McCombs v. Synthes, 587 S.E.2d 594 (Ga. 2003). · Go Syfert
McCombs v. Synthes, 587 S.E.2d 594 (Ga. 2003). Cases Citing This Book View Copy Cite
81 citation events (81 in the last 25 years) across 10 distinct courts.
Strongest positive: BUCKNER v. BOSTON SCIENTIFIC CORPORATION (gamd, 2023-06-22)
Treatment trajectory · 2004 → 2026 · click a year to view as-of
2004 2015 2026
Top citers, strongest first. 20 distinct citers. How cited ↗
discussed Cited as authority (rule) BUCKNER v. BOSTON SCIENTIFIC CORPORATION
M.D. Ga. · 2023 · confidence medium
A. Buckner’s Failure to Warn Claims A medical device manufacturer has a duty to warn the patient’s doctor of the device’s dangers, and “the manufacturer’s warnings to the physician must be adequate or reasonable under the circumstances of the case.” McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003).6 Boston Scientific emphasizes that the Obtryx “Directions for Use” package insert lists several “Known risks of surgical procedures for the treatment of incontinence,” including ongoing pain (“pelvic, vaginal, groin/thigh, dyspareunia”) and states that these “eve…
discussed Cited as authority (rule) COLLETT v. OLYMPUS OPTICAL CO LTD
M.D. Ga. · 2023 · confidence medium
The manufacturer of a medical device has a duty to warn the patient’s doctor of the dangers involved with the product, and the warnings “must be adequate or reasonable under the circumstances.” McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003).
cited Cited as authority (rule) Shakine Hardaway v. MacOn-bibb County
Ga. Ct. App. · 2022 · confidence medium
McCombs v. Synthes, 277 Ga. 252, 253 ( 587 SE2d 594 ) (2003).
discussed Cited as authority (rule) Karen Leigh Hubbard v. Bayer Healthcare Pharmaceuticals Inc.
11th Cir. · 2020 · confidence medium
Under Georgia’s learned intermediary doctrine, the drug manufacturer “does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient’s doctor.” Id. (quoting McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 594 (Ga. 2003)).
discussed Cited as authority (rule) Sherr-Una Booker v. C. R. Bard, Inc.
9th Cir. · 2020 · confidence medium
Under the learned-intermediary doctrine, “the manufacturer of a prescription drug or medical device does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient’s doctor, who acts as a learned intermediary between the patient and the manufacturer.” McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003).
cited Cited as authority (rule) HARDISON v. BIOMET INC
M.D. Ga. · 2020 · confidence medium
Ga. 2010) (quoting McCombs v. Synthes, 587 S.E.2d 594, 595 (Ga. 2003)).
discussed Cited as authority (rule) LUDY v. ELI LILLY & COMPANY
S.D. Ind. · 2020 · confidence medium
McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003) (citing Ellis v. C.R.
cited Cited as authority (rule) May v. Ethicon, Inc.
N.D. Ga. · 2020 · confidence medium
Ga. 2010) (citing , 277 Ga. 252 , 253, 587 S.E.2d 594, 595 (2003)).
discussed Cited as authority (rule) Centocor, Inc. v. Hamilton
