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Drug and Medical Device Liability and Policy Outline
I. Introduction and Warnings I
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 a. What changes when there are aggregate cases?
b. E-Discovery c. 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?
B. The development of modern drug and device liability law: the short version
1. Short history of FDA regulations a. 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)
b. 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.
c. 1962: Amendment to FD&CA
i. Originally a compulsory patent licensing bill ii.
Switched to safety focus 1) Required safety and effectiveness, affirmative approval 2) Passage galvanized by Thalidomide tragedy d. 2007: FDA Amendments Act of 2007 (2004 Merck withdrawal of Vioxx)
i. FDA given authority to require post-approval studies/labeling changes ii.
HCPs obligated to report adverse reactions
2. Short history of the development of theories of product liability a. Negligence i.
π had burden of proof ii.
Contributory negligence barred recovery b. Res ipsa loquitur i.
Moderated π's burden of proof ii.
But Δ had to have exclusive control and accident of a kind that would not have occurred without negligence c. Implied Warranty i.
Need not prove negligence, but needed sale and privity d. 1916 - MCPHERSON v. BUICK, Justice Cardozo, N.Y. Ct. App.
i. Privity not necessary e. 1944 - ESCOLA v. COCA COLA BOTTLING, Justice Traynor concurrence, Cal. Sup. Ct.
i. Negligence and warranty should be dispensed with and strict liability imposed when manufacturer put product on market which proved to have defect f. 1963 - GREENMAN v. YUBA POWER PRODUCTS, Justice Traynor, Cal.
i. No negligence and no warranty
1 Drug and Medical Device Liability and Policy Outline ii.
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 a. CUTTER POLIO VACCINE INCIDENT (1955)
Fast-forward to the i.
Traditional principles concerning warranty and privity do not apply 1980s, one vaccine to the manufacturer-doctor-patient distribution became so expensive ii.
Strict liability assures compensation for the injured and distributes that its usage was the cost among those who benefit from the vaccine. The actually curtailed,
manufacturer has an incentive to ensure the safety of the product.
plus manufacturers b. GOTTSDANKER v. CUTTER LABORATORIES (1960)
went out of business i.
Found in favor of π on basis of implied warranty.
(thus reducing ii.
Product was intended to be made with an inactive virus rather than a supply).
iii. 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.
iv. Even though the manufacturer did not intend for a live virus, it
Finding in favor of π:
produced a product with a live virus.
makes a difference c. GRINNELL v. CHARLES PFIZER & CO., INC. (1969)
with the courts when i.
Court contrasts this case with Gottsdanker.
the π has won below ii.
This is a situation where liability was imposed on a manufacturer and the Δ appeals.
without any evidence of an impurity or a defect in the product, other than that it caused an injury to the π.
iii. 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.
iv. Courts references Rest. 2d Torts § 402A, cmt. k, but didn't apply it since it wasn't raised by either party.
Significant d. LEWIS v. BAKER (1966)
strengthening of FDA
i. Notion that drugs were in this category of products that could not be gave courts comfort made safer and therefore were not subject to the strict confines of that backing off strict
Rest. 2d Torts § 402A, cmt. k of strict liability liability would not ii.
Grinnell didn't discuss FDA approval and labeling.
create unsafe iii.
If you took rationale of Grinnell and applied it to Lewis, the conditions.
manufacturer would be liable.
iv. 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.
e. Rest. 2d Torts § 402A, cmt. k.
i. 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.
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II. Introduction and Warnings II
A. Recap: Development of Drug & Device Liability Law
1. Courts in the 1960s flirting with imposing liability based only on injury - equating injury with defect a. GOTTSDANKER: Liability based on defective manufacturing/testing even though no fault b. GRINNELL: Liability based on causal connection between vaccine and injury
2. Rest. 2d Torts § 402A (1965)
a. Special liability of seller of product for physical harm to user or consumer i.
(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.
ii. (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 a. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.
These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve.
b. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is unreasonably dangerous.
