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  • 1.

    What are the basic laws governing the safety requirements that products must meet?

  • 2.

    What requirements exist for the traceability of products to facilitate recalls?

  • 3.

    What penalties may be imposed for non-compliance with these laws?

  • 4.

    What requirements are there to notify government authorities (or other bodies) of defects discovered in products, or known incidents of personal injury or property damage?

  • 5.

    What criteria apply for determining when a matter requires notification and what are the time limits for notification?

  • 6.

    To which authority should notification be sent? Does this vary according to the product in question?

  • 7.

    What product information and other data should be provided in the notification to the competent authority?

  • 8.

    What obligations are there to provide authorities with updated information about risks, or respond to their enquiries?

  • 9.

    What are the penalties for failure to comply with reporting obligations?

  • 10.

    Is commercially sensitive information that has been notified to the authorities protected from public disclosure?

  • 11.

    May information notified to the authorities be used in a criminal prosecution?

  • 12.

    What criteria apply for determining when a matter requires a product recall or other corrective actions?

  • 13.

    What are the legal requirements to publish warnings or other information to product users or to suppliers regarding product defects and associated hazards, or to recall defective products from the market?

  • 14.

    Are there requirements or guidelines for the content of recall notices?

  • 15.

    What media must be used to publish or otherwise communicate warnings or recalls to users or suppliers?

  • 16.

    Do laws, regulation or guidelines specify targets or a period after which a recall is deemed to be satisfactory?

  • 17.

    Must a producer or other supplier repair or replace recalled products, or offer other compensation?

  • 18.

    What are the penalties for failure to undertake a recall or other corrective actions?

  • 19.

    What powers do the authorities have to compel manufacturers or others in the supply chain to undertake a recall or to take other corrective actions?

  • 20.

    Can the government authorities publish warnings or other information to users or suppliers?

  • 21.

    Can the government authorities organise a product recall where a producer or other responsible party has not already done so?

  • 22.

    Are any costs incurred by the government authorities in relation to product safety issues or product recalls recoverable from the producer or other responsible party?

  • 23.

    How may decisions of the authorities be challenged?

  • 24.

    Is the publication of a safety warning or a product recall likely to be viewed by the civil courts as an admission of liability for defective products?

  • 25.

    Can communications, internal reports, investigations into defects or planned corrective actions be disclosed through court discovery processes to claimants in product liability actions?

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With a well-earned reputation as a litigation powerhouse, Shook, Hardy & Bacon is the go-to firm for the world’s leading health, science and technology companies. In addition to fielding the largest product liability practice in the world, Shook handles commercial litigation, environmental and toxic tort, and intellectual property disputes for the pharmaceutical and medical device, food and beverage, and consumer goods industries.

View more information about Shook Hardy & Bacon LLP

Kansas City
2555 Grand Blvd
Kansas City
T: +1 816 474 6550
F: +1 816 421 5547


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