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What Is Required on Drug Warning Labels in Florida? It Depends
Generally, patients who are harmed by a specific drug may be able to seek compensation from the drug's manufacturer for a defective drug or for failing to tell patients about possible side effects of the medication.
November 04, 2011 /Medical PR News/ -- Americans are not just clipping coupons to cut costs these days. A new Consumer Reports poll finds that they are making potentially dangerous choices about prescription medications to save money as well. On average, Americans regularly take 4.5 medications and 75 percent of those are the generic equivalent to a more expensive, brand-name drug.
Generally, patients who are harmed by a specific drug may be able to seek compensation from the drug's manufacturer for a defective drug or for failing to tell patients about possible side effects of the medication. But, a recent U.S. Supreme Court case, PLIVA, Inc. v. Mensing, may have made it more difficult for injured patients to recover money damages for injuries related to the use of a generic drug. The Court held that generic manufacturers are not liable for failure to warn claims based on state law if they used the same label as the brand-name drug.
Warning Labels
The Food and Drug Administration (FDA) has established labeling and warnings standards to ensure patients are adequately informed of the risks associated with taking a particular drug. All new drugs go through a FDA approval process before being sold on the market. The review process involves lengthy and costly clinical testing and is intended to protect patients from devastating side effects or interactions with other drugs.
In 1984 Congress changed the requirements for testing of generic drugs, and allowed generic drugs to gain FDA approval if the manufacturer could show that the drug was equivalent to one that already approved by the FDA. This allowed manufacturers to bypass the costly approval process and develop generic drugs inexpensively.
A brand-name manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the brand name drug.
The legislative efforts to expand the production of generic drugs have been wildly successful and costs for prescription drugs have decreased. In many cases, once a generic hits the market, the name-brand manufacturer stops selling its branded equivalent.
Reglan (Known Generically as Metoclopramide)
Reglan is used to treat persistent heartburn, and in diabetic patients to treat nausea, vomiting and stomach/abdominal fullness. Reglan works by blocking dopamine and speeds the digestive process. A known side effect of Reglan is a neurological disorder called tardive dyskinesia that leads to uncontrolled movements similar to Parkinson's disease. In fact, studies have shown that 29 percent of patients who take the drug for several years develop the disorder. Because of this risk, it is recommended that the drug not be used more than 12 weeks at a time.
In 1985, the generic label warned that tardive dyskinesia may develop in patients treated for more than 12 weeks. In 2004, the brand-name Reglan manufacturer requested -- and the FDA approved -- a stronger label warning that Reglan therapy should not exceed 12 weeks. In 2009, the FDA ordered an even stronger warning against extended use on Reglan labels, directing that Reglan must not be used longer than 12 weeks in all but rare cases.
Reglan, Pliva and Name-Brand Versus Generic Labeling "Makes No Sense"
Pliva is a drug manufacturer with major markets in the United States. Among other drugs, Pliva manufactures a generic form of Reglan (metoclopramide). In the PLIVA case, two women sued the drug maker, arguing that the generic version of Reglan that it created and sold was not labeled properly to adequately warn them of potential side effects when they were prescribed the drug in 2001 and 2002. Pliva claimed that FDA regulations required the same warning label on generic metoclopramide as what appears on brand-name Reglan and that the state law failure-to-warn claims were barred by federal statutes.
In a 5-4 decision, the U.S. Supreme Court found that the women's claim that Pliva failed to adequately warn of the dangers of taking Reglan was preempted by FDA regulations related to labeling and the drug manufacturer was not liable for the state law claims. State law required a manufacturer to warn of dangers and provide adequate instructions for safe use of a product, but Federal law requires the labeling on a generic drug to match a brand-name drug label. The manufacturer of the generic drug cannot change its label unilaterally.
If drug labeling must be changed, the brand-name drug manufacturer must follow the FDA's "changes-being-effected" (CBE) process. Only brand-name manufacturers can use the CBE process. Under federal law, Pliva was not able to change the labeling on its generic version of Reglan unless Reglan's own manufacturer went through the CBE process with the FDA.
The Court found an impossible conflict between state and federal law. Justice Thomas pointed out that if Pliva had changed the labels on its generic form of Reglan to comply with the state law duty to warn, they would have violated federal law. Justice Sotomayor expressed concern over the "absurd result" that undermines the principle that generic and brand-name drugs are the "same" in nearly all respects. She also noted that the decision would leave those injured by inadequate warnings on generic drugs with no claim for compensation.
Generic Prescriptions
Advocacy group Public Citizen has called on the FDA to revise regulations so that generic drug manufacturers can update labels to warn patients about risks. Patients will benefit from improved drug safety if generic manufacturers can use FDA procedures to revise generic drug labeling to warn of risk.
The duty of generic drug manufacturers to warn patients is an unsettled area of the law. Thus it is more important than ever to contact an experienced personal injury attorney to consider and fully understand your rights if you suffer adverse side effects related to taking a generic medication.
Article provided by Law Offices of Corey Leifer, P.A.
Visit us at www.leiferlaw.com
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