Human Factors Experts Testimony in Product Liability Cases Is On the Rise

April 7, 2010

The Food and Drug Administration (FDA) has regulations, guidance documents and industry standards in relation to the use of human factors experts, which allow for more effective cross-examination and a strong defense in Product Liability Cases. With these regulations, human factors not only base their expert opinion on speculation, but also on facts.

You may be asking yourself, what are Human Factors, well it is the study of the relationships between humans, the tools they use, and the environment in which they live and work.

It is with these tools that human factors experts are allowed to testify in cases to provide opinions regarding the adequacy and efficacy of warnings and/or the impact of human factors in the design of products. The Expert must be able to identify a reliable scientific basis for his/her opinion to be used as testimony. It is the goal of the human factors professional to eliminate user error through proper product design and labeling.

Medical devices that are designed by the FDA are designed with the human factor principles in mind. According to the FDA manufacturers must use the following three device classes/guidelines when manufacturing a device for human use:

  • The Manufacturer must consider human factors in the development of the device. Such things as what the user sees, feels and hears;
  • The Manufacturer must test all devices for the potential in error use by the user;
  • The Manufacturer, when conducting risk analysis of the device, must consider user error.

These three device classes must all be subject to good manufacturing practices (GMPs) and these can be found in its Quality System Regulations. It is imperative that the medical device withstand the actions and inactions of its intended user, in order to design an error-tolerant medical device. It is important that the developer consider the characteristics of the worst case user. It is this underlying philosophy that human factor experts are used for.

These Human Factors Principles are also embraced by the Association for the Advancement of Medical Instruments (AAMI), the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO)

Estranged Spouses Waiting to Get Divorced Because of the Recession in MD, VA and DC

March 23, 2010

Breaking up is hard to do in time of Recession. Divorce has become something that some couple can not reach because of the decrease in house values and the increase in unemployment. Often, there is not enough money to hire attorneys, pay for separate households, fight for child custody and go to court.

A growing number of couples are deciding to wait until this economic storm passes to get divorced. Some are even taking new approaches, and living together as they separate in order to make ends meet.

David Goldberg, a divorce attorney in Gaithersburg, Maryland says he has a lot of files just sitting in his drawers because people can not move forward with a divorce. He has worked with families for over 40 years and says that he has never seen a time like this one. He has experienced that a lot of divorced couples are also having to file for bankruptcy in order to get by.

Paulene Foster, a federal worker from Olney, Maryland says she had to wait a year to get divorced because of precarious finances. She had to share her house with her estranged husband – he lived in the basement, while she lived upstairs. She finally filed for divorce last month with a $105 check after having to go to a self-help law clinic in Montgomery County, Maryland.

Other couples have to face the reality that they owe more on their family home than they would get if they sold it. In the past, couples were able to divorce quicker because they had enough equity in their homes so that both spouses could re-create lives not so different from their old ones. Now more divorced people go from homeowners to renters.

The National Marriage Project states that in 2008 (the first year of the recession) a modest decline in divorces was reported due to the Recession. That was about 838,000 divorces granted in 44 states. In 2007, however, 856,000 divorces were finalized, at a time when there was a growing economic strain in the United States. This shows a link between tough times and divorce.

W. Bradford Wilcox, director of the National Marriage Project at the University of Virginia, says that some families are pulling together in this time of economic turmoil, and others are postponing divorce until there is a rebound in the economy and home values. The cost of a divorce can range from $100 on a do-it-yourself basis with little dispute to up to $20,000 or more for a divorce that ends up going to court.

Kirk Wilder, a lawyer in Manassas, Virginia says that in some cases, spouses are not fighting for the home, but are more willing to let the other spouse keep the home. That is a huge change from years pasts.

In the District of Columbia and Northern Virginia it is a little easier for spouses to divorce since they can live in the same house during the required separation period, while in the State of Maryland spouses must be physically separate and living in separate residences for a required full year.

In other words, the longer this severe economic downturn continues, the larger the backlog of divorces will be.