Edward P. Richards
Harvey A. Peltier Professor of Law
Louisiana State University School of
Law richards@lsu.edu
http://biotech.law.lsu.edu
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FDA History is the History of Drug
Injuries
FDA Regulation Tries to Prevent Future
Injuries
Tort Litigation Compensates for Past
Injuries
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Tort Law for Drugs is State Law
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Basic Theories are the Same
Significant Variation on Details
Federal Courts Apply State Law
Individual Judges Have Great Discretion
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Many Case Depend on Whether the Judge
Admits the Plaintiff's Evidence
Forum Shopping
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Traditional Cases Were Usually Based in
Negligence
Had to Show Legal Relationship –
Privity
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No Relationship Between Patient and Drug
Company
Ended with Pharmacist
Made Sense when Pharmacists
Compounded all the Drugs
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Courts Found Privity Out of Date with the Industrial Revolution
Thomas v. Winchester (1852)
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Supplier Provided Belladonna rather than
Dandelion
Privity would have Blocked the Claim
Court Limited Privity for Dangerous
Activities
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Many States Imposed Strict Liability for
Ultrahazardous Activities
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Blasting
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Impounding Water
Plaintiff did not need to Show Negligence, only Injury Due to the Activity
Very Limited Application – not generally extended to Drugs
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Must Show Breach of Standard of Care
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What a Reasonable Manufacturer Would
Do?
Only Evidence is Other Manufacturers
Must Show What Happened to the
Specific Batch
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Predate Strict Liability
Related to UCC Warranties
Cannot Disclaim for Personal Injuries
Based on Promises
Special Problem for Promoting Off-Label
Uses
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Manufacturer Is Held to Specific Promises
Shatterproof Windshield Case
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Claimed It Was Just “Puffing”
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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?
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Implied From the Context of the Sale
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A Product Is Safe for What It Is Sold for
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FDA Approved Drugs Have Only the Stated
Risks
Implied Warranty of Fitness for a Specific
Purpose
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Manufacturer or Seller Says the Product Is
Good for Something Other Than Its Usual
Purpose
Use of Drugs For Unapproved Purposes
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Jeep Sold for off the Road Use
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Rolled and Killed and Injured Passengers
Made Like a Sardine Can
Manufacturer Claimed Improper Use
How Do You Prove?
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Advertising
Representations by Sales Persons
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Hard to Prove Negligence for Products
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Generic Goods - No Specific Information
Defendant’s Have Lots of Resources
Defects Affect Lots of People
Strict Liability Encourages Safety
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Cannot Escape Liability by Just Doing What
Others Do
Safer Products = Lower Costs
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(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
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(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 .
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(2) The rule stated in Subsection (1) applies although
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(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.
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Comment K
Key Defense for Drugs
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Recognizes that Many Drugs are Very
Dangerous
Pasteur Rabies Vaccine Example
Looks at the Label Information
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Does it Explain How to Use the Drug?
Does it Warn about Dangers?
Did it Get to the Decision-maker?
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Usually Both Sellers and Manufacturers
Are Liable
Health Care is Different
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Product v. Service Distinction
The Patient is Not the Buyer
The Doctor is Not the Seller
The Hospital is Not (Considered) a Supplier
Limited Liability for Pharmacies
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Manufacturing Defect
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Easy to Prove
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Limited Number Affected
Example: Improper Sterilization
Design Defect
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Effects Every Unit
Includes Warnings
Thalidomide, DES, Mer-29
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Why Does the Defect Make the Product
Unreasonable Dangerous?
Did the Defect Cause the Patient's
Injury?
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Often Circular in Drugs
Bendectin Causes Birth Defects so
Bendectin is Defective so Bendectin Caused
My Baby's Birth Defect
Expert Testimony is Critical
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Courts Use Two Tests
Consumer Expectations
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Usually OTC Drugs
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Big Issue with Direct Promotion
Risk/Benefit Analysis
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Rx Drugs
Little Deference to FDA Determinations
Danger to One Group Can Deny to All
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Learned Intermediary Defense
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Was the Doc Properly Warned?
Did She Rely on Manufacturer's
Representations?
Does the Manufacturer/Seller
Encourage Misuse?
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Over-Promotion - Chloramphenicol
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Selling For Improper Use - Oximeters
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Is There A Regulatory Compliance
Defense?
What If The FDA Will Not Let You
Include A Warning?
What Is The Evidentiary Value Of An
FDA Label?
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Internet Sales
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No Doc
No Information
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Manufacturers Know About It
Non-Physician Prescribers
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States Are Broadening Who Can Prescribe
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Courts Have Not Found Nurses, Physicians
Assistants, and other Non-Physicians to be
Learned Intermedi22aries
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