Pre-Emption Doctrine Would Make FDA Responsible For All Drug Problems, Shield Big Pharma From Lawsuits

Johnson & Johnson is waiting to hear whether or not a judge in Ohio will allow any lawsuits over its Ortho birth control patch to move forward, and the New York Times says lawyers on both sides think there’s a good chance he may find in the company’s favor based on the doctrine of pre-emption. The argument goes that it’s the FDA’s responsibility to monitor the safety and labeling of drugs that go to market, and therefore if something goes wrong, it’s the agency’s fault and not the pharmaceutical company’s.

The Ortho patch releases high levels of estrogen and can cause problems for some patients, but J&J says it’s the FDA’s fault for not requiring a label sooner:

The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.

Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly.

“We have regularly disclosed data to the F.D.A., the medical community and the public in a timely manner,” Ms. Vanderham said. “Ortho Evra is a safe and effective birth control option for women when used according to the labeling.”

But Janet Abaray, a plaintiff’s lawyer from Cincinnati, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities.

“Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies,” Ms. Abaray said.

“Drug Makers Near Old Goal: A Legal Shield “ [New York Times] (Thanks to Beth!)

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  1. snazz says:

    BEST PICTURE EVER!

  2. jscott73 says:

    oh man, why does that cartoon guy look so familiar, i’m thinking ’80s…

  3. RAREBREED says:

    @jscott73:
    That thing was in He-Man!

  4. rmz says:

    …And as a result, the FDA testing-and-approval process would take 20 years, in order to avoid lawsuits from insufficient product testing.

  5. snazz says:

    Orko

  6. jscott73 says:

    @RAREBREED: That’s what I was thinking, but he was a late-comer right, like after She-Ra.

  7. r081984 says:

    The doctors should have some liability. They know the risks when they give patients these drugs.

    I would say the liability should be like this:
    60% Drug Companies
    30% Doctors
    10% FDA

  8. JustAGuy2 says:

    @jscott73:

    He was the comic sidekick – kind of He-Man’s Scrappy Doo.

  9. dreamcatcher2 says:

    This actually makes a certain amount of sense. The problem is, how do we then encourage the correct behaviors of a) due diligence and b) full disclosure? It would be quite hard to motivate the FDA to act more responsibly than it does, because there are no carrots and sticks we can use on a government agency. The tone of the agency is set by the executive branch.

    Companies still need to be held liable for not releasing negative information they have discovered, that’s endangerment plain and simple, but the fact is the court system is poorly positioned to decide whether or not a company has performed sufficient and satisfying research. It requires a team of experts to evaluate that, and after the team of experts signs off, if no further negative evidence exists, why should the company think they need to do any more?

    It’s a vexing problem. How do we keep the team of experts that is able to evaluate scientific value without giving up all of our incentives and punishments to encourage correct behavior? Should FDA scientists/administrators go to jail if they have behaved improperly? Sometimes it is easy to show they have ignored research and acted with conflicts of interest, but how can the court detect whether or not they are just acting dumb?

  10. Comms says:

    Maximum profits, minimum responsibility.

  11. fordpickup says:

    It’s fun that the battle cry of big business is usually “less government involvement,” but the second it’s in the best interest of an company’s bottom line to blame the government for a “lack of oversight and responsibility” they’re the first ones to say its the government’s fault for not regulating the industry enough.

  12. hypochondriac says:

    ,If this passes I see no new drugs being approved ever. I would support it if the drugs companies agree to turn over 50% of the profits to the FDA. That way the FDA can no longer use lack of funding as an excuse.,

  13. cde says:

    J&J should have been pro-active in adding the warning on the label, without needing to be required to. It’s their own fault.

  14. cde says:

    @JustAGuy2: Since when do comic sidekicks (scooby and shaggy and et-al) have comic sidekicks (scrappy)

  15. Dashrashi says:

    @fordpickup: Exactly. The most offensive thing about this argument is that its champions (“Why doesn’t the government do its job better?”) are exactly the ones who turn around and lobby the government (or, hell, vote in Congress) to gut the FDA and other regulatory agencies. They should be ashamed of themselves. It’s monstrous, and beyond disingenuous.

