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Changing the landscape for FDA approvals - Mass High Tech Business News
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state authority over drug regulation last month. The result may havelong-lasting impacts for drug researchers and manufacturers. By Guest Column: Four
affirming a multi-million dollar verdict in a product liability case -- Stay Informed
takeaways from the
rejecting a drug maker’s argument that a federally approved label bars settlement [April 7,
state law claims -- the court effectively required drug manufacturers to closely monitor side effects even after U.S. Food and Drug Patent Watch: Ideas
Administration approval. This decision deviates a bit from recent case to help keep your
law and deserves an explanation. There may also be implications for bottomline from
bottoming out
Bio patent lawyers
The case of Wyeth v. Levine involved administering Wyeth’s leave Lahive for
anti-nausea drug Phenergan by the “IV-push” method. Susan Levine, a McCarter & English
professional musician, suffered from migraines and received a needle- with-plunger injection of Demerol (for the headache) and Phenergan (for nausea). Because the latter drug accidentally entered one of Devices: Protect IP
for combination
Levine’s arteries – rather than a vein, as advised by the label – products carefully
gangrene set in that resulted in the loss of Levine’s arm, and her Patent Watch: New
patents in
prosthetics and
Levine sued on state law grounds, and a jury found that because the cyberkinetics
risk of gangrene and amputation could be almost always avoided by the “IV-drip” (a drip bag using saline solution) rather than the“IV-push” method (as was used). Wyeth was negligent and that IV-push-administered Phenergan was a defective product. Wyeth had been aware of the gangrene risk since at least 1967.
Wyeth’s defense relied on FDA approval, and therefore federal “preemption” of state law.
The FDA approved Phenergan in the 1950s, subject to labeling that included a generalgangrene warning. But over the years, even as Wyeth became aware that the IV-dripmethod all-but-eliminated the catastrophic risks, the company did not sufficiently update its label. After all, it argued, the label described the risk, and the FDA had approved thelanguage.
The Supreme Court held that Wyeth had a duty to update its labeling to reflect theknowledge that it acquired over the years. (Interestingly, Congress authorized the FDA onlyin 2007 to compel label revisions in the face of new [adverse] information.) FDA requirements, according to the court, are a “floor” and not a “ceiling” for state regulation.
The Wyeth result –- allowing a tort case to proceed even though there was FDA approval –- initially appears to contradict the Court’s decision a year ago in Riegel vs. Medtronic. There,the Court reviewed a different statutory section, which empowered the FDA to reviewmedical devices prior to introduction and explicitly pre-empted state regulation. As a result,the court in the 2008 Medtronic case barred state tort claims arising from damage caused by FDA-approved medical devices. (Further complicating matters, in a 1996 device caseinvolving Medtronic and a still different section of the statute, the court found that state tortclaims were not preempted.) Because the applicable federal pre-emption provision for drugs is narrower, the Wyethdecision came out the opposite way (i.e., against the manufacturer). This means that even after FDA approval, drug makers have a duty to monitor their products and update their Changing the landscape for FDA approvals - Mass High Tech Business News
ili.ate publications:, Boston Business Journal,,, Finally, there is an unanswered question for device manufacturers: Having obtained FDA approval, what obligations do they have when a defect comes to light after approval?Justice Ginsburg, the sole dissenter in the 2008 Medtronic case, raised that question in herfirst footnote in that case. The question for the future is whether the court will find the statutory device preemption language (whether-or-not subject to a product recall) or apattern of post-FDA-approval harm to be more compelling. And for observers who assumedthat there is a reliable pro-business majority on the Roberts court, the Wyeth decisionsuggests a less certain result than the industry might prefer.
Matt Henshon and Terry Klein practice at the Boston-based boutique of Henshon ParkerLLP. They have no attorney-client relationship with any company named in this article. Comments
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