My Product Is on the Market; Now What? Kyle R. Cummins Butler Snow - - PowerPoint PPT Presentation

My Product Is on the Market; Now What?

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Kyle R. Cummins Butler Snow LLP

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• 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

Post-Sale Considerations

Design Claims

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• 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

What Is a Design-Defect Claim?

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• 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.” Design Defect – Standards

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• 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

Safer Alternative Design – Considerations

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• A different device that presents different advantages and disadvantages
• Alternative surgeries in place of implantation of a medical device

Safer Alternative Design – What Should Not Qualify

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• 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

Design Defect – Example Case

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• 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)

Design Defect – Does FDA Compliance Mean Anything?

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• 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 Subsequent Remedial Measures

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• 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. Subsequent Remedial Measures - Rationale

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• 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)

Subsequent Remedial Measures – Permissible Uses

Warning Claims

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• 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). Traditional Products Liability – Duty Stopped at Sale

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• 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

Restatement (Third) of Torts: Products Liability § 10

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• “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).

Post-Sale Duty in Drug and Device Cases

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• 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 Duty to Warn of Design Improvements?

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• Continue to assess risk-benefit profile of device
• Monitor similar products
• Keep current with scientific literature
• Report and analyze adverse events

Best Practices

QUESTIONS? kyle.cummins@butlersnow.com

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