Reglan (Metoclopramide) Lawsuit Consolidation Being Considered Today
Published: May 28th, 2009 • Comments: 6
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The U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear oral arguments today about whether to consolidate all lawsuits involving Reglan and generic metoclopramide drugs, which have been linked to an increased risk of a serious movement disorder known as tardive dyskinesia.
A motion to form an MDL, or Multidistrict Litigation, was filed on behalf of plaintiffs in 15 Reglan lawsuits pending in 11 different district courts throughout the United States, asking the Panel to consolidate all cases before one judge for pretrial proceedings to eliminate duplicative discovery, avoid conflicting rulings and serve the convenience of the parties, witnesses, attorneys and the courts.
Reglan is the brand name for metoclopramide, which is prescribed to treat gastrointestinal disorders like diabetic gastroparesis, GERD (gastroesphageal reflux and delayed gastrict emptying. Although the medication is only approved for short term use of up to 12 weeks, it is often prescribed for longer periods and at higher doses, which substantially increases the risk of Reglan tardive dyskinesia side effects.
Tardive dyskinesia is a neurological disorder that causes involuntary and repetitive movements of the lower face and limbs, such as lip smacking and pursing, chewing, grimacing, rapid eye movements and impaired finger movements. The condition is often permanent and there is no known effective treatment available.
The plaintiffs’ request for Reglan lawsuit consolidation is being opposed by the various pharmaceutical companies involved in the litigation, including Wyeth, who manufactured the brand name Reglan products, and several manufacturers of generic versions, such as Baxter, Pliva, Barr, Duramed, Actavis, Teva and Scwarz Pharma.
The drug makers have indicated that consolidation is not necessary, pointing to more than 20 years of Reglan litigation since the first case was filed in 1998. More than 70 metoclopramide lawsuits have been filed in federal and state courts, of which 80% have been resolved.
In oppositions filed before the hearing, the defendants pointed out that of the 15 Reglan lawsuits referenced in the motion filed by the plaintiffs, only 11 are at issue at this time, as four have been resolved. In addition, of the remaining cases, three are already “trial ready” with 2009 trial dates and another 5 cases have 2010 trial dates.
Transfer of the remaining cases would hinder the continued efficient resolution of the remaining cases, according to the defendants. In addition, with most of the generic discovery from the pharmaceutical defendants already complete, the drug makers point out that an MDL is not necessary.
In February 2009, the FDA announced that they are requiring that a new “black box” warning be added to all metoclopramide drugs about the tardive dyskinesia risks with Reglan, which some have speculated will lead to an increase in the number of lawsuits filed. However, the drug makers indicate that they believe the impact of the new warning will be minimal since the content was already on the label elsewhere.
Following today’s hearing, the Judical Panel on Multidistrict Litigation will determine whether consolidation is warranted and, if so, determine which jurisdiction the cases should be transferred to. The plaintiffs have suggested that the District of Nevada would be the best location. However, the defendants have proposed various other districts if the Panel establishes the MDL.
Comment by WILLIE on 28 July 2009:
been having problems since been taking Reglan. But all my doctor can say is keep taking meds added mirapex for the leg movement and the lip and eye just involuntary muscle that should stop.
Comment by linda on 6 August 2009:
DAD was shakeing violently and I kept saying we cannot tolerate (extraprmyradial side effects Akathesia and Tardive Dyskinsia was APPARENT) they kept administering dispite contradictions! for 6 months! I am ruiened! It is hell to see him tortured and have no power to help him I was desperate and RISK MANAGEMENT just wanted to HID so they did behind HIPAA!
PLEASE HE IS DEAD.I CANT STAND IT!
Comment by Pam on 8 September 2009:
I just found out about these lawsuits. I have Tardive Dyskenesia due to long term use of Reglan, metaclopramide. I called an Atty last year when it was discovered and he said nothing could be done except to sue the Doc. I will try to get in the lawsuit. I was working for 4 Cardiologists at the time and they said nothing. My sister, an RN is the one who diagnosed me and had me go to my Primary Doc and then to a Neurologist. He’s been wonderful. For anyone in St. Louis, his name is Eli Feen at St. Louis University. I am on Tizanidine and Clonazepam. He was able to reduce my dose over time but I will be on it the rest of my life.
