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Has the Court Made Generic Drugs Too Risky?

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Americans have long believed in accountability. Harm someone and you should be held responsible, both criminally and civilly. That's why we have lawyers and courts.

If your neighbor recklessly cuts down a tree that falls on your house, you should be able to sue him for damages. If an airplane company builds a plane with serious flaws that lead to a crash and the loss of lives, we have always believed that the families have a right to sue the airline for pain and suffering.

Why is it, then, that generic drug companies should get a free pass when it comes to the damage their medicines may cause? That's the likely outcome of a recent Supreme Court ruling. The American public may not understand all the implications of this game-changing decision yet.

On June 24th, in a 5 to 4 vote, the court determined that patients have very little right to sue generic drug companies for damages caused by their products. In this case a New Hampshire woman, Karen Bartlett, took a non-steroidal anti-inflammatory (NSAID) pain drug prescribed by her doctor. The medication, called sulindac, was once sold only by Merck under the brand name Clinoril. It was first approved by the FDA in 1978 and became available as a generic in the early 1990s.

In December, 2004, Karen Bartlett received a prescription of sulindac because of a painful shoulder. The generic formulation she took was made by Mutual Pharmaceutical Co., a division of Sun Pharmaceutical Industries, Ltd., of India. Over the next several weeks she developed a life-threatening reaction called Stevens-Johnson syndrome and toxic epidermal necrolysis.

It is hard to put into words the devastation of such a disastrous adverse drug reaction. Imagine, if you can, what it would be like to be burned over 65 percent of your body. The medicine that was supposed to ease her shoulder pain caused much of her skin to slough off. Much of her body was an open wound. Karen spent over two months in a burn unit, most of that time in a drug-induced coma to shield her somewhat from the incredible pain. She underwent 12 eye surgeries and was left nearly blind. She is severely disfigured and suffers from numerous disabilities caused by the drug. [To view photographs of others with Stevens-Johnson Syndrome, here is a link. We caution, though, that these photos are very hard to handle.]

The doctor who prescribed Karen the sulindac admitted that he had not read the official prescribing information or drug insert and presumably had not warned her of this potential risk. Even though the generic drug label mentioned "severe skin reactions," it did not describe toxic epidermal necrolysis.  [By the way, the FDA eventually strengthened the warning on sulindac and all other NSAIDs in 2005 to caution about toxic epidermal necrolysis.] Because of her injuries, Karen Bartlett sued Mutual Pharmaceutical for compensation for the damage its drug caused.

A judge dismissed one of her claims that there was an informational defect (inadequate warning) on the grounds that the doctor hadn't bothered to read the label. The judge in his infinite wisdom concluded that a more accurate and thorough warning would not have done Karen any good because the doctor would not have read it anyway. The judge did allow her to sue Mutual Pharmaceutical on another point, however. Her attorneys argued that sulindac was unsafe because of its chemical nature. In other words, the drug had a design defect that could cause permanent human damage. Think of it a bit like a design flaw on an airplane that could lead to a crash.

The two-week trial resulted in a jury verdict in favor of Karen Bartlett. She was awarded $21 million in damages. You might think the case would have ended there, but the company appealed the decision. The First Circuit Court of Appeals agreed with the jury verdict, but once again Mutual appealed. This time it went to the Supreme Court. And this week in its 5 to 4 ruling, the Court decided that the manufacturers of generic drugs cannot be sued under local state law because of bad or even life-threatening reactions. Karen Bartlett's $21 million award was overturned on the grounds that federal law trumps state law. If the FDA has approved a generic medication and the wording on its official prescribing information, then there is no legal recourse--no matter how badly someone may be damaged.

Last year the Supreme Court determined that, while brand name drug companies could be held liable for inadequate warnings on a medication label, the makers of generic drugs using the same inadequate warning get off scot free if their medicines cause irreversible damage. Illogical? In our opinion this makes no sense whatsoever, but it is now the law of the land.

What is so totally bizarre about all of this is that severe or life-threatening drug side effects may not be discovered for years or even decades. The FDA has admitted that it frequently misses serious adverse drug reactions when it approves a medication. A brand name medicine could lose its patent and disappear from the market before a deadly drug reaction is discovered. In such a case, a patient's family could not sue the generic manufacturer even if there were indisputable proof that the drug killed their loved one. That's because federal law requires that the generic drug company use the identical label as the brand name medicine, even if it is flawed. The generic company could not warn patients of the newly discovered danger even if it knew about the hazard.

BOTTOM LINE

Here's our bottom line. If you are taking a generic drug, your legal recourses are now severely limited if you are damaged. If you die because of a toxic reaction to your medicine, your family probably won't be able to sue.

