Accepting Cases

Benzocaine Lawsuits

Attorneys are preparing cases for adults, children and babies who were harmed by over-the-counter oral health products that contain benzocaine. Potentially hundreds of lawsuits may be filed against manufacturers of these products, many of which were marketed to treat teething pain in infants.

Suffering from methemoglobinemia after using Benzocaine?

If you or your child used Benzocaine products and developed the serious and potentially fatal blood condition methemoglobinemia, you may be entitled to compensation.

Benzocaine - Cetacaine
Benzocaine Lawsuit Facts
  1. Injuries Methemoglobinemia
  2. Manufacturers Pfizer, Reckitt Benckiser, Cetylite, Onset Dermatologics, Beutlich Pharmaceuticals, Colgate-Palmolive, Church & Dwight, Sultan Healthcare
  3. Top Settlement None yet
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*UPDATE: In May 2018, the U.S. Food and Drug Administration warned against using over-the-counter benzocaine products to treat teething pain in infants. Drugwatch’s legal partners are reviewing cases of infants, children and adults who developed methemoglobinemia after using benzocaine-containing oral health products.

Interest in benzocaine lawsuits centers on methemoglobinemia, a known side effect of benzocaine.

Methemoglobinemia happens when oxygen levels in the blood drop dangerously low. Symptoms include cyanosis (bluish color of the skin) and chocolate brown-colored blood. The condition can be fatal.

More than 400 people have developed methemoglobinemia from benzocaine use since 1971, according to the U.S. Food and Drug Administration.

At least four people, including one infant, died of methemoglobinemia between February 2009 and October 2017.

Benzocaine is a topical anesthetic found in many products. In May 2018, the FDA directed manufacturers to stop marketing benzocaine products to treat teething pain in infants. The agency also told makers to include a warning about methemoglobinemia.

What Benzocaine Injuries Can I Sue for?

Infants, children and adults who developed methemoglobinemia after using benzocaine-containing oral health products may be eligible for compensation.

Eligible plaintiffs would have used an over-the-counter benzocaine product at least once and experienced symptoms of methemoglobinemia within two hours of using the product. They would have been hospitalized as a result of this injury.

Relatives of people who died from benzocaine-induced methemoglobinemia may also have legal cases.

Benzocaine Lawsuit Eligibility
  • Infant, child or adult
  • Developed methemoglobinemia
  • Used at least one dose of an OTC product containing benzocaine
  • Experienced symptoms of methemoglobinemia within two hours of using an OTC benzocaine product
  • Case occurred 2008 to present

What Products May Be Named in Benzocaine Lawsuits?

Over-the-counter benzocaine products come in brand-name gels, sprays, ointments, solutions and lozenges. Benzocaine is also in store brand products and generics.

OTC Benzocaine Products & Manufacturers that Could Face Lawsuits
Product Manufacturer
Anbesol Pfizer
Baby Orajel Church & Dwight
Cepacol lozenges Reckitt Benckiser
Cetacaine Cetylite
Exactacain Onset Dermatologics
HurriCaine Beutlich Pharmaceuticals
Orabase Colgate-Palmolive
Orajel Church & Dwight
Topex Sultan Healthcare

How to File a Benzocaine Lawsuit

An important step in filing a benzocaine lawsuit is to find an experienced lawyer. Most qualified benzocaine lawyers will review and file cases for no charge. These lawyers typically do not collect any money from their clients until they win an award or settlement.

Timeframe for Filing a Benzocaine Lawsuit

Attorneys are accepting cases that occurred in 2008 or later. If you or a loved one used a benzocaine product and suffered methemoglobinemia in 2008 or any year after, you may have a legal claim.

It is important to contact a lawyer right away as there is a time limit for filing certain lawsuits. A lawyer will be able to tell you the statute of limitations for your case.

Seeking compensation for methemoglobinemia after using Benzocaine? Get a Free Case Review

Public Citizen Benzocaine Lawsuit & FDA Warnings

The advocacy group Public Citizen filed a lawsuit against the FDA in 2017. The lawsuit sought to force the agency to act on a petition Public Citizen had filed in 2014 over benzocaine uses and warnings.

