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.

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.