Products Liability For Pharmaceutical Scientists Edward P. Richards Harvey A. Peltier Professor of...
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Transcript of Products Liability For Pharmaceutical Scientists Edward P. Richards Harvey A. Peltier Professor of...
Products Liability For Pharmaceutical Scientists
Edward P. RichardsHarvey A. Peltier Professor of LawLouisiana State University School
http://biotech.law.lsu.eduClick Here For Updated Slides
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History of Drug Liability
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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Multiple Sovereigns
Tort Law for Drugs is State Law Basic Theories are the Same Significant Variation on Details Federal Courts Apply State Law
Individual Judges Have Great Discretion Many Case Depend on Whether the
Judge Admits the Plaintiff's Evidence Forum Shopping
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Negligence Traditional Cases Were Usually
Based in Negligence Had to Show Legal Relationship –
Privity No Relationship Between Patient and
Drug Company Ended with Pharmacist
Made Sense when Pharmacists Compounded all the Drugs
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Fall of Privity
Courts Found Privity Out of Date with the Industrial Revolution
Thomas v. Winchester (1852) Supplier Provided Belladonna rather
than Dandelion Privity would have Blocked the Claim Court Limited Privity for Dangerous
Activities
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Early Strict Liability Many States Imposed Strict Liability for
Ultrahazardous Activities Blasting 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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Limits of Negligence
Must Show Breach of Standard of Care What a Reasonable Manufacturer
Would Do? Only Evidence is Other Manufacturers
Must Show What Happened to the Specific Batch
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Warranty Theories
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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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?
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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
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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
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Shift to Strict Liability
Hard to Prove Negligence for Products Generic Goods - No Specific Information Defendant’s Have Lots of Resources
Defects Affect Lots of People Strict Liability Encourages Safety
Cannot Escape Liability by Just Doing What Others Do
Safer Products = Lower Costs
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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.
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Limited 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.
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Unavoidably Unsafe Products Comment K Key Defense for Drugs
Recognizes that Many Drugs are Very Dangerous
Pasteur Rabies Vaccine Example Looks at the Label Information
Does it Explain How to Use the Drug? Does it Warn about Dangers? Did it Get to the Decision-maker?
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Who Else is Liable?
Usually Both Sellers and Manufacturers Are Liable
Health Care is Different 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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Product Must Be Defective Manufacturing Defect
Easy to Prove Limited Number Affected Example: Improper Sterilization
Design Defect Effects Every Unit Includes Warnings Thalidomide, DES, Mer-29
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Plaintiff Must Show Causation Why Does the Defect Make the
Product Unreasonable Dangerous? Did the Defect Cause the Patient's
Injury? 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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Is it Unreasonably Dangerous?
Courts Use Two Tests Consumer Expectations
Usually OTC Drugs Big Issue with Direct Promotion
Risk/Benefit Analysis Rx Drugs Little Deference to FDA Determinations Danger to One Group Can Deny to All
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What if the Doc Uses the Drug Improperly?
Learned Intermediary Defense Was the Doc Properly Warned? Did She Rely on Manufacturer's
Representations? Does the Manufacturer/Seller
Encourage Misuse? Over-Promotion - Chloramphenicol Selling For Improper Use - Oximeters
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FDA Labels And Products Liability
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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Brave New World Internet Sales
No Doc No Information Manufacturers Know About It
Non-Physician Prescribers States Are Broadening Who Can Prescribe Courts Have Not Found Nurses, Physicians
Assistants, and other Non-Physicians to be Learned Intermedi22aries