WASHINGTON, March 4 (Reuters) - The U.S. Supreme Court on Wednesday ruled against the drugmaker Wyeth in a closely watched case, holding that pharmaceutical companies can be held liable for harm from medicines which carry warnings approved by federal regulators.
By a 6-3 vote, the high court ruled that labeling approvals by the U.S. Food and Drug Administration does not preempt state laws and shield companies from legal damages as part of liability claims.
This is huge. If this case had gone the other way, the same drug companies that get their drugs approved by the FDA by submitting cherry picked studies and heavily massaged data, the FDA run by executives who go right back to the drug industry when they leave the FDA, would have been protected from lawsuits from those patients their drugs harmed.
Instead, the court ruled that the company still has a responsibility to protect the people who use their drugs no matter what the FDA says.
While the business press is treating this as a victory for trial lawyers, it is worth noting that trial lawyers don't take cases unless someone has been seriously maimed or killed. If they are maimed or killed by a drug because the company that provides that drug omitted to mention that the drug could maim or kill in the information it gives doctors, the drug company should pay a price. It will be far less than that paid by the victims of their negligence.
The real benefit of this decision is not for trial lawyers. It is for you, the patient. The drug companies have known all along about the studies they have kept hidden from the FDA and from the public. They also know how the data has been massaged to hide certain findings when they earned product approval. We saw this when Avandia's connection with heart attack finally was made public many years after the company had suppressed this information. We just saw this in the case against the makers of Seroquel who also hid data showing their drug to be less effective than older drugs and more likely to cause diabetes in people who otherwise would not have gotten it.
Now thd drug companies whose drugs' hidden dangers have not been revealed have been put on warning. They will be subject to ruinous law suits if they don't do something to protect the public against the dangers that they already know their drugs present.
Like, for example, the likelihood that Januvia's inhibition of DPP-4 is turning off the tumor suppressor gene you need to survive prostate cancer, melanoma, lung cancer, and ovarian cancer.
There are studies that could be done to determine if this is the case. They have not been done. The only screening done currently when the FDA approves a drug, to rule out that it causes cancer, is screening to see if the drug causes cancer in test tube cells or rodents. No one is saying Januvia causes cancers, only that it turns off our cancer fighting mechanism.
Most of us develop one or two cancerous cells many times throughout our lifetimes, but our tumor suppressor genes kill them. There is no research to see what happens to people harboring one or two cancerous cells when you give a drug that turns off the anti-cancer genes, and that is exactly what Januvia is doing.
It may take ten years until the Januvia-related cancer epidemic becomes evident. At least, with this latest Supreme Court case decided, the company selling it, whose scientists must know of the tumor suppressant features of DPP-4 will not be able to say, "The FDA approved Januvia, so we're off the hook."