Lance v. American Edwards Laboratories

452 S.E.2d 185, 215 Ga. App. 713, 94 Fulton County D. Rep. 4117, 1994 Ga. App. LEXIS 1354
CourtCourt of Appeals of Georgia
DecidedDecember 2, 1994
DocketA94A1561
StatusPublished
Cited by12 cases

This text of 452 S.E.2d 185 (Lance v. American Edwards Laboratories) is published on Counsel Stack Legal Research, covering Court of Appeals of Georgia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Lance v. American Edwards Laboratories, 452 S.E.2d 185, 215 Ga. App. 713, 94 Fulton County D. Rep. 4117, 1994 Ga. App. LEXIS 1354 (Ga. Ct. App. 1994).

Opinions

McMurray, Presiding Judge.

Glenda Lance filed an action against her physician, his employer and the manufacturer and distributors of a medical device (designed for implantation into the human stomach) known as the Garren-Edwards Gastric Bubble (“the gastric bubble”), alleging medical malpractice, breach of express warranty, breach of implied warranty and [714]*714products liability. Her spouse, Floyd Lance, sued for loss of consortium. Summary judgment was entered in favor of Ms. Lance’s physician and his employer and this judgment was affirmed in Lance v. Elliott, 202 Ga. App. 164 (413 SE2d 486).

The Lances dismissed their original complaint and later filed a renewal action against the designer and manufacturer of the gastric bubble, American Edwards Laboratories, and the distributors of the gastric bubble, American Hospital Supply Corporation and Baxter Travenol Laboratories, Inc., n/k/a Baxter International, Inc. (defendants), seeking damages allegedly sustained when a gastric bubble ruptured through a hernia in Glenda Lance’s abdominal wall. The Lances based their claims on theories of strict liability, negligent design and negligent manufacture. Defendants denied the material allegations of the complaint and filed a motion for summary judgment, contending the doctrine of federal preemption bars the Lances’ products liability claims. Defendants argued in their supporting brief that the gastric bubble is subject to the Medical Device Amendments (“MDA”) to the Federal Food, Drug & Cosmetic Act, 21 USC § 360c, and that their compliance with all statutory and regulatory requirements of the MDA precludes imposition of higher state standards for design, manufacture and use of the gastric bubble.

The evidence, construed in a light which most favorably supports the Lances’ claims, reveals the following: The gastric bubble is a medical device used for treatment of severe obesity. It is designed to decrease food cravings via insertion, inflation and floatation of a bubble in the upper region of a patient’s stomach. The gastric bubble is available only upon prescription, application (insertion) and supervision of a physician and is not readily recommended for patients with abdominal wall hernias. Such patients are at high risk for serious complications, i.e., hernial ruptures.

Glenda Lance consulted a physician regarding her problem with chronic obesity and, despite Lance’s history of abdominal surgery and hernias, this physician suggested use of a gastric bubble for treatment of Ms. Lance’s condition. The physician advised Ms. Lance of certain dangers associated with use of the gastric bubble, but he did not inform her that the gastric bubble “should not be inserted in a person with an incisional hernia. [Nor was it ever] indicated to [Ms. Lance] that because [she] had a prior incisional hernia, that the gastric bubble should not be used. [Ms. Lance] was never given any information from the manufacturer that suggested that in a patient with a prior incisional hernia there was a possibility that the gastric bubble would deflate and migrate to the incisional hernia.”

On April 7, 1987, a gastric bubble was inserted into Glenda Lance’s stomach by her physician and, within 20 days, Ms. Lance began experiencing severe abdominal pain. However, the problem was [715]*715not accurately diagnosed until June 13, 1987, when the gastric bubble in Ms. Lance’s body burst through a hernia in her abdominal wall. The device was then surgically removed.1

The trial court granted defendants’ motion for summary judgment “based on the preemption doctrine [and] the court’s finding [that the] medical device at issue is dispensed by prescription only and [that] any obligation to warn the patient is the doctor’s.” This appeal followed. Held:

The Lances contend the trial court erred in granting defendants’ motion for summary judgment, arguing that genuine issues of material fact remain as to defendants’ liability for failing to warn her of the known danger of inserting a gastric bubble into a patient with an “incisional” hernia. Defendants contend they had no such common-law duty to warn because of federal preemption under the MDA. See 21 USC § 360k (a).

“The Supremacy Clause of the United States Constitution dictates that federal law preempts inconsistent state law. U. S. Const., Art. VI, cl. 2. ‘Pre-emption may be either express or implied, and is “compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Jones v. Rath Packing Co., 430 U. S. 519, 525 (1977).’ Fidelity Federal Savings & Loan Association v. de la Cuesta, 458 U. S. 141, 152 (102 SC 3014, 73 LE2d 664) (1982). Although it is often necessary to examine legislative history to determine whether Congress intended to preempt state law, ‘when a federal statute unambiguously precludes certain types of state (law), we need go no further than the statutory language to determine whether the state (law) is preempted.’ Exxon Corp. v. Hunt, 475 U. S. 355, 362 [(106 SC 1103, 89 LE2d 364) (1986)].” Poloney v. Tambrands, Inc., 260 Ga. 850 (1) (412 SE2d 526). In the absence of express preemptive language, Congressional intent may be inferred “where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress ‘left no room’ for supplementary state regulation. Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230 (1947).” Hillsborough County, Fla. v. Automated Med. Laboratories, 471 U. S. 707, 713 (105 SC 2371, 85 LE2d 714).

In the case sub judice, defendants cite no specific federal provision imposing a duty upon them to warn consumers of dangers associated with use of the gastric bubble and they assert no persuasive argument that federal regulation leaves no room for supplementary state regulation requiring warning labels or notices for devices similar [716]*716to the gastric bubble. Further, we have examined the MDA and find no barriers to state regulations of medical devices similar to the gastric bubble. See Hillsborough County, Fla. v. Automated Med. Laboratories, 471 U. S. 707, 713, supra. Compare Poloney v. Tambrands, Inc., 260 Ga. 850 (1), supra. It therefore appears the trial court erred in granting defendants’ motion for summary judgment “based on the preemption doctrine.” However, we find no error in the trial court’s ruling that defendants had no duty to warn Ms. Lance of dangers associated with use of a gastric bubble in patients with abdominal hernias.

In Walker v. Jack Eckerd Corp., 209 Ga. App. 517 (434 SE2d 63), a majority of the Court of Appeals of Georgia held that pharmacists have no common-law duty to warn a customer or notify a physician that a drug is being prescribed in a dangerous amount, stating that it is the duty of the prescribing physician to warn the patient of any dangers associated with taking the drug. Id. at 520 (2), 522, supra.

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Lance v. American Edwards Laboratories
452 S.E.2d 185 (Court of Appeals of Georgia, 1994)

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Bluebook (online)
452 S.E.2d 185, 215 Ga. App. 713, 94 Fulton County D. Rep. 4117, 1994 Ga. App. LEXIS 1354, Counsel Stack Legal Research, https://law.counselstack.com/opinion/lance-v-american-edwards-laboratories-gactapp-1994.