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Teething TabletsCause for Concern for Consumers

Teething Tablet Lawsuit

Teething tablets, gels, sprays, and ointments, in recent years, have come under fire for serious safety concerns and their inability to relieve symptoms related to teething. There are two notable types of teething products - homeopathic remedies containing belladonna and over-the-counter products containing benzocaine, such as Orajel.

Litigation Updates

FDA Warning Issued to Consumers – Teething Products Containing Benzocaine Pose Risk to Children

May 23, 2018 - Over-the-counter teething products are now being investigated by the FDA. In a statement to the public, the FDA warned consumers of the serious risk teething products containing benzocaine pose to infants and children. Those products can be "gels, sprays, ointments, solutions, and lozenges under the OTC brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel, and Topex, as well as store brands and generics."

Cases Filed in the Superior Court of California

April 2018 - Currently, this litigation is coordinated before Judge Carolyn Kuhl in the Superior Court of California for the County of Los Angeles. We recently had a hearing to discuss some final details regarding discovery protocols but should begin collecting documents shortly. Right now, we expect to receive over a million pages of documents which we will review before beginning depositions. We are likely approximately 24 months from our first trial.

 

What are Teething Tablets?

As babies begin teething, parents look for products that can help soothe the child and provide pain relief, such as teething tablets, gels, sprays, ointments, solutions, and lozenges. Teething products have been around since the early 1900’s and are supposed to provide temporary relief for the teething infant, but the products have been linked to dangerous side effects. Reportedly, teething products contain:

  • Chamomile to relieve irritation
  • Coffee seeds for calming
  • Calcium phosphate for growing teeth
  • Benzocaine and/or belladonna to relieve inflammation and pain

Belladonna is a poison that can cause injury and death. Hyland’s teething products that contain belladonna, according to FDA adverse event reports, have caused hundreds of injuries in infants and multiple infant deaths.

Over-the-counter Benzocaine products are also dangerous. After reports of serious injuries, the FDA issued a warning to consumers stating that due to the growing number of reports and lack of efficacy, they would begin to investigate the teething products containing Benzocaine.

 

Homeopathic – Hyland’s Teething Tablets

Hyland’s Teething Tablets are a dangerous, homeopathic remedy that has been advertised to temporarily soothe a teething baby. Reports of serious side effects, including death, were brought to light as early as 2006. In 2017, a teething tablets recall was finally issued. Since then, TorHoerman Law has filed a teething tablet lawsuit to hold the manufacturer of these dangerous products liable for their negligence.

 

What is Belladonna Drug?

Belladonna commonly referred to as “deadly nightshade”, is a poisonous plant native to Europe and parts of Asia that have been used as a poison since Roman times. Belladonna has been used in homeopathic products.

The amount of belladonna that exists in Hyland’s teething products is inconsistent and could cause belladonna poisoning, which may be deadly to infants.

Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, is now warning parents:

“We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their healthcare professional for safe alternatives.”

According to the FDA, products like Hyland’s Homeopathic teething tablets and gels that contain inconsistent amounts of belladonna put children under the age of two years old at unnecessary risk.

 

Hyland’s Homeopathic Teething Tablets Not FDA-Approved

Contrary to common belief, homeopathic teething products have never been approved by the FDA for safety and effectiveness.

Multiple infant deaths were reported to Hyland’s and the FDA and should have been an early warning sign that there was a serious safety issue with the Hyland’s Teething Tablets – an issue that could not be ignored. Yet, more tragic stories of teething tablet injury would soon follow.

Since hundreds of injuries and many deaths have been reported to the FDA, the agency has announced it will propose new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs. According to the FDA, homeopathic medicines have brought more than $3 billion to the industry, but it is largely unregulated. As a result, the FDA has vowed to take a more serious look at the processes and take steps to prevent other individuals from being injured in the way many infants were due to Hyland’s Baby Teething Tablets.

 

Over-the-Counter Benzocaine Teething Tablets

What is Benzocaine?

Benzocaine is the active ingredient used in over-the-counter teething products. It has been advertised to reduce pain but has been associated with a rare, but serious condition called Methomoglobonemia. The condition causes the reduction of oxygen carried in the bloodstream, resulting in severe injury or death. The injuries can include blue or grey nails, difficulty breathing, excessive sleepiness, lethargy, pale skin, seizure, SIDS, or death.

In 2011, the FDA issued a warning about Benzocaine. According to the warning, an estimated 400 or more cases of benzocaine-associated Methemoglobinemia had reported to the FDA or published in medical literature since 1971.

 

What Products Were Listed in the FDA Baby Tablet Warning?

