SCOTUS Shields Generic Drug Manufacturers From Liability

by Crane-Station
cross posted at Firedoglake/MyFDL

In July of this year, The Supreme Court of the United States (SCOTUS) issued an Orwellian 5-4 opinion that shields generic drug manufacturers from liability for harm caused by generic ‘equivalent’ drugs. Karen Bartlett, a New Hampshire resident, sued a generic drug manufacturer after the drug caused permanent disability and disfigurement. After Ms. Bartlett emerged from a coma, she endured thirteen surgeries, and remains legally blind. Justice Alito, who authored the majority opinion, called her situation “tragic,” but then essentially told her and all others in her life-altering situation to go pound sand.

To put it mildly, this SCOTUS decision is horrendous, because it leaves people like Karen Bartlett and others, who are harmed by generic drugs no recourse whatsoever. As Justice Sotomayor states in her dissent:

If manufacturers of products that require preapproval are given de facto immunity from design-defect liability, then the public will have to rely exclusively on imperfect federal agencies with limited resources and sometimes limited legal authority to recall approved products. And consumers injured by those products will have no recourse.

What Justice Sotomayor is saying in her dissent is that when Congress passed the Food and Drug Act, it meant to protect people; it did not pass a law that says one has no remedy when harmed, by removing any basis for a lawsuit in the state courts.

However, the majority disagreed, relying on the supremacy clause to flip the bird both to state courts and to victims of harm. SCOTUSblog explains ‘in plain English:’

In this case, the label in question did not mention the side effect that caused the injury (which took the form of third-degree burns on much of the plaintiff’s body). The answer is that the plaintiff cannot sue the manufacturer. Because the FDA has approved the product and the label, the state court cannot impose damages for harm from using the product.

Ironically, had Ms. Bartlett taken the brand version of the same drug (Clinoril, marketed by Merck), she could have sued Big Pharma, when she suffered from Stevens-Johnson Syndrome, the life-threatening skin condition that she contracted after taking sulindac, the generic version of Clinoril. In an article titled Supreme court rules it’s o.k. for drugs to hurt you, Eric L. Zielinski explains:

In March 2009, the Supreme Court ruled that consumers could sue Big Pharma companies for damages if they were harmed by brand-name drugs.

Directly going against this historical landmark decision, the Court’s decision against Bartlett surprisingly gives generic drug companies a new-found immunity. However, this is not the first time the Court has ruled against common sense and integrity.

According to L.A. Times, “The court has now handed down two rulings that have closed the door to lawsuits from people injured by a generic drug.” With 80 percent of FDA-approved drugs on the market being made by generic sources, this puts most Americans at an unreasonable risk of being harmed and having no retribution.

(my bold)

The Elephant in the Room: Brand versus Generic

What is not addressed in the SCOTUS ruling is this elephant in the room: While generic drugs may contain the same key ingredient (in some amount) as the brand drugs, nobody purchases a generic drug because it is more effective than the brand version. People purchase generics because they are cheaper. Often, these generics are less effective or even ineffective. As David DiSalvo of Forbes explained in October of 2012:

For years we’ve been told that generic drugs are equivalent to brand names in every way that matters. Well, guess what, that’s not necessarily so; the Food and Drug Administration (FDA) just pulled a generic for the antidepressant Wellbutrin off pharmacy shelves for not being as effective as the brand name.

Are you surprised? I am not. I suffer from debilitating migraine headaches, so when the drug I take to abort these headaches (Imitrex) came off patent, making the cheaper generic version available, I was elated. However, effectiveness of the generic version of Imitrex is not the same as brand. Just last month, I ended my relationship with CVS pharmacy, because they sold me sumatriptan (generic Imitrex) that not only was ineffective; it made the headache worse. When I reported my experience to the pharmacy, they refused to look into it.

Victoria L. Dunckley, M.D. reported for Psychology Today in 2012:

I recently met a rep from a well-known chemical company (whose name I won’t mention) who had traveled to India to visit their generic drugs plant. “Let me tell you something,” she said. “Anyone that says that generic drugs are the same as brand name is lying.” She went on to tell me how appalling the plant conditions were, and that there were major safety and contamination concerns.

