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It's the kind of tragedy that leads to difficult legal decisions.  A woman took a generic drug, prescribed by her doctor for an on-label use approved by the FDA. She developed a rare, but known, side-effect, and suffered serious permanent damage.  Who's at fault?

The story in today's New York Times concerns Karen Bartlett of Plaistow, NH, who took sulindac.  It's a pain killer in the NSAID category.  The brand-name form, Clinoril, is made by Merck and was approved by the FDA in 1978.  The generic sulindac was made by Mutual Pharmaceutical. Ms. Bartlett got Stevens-Johnson Syndrome. Her skin began to fall off.  She was comatose for months and ended up legally blind, disfigured, barely able to walk, unable to work.  Her life is basically ruined.

But there was nothing "wrong" with the drug; it was made correctly.  The label warns of possible side effects.  But the Supreme Court ruled a couple of years ago that generic drug makers cannot be sued for harm caused by drugs when the warning label was inadequate. Generic makers don't print their own labels -- the brand-name maker does that, and the generics have to copy it.  But the brand-name drug didn't harm the patient. So in that case, the patient lost.  In the Bartlett case, the label had a warning; the question is whether the generic maker gets the same protection in this case when the rare side effect occurs.  Had she taken brand-name Clinoril, she would have won damages from Merck.

There are only two bad outcomes possible within the American legal and medical system as it exists.  So the Times article, and the Court, are ignoring the elephant in the room.

If Ms. Bartlett wins the case, then generic drug makers will be held liable for labels that they do not control.  This may discourage companies from making generic drugs, which are generally chemically identical to brand-name drugs but a lot cheaper.  Generics are one of the few things that lower the cost of medical care. At least in some states, pharmacists are required to substitute generics for brand-name drugs unless the doctor specifically says otherwise, and insurance companies much prefer generics.  (They aren't always quite identical, which is why substitution isn't always possible.)  Drug shortages might even occur -- they are already happening in some generics.  This would be a very bad outcome.

If Ms. Bartlett loses the case, then she and other patients who are harmed by drugs will be without recourse.  This would often leave them damaged without the ability to support themselves, and with no one to sue for the damages, no one to pay their ongoing medical bills.  This would be a very bad outcome.

Those are the two Sophie's choices, essentially whom do you kill?  It is the sort of philosophical problem that serious journalists like to raise, and that lawyers like to discuss.  It is also bullshit.

The two choices before the court are created by our medical system, which is designed to make profits for providers and insurers alike; it treats medical care as a discretionary product, like TV sets and vacation travel.  And it's created by our legal system, which has to find fault with someone in order to recover for damages.  The cost of the medical system is driven up by "defensive medicine", extra tests and procedures performed in order to avoid malpractice suits, but there are also bad doctors who need to be policed by the malpractice system that Republicans want to do away with.  If the patient has medical insurance, then her insurance company has every incentive to sue the drug company, lest its costs be raised.

This case wouldn't happen in mos of Europe.  Bad things happen there too.  But a true universal health care system, one run for the public's benefit rather than for private profit, would simply cover the patient's medical needs for the rest of her life if necessary.  Social insurance would cover her living expenses since she was disabled.  If the drug company was truly at fault, they could be sanctioned.  But if it's just bad luck -- one out of some huge number of patients has the bad reaction, but most patients are helped -- then drug regulators decide on whether or not a drug is worth the risk.  It would be a balance, not a battle.  The courts probably wouldn't even get involved.

That's why the two choices before our courts are so bad.  We are all about profits and lawyers.  Everything is about money.  Nothing is about people.  The business of America really is business, and to hell with the human collateral damage.  Until we rethink our medical care system holistically, and not just patches to the private system, we'll still be stuck with these bad choices.

Originally posted to Frenzy. Illusion. Shadow. Fiction. on Mon Mar 04, 2013 at 07:10 PM PST.

Also republished by Community Spotlight.

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How should harm from generic drugs be handled?

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Comment Preferences

  •  maybe not pertinent to this frightening story, but (17+ / 0-)

    in my letter to President Obama re: his apparent support of chained CPI for SS recipients, one of the questions I asked him was, how does a senior "buy down" when he/she is already purchasing the cheapest generic medications available?

    otoh, maybe it is

    pertinent

    "Show up. Pay attention. Tell the truth. And don't be attached to the results." -- Angeles Arrien

    by Sybil Liberty on Mon Mar 04, 2013 at 07:23:16 PM PST

  •  well said. (7+ / 0-)

    interesting comment thread here regarding sulfa derivatives which are often at fault for this type of reaction

  •  The label seems to be a red herring (4+ / 0-)

    Was it inadequate? Was it not the same label as is on the brand, therefore adequate?

    In that case, the brand company would pay had she taken the brand, and the generic company if she took the generic unless there is an issue with the label, in which case the generic company pays, and they sue the brand manufacturer for a faulty label.

    I hope that the quality of debate will improve,
    but I fear we will remain Democrats.

    Who is twigg?

    by twigg on Mon Mar 04, 2013 at 08:08:33 PM PST

    •  The label was inadequate, and it was the same (4+ / 0-)
      Recommended by:
      mungley, barbwires, MichaelNY, HiBob

      label as the branded drug.  She took the generic.  The Court has held that a person taking a generic drug can't sue the manufacturer of the generic over an inadequate label because, by law, the generic MUST have the same label as the branded drug.  