What is the answer? You won't be able to give up on generic drugs, nor do we think you should. Your insurance company will almost assuredly require that you take a cheaper generic over a branded medicine whenever possible. We do worry about the FDA's approval process of generic drugs (see our victory in the Budeprion XL 300 case) and we worry even more about the FDA's ability to monitor the qualilty of generic drug manufacturing facilities in countries like India and China. See the Ranbaxy story for confirmation of our concerns

Your only recourse is to become far better informed about the side effects and dangerous drug interactions of any medicine you swallow. At the first signs of problems you absolutely MUST inform your physician and your pharmacist to find out what to do. In the case of something as deadly as Stevens-Johnson Syndrome or toxic epidermal necrolysis, stopping the drug at the very first sign of symptoms is essential to survival.

SULINDAC (Clinoril) AND OTHER NSAID SIDE EFFECTS:

  • Digestive tract distress, heartburn, stomach pain, nausea, vomiting, diarrhea, constipation bleeding ulcers, perforated ulcers (a life-threatening complication)
  • Dizziness, unsteadiness, spaciness, sleepiness
  • Headache
  • Rash, skin reactions, Stevens-Johnson Syndrome & toxic epidermal necrolysis (life-threatening complications that require immediate emergency treatment)
  • Liver damage, kidney damage
  • Fluid retention, edema
  • Ringing in the ears
  • Sensitivty to sunlight
  • Heart attack, stroke, blood clots
  • Hypertension
  • Heart failure
  • Asthma, breathing difficulty, severe allergic reactions
  • Anemia, blood disorders
  • Changes in vision
  • Meningitis

For more than 35 years we have been trying to warn patients that it is absolutely necessary to become informed about common and serious side effects. Our most recent book, Top Screwups Doctors Make and How to Avoid Them, provides people with a road map to help them avoid life-threatening drug reactions. We hope no one ever again ends up like Karen Bartlett, irreversibly damaged with no legal recourse. We know, however, that people will continue to suffer severe or even life-threatening reactions while taking generic drugs. With the Supreme Court ruling, most will have little legal respite and the generic manufacturers will have little, if any, accountability. That doesn't seem fair to us. What about you?

Here's what a New York Times editorial had to say about the decision.

Share your thoughts about the Supreme Court ruling below.

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The Supreme Court decision shows us what kind of people are running our government these days. Either no common sense at all or being paid off by the drug companies. Makes one feel helpless since we have no say so about who serves on the highest court in the land.

Would it do any good to start a campaign to contact Supreme Court members and urge them to rethink their position?

Why are we the people not aware of these sort of case before they happen? Is there nothing we can do to protect ourselves from drug corporations?

Can this be addressed by the FDA if it chose to narrow their standards for bioequivalence? Could pressure be brought to bear on them to do that?

I thank you for all information. I've been reading your articles in the Cleveland Plain Dealer before I purchased my first computer. Thanks again.
JL from Streetsboro, Ohio

I recently was given generic timolol eye drops. I really like the clear bottle - I can see when the bottle is getting low, but I discovered there was no opening when I tried to put the drops in.

I had to take a knife & cut off the top in order to use the medication. A kitchen cutting board & knife are not as germfree as a lab should be, but more importantly, people using those drops have vision problems. If you cut too far down the tip, you would use far more medication than necessary & run out before the insurance company would ok a refill.

Insurance companies are another issue. If you use a local pharmacy for the 1st bottle, you have to wait a month before they will process the mail order for another. I always like to have a spare bottle on hand in case one is dropped or misplaced. If I find myself out before that is received, I must call in & get a mail order override in order to get a bottle at the local pharmacy.

Last year I had a terrible reaction to the generic NSAID etodolac while visiting my daughter out of town. Just before leaving on my trip, my doctor prescribed me to take 500 mg twice a day for one week and then reduce to 500 mg a day for an old torn lateral meniscus injury.

On day seven and late at night, I had a horrible measles-like rash over my entire body, welts on the back of my neck, beet red and itching skin into my scalp, and a very rapid heart beat. I guess I should consider myself lucky that I did not have any more serious or lasting problems such as Karen. I am, however, now very sensitive to any NSAID that I take, so I avoid them.

My medication was made by Eon Labs out of New York who pride themselves with this statement, "The company focuses on drugs that are difficult to make and it strives to introduce the generic equivalent of brand name drugs on the first day patent protection expires."

Perhaps this is one of the problems with all generics in that there is too big a rush to corner the market on a certain drug without verifying its quality.

I am allergic to sulfa and was taking losartan at the time and I now read that it can interact with etodolac and perhaps this caused my problems.

