Big Pharma Goes Before Supreme Court To Get State Lawsuits Banned

“Pre-emption” is a legal doctrine that says the federal government can claim all regulatory power over an area or subject, barring states from acting on their own. The drug maker Wyeth has brought a case before the Supreme Court arguing that a woman in Vermont, who lost her arm due to a drug complication that Wyeth knew about but did not publicize, cannot sue them in state court because of pre-emption. Wyeth says that only the FDA has the power to regulate it—and since the FDA approved Wyeth’s drug label, it’s the FDA’s responsibility. We think Wyeth is pretending to care about federal-versus-state power in an attempt to weasel out of any responsibility.

We understand why Wyeth would pursue this line of reasoning—after all, if they win, then it will put an end to personal lawsuits against drug companies. But if Wyeth got its way, the result would require a huge expansion in the FDA’s role in bringing drugs to market and monitoring them afterward, because the FDA would have to shoulder the burden of responsible drug testing and labeling. If the FDA took over this responsibility, it would have to balloon to an enormous and almost certainly unwieldy government agency, and it would likely slow down the time it takes to bring new drugs to market.

On the other hand, it’s quite possible that the FDA would simply hobble along in an underfunded, understaffed state, paralyzed by bureaucratic jams and strangled by politicians and the lobbyists who feed them.

This is why we think Wyeth is being duplicitous, by arguing for one thing—greater federal regulation—while knowing that in reality, having only the FDA to answer to will mean less risk of being held responsible for mistakes, incomplete research, or inappropriate marketing.

We’re sure Wyeth would love to have it both ways, with limited regulatory oversight combined with the protection of a federal agency that’s largely toothless. We hope the Supreme Court tells Wyeth to pay the Vermont woman her $7 million—and to label its drugs more clearly if it wants to avoid such payouts in the future.

“Consumer Issues Top Supreme Court’s Docket” [NPR]
“Plainfield Pianist’s Case Could Affect Nation” [WCAX] (Thanks to Michael Belisle!)
(Photo: Getty)

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  1. ThinkerTDM says:

    Let me see- Wyeth, who has billions of $, versus a judge, supposedly looking out for the rights of the citizens.

    Money always wins, hands down.

    • ChrisC1234 says:

      @ThinkerTDM: “versus a judge, supposedly looking out for the rights of the citizens”

      and that is the invalid assumption that all of us tend to make…

    • agnamus says:

      @ThinkerTDM: Let me see- Wyeth, who has billions of $, versus a judge, supposedly looking out for the rights of the citizens.

      Money always wins, hands down.

      Ahem: Let me see- Wyeth, who has the constitution on its side, versus judges, supposedly looking out for the integrity of the constitution.

      The constitution usually wins, hands down.

      There, I fixed it for you. hth.

      • Applekid ┬──┬ ノ( ã‚œ-゜ノ) says:

        @agnamus: So, problems with drugs perscribed by physicians who are licensed within each state isn’t something the states should be involved in as far as restitution?

        If a state court proved that Wyeth withheld drug complication information that caused actual irrepairable harm (which it sounds Vermont did), why not let justice run the course?

        Where in the Constitution does it say medicine is a federal responsibility, anyway?

        • agnamus says:

          @Applekid: We shouldn’t let justice run the course here because we have a state judicial decision that conflicts with an FDA regulation under 21USC352. Aside from the whole preemption thing, from a “justice” point of view, I feel more comfortable with the FDA regulating my drugs (they’re experts, they’ve been doing it a long time, regulating drugs is their jobs) than VT supreme court justices (who don’t do full time drug regulation–they may be legal experts but they usually know nothing about drugs).

          Oh, and authority to regulate medicine comes from the commerce clause of the constitution. If it travels across state lines or could enter the interstate stream of commerce, Congress can regulate it. The 10th amendment says that any laws Congress legally passes trump state law when state and federal law conflict.

          • Trai_Dep says:

            @agnamus: The judiciary often – almost always, really – has to rule in areas that they’re not experts in. That’s what witnesses, sworn testimony and Special Masters are for.
            It’s why courts are set up the way they are: it’s a pretty good system that has worked well for, donno, 4,000 years?
            Or, are you suggesting that judges can only rule over issues they know intimately, and basically become a Bar Association?

            • agnamus says:

              @Trai_Dep: No, but I am saying that they don’t hear testimony of this sort every day. I trust the people that do much more than the people that don’t.

          • Applekid ┬──┬ ノ( ã‚œ-゜ノ) says:

            @agnamus: That whole “regulate interstate commerce” bit has been stretched waaaaay to far when it is used for pretty much every act of government ever. Talk about the mother of all loopholes.

            • Trai_Dep says:

              @Applekid: The most egregious example of this was when the Supremes barred states from decriminalizing medical marijuana.
              That is, “commerce” that doesn’t legally exist – or exists completely outside of the law – was used to stop states from providing alternatives to their desperately ill inhabitants seeking relief.
              If a rule is arbitrarily applied, it’s no rule: it’s a fig leaf.

