While generic drug manufacturers would like consumers to believe that generic versions of drugs are exactly equivalent to the name brands, this is not usually the case.
Consequently, some people who switch from a name brand to a generic drug experience what doctors term a “therapeutic failure.” What this means is that while the name brand drug worked to control the patient’s condition, the generic version does not. Patients may also experience new or different side effects. Hardly chemically identical.
Poor Quality Control
So, how are dangerous generic drugs getting into the American marketplace? One problem is that manufacturers are using raw materials from China, India, and other areas where quality assurance is not strict. It is worth noting that many over-the-counter medicines, such as ibuprofen and acetaminophen, are currently being imported from these same areas. In the opinion of our Chicago injury attorneys, it is only a matter of time before a major safety incident occurs with these products, as well.
But why doesn’t the FDA stop these problems? The simple answer is that the FDA is dramatically underfunded and understaffed to confront the task before it. The FDA pulls and tests only about 300 doses of prescription medication each year. This means that only about one in ten million doses are inspected each year. And, although the FDA is supposed to inspect the facilities where drugs are manufactured at least once every two years, due to the lack of adequate resources, in fact some drug companies have only one plant inspected every four years. And only 200 plants have been inspected in China and India in the last seven years.
Risks of Generic Drugs
The risks of generic medications are hardly academic. The next year will bring a rash of new generic medications on the market, as the patents expire on a number of the biggest drugs in America. In fact, 7 of the top 20 best-selling international medications have patents expiring in the next 14 months. This includes Lipitor, a commonly-prescribed anti-cholesterol medication, and Plavix, a commonly-prescribed blood thinner.
Also included are common medications for asthma, diabetes, depression, HIV, blood pressure, and bipolar disorder. In the next four years, drugs which account for around $255 billion in annual international sales have expiring patents. In fact, Blue Cross Blue Shield estimates that up to fifteen percent of the American population is currently taking a medicine with a patent expiring in the next few years.
And the problems with generic safety will only get worse, thanks to a recent ruling from the U.S. Supreme Court. In this year’s term, the Court ruled that generic drugs are required to do nothing more on their labels than mirror the labels of the name-brand drugs. This decision, in Pliva v. Mensing, provides extensive protection for generic drug manufacturers, but none for innocent patients. In effect, the decision means that even when there are indications that a generic version of a drug causes catastrophic or fatal side effects not present in the name brand, up to and including kidney failure, the drug manufacturer need not provide a warning to those who take the drug.
In fact, the Court ruled that even if state consumer protection laws would require the drug maker to provide a warning, federal law preempts those state requirements and in fact mandates that the drugmaker not provide a warning, if that warning is not present on the name-brand label.
Our serious injury attorneys are more than troubled at this state of affairs. The lack of warning labels is by no means the only type of legal claim available to the victims of generic drugs. And as the legal responsibilities of the manufacturers of generic drugs continue to develop, we hope that the legal redress for those injured by these dangerous drugs will become easier to access. In the meantime, we urge consumers to take care when using generic drugs, and to weigh the risks carefully before choosing these products.
Stephen M. Passen of Passen & Powell has over 30 years representing individuals against large corporations in serious personal injury and wrongful death cases. To speak with one of our top-rated injury attorneys, call us at (312) 527-4500 or email us at firstname.lastname@example.org.