The products listed in the warning are sold as gels, sprays, ointments, solutions, and lozenges under the following names:

  • Anbesol;
  • Orajel for Babies;
  • Cepacol;
  • Chloraseptic;
  • Hurricaine;
  • Orabas;
  • Orajel and;
  • Topex
  • Other store brands containing Benzocaine

Teething Tablets Lawsuit

Hyland’s Teething tablet lawsuits are currently filed and being litigated. Additional teething tablet lawsuits may soon be filed against other manufacturers.

 

Should I File a Teething Tablet Lawsuit?

A corporation, by definition, is profit-seeking. There is no requirement that a corporation acts morally. Unfortunately, too often we see dangerous products remain on the market when corporations prioritize profit over people, as we believe is the case with these products.

 

 

Timeline

FDA Will Begin Crackdown on Dangerous Homeopathic Medicine

December 21, 2017 - This week, the Food & Drug Administration (FDA) announced they will begin to crack down on the dangerous homeopathic medicine industry. This a welcome announcement to the many who criticize the industry for producing products that could be contaminated with dangerous ingredients, such as infant teething tablets containing belladonna, or selling products that are designed to treat serious conditions in lieu of medically approved products that will treat the illness.

In recent years homeopathic medicinal products have come under fire for being unsafe and unhelpful. In the past ten years, Hyland's has sold infant teething tablets that contained unsafe amounts of the toxic, but natural, chemical, belladonna. In 2016, there were reports of more than 400 injuries and 10 deaths allegedly caused by the teething tablets.

According to the FDA, the dangerous homeopathic medicine industry has grown into a $3 billion enterprise, but it remains largely unregulated. Since a 1988 decision, the FDA has not regulated homeopathic medicinal products the same as they would for standard medical products. Similar to dietary supplements, homeopathic products are not reviewed for safety or effectiveness by the FDA. Unlike dietary supplements though, homeopathic medicinal products can state on the label what the product is intended to treat. It is for that reason many believe the products should be regulated under the same criteria as FDA approved pharmaceuticals or medical devices.

The 1988 decision has come under fire in recent years prompting the FDA to revisit the standards with a public hearing which began Monday, Dec. 18, 2017, and will end 90 days from that date. The public is invited to voice their concerns regarding the homeopathic industry by submitting comments to the FDA for review.

The overall goal, according to the FDA, is to begin cracking down on the products that pose the biggest safety risk, such as those for children or serious illnesses.

"We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm," Dr. Scott Gottlieb, FDA commissioner said.

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Lack of Testing for Safety and Effectiveness of Homeopathic Medicines?

August 8, 2017 - The recent recall of homeopathic teething tablets has left many parents asking, "Why didn't the FDA act sooner?" The answer is complicated, but the FDA was limited in what it could do about the homeopathic medicines because unlike most drugs, the FDA only regulates the marketing and manufacturing of homeopathic medicines.

For homeopathics, the FDA does not test or evaluate the products for safety or effectiveness. The FDA also does not perform any premarket evaluation for such products. Instead, the Homeopathic Pharmacopoeia of the United States (HPCUS), an organization started by the American Institute of Homeopathy, sets the industry standards.

Homeopathics are not scrutinized under the same objective lens as FDA approved drugs, which is obviously dangerous in situations where there are safety issues with homeopathic medicines. Instead, homeopathics must meet standards set by the people who profit from them in the market. With the profits of homeopathics, it is not surprising dangerous products have slipped through the cracks of this self-governed profession. Some reports have estimated that sales of homeopathic medicine have grown to 2.9 billion dollars in the United States alone. Unfortunately, self-regulation in the lucrative homeopathic market has proven to be ineffective.

For example, Hyland's teething tablets were a homeopathic product that was allowed to remain on store shelves for entirely too long. After more than 400 reported seizures and at least 10 reported deaths, the product was finally pulled from the market.

In 2015, the FDA warned consumers of the dangers of taking any asthma product labeled as a homeopathic drug because it had not been tested for safety or effectiveness.

Currently, only homeopathics used to treat relatively minor or common illnesses, such as a cold or headache, can be sold without a prescription.

There is a push for the FDA to have more oversight over homeopathic medicines to protect consumers from the possible dangers associated with these products. Currently, homeopathic drugs are not subject to 'new drug approval requirements' because the only ingredients that can be used in the products are pre-approved on the HPCUS list. This self-regulating and often times self-serving organization does not ensure the safety of the products. Testing for the safety and effectiveness of homeopathics must become standard practice.

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FDA Confirms Toxic Belladonna Plant In Homeopathic Teething Product

May 17, 2017 The Food and Drug Administration (“FDA”) is now advising parents to not use Hyland’s homeopathic teething products containing belladonna. According to a news release on January 27, 2017, the FDA stated that recent laboratory analyses "found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products."