            • agnamus says:

              @Applekid: Regardless of whether it should be the law, it is the law.

        • Inglix_the_Mad says:

          @Applekid:

          Right in article 22 of the conservative constitution:

          “And Lo, any power that might threaten the bottom line of a corporation is power devolved to the least likely to hold the corporation responsible.”

          I’d be fine with this, but isn’t this a Federalist vs State’s rights issue that’s been decided? I mean, should this happen, this company is expanding Federal power over the states. I thought Republicans were all gung-ho “State’s Rights?” Oh wait, that’s only on certain issues that they think will roll better for their point of view in that smokescreen. Sure as heck better not try the “State’s Rights” argument for “Right to Die” or “Medical Marijuana” because they ignore it then.

          This company should STFU and pay up. The judges of the Supreme Court that might wish to change this are changing how many years of case law? 50+? Talk about legislating from the bench, something Conservatives claim to hate. Oh wait, that’s bullsh*t too? What do conservatives stand for again?

          • agnamus says:

            @Inglix_the_Mad: Sorry, slick, but this massive expansion of federal power came from the courts that FDR packed with anti-states’ rights justices to get the New Deal through. See Wickard v. Filburn, 317 U.S. 111 (1942).

  2. Scuba Steve says:

    “Wyeth says that only the FDA has the power to regulate it-and since the FDA approved Wyeth’s drug label, it’s the FDA’s responsibility.”

    I prefer the pitchfork and angry mob regulations myself.

  3. kate (wink wink) the maverick says:

    How will this not end badly for the consumer? If the drug companies aren’t held responsible and they know they won’t be then they have no motivation to actually make drugs that help and not hurt people.

    • agnamus says:

      @kate (wink wink) the maverick: The motivation to make effective drugs comes from the (minor, I admit) check that doctors and insurance companies provide. If a medicine sucks, doctors won’t prescribe it and insurers won’t cover it.

      And the ability to litigate is almost always consumer neutral. In exchange for a greater ability to sue, you have to pay higher prices (to compensate manufacturers for risks inherent in products that they can’t control). When you can sue less often, you pay less.

      • equazcion says:

        @agnamus: While doctors will know if a drug is effective due to a prominent success rate, they won’t necessarily know if it’s caused dangerous side-effects in a small percentage of users, if the drug company was careless (or maliciously hid or downplayed certain results) in pushing a medicine through the approval process.

        Though I agree with you that the ability to sue is a double-edged sword since it raises prices for everyone. Still though, in my opinion, the companies shouldn’t be able to simply toss blame on the FDA for approving their faulty drug. If they can claim no responsibility for approved drugs, our drugs might get cheaper, but they might get a whole lot riskier too. Manufacturers need to know that if they make a drug that ends up harming people it will be their ass on the line, not someone else’s.

        • agnamus says:

          @equazcion: They’re not tossing blame to the FDA. The product is safe. A moron nurse stuck a needle in an artery instead of a vein. The woman in this case successfully sued in state court saying the box should have had a warning. VT tort law apparently holds that a label would have been justified (e.g. one extra cent per dose to cover the extra ink). But, drug boxes are regulated by the FDA–even if Wyeth wanted to warn patients that your nurse could screw you up with their product if (s)he sucks, they couldn’t do so without being fined by the FDA. The double bind sucked for Wyeth, and they shouldn’t be punished for the federal (i.e. uncoordinated) nature of our government.

          The manufacturer just shouldn’t be on the line here. Sue the h

          • equazcion says:

            @agnamus: That might be what happened in this particular case, but this action has wider implications than this one case. Wyeth is trying to put an end to all state lawsuits against drug companies. Or at least that is the assumption in this article, and since a Supreme Court ruling does tend to set a precedent, I have to agree.

            • agnamus says:

              @equazcion: This will only put an end to state lawsuits in very limited circumstances i.e. where the FDA has a regulation on point. To my knowledge, the FDA has no regulations that say “You can make unsafe drugs because we’re in the pocket of greedy corporations.” Sure, they have regulations that differ slightly (e.g. labeling requirements) from state common law, but it’s not doom and gloom. Regardless, the avenue of suing in federal court will remain. Drug companies lose in federal court all of the time.

      • @agnamus: You’re making a HUGE assumption about the role of doctors and insurers. A good number of doctors will always prescribe the newest and latest drug without thoroughly reading all the documentation (which is, to be fair, an enormous feat).

        These pharmaceutical companies have a very large monetary motive to release new drugs which have no generic equivalent and many times downplay the side affects or risks associated with the drugs they release. Just look at Bayer’s post heart-surgery drug Trasylol which is believed to have caused numerous deaths which Bayer either ignored in testing or ignored early warnings of the drugs failure.

        The FDA doesn’t have the means to test these drugs so they rely on pharmaceutical companies tests, and if they believe the tests are sufficient they approve it. But if the pharmaceutical company ignores a certain aspect which they had reason to suspect and the FDA doesn’t notice and approves it, under Wyeth’s view, the FDA would be liable and not the drug company.