  16. jscott73 says:

    @fordpickup: precisely, they are like a bully in school doing what they want until someone stands up to them then they hide and run behind the teacher.

  17. hypochondriac says:

    @r081984: Doctors relay on what the drug companies and FDA tell them. Why should they be punished if the drugs companies fail to disclose information

  18. rellog says:

    This is like a drunk driver saying that the cops are responsible because they didn’t pull him over before he hit another car… idiotic!

  19. Comms says:

    @hypochondriac: Or, do make it funnier, if I were someone in charge of the FDA I would just reject everything put forth by the FDA. New drug? Rejected. Bottle of water? Rejected.

    Of course, what this does is puts as much of the responsibility on the FDA as possible and, by extension the taxpayer. Which is awesome for J&J because if a drug gets approved they get to roll around in fat sacks of money and when it turns out they fucked up and people developed explosive gonorrhea they get to say, “nuh uh, not my fault” and then the taxpayers get fucked again!

    hoorj the system works!

  20. bohemian says:

    Wow. Is this the new corporate strategy. Dump responsibility for everything on the government? Sub prime loans, medical disability, bad drugs?

  21. Megladon says:

    Dump all stock in J&J, i have a feeling they will never have anything approved for sale EVER within the United States.

  22. magic8ball says:

    Am I wrong in thinking that government agencies are immune from lawsuits?

  23. strangeffect says:

    Oh this is bullshit.

  24. Xay says:

    Great idea – let’s have one of the most politicized and underfunded agencies (relative to responsibilities) responsible for every drug that enters the market. How about holding the company that omitted data from the studies they submitted with their application liable to the government?

  25. Xay says:

    @magic8ball: No you are not wrong. That would be the baseball sized, nail studded butt plug for the consumer.

  26. Seth_Went_to_the_Bank says:

    This means all a drug company has to do is mislead the FDA into approving a drug… and then blame the FDA for approving it if there are problems.

    And yes, they already do this, but they weren’t shielded from lawsuits, which was some deterrent from covering up the drug study results which could hinder the introduction of a new pharmaceutical.

    With the FDA as the only agency on the hook, you can expect penalties for misleading the public and the FDA to drop from hundreds of millions of dollars to government-size fines of $50,000 here and $30,000 there.

  27. Imhotep says:

    How conveeeenient! (Church-Lady emphasis)
    Big Pharma is being protected by the FDA which is run by ex-Big Pharma heads. There’s a revolving door between all of the govt. agencies and big industry. i.e. Big oil heads run the EPA, etc. etc. ad nauseum.
    Well, isn’t that SPECIAL?!

  28. Okay, wait… Drug companies lobby congress to make drug authorization quicker and easier, forcing the FDA to rely on the drug companies internal studies about their products rather than preforming long and costly independent studies. Then, the drug companies alter their studies and intentionally avoid disclosing negative side effects to the FDA to avoid the FDA attaching warning labels. Then when the companies get sued they’re not liable because the FDA failed to provide warnings with the faulty and unreliable data provided by the drug companies?

    I mean, seriously? I’m ready to line some motherfuckers up against the wall if this bullshit goes down.

  29. humphrmi says:

    @rmz: I’m not sure that the FDA can be sued for product liability.

    There is some discussion about that going on here: [cr4.globalspec.com]

    Basically it’s a question as to whether the FDA can be held legally responsible.

    There is a case where the FDA was sued in 2007, I don’t know the outcome, but that wasn’t for monetary damages, it was to force them to withdrawal the OTC designation of the “Morning After Pill” : [www.lifesitenews.com]

  30. Dashrashi says:

    @anonymousryan: I know. It’s unreal. Kafka-esque.