I also am 74 and this is one drug that is listed on the Beers List as a potentially inappropriate medication to use in older adults (and my doctor is a geriatrist). Thank you so much for introducing me to the Beers List (my Target pharmacist thought he had heard of it)!

In any event, I reported my reaction to the FDA MedWatch. I wonder if my doctor took the time to make a report? Please continue to keep us informed on these very important medical topics so vital to our survival!

Thank-you for keeping us informed. Because of you many people will be helped and healthy.

Thank you Joe and Terry very very much for issuing the alert about dangerous generic drugs. The mainstream media will not inform us of this danger.

I suggest that every reader of your email alert contact their U.S. Senator & Congressperson and urge them to pass legislation to overturn a horribly bad court decision and in doing so protect us from dangerous drugs.

I'm very surprised that the insurance companies have not jumped on this......the injured party has had and will continue to have huge expenses which the insurance company now has no recourse to be reimbursed. Of course, if Medicare is the covering policy, we know why nothing has been heard, they don't know squat about what is happening in the real world. But BCBS, Humana, etc. normally get a huge return on what they have paid out when a lawsuit is won, naturally, coming out of the award to the patient or family. This is a distressing turn of events.

As I have frequently posted, I had a severe reaction to a generic called Gabapentin. The pharmacy used more than one manufacturer.

I am permanently disabled and my feet will never be the same (I have neuropathy and it is ironic that this drug is given to people for neuropathy). I do not blame the doctor.

As People's Pharmacy previously stated, this drug was given for "off-label use" purposes and the company was fined for this. That doesn't help those of us permanently affected.

I'm sure it works for some and that's great but for me, it became a nightmare and still is years after.

I never thought of suing because I felt it would be fruitless and now I know.

I'm already disgusted with our government and this is yet another example of our loss of freedom.

I really appreciate getting this info but how do you fight the Supreme Court? If anyone out there knows how to start a petition or stage a demonstration, I'll be more than happy to jump on the bandwagon. This ruling is a slap in the face to all that are forced to use the generic drug.

P.S. Thank you to the Graedon's. I wish that the Supreme Court was made up of caring, compassionate people like you.

Thank you once again for helping the public be informed! I have always said that I am the one most concerned about my health and responsible for it!

Several folks mentioned feeling helpless or not having any control. I must admit I sometimes wonder if one or a few small voices can make a difference but I think, especially in light of this particularly horrible side effect, that we need to remember to speak up!

Also, I think we do have a say by voting our elected officials into office. It's sad that in cases like these it's all about the law not what's right or moral. Shame on us, living in America, an amazing country where side effects so profound happened to this poor woman and she has no compensation or recourse? Like any amount of compensation would make the drug reaction worth it? An ounce of prevention is SO worth a pound of cure!

My health plan no longer covered Zoloft, so I have tried the generic. I have found that I sometimes get a strange and very uncomfortable feeling in my solar plexus. It is like what one might feel in a frightening situation. In trying to figure this out, I wonder which comes first, this feeling or the anxiety that seems to go with it. They seem to be intertwined. With the real Zoloft, 50 mg, I have not have this experience.

The answer is simple with big pharma and government....follow the money.

This yet one more incredible decision out of this court. Won't get into all that as it is difficult to imagine having any effect on the Court.

The problem seems to be the way the FDA approves generics. In addition to approval of a generic formulation they should have the legal authority to closely monitor EVERY manufacturing site for any drug over which they have approval authority--regardless of the location of the the plant. In addition to the authority they should be given the personnel and funds to accomplish this. If manufacturers who are located out of the US do not want to comply they should not be allowed to supply their drugs to any federal or state contract put out for bid.

I would hope that any restriction such as this would keep their drugs out of commercial pharmacies but cannot speak to that as I have no knowledge.

I am so sorry for Ms Bartlett's pain and her loss of the settlement because of the SC decision. I suspect these sorts of settlements such as her initial one occur all the time but do not result in the results being appealed to higher courts. If it had been a lesser amount the manufacturer would probably have just settled and called it the "price of doing business" and never appealed.

The Graedons have alerted us to problems to many generic drugs and in many and their manufacturing processes--THANK YOU so much.

I know it is difficult for many people to be savvy consumers--if you have a question about a medication after reading the info you received with your prescription: ASK your pharmacist, ASK your doctor--do not take a drug you are not totally familiar with. If you are fortunate to have health insurance and receive mail order prescriptions--call the company affiliated with your insurance and ASK them.

