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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@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.
@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.
“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.
@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.
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.
@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?
@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.
Seth is exactly right. As I posted on my own blog about this NYT article:
@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.
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.
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.
@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?
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!
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!”
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.
@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.
i used that patch for one day and had problems breathing.
@wring: The patch is supposed to go on your arm.
Contraceptives pump estrogen into your body? WHAT?!
All birth control is dangerous to a degree.
@backbroken: not necessarily.
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.
@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).
@backbroken: nice, cha ching!
Can consumers even sue the FDA? Aren’t they immune to most lawsuits?
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.
@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.
@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?
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).
Preemption is a word. No need for the Pre-emption.