"Some in need of restraint, many in need of protection."
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| Justine Cadet, News Editor |
In an eagerly anticipated verdict, the Court voted 6-3 that patients have the right to sue pharmaceutical companies, even if the medications that caused the harm are approved by the FDA.
"The court holds that a state tort jury, rather than the FDA, is ultimately responsible for regulating warning labels for prescription drugs," said Justice Samuel Alito, who dissented in the verdict. However, as Keith suggests, protection should be accompanied by restraint, and it is the responsibility of the consumer not to plug the courts with frivolous suits.
The verdict came as a surprise to those who have been following the Court's pre-emption decisions over the past year, especially considering the same justices chose to protect medical device companies for FDA-approved devices in the similar case of Riegel v. Medtronic.
This highly controversial decision led members of the House and the Senate to introduce the Medical Device Safety Act of 2008, which sought to preserve state product liability lawsuits.
Recently, the New York Times reported that Reps. Henry A. Waxman, D-Calif., the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr., D-N.J., the head of its health subcommittee, soon plan to reintroduce this legislation that could nullify the Supreme Court decision. The parallel Senate bill, sponsored by Edward M. Kennedy, D-Mass., and Patrick J. Leahy, D-Vt., is expected to be reintroduced in coming months as well.
While consumers made strides in protection, executives at various cardiovascular vendors felt far less secure, as many have gotten reshuffled around during these tough economic times, including execs at Eli Lilly, Epix Pharmaceuticals, CardioNet and Bristol Myers Squibb. There have even been rumors that Bristol Myers is searching for a new CEO.
On these topics, or any others, feel free to contact me.
Justine Cadet, News Editor
jcadet@cardiovascularbusiness.com