Paxil Preemption Ruling Overturned
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A federal judge in Indiana has vacated his previous ruling
that wrongful death claims brought against the makers of Paxil were preempted
by federal regulations. This reversal will now allow the claims to be heard.
The judge, David Hamilton, said that in the previous ruling the “court
failed to appreciate the significance of the fact” that a drug manufacturers can
modify the label of a medication without FDA approval, if they have reasonable
evidence of serious harm that could be inflicted on patients. In the case of
Paxil, SmithKline Beecham Corp. (now GlaxoSmithKline), failed to revise the
label when they were well aware potential harm to recipients of the drug.
In the next term the Supreme Court will address the issue of
preemption related to pharmaceuticals in the case Wyeth v Levine. The basic
question that the court will have the duty of answering is whether the FDA’s
approval of a medication should preempt state product liability lawsuits
brought over injuries incurred by recipients but not specifically warned of on the
label of a drug.
This is a very serious and intricate question that court
must address in the coming months. If the court were to decide that lawsuits
would be preempted by FDA approval, as they did for certain medical devices in
Riegel v Medtronic, it would be a catastrophic blow to the plaintiffs’ rights.
Hopefully the court will not be influenced by big pharma’s attempt to demonize
the trail lawyers and product liability lawsuits.
While it is true that some trial attorneys have brought
forth frivolous lawsuits that have given the entire industry a bad name, they
are very much in the minority. Most plaintiffs’ attorneys truly do care for
their clients and have chosen to work in the field that they do out of
compassion for victims.
Pharmaceutical companies are amongst the richest companies
in the world. Their greed and desire for profit transcends all barriers. On
numerous occasions pharmaceutical companies have concealed evidence of adverse effects from their products, all in an effort to make more profit off of a
medication that they knew was placing innocent victims in harm’s way.
These business giants must be held accountable for the
injuries incurred from the medications that they make. If the tens of millions
spent on lobbying each and a small portion of the multi-billion dollar profits
seen by some companies each and every year were to go into making safer more
effective drugs and better research, maybe there would not be a great need for
plaintiffs’ law in this area. But as it stands now, the victims of defective
medications need help more than ever.