In a devastating opinion for consumers, the Supreme Court has ruled that generic drug companies can not be held liable for failing to warn about known side effects of medications they sell, so long as their labels are identical to those of the original brand-name product. The ruling may have an impact on thousands of generic drug lawsuits filed throughout the United States, involving problems with generic versions of drugs like Reglan, Accutane, Darvocet, Zocor and others.
The 5-4 decision in Pliva Inc. v. Mensing was handed down by the Supreme Court today, split along ideological lines among the justices.
The case involves a lawsuit filed by two women against generic manufacturers of metoclopramide, known more commonly by its brand name, Reglan. The two women, Julie Demahy and Gladys Mensing, sued Actavis, Teva Pharmaceutical Industries, Mylan and other generic drug makers for failing to warn that generic Reglan carried a risk of a rare movement disorder known as tardive dyskinesia.
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Learn MoreThe generic drug makers filed the appeal to the U.S. Supreme Court, arguing that the generic drug lawsuit should be pre-empted because federal law prohibited them from deviating from the original Reglan prescribing labels. Therefore, they claimed that they should be immune from a lawsuit for failing to adequately warn about the risk of tardive dyskinesia from Reglan.
Although plaintiffs argued that the drug makers had other avenues of warning, such as “dear doctor” letters, the Supreme Court overturned a lower court ruling and found that the plaintiffs’ claims were pre-empted by federal law.
The conservative justices agreed with drug manufacturers, and ruled that generic drug makers were isolated from consumer lawsuits as long as they cloned previous drug labels. Justice Clarence Thomas, who wrote the opinion for the majority, said it was impossible for drug manufacturers to follow federal laws requiring duplicate labels while also following state laws requiring safer warnings. Thomas wrote that states laws have to give way to federal power in this case, despite any potential risks to consumers.
Plaintiffs argued against that interpretation of the laws, saying that generic drug manufacturers could have simply asked the FDA to allow them to put more stringent warnings in place in other ways. The FDA has indicated that regulations exist that require generic drug manufacturers who become aware of problems to “ask the agency to work toward strengthening the label that applies to both the generic and brand-name equivalent drug,” but Thomas wrote that the test for whether the laws are impossible to follow require that the manufacturers be able to meet both state and federal standards without outside assistance.
FDA officials argued that all generic drug manufacturers have to do is call and the FDA will determine if updated labels are needed, but Thomas rejected that argument, saying the court would not address it because it has already determined that pre-emption conditions exist.
“We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated,” Thomas wrote, but went on to state that it is not the court’s job to decide if regulations passed by Congress are unusual or bizarre.
Thomas specified that the ruling does not contradict an earlier Supreme Court judgment in Wyeth v. Levine, which found that brand-name drugs were not exempt from product liability lawsuits, because they could easily meet both state and federal laws without conflict.
Justices Sonia Sotomayor, Ruth Bader Ginsburg, Stephen Breyer and Elena Kagan dissented with the ruling, siding with the protection of the public from potentially dangerous drugs as the higher priority for the court.
“We have traditionally held defendants claiming impossibility to a demanding standard,” Sotomayor wrote for the dissenting judges. “Until today, the mere possibility of impossibility had not been enough to establish pre-emption.”
Sotomayor pointed out that there was a mechanism in place to avoid impossibility through the FDA and accused conservative justices of straining legal interpretation to the detriment of consumers and the advantage of pharmaceutical companies.
“The Court gets one thing right,” Sotomayor wrote. “This outcome makes little sense.”
Tardive dyskinesia is a rare movement disorder associated with repetitive and involuntary movements, particularly involving the lower face and limbs. Symptoms can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. Long-term use of Reglan has been linked to an increased risk of tardive dyskinesia and there is no known effective treatment of the disorder, with the involuntary movements often persisting even after use of the drug has stopped.
A number of similar tardive dyskinesia lawsuits over Reglan are pending in courts throughout the United States against generic drug makers. Brand-name Reglan was originally formulated and marketed by Wyeth, but it is currently only available as a generic metoclopramide.
In February 2009, the FDA required that manufacturers of all variations of generic metoclopramide add a black box warning about the Reglan tardive dyskinesia risk, which is the strongest warning that can be placed on a prescription medication. The generic drug makers were also required to develop mitigation and risk evaluation strategies to help ensure patients are aware of the potential metoclopramide side effect.
