admissible evidence to support the fact.

Fed. R. Civ. P. 56(c)(1).
A party “cannot create a genuine issue of material fact through mere speculation or the
building of one inference upon another.” Beale v. Hardy, 769 F.2d 213, 214 (4th Cir. 1985).
Therefore, “[m]ere unsupported speculation . . . is not enough to defeat a summary judgment
motion.” Ennis v. Nat’l Ass’n of Bus. & Educ. Radio, Inc., 53 F.3d 55, 62 (4th Cir. 1995). The nonmoving party cannot create a genuine issue of material fact by presenting his or her own conflicting
versions of events. Barwick v. Celotex Corp., 736 F.2d 946, 960 (4th Cir. 1984) (“A genuine issue
of material fact is not created where the only issue of fact is to determine which of the two
conflicting versions of the plaintiff’s testimony is correct.”).
B. Products Liability
“Under South Carolina law, a ‘products liability case may be brought under several theories,
including negligence, strict liability, and warranty.’” Sauls v. Wyeth Pharms., Inc., 846 F. Supp. 2d
499, 502 (D.S.C. 2012) (quoting Rife v. Hitachi Constr. Mach. Co., 609 S.E.2d 565, 568 (S.C. Ct.
App. 2005). Proximate causation is critical to any theory under which a products liability case
proceeds, and requires a showing that “‘the injury occurred because the product was in a defective
condition unreasonably dangerous to the user.’” Id. (quoting Holst v. KCI Konecranes Int’l Corp.,

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699 S.E.2d 715, 719 (S.C. Ct. App. 2010)).2

Prescription drugs are neither defective nor

unreasonably dangerous if accompanied by proper directions and warnings. See Brooks v.
Medtronic, Inc., 750 F.2d 1227, 1229-30 (4th Cir.1984) (explaining that prescription drugs often
cause unwanted side effects and are deemed “unavoidably unsafe,” but are not defective or
unreasonably dangerous if adequate warnings of potential side effects are included). “Failure to give
such a warning constitutes a ‘defect’ in the product and renders the manufacturer liable for selling
a product in an unreasonably dangerous manner.” Id. at 1230.
In South Carolina, the learned intermediary doctrine applies to prescription drug
manufacturers. Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992). Under the learned
intermediary doctrine, “the manufacturer’s duty to warn extends only to the prescribing physician,
who then assumes responsibility for advising the individual patient of risks associated with the drug
or device.” Id. In a prescription drug case, a plaintiff must not only show that the drug
manufacturer’s warning was inadequate, but “also establish that the inadequacy of the warning was
the proximate cause of the plaintiff’s injury.” Sauls, 846 F. Supp. 2d at 502 (citing Stanback v.
Parke, Davis, & Co., 657 F.2d 642, 645 (4th Cir. 1981)). In light of the learned intermediary
doctrine, “the burden remains on the plaintiff to demonstrate that the additional non-disclosed risk
was sufficiently high that it would have changed the treating physician’s decision to prescribe the
product for the plaintiff.” Odom, 979 F.2d at 1003.

2

Proximate causation is also a necessary element of a claim under the SCUTPA. See Wright
v. Craft, 640 S.E.2d 486, 498 (S.C. Ct. App. 2006) (To establish a claim under the SCUTPA, a
plaintiff must prove: “(1) the defendant engaged in an unfair or deceptive act in the conduct of trade
or commerce; (2) the unfair or deceptive act affected public interest; and (3) the plaintiff suffered
monetary or property loss as a result of the defendant’s unfair or deceptive act(s).”).
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DISCUSSION
Defendant argues it is entitled to summary judgment because Plaintiffs cannot establish
proximate causation, which is an element of all of Plaintiffs’ claims.3 Defendant contends Dr.
Knight testified he would not have changed his decision to prescribe Cymbalta had he been provided
additional warnings about withdrawal symptoms, which Plaintiffs allege should have been provided.
Dkt. No. 24-1 at 14-17. Defendant also contends Dr. Knight had independent knowledge of the risk
of withdrawal symptoms associated with Cymbalta (id. at 10-14), and that Dr. Knight did not rely
on the Cymbalta label for risk information when prescribing Cymbalta to Mr. Carnes. Id. at 17-19.
Plaintiffs first argue that, under South Carolina law, it is unsettled whether the learned
intermediary doctrine applies in a prescription drug failure-to-warn case against a drug manufacturer.
Dkt. No. 27-1 at 7. In 1984, the Fourth Circuit explained in a failure-to-warn medical device case
that, “[a]lthough the South Carolina Supreme Court has not addressed the issue, we conclude it
would adopt the [learned intermediary doctrine], generally accepted and supported by sound policy,
restricting the manufacturer’s duty to warn to the prescribing physician.” Brooks v. Medtronic, Inc.,
750 F.2d 1227, 1231 (4th Cir. 1984). In 1992, the Fourth Circuit applied the learned intermediary
doctrine in a failure-to-warn case concerning a prescribed intrauterine device (“IUD”), and explained
that the doctrine applies to physicians prescribing “drug[s] or device[s].”. Odom v. G.D. Searle &
Co., 979 F.2d 1001, 1003 (4th Cir. 1992). Odom has not been overruled, and it has continuously
been followed by district courts within South Carolina. See, e.g., Sauls v. Wyeth Pharms., Inc., 846
F. Supp. 2d 499 (D.S.C. 2012) (applying learned intermediary doctrine in case involving prescription
drugs); Fisher v. Pelstring, 817 F. Supp. 2d 791 (D.S.C. 2011) (same). Plaintiffs have not identified,
3

