Showing posts with label warnings. Show all posts
Showing posts with label warnings. Show all posts

August 17, 2017

California Proposition 65 regulations amended to require more specificity on warnings

On August 30, 2016, (yes a year ago) the California Office of Administrative Law approved the adoption of amendments to Article 6, "Clear and Reasonable Warnings", of the California Code of Regulations.  This was a regulatory "repeal and replace" and not a legislative one so as a result it was further off the news "radar". The new regulations provide, among other things, methods of transmission and content of warnings deemed to be compliant with the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). Prop 65 regulations are promulgated by the Office of Environmental Health Hazard Assessment (OEHHA) which also maintains the Prop 65 chemical list and is one of 6 agencies under the California Environmental Protection Agency (CalEPA).

Most companies already know that any consumer product sold in California must comply with Proposition 65, meaning that their products sold in California cannot contain harmful amounts of the chemicals on its notorious 800 chemical list (and growing). Its important to keep in mind that this list continues to grow and is much more extensive than the EU REACH law/regulation (which currently lists only about 200 chemicals). Its also much more extensive that the US Consumer Product Safety Commission's (CPSC) regulations which are mostly confined to lead and Phthalates. There has been quite a bit of publicity surrounding Monsanto's futile legal efforts to keep RoundUp weed killer off the Prop 65 list.

The difficulty with the new warning requirement (which does not go into effect until August 30, 2018) is that if you test and if you find something on the list in your product you must now have specific "safe harbor" warnings that include any of the 800 chemicals on the list that might be in your product in harmful amounts. Under the old abolished regulations you could utilize a "safe harbor" (provision of a statute or a regulation that specifies that certain conduct will be deemed not to violate a given rule) warning that did not need to specify which of the 800 chemicals on the list might exist in the product. Now of course one can debate the merits of warnings generally, especially the efficacy of one that lists the offending complex chemical name over one that does not, but we don't have enough space on this post to have that debate. The point is this is now the current state of the law and my advice is to try to steer clear of Prop. 65 suits (just like ADA suits and host of others). Also these warnings cannot exist solely in user's manuals unless you are a vehicle manufacturer who got special dispensation under the new regulations (but even they still must have stand alone warnings)

The other interesting issue is that if your company was part of a settlement of a Prop 65 suit. Under the new law a company that is a party to a court-ordered settlement or final judgment establishing a warning method or content, is deemed to be providing a “clear and reasonable” warning for that exposure for purposes of the new law, if the warning fully complies with the order or judgment. This covers a few companies in the bicycle arena. It's not known how many total companies are exempted by this as that would depend a lot on the terms of the settlement and (I assume) the chemicals ("the exposure") involved in that particular suit.

Clearly there is going to be lots of work ahead in the next year for all consumer product manufacturers, brands, distributors, resellers, and retailers (on line and off). You can be sure Amazon, Walmart and all the big retailers are well aware of these issues and they will surely come up in contract negotiations with sellers to most large retailers.

Law Offices of Steven W. Hansen | | 562 866 6228 © Copyright 1996-2013 Conditions of Use

November 11, 2014

High profile helmet case against Citi bike

This is an interesting recent case against the very large and prominent Citi Bike operation in New York. There has been a lot of media attention on them.  Unfortunately it is not clear from the article what stage the case is in. Our research shows that it was filed February 27, 2014. I suspect that some discovery will need to take place before dismissal motions can be made on legal grounds. There is no discussion in the article as to what legal issues are at play. We will try to keep you posted on this case as it progresses. Additional dates we now know about are as follows: No party may make a motion for summary judgment until May 11, 2015 (this weill be a key date). Discovery is due to be completed by 2/9/2015. Expert witness discovery due by 4/9/2015.

Law Offices of Steven W. Hansen | | 562 866 6228 © Copyright 1996-2013 Conditions of Use

March 18, 2012

The new ANSI Z535 standards and drafting better user / owner manuals

We have been assisting clients with the drafting or users (or owners) manuals for some time. Companies have become much better about drafting these manuals in recent years, however many company's manuals are still seriously lacking in many areas. The biggest problem we see is that companies do not think out a long term strategy with respect to manuals, how they are to be effectively and ultimately delivered to consumers and developing a framework for revising them over time, to name a few areas that are lacking.

If your company does not have any manuals (or recent, well drafted manuals) this may be the time to get started or at least do a refresh on what you have and to rethink your entire strategy. The reason this may be a good time is that ANSI (American National Standards Institute) has just recently published two key standards dealing with warnings and drafting these manuals. The two standards are:

ANSI Z535.4 "Product Safety Signs and Labels" originally published in 1991. The 2007 version was revised and published in Sept 2011; (again this one only involves so called "on product" warnings)

ANSI Z535.6 "Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials" originally published in 2006. The 2006 version was revised and published in Sept 2011; (this standard deals with complete manuals and is meant to be complimentary to Z535.4)

There are 4 other standards in the ANSI Z 535 series ( Z535.1, Z535.2, Z535.3, and Z535.5) that are not directly relevant for drafters of manuals for recreational products.

Now of course none of the Z535 series standards tell you what to say in your manuals or warnings or even what substantive topics to cover, (that is usually covered by more substantive standards like the EN 14781 entitled "Racing bicycles - Safety requirements and test methods", for example) but the Z535 standards do tell you the manner in which you should convey it, including organization, style, graphics etc. From our own review I will say that most manuals that we have not assisted on are poorly organized. Z535 aims to improve that problem specifically.

Another thing to keep in mind is that a manual is not all about "warnings" but also about instructing users on how to assemble, use or maintain the product. We always say that if users are properly instructed often times the need for the warning is reduced. But you need both components. Another area lacking in manuals is instructive, intelligent warnings. For example we often see the generic warning: "use of this product may result in serious injury or death...." Great info. That's true with almost any product. You need to tell the user the specific areas or details about the product where he or she is most likely to get hurt and how the injury is likely to occur (the mechanism of injury). This is the reason most people's eyes glaze over when reading warnings. You are not telling them something they don't already know. (think about cigarette warnings and recent controversy about making them have more impact)

Now many people will say that just having a "standard" does not guarantee that you will get past a "failure to warn" claim and I would agree with them (see my prior article Using Standards in Defending Product Liability Cases, for more detail on that issue). However whenever you fail to meet or at least demonstrate that your company at least considered a standard in drafting a warning or manual, you can pretty much be assured that overcoming a failure to warn claim will be an uphill battle with a judge or jury. The reason is that standards (especially those from recognized bodies like ANSI, ISO or ASTM) are seen as embodying years of diligent work by the worlds experts on the subject, application of the scientific method, and in most cases some democratic form of creation. That's hard for most companies to compete against in house.

At a minimum you need someone with legal training (in the relevant field of product liability) and some knowledge of the the substantive area being warned about, to review your manual at least every 2-3 years or more often if substantial changes to the manual or product are being made. Having someone outside the company critique the manuals is essential. This is a continual process and should be examined in a comprehensive fashion; again not just the manuals themselves but the delivery system, the design, the languages, the timeline etc. Once this is done properly inside people can be trained to carry on the work on a yearly basis.

Law Offices of Steven W. Hansen | | 562 866 6228 © Copyright 1996-2012 Conditions of Use