      I think what you're describing is a more workable system (she dues the generic, they sue the manufacturer), but that's apparently not the way it works.  She can't sue the maker of the generic at all (at least successfully).  

      •  Why was the label inadequate? She took (0+ / 0-)

        the drug via prescription. The doctor had a responsibility to know the side effects of the drug, and the drug company had a responsibility to make the doctor aware it per a doctor's orders. The doctor should be informed of a drug's side effects beyond what a label would tell the patient. If that drug had any potential complications, it was the company's responsibility to make that known to physicians, who don't even see the label itself.

        The label itself should not be relevant at all. Based on the available information, I can only conclude that the label is indeed a red herring offered up by drug company's the legal defense team.

        Per the NY Times,

        "Ms. Bartlett’s case is slightly different because she did not argue that the drug’s warning label was inadequate. She claimed that the drug itself was defective. But Mutual has contended that the rationale is the same since, like the label, it has no control over the drug’s design."

        Unless the diarist can add information not available in this diary, it sounds like the diarist is playing along with the drug company's bullshit. Based on the information here and in the Times, there absolutely was something wrong with the drug itself. Just because the generic drug was the same as the drug manufactured by Merck does not mean there was nothing wrong with the drug. If a generic drug has dangerous side effects, the generic drug is liable regardless of its similarity to a brand name drug.

        On the other hand, it's totally inappropriate for a brand name company to dictate what's on a generic's label. I do think the diarist has brought up an important issue.

        •  I'm not "playing along" with anyone (5+ / 0-)

          Drugs have side effects and even good drugs occasionally result in bad reactions.  Because we have a broken health care system, victims of really bad luck have to rely on tort claims to cover their harm.  Taking drugs off the market would result in even greater harm, spread among the many people who lose the use of the drug.  And there are few drugs that never lead to bad reactions.

          •  IIRC, there is also a problem with some generics (4+ / 0-)
            Recommended by:
            barbwires, Bright, MichaelNY, HiBob

            because they need not be identical in ALL respects to the branded product, so it is possible that a generic's different formulation of parts of a drug may act differently.

            •  True (1+ / 0-)
              Recommended by:
              MichaelNY

              My family does pay extra for some brand name medication precisely because the generic apparently caused side effects.  But in such cases, harm caused by the generic's difference could be charged, I'm pretty sure, to the generic maker.  The problem in these two cases is that the actual brand-name drug can cause the occasional side effect, and that risk naturally happens with the generic as well.

    •  Generics are not always chemically equivalent (6+ / 0-)

      to the brand name products - instead the FDA requires them to be "biosimilar' (or some such thing).

      Therefore is seems really strange that generics would not be required to have their own labeling requirments - in particular regarding the "inert" ingredients that can vary from the generic to the brand name formulation (and in this case "inert" does NOT mean what one might assume it does . .. .).

      •  The term is "bioequivalent" (6+ / 0-)

        Which the FDA defines as:

        "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study."
        To use the drugs mentioned in the article:

        Sulindac, when given in the same manner, and in the same dosage, as Clinoril, must produce the same amount of the same active ingredient** in the blood (or wherever it is active) over the same time span.

        **Sometimes the active ingredient is not the thing in the pill, but a compound it's converted to in the body. The amount of that "active metabolite" must then be the same.

        We don't want our country back, we want our country FORWARD. --Eclectablog

        by Samer on Tue Mar 05, 2013 at 07:43:08 AM PST

        [ Parent ]

        •  "Moiety"? Sheesh. (4+ / 0-)

          Gee thanks, FDA, that makes it perfectly clear.

          I read up on "moiety" in Wiki, and it looks like the FDA could have simply said "active ingredient or ingredients", since "functional group" is one of the definitions.

          But then, when I read "molar", despite my teeny bit of chemistry education, I think "having to do with a small, blind mammal with really big front feet".  Which seems appropriate;  "the International System of Units ...... The seventh base unit, the mole, was added in 1971 by the 14th CGPM".

          I am become Man, the destroyer of worlds

          by tle on Tue Mar 05, 2013 at 09:01:45 AM PST

          [ Parent ]

          •  "Moiety" is a perfectly cromulent word (2+ / 0-)
            Recommended by:
            LilithGardener, HiBob

            Although I'm not sure they (yet) have a day named after it, like they do for Mole Day (October 23, of course!).

          •  In chemistry each of the words (6+ / 0-)

            in your comment have distinct definitions.

            In chemistry a moiety is part of a molecule; it may be a functional group, or not. It might be a kind of molecular scaffold.

            A functional group is a subset of moiety. An acidic group or a basic group is a functional group (there are many other kinds). A lipid, one that is a fatty acid, has two moieties (an acidic head, and a carbon chain tail), but only one functional group (the acidic head).

            In pharmaceutical science and active ingredient is the molecule that eventually has medicinal action within the body. (Which is not the same as a drug). All the other ingredients in the pill or capsule or solution are inactive ingredients. Not because they have no chemical effects, but because they have not therapeutic effects within the body.

            Molar is a useful chemical unit of measure the same way a dozen is a useful unit in food. A dozen eggs is a useful number for farms and groceries and consumers as they conduct their transactions.

            A mole of molecules is a useful unit in chemistry. 1 Molar salt or buffer solutions, saline has a definite molar concentration of salt and buffer, millimolar or micromolar concentrations are used to report measured amounts of things in a blood sample.