  31. trujunglist says:

    And then if this somehow goes into effect, any time food is tainted, it would have to be the fault of the FDA as well, because they didn’t catch the company fucking up.
    Yeah J&J, it’s called self-regulation. If you think there’s a problem with your product, you may want to tell people about it, even if the FDA doesn’t catch it. Imagine what would happen if we had something like 100s of spinach factories patrolled by one terribly unequipped, understaffed, and underfunded agency! Why, we’d have massive amounts of e. coli infections and who knows what else?? Thank God the spinach factories are there to protect us, Joe Consumer.
    Wait.. what? Where am I? Goddamnit Mr. Mxyplyx!!!!!!!!!

  32. G-16 says:

    @r081984: or rather they should know the risks.

    I think if the companies are not responsible for the drug and it falls all on the FDA than the drug companies will not have any quality control and just release a drug saying it will do x when they really have not clue.

  33. Grrrrrrr, now with two buns made of bacon. says:

    Man, Orko has sold out to Johnson and Johnson. That’s sad. If He-Man starts doing Viagra commercials, I might as well throw in the towel.

  34. Seth_Went_to_the_Bank says:

    @anonymousryan: Ding ding ding, we have a winner.

    Right on the money, Anonymousryan. They made the FDA rely on the drug companies, and now the drug companies don’t want to be responsible for their own data…

  35. trujunglist says:

    @Grrrrrrrrr:

    By the power of Viagra, I have a bonerrrrrrrrrrrr!

    *ahem* *adjusts tie*

  36. wickedpixel says:

    Love this quote:
    “Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies,” Ms. Abaray said.

    Um, shouldn’t we change the name to the “Food Administration” then?

    </snark>

  37. modenastradale says:

    @rmz: No, I don’t think so. I don’t think the FDA has waived its sovereign immunity — you simply *can’t* sue the FDA.

    This surely won’t become the national policy, even if some Ohio court gives Johnson & Johnson what it wants. The result would be unfettered marketing of drugs with almost no oversight (the FDA is a joke), and no avenue of redress for the percentage of consumers who are guaranteed to be injured by reckless drug marketing.

  38. stillkarenann says:

    @r081984: Did you purposefully leave out “the consumer” in your percentage chart?

  39. differcult says:

    This blows my mind. The pharma companies are destroyed by law suits. This country will let people smoke and drink all they want. All because there is a little warning on the bottle. But the second one person dies from a controled drug….All hell breaks.

    Vioxx is a good example. A product the declared most of its risk, caused problems with very few people.

    Doctors knew what they were giving out and people knew what they were taking. Yet, they still get paid by Merck.

  40. cde says:

    @differcult: Easy, because people know what alcohol and cigarettes do ahead of time. How many people knew Vioxx would give you heart problems instead of just fixing whatever it was supposed to fix.

  41. Donald Rumsfeld was CEO of Searle (Acquired by Monsanto) he, through his government connections, gets Nutra-Sweet FDA Approved and put on the market, despite protests from the National Beverage Association.
    So when it is finally verified that Nutra-Sweet is deadly, and causes a launry list of side effects, are we going to now hold the FDA accountable?

  42. Apologies for typos. I am having surgery on my eye this week. All blurry. Didn’t see typos until too late…..

  43. trujunglist says:

    @suburbancowboy:

    Where are the eye pills when you need them? Fucking FDA, goddamn them.

  44. chemman says:

    @cde: While I don’t agree with J&J’s approach here. The FDA should not be solely liable, but I do believe they hold some liability when they approve the drugs, because using your example; J&J cannot change the label whenever they want, it has to be submitted to and approved by the FDA before any changes can be made to it. Also, while I don’t agree with it, many pharmaceutical companies pay the FDA to review their submissions. If the companies are paying for the review, not only by paying taxes but directly paying for the review, shouldn’t they get some sort of partial protection? What are they paying for then? Should there just be free market drug production and let the market weed out the bad apples? They’d get sued out of business and the FDA wouldn’t be needed right?

  45. rlee says:

    So, let me see if I have this straight. J&J informed the FDA of an issue that should lead to a labeling change. FDA did not act promptly to require the change. J&J didn’t change the label until FDA required it. So, it’s all the FDA’s fault, because of course J&J couldn’t change the label until the FDA required it. Uh, what?

