Saturday, April 04, 2009

Pharma Innovation in Legal Jeapordy

Lawrence McQuillan writes a fascinating and frightening article regarding recent court rulings that will have a potentially tremendous negative impact on drug innovation. You can read the article here.
The recent Supreme Court ruling in Wyeth v. Levine (which held that even when a drug has been approved by the FDA, the drug manufacturer can still be held liable under state law) has garnered a lot of press.
But an even more frightening decision was rendered in CA in the case of Conte v. Wyeth.
McQuillan writes:

In Conte, a California appellate court ruled that those harmed by a drug don’t have to settle for suing just the manufacturer: now they can sue the inventor as well....The case involved plaintiff Elizabeth Conte, who claims to have suffered severe neurological problems after taking a generic version of the antacid drug Reglan. Conte first sued the generic drug’s manufacturer, alleging that the company was liable for the injuries caused by its product. But then she filed suit in California state court against Wyeth, the inventor of Reglan, though she had never taken Wyeth’s product. Incredibly, the appellate court ruled that Wyeth was legally liable for any adverse effects caused by the generic version of its drug. The makers of the generic product got off scot-free....In January 2009, the California Supreme Court decided not to review the decision, so it’s now Golden State law. Wyeth’s warning labels, and those of other drug inventors, will now apply not just to their own products, but also to those of other companies, which they do not control....The Conte ruling carries extremely harmful implications for drug innovation. The typical pharmaceutical company spends more than $1 billion developing a new drug and bringing it to market through a complicated approval process. Given current patent law, the company has just a few years to recoup its investment before generic drugmakers can enter the marketplace and churn out copies sold at a fraction of the original’s price. Making drug inventors responsible for problems with generics makes drug development that much more expensive—so much so that many companies will likely no longer be able to afford it. They’ll pull out of the market, and pharmaceutical innovation will decline. Conte also guarantees that pharmaceutical-company resources that would have been used for R&D will now be spent on legal defense.

In the long-run, the societal costs of these decisions will be staggering. Innovation will be stifled.
Drugs that could be developed that will save and/or improve people's lives will never leave the lab. It truly amazes me that the courts can arrive at these type of conclusions and that these types of decisions can actually be rendered.

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