            Hope that helps make it a little less like Greek.

            "They did not succeed in taking away our voice" - Angelique Kidjo - Opening the Lightning In a Bottle concert at Radio City Music Hall in New York City - 2003

            by LilithGardener on Tue Mar 05, 2013 at 06:47:18 PM PST

            [ Parent ]

          •  Pure water is 55 molar (1+ / 0-)
            Recommended by:
            Roadbed Guy

            That's because 1 Liter (a unit of volume) is big enough to hold 55 moles of water molecules (at standard temperature and pressure).

            Molar = moles per Liter

            1 mole = 6.2 x 10^23 molecules

            1 milliLiter = 1 cc = 1 cubic centimeter

            "They did not succeed in taking away our voice" - Angelique Kidjo - Opening the Lightning In a Bottle concert at Radio City Music Hall in New York City - 2003

            by LilithGardener on Tue Mar 05, 2013 at 08:48:24 PM PST

            [ Parent ]

        •  I was under the impression... (3+ / 0-)
          Recommended by:
          barbwires, MichaelNY, Roadbed Guy

          ...that bioequivalence in this case was defined as allowing a range of blood levels that was between 66% and 125% (or was it 75% and 133%, which would make at least a tiny bit more sense?)

          I know that many doctors refuse to allow generics in drugs where the therapeutic dose is close to the toxic dose, or where side effects rise steeply with dosage levels. (Many psycoactive drugs fall into this category, especially epilepsy drugs.)

          Why? Well, your pharmacy has you on a generic that gets your blood levels up to 125% of what the brand name drug would. You have your prescription adjusted carefully so that it is at just the right level. Six months later, without telling you or giving you any option at all, the pharmacy gives you your next prescription from a different generic company, one where the bioavailability is such that you end up with 66% of the brand-name drug instead of 125%. And suddenly you are literally at half the dosage that you were last week, and you have a seizure. Better hope you're not driving when it happens, too!

          Or, well, there's the other way, also. Suddenly doubling your dosage of anti-seizure medication can cause permanent brain damage, or all sorts of physical side effects, if you're not lucky.

          Generics are typically fairly safe just because there's a pretty broad band of therapeutic dose levels that will be effective and not cause too many problems. But a lot of doctors don't know which medications that's not true of, and in those cases generics can kill you, maim you, or just make your life miserable.

        •  Thanks for the input (0+ / 0-)

          however the term "biosimilars" also seems to exist

          But maybe that's not germane to the current discussion.

        •  That's a topic that really hasn't (0+ / 0-)

          been discussed in this case as far as I can tell: were the actual pills she took bioequivalent to Clinoril?

          Drug companies, especially generic drug companies, are often no longer manufacturers in the traditional sense. They're more like supply chain managers. They direct one contractor to procure  fine chemicals and synthesize the active ingredient; that contractor sends the batch to the next contractor who mixes the formulation, who sends it to the next contractor for fill and finish or tablet forming, and probably a fourth contractor for packaging. The next batch might be all different contractors, depending on who submitted the lowest bid. The "manufacturer" is responsible for paperwork, not manufacturing.

          Between all of the outsourcing and the low(er) profit margins, accidents happen.

          At a minimum in cases like these I would hope they ran basic lab tests to determine the composition of both pills remaining in her bottle and other pills from that batch. While the correct formulation of this drug is known to cause these side effects, it's still possible the severity was linked to problems like a higher amount of the active ingredient in the generic.

          In a case where they really need to answer a question of bioequivalence though, the only real way to do it is to run a small trial that looks at blood plasma levels.

  •  SKL - I am confused (7+ / 0-)

    Whether it's the brand name drug or a generic if the label lists as one of the potential side effects something that actually happens to the patient why would either be required to pay damages? I can certainly understand the liability if the label did not include a specific side effect and someone had a life altering reaction. However, what protection from liability does the label provide if it included the known, but rare, side effect in those cases where the side effect occurs? Is there any legal liability? Has Merck set up a no-fault payment schedule for patients who have these rare, but known, side effects?

    "let's talk about that"

    by VClib on Mon Mar 04, 2013 at 09:31:08 PM PST

    •  I think we're talking about a situation where (1+ / 0-)
      Recommended by:
      MichaelNY

      the label doesn't provide adequate warning - the person experiences a side effect that the manufacturer was aware of, but failed to warn of on the label.  

      •  There was a warning in this case (1+ / 0-)
        Recommended by:
        MichaelNY

        This is the second SCOTUS case on similar issues.  In one decided a couple of years ago, there was no warning on the label, but the generic maker was held harmless because they were not even permitted to write their own label.  The brand-name maker was held harmless because they didn't harm that particular patient.  Sort of a catch-22 in a tort-based system, dontcha think?

        In the new case, the label did have the warning.  The patient sued on grounds that the drug was simply defective and shouldn't have been marketed, even though it had FDA approval.  Typically the FDA approval does not get a brand-name drug maker off the hook.  But again the generic maker can only use the same label, warning and all.

        If the "biosimilar" generic were not identical and the difference from the brand-name drug were what caused the harm, then it would be a very different case, but there is no evidence that the generic was not a good copy of the original.

        •  KSL - if the rare side effect was on the label (2+ / 0-)
          Recommended by:
          Bailey2001, Wednesday Bizzare

          Why would either company have any liability? While I feel very sorry for the patient I would hope that is where the SCOTUS will come down on this one.

