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June 23rd, 2011
04:30 PM ET

Is your medication safe?

The Supreme Court ruled Thursday that generic drug companies do not share the same level of responsibility as their brand name counterparts in terms of updating warning labels when significant new risks of taking the products are presented.

It's a decision that Judge Sonia Sotomayor says leads to unfathomable and "absurd consequences" for patients.

The plaintiff in the case, Gladys Mensing, started taking the generic version of an acid reflux medication in 2000, and by 2005 she had developed involuntary muscle movements in her hands and feet and her speech became slurred. She sued the generic drug's manufacturer, claiming the label provided insufficient information about the risks of tardive dyskinesia, the neurological condition she developed.

Studies had shown the drug posed a health risk, but the brand name had not updated the label, and as a result, neither had the generic manufacturers. In 2009 the FDA issued a mandatory black box warning on the brand name drug, noting that the “benefit is thought to outweigh the risk of developing tardive dyskinesia,” when the medication is used for longer than 12 weeks.  The labeling on the generic version also changed then.

The Supreme Court ruled that if the generic manufacturers had independently changed their labels, they would have violated the federal requirements that their labels be the same as the corresponding brand-name. Generic manufacturers say reinventing “the costly research and testing FDA required to approve the brand drug” would harm their goal of “making prescription drugs available to as many people as possible at the lowest possible cost.”

According to the American Association for Justice 70% of all prescriptions are filled with generic versions, accounting for about 2.6 billion prescriptions every year. It is calling the Supreme Court's decision a “disastrous outcome for patient safety.”

Judge Sotomayor also expressed concern. In her dissent she states, "If a consumer takes a brand-name drug, she can sue the manufacturer for inadequate warnings under our opinion in Wyeth. If, however, she takes a generic drug, as occurs 75 percent of the time, she now has no right to sue."

So what should you do if you’re worried about the safety of your drugs? Experts say there are a few things you can do each time you receive a new prescription.

The National Institute of Health has website called DailyMed where consumers can look up their drug by class and brand name, and find up-to-date information about labeling, package inserts and more.

Dr. Douglas Bremner, a professor of psychiatry and behavioral sciences at Emory University, encourages patients to chat with other patients about their experiences. He recommends checking out Medications.com and Askapatient.com, and read about the experiences others have had with the medication you have been prescribed.


soundoff (15 Responses)
  1. KY Pharmacist

    Best advise I can give is to remind patients to discuss any symptoms or concerns that arise after taking a new medicaiton. Your pharmacist is the medication expert and is there to help you!

    June 24, 2011 at 07:26 | Report abuse | Reply
    • JLB

      In an ideal world a pharmacist may be there to help you, but in my experience they are only there for show. I actually tried to ask about my perscription once and was told to just look it up. I have also had pharmacists not even know enough about my perscription to give me the proper thing. I was given a perscription once that even said on the label 'mix before giving to patient.' In the three months I had to take it only one pharmacist (fortunatly the first one) knew this. I had one tell me that I could just do it myself, really it was easy. I had one look totaly dumbfounded when I opened the packaged and tried to show her the instructions FOR THE PHARMACIST on how to mix it. A fellow pharmacist actually walked up behind her while we were talking and took over. I have very little faith in pharmacists.

      June 24, 2011 at 09:17 | Report abuse |
    • eg

      completely agree with you JLB

      June 24, 2011 at 09:49 | Report abuse |
    • Billy

      If you don't like it, Buy Originals Only So You Can Sue the Original Manufacturer. Shesss, Everybody just wants to get out of having to work!

      June 24, 2011 at 12:14 | Report abuse |
    • GA PharmD

      I am shocked and truly sorry that you do not have a good pharmacist to help you. Unfortunately, all pharmacists are not created equal and all pharmacy schools do not put out good pharmacists. You have the legal right to be counseled on your medication. When you pick it up and sign for it you can request counseling before you sign (that is why you are signing).

      This being said the patient must take some ownership. There are some limitations with the current retail practice model. If you come through the drive-through at 5:00pm my technicians may rush you out. If you come in at 5 minutes until closing, same thing will probably happen. If you walk up to the counter talking on your cell phone, don't expect to be treated very well, if your conversation is more important than your health then don't expect a pharmacist to value your health over that phone call (must be awfully important, you wouldn't do that at the doctor's office). If the pharmacist doesn't have time to talk right then, ask "when would be a better time for us to talk about my medications?" You may have to wait a while to talk to a pharmacist, we are the rate limiting step for everything in a drug store and the big chains don't want to pay for extra pharmacists to "counsel patients". Be patient, we want to help you. If your pharmacist is incompetent or unhelpful, take your business elsewhere, you can transfer most prescriptions to another drug store (some controlled substances cannot be transferred according to law). I assure you, all pharmacists are not incompetent and lazy (nor are all chain pharmacists money-grubbing idiots). I encourage you to respect the limitations that most pharmacists operate within and to respect the pharmacist as an educated healthcare professional. Most pharmacists are very knowledgeable and willing to help you.