With this SCOTUS ruling, generic drug manufacturers are off the hook. What is extra appalling is the transparent double standard that once again favors the rich. If you are wealthy enough to purchase brand-name drugs, remedy is available through state court, in case of a harmful drug-related event, but if you are not all that well-off (and that includes the 80 percent of America that consumes generics), and you experience a generic drug-related harm, there is no remedy.

note: The history, analysis, events, opinion and related opinions of this case (Mutual Pharmaceutical Co. v. Bartlett), including the Petition for Certiorari and briefs are available here. The “80 percent” number, and other statistics on pharmaceutical spending are in the report titled The Use of Medicines in the United States: Review of 2011, by IMS Institute for Healthcare Informatics.

Also, at the end of the video is a link, with more information.

42 Responses to SCOTUS Shields Generic Drug Manufacturers From Liability

  1. Boyd says:

    Shelly Zimmerman’s back in the news carefully setting up her big payday

    • Trained Observer says:

      SheLie and Fogen are both opportunists, but her opportunities seem to have the upper hand at present.

      • ay2z says:

        and both are in this morning’s news. OS makes SZ look like a liar by their misquote of what she says on Today show, by saying ‘hand on hip’ (gun), but what she actually says is unbuttoned shirt and hand in shirt, so OS writer and editors, is at fault for their misquote, clearly.

        Two incidences, every week, this is every week. GZ stopped for infractions again (Brevard some time ago), what’s he doing, the county-country speedo tour? (video on OS– he can break more laws, this time his 5% tint on the front side windows which he can break the law for, because of the mantra ‘I get death threats). Q why would an officer attend to the passenger side only? Is that protocol or even basic common sense safety when stopping a vehicle? Naw, he did it for GZ when he got the plate run. O’l buddy.

        SZ’s latest installment on the Today show with Matt Lauer. Lauer is not giving her a free ride on the credibility issue. sort of.

        http://www.today.com/news/george-zimmermans-wife-i-have-doubts-i-also-believe-evidence-8C11257699

        • Trained Observer says:

          Hip? Chest? The lends credence to wide-held belief that some Sentinel reporters don’t know their asses from their elbows.

    • Deborah Moore says:

      Saw the short article at Huffington Post, but didn’t have the stomach to watch the video. That chick needs counseling, not face time. That Matt Lauer must be a freak pimp.

      • ay2z says:

        She said something interesting, said about filing charges, that the police made it clear to her if charges were filed, both were going to jail and she would be the only one not going home.

        If that was witnessed, I wouldn’t have pressed charges either. Her manipulate spouse-child-killer got her hogtied when he and his familyl got her to lie to the court. Perfect if you want to discredit your spouse and not have them believed when they tell tales out of marriage. Big point score for GZ if he wanted rid of her after he used her.

        • ay2z says:

          She needs a less flamboyant lawyer to help her credibility.

        • Trained Observer says:

          ay2z — I thought that was interesting, too. But what if her dad had pressed charges against Fogen? He’s the one who allegedly got socked in the nose. As a witness, I can see why they all would have been hauled off for jailhouse interviews. But just because she’s on probation, why would she, as a witness, be overnighting in jail? Am not getting that.

  2. Boyd says:

    Alito’s from my Hometown. Trenton,NJ from a part of town called Chambersburg or Little Italy. My mom taught in the ‘burg’ for 20 years.

    Back in the days I lived in Trenton we had 3 parts of town, The Italian side, the Black side , and the ‘everybody else’ side. The ‘burg’ was the Italian side. Blacks, Do not walk over there you’ll get beat up. Once I was considering moving over to that part of town. My mom said “better tell them you’re black”. ????? So I did, the guy said “well, I don’t care, but you’re mom is right, a lot of people here are racist”. The best way to describe the burg is Spike Lee’s Jungle fever movie. That’s Alito’s upbringing environment. I think Scalia may have come from a similar hood in North Jersey.

    When I read his bio I knew he was a terrible pick for the Supreme court. I know what his decisions will be before any debate.

  3. Trained Observer says:

    This post has been a jaw-dropper. I’d been under the impression that generics were duplicates of the real thing except for non-drug ingredients (dye coloring or shape of pills, for example) and packaging. Am fortunate that I don’t take prescription meds, but despite inclination toward generic products (like Walgreen’s brand instead of Head & Shoulders shampoo or multiple vitamins) in daily life, I’ll rethink when the day comes for meds.