          "let's talk about that"

          by VClib on Tue Mar 05, 2013 at 08:18:10 AM PST

          [ Parent ]

          •  If the rare side effect were listed (1+ / 0-)
            Recommended by:
            LilithGardener

            the doctor and patient would have acted the same.

            If patients deserve compensation for side effects, that should be the case whether or not the side effect was listed, and the cost of the drug increased to reflect this cost.

            The most important way to protect the environment is not to have more than one child.

            by nextstep on Tue Mar 05, 2013 at 11:27:42 AM PST

            [ Parent ]

          •  I agree. If I take a pill that lists "possible (1+ / 0-)
            Recommended by:
            MichaelNY

            stroke" as a side effect and I have a stroke....should I be able to sue?

            Seems to me that the answer would be no I couldn't sue as I was warned via the label and I choose to take it anyway.

            •  What's to stop... (1+ / 0-)
              Recommended by:
              MichaelNY

              ...every drug manufacturer from just listing every possible side effect that could ever happen on a piece of paper that they distribute with every drug? That way they're never responsible for any side effect that ever happens.

              Or how about if you sell bicycles, and you put a warning message on the bikes that say 'these bicycles are sometimes known to fall apart, and if that happens while you're crossing a busy street you could be run over'. Does that mean that the manufacturer isn't liable for people who are run over because your bicycle falls apart while crossing a crowded street?

              The fact is, in the US, people who are harmed by your product have the right to sue you and recover damages, whether or not they were warned about the possibility that your product would harm them. There are limited exceptions to this rule, some specific (vaccines), some general (activities generally acknowledged to be very risky, although that's not always a defense). But in general, if you're harmed by a product, you can sue to recover the damages. It's how the system works.

              If you allow a simple warning to stop people from recovering damages, you have two societally unfortunate results: one, you have companies that issue lots of warnings and make increasingly unsafe products, in a race to the bottom that ends with lots and lots of dead people, especially poor people. And two, you end up with lots of people hurt by products that are either taken care of at taxpayer expense or, these days, are not taken care of by anyone and end up in miserable poverty, unable to work but (because of red state red tape and/or simple incapacity) often unable to have themselves declared disabled either.

              The current solution is that the manufacturer and/or seller of the product is liable for the damage it does. This gives them an incentive to make the product as safe as they possibly can, and also forces them to charge a little more per piece to cover the costs of people who might be damaged by the product anyway.

              It's not perfect, but give the record profits of the pharmaceutical sector, over and over and over again, it doesn't seem to be hurting people too much. (It's pretty clear that if they suddenly had no legal liability, prices wouldn't go down... profits would go up. Otherwise the profit margins on the drugs wouldn't be so high. And please, all you pharma-libertarians out there, spare me the lecture on drug development costs, because I know about a dozen times more about them than you do.)

              •  Fred - the label cannnot include side effects that (3+ / 0-)
                Recommended by:
                LilithGardener, MichaelNY, HiBob

                weren't presented in the clinical trials or that other drugs of the same class haven't reported as actually occurring. Drug companies cannot just create a laundry list of potential side effects and attach it to every drug label.

                I don't know what the current case law is on this point, although I will read some of the briefs after which I will understand this better. There is an assumption of risk issue if the side effect is on the label. As you note, in the case of vaccinations we know that if you give anything to ten million children a very small number of them will have devastating consequences. The vaccine manufacturers and the federal government have established a no-fault process by which the children are cared for without any formal trial process required and the companies, who fund a pool to care for the children, are not liable for any damages.

                It will be interesting to follow this case.

                "let's talk about that"

                by VClib on Tue Mar 05, 2013 at 03:20:23 PM PST

                [ Parent ]

                •  Currently, this is sort of true (1+ / 0-)
                  Recommended by:
                  VClib
                  Fred - the label cannnot include side effects that
                  weren't presented in the clinical trials or that other drugs of the same class haven't reported as actually occurring.
                  My understanding of the situation is that if even a single person reported a given side effect in the clinical trials (even if it was obviously not the fault of the drug) then it can be listed. And it's pretty obvious that during a large clinical trial, you will get an enormous number of symptoms that could be listed as side effects, including more or less every common, uncommon, and even rare (as opposed to 'very rare' or 'extremely rare') health condition you can think of.

                  In addition, I know that they can add possible side effects based on post-release reports, again even if there is not even a suspicion that it is actually related to the drug. (All they have to do is claim the possibility that it might be, there is no burden of proof.)

                  So no, they can't list every possible condition. But they can certainly get a good run-up at it. And that's only in the current situation; if the labeling actually gave them a solid defense against product liability lawsuits, I have no doubt that they would find ways to list orders of magnitude more side effects.

                  As for the assumption of risk, my understanding (coming at this as someone who knows more about drug trials than they do about this legal stuff) is that that is an awfully weak reed to depend on. (Liability waivers, for example, often seem worth approximately what you paid for them, in paper and ink.) The vaccine thing is a very specific case with very specific laws and protections, but so far as I know drug manufacturers are reliant on standard product liability law, which does not have anything like that.

                  I agree it will be interesting to see what happens, but honestly, I fully expect that product liability law will emerge from this Supreme Court very different than it currently is. I fully expect to see major changes in any part of the law that favors the individual over the corporation over the next ten to fifteen years, and I'm sure that liability law will be at the forefront of that.