Tex. · 2012 · confidence medium
Searle & Co., 567 A.2d 398, 399-401 (Del. 1989); Mampe v. Ay-erst Labs., 548 A.2d 798, 801-02 , 802 n. 6 (D.C.1988); Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104 (Fla. 1989); McCombs v. Synthes (U.S.A.), 277 Ga.252, 587 S.E.2d 594, 595-96 (2003); Craft v. Peebles, 78 Hawai'i 287 , 893 P.2d 138, 155-56 (1995); Sliman v. Aluminum Co. of Am., 112 Idaho 277 , 731 P.2d 1267, 1270-71 (1986); Hansen v. Baxter Healthcare Corp., 198 Ill.2d 420 , 261 Ill.Dec. 744 , 764 N.E.2d 35, 42 (2002); Humes v. Clinton, 246 Kan. 590 , 792 P.2d 1032, 1039-41 (1990); Hyman & Armstrong, P.S.C. v. Gunderson, 279…
discussed Cited as authority (rule) Lee v. Mylan Inc.
M.D. Ga. · 2011 · confidence medium
However, pursuant to Georgia’s learned intermediary doctrine, a prescription drug manufacturer “ ‘does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient’s doctor, who acts as a learned intermediary between the patient and the manufacturer.’ ” Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 815 (11th Cir.2010) (quoting McCombs v. Synthes (U.S.A.), 277 Ga. 252, 253 , 587 S.E.2d 594, 595 (2003)).
discussed Cited as authority (rule) In Re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation
M.D. Ga. · 2010 · confidence medium
Under Georgia’s learned intermediary doctrine, a medical device manufacturer “does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to *1366 warn the patient’s doctor, who acts as a learned intermediary between the patient and the manufacturer.” McCombs v. Synthes (U.S.A.), 277 Ga. 252, 253 , 587 S.E.2d 594, 595 (2003).
cited Cited as authority (rule) Weilbrenner v. Teva Pharmaceuticals USA, Inc.
M.D. Ga. · 2010 · confidence medium
McCombs v. Synthes (U.S.A.), 277 Ga. 252, 253 , 587 S.E.2d 594, 595 (2003).
cited Cited as authority (rule) Dietz v. Smithkline Beecham Corp.
11th Cir. · 2010 · confidence medium
McCombs v. Synthes (U.S.A.), 277 Ga.252, 587 S.E.2d 594, 594 (2003) (footnotes & quotation marks omitted); accord Ellis v. C.R.
examined Cited as authority (rule) Gourdine v. Crews (4×)
Md. · 2008 · confidence medium
Searle & Co., 567 A.2d 398, 400 (Del.1989); Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104 (Fla.1989); McCombs v. Synthes, 277 Ga. 252 , 587 S.E.2d 594, 595 (2003); Kirk v. Michael Reese Hosp. & Med.
examined Cited as authority (rule) State Ex Rel. Johnson & Johnson Corp. v. Karl (4×)
W. Va. · 2007 · confidence medium
This is so because the prescribing physician, acting as a 'learned intermediary’ between the manufacturer and the consumer, weighs the potential benefits against the dangers in deciding whether to recommend the drug to meet the patient’s needs.” (internal citations omitted)); McCombs v. Synthes, 277 Ga. 252, 253 , 587 S.E.2d 594, 595 (2003) (applying the doctrine in a medical device context, but stating that "[u]nder the learned intermediary doctrine, the manufacturer of a prescription drug or medical device does not have a duty to warn the patient of the dangers involved with the produc…
