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  4.  » Drug companies aren’t always liable for label errors in Illinois

Drug companies aren’t always liable for label errors in Illinois

In a lot of cases, drug companies in Illinois are responsible for labeling mistakes. For example, if the label does not tell about side effects and a person is then harmed when taking the drugs, the company can be sued for putting out dangerous products, though the same products could have been sold with the correct labels in place.

There is one situation, however, in which generic companies may not be held responsible under the Illinois state laws due to federal regulations. This was established in a court case known as Mutual Pharmaceutical Co. V. Bartlett.

In the case, a woman took a drug and was disfigured and blinded by the drug. The label did not mention the issues that caused her disfigurement, and she sued the company that made the generic version of that drug.

The company protested, though, saying that it was not their fault that a warning had not been on the label because they had no choice but to use the exact label that the FDA approved for the original drug. Under federal regulations, they weren’t allowed to make any changes. The court found that, due to their inability to stray from what the FDA had approved, they were not liable.

This rule was clearly put in place to make sure that companies did not alter the labels and leave things out, but it also means that they couldn’t legally make changes to tell consumers about newly-discovered side effects, even if they knew about them, as the FDA had deemed that illegal on the federal level.

Cases like this show just how important it is to know about every single step in the legal process if you’ve been harmed by a dangerous product or a drug.

Source: Cornell University Law School, “Mutual Pharmaceutical Co. v. Bartlett,” accessed March. 26, 2015

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