 |
Protecting O&P Companies from Product Liability
By Sylvia A. Ezenwa, JD 
In today's litigious society, the risk of product liability lawsuits is great and, therefore, should be factored into the cost of doing business. Under product liability law, a person who has been injured by a defective product (i.e., a plaintiff) may attempt to recover monetary compensation or "damages" for the injury by suing any company or individual (i.e., the defendant) involved in the product's manufacture, distribution, or sale.
1
Product liability lawsuits usually are decided in two stages: First, a court will determine whether the defendant was responsible or "
liable
" for the injury to the plaintiff; and second, if liability is found, the court will assess the kind and amount of damages to award to the plaintiff.
2
Notably, there is no uniform, federal law used to decide product liability cases throughout the United States. Rather, in such cases, the laws of individual states govern both the determination of liability and the assessment of damages.
3
Product Liability within O&P
Within the O&P industry, defective orthotic and prosthetic devices and components trigger most product liability lawsuits. The plaintiffs in such lawsuits are typically patients who have been injured by a defective device, and defendants may include the device's manufacturer, distributors, and retailers. However, distributors and retailers also may be plaintiffs, suing the manufacturer of a defective device to recover business-related damages such as loss of reputation, goodwill, and profits, resulting from their distribution and sale of the defective product.
4
How Liability Is Determined
A product liability lawsuit begins when a plaintiff files a complaint in court. The complaint must state one or more legally recognized causes of actions.
5
A "
cause of action
" is like a template, which shows a plaintiff what he must prove in court in order to recover damages or monetary compensation from the defendant. There are three causes of action commonly raised by plaintiffs in product liability lawsuits: (1) strict product liability; (2) negligence; and (3) breach of warranty.
6
(1) Strict Product Liability
To establish strict product liability, a plaintiff must prove that: (1) a product was defective and unreasonably dangerous when it left the manufacturer's control; and (2) the defect caused the plaintiff's injury.
7
"A product may be unreasonably dangerous because of a defect in manufacturing, design, or marketing. A defendant's failure to warn of a product's potential dangers when warnings are required is a type of marketing defect. Liability will attach if lack of adequate warnings or instructions render an otherwise adequate product unreasonably dangerous."
8
Moreover, in strict liability cases, the defendant's care in manufacturing or handling a defective product is irrelevant and cannot be considered a defense to a plaintiff's allegations. However, a defendant can only be held liable for injuries to "
foreseeable plaintiffs
," which means those plaintiffs that an ordinary person might expect to be injured by the product.
9
In the case of defective prosthetic devices, foreseeable plaintiffs include patients, and perhaps, clinicians, and other end users and handlers of the devices.
(2) Negligence
To establish negligence, a plaintiff must prove that: "(1) the defendant had a legal duty to exercise reasonable care' in manufacturing the product and (2) to warn all foreseeable users of all foreseeable dangers, the defendant failed to perform this duty, and (3) the defendant's failure to perform this duty caused the plaintiff's injury."
10
Manufacturers are the most susceptible to negligence claims, although, in certain situations, distributors and retailers may be found negligent as well. For instance, if a prosthetic device or component is neither packaged nor in a sealed container, a retailer might be expected to use reasonable care to inspect the device for
apparent or visible
defects, and may be found negligent if there was a feasible procedure for inspecting the device that was not used. In contrast, a retailer would not be expected to discover
latent or hidden
defects in a prosthetic device, unless the retailer also was the manufacturer of the device, packaged it prior to sale, or could have tested it for safety, but chose not to.
11
Finally, manufacturers, distributors, and retailers may be found negligent for failing to warn consumers of the hazards of a product, or of the existence of a potentially dangerous condition in the product, especially when there are state or federally mandated warnings or labels that were supposed to be used, but were not.
12
To establish "
negligence per se
," which is a form of negligence, a plaintiff must prove that: (1) the defendant violated a statute or regulation; and (2) the statute or regulation was specifically intended to prevent the kind of injury the plaintiff suffered.