This announcement comes after the FDA issued a warning in September of 2016 advising against usage and after the homeopathic teething tablets and gels had been linked to the deaths of 10 children and 400 adverse reports. In response to the FDA’s warning, the manufacturer Hyland’s released a statement, announcing, in part:

We have seen recent reports related to issues linked to use of homeopathic teething tablets and gels. Hyland’s has not been made aware of any data that supports the claims in these reports. Our understanding is that the Food and Drug Administration’s investigation of these products is still ongoing. The fact is that we have not been made aware of any medical or statistical evidence to support a causal link between homeopathic teething tablets and adverse outcomes at this point. We continue to request any available information and statistics from the FDA.

It seems the FDA did not take Hyland’s statement lightly.

Instead of teething gels or tablets, the American Academy of Pediatrics recommends gently rubbing or massaging the child’s gums with your finger and giving the child a cool (not cold) teething ring or a clean, wet, cool washcloth to chew on.

TorHoerman Law is warning any parent that has any of the following products in their home to discontinue use immediately and to consult with a doctor about an appropriate replacement for infant teething relief:

  • Baby Orajel Naturals Gel for Teething Pain, .33 oz
  • Baby Orajel Naturals Gel for Teething Pain Nighttime Formula, .33 oz
  • Baby Orajel Naturals Tablets for Teething Pain, 125 Count
  • CVS Homeopathic Infant’s Teething Tablet, 135 Count
  • CVS Homeopathic Infants’ Teething Liquid, .85 oz
  • Hyland’s Baby Nighttime Teething Tablets, 135 Count
  • Hyland’s Baby Teething Gel, .5 oz
  • Hyland’s Baby Teething Tablets, 13 Count
  • Hyland’s Baby Teething Tablets, 135 Count
  • Hyland’s Teething Gel, .33 oz

 

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Hyland’s Finally Issued Recall of Teething Tablet Product

April 2017 - Four months after the FDA initially asked Hyland's to remove their products from shelves, the company issued a recall of all teething tablet products.

A stunning FDA recall letter dated April 7, 2017, to Jay Borneman, CEO of Hyland's, lays out shockingly strong warnings and statements about Hyland's dangerous teething products.

In the letter the FDA stated:

  • The teething tablets "represent a serious health hazard"
  • "Immediately initiate a recall of all lots"
  • Belladonna content "far exceeded the label claim"
  • Hyland's exhibited a "fundamental lack of control over the content of toxic chemicals"
  • "Significant violations of Current Good Manufacturing Practices (CGMP)"
  • The labeling is "false or misleading"
  • "FDA action is necessary to protect the public health and welfare"
  • This Class 1 recall is necessary because "there is a reasonable probability that the use…will cause serious adverse health consequences or death."

These statements are the strongest I have ever seen from the FDA and that includes Vioxx (probably the most famous FDA recall). TorHoerman Law and others have called for the company to recall the products for some time now. However, Hyland's has continuously refused to issue a recall and protect the families using their products. Finally, Borneman and Hyland's have no choice but to do what they should have done years ago and recall its products.  Hyland's will finally remove the products from the shelves, but it is beyond comprehension that it took this type of FDA action to make it happen.

This is one of the most heinous examples of a company and its CEO putting profits over people – in this case, innocent babies that are teething! Jay, how much money have you made selling the product to vulnerable parents trying to give their child a healthy pain reliever for their teething?  How much? Frankly, I don’t know how they sleep at night without imagining the number of infant deaths their products have caused.

Hyland's has shown time and time again that they will not do the right thing unless forced to. We are pleased the FDA took action, but it does not end the suffering of parents and kids who have been injured. Unfortunately, many infants suffered seizures or died. Their deaths were often attributed to Sudden Infant Death Syndrome (SIDS), but we do not believe these babies were SIDS victims. We look forward to representing the grieving families that have contacted us in their teething tablet lawsuits.

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FDA Advised Consumers to Stop Using Product Immediately

January 2017 – After finding that belladonna levels in Hyland's teething tablets vastly exceeded the safe levels advertised on the label, the FDA advised consumers to stop using teething tablets immediately and throw them away. The FDA urged Hyland's to issue a recall of their teething products.

FDA Issued Second Warning Regarding Hyland’s Teething Tablets

September 2016 - As a result of the high frequency of teething tablet injury reports, the FDA issued a secondary warning urging parents and caregivers not to use Hyland's teething tablets.

In the warning the FDA explained that, "Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy," the warning went on to explain that, "The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children."

Hyland's responded by announcing that they would no longer distribute teething medications to store shelves in the U.S. The manufacturer stood by its claim of safety and attested that the decision to stop U.S. distribution was based on "confusion among parents and limited access to the medicines" due to the FDA's recent warning.

