Although a final ruling from the U.S. Supreme Court isn’t expected until this summer, things aren’t looking good for generic drug manufacturers. At issue is whether their labeling has to reflect important medical warnings – even when those warnings aren’t required by the FDA.This is especially important for drugs that are sold without a prescription but which may be taken on the recommendation of a physician. Drugs like Motrin (ibuprofen), aspirin and Tylenol (acetaminophen) would fall under this category. A physician may tell someone to take an over-the-counter preparation as part of his or her therapy. The patient then has to rely on the package information available at the point of purchase – without the input or oversight of a pharmacist.
The latest case involves a minor child who was prescribed Motrin following surgery to remove two moles. The pain reliever was purchased by his parents as a generic in the over-the-counter version. Subsequently, the child developed a high fever and liver failure. This was determined to be due to an interaction between the ibuprofen and the anesthetic used in the mole surgery.
Although ibuprofen is known to cause liver problems with some anesthesia drugs, this information is not printed on the package label and without the intervention of a pharmacist the parents had no way of knowing about the risks. The manufacturer claims their liability is limited because the package label is approved and certified by the FDA and isn’t required to list all the possible drug interactions. In fact, to produce a label that isn’t approved by the FDA is a violation of federal law by itself.
Previous rulings hold that manufacturers cannot escape liability with this excuse. The courts point out that companies do not normally submit such labeling and if they did, the FDA might approve it. In other words, simply meeting the minimum standards of the FDA doesn’t allow them to avoid lawsuits.
Billings personal injury attorney, Solomon Neuhardt, expressed it this way, “If a drug manufacturer cannot adequately communicate the risks to consumers, they have no business selling it outside the framework of medical supervision. This is a case of profits driving out common sense. Imagine how devastated the parents are – they thought they were doing the right thing, completely unaware that their own child would end up needing a liver transplant because they purchased something off the shelf.”
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About Solomon Neuhardt:
Solomon Neuhardt is the owner and lead attorney at Neuhardt Law Firm, a member of the American Bar Association, the American Association for Justice, and represents individuals and families in personal injury cases, including accidents, medical malpractice, defective products, dog bites, and insurance disputes.
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