Products Liability Products Liability Issues in Health CareIssues in Health Care

IntroductionIntroduction

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Warranty TheoriesWarranty Theories

Predate Strict LiabilityPredate Strict Liability Related to UCC WarrantiesRelated to UCC Warranties Cannot Disclaim for Personal Cannot Disclaim for Personal

InjuriesInjuries Based on PromisesBased on Promises

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Express WarrantyExpress Warranty

Manufacturer Is Held to Specific Manufacturer Is Held to Specific PromisesPromises

Shatterproof Windshield CaseShatterproof 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

Can Be Written or VerbalCan Be Written or Verbal Can Physicians Give Binding Warranties Can Physicians Give Binding Warranties

About Products?About Products?

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Implied WarrantiesImplied Warranties

Implied From the Context of the SaleImplied 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 FDA Approved Drugs Have Only the Stated

RisksRisks Implied Warranty of Fitness for a Specific Implied Warranty of Fitness for a Specific

PurposePurpose• Manufacturer or Seller Says the Product Is Manufacturer or Seller Says the Product Is

Good for Something Other Than Its Usual Good for Something Other Than Its Usual PurposePurpose

• Use of Drugs For Unapproved PurposesUse of Drugs For Unapproved Purposes

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Jeep CaseJeep Case

Jeep Sold for off the Road UseJeep Sold for off the Road Use• Rolled and Killed and Injured Rolled and Killed and Injured

PassengersPassengers• Made Like a Sardine CanMade Like a Sardine Can• Manufacturer Claimed Improper UseManufacturer Claimed Improper Use

How Do You Prove?How Do You Prove?• AdvertisingAdvertising• Representations by Sales PersonsRepresentations by Sales Persons

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Public PolicyPublic Policy

How Do You Prove Negligence?How Do You Prove Negligence? Why Is This Hard for Products?Why Is This Hard for Products?

• Generic Goods - No Specific Generic Goods - No Specific InformationInformation

• Defendant’s Have Lots of ResourcesDefendant’s Have Lots of Resources Defects Affect Lots of PeopleDefects Affect Lots of People Strict Liability Encourages SafetyStrict Liability Encourages Safety

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Restatement of Torts 402aRestatement of Torts 402a

(1) One who sells any product in a defective (1) One who sells any product in a defective condition unreasonably dangerous to the user condition unreasonably dangerous to the user or consumer or to his property is subject to or consumer or to his property is subject to liability for physical harm thereby caused to liability for physical harm thereby caused to the ultimate user or consumer, or to his the ultimate user or consumer, or to his property, ifproperty, if

(a) the seller is engaged in the business of (a) the seller is engaged in the business of selling such a product, andselling such a product, and

(b) it is expected to and does reach the user or (b) it is expected to and does reach the user or consumer without substantial change in the consumer without substantial change in the condition in which it is sold.condition in which it is sold.

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Defenses under 402aDefenses under 402a

(2) The rule stated in Subsection (1) (2) The rule stated in Subsection (1) applies althoughapplies although

(a) the seller has exercised all possible (a) the seller has exercised all possible care in the preparation and sale of his care in the preparation and sale of his product, andproduct, and

(b) the user or consumer has not (b) the user or consumer has not bought the product from or entered bought the product from or entered into any contractual relation with the into any contractual relation with the seller.seller.

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Is It a Product?Is It a Product?

Product Versus ServiceProduct Versus Service• SoftwareSoftware• Custom HouseCustom House• Customer Designed Product - Rides at Customer Designed Product - Rides at

Disney LandDisney Land• Big Issue In Health CareBig Issue In Health Care

Special Shield LawsSpecial Shield Laws• Blood BanksBlood Banks• VaccinesVaccines

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Is It in the Stream of Is It in the Stream of Commerce?Commerce?

Display at Trade ShowDisplay at Trade Show Custom Machine at FactoryCustom Machine at Factory Do You Have to Buy It?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

Experimental Drugs and DevicesExperimental Drugs and Devices

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Is the Defendant a Seller?Is the Defendant a Seller?

Everyone In The Chain is LiableEveryone In The Chain is Liable• Not the Case in Health CareNot the Case in Health Care

Casual Seller?Casual Seller?• You Sell Your Used CarYou Sell Your Used Car• You Make Clocks for a Hobby and Sell You Make Clocks for a Hobby and Sell

OneOne Special Rules for Used GoodsSpecial Rules for Used Goods Manufacturer Is Always LiableManufacturer Is Always Liable

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How is Health Care How is Health Care Different?Different?

The Patient Is Not the BuyerThe Patient Is Not the Buyer The Doctor Is Not the SellerThe Doctor Is Not the Seller The Hospital Is Not (Usually) a The Hospital Is Not (Usually) a

SupplierSupplier Who Do You Warn?Who Do You Warn? What Is the Role of The Learned What Is the Role of The Learned

Intermediary?Intermediary? Otherwise The Same Theories As Otherwise The Same Theories As

Consumer ProductsConsumer Products

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Is the Product Only Is the Product Only Ancillary to a Service?Ancillary to a Service?