Plaintiffs do not dispute that proximate causation is an element of all of their claims.
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and the court is unaware of, any decision from the South Carolina Supreme Court or Court of
Appeals rejecting the learned intermediary doctrine in a prescription drug case.4 The court, therefore,
is bound to follow the law of this Circuit as set forth in Odom.
Plaintiffs argue that, even assuming the learned intermediary doctrine applies to this case,
genuine issues of material fact preclude summary judgment. Dkt. No. 27-1 at 8. Specifically,
Plaintiffs argue that there are issues of fact as to (1) whether Dr. Knight was adequately informed
of Cymbalta’s withdrawal risks (id. at 8-14); (2) proximate causation (id. at 14-18); and (3) whether
Dr. Knight relied on Cymbalta’s product labeling (id. at 14-21).
To determine whether Plaintiffs have established proximate causation, the court need not
evaluate the adequacy of Cymbalta’s warning. Rather, the court must consider whether Mr. Carnes’
physician would have changed his prescribing decision had there been a different warning. See
Odom, 979 F.3d at 1003 (“The sole issue in this case, therefore, is whether an appropriate warning
to Odom’s doctor about the risk of sterility would have deterred him from prescribing the IUD.”);
Sauls, 846 F. Supp. 2d at 504 (“Numerous courts have concluded that a plaintiff fails to carry her
burden in establishing proximate cause in the absence of any evidence demonstrating how an
adequate warning would have altered a physician’s prescription decision.”). As two physicians
prescribed Cymbalta for Mr. Carnes, the court considers each physician below.
Dr. Knight. Dr. Knight testified that, had he been provided the warning Plaintiffs allege
would have been adequate, he still would have prescribed Cymbalta to Mr. Carnes in the summer

4

See Madison Am. Home Prods. Corp., 595 S.E.2d 493, 496 (S.C. 2004) (in rejecting strict
liability claim against pharmacist for dispensing drugs as prescribed, court explained “strict liability
[for pharmacists] is inconsistent with the learned intermediary doctrine, which places the duty to
warn on the prescribing physicians, and not pharmacists . . . .”).
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of 2011.5 Plaintiffs attempt to create a genuine issue of material fact by citing to an earlier portion
of Dr. Knight’s deposition in which Dr. Knight agreed with counsel’s statement that “prescribing
a drug for a patient is a joint decision-making process.” Dkt. No. 27-1 at 14-15. Without any legal
authority, Plaintiffs attempt to displace the learned intermediary doctrine by characterizing Dr.
Knight’s process of prescribing a drug as a joint decision between himself and his patient. Plaintiffs
further argue that had a stronger warning been included, Dr. Knight would have conveyed the risk
to Mr. Carnes, who testified he would not have taken Cymbalta had he been informed of the risk of
withdrawal symptoms. Id. at 15-17. Once again, Plaintiffs attempt to shift focus to the patient’s
decision to take the prescription drug, despite the learned intermediary doctrine, which requires the
court to focus on the physician’s decision to prescribe the drug. Plaintiffs have failed to identify any
testimony creating a genuine issue of material fact that a stronger warning would have altered Dr.
Knight’s prescribing decision.

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Dr. Knight testified as followed:

Q: Okay. Now, I want to ask you one more question. Let’s say you had before you
the QuarterWatch article that [Plaintiffs’ counsel] showed you and the entire Perahia
article that he -- that I've just shown you with this -A [Knight]: Uh-huh.
Q: -- hard data, and you were with Mr. Carnes, deciding whether or not to prescribe
Cymbalta to him, given how he presented to you and his medical history in the
summer of 2011, would you have still made the decision to prescribe Cymbalta as the
most appropriate medicine for him at that point?
[objection omitted]
A: I would have. Because I still think that the benefit would outweigh the risk.
Knight Dep. 115:1-17.
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Further, Defendant argues that, despite Dr. Knight’s unawareness of the articles and studies
cited by Plaintiffs, Dr. Knight had independent knowledge of the risk of withdrawal symptoms
through his training and his own experience. Dkt. No. 24-1 at 10. Defendant cite to Dr. Knight’s
testimony that he knew of withdrawal symptoms associated with Cymbalta, having learned about
them in medical school, during his residency, and from patients who experienced withdrawal
symptoms. Id. at 10-11 (citing Knight Dep. 13:1-15:7). He agreed that he knew of the following
withdrawal symptoms: dizziness, nausea, headache, paresthesia, fatigue, vomiting, irritability,
insomnia, diarrhea, anxiety and hyperhidrosis. Knight Dep. 41:20-42:12. Dr. Knight also testified
that “more than half” of his patients experienced some type of withdrawal symptom following abrupt
discontinuation of Cymbalta. Id. at 47:22-48:6.
Defendant contends that, because Dr. Knight had independent knowledge of the risk of
withdrawal symptoms and the frequency of risk of withdrawal upon abrupt termination of Cymbalta,
any failure to warn Dr. Knight did not cause Mr. Carnes’ injuries. Dkt. No. 24-1 at 14 (citing Odom,
979 F.2d at 1003). In Odom, while applying the learned intermediary doctrine, the Fourth Circuit
cited the treating physician’s independent knowledge of the risk of pelvic inflammatory disease
associated with intrauterine devices (IUDs), as well as the physician’s own estimate of the risk,
which “exceeded that of Mrs. Odom’s expert.” 979 F.2d at 1003. The court explained “[t]hat
knowledge did not alter [the physician’s] stated judgment that in 1979, the Cu-7 IUD was an
appropriate contraceptive for women who wanted to have more children in the future, and that it
remains so today.” Id. The court affirmed summary judgment in favor of the manufacturer. Here,
Dr. Knight had knowledge of the risk of withdrawal symptoms associated with Cymbalta
independent of any warning included on Cymbalta’s product label. Dr. Knight also estimated that
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“more than half” of his patients experienced withdrawal symptoms upon abrupt discontinuation,
which is more than the frequency of risk cited by Plaintiffs (44%–50%).
Plaintiffs argue that any independent knowledge Dr. Knight had about withdrawal symptoms
was inadequate. Dkt. No. 27-1 at 11-12. Plaintiffs highlight that Dr. Knight had only prescribed
Cymbalta to approximately 50 patients. Id. Although more than half of those patients experienced
withdrawal symptoms, Plaintiffs contend that such a small sample size is inadequate to inform Dr.
Knight of the actual risk.6 Id. Contrary to Plaintiffs’ position, courts have found physicians to have
independent knowledge of risks associated with prescribed devices and drugs based, at least in part,
on clinical experience. See Odom, 979 F.2d at 1003 (citing physician’s testimony that he had
independent knowledge of risk through own experience and training); Porterfield v. Ethicon, Inc.,
183 F.3d 464, 468 (5th Cir. 1999) (applying learned intermediary doctrine, no proximate causation
where physician knew of risk associated with implanted mesh based on surgical literature, own
experience, and colleagues’ experience).