Sadly we all have to be informed consumers; keeping up with publications such as the Peoples Pharmacy is one way of keeping up. You can also go to:
http://www.fda.gov/ - home page of the Food and Drug Administration. On their homepage you can subscribe to newsletters that may be of interest that list recalled items, food contamination outbreaks, etc. The pubs are delivered automatically to your email address and take only a few minutes to scan for anything you might be interested in.

Again, my thanks to the Graedons.

I would hold the Doctor responsible for not reading the prescribing information and potential side effects and informing the patient. There is also the issue of personal responsibility. What ever happened to looking out for one's self instead of relying on others and the government to protect us?

(Sigh) Our government used to protect us. Now, because business has more influence and $$ are more important that the welfare of citizens we're on our own on so many issues.

This is awful! Our government has forgotten about the people of this country & are not taking care of us. How the Supreme Court could come to this decision is beyond me. From now on I will do more research on my prescriptions before taking them.

My heart breaks for Karen & her family.

In article in today's Cleveland Plain Dealer, an attorney experienced with pharmaceutical drug litigation says "I would urge consumers to contact the FDA directly and make their concerns known, and perhaps that will allow the FDA to recognize the seriousness of the problem."

In the longer term, the only answer is for Americans to work together to take back our bruised and battered "democracy" from the corporations that are shredding it by buying our politicians and even our judges.

There is a non-partisan, grassroots national effort underway to reverse more than 140 years of corporations steadily gaining constitutional rights that were intended for human beings. The infamous Citizens United case of 2010 was only a symptom of a much deeper disease, so don't think overturning Citizens United will have any lasting effect.

For the real thing, we need a Constitutional Amendment clearly stating that: 1. Corporations are not people, and therefore are not entitled to constitutional rights; and 2. Money is not speech, and therefore political contributions can be regulated.

Contacting the Supreme Court will do no good. They are focusing on existing laws.

Contact your US Senators and your Congresspeople. Contact them (politely and firmly) over and over until you get a response. Telephone their staff in the local (not Washington, DC) offices. Visit your representatives during their home office hours and other public appearances. Make personal visits to their local staff. (Send emails; send letters; make phone calls.)

Every time you can, ask candidates for these offices whether or not they will vote to provide the laws and funds needed to improve regulation of ALL drugs, including generics. If the answer is no, the follow-up question is "why not."

Clearly, it's the LAWS that need to be changed. And, of course, we know that Big Pharma (not little actual users) are the ones with the clout. Big Pharma includes the makers of generics.

But if we all just give up and don't do anything, then we're part of the problem.

Maybe it's time for an "occupy drug stores" movement.

Unfortunately, all we do is complain about these situations. Where can we go to get something moving.

This is a terrible injustice and now we are protecting the countries that make these medications that in some instances poison us. What on earth are the drug companies doing besides hiring expensive lawyers to get these cases overturned.

How can the general public fight these large corporations with there unlimited funds to hire large law firms to skirt around all the laws and wording on all the medications today. We don't stand a chance.

At some point, everyone will need a medication and we are at their mercy...God help us! WHERE IS AMERICA?

The whole generic medicine situation just makes me sick. It just floors me that neither the Supreme Court or drug companies really care about people - the drug companies just care about making more money. It's ALWAYS about money, greed & politics - money is more important than the well-being of humans. It is so sad that it has come to this. Where is the humanity?

Maybe the original manufacturer should be the one that is liable.

They are the ones that did the testing and got the FDA approval.

All the generic manufacturer is doing is reproducing what was already approved.
And they are doing it at much less cost, a benefit to us all.

The generic manufacturer never had the development costs to recoup and risk.

If the generic was different, badly produced, or defective then they are responsible.

Tis a totally awkward situation.

I wonder how many members of the Supreme Court use generic drugs prescribed by their doctors. I wonder.

Look what happened with bupropion, the generic of Wellbutrin. Finally, after years of complaints it was taken off the market. Now we are hearing about many drugs like that and worse getting a free pass. Wrong decision!

This is almost unimaginable but is unfortunately becoming the norm in this country. It is bad enough that many doctors are not well informed about the drugs they are prescribing, but now we have a Supreme Court that seems only interested in being politically correct.

From all I read, the FDA is really a joke. I have little or no faith in their ability or desire to actually protect the American people which is what the agency was designed to do.

The doctors have played a huge role in creating this problem because many of them either do not know or are not interested in the serious side effects many of these prescription drugs can cause. Some doctors are negligent at best and some seem to be completely incompetent, not to mention the fact that the drug companies are basically bribing the doctors to push their drugs on the public. Unfortunately, money is the name of the game in our society today, regardless of the industry or the outcome.

