Hundreds of parents say the popular over-the-counter laxative Miralax causes severe neurological symptoms in young children:
Now, these families are considering a major lawsuit against the product's manufacturer, German pharmaceutical conglomerate Bayer.
While this litigation is currently closed, learn more about Nutribullet lawsuit settlements from our team of attorneys.
Bayer’s popular nonprescription laxative Miralax is widely-used by parents nationwide as a remedy for constipation in their children. Yet the FDA never approved the drug for pediatric use, and thousands of reports of severe side effects in children have surfaced since Miralax was first released in 1999. Now parents are filing lawsuits, seeking to hold Bayer responsible for harm they say was needlessly inflicted on their children due to the company’s negligence in warning the public of risks and other alleged misconduct.
Miralax is an over-the-counter laxative that comes in powdered form, to be mixed and ingested with water. It’s currently manufactured by healthcare conglomerate Bayer Corporation. The drug was originally developed and produced by Braintree Laboratories, Inc., and at the time of its 1999 release, it was approved as a prescription-only laxative. In 2006, the FDA accepted the manufacturer’s request to change Miralax to an over-the-counter drug and approved its use in adults for up to 7 days at a time without medical supervision.
The active chemical compound in Miralax is a type of polyethylene glycol (PEG) that acts as an osmotic laxative, which means it eases constipation by drawing water into the bowels, softening the stool and lubricating its passage through the colon.
PEG is a polymer — a large molecule that consists of a long repeating chain of a smaller subunit molecule. The subunit molecule that’s strung together to create PEG is ethylene glycol, which is currently the most commonly-used type of antifreeze. Though ethylene glycol itself is highly toxic, when multiple molecules of ethylene glycol join together into a chain, the resulting polymer is a completely different molecule with its own distinctive set of properties.
PEG is produced and distributed commercially under the trade name Carbowax, and comes in a variety of sizes / lengths that exhibit unique properties useful in many cosmetic, food, and industrial applications. Typically, these size classes are named by the average molecular weight of the PEG molecule in question.
For instance, smaller PEG’s, such as PEG 400, which has a molecular weight of 400 grams per mole, are widely-used in cosmetics to help other ingredients penetrate more deeply into the skin. On the other hand, PEG 3350, the specific PEG used in Miralax, which falls somewhere in the middle of the size spectrum of PEGs offered by chemical manufacturers, doesn’t have this penetrative effect, and is used as a laxative precisely because it’s supposed to be very poorly absorbed by the digestive tract.
Although PEGs are praised for being relatively inert — that is, they’re not likely to interact in harmful ways with other chemicals — they have reportedly caused many individuals to suffer from serious complications.
Some people are acutely allergic to products containing PEGs. A study from the Danish Anaesthesia Allergy Centre found an “increasing frequency” of immediate hypersensitivity to PEGs, which caused reactions “mild to life-threatening” in severity. Unfortunately, according to the study authors, the medical community harbors a general “lack of suspicion” towards PEGs, believing them to be extremely safe for everyone, which puts allergic individuals at risk of “repeated life-threatening reactions” because most doctors are not aware of the potential risks of PEGs, leading to frequent misdiagnosis of allergy symptoms.
Even if PEG 3350 is indeed as safe as manufacturers would have you believe, consumers could still be at risk due to the possibility of PEG 3350 degrading and releasing fragments of toxic ethylene glycol and diethylene glycol.
In fact, the FDA itself tested a number of Miralax batches and detected trace levels of ethylene glycol and diethylene glycol. Even though the amounts of these poisonous chemicals in the test batches were lower than the FDA’s limit for toxicity, many parents are still highly concerned, especially considering the fact that many children are given Miralax for extended periods of time.
Though Miralax is only FDA-approved for use in adults for short-term (up to 7 days) treatment of constipation, parents are often encouraged to give the drug to their children regularly for months or even years on end. Because PEG 3350 (polyethylene glycol with an average molecular weight of 3350 g/mol), the active ingredient in Miralax, has a reputation as an effective laxative with few side effects, doctors have come to rely on it as the “go-to” remedy for children struggling with chronic constipation.
But the vast majority of published research studies examining the safety and effectiveness of Miralax are clinical trials performed on adults, not children. Even if Miralax may indeed be virtually harmless in adults due to negligible gut absorption, as current research suggests, scientists can’t assume the same is true for children, whose digestive systems are often more sensitive and vulnerable to toxins. You can learn more about why drugs can work differently in pediatric patients in this Editor’s Web guide.
The authors of the citizen’s petition asked the FDA to take action by:
In support of its assertions and demands, the citizen’s petition included a long list of attached materials such as physician reports, extensive statements from parents of children suffering Miralax side effects, summaries of a wealth of published research on possible Miralax hazards, and adverse FDA event reports.
