1. Products Liability For Pharmaceutical Scientists Edward P. Richards Harvey A. Peltier Professor of Law Louisiana State University School of Law richards@lsu.edu http://biotech.law.lsu.edu Click Here For Updated Slides

2. 2 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

3. 3 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

4. 4 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

5. 5 Fall of Privity Courts Found Privity Out of Date with the Industrial Revolution Thomas v. Winchester (1852) Supplier Provided Belladonna rather than Dandelion Privity would have Blocked the Claim Court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

6. 6 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

7. 7 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

8. 8 Warranty Theories Predate Strict Liability Related to UCC Warranties Cannot Disclaim for Personal Injuries Based on Promises Special Problem for Promoting Off-Label Uses

9. 9 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?

10. 10 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

11. 11 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

12. 12 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

13. 13 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.

14. 14 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.

15. 15 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?

16. 16 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

17. 17 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

18. 18 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

19. 19 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

20. 20 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

21. 21 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?

22. 22 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