It is so important for everyone to inform themselves and stay updated on what is happening in the medical and drug industries, and more importantly, take personal responsibility for your own health and wellness.

I greatly appreciate the People's Pharmacy and others like you who are making information available. It is crucial in the world we live in today.

As a health care provider, I read and enjoy your site, and often use the recommendations for patients.
Many medications have the potential for this reaction, antibiotics in particular. My thoughts are that just because a person experiences a side effect, it does not mean that the manufacturer was at fault. I'm sure this side effect was included with the printed prescription information.

If the providers were to go over every potential side effect of every medication the world might be a better place, as there would never be time to see patients.

Bottom line, always be aware that side effects can happen with any medication (and some foods, processed or non processed); we are all individuals and will manifest symptoms differently.
Continue your good work.

I am one of those people who, like canaries in the mines, will probably develop some or most of the side effects of any prescription drug my doctor prescribes. Many doctors do not want me for a patient because they cannot hand me a prescription after five minutes of their presence. And in my opinion, doctors today, overall, do not read side effects.

An internist I really liked once told me that if he "read the side effects" on every drug (he) prescribed, (he) would never write another prescription as long as he lived. And it was, I believe, a pharmacology professor at the medical school in Pennsylvania who told every entering class of students that if they didn't remember anything else about his class, to always remember that every drug is a deadly poison.

I do take two blood pressure medications: one generic and one name brand. Norvasc is a calcium channel blocker and the generic form simply does not control blood pressure. I have a sister-in-law and two friends who have to have the name brand to get any benefit at all from the drug.

But I do not take anything else and at age 70, I really have to fight the doctors to keep them from giving me drugs I don't need and don't want.

One of my friends is a microbiologist. She and I decided to learn all we could learn about nutrition because we did not want to end up as two little old ladies in a nursing home and taking dozens of pills daily. We try to eat a healthy diet without going overboard. I have found that a handful of walnuts four or five times a week and avocado/tomato salad will control my cholesterol at healthy numbers (about 200), ginger tea helps with digestion, pomegranate extract helps keep arteries clear, and Rescue Remedy and yoga will help with stress. And my life is stressful because I lead a large and very active Crime Watch in Dallas, Texas.

My husband, on the other hand, took statins and now suffers from peripheral neuropathies and memory loss. His doctor admits that statins probably caused the problems. He takes blood pressure medication, prostate medication, a generic of Singulair, pain medication, and at age 74, he's not doing well at all.

Every person in today's world needs to learn how to eat a healthy diet, exercise comfortably, manage stress, and teach his or her doctor how to be a good provider of medical knowledge, expertise, assistance, and how to encourage a healthy attitude, less dependence on drugs, and the willingness to "first do no harm".

I take the drug Corey for hbp. Tried the generics but they did not work. My ins. co. would not pay for brand so I'm stuck with t he big price. I take a lot off meds as I have a lot of problems. All of them are generic and there's nothing I can do. These ins. Co. Are going to have to answer to a higher power one day for their greed.

I took two different generics for Arimidex (which I took for 3 1/2 years after a lumpectomy) when they became available -- and my insurer would only cover generics at that point. I started having "suspicious" mammograms, ultrasounds and had to have two breast MRIs and a biopsy (negative) shortly after. I was concerned that the generics were suddenly causing this problem after nearly four years of no problems after a lumpectomy so I opted to join the Astra Zeneca $40 a month program which I paid myself.

I finally decided to have a bilateral mastectomy to hopefully avoid many more "tests" --- and there was a cancerous lymph node in one of the removed breasts. I can't help but wonder if the generics were the cause -- one made by Teva and one by Dr. Reddy.

It certainly seems unfair that a generic manufacturer of a Rx drug escapes liability for side effects when the ANDA approval is based on the record of safety data of the referenced listed drug, ie, the brand-name manufacturers' NDA.

The generic company greatly benefits monetarily by only referencing the safety data rather than generating new data itself. Now that SCOTUS has issued its rulings, it is incumbent on Congress to pass legislation that corrects this outcome.

Congress also needs to modify existing law with regards to the "same as" requirement for labeling of generic drugs so that new safety information can be incorporated in both the brand and generics labeling in a expeditious and coordinated manner.

It should be noted that a generic manufacturer has the same requirement to report side effects to FDA just the same as the brand-name company who obtained the original approval and labeling. Side effects that are both serious in outcome and not included in the approved labeling must be reported to FDA in an expedited manner and this serves as a signaling system for FDA and the manufacturer to update the labeling once on the market.

These reports must be submitted without prejudgement as to whether the drug may have caused the adverse reaction.