        In my view, the threat of a major lawsuit is the only thing keeping the drug companies honest (or at least sort of honest). They argue for tort reform as cost lowering but are any of us to really believe they’ll voluntarily lower their prices once its passed? They’re obliged to their shareholders to create profits, which is one of the major problems of mixing capitalism and healthcare.

      • RStewie says:

        @agnamus: I like your idealistic approach to consumerism, but I have to point out the .44cal size holes in your theory.

        Doctors are regulary courted by drug companies, and on many occasions it can be noted that an ineffective drug with a vibrant marketing plan is regularly prescribed by doctors.

        Also, the right to sue doesn’t effect the price of drugs on the market to any degree noticeable to the consumer. The price of drugs are set by massive contracts held at levels MUCH higher than the consumer.

        That’s why Medicare/Medicaid got into so much hot water when the “Devil-Company” that is Wal-Mart laid the smack down on prescription drugs and started offering generics for $4. All of a sudden, it was noted that, if the right pressure were applied, the consumer COULD afford prescription drugs.

        But, again, I love your optimism!

    • katbur2 says:

      @kate (wink wink) the maverick:
      They of course have the motivation to make effective and safe medications. However, this does lead them further down the path of not sharing all possible side effects and risks that come with their treatments. I hope that there are consumer advocates who are on our side in this case.

      • kate (wink wink) the maverick says:

        @katbur2: I guess I didn’t phrase it well. I know they have to make drugs that help so doctors will prescribe them but I am afraid they will not release side effects and studies.

  4. Reeve says:

    I do not think a ruling that you can not sue in state court would mean the only enforcement would be through the FDA. Rather, no suit in state court would mean that plaintiff’s would have to sue in federal court. There may be certain disadvantages for plaintiff’s suing in federal court but I believe the characterization that people would only be able to enforce through the FDA is incorrect.

    • agnamus says:

      @Reeve: There would be effectively no enforcement for claims of this type.

      In short, Levine sued for and won a massive judgment in VT court on a claim that the manufacturer should be held liable for a mislabeled product. It turns out that if a nurse accidentally shoots Phenergan (an anti-nausea drug) into an artery, it’ll cause gangrene and amputation ensues. Levine lost and arm, and she argued (and won in VT on a claim that) the box should have had a better label. Something like “It’s not worth it to administer this product by push IV because your nurse could suck at her job. An arm isn’t worth being free of nausea sooner.” The preemption claim comes because pharmaceutical boxes are heavily regulated by the FDA. You can’t just decide what you put on it if you’re a manufacturer. The addition of such a warning may or may not have been in violation of FDA regulations.

      So Wyeth was in the bad situation where they either had to: (1) Do nothing and risk liability to people like Levine, (2) Change the box and risk a massive FDA fine, or (3) Yank the product from the market because some nurses suck at their job.

      The preemption argument is basically that if the federal government has the power to regulate something, it’s regulations always trump state laws and regulations because of that whole “highest law in the land” nonsense in the Constitution.

      So, in short, no, there would be no enforcement at all if Wyeth wins. Having a medicine label that is up to federal snuff obviously does not break FDA regulations. There would be no ability to sue under state law since federal law would now preempt any state-law claims a plaintiff may bring.

      I personally think Wyeth should win. Medicine is good, and all other things being equal, I’d rather they continue making medicine without fear of contradicting state and federal law. That’s what’s at stake here.

      • Reeve says:

        @agnamus: My point is there may still be a federal law claim that can be brought. I do admit that this may not offer as much protection for the plaintiff but it is still something.

  5. Jean-Baptiste Emanuel Zorg says:

    Wyeth says that only the FDA has the power to regulate it-and since the FDA approved Wyeth’s drug label, it’s the FDA’s responsibility.

    This is the exact same reasoning that the current administration used in 2003 to completely override State regulations and laws regulating banks – predatory lending laws, fair lending laws, consumer protection laws, you name it.

    This was at the height of the corporate greedfest. All 50 State Attorneys General opposed it. All 50 State banking superintendents opposed it. But the banks wanted it, and the lobbiests wanted it, so the Bush administration took it all the way to the Supreme Court, and won.

    And now we all see how well that worked out.

    Of course, since the banks won that case, it’s only to be expected that every other large interstate industry will push for the exact same thing. I suspect the end results will be about the same for the consumers.

    • Inglix_the_Mad says:

      @TinyBug:

      “State’s Rights” I love how Republicans toss that around during elections then conveniently forget it when a lobbyist cries.

    • jhurley03 says:

      @TinyBug: We are in the current financial crisis because of the Clinton administration, Democrats and “community groups” like Acorn. The meltdown happened during the Bush admin., but the Community Reinvestment Act of 1995 allowed for people to get mortgages that they couldn’t afford without documentation. Back in 2005, the Republicans(including John McCain, you can find the clip of him talking about it online) tried to get a bill going that would have regulated Fannie Mae and Freddie Mac, the Democrats, including Barney Frank, Chair of the House Financial Services Committee, said that the two companies are fine. He even said they were fundamentally sound back in July, a month before they collapsed.