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Plaintiffs do not argue that Dr. Knight was unaware of certain withdrawal symptoms or of
the frequency of withdrawal symptoms. Rather, Plaintiffs argue that Dr. Knight’s knowledge was
insufficient because it was based on his own experience, as opposed to “statistically significant”
research:
Over the course of his entire career as a practicing physician, Dr. Knight has had the
occasion to prescribe Cymbalta for only about fifty (50) patients, which he
characterized as just 5% of his entire patient population – “if that much.” By
contrast, the 2005 JAD article contained a pooled analysis, collected from nine multicenter clinical trials, involving 2,008 total patients. The extensive research laid out
in the JAD article was focused entirely on Cymbalta withdrawal symptoms and the
authors reached conclusions about statistical significance, two facets absent from Dr.
Knight’s un-memorialized observations in clinical practice.
Dkt. No. 27-1 at 11-12 (footnotes omitted).
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In light of Dr. Knight’s testimony that he had independent knowledge of the risk of
withdrawal symptoms associated with Cymbalta and the frequency of that risk upon abrupt
discontinuation, and that he still would have prescribed Cymbalta for Mr. Carnes had he been
presented with a stronger warning, Plaintiffs have failed to establish that Mr. Carnes’ injuries were
proximately caused by Defendant’s failure to adequately warn Dr. Knight of the risk of withdrawal
symptoms associated with Cymbalta.7
Dr. Singaraju. Plaintiffs contend that Dr. Singaraju testified that a stronger warning
would have changed her prescribing decision:
Lilly counsel asked Dr. Singaraju whether she would still prescribe Cymbalta for
Plaintiff if the product labeling had disclosed the heightened risk. The first time,
she responded: “I’m not sure.” When Lilly counsel pressed, asking Dr. Singaraju
whether she would still continue Plaintiff on the drug if the heightened risk had
been disclosed, she answered flatly: “No.”
Dkt. No. 27-1 at 5 (footnotes omitted). Contrary to Plaintiffs’ characterization, “[w]hen Lilly
counsel pressed,” Dr. Singaraju testified as follows:
Q: So if the label for Cymbalta, when you first saw him in March of 2012, had a
45 percent discontinuation rate on it, would you have continued to prescribe that
medication for him in that reduced rate?
A [Singaraju]: No.
Q: Even though it said that – well, did you want to taper him off of the drug?
A: Yes. I mean, I would probably watch him closely or follow up more closely.
Q: At that point in time –
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Defendant also contends that Dr. Knight did not rely on the Cymbalta label when
prescribing Cymbalta to Mr. Carnes. Dkt. No. 24-1 at 17-19. In light of the court’s determination
that Dr. Knight would not have changed his prescribing decision had a stronger warner been issued,
the court need not reach what Defendant describes as an “independent basis for finding no proximate
cause.” Dkt. No. 24-1 at 18.
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A: Yes.
Q: – would – your choice would have been to gradually reduce the dose –
A: Uh-huh.
Q: – or discontinue him altogether?
A: Gradually reduce.
Q: And would it be a better course of action to gradually reduce the dosage?
A: Yes.
Q: So, Doctor, even if the label had this information that [Plaintiffs’ counsel] has
suggested to you that it should have, that it should have a rate of 45 percent,
would you still have gradually reduced that dose for Mr. Carnes?
A: Yes.
Singaraju Dep. 132:22-133:24.
Dr. Singaraju did not make the initial decision to prescribe Cymbalta for Mr. Carnes, but
rather began treating Mr. Carnes while he was taking Cymbalta in a 60 mg dose. Dr. Singaraju
decided first to lower the dose to 30 mg and then to terminate Cymbalta completely and prescribe
Lyrica. Contrary to Plaintiffs’ characterization of Dr. Singaraju’s testimony, Dr. Singaraju did not
state that her decision to taper Mr. Carnes’ Cymbalta prescription would have been affected by a
stronger warning.8 Plaintiffs have, therefore, failed to establish that Mr. Carnes’ injuries were
8

Mr. Carnes testified that he did not recall Dr. Singaraju reducing his Cymbalta dosage to
30 mg. Mr. Carnes also testified that when he initially informed Dr. Singaraju about his desire to
stop taking Cymbalta due to weight gain, Dr. Singaraju did not talk to him about “tapering down on
the dosage” and “said that stopping Cymbalta should be okay. She said, you shouldn’t have any side
effects from doing that.” Carnes Dep. 168: 18-24. Mr. Carnes testified that, at the same visit, Dr.
Singaraju prescribed Lyrica, but that he did not start taking Lyrica. Carnes Dep. 175: 16-19; 191:
15-18.
As explained earlier, Plaintiffs do not raise the dosage issue in their opposition brief. Even
assuming a factual dispute exists as to whether Dr. Singaraju prescribed a lower dosage at the March
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proximately caused by Defendant’s failure to adequate warn Dr. Singaraju of the risk of withdrawal
symptoms associated with Cymbalta.
Plaintiffs’ claims, therefore, fail because Plaintiffs cannot establish that Defendant’s failure
to adequately warn of the risk of withdrawal symptoms associated with Cymbalta proximately
caused Mr. Carnes’ injuries.
CONCLUSION
For reasons stated above, Defendant’s motion for summary judgment is granted.
IT IS SO ORDERED.

s/ Cameron McGowan Currie
CAMERON MCGOWAN CURRIE
Senior United States District Judge
Columbia, South Carolina
December 16, 2013

2012 appointment as part of a tapering down method, Mr. Carnes testified that his wife split his
Cymbalta tablets (60 mg) for some period to relieve or reduce withdrawal symptoms. Mr. Carnes
explained that, after initially stopping Cymbalta, he experienced “zapping.” Mr. Carnes started
taking Cymbalta again to relieve his symptoms until his wife developed the idea of “cutting the
dosage down.” Mr. Carnes testified that his wife accomplished this by “pulling [the pills] apart,
raking out all the pellets in there, getting a smaller dosage, putting the pills back together and then
giving them to me, to lessen the dosage.” Carnes Dep. 177:4-7. Mr. Carnes did not provide any time
frame for this process.
There appears to be no dispute that Mr. Carnes was, in fact, taking a reduced dosage of
Cymbalta during the discontinuation process. Plaintiffs have not established that a stronger warning
of the risk of withdrawal symptoms upon abrupt discontinuation would have altered the
discontinuation process utilized by Mr. Carnes.
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