Hyland's Teething Tablets & Gel Lawsuit

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An experienced product liability attorney can help you understand your legal options. Other consumers of these potentially lethal teething products have already filed lawsuits.⁽¹⁾

If your child experienced serious or life-threatening medical complications, was hospitalized, or died after consuming a teething product containing belladonna, we urge you to contact us immediately. Serious medical complications linked with these products have included:

Seizures
Loss of consciousness
Difficulty breathing
Signs of lips or face turning blue
Hospitalization
Emergency treatment
Death resulting from belladonna poisoning

The following homeopathic teething products, among others, contain belladonna. If you purchased one of these products and your child suffered severe medical complications and was hospitalized after ingesting either teething tablets or gel, we invite you to contact us for a free initial consultation:

Hyland’s Baby Natural Relief Teething Tablets
Hyland’s Baby Natural Relief Nighttime Teething Tablets
Hyland’s Baby Teething Gel
CVS Homeopathic Infants’ Teething Tablets

You can reach us by phone by calling or by filling out the form on this web page. One of our representatives will be in touch with you shortly.

Hyland’s Recalls Belladonna Teething Products After Repeated Warnings

At Weitz & Luxenberg,

our attorneys specialize in defective drugs and medical devices and can provide you with the knowledge and expertise necessary to help you consider your legal options.

On April 13, 2017, Hyland’s recalled the last of its belladonna-containing Hyland’s Baby Teething Tablets from the market after repeated U.S. Food & Drug Administration (FDA) warnings and hundreds of adverse event reports.^{(2) (3)} Hyland’s had discontinued the manufacture of its belladonna-containing teething products following the FDA warning in October 2016. However, it had allowed existing products to remain in some stores and to be widely sold through the Internet. Sadly, for some parents this recall may have come too late to save their child from the risk of death or serious harm.

For years, Hyland’s and other manufacturers have been promoting their homeopathic teething products containing belladonna as safe, effective, and natural. Hyland’s website claims its teething tablets “make nights bearable, days livable, and truly make the teething years way more groovy.”⁽⁴⁾

According to a Hyland’s “Fact Sheet,” “a 10-pound child would have to accidentally ingest, all at the same time, more than a dozen bottles of 135 Teething Tablets before experiencing dry mouth from the product.”⁽⁵⁾

Unfortunately for consumers, however, the use of Hyland’s Baby Teething Gel or Tablets, or other manufacturers’ teething products containing belladonna, can prove life-threatening — and even lethal. Infants and young children have died or experienced very serious adverse events shortly after ingesting belladonna-containing teething products.⁽⁶⁾

In fact, the FDA’s Adverse Event Reporting System (FAERS) has received ten reports of deaths and hundreds of reports of serious injuries that were thought by parents or medical reporters to be potentially linked to belladonna-containing homeopathic teething tablets.⁽⁷⁾

If you gave your baby Hyland’s Baby Teething Gel or Tablets and he or she had an adverse reaction that required hospitalization, you may be able to seek compensation from the manufacturer.

At Weitz & Luxenberg, our attorneys specialize in defective drugs and medical devices and can provide you with the knowledge and expertise necessary to help you consider your legal options.

Hyland’s Baby Teething Gel & Tablets Conduct Questioned

“At Weitz & Luxenberg, we have read the reports submitted to the FDA’s Adverse Event Reporting System. The descriptions are painful to read,” says Ellen Relkin, Practice Group Co-Chair of Weitz & Luxenberg’s defective drugs and medical devices litigation unit. “No parent should ever have to watch their child suffer such frightening medical complications when such harm was avoidable,” she adds.

“We find it disturbing that Hyland’s would continue to allow such dangerous products to be sold in some stores and on the Internet after the FDA’s September 2016 warning that such products may pose a risk to infants and children,” Ms. Relkin stresses, noting that another manufacturer’s belladonna-containing teething products were recalled from the market months after the FDA’s 2016 warning.

Our attorneys at Weitz & Luxenberg intend to hold Hyland’s accountable for what we believe are unconscionable actions. Our attorneys are fully prepared to seek compensation for the harm you and your family have suffered.

Hyland’s Teething Products Complications

In recent years, the FDA has received hundreds of reports describing significant medical complications or death in children and infants ingesting belladonna-containing teething products.^{(8) (9) (10) (11)}

One person reported, “Have used Hyland teething tablets as needed and per instructions since my son started teething … He was completely unconscious … and taken by ambulance to the ER. He was unconscious and not moving or responding for four hours straight. The [doctor] said he’d had a seizure.”

Another report dated May 24, 2013, states, “Son started having seizures. Using baby teething tablets for one month prior to this. No fever at the time of seizure. Seizure in 2012 caused him to lose oxygen to brain. Went to … hospital and was hospitalized for 2 ½ to 3 weeks. Underwent gastric tube surgery secondary to oxygen loss to brain. Seizure presented as shaking and drooling for 1 minute.”