Although the first Reglan tardive dyskinesia lawsuit was filed in 1998, the number of claims has increased since the black box warning was added. The ruling is likely to have an impact on thousands of generic Reglan lawsuits that are pending in cases throughout the United States.
The Supreme Court ruling may also impact lawsuits filed by consumers who were injured by undisclosed side effects of other generic medications. In recent years, a number of generic Accutane lawsuits have been filed against drug makers for failing to warn about the risk of inflammatory bowel disease from the acne medication. Generic Darvocet lawsuits have been filed on behalf of consumers who suffered severe heart problems as a result of the popular painkiller, which was recalled last year. More recently, a number of consumers have been reviewing potential generic Zocor lawsuits as a result of inadequate warnings that high doses of the cholesterol drug have been associated with an increased risk of a serious and potentially life-threatening muscle injury, known as rhabdomyolysis.
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JustineMarch 29, 2015 at 11:20 pm
Hello, I am sorry to hear of everyone's misfortune and I empathize. I believe since this country is ruled by capitalism, the FDA is more interested in getting paid by the big pharmaceutical companies to approve drugs they know are toxic and dangerous to We the people. It is a monopoly. You and I can NOT trust the doctors, the pharmaceutical companies, the pharmacists, the lobbyists, the politician[Show More]Hello, I am sorry to hear of everyone's misfortune and I empathize. I believe since this country is ruled by capitalism, the FDA is more interested in getting paid by the big pharmaceutical companies to approve drugs they know are toxic and dangerous to We the people. It is a monopoly. You and I can NOT trust the doctors, the pharmaceutical companies, the pharmacists, the lobbyists, the politicians, The Supreme court judge or The System. We as consumers must look out for our own best interests, fight the good fight best we can, and realize Big Brother is not only watching, but very much in control of the masses, and cares not for our best interests, but only for how They will profit. I am a double widow, my second husband was a veteran marine. I have three sons, My youngest has a very rare genetic disorder and requires constant care. I suffer from a lot of health problems. I also have depression and PTSD. I have been giving many psychological medications throughout the years. Most recently I was on a low dose of Risperdone. This is a generic for Risperdal. Its an antipsychotic intended for schizophrenic people, and people who are violent. I was taking it at night for anxiety. I was on a low dose for two years. I developed tardive dyskenisia and tardive dystonia. This is a very painful and socially awkward condition. I am unable to work, and I'm having difficulty caring for my children now. I may have to relinquish custody of my youngest son who has progeria to a group home or some hospital or institution. I was NOT warned that the medicine I was taking could cause an irreversible neurological condition. There was NO warning and I did NOT know I was high risk to get this problem, but the doctor and pharmaceutical companies DEFINITELY knew. I am not schizophrenic and was prescribed medications off label use. I neglected to investigate the possible serious side effects. I hope to find legal representation soon, but so far, I have not because I took a generic version instead of a brand name drug. I plan to be a MUCH MORE careful consumer from now on, but I am permanently disabled, and barely scraping by on SSI. I am being referred to a neurologist but I already know there is no cure for my type of movement disorder. There are treatments but they only help some people, and it's a temporary fix. If you think only one person is small to make a difference, try sleeping locked in a room with a mosquito. "When The People are afraid of their Government it's tyrancy, but when The Government is afraid of its people, that's democracy"
lucky nicholsApril 23, 2012 at 5:41 am
Marvin, I couldn't agree with you more. I was going to add that Thomas had 4 supporters. Mom beat me to it. The conservative justice system is no justice at all.Steven, I've been there. Is there anybody in the world that can help me? For every door that closes, you are locked out. People are dying, incapacitated. James, I am looking for an answer to your question. I don't know, which is the reaso[Show More]Marvin, I couldn't agree with you more. I was going to add that Thomas had 4 supporters. Mom beat me to it. The conservative justice system is no justice at all.Steven, I've been there. Is there anybody in the world that can help me? For every door that closes, you are locked out. People are dying, incapacitated. James, I am looking for an answer to your question. I don't know, which is the reason I found this site. I don't have answers and can't seem to get any. I just happened to be a filer of darvocet(generic). What I don't understand is, if you can't deviate from a drug, shouldn't that deviatation be for everything. Why can't you be governed by the same laws. If there is no difference, the effectness, side effects, warnings, shouldn't they be the same? The liability should rest on both. Regardless of the conservative bull, bottom line, you are a victim, no more or less if they have the same ingredients. That makes no sense. If its not the courts business to regulate the conservative Congress on its bizzare laws. You based a ruling on these bizarre laws. You are as bizarre as the ruling you agree on. Who should decide these things? Lobbyists? We suffer because we elected them. I didn't but since I am affected it is we. They have to much power. No, none of them will ever go thru what we are dealing with because there meds are probably free if not they can afford to go non generic. A fricking apology. REALLY! and now all the conservative judges will base there ruling on this one. I wonder if all conservatives are placed on the drug lawsuits? If one company was deemed that they were at fault, then this is the standard they should have used. How can you say one generic is liable but others are not.
