Products Liability

Introduction to Health Care Products Liability

Introduction

Warranty Theories

Predate Strict Liability

Related to UCC Warranties

Cannot Disclaim for Personal Injuries

Based on Promises

Express Warranty

Manufacturer Is Held to Specific Promises

Shatterproof Windshield Case

Claimed It Was Just "Puffing"

Court Said It Was a Clear Promise

Did Not Matter If It Was Impossible

Can Be Written or Verbal

Can Physicians Give Binding Warranties About Products?

Implied Warranties

Implied From the Context of the Sale

A Product Is Safe for What It Is Sold for

FDA Approved Drugs Have Only the Stated Risks

Implied Warranty of Fitness for a Specific Purpose

Manufacturer or Seller Says the Product Is Good for Something Other Than Its Usual Purpose

Use of Drugs For Unapproved Purposes

Jeep Case

Jeep Sold for off the Road Use

Rolled and Killed and Injured Passengers

Made Like a Sardine Can

Manufacturer Claimed Improper Use

How Do You Prove?

Advertising

Representations by Sales Persons

Public Policy

How Do You Prove Negligence?

Why Is This Hard for Products?

Generic Goods - No Specific Information

Defendant's Have Lots of Resources

Defects Affect Lots of People

Strict Liability Encourages Safety

Restatement of Torts 402a

(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

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

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

Defenses under 402a

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

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

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

Is It a Product?

Product Versus Service

Software

Custom House

Customer Designed Product - Rides at Disney Land

Big Issue In Health Care

Special Shield Laws

Blood Banks

Vaccines

Is It in the Stream of Commerce?

Display at Trade Show

Custom Machine at Factory

Do You Have to Buy It?

Test Drive at the Car Dealer?

Broken Cookie Jar Lid at Walmart?

Leases

Give-aways

Experimental Drugs and Devices

Is the Defendant a Seller?

Everyone In The Chain is Liable

Not the Case in Health Care

Casual Seller?

You Sell Your Used Car

You Make Clocks for a Hobby and Sell One

Special Rules for Used Goods

Manufacturer Is Always Liable

How is Health Care Different?

The Patient Is Not the Buyer

The Doctor Is Not the Seller

The Hospital Is Not (Usually) a Supplier

Who Do You Warn?

What Is the Role of The Learned Intermediary?

Otherwise The Same Theories As Consumer Products

Is the Product Only Ancillary to a Service?

Is It Why You Get the Service?

Who Selects It?

Does the Provider Make Money off It?

Hospitals and Physicians

Traditionally Exempt

Economics Have Changed

Missouri Tried Limiting the Exception

Struck Down

Expected and Does Reach Consumer Without Substantial Change?

Has There Been Unanticipated Modification?

Is It Substantial?

Is There Expected Modification by an Intermediary?

Does the Manufacturer Know That Users Modifies the Product?

Manufacturing Defect?

Is Something Broken?

Was It Made Incorrectly?

Was There a Defect in the Material?

Improper Sterilization?

Is It a Component Part That Fails?

Is the Component Part Manufacturer Liable?

Is Made for This Specific Purpose, or Is It Generic?

O-Ring in Anesthesia Machine

Design Defect?

Selection of Parts - Shopsmith

Bad Design - Jeep

Alternative Design?

Feasible?

Cost-effective?

Does It Create New Risks?

Was It Known or Knowable at the Time?

Big Issue In Health Care

Proving Defects

Manufacturing Defects

Show What the Defect Is

Show Why It Creates the Danger

Show It Meets the Other Elements

Design Defect

Must Show That It Was an Improper Design

Really a Negligence Standard

How Is the Danger Linked to the Defect?

Failing to Prevent Known Risks

Absence of Safety Devices

Defective Safety Devices

Does It Cause the Injury?

Directly? (Weak Chain on the Chainsaw)

Indirectly? (Crashworthiness)

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

Unreasonably Dangerous?

Based on Consumer Expectations

Chainsaws V. Sump Pumps

Drug Cases

Chloramphenicol Case

Chloroquine

Unpreventably Dangerous Products

Warnings and Information Are Critical

Comment I

Products That Are Dangerous As Used

Good Whiskey

Good Tobacco

Are There Unexpected Risks?

Fetal Alcohol Syndrome

Premature Babies

Were There Misrepresentation?

Tobacco Additives

Claims that Smoking Is Not Addictive

Comment K

Drugs and the Like

Always Dangerous

Must Balance Risks and Benefits

Key Is Warning/information

Who Do You Warn?

Physician?

Patient?

What About Home Health Care?

Is the Info Understandable for the Audience?

Was There Misuse?

Could It Be Anticipated?

Lawnmower Cases

Juggling Chainsaws

Is the Misuse Directly Related to the Injury?

Does the Manufacturer/Seller Encourage Misuse?

Over-Promotion

Selling For Improper Use - Oximeters

Is It a Warning Issue?

Is There Enough Information?

Is It Understandable?

What Reading Level and Language?

Is It Diluted?

Is the Warning Obvious?

Where Is It?

How Big Is It?

Who Gets The Warning?