    Supreme court ruling, makes no sense whatsoever,and needs to be revisited. .

    • Boyd says:

      they’re allowed some degree of difference. usually it’s almost the same. But it’s not uncommon for a generic to not have the same effect as the real thing.

  4. aussie says:

    Sorry, guys, but I have to totally back the court on this one. They are right.

    Go down to p42 of
    http://sblog.s3.amazonaws.com/wp-content/uploads/2012/09/12-142-Bartlett-Cert-Petition-FINAL-1.pdf

    where it finally explains it in plain English

    “…the “special, and different, regulation of generic drugs” under federal law meant that the Constitution bars states from imposing liability on a manufacturer that has no ability to change its product…”

    You can’t sue the generic manufacturer, because he HAS NO CHOICE in the product or labelling — these are governed by Federal law to be IDENTICAL to the name brand.

    The NAMED brands, being under a different law, do have to go through a lot of trials etc to get permission to market their products, BUT they are ALLOWED to ADD extra warnings to their labels WITHOUT FDA permission. The generic maker is not, because his product has to be the SAME as the brand name – “a generic pharmaceutical product must be the same as [its branded equivalent] in active ingredients, safety and efficacy and hence, …. with labeling”,

    This is great decision by the court. If they allowed generics to be sued, for things beyond their control, then Big Pharma would just support enough cases against them to put them out of business.

    Stevens-Johnson Syndrome affects only 2 to 6 people per million per year, and it is an immune reaction to any one of dozens of different drugs. So no evidence her generic caused it in the first place. If it did, the branded one would have done so too, as they are IDENTICAL in their active ingredients. And likely that would not have had a warning, either, as quite likely NOBODY got this during the trials (in which they list as side effects everything and anything the people in the trial reported, without any checking that they are related to the trialled drug. That is why dizzyness, headaches and stomach upsets etc are listed as “side effects” of just about every drug).

    • crazy1946 says:

      aussie, While after reading your link and your words, I can only partially agree. Have you actually looked at many of our generic drugs, and read the ingredient list and compared them to the original drug ingredients? If what the SCOTUS wrote is correct then we have a big problem with the generic drug makers, many of which are owned by the big companies that made the drugs to begin with. I challenge anyone out there to read the label and explain why the ingredients are not the same…. Yet we are being told here that they must be the same… Hmmm, something seems to be wrong here… But what the heck, it’s only a few people out of millions that die from this problem, and we need to get rid of a few people anyway, right? I wonder if the members of the SCOTUS would have ruled differently if they or one of their family members had been the victim of one of these drug manufactures? Bottom line is that this is another way for the GOP/TP to impose Tort reform on the people of this nation to the benefit of the “Real Owners of this Nation”….

    • I disagree, Aussie.

      Generics often do not have the same ingredients and that is well settled, although insurance companies claim otherwise.

      Manufacturers of generics claim they do have the same ingredients, but they often do not and when they don’t, and a patient dies or suffers an injury, he or she has no recourse.

      There is nothing stopping a dirtbag from creating a corporation, constructing a lab in a country without regulations, producing a generic version of a drug out of the cheapest chemicals available and marketing it as the next godsend.

      That’s why I say the case is a license to commit fraud without consequence.

      There is no good reason why the manufacturer of a drug, whether name brand or generic, should be shielded from liability for the harm they cause. Indeed, the manufacturers of name brand drugs can be sued and held liable. Not so with the manufacturers of generics and that is a distinction that makes no sense.

      The manufacturers of generics can purchase insurance to cover liability for the harm they cause, although now there is no reason to do so in the United States.

      Incidentally, the federal court jury in the Bartlett case found that the generic drug was unreasonably dangerous and caused the injury.

      • Boyd says:

        true, when medicine became a generic it did not have the same effect.

      • aussie says:

        The main (working) ingredients are meant to be the same. The fillers and conditioners and talc to make it into tablets with can be different. The active ingredient has to be the same and in the same dosage. Don’t forget even brand ones exist in different formulations from different manufacturers.

