My Product Is on the Market; Now What? Kyle R. Cummins Butler Snow LLP BUTLER SNOW | 1
Post-Sale Considerations • Design Claims • Safer Alternative Designs • Subsequent Remedial Measures • Duty to Warn of Design Improvements? • Failure to Warn Claims • Continuing Duty • Post-Sale Duty to Warn BUTLER SNOW | 2
Design Claims
What Is a Design-Defect Claim? • Distinct from manufacturing defect and failure to warn • Factors: • Availability and feasibility of alternative designs at time of manufacture • Conformance to design standards in the industry • Risk-utility • Utility to user • Likelihood to cause injury • Seriousness of injury • Ability to eliminate unsafe character BUTLER SNOW | 4
Design Defect – Standards • Restatement (Third) of Torts: Products Liability, Section 6 • Not defective in design unless risks of harm are so great that no reasonable healthcare provider possessing knowledge of those risks would prescribe the drug to any class of patients. • Restatement (Third) of Torts: Products Liability, Section 2(b) • A product “is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design . . . and the omission of the alternative design renders the product not reasonably safe.” BUTLER SNOW | 5
Safer Alternative Design – Considerations - Competitor design as alternative design - Practical adoption of the alternative design at the time of sale - Advantages and disadvantages of the alternative design - Production cost of alternative design BUTLER SNOW | 6
Safer Alternative Design – What Should Not Qualify • A different device that presents different advantages and disadvantages • Alternative surgeries in place of implantation of a medical device BUTLER SNOW | 7
Design Defect – Example Case • Jablonski v. Ford Motor Co. , 955 N.E.2d 1138 (Ill. 2011). • Design claim: fuel tank should have been in a different location • Plaintiffs present evidence of company knowledge and industry standard • Plaintiffs’ expert conducts tests on proposed alternative design • Court rejected alternative design • Court ruled in Ford’s favor BUTLER SNOW | 8
Design Defect – Does FDA Compliance Mean Anything? - Preemption - Compliance with FDA standards may be relevant - Restatement (Third) of Torts: Products Liability § 4: “[A] product’s compliance with an applicable product safety statute or administrative regulation is properly considered in determining whether the product is defective with respect to the risks sought to be reduced by the statute or regulation, but such compliance does not preclude as a matter of law a finding of product defect.” - Lewis v. Johnson & Johnson , 991 F. Supp. 2d 748 (S.D.W. Va. 2014) - Otero v. Zeltiq Aesthetics, Inc. , 2018 WL 3012942 (C.D. Cal. 2018) BUTLER SNOW | 9
Subsequent Remedial Measures • Fed. R. Evid. 407 • When measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove : • Negligence; • Culpable conduct; • A defect in a product or its design ; • A need for a warning or instruction. • But evidence may be admissible as: • Impeachment • To demonstrate ownership, control, or feasibility of precautionary measures BUTLER SNOW | 10
Subsequent Remedial Measures - Rationale • Rejects the notion that “because the world gets wiser as it gets older, therefore it was foolish before.” Baron Bramwell Hart v. Lancashire & Yorkshire Ry. Co. , 21 L.T.R.N.S. 261, 263 (1869). • Attempts to encourage (or at least not discourage) companies from making design improvements. BUTLER SNOW | 11
Subsequent Remedial Measures – Permissible Uses • Impeachment • To demonstrate ownership or control • To demonstrate the feasibility of precautionary measures • Example: Boeing Airplane Co. v. Brown, 291 F.2d 310 (9th Cir. 1961) BUTLER SNOW | 12
Warning Claims
Traditional Products Liability – Duty Stopped at Sale • General Products Liability • “A product is defective when, at the time of sale or distribution , it contains a manufacturing defect, is defective in design, or is defective because of inadequate instructions or warnings.” RST 3d § 2. • Romero v. International Harvester Co. , 979 F.2d 1444, 1450 (10th Cir. 1992). BUTLER SNOW | 14
Restatement (Third) of Torts: Products Liability § 10 • Recognition of post-sale duty to warn is “relatively new” for general products • Liability for failing to warn after the sale of a product if a reasonable manufacturer would provide such a warning • When a reasonable manufacturer would provide a warning after sale: • (1) Knows or should know the product poses substantial risk of harm; • (2) People to warned can be identified and are unaware; • (3) Warning can be effectively communicated to those people; and • (4) Risk of harm is sufficiently great to justify burden of providing warning BUTLER SNOW | 15
Post-Sale Duty in Drug and Device Cases • “In cases involving prescription drugs the courts have imposed a continuous duty to keep abreast of the scientific developments touching upon the manufacturer’s product and to notify the medical profession of additional side effects discovered from its use.” RST 3d § 10 cmt. c. • Example: Stanger v. Smith & Nephew, Inc. , 401 F. Supp. 2d 974, 978 (E.D. Mo. 2005). BUTLER SNOW | 16
Duty to Warn of Design Improvements? • Back to Jablonski v. Ford Motor Co. , 955 N.E.2d 1138 (Ill. 2011). • Plaintiffs also claimed that Ford should have warned of a design improvement BUTLER SNOW | 17
Best Practices • Continue to assess risk-benefit profile of device • Monitor similar products • Keep current with scientific literature • Report and analyze adverse events BUTLER SNOW | 18
QUESTIONS? kyle.cummins@butlersnow.com BUTLER SNOW | 19
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