              •  ok, well but what if you have to take the drug and (2+ / 0-)
                Recommended by:
                MichaelNY, HiBob

                you know about the side effects and the drug has been made as safe as possible....should you then be able to sue? How many lives are saved with certain drugs that have risks but the drug can enhance or save lives and so people decide to risk it?

                Should all cancer patients sue when the have the side effect of hair loss?

                What about the known issue of strokes with birth control pills?

                Asprin and Reye syndrome?

                RA medications and their mult side effects but highly needed?

                •  Who decides? (0+ / 0-)
                  you know about the side effects and the drug has been made as safe as possible....should you then be able to sue?
                  Who decides that 'the drug has been made as safe as possible'? Who decides that the bicycle has been made as safe as possible, and that therefore you being paralyzed by having it fall apart out from under you should not be considered the fault of the manufacturer?

                  In any case, you can disagree with the way the law works (although I personally think that, given our current legal system, there are no changes that could improve it without a radical overhaul of the entire concept behind the system) but the fact of the matter is, if you are injured by the product that you were sold, then you have the right to sue and collect damages, with limited exceptions.

                  •  Can you answer the specific questions I asked: (1+ / 0-)
                    Recommended by:
                    MichaelNY

                    Should all cancer patients sue when the have the side effect of hair loss?

                    What about the known issue of strokes with birth control pills?

                    Asprin and Reye syndrome?

                    RA medications and their mult side effects but highly needed?

        •  I doubt there is a legal theory to back this up (2+ / 0-)
          Recommended by:
          VClib, MichaelNY

          but I think that if the generic product was truly a product within spec, that the brand and generic should have to split liability.

          The brand because the are the innovator company who brought the drug to market, and the generic because they get to piggy back on the Brand's clinical trials and established market.

          The generic doesn't have to do all the clinical trials on their product. They don't have to show efficacy. They only have to show chemical identity of the active ingredient, equivalent bioavailability and toxicity of the active ingredient, and similar shelf-life.

          "They did not succeed in taking away our voice" - Angelique Kidjo - Opening the Lightning In a Bottle concert at Radio City Music Hall in New York City - 2003

          by LilithGardener on Tue Mar 05, 2013 at 06:53:32 PM PST

          [ Parent ]

        •  If the drug OR the label is defective (1+ / 0-)
          Recommended by:
          MichaelNY

          I think liability should attach to both the original and the generic manufacturer. The generic did not have control over the label; it had control over whether or not it chose to make and sell the drug, and the due diligence it exercised in that desision. As pointed out upthread, the patient should sue the generic manufacturer, the generic manufacturer should sue the original manufacturer.

    •  Shit happens (2+ / 0-)
      Recommended by:
      VClib, K S LaVida

      I think the real problem is that when you ingest a chemical there is some non-zero probability of something awful happening.  It isn't due to a defect by the manufacturer, or a failure to label (have you ever really read all the inserts that come with a prescription?).  It's due to the fact that everyone is unique, and some people are going to have an adverse reaction to just about anything.  (I still remember the first time I heard some people could die from peanuts, or some people can't eat wheat.)  This is an essential risk of taking anything.  
      Obviously, what needs to be in place is a form of insurance that pays for the out-lier patient reaction without having to determine whose "fault" it is.  It isn't anyone's fault.  Universal health care does this, but so would some kind of insurance that manufacturers pay into based on the sales of a drug and the incidence of adverse reactions to that drug.  

      I'm still mad about Nixon.

      by J Orygun on Tue Mar 05, 2013 at 08:35:21 PM PST

      [ Parent ]

  •  Nothing Is About People But Our Founding Sentence. (2+ / 0-)
    Recommended by:
    blueoasis, koosah
    Image Hosted by ImageShack.us

    We are called to speak for the weak, for the voiceless, for victims of our nation and for those it calls enemy.... --ML King "Beyond Vietnam"

    by Gooserock on Mon Mar 04, 2013 at 09:34:12 PM PST

  •  No one is at fault (13+ / 0-)

    It's just horrible, terrible, bad luck - something that happens in America every day.

    It's ridiculous to waste all this money litigating the case, when in fact the woman needs treatment and support whether anyone is at fault at all.

    This is I think one of the most important parts of single payer, an acceptance that if you have a medical issue, that it will be paid for and dealt with because you're a citizen and because you need care, without having to hope there's someone to blame.

    Fry, don't be a hero! It's not covered by our health plan!

    by elfling on Mon Mar 04, 2013 at 10:46:05 PM PST

    •  It's ultimately not a "blame" problem, it's a cost (2+ / 0-)
      Recommended by:
      BRog, Wednesday Bizzare

      problem. In that context, this

      This is I think one of the most important parts of single payer, an acceptance that if you have a medical issue, that it will be paid for and dealt with because you're a citizen and because you need care, without having to hope there's someone to blame.
      is naive in a nation of 325M+.
    •  Even in a single payer system, (1+ / 0-)
      Recommended by:
      samanthab

      you can't have drug companies lying about the side effects of medication, though.  PErhaps we would have a system where only the government would be able to go after the manufacturers, but still, someone would have to be able to prevent a drug company from just lying about potential side effects.

