Importance of Documents
Documents that Hurt
Lack of Documents Hurts
Documents that Help
Documents on Post-Sale Issues
A manufacturer or product seller can be potentially liable under a theory of negligence after sale of their product. In addition, current U.S. regulatory and common law requirements apply to information that was obtained or should reasonably have been obtained that identify an unsafe condition. The potential liability for violations of U.S. and possibly foreign regulatory laws is always present. All of these laws contain a duty to report to the government if threshold safety events occur. This enhanced focus makes it even more important that a manufacturer gather, analyze and document safety information received from anywhere in the world.
Anything less than a “reasonable” effort at obtaining and analyzing post-sale information may be considered negligent by a U.S. jury in determining whether the manufacturer should have known about the problem before the accident occurred or by a government agency in deciding whether the manufacturer should have reported the safety issue to the government. Therefore, deciding what is reasonable under the circumstances is important to determine and document.
Manufacturers will receive documents and information from consumers, health care professionals, government agencies, consumer groups, and plaintiffs’ attorneys. The growth of the internet and social networking has made it even easier to find this information if you are looking for it and easier for manufacturers to receive this information from those who want to communicate it to them. Many of these documents and reports will be unverified, overstated, inaccurate, and incomplete. Nonetheless, the existence of such communications means that the manufacturers cannot claim they did not have notice of such incidents or complaints. Manufacturers will have to decide how to follow-up and investigate these reports to get to the truth but also to minimize the unnecessary and unsupported problems that they could cause.
It is very important for the manufacturer and others in the chain of production and distribution to establish procedures to identify, review and analyze all of the information that might relate to the safety of their products in use and to funnel it to trained personnel to evaluate so that a decision can be made about any appropriate actions. In addition, this will help the company respond to inquiries concerning safety made by the government, the press, or consumers. Being aware of all information – good and bad, true and untrue, complete and incomplete – can be helpful as long as the important information can be sorted out and adequately evaluated and documented. Part 2 of this article will deal with these issues.
Kenneth Ross is Of Counsel to the Minneapolis office of Bowman and Brooke LLP where he practices in the areas of product safety and liability prevention and advises manufacturers, product sellers and insurers on ways to identify, evaluate and minimize the risk of products liability and contractual liability. These guides do not constitute legal advice and are very general. You should consult competent legal counsel or Medmarc Loss Control before acting on any of the information in these guides.
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Medmarc is a part of ProAssurance Group, a family of specialty liability insurance companies. The product material is for informational purposes only. In the event any of the information presented conflicts with the terms and conditions of any policy of insurance offered from ProAssurance, its subsidiaries, and its affiliates, the terms and conditions of the actual policy will apply.
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