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SCOTUS: Plaintiffs can sue drug companies

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The U.S. Supreme Court says pharmaceutical companies can be sued in state court over alleged drug effects, even if the Food and Drug Administration has approved the medication and its warning label.

In what some are describing as a landmark decision Wednesday in Wyeth v. Levine, No. 06-1249, justices voted 6-3 against the drug giant and issued a major defeat to the pharmaceutical industry. The majority determined that the federal regulation and warning label approval doesn't preempt state laws and shield companies from damages as part of liability claims.

The decision is a blow to companies such as Indianapolis-based Eli Lilly, which have long sought to establish federal oversight as a single standard for preempting state law and had support from the Bush administration that pushed to shield pharmaceutical industries from negligence suits.

Critics say this Wyeth ruling could lead to a flood of litigation in state courts, while others contend it simply reinforces what should already be happening.

Indianapolis attorney Irwin Levine, who has no connection to this case but represents multiple plaintiffs against Wyeth in other cases nationally, said the SCOTUS decision makes a lot of sense.

"The FDA, which we all know is overburdened, underfunded, and can't even keep our food supply safe, is not the end all, be all for consumer safety," he said. "Drug companies wanted a free pass, but the court determined that the FDA approval is not a get-out-of-jail-free card."

Justices found in favor of Diana Levine, a once-professional musician who received a $6.8 million jury award in Vermont after she developed gangrene and lost her right forearm because of how Wyeth's anti-nausea drug, Phenergan, was administered. The trial court concluded that Levine's injury would not have occurred if the drug's label had included an adequate warning about the significant risks of delivering it by means of the IV-push method.

The court rejected the drug maker's arguments that the FDA had approved warning labels for the drug and that trumped state law under which the suit was filed.

"State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly," authoring Justice John Paul Stevens wrote. "They also serve a distinct compensatory function that may motivate injured persons to come forward with information."

Justice Stevens wrote a footnote that conceded the FDA has "limited resources to monitor the 11,000 drugs on the market," and he mentioned a series of studies lamenting the federal agency's inability to use its drug-approval authority to ensure that pharmaceutical companies are doing all that they must do to warn doctors and patients about the risks of new drugs and of the methods of administering them to patients.

Writing for the minority, Justice Samuel Alito called the ruling a "frontal assault" on the FDA's regulatory regime for drug labeling and that the warnings in this case sufficiently warned of the possible dangers.

"This case illustrates that tragic facts make bad law," he wrote.

"The unfortunate fact that respondent's healthcare providers ignored Phenergan's labeling may make this an ideal medical malpractice case," he later wrote.

Indianapolis attorney Scott Montross said he finds it refreshing that the court refused to accept the attempts to further extend the preemption limitation, which had come from a ruling last year denying plaintiffs the right to sue medical-device makers because of express language.

Justice Stevens' recognition that Wyeth received notice about 20 similar incidents but didn't attempt to strengthen the warning label shows the dangers of what could have happened in this case had the decision been different.

"(That) demonstrates how dangerous it is to cloak a manufacturer with any immunity, be it for prescription drugs or medical devices," Montross said. "The pre-emption doctrine removes the incentive to the manufacturer to monitor the use of its products and to take reasonable steps to protect innocent patients."

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  1. So that none are misinformed by my posting wihtout a non de plume here, please allow me to state that I am NOT an Indiana licensed attorney, although I am an Indiana resident approved to practice law and represent clients in Indiana's fed court of Nth Dist and before the 7th circuit. I remain licensed in KS, since 1996, no discipline. This must be clarified since the IN court records will reveal that I did sit for and pass the Indiana bar last February. Yet be not confused by the fact that I was so allowed to be tested .... I am not, to be clear in the service of my duty to be absolutely candid about this, I AM NOT a member of the Indiana bar, and might never be so licensed given my unrepented from errors of thought documented in this opinion, at fn2, which likely supports Mr Smith's initial post in this thread: http://caselaw.findlaw.com/us-7th-circuit/1592921.html

  2. When I served the State of Kansas as Deputy AG over Consumer Protection & Antitrust for four years, supervising 20 special agents and assistant attorneys general (back before the IBLE denied me the right to practice law in Indiana for not having the right stuff and pretty much crushed my legal career) we had a saying around the office: Resist the lure of the ring!!! It was a take off on Tolkiem, the idea that absolute power (I signed investigative subpoenas as a judge would in many other contexts, no need to show probable cause)could corrupt absolutely. We feared that we would overreach constitutional limits if not reminded, over and over, to be mindful to not do so. Our approach in so challenging one another was Madisonian, as the following quotes from the Father of our Constitution reveal: The essence of Government is power; and power, lodged as it must be in human hands, will ever be liable to abuse. We are right to take alarm at the first experiment upon our liberties. I believe there are more instances of the abridgement of freedom of the people by gradual and silent encroachments by those in power than by violent and sudden usurpations. Liberty may be endangered by the abuse of liberty, but also by the abuse of power. All men having power ought to be mistrusted. -- James Madison, Federalist Papers and other sources: http://www.constitution.org/jm/jm_quotes.htm RESIST THE LURE OF THE RING ALL YE WITH POLITICAL OR JUDICIAL POWER!

  3. My dear Mr Smith, I respect your opinions and much enjoy your posts here. We do differ on our view of the benefits and viability of the American Experiment in Ordered Liberty. While I do agree that it could be better, and that your points in criticism are well taken, Utopia does indeed mean nowhere. I think Madison, Jefferson, Adams and company got it about as good as it gets in a fallen post-Enlightenment social order. That said, a constitution only protects the citizens if it is followed. We currently have a bevy of public officials and judicial agents who believe that their subjectivism, their personal ideology, their elitist fears and concerns and cause celebs trump the constitutions of our forefathers. This is most troubling. More to follow in the next post on that subject.

  4. Yep I am not Bryan Brown. Bryan you appear to be a bigger believer in the Constitution than I am. Were I still a big believer then I might be using my real name like you. Personally, I am no longer a fan of secularism. I favor the confessional state. In religious mattes, it seems to me that social diversity is chaos and conflict, while uniformity is order and peace.... secularism has been imposed by America on other nations now by force and that has not exactly worked out very well.... I think the American historical experiment with disestablishmentarianism is withering on the vine before our eyes..... Since I do not know if that is OK for an officially licensed lawyer to say, I keep the nom de plume.

  5. I am compelled to announce that I am not posting under any Smith monikers here. That said, the post below does have a certain ring to it that sounds familiar to me: http://www.catholicnewworld.com/cnwonline/2014/0907/cardinal.aspx

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