Pharmaceutical companies are caught in between following approved drug labeling by the Food and Drug Administration (FDA) and specifying health risks of the drugs they manufacture including those extremely rare adverse effects.
The current package insert in medicines being sold in the market proves to have limited information while conforming to the instructions by the FDA and this weakens the defense of the drug companies against state tort laws as demonstrated during the decision of the United States Supreme Court in the case of Wyeth versus Levine in 2009.
The FDA mandated in its draft in 2000 that drug manufacturers should not include in their drug labels for health warnings very explicit reference to rare diseases or even include frightening "life-threatening disease" language.
Wyeth previously used this reasoning during the case but the Court dismissed that it is possible for manufacturers to simultaneously comply with both FDA and state-court-determined labeling requirements by using CBE or "Changes Being Effected" and then seeking for the approval of FDA for the determined changes.
It turns out that this plan only allows limited circumstances in which after-the-fact changes are permissible and drug companies still come out defenseless against preempted cases once unilateral modification by manufacturers are not permitted by the FDA.
The FDA has long been receiving criticisms regarding its regulations and, in multiple times, proven to be not infallible as how the court makes it out to be. The regulations set by the FDA appear as a double-edged sword as that it not only weakens the defense of drug manufacturers but it also endangers the safety of the public.
One of these cases was when a 15-year-old Utah girl named Shyra Kallas committed suicide on November 2002 while taking Zoloft which is an SSRI or Selective Serotonin Reuptake Inhibitor, a type of antidepressant.
The legal brief stated that it is the discretion of the FDA to "judge whether there is reasonable evidence of an association between a particular risk and a drug that triggers a drug manufacturer's duty to warn under the law" instead of it firstly being the drug manufacturers' duty.
Because the FDA did not see the suicidal tendencies increasing as an adverse effect of the drug, the case was dismissed rendering Pfizer not liable because the drug regulating agency failed to recognize the said effect before the child died.
The United States Supreme Court initially considered a certiorari petition in a conference to be held on January 8, 2016 to clear up the confusion regarding failure-to-warn claims concerning pharmaceutical companies and FDA mandated labels. While they are at it, it is only right that they re-scrutinize the rules by FDA in conformity to the law.
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