      Plus, Bush never override anything, he made proposals for tougher regulation, which is what the Democrats are calling for 5 years down the rode, but they were just that, proposals. He wasn’t able to get them passed.

      I could keep going on, but the election is coming up soon, and I am sure you have to do a lot of research on Obama, so you can find some “experience” that he has, so you will feel justified for voting for him on Nov. 4.

      • Jean-Baptiste Emanuel Zorg says:

        @jhurley03:

        We are in the current financial crisis because of the Clinton administration, Democrats and “community groups” like Acorn. but the Community Reinvestment Act of 1995 allowed for people to get mortgages that they couldn’t afford without documentation

        Republicans have been in control of the House of Representatives for 12 of the last 14 years, the Senate for 11 of the last 14, and the Executive branch for 8 of the last 14 years. But this is the fault of Bill Clinton, the Democrats, and minorities? Please, do us all a favor as save the ill-informed partisan hackery for some other site.

        The CRA – which was passed in 1977, not 1995 – had nothing to do with our current situation. Not only were the majority of the institutions involved in the subrime crisis (and the subsequent mess) NOT regulated by the CRA, a recent study shows that CRA Banks were substantially less likely than other lenders to make the kinds of risky home purchase loans that helped fuel the foreclosure crisis.
        Here’s a good explanation: [www.newamerica.net]

        And while Congressional Democrats do share some blame for opposing stricter regulations on FM, Fannie and Freddie are only a miniscule part of the current crises.

        Plus, Bush never override anything, he made proposals for tougher regulation,

        Oh yes – George Bush, the champion of governmental regulation and oversight. Heh.

        Seriously dude, there is a lot to this crisis:
        – the repeal of Glass Steagall protections by the Financial Services Modernization Act
        – the exemption of extremely risky securities from regulation through the Commodities Futures Modernization Act
        – SEVENTEEN consecutive interest rate cuts by Greenspan,
        – combined with the never ending stream of rhetoric from the Whitehouse about the “ownership society”
        – which led to a feeding frenzy of epic proportions in the housing markets, and consumption in general
        – the abysmally stupid decision by the SEC to waive leverage rules
        – the illiquidity caused by the subsequent 30 to 1 leverage ratios when the mortgages started to go down the crapper
        – the 100 million dollar lobbying effort by the banks to change bankruptcy laws
        – the creation of ever riskier asset backed securities and collateralized debt obligations,
        – the agencies that rate securities and the fact that they get fees from the companies whose products they are rating
        – the use of credit default swaps to “insure’ these crap securities and the undercapitalization of said insurance
        – the fact that the financial forecasting models used by all these securities companies and hedge funds weren’t updated to account for all the newly created event risk associated with the newly created POS CDOs

        When you’re prepared to discuss the overuse of credit arbitrage by huge hedge funds combined with the bottomless greed of lenders which led them to abandon long standing lending standards like employment history, income, down payments, credit rating, assets, property loan-to-value ratio and debt-servicing ability just to sell more mortgages that could be bundled into unregulated, improperly rated securities and sold off to unregulated financial institutions in a chain of overlevereged, badly modeled, underinsured, unregulated transactions, when you’re ready to have that discussion, come on back and maybe you can sit at the grown-ups table.

        Until then, though, take your hacktackular partisan talking points and shove them back into the orifice you obviously pulled them out of.

        • Tiber says:

          @TinyBug: Not only that, but even if what jhurley03 said were true, if banks were being forced to hand out loans that were unprofitable or risky against their will, you can bet your ass they’d be throwing money around to lobby against it, especially if it left them so under-capitalized. And given the amount of power lobbyists have, some time in those 30 years they probably could have gotten it repealed if they had wanted to.

          From my understanding, NOTHING the government did on either side of the aisle caused the mess, so much as enabled it. Repealing the Glass Steagall Act allowed banks to sell these ‘investments’, but it’s not as if they were told to make as many bad loans as they want. In fact, other countries have allowed this type of trading, and they haven’t had a problem like this. No matter how much you try and spin this, it all comes back to the banks.

          Yes, some Democrats did get too cozy with lobbyists, and they do deserve the blame for that. However, this is a complex issue, so if you’re going to be finger-pointing, you’ll be needing a lot of hands.

          • Jean-Baptiste Emanuel Zorg says:

            @Tiber: “Enabling” is a good choice of words for the feds involvement. But I disagree that there was nothing they did that was a direct contribution – The consumer spending frenzy that resulted from the seemingly neverending stream of interest rate cuts was a huge factor in this entire mess.

            As you say, there’s plenty of blame to go around, but rather than blaming individuals, I like to lay the blame on attitudes and policies: Deregulation, less oversight, the free market will fix its own problems, deregulation, lack of transparency, the ownership society, deregulation.

