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Products Liability Practice Guide
Copyright 2017, Matthew Bender & Company, Inc., a member of the LexisNexis Group.

5-63 Products Liability Practice Guide 63.syn




Thomas H. Bleakley;; John J. Vargo, Editor

Chapter Summary


This chapter from Products Liability Practice Guide discusses products liability litigation involving drugs. It notes that drug product liability cases tend to revolve around one unifying consideration: In any given situation, does the benefit of the drug outweigh the risk of using it in a particular patient? A variety of permutations spin off this consideration, but the constant need to keep this focus in mind is crucial to plaintiff and defense counsel alike.

The chapter first discusses legal theories and defenses common to drug products liability litigation. Theories of liability raised in drug products liability cases include negligence, strict liability, breach of warranty, and violation of state consumer protection laws.

The chapter next provides examples of litigated drugs and the associated injuries. Some of the drugs that have been the most frequent subjects of litigation, and their alleged effects, include: antibiotics, causing allergic reactions; chloramphenicol, related to aplastic anemia; Cleocin, claimed to produce colitis; the "Mycin" drugs, which have been linked to vertigo, hearing loss and kidney damage; tetracycline, alleged to produce tooth staining and certain phototoxic reactions; nitrofurantoin, said to be responsible for certain urinary tract disorders; and cloroquine, allegedly related to vision impairment. More serious effects have been alleged in litigation involving bendectin, an anti-morning sickness drug allegedly related to certain birth defects; DES, a synthetic hormone linked to vaginal cancer and other reproductive injuries; and vaccines, such as DPT, claimed to have caused seizures and paralysis, and polio vaccine, alleged to have triggered the disease it was developed to prevent. Five categories or groups of drug products have generated a substantial volume of litigation. These products are listed to illustrate the types of injuries claimed by many plaintiffs to have been caused by these products, and to describe the variations of legal response (by both plaintiffs and defendants) required under each set of circumstances.

The chapter then discusses practical problems and solutions in drug product liability cases. These cases are difficult and expensive. They are defended vigorously by companies who are often willing to spend more than a case is worth to vindicate their product and discourage additional claims. Prior to accepting a case, counsel should be satisfied that the client's claim has a substantial basis and has incurred serious injury. Adequate discovery is essential in products liability cases and expert testimony plays a key role in prosecuting or defending them. Counsel must be familiar with the pertinent medical literature in order to identify the medical issues and discuss them intelligently with experts. Because documents and testimony produced in discovery are likely to be extensive, counsel must have a systematic method of indexing data. The recent development of "networking," allowing plaintiffs' counsel to share information and evidence in similar cases has been of great value to the plaintiffs' bar in pursuing drug cases. Since drug products liability cases frequently involve many plaintiffs suing a single defendant, various procedural devices have been used to avoid multiplicity of litigation, including consolidation, multi-district litigation, and less frequently, class actions. In some cases manufacturers overwhelmed by claims have resorted to filing under the Federal Bankruptcy Code, which has the effect of consolidating all claims.

This chapter concludes with sample pleadings, discovery requests, a sample protective order, and a checklist of expert qualifications. A research guide is included.

Products Liability Practice Guide (Matthew Bender) provides an unparalleled collection of winning strategies and tactics for an entire range of products. It provides step-by-step guidance through each phase of a products liability case from the initial fact-gathering process, to use of forensic experts, to effective trial strategy. It also includes chapter-by-chapter topical treatment of specific products, from asbestos, all-terrain vehicles, clothing and contraceptives, to toys, airplanes, tobacco, firearms and more. In addition, practice aids are provides throughout the publication, including checklists, forms, commentary, trial pointers, sample pleadings, and research guides.


Torts,Damages,Punitive Damages,Products Liability,Fraud,Misrepresentation,Negligence,Drugs,Drug Products Liability,Warranty,Consolidation,Multi-District Litigation,Class Action,Antibiotic,Cleocin,Chloramphenicol,Mycin,Tetracycline,Nitrofurantoin,Cloroquine,Bendectin,DES,Vaccine,Polio Vaccine


Related chapters include Chapter 2, Initial Client Interview; Chapter 4, Investigation; Chapter 11, Preparation of Pleadings; Chapter 12, Product Experts--Plaintiff's View; Chapter 13, Product Experts--Defense View; Chapter 15, Defenses and Bars; Chapter 16, Discovery; Chapter 17, Proving Damages; Chapter 18, Punitive Damages--Plaintiff's View; Chapter 19, Punitive Damages--Defense View; Chapter 20, Trial Strategy--Plaintiff's View; Chapter 21, Trial Strategy--Defense View; Chapter 22, Effective Trial Presentation; and Chapter 62, Contraceptives.


See Lawyers' Guide to Medical Proof (Matthew Bender) for practical, down-to-earth advice on the psychology of a personal injury trial, including the latest advances in courtroom strategies, and insight on how to gather expert witnesses, examine reports of events that cause the injury, and acquire the basic medical background to effectively develop a case.

See Frumer & Friedman, Products Liability (Matthew Bender) for coverage of every facet of products liability law, including discussion of manufacturers, retailers, wholesalers, middlemen, repairers, and advertisers as potentially liable parties; liability under the theories of strict liability in tort, breach of warranty, negligence, misrepresentation, and fraudulent concealment; and state products liability legislation and statutory references.

See Personal Injury Defense Techniques (Matthew Bender) for a discussion of a wide range of the substantive and practical legal problems faced by defense counsel, along with suggestions for the best ways to remedy them, with coverage of such topics as insurance defense, liquor liability, medical malpractice, premises liability, products liability, toxic torts, and damages.

See Jury Instructions on Products Liability (Matthew Bender) for jury instructions that cite supporting case law, including relevant law review articles and annotations to American Law Reports, covering such topics as strict products liability, parties, warranty liability, misrepresentations, design defect liability, manufacturing, testing, inspecting, duty to warn, matters of proof, defenses, and causation.

See Manual for Complex Litigation (Fourth) (Matthew Bender) for guidance in managing complex cases, with coverage of pretrial, trial, and post-trial procedures; special problems in multiple jurisdiction litigation, class actions, and mass tort actions; and particular types of litigation, such as antitrust, securities, and Superfund cases.
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