Pharmaceutical companies have a responsibility to ensure the product they are putting out on the market is safe for those who use it for the purpose intended. When it isn’t safe or there is a possibility of developing serious side effects, manufacturers must inform consumers of those risks.
However, federal law in some cases contradicts this rule as it relates to the makers of generic drugs. This is why some of those who suffered severe effects as a result of consumption of a generic heartburn/gastric reflux medication are finding it difficult to obtain compensation.
The brand name of the drug is Reglan. The generic product is called metoclopramide. The question is not whether this drug causes harm. Indeed, it is known to cause a serious neurological disorder called tardive dyskinesia.
At issue in Strayhorn v. Wyeth Pharmeceuticals Inc., et al., recently reviewed by the U.S. District Court of Appeals for the Sixth Circuit, is whether either the brand name manufacturer or the manufacturer of the generic product had a duty to warn users of that risk.
Our product liability attorneys recognize that a loophole in the laws designed to protect consumers could make proving that difficult.
In the Strayhorn case, there are actually seven plaintiffs, whose cases were grouped together for the purposes of congruity in pretrial matters.
Each of the plaintiffs in this group allege that they ingested metoclopramide, which resulted in them developing tardive dyskinesia. This is a difficult-to-treat condition characterized by involuntary, repetitive body movements. The condition has the potential to severely impact a person’s life and livelihood.
The plaintiffs sued both the makers of the generic product, as well as maker of the brand name product.
The district court in this case granted the defendants’ summary motion to dismiss. For the makers of the brand name product, the claim was dismissed on the grounds that none of the plaintiffs in question ingested the brand name product. All consumed the generic version.
The claim against the generic manufacturer was also dismissed, on the grounds that all of the plaintiffs claims are preempted by the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. 301-399f, as it applies to the 2011 U.S. Supreme Court ruling handed down in PLIVA, Inc. v. Mensing.
The PLIVA case was an important one in the realm of product liability, particularly as it relates to drug manufacturer claims of failure to warn. The court determined that while state laws may require drug companies to warn consumers of potential dangers, generic manufacturers are required under federal law to use the same labels produced by the brand name manufacturer. That means they had no control over what those labels said, and therefore they could not be held liable for failing to include certain information on them.
Of course, this creates a tough situation for those who have been harmed by generic drugs.
It was based on this reasoning that the sixth circuit appellate court affirmed the earlier decision handed down by the district court in the Strayhorn case.
There may still be options available to individuals who have been harmed by the consumption of generic drugs, but those options may be somewhat limited. A product liability attorney can further advise of potential avenues of recourse.
Contact our South Carolina personal injury lawyers at Lee Law Offices today by calling 800-887-1965.
Strayhorn v. Wyeth Pharmeceuticals Inc., et al., Dec. 2, 2013, U.S. Court of Appeals for the Sixth Circuit, Appeal from the U.S. District Court
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Carolina Defective Product Watch: Surge Protectors Create Fire Risk, Nov. 16, 2013, South Carolina Product Liability Attorney Blog