            Those are what got us here.

            And as long as lobbiests for the big corporations can continue to line the pockets of the pols with hundreds of millions of dollars in campaign contributions, free dinners, trips, clothes, houses, vacations, blah blah blah it will not stop.

            Yes, we’ll probably fix it this time. Again. At an unbelievably enormous cost to our country. But until we have a fundamental shift in the way this country is governed, it will happen again 20-30 years from now regardless of any regulations that get put into place right now.

            • Tiber says:

              @TinyBug: Ok, I’ll grant you the interest one.

              Time does heal all wounds, including financial, but I don’t see anything to stop it from happening again.

              The Glass Steagal Act was formed because speculation was a contributor to the Great Depression. When the vote to repeal that part of the act came up, banks said that we could learn from our mistakes, and that we could regulate out the kinks.

              Then history repeated itself.
              I bring this up because it’s part of the issue of big vs. small government. Even if the government shifts in one direction, it’ll eventually swing back the other way. Unless we all subscribe to one ideology on government, which will never happen, no change in government will be permanent.

              • Jean-Baptiste Emanuel Zorg says:

                @Tiber:

                The Glass Steagal Act was formed because speculation was a contributor to the Great Depression. When the vote to repeal that part of the act came up, banks said that we could learn from our mistakes, and that we could regulate out the kinks.

                Then history repeated itself

                Indeed

    • href=”#c8187701″>keith4298: Cigarettes with vitamins — yeah, well-put. More than that even, it’s like putting the cigarette industry in sole control of selling treatments for lung-cancer.

      I’ve always said, making a private company profit from people’s illnesses was just *never* a good idea. Pure capitalism all but DICTATES that they’ll act like monsters in that situation.

  6. legwork says:

    Oh yea, I’d love to work at Wyeth.

    Must be kind of like 60yrs ago working on that cool V2 project, but aiming them for a quick visit to Mom & the kids.

  7. Wyeth is being duplicitous because all these ‘Big Pharma’ companies have lobbied to have the role of the FDA reduced to a mere rubber stamp agency. Since the government has the ability to determine who can or cannot sue them there will likely be far less litigation against the FDA than pharmaceutical companies.

  8. keith4298 says:

    ‘Big Pharma’ is acting a lot like ‘Big Tobacco’. The suppress information, claim that you can’t sue them, market to children, pay for bogus research….

    The only difference is that they make money by getting you sick AND making you better. It’s like cigarettes with vitaamins!

  9. Quilt says:

    I’ll just pop my Flintstone’s vitamins and hope things work out for the best for you guys down there in the states.

  10. FishingCrue says:

    Why is this even at the SCOTUS? Of course drug labels should be federally pre-empted. Otherwise there would be 50 states with 50 different requirements of drug labels. The real issue is whether compliance with FDA labeling requirements is enough. I doubt that this will case will be applied to all state court lawsuits against drug companies, merely those based on labeling.

  11. jhurley03 says:

    People could start going to health food stores, and stop taking most of these drugs that aren’t even needed. I know that people are probably going to say that they have to be on their drug, but we have people coming into our health food store everyday, asking if their is something they can take besides the drug they are taking right now, because it is expensive and has side effects. We put them on something that is normally a lot cheaper and has no side effects. They always come back in a couple weeks later and say that they our doing a lot better.

    I am 20 years old and have never been on an antibiotic or taken a prescription. I have never had anything worse than the flu and I have never been to the hospital. I normally only get sick once or twice a year for a few days.

    • FishingCrue says:

      @jhurley03: Don’t advise people to stop taking their medicine and replace it with supplements. Seriously. Don’t. You’re not a Dr. and you don’t have malpractice insurance.

    • Tonguetied says:

      @jhurley03: Get back to me when you’re 40…

    • tiatrack says:

      @jhurley03: Nothing has “no side effects,” and taking naturopathic drugs, with generally zero to few studies behind them, can have very serious health consequences. My husband is a nurse and has had a few patients that died when they took naturopathic drugs without the recommendation of someone without actual medical training.

  12. cf27 says:

    “failure to Warn” cases like this are a big problem, because there’s always an additional warning that could be attached. Juries, when faced with some person who had a rare, but serious, side effect will almost always say “But, you could have mentioned this on your warning label.”

    So, why didn’t they label? Did they want this woman to get Gangrene? Of course not. But, if companies had to anticipate all those minuscule possibilities up-front and label them, each drug would be accompanies by a book and their cost would go up accordingly (not just by the amount to print the book — it’s the research behind the book that’s expensive.) The bigger the book gets, the fewer people read it. In the end, it’s self-defeating: the warnings are all in a book that nobody reads. AND THEN, the lawsuits come out about hiding a “serious” warning on p. 76 of the book instead of on p. 1. The defense — “p. 1 has high-probability warnings; p. 76 has low-probability warnings, and this is a low-probability event” doesn’t stand up when the Jury is faced with somebody without an arm, even if he was the 1 in a billion.

