Reckis v. Johnson & Johnson (2013): When Drug Side Effects Lead to a $63 Million Verdict
Pharmaceutical drugs, while designed to heal and alleviate, sometimes carry the risk of severe, even life-altering, side effects. When these side effects occur, and when a company fails to adequately warn consumers about these potential dangers, legal recourse may be available. One such case that highlights this issue is Reckis v. Johnson & Johnson (2013), where a jury awarded \$63 million to a teenager and her family due to the devastating side effects she suffered from Children’s Motrin. This case underscores the importance of pharmaceutical companies’ responsibility to provide clear and comprehensive warnings about the risks associated with their products.
The Devastating Reaction to Children’s Motrin
In 2003, seven-year-old Samantha Reckis took Children’s Motrin, an over-the-counter pain reliever containing ibuprofen, to alleviate fever symptoms. Tragically, Samantha experienced a severe reaction, developing Toxic Epidermal Necrolysis (TEN), a rare but life-threatening skin disorder. According to Boston lawyer Bradley Henry, the condition was “like having your skin burned off of you.”
TEN causes the top layer of skin to die and shed, leading to severe blistering, peeling, and open sores. In Samantha’s case, the reaction was particularly devastating. She lost 90% of her skin, suffered damage to her lungs, liver, and heart, and tragically, became legally blind. She was hospitalized for six months and endured immense pain and suffering.
The Lawsuit and the Allegations
In January 2007, Samantha and her parents, Lisa and Richard Reckis, filed a lawsuit against Johnson & Johnson, the manufacturer of Children’s Motrin, and its subsidiary, McNeil-PPC Inc. The lawsuit alleged that Johnson & Johnson failed to adequately warn consumers about the potential for life-threatening reactions, such as TEN, associated with the drug. The family argued that the warning label on the Children’s Motrin bottle was defective because it did not sufficiently communicate the risk of developing such a severe condition.
Richard Reckis testified that he would not have administered the third dose of Children’s Motrin to Samantha if the label had warned that redness, rash, or blisters could lead to a life-threatening disease or specifically mentioned Stevens-Johnson Syndrome (SJS) or TEN.
The Verdict and Its Significance
In February 2013, after a five-week trial, a jury in Plymouth, Massachusetts, sided with the Reckis family. The jury found that Samantha’s ingestion of Children’s Motrin caused her TEN and that Johnson & Johnson negligently failed to provide adequate warnings about the drug’s potential side effects. The jury awarded Samantha \$50 million in compensatory damages and \$6.5 million to each of her parents for loss of consortium, totaling \$63 million. Including interest, the total could have reached \$109 million.
This verdict sent a strong message to pharmaceutical companies about their responsibility to adequately warn consumers about potential drug side effects, no matter how rare. The Reckis family stated, “Drug companies like Johnson & Johnson can no longer hide behind an approval by the overworked FDA as an excuse not to warn consumers about known, devastating drug reactions like SJS and TEN. Parents like us have a right to know.”
Johnson & Johnson’s Response and Subsequent Appeals
Johnson & Johnson maintained that Children’s Motrin is safe and effective when used as directed and that the drug was appropriately labeled. The company disagreed with the verdict and pursued additional legal options.
Johnson & Johnson appealed the verdict, arguing that the family’s claim of failure to warn was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) and that the causation evidence presented by the plaintiffs was insufficient. However, in April 2015, the Supreme Judicial Court of Massachusetts upheld the \$63 million verdict.
Johnson & Johnson then sought review by the U.S. Supreme Court, arguing that the Massachusetts Supreme Judicial Court erred in holding that the FDA’s rejection of warning language proposed in a citizen petition was not “clear evidence” sufficient to preempt state tort claims. However, on January 19, 2016, the U.S. Supreme Court declined to hear the appeal, leaving the \$63 million verdict intact.
The Broader Implications
The Reckis v. Johnson & Johnson case highlights several important issues:
- The Importance of Clear and Comprehensive Warnings: Pharmaceutical companies have a legal and ethical obligation to provide clear and comprehensive warnings about the potential side effects of their drugs, even if those side effects are rare.
- The “Failure to Warn” Legal Theory: This case exemplifies the legal theory of “failure to warn,” where a manufacturer can be held liable for injuries caused by its product if it failed to provide adequate warnings about the product’s risks.
- The Role of the FDA: While the FDA plays a crucial role in regulating drugs and ensuring their safety, pharmaceutical companies cannot rely solely on FDA approval as a shield against liability. They must independently assess the risks associated with their products and provide appropriate warnings.
- The Rights of Consumers: Consumers have the right to be informed about the potential risks of medications they take. When pharmaceutical companies fail to meet this obligation, injured consumers have the right to seek legal recourse.
Similar Cases and Concerns
The Reckis v. Johnson & Johnson case is not an isolated incident. Other drugs manufactured by Johnson & Johnson have also been the subject of lawsuits alleging failure to warn about potential side effects.
For example, Risperdal, an antipsychotic drug manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals, has been linked to gynecomastia (breast growth in males). Thousands of lawsuits have been filed against Johnson & Johnson, alleging that the company failed to adequately warn about this risk. Johnson & Johnson has paid billions of dollars to settle Risperdal lawsuits, including an \$800 million settlement in 2021 to resolve “substantially all” of the pending cases related to gynecomastia.
What to Do If You Suspect a Drug Injury
If you or a loved one has experienced adverse side effects from a medication, it is essential to take the following steps:
- Seek Medical Attention: Your health is the top priority. Consult a doctor immediately to address your symptoms and receive appropriate medical care.
- Document Everything: Keep detailed records of your symptoms, medical treatments, and any expenses you incur as a result of the side effects.
- Consult with a Personal Injury Lawyer: A personal injury lawyer specializing in pharmaceutical litigation can evaluate your case, explain your legal options, and help you pursue compensation for your injuries.
Conclusion
The Reckis v. Johnson & Johnson case serves as a stark reminder of the potential consequences of drug side effects and the importance of pharmaceutical companies’ responsibility to provide adequate warnings. If you or a loved one has been injured due to a drug’s side effects, seeking legal counsel is crucial to protect your rights and pursue the compensation you deserve.