      •  But the side effects were known and labeled (3+ / 0-)
        Recommended by:
        elfling, Bailey2001, LilithGardener

        I agree that if a drug company hid side effects, then the government should go after them, vs. depending on an unpredictable tort system.  But in this case SJS was a known rare side effect.  Take a drug, take a risk.  I just read the label of a drug I will possibly be taking for the rest of my life and it has all sorts of scary possible side effects... but they're rare, and the drug is still fit for its purpose.

        Every drug label has scary warnings.  Allergies and bad reactions exist.  Peanut butter is good food but some people are allergic.  Fish is good food but some people are allergic.  Penicillin was a wonder drug that led to many follow-ons (alas, needed because resistance spreads faster than new drugs are developed) but many people are allergic.  Who covers these costs?  Typically it's the patient's own insurance, if they have any.  But in extreme cases, they like to hold the drug company at fault.

      •  Drug companies have an incentive to lie. (0+ / 0-)

        If the get fined or sued, it's small potatoes compared to the profits. I was on a drug that made me gain 10 pounds in 8 weeks, which is absolutely insane. Patients who were on the drug much longer and who had developed diabetes and other dangerous illnesses sued the drug company. The drug company had hidden evidence about the enormous potential for weight gain. The patients won, and the drug company still made money hand over foot.

        •  Rarely in the case of generics (3+ / 0-)
          Recommended by:
          elfling, VClib, HiBob

          Generics are sold cheaply; they don't have high profits.  The brand-name maker makes the high profits during the course of the patent, and after that the generic makers come in and sell at low prices.  By then the drug has been on the market a while so side effects are usually known.

          Only the brand name maker has any legal ability to create warning labels; generic makers must copy them verbatim.  Failing to disclose evidence should of course be a crime on its own.

          •  Ibuprofen as an example (1+ / 0-)
            Recommended by:
            ER Doc

            Ibuprofen (probably the most common NSAID in the world except for maybe aspirin) was patented in 1961 by Boots in the UK, divested production 20 years ago, and I don't think that production is sold in the US. The two big name brands of ibuprofen in the US are Advil (Pfizer) and Motrin (Johnson & Johnson) and of course there are several generic producers as well. The only way Pfizer and J&J can make money off ibuprofen is through advertising their products with a higher cost. The patents on ibuprofen itself have long expired and the only new patentable inventions would possibly be formulations (liqui-gels) and drug combinations such as with diphenhydramine (Advil PM).

            It is just as possible to suffer from Stevens-Johnson syndrome from ibuprofen sold as Advil or Motrin as it is from the generic branded and made by companies like Teva. If it is going to happen, it's just luck of the draw what name is on the bottle. The last couple of times ibuprofen has been known to be related to SJS were Nurofen made by Reckitt Benckiser and Children's Motrin made by J&J.

            I feel sorry for anyone who gets hit with these side effects that occur with extremely rare odds. But I don't see how any judgment could go against the manufacturer presuming all the relevant laws were followed.

    •  How do you know that it's no one's fault? (0+ / 0-)

      You're not privy to information regarding whether evidence was hidden. If a drug company hides potential for side effects, of course they are liable. You're playing along with drug company bullshit, too. If it's a dangerous drug- as the patient has contended- then someone is responsible, and that someone is the drug company.

      •  All drugs are dangerous (4+ / 0-)
        Recommended by:
        Roadbed Guy, ER Doc, barbwires, VClib

        I cannot state that emphatically enough.

        This is a rare side effect, and it was on the label. It's straight up known that a handful of people will have horrible results - and that thousands or millions will get good results.

        It is extremely likely, for example, that you or someone you love has taken a particular drug that put me in the hospital with a life-threatening illness. I was the lucky winner of side-effect lotto. My insurance company, my employer, my spouse, my family, and my savings all took a hit.

        If I had been a single mom waitress without health insurance, I probably would have lost everything.

        And yet, this antibiotic saves lives every year; it is in its own way a miracle drug.

        Fry, don't be a hero! It's not covered by our health plan!

        by elfling on Tue Mar 05, 2013 at 10:16:46 AM PST

        [ Parent ]

  •  Damn, that's a horrible side effect (3+ / 0-)
    Recommended by:
    Roadbed Guy, glorificus, qofdisks

    array right there..........

    yikes.

  •  I had a rare reaction to a (2+ / 0-)
    Recommended by:
    blueoasis, glorificus

    NSAID Daypril. Vision blurring. i stopped it right away. Doctor denied that it had happened. Ain't it grand when a doctor can see through my eyes? A friend also had tics develop on one. He also stopped, unlike his friend, who took them until the tics became permanent. Those things are dangerous.

    And the situation with generics sucks. Parent company should be held responsible.

    Only thing more infuriating than an ignorant man is one who tries to make others ignorant for his own gain. Crashing Vor

    by emmasnacker on Tue Mar 05, 2013 at 03:26:56 AM PST

    •  Yes, it really, really sucks when doctors (1+ / 0-)
      Recommended by:
      emmasnacker

      don't listen to you. It more than sucks, actually. It's downright evil to be so dangerously arrogant. This is how our healthcare system trains doctors to treat patients, and it's tragic. And this is a big part of why people turn to nutty homeopathic treatments and the like. They know they aren't being treated with respect by mainstream medicine, and they look elsewhere. They don't look to the right places, and they should find better doctors. But I get why they are frustrated.