    • equazcion says:

      @cf27: I dunno, I think an educated and reasonable evaluation of which of the most important warnings to include should have turned out including this one.

      I’m not a doctor so I can’t say how common it is for drugs to cause such serious effects if they’re simply injected into an artery rather than a vein. Is this a common thing nurses are expected to know the dangers of regarding injected drugs in general? If not, I think the company should indeed be held responsible for not including it in the warnings.

  13. AthaliaShako says:

    This case is more complicated than the limited coverage (and comments) here make it sound.

    First, ThinkerTDM – Wyeth’s money was certainly important in getting the case to the Supreme Court in the first place (litigation is expensive), but that money is unlikely to sway the Supreme Court. This is a federal preemption question, and financial resources are unlikely to persuade the justices on a question of constitutional law.

    Second, Reeve – There are very few areas of law that require a plaintiff to sue in federal court. State courts have an obligation to hear federal claims, and there is a very strong presumption in favor of concurrent state court jurisdiction. Basically, the only time you have to sue in federal court is when the Constitution (e.g., for maritime law) or a federal statute (e.g., for patents) says you do.

    Although a Wyeth victory would have the practical effect of limiting plaintiffs’ theories of recovery from pharmaceutical companies, the limitation itself would be narrow. The FDA already regulates labeling for prescription medication. Levine (the plaintiff) wants state and federal courts to be able to impose independent duties to disclose (i.e., additional labeling requirements) on drug makers – after the fact of an injury – under state tort law. Wyeth, in contrast, argues that complying with both sets of requirements would obstruct the FDA and sometimes be impossible for the pharmaceutical companies.

    Reasonable people could disagree on policy grounds as to whether a Wyeth victory would be “good” or “bad” for consumers. On the one hand, plaintiffs injured by a drug could no longer claim that an FDA-approved warning label didn’t warn them enough. On the other, if drug manufacturers had to comply with different labeling requirements in different states, or if they had to expend additional resources figuring out which uniform label would satisfy the requirements of all the states, you can bet that they’d pass those costs on to consumers. Add on top of that the costs of juggling competing and potentially conflicting labeling requirements (across states and with respect to the FDA), and you begin to suspect that in the long run a plaintiff’s victory here might leave consumers (a) with more expensive drugs and (b) more confused about the drugs they were taking.

    My point isn’t to shoot anyone down, but it’s important to realize that pharmaceutical companies provide goods that consumers, for better or worse, need. The pejorative connotations of the “Big Pharma” moniker distort the issues and hinder reasoned discussion of the issues. Before jumping on the “evil corporations” bandwagon and assuming that the corporate defendant must be on the “wrong” side, we should be careful to consider the actual impact a decision in its favor might have on consumers.

    • @AthaliaShako: Very insightful and I hear you, but I see a conflict of interest in the harm you seem to be saying appropriately comes to consumers as a result of tighter regulation. If, as you say, these are products the public largely *needs*, then why should it be okay for the companies that make them to raise their prices based on doing an appropriate amount of research and providing the necessary safety information? Of course, Big Pharma says “we have to”, but then they’re making profits in the thousands of percents and won’t disclose how much of that money is going towards their insane marketing efforts, versus research. I think that if it’s appropriate to regulate how much safety information a company that provides a necessary commodity like medicine has to offer, then it’s appropriate to regulate to keep their prices reasonable too. Wyeth and similar companies are operating on the assumption that they have a “right” to make huge profits off of necessary medicines, a claim I don’t think has any merit.

  14. LesterLicinus says:

    I am a lawyer who worked as a reporter on products liability issues for several years, so I know the preemption debate very well and I thought I would clear up a few of the misleading or wrong things said here.

    The article incorrectly equates an argument for preemption with an argument for an expanded federal role in handling injury claims. This isn’t true. Generally speaking, the current system is one in which the FDA has control which drugs may be sold (approval) and state laws for the compensation of personal injuries (aka, tort law) handle injury claims once a drug is on the market. The problem is that state tort laws require evidence relating to “defects” in a product’s labeling so some conflict between what the FDA says a label should say when it was approved and what a jury in New Jersey say it should have said to have prevented a specific consumer’s injury may not match up exactlly. Premeption is the argument that the FDA approval destroys the state claim. It is not an argument that the federal government needs to handle injury claims. In addition, there is no federal version of tort law for consumer injuries, so the result would be no lawsuits.

    Its important to realize this is a reletively new battle. The pre-Bush FDA always held the view that there was no real conflict because a jury’s decision isn’t a law or regulation and, therefore, as long as a state didn’t try to have their own mini-FDA everything was fine. The Bush-FDA changed course (they are now pro-preemption).

    Another point to consider is that when this gets to the Supreme Court injured consumers will clearly lose. Medical device manufacturers already won the same issue and the Court already hinted in that decision that they would do the same for drugs.