      June 27, 2011 at 01:00 | Report abuse |
  2. DandyStryker

    So a drug company can manufacture a product that they *know* is dangerous. Then they can sell it to you without telling you about the danger's they *know* are inherent in the drug. You can then be *hurt* by that drug, and the right-wing, radical, legislating-from-the-bench Supreme Court says you can't collect damages from that drug manufacturer.

    It's becoming common place ... the 5 radical right-wing judges on the Supreme Court continually rule against common sense in order to placate the well-healed corporate interests that they've been bribed to support. The worst of these criminals is Clarence Thomas who openly takes gifts from associates who have a fiscal interest in cases that go before the Supreme Court. Yet Thomas refuses to recuse himself, and the corrupt chief justice of the Supreme Court (a Bush appointee) refuses to make Thomas step down.

    If this ruling isn't enough to make Americans hopping mad, I don't know what is. The right wingers on the Supreme Court just handed the drug companies a free pass to kill the people that use their products, without having to worry about any consequences at all.

    June 24, 2011 at 09:53 | Report abuse | Reply
    • another patient

      Dandy, of course the product they sell is dangerous. It's a drug! Risk vs benefit. We are all too drug happy in the US.

      June 24, 2011 at 09:59 | Report abuse |
    • Scott

      This decision is an outright absurdity. I wonder if justice Thomas said anything this time? What a disgrace.

      June 26, 2011 at 21:12 | Report abuse |
  3. another patient

    @JLB
    Wow, my first thought was find another pharmacy/pharmacist, but it looks like every pharmacist you have interacted with is clueless. Luckily I live in a location where there are tons of pharmacies, so I literally "interviewed" several of them when I moved to the area, found one I was comfortable with, and have had a great pharmacist/patient relationship for years. Good luck to you.

    June 24, 2011 at 09:56 | Report abuse | Reply
  4. John - NJ

    These conservatives on the Supreme Court do not have the interests of the people, only the corporations. Impeach!

    By the way, do you know where your generic drugs are coming from and if that country oversees their production as carefully as in the USA? How about labeling the drugs point of origin to let the consumer decide if he wants to take the chance of a drug coming from China.

    June 24, 2011 at 10:40 | Report abuse | Reply
  5. Jeff

    The pharmacist has a duty to warn of any potential side effects of a medication. In response to JLB go to your local community pharmacist and ask about your meds. Walgreens, walmart, and cvs pharmacists have decided that they are way to busy to help their patients. I am a pharmacist in a local community pharmacy here in oklahoma and would welcome the opportunity to step out from behind the counter and discuss any issues that the patient may have. We are the most accessable healthcare provider there is. The community pharmacist will bend over backward most of the time to help out their patients because that is how they make a living, whereas the big chain pharmacist are really only there to draw a paycheck for 8 hours and go home. My best advice is to go to the local community pharmacist and ask questions, they will really appreciate it.

    June 24, 2011 at 14:38 | Report abuse | Reply
  6. Joseph R Loegering

    There is not one Generic Medication that I have not had serious Adverse Reactions to, especially worse to those from the Generic Drug Manufacturer Sandoz, and normally it is not the Medication that I have adverse Reactions to, I have no Adverse Reactions to Bicillin or Penicillin, but any Tab or Capsule Penicillin with Inert Ingredients will cause Rashes and Blood in my Stool and Urine, because of the Inert Ingredients the Manufacturers add to them. Each Manufacture adds different Inert Ingredients, and some are worse than the others. Anything with Inert Ingredients made from Corn cause Adverse Reactions, and anything made with Cellulose Beta-Glucans like in Yeast, Wheat, Rye, or Barley, or Sugar Alcohols cause even more serious Adverse Reactions, they almost killed me with them again last yer and I still cannot get my Medical Records and get them straightened out so that I can get the Medical Treatment that I need without more serious Adverse Reactions. They sent me to a Patient's Advocate who jus said, "Without any Medical Records, your word is not very Credible, " when the whole Problem the whole time is the Doctors falsely call me delusional about the Adverse Reactions because they did not get it from a Doctor, and they have none of my Medical Records because someone deliberately threw them out! When I handed one of the VA Doctors Hard Copies that show I have Immune System Adverse Reactions to those things, he threw them back at me and assaulted me claiming that the other Hospital Labs were in Error or not accurate! See what few Medical Records I could get here Replace the DOT with a Period for a Link tinyurlDOTcom/5svetk2

    June 25, 2011 at 06:42 | Report abuse | Reply
  7. Evan

    The Supreme Court decision will not make your medication any more or less safe. You don't read the warnings anyway.

    June 25, 2011 at 15:29 | Report abuse | Reply
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