DTCI: Make No Bones About It

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karns By Timothy L. Karns

While there is no shortage of challenges facing the food and beverage industry, one of the most prevalent issues today is product liability claims resulting from foreign objects inadvertently incorporated into finished products. Despite the use of numerous safeguards in a production facility, food manufacturers can never eliminate the possibility that a physical hazard will be introduced during the manufacturing process. This is especially true where the hazard is an object that is intrinsic to the product, such as bone or gristle.

Indiana’s Product Liability Act, Indiana Code §§ 34-20-1-1 through 34-20-9-1, governs all actions brought by a user or consumer against a manufacturer or seller for physical harm caused by a product regardless of the theory of liability. See Ind. Code § 34-20-1-1. The Act provides, in pertinent part:

a person who sells, leases, or otherwise puts into the stream of commerce any product in a defective condition unreasonably dangerous to any user or consumer … is subject to liability for physical harm caused by that product to the user or consumer … . Ind. Code § 34-20-2-1.

Thus, in order to prevail in a product liability action, “the plaintiff must prove that the product is in a defective condition which renders it unreasonably dangerous.” Welch v. Scripto-Tokai Corp., 651 N.E.2d 810, 814 (Ind. Ct. App. 1995).

“The requirement that the product be in a defective condition focuses on the product itself while the requirement that the product be unreasonably dangerous focuses on the reasonable expectations of the consumer.” Id. at 814 (emphasis added). Specifically, a product is in a defective condition if at the time it is conveyed by the seller to another party, it is in a condition:

(1) not contemplated by reasonable persons among those considered expected users or consumers of the product; and

(2) that will be unreasonably dangerous to the expected user or consumer when used in reasonably expectable ways of handling or consumption. Ind. Code § 34-20-4-1.

A product is also in a defective condition if the seller fails to give reasonable warnings or instructions to the consumer, thereby leaving the product in an unreasonably dangerous condition. See Ind. Code § 34-20-4-2; Natural Gas Odorizing, Inc. v. Downs, 685 N.E.2d 155, 162 (Ind. Ct. App. 1997), (“The Act imposes liability upon a manufacturer who puts into the stream of commerce any product without a reasonably adequate warning thereby leaving it in an unreasonably dangerous condition to any user, if such warning could be given in the exercise of reasonable diligence.”). However, a product is unreasonably dangerous only if its use “exposes the user or consumer to a risk of physical harm to an extent beyond that contemplated by the ordinary consumer who purchases it with the ordinary knowledge about the product’s characteristics common to the community of consumers.” Ind. Code § 34-6-2-146 (emphasis added).

Under this standard, when the object that causes an injury is a foreign material, such as a screw, a piece of metal or a stone, a food manufacturer will be hard pressed to avoid liability. In that situation, an ordinary consumer with ordinary knowledge of the product would not reasonably expect such an item to be present in the food. However, when the injury-causing material is an item that is intrinsic to a finished product, a food manufacturer may be able to escape liability by arguing that the injured consumer should have anticipated and guarded against the presence of the object in the food.

Although some courts rely on a distinction between foreign and natural characteristics of a food product to determine liability, a majority of courts have adopted the “reasonable expectations test” to determine whether an ingredient that caused the harm is an unanticipated adulteration or is an inherent aspect of the product. See, e.g., Morrison’s Cafeteria of Montgomery, Inc. v. Haddox, 431 So. 2d 975, 978 (Ala. 1983) (applying the reasonable expectations test the court found, as a matter of law, that a bone in a fish fillet did not disappoint such expectations); Clime v. Dewey Beach Enterprises, 831 F. Supp. 341, (D. Del. 1993), (holding, as a matter of law, that a consumer could not reasonably expect to receive a raw clam free of injurious bacteria); Mathews v. Maysville Seafoods Inc., 602 N.E.2d 764, 765-66 (Ohio Ct. App. 1991) (holding that a “consumer must reasonably anticipate and guard against the presence of a fish bone in a fish fillet”). Under the reasonable consumer expectations test, substances that are natural to the preparation of the food served are to be anticipated and, therefore, do not render the food unfit or defective. Mitchell. v. T.G.I. Friday’s, 748 N.E.2d 89 (Ohio Ct. App 2000). Thus, the reasonable consumer expectations test focuses on the final item sold to the consumer and the expectations that are engendered by the type of preparation used in making the dish.