    Lastly, the drug companies position is already the rule in some parts of the country. Michigan is the major example. Michigan took away the right to argue that an approved drug label was incorrect, effectively imposing preemption through state law. Michigan’s law has even protected the manufacturers of some recalled drugs because the recall was voluntary and was still technically “approved” even when it was clearly pulled from the market as unsafe.

  15. SadSam says:

    I’m not on the big pharma side, but if each state can require a different label/warning for a drug then you may end up with a situation similar to the fruity alcohol drinks being banned in Utah. [www.usatoday.com]

    I don’t think it benefits consumers to have drug companies deciding they don’t want to sell drugs in a certain state because of labeling requirements. With preemptions folks who are injured by drugs can still sue but only in federal court.

  16. LesterLicinus says:

    FishingCrue: “I doubt that this will case will be applied to all state court lawsuits against drug companies, merely those based on labeling.”

    Merely? I think you don’t understand that drugs are inherently dangerous products so the only claim possible is a labeling/warning claim. In other words, nearly all drug company lawsuits are labeling claims (merely = 99% of all claims involving Vioxx, Phen-Fen, etc.) It would essentially mean no compensation for injuries from drugs of any kind (the only remaining claim would be that a drug company lied to the FDA = nearly impossible)

  17. SamsonPenguin says:

    What is your point when it comes to this case. The drug was being administered to treat post surgery nausea. I have never seen a supplement that had a recommended route of IV and treats post surgery nausea, and if there is, god help you if you start injecting stuff on your own right after surgery. Who do you sue when that goes wrong?

  18. darkryd says:

    The sad thing is – The FDA is easy to bribe.

    I know a couple of drug reps who say that research is easier to push through (or have ignored) at the Agency if a few favors are done here and there for certain FDA staff.

  19. AthaliaShako says:

    SamsonPenguin – you sue the practitioner and the medical facility for negligence. The plaintiff in this case already settled her claims against a physician’s assistant, the Health Center, and the supervising physician. After that she decided to go after Wyeth’s deeper pockets.

  20. lalaland13 says:

    I’d like to see an old woman sue Pfizer for giving her husband erections because she was quite happy that he got old and impotent and wasn’t harassing her anymore. I wouldn’t care if it was a good case or not. I’d just like to see it because I hate all those Viagra/Cialis/Bonerlicious commercials.

  21. soloudinhere says:

    The court documents state the facts of the case are as follows:

    In April 2000, Ms. Levine visited a local clinic to receive treatment for a migraine headache. The clinic gave her demerol for pain and the Wyeth drug Phenergan, which is an antiemetic (treatment for nausea/vomiting). She was administered Phenergan intravenously by “IV push” which is an accepted, “on-label” delivery method for Phenergan.

    The labeling on Phenergan does include language stating the risks of IV injection, and the language is pretty strong.

    The patient received the drug intravenously, but ended up losing her arm as a result of Phenergan being exposed to arterial blood as a result of an improperly given IV push.

    She settled with the clinic that gave the injection.

    At issue is whether the federal drug labeling regulations preempt lawsuits regarding product safety in state courts.

    I personally hope that this DOES preclude people from getting insane judgments against pharma companies in state courts. You have a right to receive retribution for your harm, but what about this woman’s arm or pain and suffering is worth $7 million?

    Disclaimer: yes, I do work for a pharma company. While I don’t think any of them are saints, the drugs we make do help the vast majority of people who receive them. I know as a development scientist I certainly don’t do what I do with the aim of “making people sick and then profiting off them.”

  22. watson_2001 says:

    I am sorry, but the writer of about this article is wrong about the legal points of this case. Wyeth will not be scot free if the case gets removed to Federal court.

    The case is really about whether a lawsuit should be litigated in state court in Federal court because Wythe is subject to a Federal administrative agency.

    Even if Wyeth wins and gets the litigation transferred to some Federal District Court, Wyeth would still have to litigate the case on its merits (in view of Federal Law/or even State Law).

    There are practical concerns for why a company would want to remove litigation from a state court (bias against the company, unpredictable outcome) versus a Federal court.

  23. mythago says:

    Now that the Big Pharma fans (and their lawyers, apparently) have weighed in, may those of us who actually represent consumers comment?

    The goal of federal pre-emption is to exempt pharmaceutical companies from ANY liability if their products hurt someone. If complying with the FDA label means no lawsuit, then all a company must do is make sure the FDA labels their products exactly as they want them to be labeled. It’s a ticket for Big Pharma to write its way out of any responsibility if its products hurt someone.

    “Strong language” can be left off – a company need only bury severe side effects in a laundry list of anything that’s ever been reported, then claim they “warned” consumers, even if those people never saw the label of the product used on them.

    As for the wailing about 50 states’ labeling requirements – nonsense. Most states’ regulatory agencies track the federal agencies; some have stricter labeling requirements. What this means is that if your label is good enough for consumer-hugging California, it’s probably fine for corporate slave states like Texas. You don’t need 50 different labels.

