MiraLAX Lawsuit Over Kidney Injury Risk Allowed to Proceed

A federal judge has cleared the way for a MiraLAX lawsuit to proceed, involving claims that the laxative caused caused the development of acute kidney injury. 

In an opinion (PDF) issued on August 7, U.S. District Judge Joel Slomsky rejected a motion for summary judgment filed by the manufacturers in a case originally brought by Samuel Woniewala over the failure to adequately warn about the side effects of MiraLAX.

According to allegations raised in the original complaint (PDF) filed in June 2015, Woniewala took MiraLAX from 2009 through May 2013, under doctor’s orders and supervision for treatment of constipation.

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The lawsuit was first filed in the Philadelphia Court of Common Pleas, before being removed to the U.S. District Court for the Eastern District of Pennsylvania before Judge Slomsky, where the Defendants Merck, Bayer, and Schering-Plough Healthcare sought summary judgment, arguing, among other things, that Woniewala could not claim a failure to warn because he admitted having never read the label, and indicating that the design defect and warranty claims were prevented by federal law.

The judge sided with the plaintiff and rejected the defendants’ motion, not ruling on the merits at this time, but noting that it was far too soon in the process to come to those conclusions. He notes that the court and parties had agreed to a bifurcated discovery process, with the first phase dealing only with the issue of proof of injury and medical causation about the link between MiraLAX and kidney problems.

“Pursuant to the Court’s Order ‘Phase II’ will address liability issues including pre-emption, adequacy of the warning, proximate cause, design and manufacturing defects, and breach of warranty,” the judge’s opinion states. “The instant Motion would be more appropriate when the record is fully developed at the conclusion of ‘Phase II’ of discovery because ‘Phase II’ will address the adequacy of the warning, design and manufacturing defects, and breach of warranty.”

MiraLAX Side Effects

MiraLAX was first approved by FDA in February 1999, as a prescription laxative. The active ingredient is Polyethylene Glycol (PEG) 3350, but some tests have also discovered small amounts of ethylene glycol and diethylene glycol; ingredients found in antifreeze.

In 2006, MiraLAX was approved for over-the-counter use, and it is currently widely used long-term among many children experiencing constipation, even though it is not specifically labeled or pediatric use, or for use over extended periods of time.

In recent months, concerns have emerged about the potential side effects of MiraLAX, amid reports of children suffering seizures, epilepsy and other neurological problems.

To date, the FDA has not placed a label warning on the drug regarding potential MiraLAX risks for children, indicating that there is currently insufficient evidence of a link between PEG 3350 and child psychological side effects. However, the agency did agree to fund further research following parents’ complaints, and acknowledges that it is aware that some doctors prescribe MiraLAX to children for long-term use.

The FDA has previously confirmed that at least 167 reports of adverse events have been received involving children who experienced MiraLAX neuropsychiatric problems, but this appears to only represent a small fraction of the true number of issues experienced by kids nationwide.

5 Comments

  • JonathanAugust 5, 2022 at 9:51 pm

    I have been taking Miralax for 6 years. My doctor said it was safe. He said he has been taking it for 5 years and he was in his 30’s. I have been getting a yearly physical since I turned 60. I noticed my eGFR has been declining. Last year it was 51 and this year it is 45. Stage 3 kidney damage. Almost stage 4. Doctor requested another test so now waiting on results. I very seldom drink alcohol so[Show More]I have been taking Miralax for 6 years. My doctor said it was safe. He said he has been taking it for 5 years and he was in his 30’s. I have been getting a yearly physical since I turned 60. I noticed my eGFR has been declining. Last year it was 51 and this year it is 45. Stage 3 kidney damage. Almost stage 4. Doctor requested another test so now waiting on results. I very seldom drink alcohol so the only other thing it could be was the Miralax. I google the side effects and it said Miralax causes kidney damage. I immediately threw it in the trash. I don’t think your kidneys can repair itself. My life expectancy is 8-10 years at my age with stage 3 kidney failure. If I could do it all over again I would have done research on Miralax and found a different laxatives.

  • Shari LynnJuly 16, 2022 at 8:46 am

    Now they are injecting polyethylene glycol in the Covid mRNA injections. Ever wonder if they are trying to genocide mankind?