  46. JiminyChristmas says:

    The US Supreme Court handed down a ruling in February that applied pre-emption to the makers of medical devices. In the case in question it was a manufacturer of stents, catheters, and pacemakers.

    It is a pretty small leap to apply the recent Supreme Court precedent to this pharmaceutical case. In the event that this state case isn’t decided in favor of J&J, the likelihood of it being appealed is about 100%. The likelihood of it subsequently being settled in the Supreme Court is not far from that. Whether or not you agree with the conclusion, it doesn’t logically follow that medical devices should be pre-empted and drugs should not, so expect the Supreme Court to have the final word on this.

    I have to wonder if there aren’t going to be some unintended consequences for J&J, et al. If the FDA is going to basically indemnify the makers of any product they approve, I expect that approval process to be radically different from what it is today.

  47. cde says:

    @chemman: The whole label thing should be that they can’t add information that contradicts the FDA required information, or remove required FDA information, but they should be able to add more information/warnings. Fda says albinos shouldn’t take it, manufacturer says redheads shouldn’t take it either.

    Then again, the issue is that even though they pay the FDA, if they hid or otherwise obscured the information the FDA needed to provide valid warning labels, they should 100% be liable. People should still be able to sue the company, but if in court, it was found that the company provided full, acurate disclosure of the condition but the FDA ignored it, then the FDA is liable and pays both the person/class suing and the company’s legal fees.

    Then again, if the company truly feels that the side affect is truely a problem or of great merit, they should petition the FDA to include it on the warning.

  48. cde says:

    @JiminyChristmas: But it does logically follow. Medical devices do not cause random problems. At most, the only problem they create is infection/rejection by the body. A pacemaker isn’t going to make you develop kidney or liver problems. Drugs/Chemicals intended for the heart would, and can.

  49. trujunglist says:

    @cde:

    Yeah, I don’t really see a problem with adding additional warnings that aren’t approved by the FDA. Obviously the drug makers would have a problem with that though, since any additional problems that they have to admit to will cause 1 less person to buy their product. So in reality, although self regulation is by far the most effective way for EVERYONE, the self interest of just 1 company makes that impossible, let alone every single company out there.
    The funniest part about it is that J&J didn’t want the label on there and probably would’ve done everything possible to keep it off so it can sell more product, but the FDA did it for them, so when they get caught…. hey, blame the FDA! We totally warned them and stuff, we swear!

  50. mjsager says:

    As someone who is dealing with the after effects of a serious drug reaction right now, I think that companies who hide the truth need to be held financially liable. Its one thing if they are honest with all the risk factors, its another if they are dishonest to make profit while the drug is under patent protection.

    I also think that its important for the FDA to fundamentally change to protect consumers.

    FYI, I took levaquin, a common antibiotic and now face permanent nerve damage.

  51. JiminyChristmas says:

    @cde: You are sorely mistaken. The February Supreme Court case was brought by a man injured by a catheter that shattered during implantation and punctured an artery. The same company, Medtronic, had to recall 10s of thousands of ICDs (implantable cardiac defibrillators) in 2005 due to faulty leads and battery failures.

    Guidant, now part of Boston Scientific, faced a recall of even larger scope in the same year due to battery failures, and ended paying almost $200 million in claims.

    In general, device failure is not rare and can produce serious complications. Imagine what might happen if a metallic arterial stent fractured in place. Device failure aside, non-healing wounds, blood clots, and internal bleeding are regular complications of device implantation of all kinds.

  52. Pharmerist says:

    @dreamcatcher2: No, it doesn’t make sense. And the rest of your post follows that fallacy. The FDA is the last line of defense for the rest of us once Big Pharma has tested their drugs. I realize that Pfizer et al would love to pass the pesky externality of testing on to the public at large, but that’s simply not how the system was set up. Nice try.

  53. r081984 says:

    “Did you purposefully leave out “the consumer” in your percentage chart?”
    @stillkarenann:
    How can you place any blame on the consumer?
    Only doctors can prescribe medication. They make over $200K a year to take the responsibility.