      •  Patients do not have to be victims. They can ... (1+ / 0-)
        Recommended by:
        emmasnacker

        ... get educated, participate fully in their own health care, refuse to treat docs as demigods and make their own decisions while taking into consideration the advice of a professional with an advanced degree & experience.

        Penn State - Rug too small, dirtpile too big, not enough brooms.

        by WereBear Walker on Tue Mar 05, 2013 at 09:20:58 AM PST

        [ Parent ]

        •  The problem with statements like these... (3+ / 0-)
          Recommended by:
          emmasnacker, barbwires, J Orygun

          ...as admirable as they are in concept, is that not everyone has the time, inclination, literacy, intelligence, or wherewithal to become an active participant in every aspect of their life for which they hire experts.

          The reason we hire the experts is to be the expert and give us guidance. If you think that a man who (e.g.) never got past the 9th grade because he couldn't read is going to suddenly become an expert on his own health care, or should be expected to, then you are basically blaming the victim here. People should not have to have a solid grounding in pathology to be examined by a doctor for a fungal infection, or in pharmacology to be written a prescription, any more than they should have to have a fundamental understanding of microeconomics in order to open a bank account.

          Blaming people for not being 'educated consumers' basically relegates the bottom 1/3 of the income spectrum in the US to non-personhood, because they're too busy working three jobs, taking care of kids, and in extreme cases starving on the streets to become 'educated consumers' of medicine, law, or any of the many other fields for which this advice regularly appears.

      •  Well, I have to say that I've had some (0+ / 0-)

        damn fine results with a number of the nutty homeopathic tx. Studied with an herb man in my early 20s, learned a lot, and use herbs to this day. Have even had a couple of more intelligent and caring doctors quiz me on treatments that I've used, and approve of them, not because they really liked them, but because they worked.

        Only thing more infuriating than an ignorant man is one who tries to make others ignorant for his own gain. Crashing Vor

        by emmasnacker on Tue Mar 05, 2013 at 04:16:41 PM PST

        [ Parent ]

  •  The worst aspect of this situation is that this (7+ / 0-)

    poor woman now gets to go from being an unintentional victim of the American Corporate Health Care system to being thrown into that equally victimizing system of American Law...where corporations like Merck and Mutual Pharmaceuticals are considered to be "people," just like her.  

    Metaphors be with you.

    by koosah on Tue Mar 05, 2013 at 04:33:35 AM PST

  •  A solution might be how New Zealand (6+ / 0-)

    deals with those harmed vaccines - yes, there are some (almost literally this is a one out of a million type situation).

    IOW, the medical intervention does great good overall and should be allowed (or even encouraged) but for whatever reason, a few people are disproportionately (even horrifyingly) harmed.  

    There should be a mechanisms to compensate them without turning the whole affair into a titanic black and white struggle between good and evil .. . .. .

  •  Agree with the diary, but I would take issue (2+ / 0-)
    Recommended by:
    K S LaVida, BRog

    With the notion that the malpractice system is there to 'police bad doctors'. Unfortunately the malpractise system does not do even that. Studies have shown that only 2% of medical error leads to malpractise, as well as the fact that roughly a third of awards do not lead from demonstrable medical neglect or error; they are precisely this sort of happening to this unfortunate woman.

    Ultimately the malpractise issue is inseparable from the issue of providing healthcare to everyone. Solve one, and you go a long way toward solving the other. This does not make me popular with my physician or trial lawyer friends, but that is the way it goes. . .and certainly something I can live with.

    An empty head is not really empty; it is stuffed with rubbish. Hence the difficulty of forcing anything into an empty head. -- Eric Hoffer

    by MichiganChet on Tue Mar 05, 2013 at 05:48:18 AM PST

  •  Seems like (1+ / 0-)
    Recommended by:
    Samer

    The solution is to give generic manufacturers should be given more leeway on the labeling and required to take on the responsibility for those labels.

    They shouldn't be held responsible for inadequate labels if they have no say in what the label says, but they should be held accountable for the results of their product.

    "Don't be defeatist, dear. It's very middle class." - Violet Crawley

    by nightsweat on Tue Mar 05, 2013 at 06:48:51 AM PST

    •  It is very difficult to craft a regulatory scheme (6+ / 0-)

      that would permit generic manufacturers to adopt their own versions of labels and at the same time preserve consistency across labeling for all manufacturers' version of the same drug.  The concept underlying generic drugs as established under the aegis of the Hatch-Waxman Amendments to the Food and Drug Act, is that once a brand drug is off patent, a generic manufacturer can obtain permission to manufacture and market a "bioequivalent" version of the brand drug without recreating the incredibly costly safety and efficacy clinical trials necessary for original approval of the drug.  The assumption is that if the drug has the same active pharmaceutical ingredient(s) and the formulation is "bioequivalent", that is metabolized by the human body in the same way as the brand, it will have the same safety and efficacy profile.  Put simply, once the drug is in your bloodstream, your body can't tell what color the tablet is or who made it.  Not having to reproduce clinical trials (as well as greatly reduced marketing costs) are what permits generic drugs to be sold for as much as 10% or less of the cost of the brand equivalent.  Since the passage of Hatch-Waxman in the late '70s, this has saved consumers, and the healthcare system literally billions of dollars.