  • JanetMay 25, 2022 at 3:10 pm

    I have recently had some abnormal blood results in regards to my kidneys. As I started researching this, I came across some articles about Mirawlax and the kidneys. I had been using Miralax for over a year at my doctor's orders for constipation. Though it helped with constipation, I never felt like this was a very healthy alternative. I am now in the process of trying to figure out what is cau[Show More]I have recently had some abnormal blood results in regards to my kidneys. As I started researching this, I came across some articles about Mirawlax and the kidneys. I had been using Miralax for over a year at my doctor's orders for constipation. Though it helped with constipation, I never felt like this was a very healthy alternative. I am now in the process of trying to figure out what is causing my issues and am definitely discontinuing the use of Miralax.

  • DianeJuly 1, 2021 at 2:48 pm

    I was told by my gastroenterologist to take miralax for chronic constipation, in doing so I have had issues with my kidneys. I noticed something was wrong but every time I complained about it "they" meaning the Dr office never said it could be miralax? I'm also concerned that these Drs in ga don't care what they are doing to the very people that come to them for help. I had stopped taking miralax [Show More]I was told by my gastroenterologist to take miralax for chronic constipation, in doing so I have had issues with my kidneys. I noticed something was wrong but every time I complained about it "they" meaning the Dr office never said it could be miralax? I'm also concerned that these Drs in ga don't care what they are doing to the very people that come to them for help. I had stopped taking miralax 2 weeks ago but was on that stuff for months.

  • SirMay 23, 2018 at 10:17 pm

    “Texas Survival Statue” A Personal Injury and a Negligence Lawsuit: At the Nursing Home, on August 16, 2017, Doctor “M” was informed by Nurse “O” that, my Mother was constipated and she did not have a bowel movement in 12 days. Doctor “M” and Nurse “O” did not order an enema, suppository or Abdomen X-ray for the Patient. No one checked for or removed the Patient's Fecal Impaction. Doctor “M” or[Show More]“Texas Survival Statue” A Personal Injury and a Negligence Lawsuit: At the Nursing Home, on August 16, 2017, Doctor “M” was informed by Nurse “O” that, my Mother was constipated and she did not have a bowel movement in 12 days. Doctor “M” and Nurse “O” did not order an enema, suppository or Abdomen X-ray for the Patient. No one checked for or removed the Patient's Fecal Impaction. Doctor “M” ordered the Patient to take a dose of Magnesium Citrate; and the Patient did not have a bowel movement in 14 hours. Therefore, Primary-Doctor “A” ordered the Patient to take a dose of MiraLax. Suddenly, the Patient had Dangerous and Life-Threatening Side Effects from the Polyethylene Glycol (Antifreeze) in MiraLax. The Antifreeze crystallized in the Patient’s body. Therefore, the Patient was sent to the Hospital Emergency Room; and she was treated for Low Blood Pressure, Kidney Failure, Fecal Impaction, High Potassium, Low Hemoglobin, Dehydration, Dysphagia and Aspiration Pneumonia. The Patient had a Feeding Tube Operation and she was given Morphine for her Pain and Suffering. A Fecal Impaction is suppose to be ruled out, before a patient is given MiraLax. Obviously, MiraLax was the wrong drug for the Patient; and to add insult to injury, the Doctor ordered the Patient to keep taking MiraLax for 30 days…until the day she died. The Doctor did not follow the Food and Drug Administration (FDA) Regulations or the instructions on the MiraLax medicine bottle that said, “USE NO MORE THAN 7 DAYS.” The Patient's son had already discontinued the medicine with a "BLACK BOX WARNING." The Doctors at the Nursing Home and the Hospital’s MD-Specialist had discontinued treating the Patient with MiraLax; but, Doctor “A” disregarded the other Doctors orders and he continued the MiraLax regimen. Doctor “A” was the Patient’s Doctor in the Hospital and at the Nursing Home (2 years). Autopsy Results: Bronchopneumonia, Medical Records and Hospital Bill are available. Proof: Three (3) Nursing Home Employees put False Information on Medical Reports. Purpose of the Texas Survival Statute The Texas Legislature developed the Texas Survival Statute to provide you, a surviving family member, the right to file a claim on behalf of your loved one’s estate for medical expenses your loved one incurred before they died, the value of their pain and suffering and their funeral expenses. Survival claims give the representative of the estate the opportunity to recover the compensation that your loved one would have recovered if they had not died, but had just suffered personal injury instead. This Survival Statute also allows you the opportunity to hold the person or corporation responsible for their wrongful behavior. One person represents the claim. 4 Elements to Prove: You are a legal representative of your loved one’s estate; Your loved one had a cause of action for the personal injuries they suffered before they died; Your loved one would have been able to bring a personal injury claim had they survived the defendant’s wrongful conduct. The defendant’s negligent actions caused the injuries that resulted in your loved one’s death.

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