    The day a consumer can prescribe their own medication is the day its their fault for taking the drug.

  54. differcult says:

    @cde: Easy…anything you put in your body comes with some sort of problem. You can’t really think clinical studies are going to be right even 50% of the time….I know i research any drug I take, before putting it in me.

  55. Aphex242 says:

    Scary, scary stuff. If you ask me, the pharmaceutical company should be on the hook for making sure it’s safe, and the FDA needs to double-check. That worked just fine in the past, I don’t know why it needs to be changed now.

    God help us if this goes through the Supreme Court. Yikes.

  56. mjsager says:

    @differcult:

    Do you really know? How do you know if the studies you are using to research the drug are tainted by the drug company?

  57. Seth_Went_to_the_Bank says:

    @chemman: You wrote: “; J&J cannot change the label whenever they want, it has to be submitted to and approved by the FDA before any changes can be made to it.”

    The problem is the drug companies intentionally mislead the FDA all the time. The drug companies have also successfully lobbied to make the FDA extremely weak. Therefore, denying consumers the ability to sue drug makers will result in almost no oversight of the drug companies or punitive fines for a company that causes harm to patients by burying damaging information about their drugs. Whereas the “market” can currently punish a drug company with hundreds of millions of dollars in court, the FDA will be limited to fining companies in the range of $50,000 to $100,000.

    Do the math.

  58. Amy Alkon000 says:

    Seth is exactly right. As I posted on my own blog about this NYT article:

    A knowledgeable friend in the stats end of medicine e-mailed me:

    Read this one very carefully. What is happening will make “medical care” particularly deadly in the U.S.: Once pre-emption is in place, most of what will be reported by the companies for approval will be fraudulent in the fashion described in the article (or more cleverly so).

  59. cde says:

    @JiminyChristmas: Your comparing mechanical failure in a part to unreported systematic side effects in drugs. Mechanical parts fail. Parts used in them fail. The manufacturing process is not always perfect, and bad batches happen. Take your icd example. 10s of thousands recalled? Out of how many sold that year? Probably made at one plant with parts from one specific supplier (like the Apple/Toshiba/Sony battery issue where they were all sony cells). With the batteries, there is a chance of pre-mature failure (how ever small in batteries prepared for medical devices), and that is KNOWN.

    Medicine on the other hand, goes through a stricter production testing process, so all batches will act the same. So the problem is when the formula used is what causes failures and unintended side effects. The people who died from vioxx would have died from taking a pill made in plant A with supplier parts X, perfect batch 1 just as they would have from plant B with part supplier Y, perfect batch 24. It’s a design flaw compared to a production flaw.

    Now, I haven’t seen or read the Supreme Court ruling, but based on them giving manufacturers immunity, I disagree with them. However, it is more reasonable to allow a company with a patently safe design to not suffer for something out of their hands (like the multiple layers of the manufacturing process) then to allow a company with a flawed design where nothing physically went wrong (in terms of implementing the design/making the pills) to get away with it.

  60. UNSTOPPABLE says:

    AWESOME!!! Being forced to sue the Government instead. The one sure way to make sure you run out of money LOOOOOOOONG before you see a judge and ensure that nobody ends up writing you a cheque yet maintaining the illusion that you still have rights. America is a goddamed shithole.

  61. mikeb380 says:

    This is called passing the buck. J&J should have changed the labels without a government agency forcing them. Thus the reason for a government agency in the first place. The pharmacos only care about lining their own pockets.

  62. chemman says:

    @Seth_Went_to_the_Bank: & CDE: I completely agree that drug companies should be held liable 100% if they with hold data and/or intentionally mislead the FDA. I did not realize that was the case here with J&J. I was simply arguing that as it is currently required, companies cannot change the label without FDA approval. I think a mixed liability is more appropriate, as someone mentioned earlier maybe 60% of liability for the company, 30% FDA and 10% doctor, since they are prescribing the drug and should be monitoring for harmful side effects.
    Not that I want the FDA paying out on lawsuits, because ultimately that money comes from us in taxes and higher costs of medications. But if the FDA was liable, it could force them into a better system of approving and monitoring drug problems. As some noted, it will take longer, but you can’t have it both ways. People expect fast drug approvals but also want the drug to be fully characterized and known side effects in all genetic scenarios, it’s just not possible. No matter how much you study a drug, there will always be a chance for a bad side effect no matter what drug it is. Did you know 500 to 800 people a year die from taking aspirin? How come aspirin manufacturer’s haven’t been sued out of business?

