Multimillion-Dollar Suit Filed Against Maker of Baby Medicine

A Webster Groves law firm has filed a multimillion dollar lawsuit against the maker of a popular over-the-counter toothache medicine for infants that the Food and Drug Administration (FDA) says is associated with a rare but potentially fatal condition.

Onder, Shelton, O’Leary & Peterson filed the suit against Church & Dwight on behalf of Christine Bushman, of an unincorporated area in St. Louis County, and Susie Vongsaly of Illinois.

The lawsuit, filed in the Federal Court of the Southern District of Illinois, states that Bushman and Vongsaly would not have purchased Church & Dwight's Baby Orajel PM or Baby Orajel Nighttime Formula had they known of potentially fatal risks associated with the products that are applied to an infant's mouth or gums to reduce pain while teething.

The suit alleges that Church & Dwight misled consumers by marketing the products as safe and effective without warning them that the drug’s active ingredient, benzocaine, has been associated with methemoglobinemia. That condition reduces the amount of oxygen delivered to body tissues, the National Institutes of Health states on its website.

The law firm hopes that a judge will grant the suit class-action status. Onder, Shelton, O’Leary & Peterson estimates Bushman and Vongsaly represent tens of thousands of consumers who would not have purchased the products had they known about methemoglobinemia risks.

The suit is seeking more than $5 million in economic damages.

The lawsuit, filed in May, follows an FDA drug safety communication that methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and that in the most severe cases, the condition can result in death. The condition occurred mainly in children ages 2 or younger, the agency states.

“When we found out about the FDA report, we started telling parents and friends not to use Orajel,” said Jim Onder, a partner of the Webster Groves law firm.

Onder recalled using the product on his own child, a decision that sparked an argument with his wife, who said he was applying too much of the product.

“I told her she was crazy,” Onder said. “I told her that a company wouldn’t have you put a product in a child’s mouth if it wasn’t safe.”

Now he thinks otherwise.

Onder said the motivation behind the suit is to warn parents of dangers associated with the drug.

“The ultimate goal would be to get the company to include a warning (about the risk of methemoglobinemia) on its product,” Onder said.

The suit alleges that Church & Dwight knew about the risk of Orajel formulations causing methemoglobinemia when the company acquired Del Pharmaceuticals, the company that originally manufactured and marketed Orajel.

“The FDA has warned of the association of methemoglobinemia and benzocaine use since as early as 2006, and studies linking the two existed prior to that time,” the suit states.

The FDA’s website states the agency issued patient safety reports in 2003 and 2006 warning of methemoglobinemia being associated with benzocaine sprays. The agency has received multiple reports of adverse events associated with benzocaine-containing products over the years.

The suit seeks economic damages in the form of a consumer refund of the price for each purchase of Baby Orajel PM and Baby Orajel Nighttime Formula and that the company turn over profits from the sale of the products.

Church & Dwight reported about $2.6 billion in net sales of all products for 2010, according to the company’s annual financial report.

Although the company identifies Orajel as a “power brand,” it is most known for its Arm & Hammer brand, which includes baking soda, carpet deodorizers and laundry detergent. The company also makes Trojan condoms and First Response home pregnancy, ovulation and fertility test kits.

Church & Dwight declined to comment on the lawsuit.