Leahy, Franken, Bingaman, Whitehouse, Brown, Coons, Blumenthal Introduce Bill To Protect Consumers Using Generic Drugs

Bill Addresses Supreme Court Decision In Pliva v. Mensing

WASHINGTON (Wednesday, April 18, 2012) – Senator Patrick Leahy (D-Vt.) introduced legislation Wednesday to address a recent Supreme Court decision that threatens to undermine the safety of consumers taking generic drugs.  The legislation is cosponsored by Senators Al Franken (D-Minn.), Jeff Bingaman (D-N.M.), Sheldon Whitehouse (D-R.I.), Sherrod Brown (D-Ohio), Christopher Coons (D-Del.) and Richard Blumenthal (D-Conn.).

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 Patient Safety and Generic Labeling Improvement Act introduced Wednesday will address this discrepancy and reverse the effects of the Mensing case.

“The Mensing decision creates a troubling inconsistency in the law governing prescription drugs,” said Leahy.  “If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings.  If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries.  The Patient Safety and Generic Labeling Improvement Act will promote consumer safety by ensuring that generic drug companies can improve the warning information for their products in the same way that brand manufacturers can under existing law.”

Leahy chairs the Senate Judiciary Committee.  Under his leadership, the Committee has held a series of hearings in recent years spotlighting the importance of the Supreme Court’s decisions on the lives of hardworking Americans, including a number of recent Supreme Court decisions decided by a narrow 5-4 majority that affect the pocketbook issues facing all Americans, from equal pay for equal work, to consumer protections, to the 2010 campaign-finance decision in Citizens United.

“Right now generic drug manufacturers are prohibited from updating their labels to accurately reflect all of the side effects or risks associated with their drugs,” said Franken. “This means that a senior in Minnesota may have no idea that a prescription drug she’s taking could cause a neurological disorder. That’s just not right. This bill will help right this wrong  to make sure that Minnesotans know exactly what risks are associated with the medications they’re taking.”

“While essential to the treatment of many illnesses, prescription drugs can pose risks and have health-threatening side effects.  For this reason, prescription drug warning labeling is an important part of ensuring consumer safety,” Bingaman said. “By giving generic drug manufactures the ability to update their labeling, this bill will help individuals make an informed decision about the medications they take.”

“Consumers of generic prescription drugs should have the same rights as those who are prescribed brand-name drugs,” said Whitehouse.  “I thank Chairman Leahy for drafting legislation to address this truly wrong-headed decision by the Supreme Court, and I hope we can take action soon to protect Rhode Island consumers.”

“Regardless of whether they use generic or brand-name drugs, Ohioans should have full access to information regarding the safety of their prescriptions,” Brown said. “This legislation would ensure that generics and brand-names are held to the same labeling standards, which is critical given that approximately 75 percent of prescriptions filled in the U.S. are generics.”

“It’s common sense that any drug manufacturer — whether generic or brand name — ought to have the responsibility of warning its users of the risks of side effects for the drugs that they sell,” Coons said. "According to the Supreme Court's decision last year in Mensing, however, federal law actually prevents generics from warning customers when they discover a new risk. I applaud Chairman Leahy for his work in drafting legislation that will fix this, keeping generic medicines safe, effective, and a key component of affordable health care.”

“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 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.

In 2008, the Supreme Court held that a patient can sue a brand-name drug manufacturer for failure to warn, in a case involving Vermont musician Diana Levine.  Leahy filed an amicus brief in the Supreme Court on behalf of Ms. Levine with 17 Congressmen, including Vermont Senator Bernie Sanders and Vermont Congressman Peter Welch.

Many public interest groups have called on Congress and the Food and Drug Administration to address the Court’s decision in Mensing.  Companion legislation is expected to be introduced in the House of Representatives by Congressmen Chris Van Hollen (D-Md.) and Bruce Braley (D-Iowa).

# # # # #

Press Contact

David Carle: 202-224-3693