        It some fly-by-night operation makes “cheap chemicals” drugs they CLAIM are generic versions of real ones, they are acting fraudulently, and could and should and can be prosecuted for that. If there is doubt about the quality of an imported generic, that can also be handled.

        The issue in this court case was LABELLING — that they had not written a warning about this potential side effect. Not that is HAD this side-effect. The brand name one does not have this warning, EITHER. The difference on which the case hinged is that the brand name original is ALLOWED to make changes (add to) its warnings. The generic is NOT. The generic has to issue the warnings exactly as agreed by FDA for the BRAND one. Basically the generics are riding on the coat-tails of the brand ones that developed the drug and got it through all the trials to get approval in the first place, and the labelling/warnings are based on those; the generic does not do any of their own, that’s why they are forced to stick to the same.

        Different if they’d found something toxic being used as a filler; that of course would be actionable.

        So if this unfortunate woman had taken the brand name one and got the same problem, she could have sued them for NOT WARNING HER. She could not sue the generic because such a warning was not authorised for them by the Federal Government.

        Of course the brand name didn’t have it either, most likely because they did not know this to be a possible side effect, as it is a very rare disease which perhaps has never happened to anyone taking this ever before….. assuming it was proven it was caused by the drug alone, not by a combination with something else. Or can every drug be trialled in combination with every other drug? should it be?

        And if they had had a warning, which says this is a VERY VERY rare possibility, and she took it anyway, then what? she can’t sue because she took the risk knowingly. At best she could sue her doctor for prescribing it. Can she though?? On that basis nobody would ever be prescribed a drug and nobody would ever take one, because they ALL have side effects.

  5. CarolMaeWY says:

    Maybe you can answer a question that has been bothering me for sometime. I forgot which Amendment in the Bill of Rights this is in, thinking First; but don’t we have the right to redress our government for wrongs committed against us? How can he Supreme Court take that right away for a generic drug or any wrong that happens to us?

    • You’re right. It is the First Amendment, which states:

      Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.

      (emphasis supplied)

      We can petition, but that does not mean that the government has to redress our grievances.

      If the squeaky wheel gets the grease, we need to amplify our squeaking.

      Unfortunately, our government only pays attention to money, not squeaking.

      Also unfortunate: the right wing hate machine has a lot of money.

      • CarolMaeWY says:

        Thanks for taking the time to answer my question. I’ve gone in front of the District Court pro se a few times on Administrative issues, property rights. The large Corp. could break the law as long as no one could prove they were hurt by that law. I have never understood that. We will only be hurt when we go to sell our home. The Corp. has already changed hands many times. The County Commissioners are no longer in office. I’ve got tons of paper, but I wonder what good it will o me.
        I have wondered if I got caught for speeding if I could get away with that excuse since I never hurt anyone? I doubt it very much.

  6. colin black says:

    My better half receives a lot of medications an pain med for her illnesses.

    A few years ago GP family docs genral practeiners under the national health care .

    Were given gharge of there own finances ie yearly budgets to manage.
    Rather than the old practice of simply billing the government /health service/taxpayers for expencies they incurred as they went along.

    Before the change over She was given only brand name medicines an regognisable names forinstance M S T morphine sulphate made by roche time release capsules.

    After there given charge of there own budgets not only did they start using generic names an differing meds zoramorph instead of the M S T .

    An generic types of all her other meds be they iron tablets or Wafrin type for her blood thiners all the while assureing me it was nothing to do with money an thease other drugs types were exactly the same .

    Thay also started a brutall slashing of the amount of pain med s theyd previously given out like candy when they didn’t have to balance there books and optimise there profits.

    It was fucking sickening for one people on thease types of med build up an tollerence over the years an the amount needed for the relief increases not decreases.

    An yet for the sake of budget they were willing to see people suffer as you can imagine I was none to compliant or a ok with this turn of events.

    In fact I went fn crazy at them threatenening to sue them got the medical council involved and shouted mal practice to any one whom would listen.

    Eventually I managed to talk sence to one of the partners at the practice an got them to back of on the re pill cull or at least slowed it down although I wasn’t able to restore it to the pre amount she was on before the financial swap over.