Comment by Susan on 16 October 2009:
Regaln was prescribed to my daughter when she was a baby for reflux. She took the medication for several years at the advice of the doctor. When my daughter stopped showing signs of reflux the doctor wanted to keep her on the medication as a precautionary measure. I decided that it didn’t make sense to keep her on a medication if she wasn’t exhibiting symptoms. So I stopped giving it to her. Shortly thereafter, I noticed a tremor in her hands. It was and is difficult for her to do anything that requires fine motor skills-shoe tying, etc. I took her to a neurologist and he could find nothing wrong except that it could be hereditary. It never occurred to me that it could be a side effect of this medicine. She continues to have the tremors and for the most part lives with it but it is there enough for her to mention or question it time to time. She just turned 10yrs old this September.
Comment by Stephanie on 4 November 2009:
In 2002, my son at 3 months was treated for severe reflux by his then pedritrician being placed on Reglan. There a incidient within the first few weeks of taking Reglan. After 15 to 20 minutes of giving him hte prescribed dosage, he eyes was fixiated with hands and feet drawning inward. I was to bring him out of the stage by talking and gentlely bouncing him. But within minutes of stopping the seizure started again. I contacted the pedrtricians afterhours office while enroute to the local children’s hospital with my sister-in-law attempting to keep him attentive. When arrived at the childrens emergency room, he immediately went into another seizure and was rushed in an exam room. By the time the ER nurse got him the exam room he was lucid but latragetic (she did not see he seizure in the waiting room) so she began to tall me he appeared normal. After a few seconds of argument, she laid him on the exam table to further exam him at my insistence. As soon as he placed on the table, another seizure occurred. The ER Nurse exclaiming Mom is always right. She quickly moves him into triage yelling with 3 attendants rushing to his aid. As I am being asked what mediciation, I stated zantac with no reaction from the doctors then reglan the doctors made eye contact and started immediate evasive actions. I watched as my seizing 3 month old son was stuck with pins and IVs. Five hours after my first call to the pedtrican afterhours line, the pedrician on call shows up to say I need to let the ER doctors do a spinal tap and admit him to the hospital for overnight. I demanded to know a spinal tap was necessary when the ER doctors stopped the seizures after being told he was talking Reglan. I was assured Reglan had nothing to do with it and thought he may have spinal mingintius. The ER Doctors never mentioned a spinal tap but rather ordered a CT Scan. The ER released my son a few hours later and I had an appoint with his regular peditrican the next morning. Since my husband was out of town at work, my father accompanied me to the pedticians office where I was accused of overdosing my son. The doctor stated the adverse reaction was related to an overdose. I indicated that the same amount prescribed was administred; so then he stated that the drug was weight sensitive. So I replied why would a doctor ever prescribe Reglan for an infant with severe reflux when an infant’s weight has the ability to change up or down dramatically within days. WIth no response, I left and went straight the pedtrician at another office that I originallly wanted for my son but was told he was retiring within the year and not accept any new patients. After pleading with the nurses, they took us to an exam room and waitied for our records to arrive via a phone call. The pedricitian woudl not release my son’s records, so this wonderful doctor phycially walking himself 2 complexes away to personally retrieve my son’s records that day. After an exam and review of the records, the new doctor ordered for the next day a full exam by a pedatrictic neurologist. That exam came back normal. SInce this incident he has had 2 surgeries (adnoids and tonsils removed) related to sleep apena, but the question I have is related to behavior. I know nothing about the disorder that Reglan seems to cause, but my son severely grinds his teeth especially during sleep, he fidgets constantly with his hands and can not keep his feet still even while sitting. Of course, most teachers have been quick to diagnose him as ADHD. His pedritrican since this incident is a partner of the retired doctor and has been wonderful, has consulted several times regarding the possibility of ADHD. He prescribed Focalin for him to see if help. On one dosage he diod not sleep for 36 hours, which of course indicates he is not ADHD. In second grade his fine motor skills such as tie shoes and writting are very difficult and frustrating. His current teacher says that he is not ADHD just frustrated because is ahead of his class mentally, but phyically is behind due to the lack of fine motor skills. She has adjusted his course work to improve his abilitiies and confidence. Of course, this no where as severe as the disorder that is descripted and not looking for compensation only to under if anyone else has a child that has displayed the same behavior after Reglan? Thank you.
Comment by Elizabeth on 21 December 2009:
I had a severe case of hyperemesis gravidarum (severe nausea). Not just vomiting/morning sickness. But vomiting constantly where I couldn’t catch my breath forget eating and drinking. Once diagnosed I was put on a reglan pump. I was on this pump for at least 6 months during my pregnancy. My son who is now 10 and being treated for ADHD is having a really hard time socially because of his constant movement and impulsivness. My son also grinds his teeth and fidgets even when on Focalin. He is a very bright child and we are very frustrated that we cannot seem to help him. Has anyone else experienced a similar situation?