 

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Hyland’s Disregarded Reported Belladonna Injury

December 2012 - The company received a report that an infant had been admitted to a hospital with an extreme fever, paleness, lethargy, and dehydration. The baby had to be flown to another hospital. The physician treating the child believed that these were "symptoms secondary to belladonna." According to Hyland's Consumer Complaint Record, the "doctor team said the child had a reaction to the belladonna." A company representative contacted the mother after the mother attempted to post negative comments online – it appears based on public documents that Hyland's blocked her posts.

The mother wanted to know "Why [does Hyland's] continue to put belladonna in tablets?" The company had the audacity to tell the mom that it would be necessary to eat 800 tablets for the first symptoms of belladonna toxicity to occur. That is even after a team of doctors told her the belladonna caused her child's injuries. The company offered her a refund. The company was more worried about blocking her online comments than protecting the families still using their products.

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Police Receive Call Regarding Infant Death Due to Teething Tablets

October 2012 - A detective received a call from a hospital to inform the detective that a baby had died while taking teething tablets. The tablets were manufactured on December 11, 2011, which was after the recall. A Hyland's employee told the detective the belladonna was safe in this reformulated product.

Parent Posts to Hyland’s Website about Poisonous Belladonna

February 2012 - A parent posted on Hyland's teething tablets web page that 30 minutes after taking the teething tablets, their son suffered a seizure and had to be taken to the ER.

The parent posted, "WARNING TO PARENTS: belladonna, an ingredient in these tablets, is poison!!" An email was circulated around Hyland's, including to CEO Jay Borneman, about the internet post. It's unclear from public documents how the company ultimately responded, but they did not warn parents or pull the product.

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Teething Tablets are Re-introduced to Market with New Formula

2011 - Hyland's began remarketing teething tablets and re-introduced them with a new formula in July 2011. Hyland's claimed it reformulated the teething tablets to reduce the amount of belladonna and revamped its production process. Hyland's told parents the tablets were safe.

Injuries and deaths soon followed and it is inexplicable that Hyland's ignored clear alerts that their products were not safe.

 

Yet Another Infant Death Occured

December 16, 2010 – The company was informed that an infant had died after taking Hyland's teething tablets.

Infant Death Occurs After Taking Teething Tablets

December 9, 2010 – The company was informed that an infant had died after taking Hyland's teething tablets. The infant demonstrated symptoms that were consistent with belladonna toxicity.

Company Informed About Another Infant Death

December 2, 2010 – The company was informed that an infant died after taking the Hyland's teething tablets.

Company Informed About Infant Death

November 2, 2010 – The company was informed that an infant had died from seizures. The doctor attributed it to Sudden Infant Death Syndrome (SIDS).

FDA Issued Public Warning to Consumers

October 23, 2010 – The FDA released a public warning urging consumers to stop using and discard Hyland's teething tablets as a result of the varying amounts of belladonna levels of belladonna and the lack of child-resistant caps on the product.

 

Hyland's agreed to voluntarily recall its teething tablets. Hyland's claimed they had "identified manufacturing processes of teething tablets that can be improved to ensure uniformity in dosage." Soon after the recall, the company and the FDA received the first notifications of deaths that were suspected to be caused by Hyland's teething tablets.

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FDA Received Reports of Serious Adverse Effects

September 2010 – The U.S. Food & Drug Administration (FDA) received reports of serious adverse events that were consistent with belladonna toxicity. The FDA tested and analyzed a sample of the teething tablets and found the products to contain varying amounts of belladonna, a natural yet highly toxic ingredient. The FDA also found Hyland's had substandard control of their manufacturing operations.

See More

+ - References

Christensen, Jen. "FDA Warns Parents against Using Teething Tablets and Gels." CNN, Cable News Network, 5 Oct. 2016, www.cnn.com/2016/10/05/health/fda-teething-tablets-warning/index.html.

"Homeopathic Teething Gels and Tablets." National Center for Complementary and Integrative Health, U.S. Department of Health and Human Services, 27 Mar. 2018, nccih.nih.gov/health/teething.

"Homeopathy." National Center for Complementary and Integrative Health, U.S. Department of Health and Human Services, 24 Sept. 2017, nccih.nih.gov/health/homeopathy.

"Press Announcements - FDA Proposes New, Risk-Based Enforcement Priorities to Protect Consumers from Potentially Harmful, Unproven Homeopathic Drugs." U.S. Food and Drug Administration Home Page, Office of the Commissioner, 18 Dec. 2017, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm.

“Press Announcements - FDA Takes Action against the Use of OTC Benzocaine Teething Products Due to Serious Safety Risk, Lack of Benefit.” U.S. Food and Drug Administration, U.S. Department of Health and Human Services, 23 May 2018, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm.

"Teething Tablet Lawsuit - Recall and Compensation Information." TruLaw, hylands homeopathic lawsuit.

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