Statistic that shows regulators have known about benzocaine methemoglobinemia since 1991
Source: Public Citizen Inc. v. Food and Drug Administration Complaint for Declaratory and Injunctive Relief

The petition asked the agency to remove infant teething pain as an approved use for benzocaine. Public Citizen asked that the benzocaine label advise against benzocaine for infant teething pain. The group also requested label warnings about the risk of methemoglobinemia on all benzocaine products used in oral care.

Public Citizen’s benzocaine lawsuit says regulators have known as far back as 1991 that benzocaine is linked to methemoglobinemia. But no warnings were issued to the public for more than 25 years.

In 1991, the FDA classified benzocaine as an over-the-county analgesic and anesthetic. At that time, the advisory review panel involved in the classification recognized that benzocaine could be linked to methemoglobinemia, according to Public Citizen. The panel also knew that infants are more susceptible to the condition.

The FDA has also said since 1991 that benzocaine medications are not necessary or useful to relieve teething pain. That’s because they tend to wash off the baby’s gums within minutes.

Fact
The U.S. Food and Drug Administration has known for more than 25 years that benzocaine is not useful for treating teething pain in infants

Between 2003 and 2014, the FDA issued several safety announcements regarding benzocaine’s risk of methemoglobinemia. In 2014, the agency told manufacturers of over-the-counter oral health products it wouldn’t object if they added a warning about the blood condition to their product labels. The FDA did not require the warning until 2018.

The FDA ultimately responded to Public Citizen’s lawsuit and petition in a letter on May 24, 2018.

“We have carefully considered your requests and share your concerns regarding the risk to public health posed by over-the-counter (OTC) oral health care drug products containing benzocaine,” said the letter from Janet Woodcock, director of the Center for Drug Evaluation and Research.

“In particular, we agree that any potential benefits of using OTC oral health care drug products containing benzocaine to treat sore gums in infants and children due to teething do not outweigh the risks of methemoglobinemia associated with these products. We also agree that there are methemoglobinemia risks for adults and children 2 years and older when using OTC oral health care drug products containing benzocaine.”

Source: Letter from Janet Woodcock, director of the Center for Drug Evaluation and Research

Is There a Benzocaine Recall for Teething Products?

The FDA did not require a recall of benzocaine products in May 2018. But the FDA urged manufacturers to stop marketing over-the-counter oral products for teething in infants and children younger than 2.

“If companies do not comply, we will take action to remove these products from the market,” the FDA announcement said.

At least one manufacturer, Church and Dwight Co. Inc., said it would discontinue its teething products. The New Jersey-based company withdrew four Orajel teething brands, including Orajel Medicated Teething Swabs and Baby Orajel.

“We are not discontinuing other Orajel products, which represent the majority of our Orajel offering,” the company said in a statement emailed to CBS News.

Benzocaine Class Action Lawsuit

There is no known class action lawsuit filed on behalf of people injured by benzocaine. Class action lawsuits involve a large group of people with similar injuries. They typically name one defendant or a small group of defendants.

Many manufacturers make benzocaine products. This may prevent people from being able to file class action lawsuits. Also, certain restrictions make class actions difficult to file.

But if there are many individual benzocaine lawsuits, the courts may assign them to one judge to speed up the process. The judge will rule on pretrial matters and preside over early trials.

In federal court, the term for organizing similar cases is multidistrict litigation. State courts may have different terms, which include mass litigation and complex litigation.

Please seek the advice of a medical professional before making health care decisions.

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4 Cited Research Articles

  1. U.S. District Court for the District of Columbia. (2017, September 21). Public Citizen, Inc. vs. Food and Drug Administration. Complaint for Declaratory and Injunctive Relief. Retrieved from https://www.citizen.org/system/files/case_documents/public-citizen-fda-benzocaine-complaint.pdf
  2. U.S. Food and Drug Administration. (2018, May 24). Letter to Public Citizen. Retrieved from https://www.regulations.gov/document?D=FDA-2014-P-1256-0004
  3. U.S. Food and Drug Administration. (2018, May 23). FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. Retrieved from https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm608325.htm
  4. CBS/AP. (2018, May 23). FDA warns benzocaine gel teething products are unsafe, wants them off the market. Retrieved from https://www.cbsnews.com/news/fda-warning-benzocaine-gel-orajel-teething-products/
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