Blumenthal Introduces Bill To Protect Consumers Using Generic Drugs
(Hartford, CT) – U.S. Senator Richard Blumenthal (D-CT) introduced legislation to hold accountable generic drug manufacturers that injure patients as a result of side effects or known risks in their products. The new law would address a loophole opened by a recent Supreme Court ruling.
“Generic drug manufacturers must clearly warn patients of known possible life threatening drug side effects – and be held accountable when they fail. Victims in Connecticut have been harmed and left without recourse. I will continue to fight to ensure this loophole no longer jeopardizes patient safety,” said Blumenthal.
The decision determined that generic drug manufacturers are not liable when failing to adequately warn patients of possible life threating side effects – even if the company knows of the risk. This means that a patient who suffers a serious side effect from a generic drug is unable to receive damages from the manufacturer, while a patient who takes a brand name drug and suffers the same side effect can be compensated by the manufacturer.
The Patient Safety and Generic Labeling Improvement Act introduced by Senators Blumenthal, Patrick Leahy (D-Vt.), Al Franken (D-Minn.), Jeff Bingaman (D-N.M.), Sheldon Whitehouse (D-R.I.), Sherrod Brown (D-Ohio), and Christopher Coons (D-Del.) will address this discrepancy and reverse the effects of Supreme Court ruling.
In Connecticut, Susan Ranstead of North Granby wrote to Senator Blumenthal asking for action on this issue. Susan’s elderly mother used a generic drug to treat and prevent osteoporosis and, as a result, developed a very painful disease that causes death to the bone in her jaw. Susan’s mother was foreclosed from legal action under the Supreme Court’s decision.
“People need to know that this issue exists with generics, because they are cheaper,” said Ranstead. “People and doctors need to know that there could be financial repercussions down the road.”
In a 2011 case, Pliva v. Mensing, a 5-4 majority of the U.S. Supreme Court held that manufacturers of generic drugs cannot be held liable under state tort law for “failure to warn,” even if the manufacturer knows that its label is inadequate. The Court based its decision on a federal law that requires generic manufacturers to use the same label as their brand-name counterparts. However, the Supreme Court held in 2008 that brand-name manufacturers can be held liable under state tort law for failure to warn, because federal law permits brand-name drugs to improve their warning labels.
The plaintiff in Mensing, Minnesota resident Gladys Mensing, developed a severe neurological disorder as a result of the long-term use of a generic drug manufactured by Pliva. She filed suit against Pliva under state tort law, arguing that the drug’s label failed to adequately warn of the risks associated with long-term use.
In the 10 months since the Supreme Court issued its decision, more than 40 judges have dismissed cases alleging inadequate labeling by generic manufacturers. Over 75 percent of all prescriptions are filled by generic drugs.
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