By Dennis Shields, LawCash CEO and Founder
Dangerous drugs cause illness and death every day. In many cases the only thing keeping pharmaceutical companies accountable are the trial bar and the personal injury and defective drug lawsuits it brings on behalf of the injured. But most Americans don’t realize that generic drug manufacturers have no legal duty to warn the public of known or “knowable” defects and dangers caused by their products, a wrong the Association for Justice (AAJ) is trying to correct.
In 2010, the Supreme Court issued a ruling which endangers the lives of millions of Americans each day. Even worse, although aware of the danger, a deadlocked Congress and FDA (US Food & Drug Administration) have failed to close a loophole that leaves all of our citizens, especially the most frail and ill, the poor, and the vulnerable, with no recourse, and left the public with no safeguards.
Generic pharmaceuticals manufacturers receive unique protection from “duty-to-warn” laws, a problem which affects 84% of American patients every day. That means that those who have medical conditions and take generic drugs are left without an essential means of ensuring the drugs they take are safe. Those who take “branded” drugs are protected by a system which mandates warning of known dangers.
In Pliva v. Mensing, the United States Supreme Court held that federal law preempts state law-based failure-to-warn tort claims against generic pharmaceutical manufacturers. The Supreme Court ruled that the federal law that mandates that generic drug manufacturers use the same labeling as their brand-name counterparts makes it “impossible” for generic manufacturers to comply with state laws instructing generic manufacturers to provide a “better” label if they can. Under what is known as “impossibility theory,” the manufacturers of generic drugs have no duty to provide warnings to the public, even if they know their drugs may be or are dangerous, or even deadly.
Most pharmaceutical product liability lawsuits result from failures to warn the public about known or knowable risks. Mensing was a 5-4 decision, with a vigorous dissent from the four liberal justices.
The dissent, rightly, accused the majority opinion of stripping consumers of their ability to pursue legal redress when injured by a generic version of a drug. Justice Sotomayor noted that “this outcome makes little sense.” Practically speaking, the public’s ability to hold drug-makers accountable in products liability lawsuits now turns on whether the pharmacist fills a prescription with a brand-name or generic drug. This isn’t what Congress or the FDA intended and it’s not fair.
The majority opinion in Mending did note that Congress or the FDA could close this loophole. However, this has not occurred. In 2016, the FDA decided to postpone the decision until 2017 on whether to make generic drugs safer for the public. In the meantime, citizens such as the family of Kira Gilbert, a 22 year-old who died as a result of taking a generic form of Darvocet before her knee surgery, continue to urge the FDA and Congress to act. The story is heartbreaking and completely avoidable.
Once again, the nation’s trial attorneys, led by the American Association for Justice (AAJ), and law firms like The Nations Law Firm are the loudest voice the public has to protect consumers from dangerous products, corporations seeking profits, and loopholes in the law.
The best practical advice I can give until the loophole is closed:
If you can reasonably afford to, when a pharmacist asks whether it’s okay to fill a prescription with a generic drug, just say no.
For more information about what to do as a consumer of generic medications, and to ensure more dangerous drug oversight and accountability visit Let America Know.