    But all they were concerned about was there friggin bugget an maximiseing there pay checks at the end of the year

    As any surplus in there buget they get to keep.

    This was brought in as a cost cutting exercise by the Government an the G P s took full advantage to line there own pockets.

    Im sure Dr Shipman would have been horrified to have suddenly start accounting for all the morphine he was using or having to look for a cheaper brand to murder his patients

  7. Single Payer is my dog in the hunt.
    Big Pharma basically wrote the Affordable Care Act (ObamaCare)….If W Bush’s shadow boss was oil – Pres. O’s boss is big pharma.
    Lobbyists from Amgen, Bayer, Squib, et. al. were present for every major healthcare meeting & lobbyists often outright wrote the legislation and gave it to the administration. So no surprise.

    That being said, whilst I think this quasi private, deeply complicated and highly intrusive affordable care act is a stinker, I hope I’m wrong. May 1 life be saved.

    I myself will not use the new healthcare exchanges here in California (where they will probably be the best) because the the Fed. Gov. will have real time access to my primary bank account, if I sign on the bottom line then; “Page 58 HC Bill: Govt will have real-time access to individuals’ finances.
    Page 59 HC Bill lines 21-24: Govt will have direct access to your bank accounts for elective funds transfer”

    More than I can really stomach for now, to give that access is anathema to me.

    Nothing is free….Ass, cash or grass!

    • Oh, man. That sucks. Big Time.

      No way I would do that either.

      I haven’t followed the Obamacare debates because I have Medicare, whatever that is anymore, and single payer is the only sensible way to go, AFAIAC.

      • On a positive note C – Our national conversation/struggle over healthcare is long overdue. The passions it raises to me show a still young, a bit flawed, yet vibrant democracy!

        Keep up the great work you and F do. You both hit a certain sweet spot in the discourse that is well needed and as the ebb and flow of ratings go, the tide will rise again, it’s physics!!

    • C-S here. Thank you for the read and comment!

      As I said on FDL: straight-up gangster, all day long. Wow, I did not know this about the bank account! I will have to take my chances, I guess, and sign up, I hope I don’t regret it. Access to finances? What finances? You know what I mean?

      Dear President Obama: We eat from a dumpster as it is. And we are not alone; please don’t steal what little we have, as we try to live our later life.

    • aussie says:

      C’mon guys CHECK WHAT YOU ARE READING

      http://www.snopes.com/politics/medical/kithil.asp

      that is all debunked propaganda referring actually to a different bill, that was never passed.

      Elijah, of course single payer would make the most sense. It will come, in time. This is still a lot better than nothing for the ~40 million Americans who up to now have not been able to have ANY insurance.

      • It would have been a hell of a lot simpler to expand Medicare coverage to everyone, regardless of age.

        That system was already in place and it worked, before the politicians began the process of dismantling it so that Big Pharma, the health insurance companies and their stockholders could insert and attach themselves into healthcare like tapeworms into intestines and hoover up obscene profits ultimately endangering and sometimes killing the host.

      • Hi Aussie! Never heard of “snopes” so I took a look. It’s a 3rd party website that claims to debunk urban legends. It’s amazing to me that a few days out from implemantation, so many of us are debating this using random unchecked websites for fact. That alone is enought to scare me away from entrusting my families care to this system. As well, The website setup by the admin. to answer questions is: http://obamacarefacts.com/obamacare-facts.php It’s a mess to me. My facts come from a combination of my Tax attorney & accountant. It’s clearly stated in the application which in many states is available as a read only doc. already.

        There are no death panels or crazy claims, of course, But I am assured that the the Federal Gov will use all financial information mined from the applicant & will cross reference with the IRS. We’re all different and have different personal situations & for me the risk is not worth the benefit, however we shall all see 😉

        • aussie says:

          Well, they DO want to cross check you’re not cheating, if you’re claiming a low-income assistance of some sort. Totally fair they should check on that; they do for other ways of getting money from the Government, too.

          I don’t see them cross-referencing or mining for a long time – it is a totally different computer system. When the Australian government wanted to do this cross referencing, they spent many billions over several years to get a computer system that was able to do it. And then they found enough cheating going on to cover about 10% of what it cost them. In the US I believe the computers can’t talk to each other even between counties (one advantage of the fragmented mini-governments system you have). So the government might LIKE to cross-check you, they won’t have the ability except perhaps on an individual basis for someone they are already very interested in for some other reason.