The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk.
c. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, it is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to
Swerve in the law -
supply the public.
heading towards strict
4. BASKO v. STERLING DRUG (2d Cir. 1969): Negligence the standard for liability, then Rest. 2d judging warning
Torts § 402A, cmt. k moved it towards 3 negligence standard. Drug and Medical Device Liability and Policy Outline a. "Although the imposition of strict liability for the idiosyncratic side effects of a drug is certainly not unthinkable, comment k provides that such a drug is neither 'defective' nor 'unreasonably dangerous' in the Sec. 402A sense if the manufacturer gives an adequate warning of the risks involved.
b. In this respect, comment k simply adopts the ordinary negligence concept of duty to warn. If proper warning is given 'where the situation calls for it,' the manufacturer is 'not to be held to strict liability for unfortunate consequences
*** merely because he has undertaken to supply the public with an apparently useful and ."
B. Approved Prescribing Information: Package Insert / PDR
1. Risperdal package insert a. 43 pages b. Black box warning (will attract a tremendous amount of π interest)
c. Description d. Clinical pharmacology e. Clinical trials f. Indications and usage g. Contraindications h. Warnings i. Precautions j. Adverse reactions k. Dosage and administration l. http://dailymed.nlm.nih.gov/dailymed/about.cfm
C. Who must be warned?
1. "Learned intermediary"
a. STOTTLEMIRE v. CAWOOD (D.D.C. 1963): for prescription drug,
warning is to doctor, not patient b. STERLING DRUG v. CORNISH (8th Cir. 1966): first use of phrase
c. REYES v. WYETH LABORATORIES (5th Cir. 1974)
i. Facts: Child got polio from Sabin oral vaccine.
1) No "learned intermediary" defense 2) What was rationale for departing from "learned intermediary" rule?
ii. Holding: "Learned intermediary" doctrine 1) Doctor is the medical expert and the person in the best position to determine whether a drug is appropriate for a patient.
2) Doctor balances the risks and benefits for the patient taking the drug.
iii. Notes: Mass immunization - who is deciding that the vaccine should be administered?
2. DTC advertising a. PEREZ v. WYETH LABORATORIES (NJ 1999)
i. Facts: Surgical injury from removal of Norplant contraceptive ii.
Notes: Who is making the decision to use a particular drug?
1) Are doctors surrendering their decision-making to patients,
managed care organizations and other insurers, and/or manufacturers?
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There seems to be a narrow category of drugs promoted via
iii. Notes: how would you determine whether a manufacturer has given an adequate warning? Where do you provide the warning: DTC
advertising or doctor or both?
1) If a patient suffers a side effect, that's the one that people point out as requiring adequate warning.
b. STATE EX REL. JOHNSON & JOHNSON v. KARL (W. Va. 2007)
i. Facts: Propulsid death case c. CENTOCOR v. HAMILTON (Tex. App. 2010)
i. Facts: Lupus syndrome from Remicade. Doctor prescribed drug before patient saw Centocor-produced video.
1) Argument made: if you really have a doctor whose will has been overcome by a persistent patient, there's another way to approach the case - via proximate cause.
d. West Va. and TX updates i.
1) WOODCOCK v. MYLAN, INC. (S.D.W. Va. 2009) and
VITATOE v. MYLAN PHARMACEUTICALS, INC.
(N.D.W. Va. 2010) held that the "learned intermediary"
doctrine, as it violates West Virginia public policy,
cannot be applied in a diversity case, regardless of what state's substantive law controls.
2) On March 25, 2011, West Virginia legislature enacted a statute declaring the public policy of West Virginia to be that the applicability of the learned intermediary rule is to be governed by the product liability law of the place of injury (lex loci delicti) - typically the residence of the plaintiff at the time s/he took the drug. W. Va. Code § 558-16(a). Great news - but only for cases filed on or after
2011. Id. at § 16(b).
ii. Texas 1) Petition for review in CENTOCOR v. HAMILTON (Tex.
