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Smart Summary

Factual and Procedural Background

Patricia Hayes Vincent, acting as the mother and legal guardian of James Victor Flynn, filed suit against C.R. Bard, Inc., Baxter Healthcare Corporation, and Bimeco, Inc. alleging strict liability and negligence based on negligent design of a patient controlled analgesia (PCA) pump. Flynn was administered morphine via the PCA pump after surgery in 1999 at Lee Memorial Hospital, and the pump allegedly malfunctioned, delivering an overdose that left Flynn totally and permanently disabled. The pump was removed after distress was discovered, but it disappeared while in hospital custody and the amount of morphine remaining was not documented. Vincent was unable to identify the exact pump used, leading the trial court to enter final summary judgment in favor of all defendants. Vincent appealed the summary judgment, challenging the dismissal of her negligent design claim against Bard.

Legal Issues Presented

  1. Whether the designer of a product may be held liable in negligence to a foreseeable user of the product despite the presence of intervening manufacturers and distributors.
  2. Whether the absence of the specific product at issue supports summary judgment against a negligent design claim.
  3. Whether the alternative theory of liability under section 433B(3) of the Restatements of Torts applies to the facts of this case.

Arguments of the Parties

The opinion does not contain a detailed account of the parties' legal arguments.

Table of Precedents Cited

Precedent Rule or Principle Cited For Application by the Court
Cintron v. Osmose Wood Preserving, Inc., 681 So.2d 859 (Fla. 5th DCA 1996) Elements required to state a cause of action for negligence (duty, breach, causation, damages). Used to outline the basic negligence framework applicable to the plaintiff’s claims.
Simon v. Tampa Elec. Co., 202 So.2d 209 (Fla. 2d DCA 1967) Support for negligence elements. Referenced alongside Cintron to establish negligence requirements.
Light v. Weldarc Co., 569 So.2d 1302 (Fla. 5th DCA 1990) Manufacturer’s duty to design a reasonably safe product for foreseeable uses. Supported the court’s conclusion that designers share the same duty as manufacturers to exercise reasonable care in product design.
Aim v. Aluminum Co. of Am., 717 S.W.2d 588 (Tex. 1986) Designer’s duty to develop a safe design, even if not the manufacturer. Used to justify imposing a duty of care on designers separate from manufacturers.
Ridley v. Safety Kleen Corp., 693 So.2d 934 (Fla. 1996) Duty of automobile manufacturers to design and manufacture vehicles to avoid foreseeable injury. Illustrated Florida precedent imposing duty on product designers/manufacturers to prevent foreseeable harm.
Ford Motor Co. v. Evancho, 327 So.2d 201 (Fla. 1976) Support for duty to use reasonable care in design and manufacture. Referenced as a foundational Florida case establishing manufacturer duties.
Stazenski v. Tennant Co., 617 So.2d 344 (Fla. 1st DCA 1993) Liability of manufacturer or designer when product defect creates a dangerous condition. Used to emphasize that designers, as well as manufacturers, create a zone of risk and may be liable.
Foster v. Ford Motor Co., 616 F.2d 1304 (5th Cir. 1980) Jury question on whether a designer exercised reasonable care in adopting a safe design. Supported the proposition that designers can be liable for negligence independent of manufacturing.
Ford Motor Co. v. Hill, 404 So.2d 1049 (Fla. 1981) Liability for negligent design should not be avoided due to subsequent manufacturing care. Used to reject shielding designers from liability due to intervening manufacturer or distributor.
Hancock v. Paccar, Inc., 204 Neb. 468, 283 N.W.2d 25 (1979) Support for holding designers liable despite subsequent manufacturing conduct. Quoted in Ford Motor Co. v. Hill to reinforce designer liability principles.
Celotex Corp. v. Copeland, 471 So.2d 533 (Fla. 1985) Explanation of alternative liability theory under Restatement section 433B(3). Rejected application of alternative liability theory to this case because only one product was involved and only one design caused injury.

Court's Reasoning and Analysis

The court began by recognizing the absence of Florida precedent directly addressing whether a product designer who is not a manufacturer, distributor, or seller can be held liable in negligence to a foreseeable user. It relied on established principles that manufacturers owe a duty to design reasonably safe products and extended this duty logically to designers regardless of whether they manufacture or distribute the product. The court cited multiple precedents and legal authorities supporting the imposition of this duty on designers, emphasizing that liability should not be avoided merely because there are intervening manufacturers or distributors.

