Products Liability Issues in Health Care Introduction

2 Warranty Theories b Predate Strict Liability b Related to UCC Warranties b Cannot Disclaim for Personal Injuries b Based on Promises

3 Express Warranty b Manufacturer Is Held to Specific Promises b Shatterproof Windshield Case Claimed It Was Just “Puffing”Claimed It Was Just “Puffing” Court Said It Was a Clear PromiseCourt Said It Was a Clear Promise Did Not Matter If It Was ImpossibleDid Not Matter If It Was Impossible b Can Be Written or Verbal b Can Physicians Give Binding Warranties About Products?

4 Implied Warranties b Implied From the Context of the Sale A Product Is Safe for What It Is Sold forA Product Is Safe for What It Is Sold for FDA Approved Drugs Have Only the Stated RisksFDA Approved Drugs Have Only the Stated Risks b Implied Warranty of Fitness for a Specific Purpose Manufacturer or Seller Says the Product Is Good for Something Other Than Its Usual PurposeManufacturer or Seller Says the Product Is Good for Something Other Than Its Usual Purpose Use of Drugs For Unapproved PurposesUse of Drugs For Unapproved Purposes

5 Jeep Case b Jeep Sold for off the Road Use Rolled and Killed and Injured PassengersRolled and Killed and Injured Passengers Made Like a Sardine CanMade Like a Sardine Can Manufacturer Claimed Improper UseManufacturer Claimed Improper Use b How Do You Prove? AdvertisingAdvertising Representations by Sales PersonsRepresentations by Sales Persons

6 Public Policy b How Do You Prove Negligence? b Why Is This Hard for Products? Generic Goods - No Specific InformationGeneric Goods - No Specific Information Defendant’s Have Lots of ResourcesDefendant’s Have Lots of Resources b Defects Affect Lots of People b Strict Liability Encourages Safety

7 Restatement of Torts 402a b (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if b (a) the seller is engaged in the business of selling such a product, and b (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

8 Defenses under 402a b (2) The rule stated in Subsection (1) applies although b (a) the seller has exercised all possible care in the preparation and sale of his product, and b (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.

9 Is It a Product? b Product Versus Service SoftwareSoftware Custom HouseCustom House Customer Designed Product - Rides at Disney LandCustomer Designed Product - Rides at Disney Land Big Issue In Health CareBig Issue In Health Care b Special Shield Laws Blood BanksBlood Banks VaccinesVaccines

10 Is It in the Stream of Commerce? b Display at Trade Show b Custom Machine at Factory b Do You Have to Buy It? Test Drive at the Car Dealer?Test Drive at the Car Dealer? Broken Cookie Jar Lid at Walmart?Broken Cookie Jar Lid at Walmart? LeasesLeases Give-awaysGive-aways b Experimental Drugs and Devices

11 Is the Defendant a Seller? b Everyone In The Chain is Liable Not the Case in Health CareNot the Case in Health Care b Casual Seller? You Sell Your Used CarYou Sell Your Used Car You Make Clocks for a Hobby and Sell OneYou Make Clocks for a Hobby and Sell One b Special Rules for Used Goods b Manufacturer Is Always Liable

12 How is Health Care Different? b The Patient Is Not the Buyer b The Doctor Is Not the Seller b The Hospital Is Not (Usually) a Supplier b Who Do You Warn? b What Is the Role of The Learned Intermediary? b Otherwise The Same Theories As Consumer Products

13 Is the Product Only Ancillary to a Service? b Is It Why You Get the Service? b Who Selects It? b Does the Provider Make Money off It? b Hospitals and Physicians Traditionally ExemptTraditionally Exempt Economics Have ChangedEconomics Have Changed Missouri Tried Limiting the ExceptionMissouri Tried Limiting the Exception Struck DownStruck Down

14 Expected and Does Reach Consumer Without Substantial Change? b Has There Been Unanticipated Modification? b Is It Substantial? b Is There Expected Modification by an Intermediary? b Does the Manufacturer Know That Users Modifies the Product?

15 Manufacturing Defect? b Is Something Broken? Was It Made Incorrectly?Was It Made Incorrectly? Was There a Defect in the Material?Was There a Defect in the Material? Improper Sterilization?Improper Sterilization? b Is It a Component Part That Fails? Is the Component Part Manufacturer Liable?Is the Component Part Manufacturer Liable? Is Made for This Specific Purpose, or Is It Generic?Is Made for This Specific Purpose, or Is It Generic? O-Ring in Anesthesia MachineO-Ring in Anesthesia Machine

16 Design Defect? b Selection of Parts - Shopsmith b Bad Design - Jeep b Alternative Design? Feasible?Feasible? Cost-effective?Cost-effective? Does It Create New Risks?Does It Create New Risks? Was It Known or Knowable at the Time?Was It Known or Knowable at the Time? b Big Issue In Health Care

17 Proving Defects b Manufacturing Defects Show What the Defect IsShow What the Defect Is Show Why It Creates the DangerShow Why It Creates the Danger Show It Meets the Other ElementsShow It Meets the Other Elements b Design Defect Must Show That It Was an Improper DesignMust Show That It Was an Improper Design Really a Negligence StandardReally a Negligence Standard

18 How Is the Danger Linked to the Defect? b Failing to Prevent Known Risks Absence of Safety DevicesAbsence of Safety Devices Defective Safety DevicesDefective Safety Devices b Does It Cause the Injury? Directly? (Weak Chain on the Chainsaw)Directly? (Weak Chain on the Chainsaw) Indirectly? (Crashworthiness)Indirectly? (Crashworthiness) b Does It Change the Way a Consumer Would Expect the Product to Work?

19 Unreasonably Dangerous? b Based on Consumer Expectations b Chainsaws V. Sump Pumps b Drug Cases Chloramphenicol CaseChloramphenicol Case ChloroquineChloroquine

Unpreventably Dangerous Products Warnings and Information Are Critical

21 Comment I Products That Are Dangerous As UsedProducts That Are Dangerous As Used –Good Whiskey –Good Tobacco Are There Unexpected Risks?Are There Unexpected Risks? –Fetal Alcohol Syndrome –Premature Babies Were There Misrepresentation?Were There Misrepresentation? –Tobacco Additives –Claims that Smoking Is Not Addictive

22 Comment K Drugs and the LikeDrugs and the Like Always DangerousAlways Dangerous –Must Balance Risks and Benefits –Key Is Warning/information Who Do You Warn?Who Do You Warn? –Physician? –Patient? –What About Home Health Care? Is the Info Understandable for the Audience?Is the Info Understandable for the Audience?

23 Was There Misuse? b Could It Be Anticipated? Lawnmower CasesLawnmower Cases Juggling ChainsawsJuggling Chainsaws b Is the Misuse Directly Related to the Injury? b Does the Manufacturer/Seller Encourage Misuse? Over-PromotionOver-Promotion Selling For Improper Use - OximetersSelling For Improper Use - Oximeters

24 Is It a Warning Issue? b Is There Enough Information? b Is It Understandable? What Reading Level and Language?What Reading Level and Language? Is It Diluted?Is It Diluted? b Is the Warning Obvious? Where Is It?Where Is It? How Big Is It?How Big Is It? b Who Gets The Warning?