JamesMarch 14, 2012 at 9:49 pm
Looking today I see that the MDL judge in the Darvon/Darvocet case has ruled against the Plaintiffs in favor of both the name brand and the generic drug manufacturers. He has dismissed the cases on both sides of this issue siding with the 5-4 supreme court decision. Is there any movement any where to have the Supreme Court or the MDL judge decision over turned?
MomAugust 16, 2011 at 12:57 am
The word 'conservative' has become a dirty word. When you have 'conservative' Supreme Court Justices prostituting themselves to drug manufacturing companies ... this shocking!
MelindaAugust 5, 2011 at 7:44 pm
On 11-12-09 I gave birth to a beautiful daughter. Unfortunately she lived only two short hours. My daughter, Isabella was born with a two-chamber heart. I was prescribed the drug citalopram or (Celexa) at least two years prior to conceiving her. When I became pregnant I was told that this was the safest medication to be on during pregnancy. Just a few short months ago I found out about the sid[Show More]On 11-12-09 I gave birth to a beautiful daughter. Unfortunately she lived only two short hours. My daughter, Isabella was born with a two-chamber heart. I was prescribed the drug citalopram or (Celexa) at least two years prior to conceiving her. When I became pregnant I was told that this was the safest medication to be on during pregnancy. Just a few short months ago I found out about the side effects during pregnancy. Since her death I have been deeply depressed thinking her passing was solely my fault. Clearly this ruling was insensitive, unfair and callous to people like myself.
stevenJune 26, 2011 at 8:39 pm
Is there anybody out there in the world who can help me? What I am writing here is very short, my health is getting worse and worse with the side effects of pain medication stated below, asd I cannot go into to much detail and have to make it very brief... Tylonel has ruined my liver over long term use - no doctor told me this - it has become enlarged and fatty like a person who drinks alcohol a [Show More]Is there anybody out there in the world who can help me? What I am writing here is very short, my health is getting worse and worse with the side effects of pain medication stated below, asd I cannot go into to much detail and have to make it very brief... Tylonel has ruined my liver over long term use - no doctor told me this - it has become enlarged and fatty like a person who drinks alcohol a lot, except I do not drink at all. When many doctors see these results, all doctors know and say to me, yes long term tylonel ruins the liver. Why did no doctor ever tell me this before putting me on these pain medications with tylonel. I have lost my quality of life. Can anything be done to compensate me from the drug manufacturers? I do love working and have not been able to, and have placed difficult financial hardship on my family. Then the doctors put me on methadone pain medication, as they said it will not affect my liver. Now I have become dependent and addicted with a list of side effects that I feel I can't go on any longer and cannot hold down any kind of work and lost most of my friernds as they just don't understand what I am going thru! It is really hard and difficult to even understand how my life got this bad...and I am not even mentioning my chronic and disabling arthritis. I find there is no help for me anywhere - believe me I called and begged all agencies for help with this addiction and illness, either I can go to a lock-up phycotic facility (this is not what I need), or there is nothing and suffering at home alone. I cannot afford $25-$35 thousand dollars to go to a drug rehab facility and cannot find any help for my arthritis other than doctors giving me pain meds... Again the drug manufactures have made me completely dependent on pain medication with no help. Can you as a human being able to help me find help without money I do not have? I will be happy to work off my expensives, I want to learn how to live with what I am going thru above and be productive to society, and my family to be proud of me again. Is there anyobdy in this world out there who can help me? Thank you, Best Wishes God Bless Steven
DavidJune 24, 2011 at 3:38 pm
I agree! Any chance this could be overturned? What does this mean for all the generic accuatane cases?
MarvinJune 23, 2011 at 5:48 pm
Justice Clarence Thomas has stated a ruling that defeats the purpose of the FDA. The FDA is supposed to protect the public. The current Supreme Court ruling negates states laws in favor of Federal law that does not put the safety of the consumer in the first priority. Judge Thomas appears to be in the pocket of the drug companies.