For example, in Mitchell v. T.G.I. Friday’s, the plaintiff was eating a fried clam strip when she bit into a hard substance she believed to be a piece of a clam shell. Id. at 90. The plaintiff experienced immediate pain and later required dental treatment for her injuries. Id. at 90-91. Consequently, the plaintiff filed a product liability action against the restaurant that served the meal and the supplier of the fried clams. Id. at 91. Both defendants filed motions for summary judgment, which the trial court granted. Id.

On appeal, the reviewing court began its analysis by summarizing the reasonable expectation test as “‘the test … for what is “reasonably expected” by the consumer in the food as served, not what might be natural to the ingredients of that food prior to preparation.’” Mitchell, 748 N.E.2d at 93 (quoting Mathews, 602 N.E.2d at 765). Thus, the Mitchell court concluded that the reasonable expectation test “is related to the foreseeability of harm on the part of the defendant.” Id. (quoting Mathews, 602 N.E.2d at 765). While the court noted that the test “usually presents a question for the jury,” it further stated that it “is clear that in some cases the occurrence of a deleterious substance must be reasonably expected as a matter of law.” Id. at 94. In fact, the court specifically stated that “‘[c]ourts cannot and must not ignore the common experience of life and allow rules to develop that would make sellers of food or other consumer goods insurers of the products they sell.’” Id. (quoting Morrison’s Cafeteria of Montgomery, Inc., 431 So. 2d at 979). Applying the reasonable expectation test to the matter at hand, the court concluded that one who eats clams can reasonably anticipate and guard against eating a piece of shell. See also Allen v. Grafton, 164 N.E.2d 167 (“Bones which are natural to the type of meat served cannot legitimately be called a foreign substance, and a consumer who eats meat dishes ought to anticipate and be on guard against the presence of such bones.”); Ruvolo v. Homovich, 778 N.E. 2d 661 (Ohio Ct. App. 2002), (holding that a consumer should reasonably anticipate the natural occurrence of chicken bone fragments in a gordita sandwich).

While it has not explicitly been adopted by Indiana’s courts, the reasonable expectations test directly comports with the Act’s definition of an unreasonably dangerous product. Consequently, where there is no dispute that the injury-causing mechanism is an object intrinsic to the finished product, a food manufacturer should explore the consumer’s understanding of the product, its preparation process and its raw ingredients early in the discovery process. A typical consumer will be hard pressed to argue that he was unaware that the animal from which the product or its ingredients were derived originally contained such an object. Accordingly, a food manufacturer may, through the filing of a dispositive motion, be able to convince the trial court that it should apply the reasonable expectations test and find, as a matter of law, the injured consumer should have reasonably anticipated and guarded against the presence of the object that caused their injury.

The reasonable expectations test is not the only defense a food manufacturer has to a product liability claim. Ind. Code § 24-20-5-1 provides that:

In a product liability action, there is a rebuttable presumption that the product that caused the physical harm was not defective and that the manufacturer or seller of the product was not negligent if, before the sale by the manufacturer, the product:

(1) was in conformity with the general recognized state of the art applicable to the safety of the product at the time the product was designed, manufactured, packaged and labeled; or

(2) complied with applicable codes, standards, regulations or specifications established, adopted, promulgated or approved by the United States or by Indiana, or by any agency of the United States or Indiana.

Thus, when the object that causes an injury is an extrinsic object, such as a screw, a piece of metal or a stone, a food manufacturer that adheres to a strict quality control program will have an avenue to try to avoid liability.

To reduce the inclusion of bone and gristle in their finished products, all food manufacturers use numerous preventative measures and safeguards in their facilities. In light of these programs and process controls, an argument can be made that the finished product, even when it contains foreign matter, was in conformity with the generally recognized state of the art applicable to the safety of the product at the time it was designed, manufactured, packaged and labeled. This is particularly true when, on the date the subject product was prepared and packaged, the manufacturer was operating its facility in compliance with the applicable requirements of the United States Department of Agriculture and/or the United States Food and Drug Administration. Thus, a food manufacturer should do everything it can to establish it has both a prerequisite program intended to prevent foreign objects from entering its production line and process control steps that are designed to eradicate any materials that are concealed in the raw materials used to make the finished product.