  63. chemman says:

    A comment about companies adding additional warning without FDA approval. Sometimes, the additional side effects and warnings are something that is readily apparent, but most often that is not the case. Clinical trials and then post launch monitoring of 10 of thousands of patients is not an exact science. When you test a heart drug in phase III trials with patients effected by heart conditions and some of the patients die, it is often difficult to directly tie the death to the drug. Even though there are placebo control groups to compare number to, the human body is very complex and no two are alike, each body is different based on genetic and environmental factors.
    In cases where it is a major side effect, I agree companies should be able to change the label without approval and also be held 100% liable if they with hold that info or delay it.
    Also, thanks to everyone on here for the very interesting discussion and well made points, you’ve given me a lot to think about. I think it’s great when sites like consumerist can get good discussions going where people can challenge each others views without resorting to name calling. Thanks!

  64. lemur says:

    Bloody hell!

    As evidenced by the crap drugs that got on the market lately, it is clear that the system is already broken. Now they want to completely remove any obstacle preventing them from flooding the market with dangerous or ineffective drugs. If they succeed, the health care system in the US will be fundamentally damaged. I’ve already decided on my own to stop taking two drugs that had been prescribed to me. Yah, I know, I should not do that but in both cases I had good reasons. In the first case, I noticed from blood tests that the drug had no effect on my cholesterol. In the second case, the net benefit from taking the drug (Zetia) was found to be largely non-existent.

    Now, the next step to make sure the customer gets really screwed is for health insurance companies to start denying coverage for medical expenses if they find that a patient has stopped taking a prescribed drug.

    So drug companies produce bogus drugs with bogus studies. The FDA approves those drugs on the basis of bogus studies. Doctors prescribes those drugs on the basis of bogus studies and then health insurance companies decide that not taking those bogus drugs is a reason to deny coverage.

    At the end of the day, they suck you dry of your money and your life. “A loser is you!”

  65. This is why I have lobbyists if the Drug companies hadn’t used there connections to gut the FDA there would be fewer problems with new medication. I really hope the next administration gives the FDA more authority. Under the current there are some drugs approved for use in the U.S. that have been banned in Europe and Canada. I find that troubling.

  66. bohemian says:

    @lemur: People have tried to say that doctors are your safety net to prevent you from taking dangerous drugs. Many professionals only know what the drug rep has told them and heavily push whatever is the latest and greatest. I had a doctor give me Vioxx (it just came out) after a car accident injury that was giving me persistent problems. When I called complaining of chest pain three days later they were stumped and told me to just quit taking it.
    I had another medical professional insist I needed to switch from an old cheap maintenance medicine to something “new”. They couldn’t state a medical reason I needed to switch. They already have a habit there of pushing whatever is new heavily.
    SOME doctors are careful about what they prescribe and others are absolutely not. Now combine this with some of the new drugs on the market with hidden side effects or that we find out later don’t even work.

    @hypochondriac: Before I consider taking something new I research it and will check to see if it is approved in Europe and Canada.

  67. wring says:

    i used that patch for one day and had problems breathing.

  68. backbroken says:

    @wring: The patch is supposed to go on your arm.

  69. milk says:

    Contraceptives pump estrogen into your body? WHAT?!

    All birth control is dangerous to a degree.

    @backbroken: not necessarily.

  70. KIRZEN2007 says:

    Actually, I see this as a very valid solution to resolving the crisis involved in the marketing of potentially dangerous medications.

    The current problem is not that the drug companies are crooked, its that the drug companies are crooked -and- the FDA is a complete joke, with zero culpability and responsibility.

