The Supreme Court ruling last week in Wyeth vs. Levine opened the door for all consumers to hold pharmaceutical companies accountable when they sell unsafe products. In fact, the Court decided that these claims can now be brought in State courts.
The drug manufacturer, Wyeth, was arguing that since the FDA had approved their anti-nausea drug Phenergan, they shouldn’t be held liable for damages it caused to patients prescribed the drug. They argued that FDA approval superseded state level “failure to warn” claims. Basically, they were arguing that a drug company cannot be responsible for any damages their drugs may cause after it has been approved by the FDA.
Diane Levine sued Wyeth in Washington State Court after losing her arm to gangrene, brought on by taking Phenergan. The jury awarded Levine $6.7 million in damages. Wyeth appealed to Vermont’s Supreme Court, which upheld the jury’s decision in favor of Levine. Wyeth then appealed to the U.S. Supreme Court which also ruled in favor of Levine.
The big manufacturers favor “preemption”, a doctrine that holds that federal law will override state law if there is a conflict between the two. The big manufacturers also argue that the FDA is best qualified to weigh all risks and benefits associated with a drug, and if the FDA says it is OK, then nobody should be able to challenge that.
This mindset is very similar to the old cigarette company defenses. For years they argued that they complied with the federal government’s requirement to tell people that cigarettes may be hazardous to health, by placing the warning on the packs. They argued that they should not be subject to lawsuits, because they did everything that the government told them to do. (In the meantime, they place dangerous and addicting compounds into the cigarettes to get people hooked on them.)
Big manufacturers are afraid of juries. They believe if juries in state courts are given the freedom to question the FDA’s rulings, then claims against pharmaceutical companies may get out of hand. In truth, they do not want to ever be held accountable, and so they send their lobbyists and millions of lobby dollars to Washington D.C. to get laws enacted that insulate them from consumer lawsuits. Obviously, it doesn’t always work, and sometime, the consumers rightfully win.
In truth, consumer lawsuits are the only thing keeping these giant drug companies in check. The threat of litigation for years has made the products in the United States a bit more expensive perhaps, but at the same time, much safer. Isn’t it a good idea to pay a few pennies more for a product, and know that it is safe, as opposed to not having these protections?
It seems that by this decision, the Supreme Court is alerting manufacturers that they are responsible for providing appropriate information regarding risks and dangers of their products to consumers. Is that a bad thing? Certainly not. It should be a minimum that we expect, especially from these big multi-billion dollar drug manufacturers. Of course, there is always the possibility of human error and we will never be able to prevent all types of mistakes. However, that is best sorted out though the legal, civil process. That is exactly what the court are for, and cases like this are the exact reasons that our forefathers wrote a document we live by, called the US Constitution.