Closing the Generic Drug Liability Loophole

Scartelli Olszewski P.C.

If you are filling a prescription with a generic drug, you probably know that you’re saving hundreds or thousands of dollars over the cost of a name brand equivalent.That’s a good thing. But if a previously undiscovered side effect of that generic medication sickens or injures you, guess who is liable? Would you believe the answer is “nobody?”In 2011, the U.S. Supreme Court ruled that generic drug makers are not responsible for updating their safety labels to warn of newly discovered side-effects and as a result cannot be held accountable in court if their drugs injure or kill Americans. As the American Association for Justice points out, consumers are left with safety labels that are not reliable and with no access to justice.The FDA has proposed a plan to fix the problem, but it is under attack from the generic drug industry. The Scranton attorneys of Scartelli Olszewski need your help to ensure Americans injured by defective drugs have access to justice. Click here to sign this petition and read on to learn why this issue is so important.

Why are generic drugs cheaper?

More than 80 percent of prescriptions in the United States are filled by a generic drug. The reason for that is no secret: generic drugs are much cheaper than their name brand equivalents. The reason for their low cost, in turn, is that generic drugs are knockoffs.When a pharmaceutical company applies for a patent on a newly invented chemical compound that may one day become a name brand drug, the date of that filing starts a 20-year window of patent protection for any resulting medications. Until those 20 years are up, the drug company that discovered or created the compound has the exclusive rights to make and sell those medications.Many things must happen before a patented chemical compound becomes a marketable drug, however. It must pass through many stages of development and testing, including human trials. The results of those tests help determine whether the FDA will approve the drug for sale. More than 90 percent of those chemical compounds never make it to market as a drug. The very few that do often then have just a few years left on that 20-year protection period to earn back the drug company’s investment in the years of research and development. That’s one reason you might see a prescription drug heavily advertised for two to three years, and then never hear about it again: its patent window closed and it no longer makes sense to spend money advertising it.Once that 20-year protection expires, any company that can figure out how to make (and sell) that drug’s chemical compound is free to do so. A company that sells a generic version of the drug doesn’t have to pay for 10 to 20 years of research and development. To be profitable, it just needs to make back its production overhead. That translates into retail prices that often are a tiny fraction of the original medication’s price.

Taking over production doesn’t mean taking over responsibility

With every prescription drug, a patient receives its “labeling,” which discloses relevant information including the drug’s ingredients and its known side effects – information that was earned mostly during research and development. Today, the labeling information usually comes in almost microscopically tiny print, on a tightly folded piece of paper accompanying the drug.Since 1984, federal law has required generic drugs to include the same labeling as the name brand drug they mimic. That might seem reasonable, until you think about it for a moment.Suppose that a new side effect turns up, maybe only after many years of using a medication? That’s what happened with a drug called metoclopramide, which is used to treat digestive issues, in 2001. Metoclopramide originally was sold under the brand name Reglan, but it lost its patent protection just five years after it came to market. Then generic manufacturers moved in with low-cost versions.Many patients who were prescribed Reglan by their doctors got the prescription filled with generic metoclopramide in order to save money, as many patients do. What nobody knew in 2001 and 2002 was that long-term use of metoclopramide can cause tardive dyskinesia, a difficult-to-treat and often-incurable neurological disorder.When some of those patients developed tardive dyskinesia, they filed lawsuits against the manufacturer of the generic metoclopramide. The case went all the way to the U.S. Supreme Court, which ruled in 2011 that the manufacturer of the generic metoclopramide was not responsible for the patients’ illnesses. The reason: the manufacturer had no control over the drug’s labeling, which did not mention the risk of tardive dyskinesia.

Generic drug makers want the FDA to be responsible for their products’ safety

Since then, efforts have been underway to reform the 1984 law and make generic drug manufacturers responsible for their own labeling.Not surprisingly, generic drug manufacturers are against these efforts. They’re happy for someone else — anyone else — to be responsible for the labeling, because then they are effectively shielded from liability for their products’ effects.Generic drug makers want the FDA to be responsible for their labels’ contents, but as we’ve argued here before, the FDA barely can stay on top of its existing responsibilities, never mind become the labeling authority for 80 percent of the drugs sold in the United States. It is past time for the generic drug industry to be responsible for the effects of its products, like virtually every other industry in the country.We’d like your help to make that happen. Sign this petition at Change.org to help us close the generic drug safety loophole that endangers the majority of Americans who take prescription drugs.