    Lets take a look at how this ‘could’ work.

    1 > Drug company provides accurate information to FDA regarding new drug XYZ, and ponies up a gigantic ‘registration fee’ for this new medication. (Lets face it, if the FDA’s going to get ‘funding’ its not going to come from a bankrupt government spiraling rapidly deeper into debt, and the drug companies -can- afford rediculous fees. Perhaps this will stimulate them to be more careful with their submissions for FDA approval.)

    2 > FDA carefully analyses this information, runs its own tests if necessary, using the additional funding to fuel clinical trials and back office research, knowing -their- ass is on the line.

    3 > Drug is released… Whooo!

    4 > Drug is found to be dangerous, FDA is sued for inadequately researching the new drug.

    5 > (Optional) FDA finds that clinical data was misrepresented by big pharma. FDA launces suit against big pharma for a rediculous metric tonne of cash, uses rediculous tonne of cash to pay for assistance for people harmed by the drug.

    You see, this way you have a regulatory agency that gives a damn about people standing between you and pharma. Would you rather have someone at J&J smile and say “Don’t worry, we checked this” or someone at the FDA go “Believe me, we -really- did check this”, or have J&J go “Its there fault” while the FDA goes “No! No, its all -their- fault”.

    There has to be a system by which blame can be accessed accurately.

  71. stillkarenann says:

    @r081984: How can you place any blame on the consumer?

    Consumers regularly self diagnose and, after seeing a commercial, hop on the net and believe they know everything there is to know. Then they go to their doctor and either blatantly tell the doctor what they think is wrong and ask for the prescription or they fool the doctor (or oftentimes, the nurse practitioner they see instead of the doctor).

  72. hi says:

    @backbroken: nice, cha ching!

  73. apeguero says:

    Can consumers even sue the FDA? Aren’t they immune to most lawsuits?

  74. Trai_Dep says:

    The popular GOP/Corporatist playbook: socialize the risks, privatize the profit.

    So when my house is broken into, sue the police department, not the crooks? Same principle.

  75. Rectilinear Propagation says:

    @cde: I would attempt to add my own uniqueness to the thread but you said it right there. It’s ridiculous to complain that you knew of the problem for years but didn’t do anything because no one was forcing you to.

    As far as the picture goes:
    [www.adultswim.com]
    It’s after the DirectTV and robot sketch.

  76. modenastradale says:

    @stillkarenann: That’s weak. Of course consumers are going to approach their physicians about drugs. That’s WHY drugs are being directly marketed to consumers rather than physicians (a pretty new practice about which I have mixed feelings).

    Oftentimes, an individual’s self-diagnosis is very useful to a physician, especially if the ailment is less common or difficult to diagnose. I’m all for self-diagnosis; people should be taking charge of their health, learning as much as they can, and using their brains. Physicians are often completely wrong in their understanding of certain conditions, so it would be foolish to trust them blindly.

    Anyways, people can’t write their own prescriptions. All they can do is provide the physician more information. And even with an OTC drug, what are they supposed to do? Fund their own long-term study?

  77. bipolarmoment says:

    I don’t know the exact pharma requirements for marketing things but I do know some about orthopedics and I’m on the fence regarding this.

    Ortho:
    1) The FDA requires you to meet some testing numbers (in orthopedics case, strength/fatigue or potentially wear) but is unwilling to tell you what they are upfront.

    2) Ortho company creates product to meet hazy FDA requirements instead of patient needs or biological loading which in turn discourages supplementary testing because hey, mommy said it wouldn’t hurt anyone. (And this is the biggest problem for multiple reasons)

    3) FDA not culpable if product fails despite their test requirements often being a design consideration [Which it never should be].

    In my experience many doctors already take quite an interest in the mechanical properties of the product so what’s a stamp from the FDA proving?

    On the flip side, the FDA is also incredibly obtuse sometimes in accepting justification for equivalence that a 5 year old could understand (and it varies wildly from reviewer to reviewer).

  78. liquiddamage says:

    Preemption is a word. No need for the Pre-emption.