The Supreme Court has now finished hearing oral arguments from the defense and plaintiff in Wyeth v. Levine, a case with profound implications for product liability litigation – specifically in the pharmaceutical industry. The decision will also set an important precedent for constitutional law, specifically in the way lower courts will interpret the doctrine of implied preemption in the future.
Derived from the Supremacy Clause of the Constitution, the doctrine of Preemption bars individuals injured by a product from filing a civil action in state court if the product complied with federal safety standards. Attorneys practicing in the field of product liability law, especially those who represent individuals injured by dangerous drugs should be closely following this development.
First, some background on the facts and procedural history of the case. The plaintiff, musician Diana Levine, began suffering from migrane headaches and turned to a local health clinic for treatment in April 2000. There, she was prescribed pain medicine as well as Phenergan, a drug manufactured by Wyeth for treating nausea. However, the physician’s assistant who administered the latter drug injected it into one of her arteries, rather than a vein — despite warnings on the drug’s label that doing so could lead to irreversible gangrene.
Tragically, as a result of receiving this negligent care, Levine ended up with gangrene and needed to have one of her arms amputated below the elbow. She filed a civil suit against the clinic and the PA for malpractice and received an undisclosed settlement out of court.
Then, in 2004, a jury in her home state of Vermont found that Phenergan’s label offered insufficient warning about the danger of that injection method compared with two other, safer ways to administer the drug and awarded her $6.7 million from Wyeth. The Vermont Supreme Court upheld the jury’s verdict in 2006.
This is where Levine’s lawsuit becomes enmeshed in the complexities of constitutional law, and why the Supreme Court agreed to hear the case. All of this will be fleshed out in a series of posts over the next few days. Stay tuned.
Here is some online reading for further background:
- Les Weisbrod at the HuffingtonPost.com
- Preview of Wyeth v. Levine at SCOTUSwiki
- Dan Slater at the WSJ.com Law Blog
Grant Richman Blog 
In trying to find any reason for preemption it appears there is basically only one argument for it and could be stated –
We (pharmaceutical companies) need freedom from product liability so that we can devote more of our profits to the development of wonderful new drugs and devices for the betterment of society.
This argument is based on a number of assumptions that are:
1. The financial weight of “frivolous law suits” has prevented the development and marketing of some number of products that otherwise would have improved or saved some number of lives. (the actual numbers are not known)
2. The increased but unknown number of new products that would/could be marketed if the industry had the protection of product liability immunity (preemption) would certainly in no way ever harm a consumer to the extent that the industry should be held accountable for this harm.
3. Without the protection of liability immunity suddenly, maybe over night, the unknown financial weight of product liability law suits could increase to an unbearable burden thought the proliferation of some number of “frivolous law suits”. We haven’t yet defined the “frivolous law suit” but it’s bad and it’s huge.
4. The manufacturer is not able to price its product to cover its failure and the cost of possible law suits; therefore it always loses money because of this unknown factor.
5. State tort is incapable of preventing frivolous law suits.
6. State torte is incapable of judging right from wrong when it comes to pharmaceutical products.
Or pharmaceutical liability resolution defies logic and is always based on emotion and results in unwarranted restitution.
Or a jury of citizens does not have the mental capacity to understand the testimony of industry experts.
7. The only reason for state tort is to make the consumer and his/her lawyers rich.
8. The FDA is the “gold standard”. Once it has decided that a drug is safe for consumption any other opinion should be considered frivolous.
9. Having to comply with liability will cause pharmaceutical companies to become confused by more than one opinion about the safety of their product as various consumers experience the ill affects of its product.
10. The FDA is properly manned, with up to date technology and has the capacity to approve and monitor all current and new products and manufacturing facilities – even after the gold rush of a liability free blockbuster heaven occurs through preemption.
11. The FDA is free of political and industry influence. It does its job with one goal in mind and that is the protection of the American consumer.
12. Pharmaceutical companies never try to falsely influence the approval of their products and will react quickly when they find a problem.
13. There is always a risk when taking any drug or device, therefore the industry does not deserve to live under the burden of accountability no matter how many people its product kills or injures.
Of course I’m being a bit facetious or maybe in the words of Daniel Troy, I’ve made it sound more like a Hollywood movie. As a matter of fact I wonder how close to Mr. Troy’s script I came?