cited Cited as authority (rule) Talton v. Arnall Golden Gregory, LLP
Ga. Ct. App. · 2005 · confidence medium
(Punctuation and footnotes omitted.) McCombs v. Synthes (U.S.A.), 277 Ga. 252, 253 (1) ( 587 SE2d 594 ) (2003).
discussed Cited as authority (rule) McCombs v. Synthes (2×)
Ga. Ct. App. · 2004 · confidence medium
As directed therein, we consider McCombs’s argument made here that there remained a jury question as to the adequacy of the warning given to her surgeon by Synthes (U.S.A.), although, as acknowledged in McCombs v. Synthes (U.S.A.), 277 Ga. at 254, “[i]n response to the summary judgment motion, McCombs did not contend that the warning to her doctor inadequately conveyed the dangers associated with the use of the plate.” The warning included in the package insert with the Synthes plate is set out in McCombs v. Synthes (U.S.A.), 250 Ga. App. at 544 , including the phrase “[tjhese devices …
discussed Cited "see" Nail v. State (2×)
Ga. Ct. App. · 2009 · signal: see · confidence high
See McCombs v. Synthes, 277 Ga. 252, 253 (1) ( 587 SE2d 594 ) (2003); Chamblin, 272 Ga. App. at 243-244 (1).
discussed Cited "see, e.g." Ironworkers Local Union 68 v. Astrazeneca Phar.
11th Cir. · 2011 · signal: see also · confidence medium
See, e.g., Reyes v. Wyeth Labs., 498 F.2d 1264 , 1276 (5th Cir. 1974)22 (“The [prescription] choice 22 In Bonner v. City of Prichard, 661 F.2d 1206, 1209 (11th Cir. 1981) (en banc), this court adopted as binding precedent all decisions of the former Fifth Circuit handed down prior to October 1, 1981. 17 [the physician] makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.”); UFCW Local 1776 v. Eli Lilly & Co., 620 F.3d 121, 135 (2d Cir. 2010) (discussing how a patient’s diagnosis, any past and current medications the patient …
examined Cited "see, e.g." Ironworkers Local Union 68 v. Astrazeneca Pharmaceuticals, LP (4×)
11th Cir. · 2011 · signal: see also · confidence low
See, e.g., Reyes v. Wyeth Labs., 498 F.2d 1264 , 1276 (5th Cir.1974) [22] ("The [prescription] choice [the physician] makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative."); UFCW Local 1776 v. Eli Lilly & Co., 620 F.3d 121, 135 (2d Cir.2010) (discussing how a patient's diagnosis, any past and current medications the patient has taken, the physician's experience with prescribing the drug, and the physician's knowledge regarding the drug's side effects all function as considerations taken into account in addition to the alleged misr…
Retrieving the full opinion text from the archive…
McCOMBS
v.
SYNTHES (U.S.A.) Et Al.
S01G1633.
Supreme Court of Georgia.
Sep 15, 2003.
587 S.E.2d 594
Warshauer, Thomas, Thornton & Rogers, Michael J. Warshauer, Lyle G. Warshauer, Brian D. Rogers, for appellant., Alston & Bird, Lori G. Cohen, Jenifer N. Stephens, for appellees., King & Spalding, Chilton D. Varner, William R. Bassett, Jr., Stephen B. Devereaux, Brown & Shamp, Robert H. Brown III, amici curiae.
Sears.
Cited by 30 opinions  |  Published
Sears, Presiding Justice.