13
The best way for O&P companies to avoid negligence per se claims is to comply with any and all applicable product safety laws, including the medical device regulations and guidance documents issued by the US Food and Drug Administration's Center for Devices and Radiological Health,
www.fda.gov/cdrh
(3) Breach of Warranty
A "
warranty
" is a promise or statement of fact about the quality or character of a product sold, made by the seller to induce the sale, and relied upon by the buyer.
14
According to the Uniform Commercial Code, which is the law that governs commercial transactions in individual states, sellers are required to conform to warranties.
15
Therefore, in order to establish a breach of warranty, a plaintiff must prove that: (1) a product did not conform to a warranty; and (2) the nonconforming feature of the product caused the plaintiff's injury.
16
A warranty may be express or implied. An "
express warranty
" is a promise included in the written or oral terms of a sales agreement in which the seller assures the quality, description, or performance of a product.
17
Express warranties can be created by a salesperson's statements, pictures or writing on a product's packaging, advertisements, or product samples or models.
18
Meanwhile, an "
implied warranty
" is "[a] promise arising by operation of law, that something which is sold shall be merchantable and fit for the purpose for which the seller has reason to know that it is required."
19
"Arising by operation of law" means that the warranty is triggered not by any statement or conduct of the seller, but by the mere fact of the product being sold.
20
In other words, any product that is sold comes with an implied warranty of merchantability and fitness for a particular purpose; and, just by selling a product, a seller is implicitly promising that: (1) the product is merchantable, i.e., fit for the ordinary purposes for which such products are to be used,
provided that the seller is in the business of selling products of that kind
; and (2) the product is fit for a particular purpose,
provided that the seller, at the time of sale, knew the particular purpose for which the product was required, and the buyer relied upon the seller's skill or judgment in selecting a suitable product for that purpose
.
21
Conclusion
If a court determines an O&P device manufacturer, distributor, or retailer to be liable for a patient's injuries, it then must assess the appropriate damages to award to the patient; that damage assessment will be discussed next month in Part 2 of this article, along with procedures that should be implemented to protect O&P companies from product liability.
Sylvia A. Ezenwa is a lawyer, author, and freelance writer based in Superior, Colorado. She is licensed to practice law in the State of Texas. She writes legal articles for trade and consumer publications.
DISCLAIMER: The information in this article is not intended to constitute legal advice. Please consult an attorney regarding your specific situation.
Copyright 2006 Sylvia Ezenwa. Reproduction of any portion of this article in any form is prohibited without the expressed, written consent of the author. References
Early, Ludwick & Sweeney, Defenses in Products Liability Lawsuits, available at www.els-esqs.com/ProductsLiabilityNewsletter.jsp (last accessed Feb. 21, 2006). Jean C. Buzby et al., Food and Rural Economics Division, Economic Research Service, US Department of Agriculture, Agricultural Economic Report No. 799, Product Liability and Microbial Foodborne Illness, app. at 39 (April 2001), available at www.ers.usda. Buzby et al., supra note 2, app. at 35. See Buzby et al., supra note 2, app. at 34. Buzby et al., supra note 2, app. at 34-35. See Buzby et al., supra note 2, app. at 36. Buzby et al., supra note 2, app. at 36. Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 382 (Tex. 1995) (citations omitted). Buzby et al., supra note 2, app. at 36. Buzby et al., supra note 2, app. at 36-37. See Buzby et al., supra note 2, app. at 37. Ezenwa--page 7 See Buzby et al., supra note 2, app. at 37. Buzby et al., supra note 2, app. at 38. Black's Law Dictionary 1586 (6th ed. 1990). Black's Law Dictionary 1531 (6th ed. 1990); Buzby et al., supra note 2, app. at 38. See Buzby et al., supra note 2, app. at 38. Black's Law Dictionary 1587 (6th ed. 1990). See Buzby et al., supra note 2, app. at 37; Black's Law Dictionary 1587 (6th ed. 1990). Black's Law Dictionary 1587 (6th ed. 1990). See Black's Law Dictionary 1092 (6th ed. 1990). Black's Law Dictionary 987, 1587 (6th ed. 1990). 
Table Of Contents - August 2006
|
|