Although compelling in nature, a product liability claim resulting from a foreign object in a finished product is not an automatic victory for the plaintiff. Caselaw from multiple jurisdictions supports the proposition that a consumer who eats certain dishes ought to anticipate and be on the guard against the presence of certain foreign materials that may be contained in those foods. Furthermore, even if a court were to find that an inclusion of a foreign object in the finished product renders it unreasonably dangerous, the manufacturer may be entitled to use the rebuttable presumption that the product that caused the physical harm was not defective and that the manufacturer or seller of the product was not negligent.•

Mr. Karns is a senior associate in the Indianapolis office of Frost Brown Todd. The opinions expressed in this article are those of the author.


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  1. I have an open CHINS case I failed a urine screen I have since got clean completed IOP classes now in after care passed home inspection my x sister in law has my children I still don't even have unsupervised when I have been clean for over 4 months my x sister wants to keep the lids for good n has my case working with her I just discovered n have proof that at one of my hearing dcs case worker stated in court to the judge that a screen was dirty which caused me not to have unsupervised this was at the beginning two weeks after my initial screen I thought the weed could have still been in my system was upset because they were suppose to check levels n see if it was going down since this was only a few weeks after initial instead they said dirty I recently requested all of my screens from redwood because I take prescriptions that will show up n I was having my doctor look at levels to verify that matched what I was prescripted because dcs case worker accused me of abuseing when I got my screens I found out that screen I took that dcs case worker stated in court to judge that caused me to not get granted unsupervised was actually negative what can I do about this this is a serious issue saying a parent failed a screen in court to judge when they didn't please advise

  2. I have a degree at law, recent MS in regulatory studies. Licensed in KS, admitted b4 S& 7th circuit, but not to Indiana bar due to political correctness. Blacklisted, nearly unemployable due to hostile state action. Big Idea: Headwinds can overcome, esp for those not within the contours of the bell curve, the Lego Movie happiness set forth above. That said, even without the blacklisting for holding ideas unacceptable to the Glorious State, I think the idea presented above that a law degree open many vistas other than being a galley slave to elitist lawyers is pretty much laughable. (Did the law professors of Indiana pay for this to be published?)

  3. Paul Hartman of Burbank, Oh who is helping Sister Fuller with this Con Artist Kevin Bart McCarthy scares Sister Joseph Therese, Patricia Ann Fuller very much that McCarthy will try and hurt Patricia Ann Fuller and Paul Hartman of Burbank, Oh or any member of his family. Sister is very, very scared, (YES, I AM) This McCarthy guy is a real, real CON MAN and crook. I try to totall flatter Kevin Bart McCARTHY to keep him from hurting my best friends in this world which are Carolyn Rose and Paul Hartman. I Live in total fear of this man Kevin Bart McCarthy and try to praise him as a good man to keep us ALL from his bad deeds. This man could easy have some one cause us a very bad disability. You have to PRAISAE in order TO PROTECT yourself. He lies and makes up stories about people and then tries to steal if THEY OWN THRU THE COURTS A SPECIAL DEVOTION TO PROTECT, EX> Our Lady of America DEVOTION. EVERYONE who reads this, PLEASE BE CAREFUL of Kevin Bart McCarthy of Indianapolis, IN My Phone No. IS 419-435-3838.

  4. Joe, you might want to do some reading on the fate of Hoosier whistleblowers before you get your expectations raised up.

  5. I had a hospital and dcs caseworker falsify reports that my child was born with drugs in her system. I filed a complaint with the Indiana department of health....and they found that the hospital falsified drug screens in their investigation. Then I filed a complaint with human health services in Washington DC...dcs drug Testing is unregulated and is indicating false positives...they are currently being investigated by human health services. Then I located an attorney and signed contracts one month ago to sue dcs and Anderson community hospital. Once the suit is filed I am taking out a loan against the suit and paying a law firm to file a writ of mandamus challenging the courts jurisdiction to invoke chins case against me. I also forwarded evidence to a u.s. senator who contacted hhs to push an investigation faster. Once the lawsuit is filed local news stations will be running coverage on the situation. Easy day....people will be losing their jobs soon...and judge pancol...who has attempted to cover up what has happened will also be in trouble. The drug testing is a kids for cash and federal funding situation.