We granted certiorari in this products liability case to consider[*253] whether the Court of Appeals erred by holding that the appellant, Linda McCombs, could not assert certain arguments on appeal concerning the “learned intermediar/’ doctrine because she had not specifically asserted them below. [1] Because appellee Synthes Spine Company (“Synthes Spine”) moved for and was granted summary judgment on McCombs’s failure to warn claim based on the learned intermediary doctrine, and because the arguments raised on appeal by McCombs concerning that doctrine were arguments that the trial court necessarily had to resolve adversely to McCombs to grant summary judgment to Synthes Spine, we reverse the Court of Appeals’s judgment and remand the case to it for consideration of McCombs’s arguments.

1. Under the learned intermediary doctrine, the manufacturer of a prescription drug or medical device does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient’s doctor, who acts as a learned intermediary between the patient and the manufacturer. [2] The rationale for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the “ ‘decision to employ prescription medication [or medical devices] involves professional assessment of medical risks in light of the physician’s knowledge of a patient’s particular need and susceptibilities.’ ” [3] Finally, as Synthes Spine concedes, under the learned intermediary doctrine, the manufacturer’s warnings to the physician must be adequate or reasonable tinder the circumstances of the case. [4]

2. In the present case, McCombs underwent spinal surgery, which involved, among other things, the installation of a plate device to stabilize her spine. [5] 6The plate, however, subsequently fractured, and McCombs brought this products liability action against Synthes Spine, as well as other defendants. Relying on the learned intermediary doctrine, Synthes Spine moved for summary judgment on McCombs’s failure to warn claim. More specifically, Synthes Spine contended that its warning to McCombs’s doctor was sufficient to sat[*254] isfy its duty to warn, and that it had no duty to also warn McCombs. In response to the summary judgment motion, McCombs did not contend that the warning to her doctor inadequately conveyed the dangers associated with the use of the plate. Based on the learned intermediary doctrine, the trial court granted summary judgment to Synthes Spine on McCombs’s failure to warn claim. On appeal to the Court of Appeals, McCombs contended that a jury question existed as to the adequacy of the warning that was given to her doctor. The Court of Appeals, however, declined to address this contention on the ground that McCombs did not specifically make this argument in the trial court. We subsequently granted McCombs’s petition for certiorari to address this holding of the Court of Appeals.

Decided September 15, 2003 — Reconsideration denied November 7,2003. Warshauer, Thomas, Thornton & Rogers, Michael J. Warshauer, Lyle G. Warshauer, Brian D. Rogers, for appellant. Alston & Bird, Lori G. Cohen, Jenifer N. Stephens, for appellees.

3. As the movant for summary judgment, Synthes Spine had to “ ‘demonstrate that there [was] no genuine issue of material fact and that the undisputed facts, viewed in the light most favorable to the nonmoving party, warrant[ed] judgment as a matter of law.’” [6] Synthes Spine contended that it was entitled to summary judgment on McCombs’s failure to warn claim based on the learned intermediary doctrine. As the movant for summary judgment, Synthes Spine thus had the burden to show that there was no issue of material fact concerning the learned intermediary doctrine and that the application of that doctrine to this case defeated McCombs’s failure to warn claim as a matter of law.

In light of the principles governing the learned intermediary doctrine, for the trial court to grant summary judgment to Synthes Spine based on that doctrine, the trial court had to conclude that the warning given by Synthes Spine to McCombs’s physician was adequate or reasonable as a matter of law. Thus, the adequacy of the warning was an issue raised by Synthes Spines’s motion for summary judgment, and was an issue necessarily resolved adversely to McCombs by the trial court. For this reason, McCombs was entitled to argue this issue on appeal, and the Court of Appeals erred in holding to the contrary.

Judgment reversed and case remanded.

All the Justices concur. [*255] King & Spalding, Chilton D. Varner, William R. Bassett, Jr., Stephen B. Devereaux, Brown & Shamp, Robert H. Brown III, amici curiae.
1

McCombs v. Synthes (U.S.A.), 250 Ga. App. 543 (553 SE2d 17) (2001).

2

See Ellis v. C.R. Bard, Inc., 311 F3d 1272, 1279-1280 (11th Cir. 2002); Williams v. American Medical Systems, 248 Ga. App. 682, 685 (548 SE2d 371) (2001); Presto v. Sandoz Pharmaceuticals Corp., 226 Ga. App. 547, 548-549 (487 SE2d 70) (1997).

3

McCombs, 250 Ga. App. at 545, quoting Lance v. American Edwards Laboratories, 215 Ga. App. 713, 716 (452 SE2d 185) (1994). Accord Ellis, 311 F3d at 1279-1281.

4

See Ziliak v. Astra Zeneca, 324 F3d 518, 521 (7th Cir. 2003); Annotation, Construction and Application of the Learned-Intermediary Doctrine, 57 ALR5th 1, 29 (1998); Restatement (Third) of Torts: Products Liability, § 6 (d) (1); Ellis, 311 F3d at 1278-1279, 1281 (trial court found that warning to physician was adequate and granted summary judgment under learned intermediary doctrine, and the appellate court affirmed).

5

The facts of the case are more fully set forth in the Court of Appeals’s opinion, and need not be repeated here in full. See McCombs, 250 Ga. App. at 543-550.

6

Talbot County Bd. of Comm’rs v. Woodall, 275 Ga. 281 (565 SE2d 465) (2002), quoting Lau’s Corp. v. Haskins, 261 Ga. 491 (405 SE2d 474) (1991).