Health Officials Warn Benzocaine Teething Products Unsafe for Infants
In a recent article from CBS News, the authors stated that the United States Food and Drug Administration has released a warning regarding the use of certain teething remedies. Specifically, the FDA has warned that benzocaine could cause serious—also deadly—side effects in young children, particularly toddlers two years old and younger. Many manufacturers have used benzocaine in teething gels and other remedies because of its numbing properties.
The FDA has provided warnings about benzocaine teething relief products for about ten years. Tragically, many children suffered serious illnesses or even died as the products continued to be used. FDA officials now argue that the teething products should be taken off shelves, insisting that there is not much evidence that shows they actually work.
Scott Gottlieb, the Commissioner of the FDA, said, “We urge parents, caregivers and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain.”
If a company that manufactures teething remedies that contain benzocaine refuses to stop selling the products, the FDA has stated it will pursue legal action. However, it is expected that most manufacturers will comply with the FDA’s request.
The FDA posted a YouTube video with the title, “Do teething babies need medicine on their gums? No.” In the video, parents were warned about using benzocaine-containing products due to the risk of methemoglobinemia, which can be a life-threatening disorder. With methemoglobinemia, the amount of oxygen in the blood is reduced because of interference with oxygen-carrying proteins. Symptoms of this dangerous disorder include headache, shortness of breath, and increased heart rate. The video also advised parents to avoid homeopathic teething remedies, which could have numerous side effects.
Benzocaine is also widely used in products intended for adult use, such as Orajel for cold sores and Anbesol for toothaches. At this time, benzocaine-containing products may remain on the market for adults, but the FDA would like for manufacturers to provide additional warnings on these products.
Church and Dwight Co. Inc., based in New Jersey, stated that it has discontinued the sale of four different types of Orajel teething products, such as Orajel Medicated Teething Swabs. Company officials noted, “We are not discontinuing other Orajel products, which represent the majority of our Orajel offering.”
The American Academy of Pediatrics states that teething creams are not recommended because they usually wash out of the mouth in just a few minutes. Experts instead recommend massaging the gums or providing teething rings to help babies with pain and discomfort.
In 2006, 2011, and 2014, the FDA warned about the use of these teething products. At that time, however, the FDA did not recommend taking the products off the market. FDA officials have reviewed 119 claims of methemoglobinemia caused by benzocaine, including 4 cases that resulted in deaths.
How are companies held responsible when their products cause injuries or death?
All manufacturers, including those that produce medications, have a duty to provide products that are safe for consumers. If a product causes harm to a person, the manufacturer may be liable in a products liability suit. Companies are strictly liable for injuries caused by their products—this means that it does not matter that the manufacturer was not actually negligent in creating or distributing the product. The consumer must show:
- The product was being used as instructed or as anticipated by the consumer;
- The product was defective;
- The consumer was injured; and
- The defective product was the actual cause of the injury.
Each of these elements must be proven for a claimant to prevail in a products liability lawsuit. If the claimant cannot prove one of the elements, the claim will be dismissed and the claimant will not be eligible to receive an award from the manufacturer.
There are three primary types of product defects.
Design defects stem from a product’s “blueprints,” or how the product was designed. For example, the teething gels described above likely contained a design defect, because they were designed to include benzocaine. Because of the benzocaine, the products were deemed defective, due to the dangerous side effects of this ingredient.
Manufacturing defects happens when an error occurs as a product is being built, assembled, or shipped. Essentially, manufacturing defects may occur at any time from a product’s creation until it reaches the consumer. Consider a batch of medication that became contaminated because it was not properly sealed in its packaging. This would be an example of a manufacturing defect.
Marketing defects occur when a company fails to provide adequate warnings or instructions with a product. For example, many medications should be avoided during pregnancy. If a drug manufacturer fails to disclose such a warning on its packaging or labeling, and a pregnant woman takes the medication, she may have a products liability claim against the manufacturer if she or her baby was harmed.
What type of compensation is possible in a products liability claim?
If a claimant prevails in a products liability claim, that claimant may be entitled to tens, possibly even hundreds, of thousands of dollars in damages. The amount of damages available depends on the facts and circumstances of the claim.
Damages may include:
- Medical expenses, such as hospital bills, emergency room bills, physical therapy expenses, surgical costs, anesthesia costs, and similar expenses;
- An estimated cost of future medical care that may be required;
- Lost wages, if the claimant missed time from work to recover;
- The cost of remodeling or altering a home to accommodate an injury, such as installing wheelchair ramps or handrails;
- Pain and suffering, which compensates a claimant for the physical discomfort he or she has endured;
- Emotional distress, such as depression, anxiety, or post-traumatic stress disorder triggered by the incident;
- Loss of consortium, which may be sought by the victim’s loved ones for the damage caused to their relationship with the victim;
- Punitive damages, which compensate a victim if the defendant’s behavior is especially egregious; and
- Any other damages that are related to the victim’s injuries.
With the assistance of an experienced products liability attorney, the odds of recovering a substantial amount of damages increases significantly. Products liability claims are notoriously difficult. After all, proving that a product, such as a medication, caused a specific injury requires a thorough understanding of the anatomy and physiology of the body, as well as applicable state and federal laws. These cases also involve numerous filing deadlines, which, if missed, may bar the victim from recovering damages. Therefore, it is best to seek the guidance of an experienced attorney if you believe that a product has caused your or your loved one’s injuries. Your attorney will carefully study the facts of your case and provide guidance into your legal options. Without an attorney, you may not realize how much in damages you are actually entitled to under the law.
Contact Parker Waichman LLP Today to Discuss Your Benzocaine Teething Product Claim
At Parker Waichman LLP, our Benzocaine teething product wrongful death lawsuit lawyers are experienced in all types of product liability claims and are prepared to help you get the money you deserve. To receive a free consultation with our Benzocaine teething product wrongful death lawsuit attorneys, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.
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