In addition, this sad report states, “After using Hyland Teething Tablets on my [5-month-old] grandson for the first time he died in his sleep. When they found him he had a temp of 102.” Cause of death was reportedly acute cardio pulmonary arrest.^{(12) (13) (14) (15)}

Belladonna Can Be Deadly

Homeopathic manufacturers like to boast that their products are “all-natural.” Belladonna, an ingredient in Hyland’s teething tablets and gels, is a plant. Belladonna, however, is also toxic.⁽¹⁶⁾

In a follow up to its September 30, 2016, warning, on January 27, 2017, the FDA announced that “its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label.” Noting that at that time Hyland’s manufacturer Standard Homeopathic Company was still refusing to recall its teething products, the FDA “recommend[ed] that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”⁽¹⁷⁾

In doing so, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research noted, “The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk” and recommended that “parents and caregivers … seek advice from their health care professionals for safer alternatives.”⁽¹⁸⁾

The FDA noted that that “homeopathic” products may contain “natural” substances, but they are not regulated the way prescription and over-the-counter medications are.

In addition, “natural” substances are certainly not necessarily gentle and mild; sometimes they are poisonous and lethal.⁽¹⁹⁾

Hyland’s claims “the manufacturing and marketing of Hyland’s homeopathic medicines are regulated as drugs by the FDA” and “The production of Hyland’s homeopathic medicines occurs within a validated process, as with any FDA-regulated drug, to ensure an accepted level of consistency in product output.”⁽²⁰⁾

The FDA, however, clarifies that “[h]omeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.”⁽²¹⁾

In addition, the FDA has repeatedly found inconsistent levels of belladonna in Hyland’s teething tablets, warning the public of the potential danger of these inconsistencies in 2010 and 2017.^{(22) (23)}

Hyland’s also asserts “homeopathic products must be manufactured in compliance with the FDA finished pharmaceutical Good Manufacturing Practices (GMPs) regulations for cleanliness, quality and testing; the FDA regularly inspects manufacturers for compliance. All Hyland’s manufacturing facilities are inspected by the FDA.”⁽²⁴⁾

The company fails to mention, however, that after inspecting one of the facilities where Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething tablets were manufactured, FDA investigators “identified significant violations of Current Good Manufacturing Practice (CGMP)… in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.” As an article in Scientific American reports regarding the company, in 2010 “FDA inspectors who examined Hyland’s facilities criticized the company for substandard manufacturing practices and found inconsistent levels of … belladonna in its products.”⁽²⁵⁾

The FDA has alerted the public that symptoms of belladonna toxicity or overdose may include:⁽²⁶⁾

Dry mouth and dry skin
Dilated pupils
Fast heartbeat
Fever
Flushed skin
Decreased urination
Hallucinations
Agitation
Disorientation
Drowsiness (in infants)

FDA Warns Consumers of Belladonna Teething Products

The FDA has warned manufacturers of teething products to resolve numerous manufacturing violations or requested the immediate initiation of recalls.^{(27) (28) (29)}

In September 2016, the agency warned consumers against using these products, saying, “Homeopathic teething tablets and gels may pose a risk to infants and children.” The FDA recommended “that consumers stop using these products and dispose of any in their possession.”⁽³⁰⁾

On January 27, 2017, the FDA published a press release confirming “elevated levels of belladonna” in some “homeopathic teething products.” The agency’s “laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label.” The FDA found levels of belladonna varied widely not only between bottles, but also between tablets within the same bottles.⁽³¹⁾

The agency also again warned consumers that “homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children.” The FDA urged “consumers not to use these products.”⁽³²⁾

Weitz & Luxenberg: A Firm with a Proven History

Weitz & Luxenberg is a national law firm with a proven history of winning. For more than 30 years, we have been representing clients who have been harmed by the irresponsible, reprehensible actions of corporations.

Our dedicated attorneys have helped secure billions of dollars in verdicts and settlements for thousands of clients over the years. We have made it our mission to hold irresponsible companies accountable.

We are particularly disturbed by Hyland’s indifference to the harm its products have inflicted. In the company’s most recent letter stating, “Dear Moms and Dads,” posted on its website, the company failed to acknowledge the FDA warning that belladonna-containing products present a serious health danger to infants and young children.⁽³³⁾

Instead, the company stated that Hyland’s was “confident” of the safety of its medicines⁽³⁴⁾ and expressed “regret [over] the concern and confusion” that consumers “may be feeling in regards to these products” in light of the FDA’s request for a recall of its Baby Teething Tablets and Baby Nighttime Teething Tablets.⁽³⁵⁾

At Weitz & Luxenberg, our attorneys are committed to seeking full and appropriate compensation on behalf of our clients, and we will work toward a just resolution. We encourage you to contact us for assistance.