    Somebody mentioned that you can still sue, just not on failure to warn. I assume that person is a defense attorney, who knows darn well that by destroying one means of holding a company accountable, the chances of succeeding in a lawsuit go down – which means that lawyers are very unlikely to take your case, since they essentially work on contingency.

    • agnamus says:

      @mythago: It’s just not true that a drug company can unilaterally change an FDA approved label to accomodate state standards, even if the state’s preferred label is “stricter.” The Solicitor General had this to say in the United State’s amicus brief at pp. 21-22. Granted, the SG is making an argument here, but his seal of approval is pretty good. The court likes to side with him.:

      ” * * * the FDCA requires a manufacturer
      to receive FDA’s approval for a new drug’s labeling.
      21 U.S.C. 355(a) and (d). Because FDA’s approval
      strikes an important balance between, among
      other things, warning of risks and not overdeterring
      beneficial uses, manufacturers ordinarily may not modify
      designs or labeling approved by FDA without first
      obtaining FDA’s approval for the change. See 21 C.F.R.
      314.70; cf. Riegel, 128 S. Ct. at 1005, 1007 (discussing
      similar requirement for Class III devices). Here, for
      example, FDA instructed petitioner that the “final
      printed labeling * * * must be identical” to the approved
      labeling. Pet. App. 165a. Indeed, a unilateral
      modification of the labeling, absent special circumstances,
      can open a manufacturer to liability for misbranding
      the drug. See 21 U.S.C. 352(a); 21 U.S.C. 352(f) (Supp.
      V 2005); 21 C.F.R. 201.100(c)(1) and (d); see also 21
      U.S.C. 355(a). If manufacturers were free to make unilateral
      changes to labeling the day after FDA’s approval
      based on information that was previously available to
      the agency, the approval process would be greatly undermined
      and the agency’s careful balancing of risks and
      benefits thwarted. The Vermont Supreme Court’s view
      that “FDA approval of a drug label” is nothing more
      than “a first step,” id. at 15a, is therefore a fundamental
      misconception of the federal regulatory framework.”

  24. Catalyst says:

    I love when cases like this one come up. On the one hand, it completely conflicts with the right wing judiciary’s supposed world view (not expanding the federal government or intruding on the states). On the other hand, it’s their big, rich buddies.

    If we’re lucky, we can get another “this ruling applies to this case only” abortion of logical reasoning like Bush v. Gore, so they can help out their buddies but try not to make it look like a complete farce.

    If only Harriet Miers had got on the bench.

  25. Difdi says:

    What do you suppose will happen when the last legal recourse a citizen has, after being screwed, gets removed?

    Reminds me of a story (probably not true) of why this one Chinese Dynasty fell. Three farmers are sitting eating a meal. One of them says to the other that they’re late for work. The other asks what the penalty is for being late. The first says “Death”. The third one then asks the first two what the penalty for armed revolt is. And, according to the story, that’s how the revolution that toppled the imperial house got started…

    Once all legal recourses are removed, and any attempt to seek justice would require violating the law…who has any incentive to obey it?

  26. soloudinhere says:

    The briefs in this case are fascinating. The SCOTUS invited the solicitor general’s opinion, which is usually a pretty good indicator of the outcome.

    Reading Chief Justice Reiber of the VT Supreme Court’s dissent is also interesting.

  27. TechnoDestructo says:

    It’s easier to sleaze your way to getting what you want in one government than in fifty.

    That is why they are doing this.

  28. mythago says:

    The SG’s opinion in an amicus brief (which you quote a portion of, but don’t link to) is not a court ruling or a law. It’s not true that because he’s the SG that “the court likes to side with him” and therefore we can assume if the SG said it, that settles it.

    In any case, the big issue here is that to avoid liability, a company need only talk the FDA into putting what it wants on the label.

  29. AthaliaShako says:

    While it may look like Wyeth and other pharmaceutical companies are earning “profits in the thousands of percents,” it’s clear from their income statements that they are not. For instance, in 2007 Wyeth reported net profits of $4.6 billion on sales of $20.4 billion. That’s a healthy return, but it’s nowhere near the astronomical rate of return that the companies are often accused of hoarding. The income statement also gives you a sense of where the rest of Wyeth’s income goes – $6.3 billion for the cost of the goods sold, $3.2 billion to R&D, and $782 million on advertising. If drug ads are bad, then perhaps we shouldn’t feel too sorry for the drug companies spending millions of dollars every year on advertising. But they are disclosing that information, and you can see that they spent roughly four times their advertising budget on R&D.

    Drugs are products that consumers need in the same sense that food and gasoline are products that consumers need. If it’s not acceptable for drug corporations to earn profits, why should we allow food and oil companies to earn them? Notwithstanding the suggestions of some politicians that windfall profits taxes are a good idea, almost every (if not every) economist acknowledges that their practical effect would be to discourage investment and production in the industries affected. If we want more R&D, whether its in the oil or pharmaceutical field, we should hesitate before we reach out to take away the fruits of the producers’ past efforts.