Drug And Medical Device Liability And Policy Outline

1. Introduction and Warnings I

   1. Format

      1. Part 1: fundamental legal issues applicable to all drug and device cases

      2. Part 2: drug and device cases in the mass tort setting

         1. What changes when there are aggregate cases?

         2. E-Discovery

         3. Complexities and demands of settling these cases

      3. Part 3: does the current way the litigation system manages drug and device claims make any sense and, if not, is there a better way?

   2. The development of modern drug and device liability law: the short version

      1. Short history of FDA regulations

         1. 1906: first comprehensive federal food and drug legislation (didn’t cover cosmetics, medical devices, misleading advertising, drug narrowly defined) (prompted by The Jungle, Upton Sinclair)

         2. 1938: Federal Food, Drug and Cosmetic Act (1937 Elixir Sulfanilamide tragedy – prepared with diethylene glycol (anti-freeze) – never tested for toxicity – 100 deaths). Required NDA demonstrate safety [but not effectiveness], drug labels with instructions and warnings, cosmetics and false statements covered, better enforcement means. But NDA approved unless rejected. No requirement of affirmative approval.

         3. 1962: Amendment to FD&CA

            1. Originally a compulsory patent licensing bill

            2. Switched to safety focus

               1. Required safety and effectiveness, affirmative approval

               2. Passage galvanized by Thalidomide tragedy

         4. 2007: FDA Amendments Act of 2007 (2004 Merck withdrawal of Vioxx)

            1. FDA given authority to require post-approval studies/labeling changes

            2. HCPs obligated to report adverse reactions

      2. Short history of the development of theories of product liability

         1. Negligence

            1. π had burden of proof

            2. Contributory negligence barred recovery

         2. Res ipsa loquitur

            1. Moderated π’s burden of proof

            2. But Δ had to have exclusive control and accident of a kind that would not have occurred without negligence

         3. Implied Warranty

            1. Need not prove negligence, but needed sale and privity

         4. 1916 – McPherson v. Buick, Justice Cardozo, N.Y. Ct. App.

            1. Privity not necessary

         5. 1944 – Escola v. Coca Cola Bottling, Justice Traynor concurrence, Cal. Sup. Ct.

            1. Negligence and warranty should be dispensed with and strict liability imposed when manufacturer put product on market which proved to have defect

         6. 1963 – Greenman v. Yuba Power Products, Justice Traynor, Cal. Sup. Ct.

            1. No negligence and no warranty

            2. Liability if proved “using the Shopsmith in the way intended and injured as a result of defect in design and manufacture”

      3. Short history of the application of those product liability theories to drugs and devices

         1. Cutter Polio Vaccine Incident (1955)

            1. Traditional principles concerning warranty and privity do not apply to the manufacturer-doctor-patient distribution

            2. Strict liability assures compensation for the injured and distributes the cost among those who benefit from the vaccine. The manufacturer has an incentive to ensure the safety of the product.

         2. Gottsdanker v. Cutter Laboratories (1960)

            1. Found in favor of π on basis of implied warranty.

            2. Product was intended to be made with an inactive virus rather than a live virus.

            3. Court analogizes to food: both are ingested and, for liability purposes, are unwholesome products (contaminated by something not supposed to be in there).

               1. All courts later looking at this decision have pointed to this analogy.

            4. Even though the manufacturer did not intend for a live virus, it produced a product with a live virus.

         3. Grinnell v. Charles Pfizer & Co., Inc. (1969)

            1. Court contrasts this case with Gottsdanker.

            2. This is a situation where liability was imposed on a manufacturer without any evidence of an impurity or a defect in the product, other than that it caused an injury to the π.

            3. The CDC promoted the use of the Sabin vaccine, even though it was more dangerous (because it was live), because it was an effective vaccine.

            4. Courts references Rest. 2d Torts § 402A, cmt. k, but didn’t apply it since it wasn’t raised by either party.

         4. Lewis v. Baker (1966)

            1. Notion that drugs were in this category of products that could not be made safer and therefore were not subject to the strict confines of Rest. 2d Torts § 402A, cmt. k of strict liability

            2. Grinnell didn’t discuss FDA approval and labeling.

            3. If you took rationale of Grinnell and applied it to Lewis, the manufacturer would be liable.

            4. This case has been used for the proposition that a FDA-approved warning proves adequacy, but it was overruled in later Oregon opinions. FDA standards are minimal. Just because the drug is approved by the FDA doesn’t prove its measure of liability.

         5. Rest. 2d Torts § 402A, cmt. k.

            1. What became the critical issue in drug liability lawsuits, and is to this day: is the warning on a company product defective or not?

               1. Inquiry as to the adequacy and effectiveness of the warning.

2. Introduction and Warnings II

   1. Recap: Development of Drug & Device Liability Law

      1. Courts in the 1960s flirting with imposing liability based only on injury – equating injury with defect

         1. GOTTSDANKER: Liability based on defective manufacturing/testing even though no fault

         2. GRINNELL: Liability based on causal connection between vaccine and injury

      2. Rest. 2d Torts § 402A (1965)

         1. Special liability of seller of product for physical harm to user or consumer

            1. (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

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

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

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

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

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

      3. Rest. 2d Torts § 402A, cmt. k: unavoidably unsafe products

         1. ...

Buy the full version of these notes or essay plans and more in our Drug and Medical Device Liability and Policy Outlines.