Despite the fact that the top courts are quite often seen as the only legal bodies that hold the power to make important decisions, this is not entirely accurate. Namely, there is quite a number of layers that operate and perform their duties underneath this governing body, and who are responsible for 'minor' cases and principles that tend to gain on intensity and gravity in dispute, for the number of people who are wrong is constantly on the rise. And all they ask is a bit more justice for them.
Regarded as certainly one of the most controversial concept, or an issue that has brought about quite a lot of attention, is the one that comes in the form of pre-emption. The main idea behind this is rooted in the presupposition that state legislators should be allowed and entitled to safeguard the pharmaceutical manufacturers from any liability, in spite of the fact that the medications and products they have manufactured previously might be responsible for causing harm to the people who have employed them for treatment purposes. Officially justified explanation states that the Federal Government has bequeathed the power for regulating the safety of medications and medical devices to the Food and Drug Administration, or as it is more popularly called the FDA.
Having all the aforementioned already clearly stated, the first related occurrence that comes to ones mind is the case of McNellis vs. Pfizer Inc. which was resolved together with the Colacicco vs. Apotex Inc. by the U.S. Circuit Courts. The defendants, i.e. the persons who were harmed claimed that the two companies in question were to be held responsible and blamed for not providing their customers (defendants included) with the adequate warnings in terms of the effect Zoloft and Paxil might induce in a person. Both of the products belong to the category of Selective Serotonin Reuptake Inhibitors, which are employed for the treatment of depression. The main concern that has led to the set of events referred to above is that people who use either one or the other of the inhibitors died by their own hand.
Upon filing an official appeal, the court made a decision that stated that the laws do pre-empt the right to claim that there was a lack of proper suicide-risk warning. Such cases, and the future ones that will surely take their place in the court room, most clearly point out to the fact that official health organizations such as the FDA or Health Canada ought to be more attentive and must take by far better care when approving and issuing any warnings.
- www.who.int/medicines/areas/quality_safety/safety_efficacy/who_emp_qsm2008.3.pdf
- www.who.int/medical_devices/publications/en/MD_Regulations.pdf
- Photo courtesy of Blondinrikard Fru00f6berg by Flickr: www.flickr.com/photos/blondinrikard/14485177503/
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