Thanks for all the info. One thing that bothers me is that when you send a prescription to your insurance company, they send you a 90 day supply. This may be convenient for both sides. However, if it is a new prescription and is a generic and you find you are one of those who have bad side effects and cannot continue taking the medication, then you have a long term supply that cannot be returned.

In the case of seniors, the insurance company has already billed Medicare. No adjustments are possible. And we wonder why Medicare is in trouble and health insurance is so expensive.

Where does responsibility lie? I have not attended a medical school, gone on to further training in the medical field, perhaps become a doctor. Many of the medication inserts are clear as mud to me. I am paying the doctor to have the knowledge of medications that I do not have. I consider myself an intelligent woman, yet have these difficulties.

What about people who are less intelligent? Is it right to say decisions on medications, knowledge of medication side effects, rest with us? Then give me the power to prescribe, forget about an office visit and payment for same. Perhaps the doctor can earn more from the drug company than he can from me and others like me. Not my fault that greed overrides all consideration of the patient.

I see many ask where has America gone? We older ones here remember a time that was very different and greed, perhaps, was better hidden. Then we were able to put our trust in the doctor, who in turn respected us and took care of us. My mother used to say that the minute we heard the doctor was coming, we began to get better.

And yes, he came to the house to see her sick children. Can you imagine bundling three sick children up and taking them on the bus to see the doctor? Spreading their illness and further damaging their health? I grew up when this country was truly great and the possibilities for a good life were there, just reach out and work hard.

Well, I am willing to take responsibility for my health: eat right, exercise, keep clean. But once sick, that responsibility passes to the doctor. Perhaps a one payer system would bring clearer demarcations of responsibility and more dedicated individuals. Today's health care system is woefully inadequate.

It is very painful to read the comments, but it is a fact that the insurance companies now insist if you don't want to take the generic drugs they pay for you will have to pay out of your pocket and it hurts because I am on a fixed Minimum security

Let's not forget that binders in generics are not the same as the original, thus changes the formula data -- so using the same label for an entirely different 'equivalent' is crazy. It's like saying a liter is equal (equivalent) to a quart. They are two entirely different measurements, ask anyone with 2 days of any sixth grade science class.

I was recently involved in an insurance law suit in which the ultimate decision was simply unbelievable to all the lay persons who were aware of it. There is an extremely destructive (and possibly self-serving) underside to our legal system which most people are unfamiliar with and do not know about.

The legal system has its own set of rules, processes, criteria, and even arcane definitions for common everyday words. The courts are fundamentally not concerned with a case's outcome, or even whether justice was served, but with whether or not proper legal protocol was followed, and whether or not all the legal "i"s were dotted and "t"s were crossed. The fact is (and I do mean "fact" literally,) that this requires the typical, average lay person to hire a lawyer.

The legal system itself is responsible for many injustices because of the extreme rigidity in the thought processes of lawyers and judges, and their gross lack of wisdom. They believe that the extremities to which they carry their hyper logical, hyper rational, and hyper rigid application and administration of law is necessary. That argument, at least theoretically, is not totally without some merit, but all too often leads to decisions and tragedies that are exactly the direct opposite of what the typical citizen understandably and justifiable expect.

I also wonder how many times, even when the victim "wins", the award is less than their legal fees.

Wow! The big thing seems to be that almighty $$$$ & nobody wants to take the blame for these issues. Wouldn't it be wise to not use the generics since they seem to be the issue? Also, understand that many Drs. do not read or know about all the side affects of drugs & they rely on the supposed guidelines. We definitely have to be our own advocates & thoroughly check things out before taking these drugs.

It's a real challenge & I find it doubly so since I have a mentally challenged child who's had to be on drugs for behavior as well as diabetes now, which was a drug induced situation as well. Thanks Joe & Terry!!!! Appreciate all the hard work you two & all the info you have for John Q. Public.

I'm astounded by the above story and the dangers of everyday NSAIDS and grateful to the People's Pharmacy for bringing these problems to light!

I don't know what to do as I have to take many generic drugs due to serious disabilities and the fact that Medicaid will only pay for generic drugs. I'm at a loss as to what to make of the NSAID problems and wonder if they apply to aspirin, that I and many others take to help prevent heart-attack and stroke as well as treat minor pain. Anybody know?

I'd like to know what percentage of people those side-effects apply to. I think we need something like the analysis given the weight-loss drug (name?) earlier in this Alert.

I HAVE to take at least 10 generic drugs on a daily basis and have done so for the past 39 years. Am I doomed? Maybe I should study pharmacology as though I had to become a pharmacist? I'll sure pay extremely close attention to every episode of The People;s Pharmacy from now on instead of just listening for enjoyment.