Is It Why You Get the Service?Is It Why You Get the Service? Who Selects It?Who Selects It? Does the Provider Make Money off It?Does the Provider Make Money off It? Hospitals and PhysiciansHospitals and Physicians

• Traditionally ExemptTraditionally Exempt• Economics Have ChangedEconomics Have Changed• Missouri Tried Limiting the ExceptionMissouri Tried Limiting the Exception• Struck DownStruck Down

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Expected and Does Reach Expected and Does Reach Consumer Without Substantial Consumer Without Substantial Change?Change?

Has There Been Unanticipated Has There Been Unanticipated Modification?Modification?

Is It Substantial?Is It Substantial? Is There Expected Modification by Is There Expected Modification by

an Intermediary?an Intermediary? Does the Manufacturer Know That Does the Manufacturer Know That

Users Modifies the Product?Users Modifies the Product?

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Manufacturing Defect?Manufacturing Defect?

Is Something Broken?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?

Is It a Component Part That Fails?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 Is Made for This Specific Purpose, or Is It

Generic?Generic?• O-Ring in Anesthesia MachineO-Ring in Anesthesia Machine

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Design Defect?Design Defect?

Selection of Parts - ShopsmithSelection of Parts - Shopsmith Bad Design - JeepBad Design - Jeep Alternative Design?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?

Big Issue In Health CareBig Issue In Health Care

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Proving DefectsProving Defects

Manufacturing DefectsManufacturing 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

Design DefectDesign Defect• Must Show That It Was an Improper Must Show That It Was an Improper

DesignDesign• Really a Negligence StandardReally a Negligence Standard

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How Is the Danger Linked How Is the Danger Linked to the Defect?to the Defect?

Failing to Prevent Known RisksFailing to Prevent Known Risks• Absence of Safety DevicesAbsence of Safety Devices• Defective Safety DevicesDefective Safety Devices

Does It Cause the Injury?Does It Cause the Injury?• Directly? (Weak Chain on the Chainsaw)Directly? (Weak Chain on the Chainsaw)• Indirectly? (Crashworthiness)Indirectly? (Crashworthiness)

Does It Change the Way a Consumer Does It Change the Way a Consumer Would Expect the Product to Work?Would Expect the Product to Work?

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Unreasonably Dangerous?Unreasonably Dangerous?

Based on Consumer ExpectationsBased on Consumer Expectations Chainsaws V. Sump PumpsChainsaws V. Sump Pumps Drug CasesDrug Cases

• Chloramphenicol CaseChloramphenicol Case• ChloroquineChloroquine

Unpreventably Dangerous Unpreventably Dangerous ProductsProducts

Warnings and Information Are Warnings and Information Are CriticalCritical

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Comment IComment I

• Products That Are Dangerous As UsedProducts That Are Dangerous As Used– Good WhiskeyGood Whiskey– Good TobaccoGood Tobacco

• Are There Unexpected Risks?Are There Unexpected Risks?– Fetal Alcohol SyndromeFetal Alcohol Syndrome– Premature BabiesPremature Babies

• Were There Misrepresentation?Were There Misrepresentation?– Tobacco AdditivesTobacco Additives– Claims that Smoking Is Not AddictiveClaims that Smoking Is Not Addictive

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Comment KComment K

• Drugs and the LikeDrugs and the Like• Always DangerousAlways Dangerous

– Must Balance Risks and BenefitsMust Balance Risks and Benefits– Key Is Warning/informationKey Is Warning/information

• Who Do You Warn?Who Do You Warn?– Physician?Physician?– Patient?Patient?– What About Home Health Care?What About Home Health Care?

• Is the Info Understandable for the Is the Info Understandable for the Audience?Audience?

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Was There Misuse?Was There Misuse?

Could It Be Anticipated?Could It Be Anticipated?• Lawnmower CasesLawnmower Cases• Juggling ChainsawsJuggling Chainsaws

Is the Misuse Directly Related to the Is the Misuse Directly Related to the Injury?Injury?

Does the Manufacturer/Seller Does the Manufacturer/Seller Encourage Misuse?Encourage Misuse?• Over-PromotionOver-Promotion• Selling For Improper Use - OximetersSelling For Improper Use - Oximeters

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Is It a Warning Issue?Is It a Warning Issue?

Is There Enough Information?Is There Enough Information? Is It Understandable?Is It Understandable?

• What Reading Level and Language?What Reading Level and Language?• Is It Diluted?Is It Diluted?

Is the Warning Obvious?Is the Warning Obvious?• Where Is It?Where Is It?• How Big Is It?How Big Is It?

Who Gets The Warning?Who Gets The Warning?