Recent rulings by the United States Supreme Court may effect every consumer’s ability to raise claims against medical device manufacturers and drug manufacturers for injuries resulting from product defects.
Medical Devices
In February 2008, the U.S. Supreme Court ruled eight to one that FDA review and approval of medical devices, such as pacemakers, protects manufacturers from state lawsuits even if the devices do not work properly. The ruling applies to Class III medical devices, which are devices that receive the highest level of FDA scrutiny prior to approval. The FDA notes that “Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”
In this case, Charles Riegel died in 1996, after a balloon catheter inserted during an angioplasty burst. The catheter was a Class III medical device, which had been approved by the FDA after extensive testing, and was made by Medtronic.
The effect of U.S. Supreme Court decision is still being determined. The decision will likely limit the options of legal recourse available for consumers injured by medical devices approved by the FDA. The decision also appears to fall in line with existing federal law governing the FDA. Federal law prevents state law from pre-empting the FDA’s approval process for medical devices.
Drug Warning Labels
The U.S. Supreme Court, in March 2009, determined in a six to three decision that even if a drug undergoes FDA review, patients injured by that drug may still pursue state liability lawsuits against drug companies.
In this case, Diana Levine (a former guitarist) lost her arm in April 2000 after she went to a Vermont health clinic for treatment of a migraine. Wyeth's Phenergan drug (an anti-nausea drug) was injected into Ms. Levine by a physician’s assistant. For this particular drug, medical personnel have several options for injecting the drug, including:
- The "IV-push" (drug is injected into a vein and is the most risky injection method)
- Intramuscular injection
- A slow intravenous drip into a vein
Unfortunately, the injection in this case was made using the “IV-push” method and was directly injected into Ms. Levine’s vein. This course of action allowed the drug to reach an artery and immediately caused gangrene. A jury in Vermont originally found that Wyeth's label had inadequate warnings regarding the dangers of the injecting the drug through the “IV-push” method and Ms. Levine was awarded $6.7 million. The Vermont Supreme Court upheld the jury’s ruling in 2006, prior to the U.S. Supreme Court upholding the jury’s determination. Wyeth had argued that the warning on the drug was sufficient because it had been approved by the FDA, which the U.S. Supreme Court rejected.
The effect of this ruling is not yet known. One possible effect is that drug companies, like Wyeth, will likely fail in arguing that a case raised by an injured patient should be dismissed, simply because the FDA approved of the warnings placed on the drug’s packaging.
Medical Malpractice Representation from Paulsen & Armitage. Thank you for reading our blog. If you suspect that you or a loved one have been injured by a defective medical device or drug, please contact us for immediate assistance. Please note that our postings do not constitute legal advice and your comments will not be treated as confidential. If you wish to discuss your legal matter with us, please contact our office for a consultation.
