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When drugs are unavoidably unsafe

It may sound odd, but there are medications in Tennessee and across the country that have serious side effects and are still on the market because they are considered “unavoidably unsafe.” When it comes to product liability, the Restatement Second of Torts states that these medications may not be subject to defective drug lawsuits.

The reason behind this is that these medications are not, by their nature, dangerous. Instead, they are simply unable to be made safe while still carrying out their intended use. To be deemed unavoidably unsafe, the drug must meet the following criteria: 

  •        There must not have been a flaw in the manufacturing process.
  •        The medication’s benefits must outweigh its risks.
  •        There must not have been improper marketing.
  •        There must not be any other alternative that would do the same job as the medication.

For example, vaccines are often held to be unavoidably unsafe. There are a number or risks involved in getting vaccinated; however, courts often hold that the benefits of vaccines far outweigh the risks.

This does not mean that every medication can be viewed in this light. If any of the above criteria is violated, a drug could be classified as defective and the victim would be able to hold manufacturers or other parties responsible for damages. For example, the Physicians Committee for Responsible Medicine reports that taking certain drugs during pregnancy could result in birth defects. If the mother who took the medication was unaware of the risks due to improper marketing or packaging, she could have grounds to sue.

Product liability claims can be especially complex, as the “unavoidably unsafe” argument illustrates. Experts encourage victims of medication mistakes to know their options.

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