Michael Best & Friedrich LLP 100 East Wisconsin Avenue, Suite 3300 Milwaukee, WI 53202

1. LITIGATION RISKS ASSOCIATED WITH FOODS THAT POSE A CHOKING HAZARDMWFPA Food Science & Technology CommitteeJuly 25, 2012 Michael Best & Friedrich LLP 100 East Wisconsin Avenue, Suite 3300 Milwaukee, WI 53202 Paul E. Benson (414) 225-2757 pebenson@michaelbest.com

2. Choking Hazards – The Litigation Perspective • Overview of Litigation Risk • Background on Choking Risks • Legal Theories Plaintiffs May Pursue • Strict Liability • Implied Warranty • Negligence • Scenarios • Failure to Warn (“I had no idea I could choke on that”) • “Foreign” Object

3. Litigation Risk Overview • When severe injuries or death occur, parties frequently look for a deep pocket to sue. • The very fact that food is intended to be ingested creates a choking risk. • Being named in a lawsuit brings costs: • Litigation is time consuming and expensive. • The litigation can create a stigma.

4. Background on Choking Risks • American Academy of Pediatrics – Policy Statement (Feb. 2010) • Choking is a leading cause of child mortality • Child development (particularly < 3 years old) is a factor • Smaller diameter airway • Undeveloped molars (for grinding food) and/or chewing habits • Food shape and consistency are factors

5. Food Shape/Consistency Factors (AAP Statement) Cylindrical Airway sized Compressible (can conform to the airway shape and completely block the passage) Examples of “High-Risk” Foods Hot dogs Sausages Hard candy Peanuts/nuts Seeds Whole grapes Raw Carrots Apples Popcorn Chunks of peanut butter Marshmallows Background on Choking Risks (cont.)

6. Legal Theory – Strict Liability • Strict liability can be imposed for food products that are sold in a defective condition and unreasonably dangerous to the user or consumer. • Restatement (Second) of Torts - § 402A • A defective condition is one not contemplated by the ultimate consumer • Unreasonably dangerous means dangerous to an extent not contemplated by the ordinary consumer who purchases it.

7. Legal Theory – Strict Liability (cont.) • The presence of unreasonably dangerous foreign substances can result in strict liability. • E.g., bits of glass in a food item • Courts have had a harder time dealing with dangerous natural substances • Bones in meat products (chicken pie, enchilada, ‘boneless’ turkey breast) • Pecan shells in caramel/pecan candies • Grain of corn in box of corn flakes • At one time, strict liability claims could not survive if based on natural substances – but that distinction has been eroding in favor of a “reasonable expectation” test.

8. Legal Theory – Implied Warranty • A strict liability analysis is very similar to the analysis that the food product is so defective that the producer violated the implied warranty of merchantability. • Such claims focus on the reasonable expectations of the consumer and relate to a failure to warn of potential dangers.

9. Failure To Warn • Types of failure to warn claims • Inherent danger to intended consumers (young children) • Danger not obvious (marshmallows)

10. Elements of a Failure to Warn Claim • A failure to warn claim is a narrower claim than one that alleges a defective product. Wyeth v. Levine, 555 U.S. 555, 565 (2009). • Such claims are based on the premise that “the failure to warn of an injury-causing risk associated with the use of a technically pure and fit product can render the product unreasonably dangerous.” Emery v. Federated Foods, 863 P.2d 426, 431 (Mont. 1993).

11. Failure to Warn – Safeguards • American Academy of Pediatrics Policy Statement Recommendation • FDA should require warning labels “on foods that pose a high choking risk to children.” • Notes that Sweden introduced age labeling on foods for infants and young children since 1979 and warning labels on peanuts since 1981. • Possible Strategies • Evaluate foods against the characteristics that define “high risk” foods – cylindrical, airway-sized, compressible

12. Are Warning Labels Effective? • [R]equiring a manufacturer to warn against obvious dangers could greatly increase the number of warnings accompanying certain products. If a manufacturer must warn against even obvious dangers, “the list of foolish practices warned against would be so long, it would fill a volume.” Requiring too many warnings trivializes and undermines the entire purpose of the rule, drowning out cautions against latent dangers of which a user might not otherwise be aware. Such a requirement would neutralize the effectiveness of warnings as an inexpensive way to allow consumers to adjust their behavior based on knowledge of a product’s inherent dangers. Liriano v. Hobart Corp., 700 N.E.2d 303, 308 (N.Y. 1998), quoting Kerr v. Koemm, 557 F. Supp. 283, 288 (S.D.N.Y. 1983).

13. Are Warning Labels Effective? (cont.)

14. Are Warning Labels Effective? (cont.)

15. Legal Theory - Negligence • The “catch all” claim – can survive even in the absence of a viable strict liability or implied warranty claim • Consider the “natural substance” issue • Natural feature of the substance may eliminate strict liability • Court could conclude that the food processor was nevertheless negligent for failing to look for and eliminate the natural substance • Four Elements to Establish Negligence: • Duty of Care • Breach of that Duty • Proximate Cause of the Injury • Damages

16. Legal Theory – Negligence (cont.) • Industry Standards can Establish the Duty of Care • If/when labeling becomes more standard, the failure to provide a warning label could be found to be substandard. • Increased Knowledge = Greater Duty to the Consumer • A greater understanding of the physics and physiology of child choking hazards can heighten the standard. • Note that one of the reasons courts began abandoning the foreign-natural distinction in strict liability cases was that technological advances made it much easier to identify and remove naturally occurring choking hazards.

17. Possible Action Steps • Evaluate food products against the high-risk factors • Size, shape and consistency • Document steps taken to minimize inherent choking risks • Example: Baby carrots – can be processed at a size that is large enough to induce chewing/cutting • Example: Grapes – likely not much that can be done from a processing standpoint • Consider warning labels

18. Questions?