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At first blush, the FDA’s recent approval of the first generic version of Actos to treat type 2 diabetes seems like great news for consumers. After all, the generic promises significant cost savings for patients.

Unfortunately, the excitement should be tempered with a note of caution. Several scientific studies show a link between long-term use of Actos and an increased risk of bladder cancer. Patients who took Actos have filed lawsuits to hold the manufacturer, Takeda Pharmaceuticals, liable. However, those taking the generic form of Actos will have limited legal recourse should they suffer similar injuries.

Generic Manufacturers Held Blameless

In June 2011, the U.S. Supreme Court made a landmark decision affecting all future claims against manufacturers of generic drugs. In Pliva, Inc. v. Mensing, two plaintiffs alleged that they developed tardive dyskinesia, a serious movement disorder, after using the generic form of Reglan (metoclopramide), a popular heartburn drug. The plaintiffs claimed the manufacturer failed to warn about the serious risks associated with the drug, and sought to hold it liable for their injuries.

The U.S. Supreme Court, however, ruled that a generic manufacturer could not be blamed for the plaintiffs’ injuries as long as their label matched the one on the name brand drug. The plaintiffs alleged that under state tort law, the generic manufacturer should have used increased warnings on its product. However, federal law requires a generic drug to have the same label as its name brand equivalent. The manufacturer of generic Reglan argued that it had no choice but to use the same label that appears on Reglan, or else it would violate federal law.

The Supreme Court agreed with the generic manufacturer. The result is that patients who are injured by a generic drug will have no legal recourse against either the generic or name brand manufacturer.

Congress is Trying to Make Changes

In May 2012, Congressional Democrats introduced joint legislation to change generic drug labeling laws. The bill would right the wrong created by Pilva, Inc. v. Mensing by permitting generic drug companies to update drug labeling when new risks are discovered. This would level the playing field between generics and brand name drugs, giving them both the power to update labels. The bill would also allow patients injured by either form of the drug to sue the manufacturer for failing to warn about the risk of serious injury.

So far, the bill has not passed. Meanwhile, hundreds of lawsuits against generic manufacturers across the country have repeatedly failed to win compensation for injured plaintiffs.

FDA Warns About Actos Bladder Cancer

The FDA approved Actos for the treatment of type 2 diabetes in 1999. The drug works by increasing the body’s sensitivity to insulin and thereby controlling blood sugar levels.

In the summer of 2011, the FDA issued a safety communication warning that Actos may be linked to an increased risk of bladder cancer. The FDA based the warning on the results of a 10-year epidemiological study. The study showed patients taking high doses of the drug, or taking it for longer than 12 months, had a 40 percent increased risk of bladder cancer. Other studies followed showing similar results, including one in France that led to a French Actos recall in July 2011.

Limitations of Using Generic Actos

On August 17, 2012, the FDA announced that it approved the first generic version of Actos tablets, made by Mylan Pharmaceuticals. Unlike when Actos was first approved, the generic version contains a warning noting that its use for over a year may be associated with an increased risk of bladder cancer.

So far, Actos lawsuits seek settlements from the brand name manufacturer, Takeda Pharmaceuticals. Unfortunately, patients injured by the generic version of Actos, and all other generic medications, may not be able to recover damages.

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