          • Hi Aussie – In my case this isn’t about enrolling for low income assistance on these new exchanges. This is for folks who already have private coverage & the Gov. is trying to pitch the exchanges to. It’s my demographic that they need to enroll, otherwise it will fail, it’s dependent on money coming in to be able to pass onto low income enrollees.

            It is not fair at all for my Gov. to check on me like a child, without probable cause to see if I’m cheating. If I am audited by the IRS (our revenuer) they give you a fair chance to collect your records, give ample time and allow you private representation for a meeting.

            Not here, the Fed can just can click the button and track. They will sweep and group together millions of people. That thought sends a chill up my spine. Just my nature I guess.

            That being said, if it saves 1 life it’s a mitzvah (good thing).

    • Deborah Moore says:

      When my daughter was little, two or so, she had one of those sit and push little cars. I made that bumper sticker and put it on.
      Tho, it was Gas, Ass or Grass. No one rides for free.
      Thanks for the memories.

  8. crazy1946 says:

    There is one more problem you did not mention. Most insurance companies will not cover the purchase of brand name drugs when a generic is available for use, unless your doctor demands that the brand name is the only one to use, and then they will not cover as much on the purchase…. More reasons we need single payer insurance in this nation….

    • C-S here on Fred’s screen. You are absolutely correct, thank you for bringing this up. Generics are actually being foisted? Pimped? on us. They are pushed, to the point where a special prescription is practically needed for brand. I could not agree more that single payer is the answer, great comment, thank you.

  9. colin black says:

    As a SCOT I think its a diabolical shycrhonistic liberty that Scot us

    Is initialy the name of Americas suprime courts of just us?

    Us Scots an particularly ME are not amused by the quirk of fate that made this possible

    AN IF Fate had the cheek to show its face to me Id slap it for its insolence.

    SCOT US Indeed

    B T Y

    Thanks for the lesson Ive often seen or heard of this Scotus but had no clue until now what it refered to.

    • I really enjoy you, colin, have to keep checking the blog for my colin fix! (C-S here, by the way, on Fred’s screen.)

      The Supreme Court of the United States is a court of appeal, an appellate court. It is the highest, and last, court of appeal in the US, and the reason it matters is, SCOTUS has unimaginable power.

      Aside from the president (also referred to sometimes as POTUS, for President of the United States), the US Supreme Court rulings affect the way we live. Congress can affect us, but it it pretty much frozen and isn’t doing all that much anymore.

      The SCOTUS receives roughly 10,000 requests each year, to review cases (might want to check that number), but they have discretion to choose. They only choose 50 or 60, and they may issue fewer opinions, like the one in the post.

      These opinions are sometimes called ‘landmark’ decisions, because they really have affect on most people, in some way.

      While this information may seem basic, most Americans, lawyers even, cannot name the justices, for example. There are nine, in the current conservative ‘Roberts’ Court: 4 usually opine to the left, 4 to the right, and Justice Kennedy is considered the ‘swing’ vote (In this case he swung to the ‘right.’)

      Here is the ruling:

      Holding: State-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA v. Mensing.

      Judgment: Reversed, 5-4, in an opinion by Justice Alito on June 24, 2013. Justice Breyer filed a dissenting opinion in which Justice Kagan joined. Justice Sotomayor filed a dissenting opinion in which Justice Ginsburg joined.

  10. Every person should read this article because everyone needs to know that they have no recourse against the manufacturer of a generic drug, if they suffer an adverse reaction to the drug and it harms or kills them.

    Yes, I know that’s outrageous, but it’s the law.

    • colin black says:

      You don’t have a recourse against anything that kills you?

      Be it a bolt of lightning or a Truck a crazed vigilante neighbourhood watchman or some drugs your allergic to.

      Once we shuffle of this Mortal Coil are days of bitching are over.

    • ay2z says:

      I haven’t read this yet, SCOTUS, that’s USS Supreme court, right? Nothing to do with other countries, just America, right???

      We need to pay attention to what the big drug ompanies are able to do in the US. Same big businesses across borders.

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