Applying these principles, the court found that Flynn, as a surgical patient using the PCA pump, was a foreseeable user, and Bard, as the designer, owed him a duty of reasonable care in design. The plaintiff submitted an unopposed affidavit from a biomedical engineer establishing a factual basis for the defective design causing the overdose. The court held that the absence of the actual pump did not negate this claim at the summary judgment stage, creating a genuine issue of material fact as to Bard’s breach.

The court rejected Vincent’s argument to apply the alternative liability theory under section 433B(3) of the Restatements of Torts, explaining that this theory applies only when multiple tortfeasors’ actions combine to cause injury and it is impossible to determine which caused the harm. Since only one pump was involved and it was designed by Bard, the theory was inapplicable.

Accordingly, the court affirmed summary judgment for Baxter and Bimeco due to the absence of the pump and lack of evidence against them, but reversed summary judgment as to Bard’s negligent design claim and remanded for further proceedings.

Holding and Implications

The court affirmed the final summary judgment in favor of Baxter Healthcare Corporation and Bimeco, Inc., but reversed the summary judgment as to C.R. Bard, Inc. on the negligent design claim and remanded for further proceedings.

This decision establishes that in Florida, a product designer who does not manufacture or distribute the product may still be held liable in negligence to foreseeable users despite intervening manufacturers or distributors. The ruling clarifies the scope of duty owed by designers and rejects shielding them from liability based solely on manufacturing or distribution intermediation. The direct consequence is that Bard’s negligent design claim survives summary judgment, allowing the plaintiff to proceed on this theory. The court did not set new precedent regarding alternative liability theories, declining to apply section 433B(3) to these facts.

Patricia Hayes VINCENT, as mother and legal guardian of James Victor Flynn, Appellant, v. C.R. BARD, INC., a foreign corporation; Bimeco, Inc., a Florida corporation; Baxter Healthcare Corporation, a foreign corporation, Appellees.

WHATLEY, Judge.

Patricia Hayes Vincent, as mother and legal guardian of James Victor Flynn, appeals the final summary judgment entered in favor of C.R. Bard, Inc., Baxter Healthcare Corp., and Bimeco, Inc. in her action against them in which she alleged claims for strict liability and negligence based on negligent design. This case presents a question of first impression in Florida whether the designer of a product may be liable in negligence to a foreseeable user of its product although there are intervening manufacturers and distributors. We conclude that the designer may be so liable.

Vincent's son was placed on a patient controlled analgesia (PCA) pump after undergoing surgery at Lee Memorial Hospital in 1999. The pump allegedly malfunctioned, delivering an overdose of morphine to Flynn that left him totally and permanently disabled. The pump was set aside after Flynn was discovered in distress, but the amount of morphine remaining in the pump was not documented and the pump permanently disappeared while in the custody of the hospital. It was because Vincent was unable to identify the pump used by her son that the trial court entered final summary judgment for all of the defendants.

In her amended complaint, Vincent alleged that Bard and Baxter were the manufacturers of the pump used by Flynn and that Bimeco was the distributor. Bard and Baxter were both alleged to be the manufacturers because in 1993, Baxter purchased the division of Bard that designed and manufactured PCA pumps. It is undisputed for summary judgment purposes that all pumps at Lee Memorial Hospital at the time of the subject incident were of the type designed by Bard, although they may have been manufactured by either Bard or Baxter. While the absence of the pump supports the entry of summary judgment in favor of Baxter and Bimeco, we conclude that at least at this stage of the proceedings, that fact alone does not support entry of summary judgment in favor of Bard with regard to Vincent's claim for negligent design.