I think I heard or read somewhere not long ago that naproxen (Aleve) was the least dangerous of the NSAIDs and wonder if that's true?????
Thanks,
JB

PEOPLE'S PHARMACY RESPONSE:

Aspirin does not appear to have many of the complications of NSAIDs like sulindac. And yes, naproxen (Aleve) does not appear as likely to cause cardiovascular complications as some other NSAIDs.

The Supreme court was wrong for taking the case in the first place. They always have the option of sending it back to the lower court that past a ruling on it, which in this case was in her favor.

This Supreme court decision is cause for alarm. Who are they protecting anyway? What benefit does this have for citizens of this country?

Most of the generics are made in other countries. Why are we protecting these companies?I suppose if we still had investigative reporters who worked for independent news papers like we used to have, one of them might follow the money and uncover the real story here.

Drug companies whose patents on drugs have run out would do well to continue to sell the drugs at a lower rate instead of letting them go to any itinerant with a laboratory. With all of the scandal surrounding generics, insurance companies would save money paying for a lower cost BRAND name than risk side effects from generics which can cause their client to become chronically and expensively ill. Insurance companies that refuse to pay for their clients to take BRAND name meds. are really at fault here too. They force the poor patient to take knowingly inferior medication. We would do better with old-time alchemists.

I personally have had too many drug reactions with no benefits from the condition for which they were prescribed. There isn't a pill for everything that ails us, no matter what one sees advertised on TV. We need to do our internet homework; Look up our conditions and become knowledgable enough to know what foods, supplements and activity will help us with this condition. We are all slightly different from one another chemically.

Pills really, really mess with our individual chemistry creating tremendous havoc in some. Consider going med free wherever possible. Demand reliable, older Brand names when drugs are a necessity. Fight the insurance company and your Dr. for this right.

This article points out the fallacy of the "free market." With medication, as in this example, it may be years before a link between a mediation and a serious side-effect may be found.

For the SCOUS to prohibit compensation for damages caused by any drug, first or second string, is totally against the American system of justice.

All I got to say is ;;;Holy Cow. I just don't know about taking generics from India. I have always wondered about generics... still a little leery of them. But am going to keep tabs on the ones produced in India. Thank you for all of your information.

Would it be possible for the wonderful Graedons to host a petition to the FDA regarding this issue of unaccountable generics producers? I mean for there to be a petition here on the web site, and they could also provide a link to it in their newspaper columns? Your thousands and thousands of readers would sign!

My comment: Among generic drugs removed from the market by the FDA in spite of widespread Physician use and knowledge are QUININE which for many years was available over the counter before making it a by prescription only and then only to be prescribed for malaria. It was an invaluable drug for prevention of leg cramps in the early years of my practice. The other drug was COLCHICINE which is now only available in a patented formulation, rather than the much less expensive generic one. Doesn't this raise the question of the integrity of the FDA also???

The Supreme Court is dominated by pro business advocates. Unless we turn the favoritism toward the consumer at the voting booth, business will prevail over the individual in most cases.

Terrible decision and most likely Congress won't reverse it, although they could.

My concern does not rest with generics alone. Tragic events occur with brand pharmaceuticals also much less "knock-offs" (generics).

Some things you just live with. Perhaps not comfortably but going to the doctor for every little thing will get you a lot of pills of all kinds so what can we hope for. As individuals we make those kinds of decisions. Some work out fine and some don't. And some don't work at all. Such is life. Live and learn-sometimes at the expense of others.

Regarding Carla's idea for a petition, I think it's a wonderful idea and would certainly sign and promote it. Such a petition is also not without precedence, Consumers Union, via its Consumer Reports magazine And online, circulates petitions to be sent to members of congress for just about every good health-related idea it supports. Most recently, to stop food companies from feeding healthy food animals (such as turkeys, chicken, swine and cattle) antibiotics used in human medicine just to fatten them up faster. It waters down the effectiveness of the antibiotics in treating human infections and will eventually make them completely useless. It makes me glad I'm on my way to becoming a vegetarian.

I believe The People's Pharmacy should promote a similar petition concerning generic drugs manufactured in suspect places on their show and online that can be digitally signed so The P's P can collect and submit them to the FDA and lawmakers or include the names and phone numbers of individual lawmakers to make it quick and easy for petitioners to respond the same way Consumers Union does.
tutorjb1

Dear dj: I have been taking Gabapentin for the third year for Shingle nerve pain! I pray the Shingles would go completely away but a small amount of pain still remains!
I also had the Shingle's shot after the first year. So far not side affects but they are uncomfortable sometimes!

