Bayer’s over-the-counter laxative Miralax is promoted as effective “without harsh side effects,” yet reports to the FDA say thousands of children experience severe adverse neuropsychiatric effects from the drug:
Outraged parents now seek legal action against Bayer.
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Miralax, an over-the-counter laxative, is supposed to be a safe, effective treatment for constipation. But thousands of parents across the country, after administering the medication as instructed by their pediatricians, are seeing their children suffer from severe adverse neuropsychiatric effects. These include seizures, mood swings, sudden shifts in personality, bouts of rage and aggression, obsessive-compulsive behaviors, and anxiety—none of which the labeling for Miralax had ever warned the public about.
Now parents are fighting back against Bayer, the current manufacturer of Miralax, accusing the company of endangering children through negligence in product manufacturing / testing, and failing to warn consumers of risks. Will Bayer end up offering settlements to families harmed by Miralax side effects?
Since the early 2000’s, the FDA has received over 2000 adverse event reports describing disturbing, unexpected side effects in children taking Miralax. Yet Bayer, though doubtlessly aware of these complaints and the fact that children form a large percentage of Miralax users, hasn’t added warnings regarding specific risks to children to Miralax labeling and advertising. Devastated parents began sharing their stories in online support groups, and with the help of the Empire State Consumer project, a nonprofit consumer advocacy organization, filed a citizen’s petition to the FDA in 2012, requesting a temporary recall and major label change for the drug, among other demands.
Although the FDA refused to recall Miralax in its 2014 response to the citizen’s petition, the Agency did acknowledge the need for further studies on Miralax and funded research grants for new clinical trials. These include trials examining the effects of possible toxic byproducts in Miralax with emphasis on pediatric patients, as well as studies on colonoscopy prep using Miralax and similar products in children. The FDA also, while rejecting the petition’s plea for a boxed warning, made several major updates to Miralax labeling according to its recommendations.
In light of these widespread FDA-acknowledged concerns and the fact that Miralax is so widely-used, particularly among parents with small children, the legal community expects many lawsuits to arise over unexpected side effects and complications from the drug in the near future.
Pharmaceutical companies are legally obligated to alert the healthcare community and the public to any potential hazards of their products, and so, especially considering how many parents had been sending in FDA adverse event reports, Bayer may soon face allegations such as failure to warn, negligence, and breach of warranty.
When large, internationally-recognized healthcare companies like Bayer find themselves up against staggering numbers of consumer lawsuits, they have to be careful in weighing their options if they want to experience continued success. Public perception is key to consumer trust and brand loyalty, and any controversy surrounding “dangerous drug” cases could severely damage a manufacturer’s reputation and cause a sharp drop in its pharmaceutical sales.
This is why, to prevent or limit negative press, such companies may attempt to resolve pending lawsuits through settlements rather than to run the risk of losing in trial. A series of trials involving popular products would not only attract unwanted media attention, they could potentially cost the company significant expenses from defense attorney fees, and in the case of a trial loss, compensatory and / or punitive damages owed to plaintiffs. Considering these possibilities, a company may decide offering compensation up front to injured consumers through a settlement agreement is the most cost-effective option.
Resolving legal claims through settlements can be highly advantageous for plaintiffs as well. Since going to trial is generally a lengthy process, plaintiffs can expect to receive compensation much sooner through settling than if they were to hold out for their day in court in hopes of winning a trial award. However, in deciding whether or not to settle, plaintiffs and their legal counsel should first carefully examine and consider the settlement terms put forth by the defendants.
Here are some of the leading reasons why plaintiffs may end up refusing a settlement offer:
A manufacturer’s misconduct in allowing its products to harm the public can result in consumers needlessly falling victim to injuries; enduring pain, suffering and emotional turmoil; becoming limited in their ability to earn a living from having to take time off of work or damage to health that causes disabilities; and incurring a large burden of medical expenses. A settlement offer should be large enough to at least plausibly compensate for all of the harm and loss inflicted due to the defendant’s actions (or inaction).
Your attorney will be able to help you come up with a reasonable settlement range for your specific case and negotiate with defendants for you to try and reach a mutually-agreed-upon amount of relief. But if the defendant refuses to offer sufficient compensation, you and your lawyer may decide to give up on settling and go forward with trial proceedings instead.
Sometimes, defendants will require that plaintiffs waive all current and future legal rights to their injury claim before they will consider handing over the agreed-upon settlement award.
You may decide this is a fair trade for the compensation offered, but many attorneys will advise plaintiffs to analyze the situation very carefully.. If it seems likely that you may incur additional Miralax injuries and / or medical expenses in the future, it’s unwise to rule out the possibility of filing another claim down the line to request further compensation
By providing settlement awards to plaintiffs, a manufacturer is not necessarily admitting fault—only acknowledging that consumers may have been injured and offering compensation in exchange for swift resolution of legal claims. On the other hand, when a manufacturer loses a trial, it is officially and publicly found liable for the injuries in question.
Some plaintiffs are compelled to file a lawsuit mainly for the purpose of publicly exposing a defendant’s misdeeds, to achieve a sense of justice and to help alert other consumers of risks, with compensation being more of a secondary concern. These individuals will likely refuse any settlements that require them to completely withdraw their claim and keep quiet about injuries they suffered, no matter how substantial the compensation offered.
But for other plaintiffs, whose primary aim is obtain enough relief to help them recover from their injuries and loss, settling for a large sum would be the more attractive option. All things considered, whether or not to settle is a highly complicated decision that only you and your Miralax attorney can make for your specific case.
In situations where defendants are looking to settle hundreds or even thousands of pending legal claims, whether due to a class action or to consolidated individual lawsuits, it’s obviously impractical to approach each plaintiff individually for settlement negotiations. Instead, companies will usually create a global settlement program designed to efficiently field settlement applications and distribute compensation according to specific terms.
A recent example from Bayer itself is the settlement program for Yaz birth control, a popular female contraceptive drug that sparked thousands of lawsuits from patients who say they suffered fatal blood clots from using Yaz. According to Bayer’s agreement, the total amount of compensation set aside for Yaz settlements was $57 million.
In order to be eligible for compensation, plaintiffs had to “opt in” between August 13 and September 12, 2015. The settlement award amount any individual claimant could expect to receive varied based on her specific case—for instance, more complications and / or hospital admissions would raise the compensation amount, and medical history details such as a high BMI or a smoking habit would lower the amount of awarded compensation.
As we’ve seen, settlement can be a viable, beneficial option for both plaintiffs and defendants in resolving their legal issues. Since most pending Miralax claims are still at a very early stage in the legal process, it’s hard to tell what the future holds for victims’ cases, but judging from recent drug litigations, especially those involving a high volume of lawsuits, drug companies like Bayer are definitely open to offering settlements to injured consumers.
However, no matter how Miralax litigation unfolds, victims should explore their legal options early to get the best possible chance at obtaining compensation for harm inflicted on their families by taking the drug. Waiting too long to take legal action may render you unable to file a claim (if you’ve exceeded the statute of limitations) or ineligible for a settlement (many settlement programs have limited funds and operate on a “first come, first serve” basis).
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