In order to state a cause of action for negligence, a plaintiff must establish that the defendant owed the plaintiff a duty, the defendant breached that duty, the breach was the proximate cause of the plaintiff's injuries, and the plaintiff suffered damages as a result of those injuries. See Cintron v. Osmose Wood Preserving, Inc., 681 So.2d 859 (Fla. 5th DCA 1996) (citing Simon v. Tampa Elec. Co., 202 So.2d 209 (Fla. 2d DCA 1967)). We have found no Florida cases directly holding that a designer of a product who did not manufacture, sell, distribute or have any other involvement in getting the product to the user may be liable in negligence for the defective design of the product. However, with regard to a manufacturer, "[t]here is no doubt whatever that the manufacturer is under a duty to use reasonable care to design a product that is reasonably safe for its intended use and for other uses which are foreseeably probable." Light v. Weldarc Co., 569 So.2d 1302, 1303 (Fla. 5th DCA 1990) (quoting Prosser, The Law of Torts 644-45 (4th ed. 1978)). If a manufacturer who is also the designer of a product is under a duty to foreseeable users to exercise reasonable care in the design of its product, we see no sound reason why a designer of a product who is not the manufacturer should not owe that same duty to users of its product. See Aim v. Aluminum Co. of Am., 717 S.W.2d 588, 590-91 (Tex. 1986) ("A manufacturer has long been held to have a duty to exercise ordinary care in the design of a product. A designer who is not also the manufacturer should share the same duty to develop a safe design.") (citation omitted); see also Ridley v. Safety Kleen Corp., 693 So.2d 934, 938-39 (Fla. 1996) ("[W]e imposed a duty on automobile manufacturers to use reasonable care in designing and manufacturing automobiles to eliminate the risk of foreseeable injury from such impacts.") (citing Ford Motor Co. v. Evancho, 327 So.2d 201 (Fla. 1976)); Stazenski v. Tennant Co., 617 So.2d 344 (Fla. 1st DCA 1993) ("Where a product is defective . . . and that defect rises to the level of a dangerous condition, the manufacturer or designer has created a zone of risk to all parties who may come in contact with the product.") (emphasis added); Foster v. Ford Motor Co., 616 F.2d 1304 (5th Cir.1980) (holding that jury question existed as to whether welder hired to design and build hayfork to be attached to front-end loader exercised reasonable care in adopting safe design).

We conclude that a designer who defectively designs a product should not be shielded from liability for negligence because of the mere fact that there was an intervening manufacturer or distributor. See Ford Motor Co. v. Hill, 404 So.2d 1049, 1052 (Fla. 1981) ("It would be a strange result if we said that a manufacturer who carefully designs a product and thereafter negligently produces it should be held liable, but a manufacturer who negligently designs the product and there-after carefully produces it pursuant to the negligent design should be relieved of liability.") (quoting Hancock v. Paccar, Inc., 204 Neb. 468, 475, 283 N.W.2d 25, 33 (1979)).

Flynn, as a surgical patient, was clearly a foreseeable user of the Bard PCA pump. Thus, Bard had a duty to Flynn to exercise reasonable care in the design of the pump. Vincent presented the unopposed affidavit of a biomedical engineer who stated that it was his opinion that the overdose occurred because of intermittent over-delivery due to electromagnetic interference that was a result of an error in the design of the pump. On the face of this record, the absence of the actual pump does not overcome this theory. Thus, a genuine issue of material fact remains whether Bard breached its duty to Flynn. Accordingly, it was error for the trial court to enter summary judgment in favor of Bard on Vincent's claim for negligent design of the PCA pump.

We reject Vincent's argument that this court should adopt the alternative theory of liability set forth in section 433B(3) of the Second and Third Restatements of Torts with regard to Bard and Baxter. Aside from the fact that no Florida case adopts that theory, it does not apply to the facts of this case. The supreme court explained section 433B(3) as follows:

This theory of alternative liability applies when the actions of two or more tortfeasors combine to create an injury and it is impossible for the injured party to show which tortfeasor actually caused the injury. . . . The theory is applicable, for example, where two tortfeasors fire weapons in the direction of the victim and the victim is injured by one bullet.
Celotex Corp. v. Copeland, 471 So.2d 533, 536-37 (Fla. 1985). Assuming it is "impossible" for purposes of section 433B(3) for Vincent to show whether the pump used by her son was manufactured by Bard or Baxter, it is undisputed that only one pump was used and it was designed by Bard. Therefore, the actions of the two manufacturers did not combine to cause her son's injuries, and section 433B(3) does not contain a theory of liability applicable to the facts of this case.

Accordingly, we affirm the final summary judgment in all respects except as to the negligent design cause of action against Bard and remand for further proceedings consistent with this opinion.

Affirmed in part, reversed in part, and remanded.

ALTENBERND, J., and CURRY, CHARLES B., Associate Judge, Concur.

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VINCENT v. C.R. BARD. INC
(Jan 3, 2007)