      But the flip side of not doing the basic science and not having access to clinical trial data, or to as extensive a range of post-marketing adverse event reports, is that generic manufacturers are not considered to (and in fact do not) have the information and perspective to evaluate warning issues as does the drug innovator (or the FDA).  Thus, the generic labels have to track the brand labeling word for word, and the brand manufacturer remains responsible for updating and revising warning language as new information comes to light.  The generics then alter their labels to reconform to that of the brand.  In many cases there are 5, 8 or more generic versions of a drug.  Even assuming that generics are deemed to have the base of information necessary to come to a judgment that a warning should be strengthened, if each manufacturer is given the leeway to adopt its version of warnings, a single drug could have 5, 8 or more sets of warnings leaving doctors with a chaotic picture to evaluate in trying to determine whether a drug is or is not appropriate for a particular patient.  The situation is further complicated by the fact that doctors generally have no idea which manufacturer's generic product a particular patient will be dispensed (luck of the draw depending on the pharmacy the patient patronizes) and virtually never actually read a generic label.  Doctors typically know drugs by their brand name and will look at the brand label if they look at any labeling at all.

      With due respect to all of the commenters above, and with appreciation for the kneejerk reaction that the big bad drug companies are marketing killer drugs completely without regard for patient safety in the sole interest of the bottom line, the legal issues posed by Mensing and Bartlett are really not part of a vast corporatist conspiracy, but are complex and unique legal problems without easy solutions.

      Something like the vaccine court model noted above may well offer a more efficient and more equitable compensation system than does the existing tort system, and designed properly might well get buy-in from industry and insurance interests that would be necessary to make it work.  But getting anything that sophisticated through a Congress as dysfunctional as this one, . . . well don't hold your breath.

  •  When drugs go Generic, FDA should write label (0+ / 0-)

    generics are essentially, public domain drugs.

    The most important way to protect the environment is not to have more than one child.

    by nextstep on Tue Mar 05, 2013 at 09:11:05 AM PST

    •  To be technical about it, if the "Reference- (2+ / 0-)
      Recommended by:
      K S LaVida, peagreen

      Listed Drug", ceases to be the NDA (or brand) drug, which happens if the brand name product is withdrawn by the innovator (for reasons other than safety, i.e., marketing concerns, etc.), that is exactly what happens.  FDA takes responsibility for maintaining the label.  However, as long as the brand drug remains the RLD, its manufacturer, as the entity which conducted the clinical trials and other basic research on the drug, remains responsible for the labeling, even if one or more generics are in the market.  In part, that is at the root of a further aspect of this controversy, which is whether the brand should be liable to an injured consumer, even if that consumer was dispensed a generic version of the drug.  Most courts to consider the question have said no, but a few have said yes, and this is still a very active area of litigation.

      •  In economic terms, the original drug company (1+ / 0-)
        Recommended by:
        VClib

        does not get any revenue when a generic drug company sells its product.  It does not make sense for the original drug manufacturer to have its potential liability increase whenever a competing company sells its version of the product.

        Drugs will have bad side effects.  If patients are to receive compensation from drug companies when bad side effects occur, the drug company that should pay is the one the patient purchased from, so drug companies can build into their prices the cost of future patient claims.  

        The most important way to protect the environment is not to have more than one child.

        by nextstep on Tue Mar 05, 2013 at 10:07:10 AM PST

        [ Parent ]

  •  thanks for the diary on this story (0+ / 0-)

    the discussion it has provoked is very informative.

    ..."For beauty," I replied. "And I for truth,-the two are one; We brethren are"... E. Dickinson

    by peagreen on Tue Mar 05, 2013 at 10:39:46 AM PST

  •  Great Diary, it's a catch 22 (0+ / 0-)

    Generics should not be sued for known side effects but originators (companies that get the drug approved) should not be sued for a product made by a different company.

    Universal Health Care is the first step in addressing issues like these. However, even with universal healthcare this is still a conundrum.

    Listen to Netroots Radio or to our pods on Stitcher. "We are but temporary visitors on this planet. The microbes own this place" <- Me

    by yuriwho on Wed Mar 06, 2013 at 02:43:26 AM PST

  •  Thanks for the diary (0+ / 0-)

    I didn't vote because I wanted to make two choices:

    Universal national health care should take care of her, regardless
    Yes, that's the ideal.
    Blame the brand-name maker who got it approved and wrote the label
    It is their fault for not noting a known side effect.

    Since, as you explain (I think I'm understanding correctly), the generic drug-maker by law has to copy the brand-name's label, it would be highly unjust and senseless to blame them in any way.

    I'm not sure how much she would get in the way of damages in a trial, but that would be for a jury to decide, if the case got that far.

    Formerly Pan on Swing State Project

    by MichaelNY on Wed Mar 06, 2013 at 04:52:17 AM PST

    •  In this case the label did have the warning (1+ / 0-)
      Recommended by:
      MichaelNY

      In the case that SCOTUS already settled, the lack of a warning on the label was held to not matter for the generic maker, since the generic maker didn't have the ability to fix the label.

      What makes the current case different is that the label did have a warning of SJS.  The plaintiff simply says that the drug was "defective", in the sense that any drug that ever causes SJS is defective, even if it works safely 99.9999% of the time (which sounds about right).

  •  Generic drugs are chemically identical....that (0+ / 0-)

    does not mean that they are the same as the brand name drug.....it is more like they are chemically similar which is a whole other ball game.  As someone who is sensitive to side effects of many medications both brand name and especially generic, this is a frightening case.  We are basically on our own at the mercy of these companies and our government's blind eye.

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