Though the FDA refused to recall Miralax in its 2014 response letter to the citizen’s petition and declared no further regulatory action was yet warranted, it did agree with the petitioners that more research on Miralax was necessary.
The FDA funded a grant for a major study examining the extent to which children on Miralax encounter side effects from ethylene glycol / diethylene glycol contamination. The grant was awarded to the Children’s Hospital of Philadelphia and is now believed to be underway, though no results or possible completion dates have yet been released by the researchers.
Though a recall on Miralax and other FDA actions, which may come into effect if the FDA-funded pediatric study and other new trials provide support for serious risks of PEG-based laxatives, would help Miralax plaintiffs by rendering their legal claims against Bayer much stronger, many victims are opting to take action as soon as possible rather than waiting for the results of these studies. Many families are now working with Miralax attorneys, seeking justice and compensation for pain, suffering, injuries, and loss that they say were caused merely by using the drug as intended by the manufacturer.
Though legal experts expect that a large volume of lawsuits involving Miralax will be filed by parents of injured children (perhaps enough to warrant the filing of class actions), adult users have actually already filed some of the earliest Miralax lawsuits. Now, let’s look at one of these claims in detail to see how a Miralax case can be presented.
In April 2015, Philadelphia resident Samuel Woniewala filed a lawsuit against the current and past manufacturers of Miralax, blaming them for his injuries from a serious kidney condition he says was an unexpected consequence of taking Miralax.
Though Woniewala had chronic kidney disease when he first started taking Miralax in 2009, his disease was diagnosed as stable at the time, and he took the drug at the recommendation of both his primary care physician and his nephrologist (kidney specialist). When he started Miralax, his creatine levels, which are used to monitor kidney function, were in the normal range.
Woniewala’s doctors continued to prescribe Miralax to treat his chronic constipation well into 2013. But starting in February 2013, he began to suffer from unexplained pain in his sides. Tragically, in May 2013, Woniewala was hospitalized for severe abdominal pain and nausea and discovered his creatine readings shot up to dangerous levels.
After a renal biopsy, Woniewala’s doctors diagnosed him with oxalate nephropathy, a dangerous condition in which long tubular crystals of calcium oxalate deposit within the kidneys, causing severe damage to the internal tissue.
Woniewala’s lawsuit detailed 4 counts describing “causes for relief”—reasons the defendants should be held responsible for Woniewala’s injuries and therefore obliged to compensate him.
Drug manufacturers, just like any other type of company, have a responsibility to protect consumers as from possible dangers of their products when used as intended. If a manufacturer fails to exercise a reasonable level of care and effort to ensure consumer safety, whether in designing, testing, producing, packaging, distributing, advertising, or any other key task performed to bring a drug to market, it may be accused of negligence if users end up suffering injuries.
Woniewala asserts that Bayer and the other defendants named in his case negligently caused his injuries through a number of actions, including:
Under the legal doctrine of strict products liability, manufacturers are held accountable for causing injuries to consumers, even if they took every possible measure to prevent injuries or harm from occurring. That is, to demonstrate a defendant is liable under strict products liability, the plaintiff mainly needs to show an injury was caused by the product in question when used for its intended purpose.
When manufacturers make promises to the public, both those explicitly stated and those implied (express and implied warranties, respectively), they can be held liable if consumers are harmed as a consequence of breaking those promises.
Woniewala argues that Bayer and the other Miralax manufacturers are guilty of breach of express and implied warranty because they represent Miralax as safe—even for patients suffering from kidney disease, as long taken under a doctor’s supervision. Yet he and many other patients ended up with severe injuries that they believe were caused by Miralax.
Plaintiffs like Woniewala are asking for thousands of dollars in relief, an appropriate amount especially considering how he suffered from life-threatening complications after taking Miralax, resulting in hospitalization, intense pain and discomfort, damage to long-term health, and a great deal of suffering and emotional turmoil, as did many Miralax users who are filing complaints.
Though it’s too early in the litigation process to judge whether or not victims of Miralax are likely to achieve justice and sufficient recovery through settlements or trial winnings, recent drug case resolutions, such as Bayer’s relatively generous Yaz birth control settlement that offered a total of $57 million to plaintiffs, suggest an encouraging atmosphere for Miralax plaintiffs.
In any case, it’s best for injured Miralax users to look into their legal options as soon as possible, to best ensure that they’ll have a chance at securing relief. Waiting too long to file suit may put your case at risk of being dismissed for exceeding the relevant “statute of limitations” (period of time during which an individual can file a lawsuit over a particular injury, which usually starts right at the time of injury).
Continue Reading: Miralax Class Action: Better Options Are Available For Victims