App. 2010) granted by Texas Supreme Court on August
26. Argument set for December 8.
D. Warnings - Additional Thoughts - Learned Intermediary
1. Rest. 3d Torts - usually followed in vaccine cases but not elsewhere a. Warn the doctor, except where there is no doctor or health care provider to lessen the risk of injury.
i. Picking up on the vaccine principles of warning the patient directly.
2. Legislative proposals
E. Did the Defective Warning Cause the Injury? (proximate cause)
1. DUNN v. LEDERLE LABORATORIES (Mich. App. 1982)
a. Facts: Contact poliomyelitis from Sabin vaccine. Doctor was apprised of the risk, but said that he would have prescribed the drug regardless.
2. PUSTEJOVSKY v. PLIVA, INC. (5th Cir. 2010)
a. Facts: Tardive dyskinesia from Raglan generic. Doctor didn't read label.
b. Holding: No proximate cause because plaintiff must demonstrate that an adequate warning would have changed the doctor's behavior.
3. No proximate cause in either case. Why?
F. Access to the Prescriber
1. ARONS v. JUTKOWTIZ (NY 2007): you as a defense counsel can have access to the doctor/prescriber (from a litigation standpoint, it's critical to put a face on your 5 Drug and Medical Device Liability and Policy Outline company that is not the terrible face a plaintiff's lawyer will paint and you want to remind the doctor about the company's literature, etc. A defense lawyer is hurt when s/he cannot access the doctor.)
a. "We see no reason why a nonparty treating physician should be less available for an off-the-record interview than the corporate employees in Niesig or the former corporate executive in Siebert. As an initial matter, a litigant is
'deemed to have waived the [physician-patient] privilege when, in bringing or defending a personal injury action, that person has affirmatively placed his or her mental or physical condition in issue.'"
b. "Again, we 'assume[ ] that attorneys would make their identity and interest known to interviewees and comport themselves ethically.'"
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III. Design and Manufacturing Defects
A. Recap - Failure to Warn Liability
1. Issues a. Under what standard do you judge warning b. Whom do you warn?
i. Contraceptive drugs: another area of exception for the general rule that it is only the intermediary that is warned.
1) There is a bias among courts as the drugs don't treat a disease. The concern is more about warnings and access to information by the consumer.
ii. DTC advertising (and the learned intermediary)
1) Risks situations where physicians' ability to tailor drugs to patients because you have aggressive patients exposed to advertising.
2) This phenomenon can be addressed by the proximate cause construct.
1. So if the doctor says "yes, normally I would have made a tailored judgment to this patient and would not have prescribed the drug," then you've got a real issue where the DTC advertising leads directly to a prescription that otherwise would not have occurred.
On the other hand, another doctor may prescribe the same drug without succumbing to patient pressure.
c. Did the warning cause the injury?
d. Was the warning adequate?
i. DUNN v. LEDERLE LABORATORIES (Mich. App. 1982)
1) Facts: Doctor knew about the risk but didn't rely on the label… and even if she knew about the risk, she would have ignored it.
ii. PUSTEJOVSKY v. PLIVA, INC. (5th Cir. 2010)
1) Facts: Doctor didn't know the magnitude of the risk, but didn't remember ever seeing the warning.
2) Holding: It was the plaintiff's duty to show proximate cause. If the doctor didn't see the warning, how could the plaintiff prove that an adequate warning would have sufficed?
iii. Adequacy may be established as a matter of law 1) If not, it goes to the jury under proper instructions N.J.
Model Civil Charge 5.40C
These cases arise when the
1. "In the case of a prescription drug, the warning must
FDA requires a black box or be one that a reasonably prudent manufacturer that you contraindicate. In the would have provided to adequately communicate abstract, the question is "you information on the dangers and safe use of the know you changed it, could product to physicians, taking into account the you have changed it sooner?"
characteristics of, and the ordinary knowledge common to, such prescribing physicians."
iv. Inadequacy must be proved by expert testimony.
v. Evidentiary value of approval by FDA of warning 1) FDA approval is a floor, not a ceiling
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