CE Marking Products for the EU – Product Liability Exposure in the US
I have discussed the topic of product liability exposure in several of my 2009 blogs. Recently, however, as I was helping a client find a company to make new metal plates with a CE Mark, company name and serial numbers for his machines, I came across advertisements from numerous consultants declaring that they could help companies CE Mark their products for modest amounts of money. Of course these claims often are understated only to have the client discover that it will cost a great deal more to finish the work, another form of “bait and switch.” And in other ads, manufacturers pursuing the lowest possible cost discover that they are buying a series of “fill-in-the-blank” templates, which are “one size fits all” for machines ranging from simple to complex. Both approaches could be categorized as a form of fraud.
Caveat Emptor (Let the Buyer Beware!)
While Americans are suckers for anything cheap, “CE Marking Lite” for machines is a bad idea for several reasons. To comply with the revised Machinery Directive, it is necessary to identify the appropriate conformity assessment procedure for your machine and/or machine product family; it is necessary to construct an Annex I Checklist; identify the relevant EN harmonized standards that will allow the manufacturer to demonstrate a presumption of conformity with the Essential Requirements; it is necessary to conduct a complete ISO 14121-1: 2007 Risk Assessment and Hazards Analysis with documentation; create a Part A Technical File and EC Declaration of Conformity.
The legal steps taken to comply with the EU revised Machinery Directive and related Directives should be clearly spelled out in your documentation so that the legal rationale and path taken is clearly written in a document for EU member state competent(national) authorities. In addition, this documentation will be vital to a legal defense in the event of a product liability lawsuit in a US Court of Law. This latter point also underscores the liability exposure for any EU based consultants in the UK, Ireland, the Netherlands, France, etc. working directly or via the internet in the EU with EU, US and other third country clients.
If an EU based consultant or consulting firm accepts money from a US based company for CE Marking Assistance, they are subject to US Law in US Federal and State Courts. The fact that these consultants are physically based in the EU is irrelevant, because they are doing business in the US.
Issues That Must Be Addressed When Complying with the Machinery Directive and Related Directives
The primary focus of the Machinery Directive and other new approach Directives is product safety and in the case of machinery, machinery safety. To this end the Annex I Essential Health and Safety Requirements (ESHSR) were designed to address the various aspects of machine safety. This also means that new designs must incorporate the elements of the ESHER into the design of new machines and modify the designs of existing machines accordingly.
To do this, it is necessary to identify the EN harmonized standards that will allow for a presumption of conformity. Many of these EN harmonized standards have been revised and are now EN ISO standards which means as ISO standards they also are American Standards, since the American National Standards Institute (ANSI) participates in the drafting of ISO standards (the implications of ANSI participation will become more apparent in future product liability litigation, see my July 10, 2009 & March 23, 2009 blogs). In short, ANSI standards are acceptable evidence to establish state-of-the-art in product safety in US Courts of Law.
I have worked with machines from simple to extremely complex. The number of EN harmonized standards can range from as few as four to 30 or more. It depends on the number of ESHSR that apply to a specific machine. To assert that the certification for simple to complex machines can be handled for US$730.00 is not only absurd, it is wildly misleading. Further, it is necessary for each machine to conduct a hazards analysis and risk assessment for the design of the machine. To suggest that all hazards analyses and risk assessments are equal and can be handled for the same amount of money is equally stupid and misleading. A competent risk assessment can take a significant amount of time to do well. The more complex the machine, the greater amount of time and detail.
Compliance with ISO 14121-1: 2007 Safety of machinery – Risk assessment – Part 1: Principles. Conducting a thorough risk assessment means that every possible hazard is identified and the reduction of that hazard to an acceptable level of machine safety by designing out all hazards, guarding against those hazards that can’t be designed out or guarded against and creating warnings and instructions for those hazards that can’t be designed out or guarded against.
Every single question in the risk assessment standard must be answered Yes, No or N/A and the answer must be written in clear English so that it can be understood if a product safety issue arises. In most instances questions will arise several years later after the original writers of the risk assessment have moved on to other positions or retired. Therefore, the answers will have to stand on their own.
Finally, it is only at the end of this process that a manufacturer can establish warnings and instructions for a machine and to determine how the machine should be marked for machine safety. Failure to issue warnings without conducting a full hazards analysis and risk assessment has resulted in punitive damage awards for plaintiffs against numerous manufacturers in product liability lawsuits in the US.
Product liability exposure will increase with the revised Machinery Directive, related Directives and the revised EN ISO standards. All companies, (domestic and foreign manufacturers, independent consultants and notified body consultants) active in the US marketplace will be subject to product liability exposure (see my July 10, 2009 blog, CE Marking Machinery – Future State-of-the-Art in American Product Liability Lawsuits). CE Marking will assume greater importance as soon as plaintiffs’ attorneys and subsequently defense attorneys begin to understand what is happening.
While the one case to date that went to trial in Minnesota in 2002 resulting in a $35 million dollar punitive damages judgment involved safety standards, it was understood by the jury as a case where a California machinery manufacturer had been making a safer machine for the EU and a less safe machine for the US resulting in an injury that crushed the skull of a worker requiring 24 hour care for the rest of his life. The attorneys and the jury didn’t know that California machinery manufacturer implemented safety standards created for the EU Machinery Directive. What the jury did know was the fact that the California machinery manufacturer knew how to make a safer machine and had been doing so for 6 years, but chose to make a less safe machine for the US Market.
How does this affect future product liability litigation in the US? Quite simple, a plaintiff’s attorney hires someone like me to serve as a legal expert to testify about the CE Marking process and how your company failed to meet the Directive’s Essential Health and Safety Requirements resulting in an injury to the attorney’s client or clients. It is similar to my involvement as a legal expert in product liability, design and contract litigation involving ISO 9001.
Presently I am talking with some attorneys about serving as legal expert concerning accidents involving US manufactured machines. I discovered that two of the manufacturers sell their machines in the EU, which means that their EU machines should be CE Marked. Therefore, the question arises, are the EU machines safer? A perusal of their Technical Files, compliance with EU harmonized standards and hazards analysis/risk assessment will provide valuable information for the lawsuit. If you have product liability and risk assessment concerns vis-à-vis the US market regarding the revised Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at email@example.com.
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