Thank you for generic alert. I had a bad exp. luckily stopped it after one dose (losarton, cozarr, generic. one pill in a m with break.. was sick by afternoon, luckily I never took it again.... how can I alert others?

This is deplorable and we should all contact our congresswomen / men to let them know how strongly we feel. This isn't even logical. What if one or more of the Supreme Court Justices or one of their family members was damaged because of side effects of a generic drug? Eh? What then?

Doctors do not read labels for sure. When I took Prevacid, it said on the insert not to take it over 8 weeks. My doctor said I should take it for LIFE. Huh? I have NO trust in the FDA either. Is "first do no harm" even part of the oath a doctor takes? I think medicine makes more people sick than anything, except maybe a diet of boxed food.

Thank you for valuable and eye-opening information.

My wife used to take Wellbutrin, periodically, for inherited bouts of depression, with good results.

She had to switch to a generic a few years ago, and developed hallucinations — really scary ones, greatly frightening the family. She stopped taking the generic and has never had such terrifying episodes again.

Thank you for your info, you are doing us great favors. THANKS !

Folke Brahme, M.D.

We need more lawyers like the ones that advertise on tv to keep the drug companies honest

This story is found in today's (July 1) issue of NaturalNews (naturalnews.com) which shows one of the uncontrollable problems with generic drugs. The Supreme Court's decision has now make it possible for all generic manufacturers to relax/lower their standards since there are no consequences to them of selling inferior drugs that can harm/kill millions of people. Not all manufacturers get caught. Generic drugs are big business. It took nine years for the following resolution:

"Thanks to investigative reporter Katherine Eban, we now know that one Indian drug manufacturer, Ranbaxy, has been making substantial profits selling bogus drugs, including generic brands of Lipitor (which is prescribed to lower cholesterol levels), and generally engaging in widespread fraud.

On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties - the most ever levied against a generic-drug company.

Eban notes that the global generic medicine market alone is worth $242 billion annually. What's worse for Americans, more 'than 80 percent of active pharmaceutical ingredients for all U.S. drugs now come from overseas, as do 40 percent of finished pills and capsules,' she says.

In the U.S., doctors and patients are trending heavily towards generic medications as a means of controlling costs. But, as the Ranbaxy case proves, this choice presents special hazards of its own."

It was not clear to me if the court's decision would still apply if it can be demonstrated that the generic is substantially different from the brand, as was the case for buproprion 300mg. And if the generic was the same, whether the brand name could be sued.

It is so very discouraging as well as empowering to be able to read & stay informed but holy cow...where's the accountability? As a newly retired health care provider I am sick about the state of health care in this country & not sure how to best address it. There are more of us than there are corporate players. Not sure how to make a difference other than to read up & stay well. Very frustrating indeed.

These are the stories the public needs to know.

DJ. Can you expand more of what happened when taking gabapentin? My wife is taking gabapentin for shingles neuropathy which has lasted for several years now. I keep wondering if there is something else that is causing the neuropathy which in this case is gabapentin. Are you saying that gabapentin caused your neuropathy?

Darn right! Drug companies should be accountable. Stop importing drugs from China where practices can be unreliable and unsafe.

My husband just returned home from filling a prescription at Target for his 50 mg of metoprolol tartrate. I was shocked to see that the manufacturing lab was none other than Ranbaxy, India's largest generic drug maker. But what do they have to lose if this medicine is substandard/unsafe? They suffer no consequences and can't be sued, thanks to this new U.S. Supreme Court decision. Since we have a great deal to lose, however, and for our own safety, he returned to Target for a new prescription which they gladly gave him.

We all are in for a lot of trouble in the future with generics because of the lack of control and strict adherence to FDA rules. India's largest pharmacy chain says it is suspending sales of all Ranbaxy drugs at this time due to the company's $500 million penalty payment, but the company's CEO comes off as unfazed. In fact, he is touting big plans in the U.S. for the company (Fierce Pharma 6/7/13). Additionally, the lab recently received a poor inspection report from the FDA for one of its facilities in India (Pharmalot 6/24//13). It never ends and will only get worse!

I am a teenager who was prescribed the generic form of Bactrim back in 2011. I as well was diagnosed with Stevens - Johnson Syndrome and TENS. It was not as severe as Mrs. Bartlett's but I do still have many issues with my eyes and esophagus along with scaring on my skin. I hate the Mensing Decision and think its ridiculous. I wish that there was something I could do to change this and be able to help others that go through something as traumatic as Mrs. Bartlett and I had to go through.

Find out who voted for or against and vote them out on the next election on these issues. How are the people being protected? Too much corruption even in the highest ranks of politics.

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