WASHINGTON — The Supreme Court said drug makers can be sued in state court over alleged defects, even if the Food and Drug Administration has approved a medication’s use.

The 6-3 ruling undercuts years of business efforts to block state suits over the safety of products from motorcycle brakes to railway cars. “This is a very sweeping decision, with significant implications for areas other than the regulation of prescription drugs,” said Jay Lefkowitz, a former policy adviser to President George W. Bush.

Companies have long sought to establish federal rules as a single standard trumping state law, and enjoyed a push under the Bush administration to shield industries from negligence suits.

The case was brought by Vermont musician Diana Levine, who went to a clinic complaining of migraines. She was injected with antinausea drug Phenergan, made by Wyeth. Though the drug label permitted intravenous injection, it said “extreme care” was needed to avoid hitting an artery, because “likely” complications included “gangrene requiring amputation.”

That happened to Ms. Levine, whose right forearm was amputated. She sued Wyeth, alleging the label should have barred intravenous injection, and a state jury awarded her $7.4 million. Wyeth appealed to the Supreme Court, arguing that Ms. Levine had no right to sue, because the FDA approved the drug’s label.

Writing for the court, Justice John Paul Stevens concluded that Congress saw state liability laws as bolstering, not undercutting, the FDA’s mission of ensuring drug safety. With 11,000 drugs on the market in the U.S., he wrote, the FDA’s own advisory panels have said it lacks resources to protect the public.

A 2006 Bush regulation reversed prior FDA policy by declaring state law interfered with the agency’s mission. Justice Stevens wrote that the agency’s new position was “inherently suspect” because it supplied no supporting evidence and failed to follow procedures for public comment. “Congress has repeatedly declined to pre-empt state law,” he wrote.

Dissenting Justice Samuel Alito argued that being covered by federal regulation gave Wyeth immunity from state law. “This case illustrates that tragic facts make bad law,” he wrote.

Research:

WYETH v. LEVINE

http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf (Links to an external site.)Links to an external site.

Phenergan

http://www.drugs.com/phenergan.html (Links to an external site.)Links to an external site.

Oyez:  Wyeth v. Levine

http://www.oyez.org/cases/2000-2009/2008/2008_06_1249/ (Links to an external site.)Links to an external site.

FDA Fails to Protect Americans from Dangerous Drugs and Unsafe Foods, June 27, 2006

https://cspinet.org/new/200606271.html (Links to an external site.)Links to an external site.

FDA’s Special Agents: On the Job to Protect the Public, July 24, 2013 (Links to an external site.)Links to an external site. by FDA Voice (Links to an external site.)Links to an external site., By: John Roth

https://blogs.fda.gov/fdavoice/index.php/2013/07/fdas-special-agents-on-the-job-to-protect-the-public/ (Links to an external site.)Links to an external site.

The FDA, Preemption, and Public Safety

Lawrence O. Gostin (Links to an external site.)Links to an external site. (bio) (Links to an external site.)Links to an external site.

https://muse.jhu.edu/article/449652/pdf (Links to an external site.)Links to an external site.

S.954 – FDA Accountability for Public Safety Act114th Congress (2015-2016)

https://www.congress.gov/bill/114th-congress/senate-bill/954/text

Legal Basis for Liability in Product Cases

http://injury.findlaw.com/product-liability/legal-basis-for-liability-in-product-cases.html (Links to an external site.)Links to an external site.

Questions for your paper:

1. From a business standpoint, the medical field is constantly looking to new research and opportunities for cures. The FDA has supported this movement and allowed drug companies to bring out new drugs into the market that have promising results, yet may be experimental without enough data.  Research the drug Phenergan used in this case and find out how long this drug has been on the market.  When you’re done, based on your research, do you believe that the label which stated that “”extreme care” was needed to avoid hitting an artery, because “likely” complications included “gangrene requiring amputation.”” Was enough warning or is this a case of gross negligence? Should this drug have been banned all together due to it’s highly dangerous nature?   Explain your answer.
2.  In the brief, Oyez: Wyeth v. Levine, it states that, “the Court asserted that the manufacturer bears ultimate responsibility for the content of its labels at all times. The Court then rejected Wyeth’s argument that requiring it to comply with the state-law duty to provide a stronger warning would interfere with Congress’ purpose of entrusting the FDA with drug labeling decisions.”  Do you believe Wyeth’s argument regarding an interference was a convenient excuse, or can you find proof that in fact Wyeth is bring up a valid argument?  Be sure and cite your sources.
3. In the article, it states that, “Companies have long sought to establish federal rules as a single standard trumping state law, and enjoyed a push under the Bush administration to shield industries from negligence suits.” It also goes on to point out that “Justice John Paul Stevens concluded that Congress saw state liability laws as bolstering, not undercutting, the FDA’s mission of ensuring drug safety.” Where as, “Dissenting Justice Samuel Alito argued that being covered by federal regulation gave Wyeth immunity from state law. “This case illustrates that tragic facts make bad law,” he wrote. The questions posed in the case comes down to this, Should federal law preempt state law in a personal injury action against a drug manufacturer for failing to include an appropriate warning label where the drug in question met the labeling requirements of the Food and Drug Administration?  Should the FDA have this kind of protection?  Why or why not?  After doing research into this case, determine which side of the case you stand on, either Justice John Paul Steven’s conclusion or Justice Samuel Alito.  Explain your decision and discuss it with your peers.
4. Further, should any company, such as drug manufacturers who are regulated by the government, ever have complete immunity from being sued for negligence when they produce a product that is potentially dangerous to the public, or should strict liability always be applied, as it is for privately held companies who manufacture products?  Why or why not?
5. Based on your findings, and the acticle, “Legal Basis for Liability in Product Cases”, did Wyeth breach their legal duty of care to the plaintiff, Diana Levine?  Can all five basic elements be proven for negligence in this case? http://injury.findlaw.com/product-liability/legal-basis-for-liability-in-product-cases.html (Links to an external site.)Links to an external site.