Hylands Homeopathic Teething Tablet Lawsuit

Teething tablet lawsuits are currently being filed on behalf of families who believe a Hylands or CVS teething product may have caused seizures or other injuries to their child as a result of inconsistent levels of belladonna found in the tablets.

Homeopathic teething tablets made and distributed by Raritan, CVS, Hyland’s, and others are intended to soothe teething babies and are classified as over-the-counter medicines. But such tablets have not been assessed or approved by the FDA for safety or efficacy, and the agency has said it does not know of any proven benefits connected with homeopathic teething products.

Homeopathic teething tablets started to gather negative attention almost a year ago when the FDA issued a consumer alert warning parents to dispose of homeopathic teething tablets and gels sold by CVS, Hylands, and others because they contained inconsistent levels of belladonna, a toxic substance if not controlled in its use.

The FDA is aware of at least 400 reports of seizures and other side effects as well as 10 deaths and based on conversations that we have had with nervous parents, we believe these numbers will rise.

In September 2016, the FDA warned consumers that medical care may be necessary if their children experience seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after using homeopathic teething tablets or gels.  The FDA had been analyzing these adverse events since a 2010 safety alert about homeopathic tablets.

Homeopathic Teething Product

Every parent knows the horrible feeling of not being able to help a teething child. We have all searched for ways to end the misery we see our precious infants go through when new teeth come in. So, it is no surprise that products claiming to give “natural relief” to teething infants would be highly sought after.

Homeopathic medicine is a booming industry and continues to grow substantially. According to a 2007 study, US adults spent an estimated $2.9 billion on the purchase of homeopathic medicine, which has since increased to approximately $6.4 billion in 2012.  Financial Growth Chart for Homeopathic Medicine from 2007 - 2015 and Beyond

Homeopathic drugs are derived from botanical, mineral or biological substances. The homeopathic teething tablets have been reported to include the following ingredients:

  • Chamomile to relieve irritation
  • Coffee seeds for calming
  • Calcium phosphate for growing teeth
  • Belladonna to relieve inflammation

It is this last ingredient, Belladonna that is believed to be linked to the heart-breaking adverse events reported in infants. Belladonna is a poisonous plant also known as deadly nightshade whose roots and leaves are used to make a variety of medicines such as sedatives, cough suppressants, and painkillers.

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Teething products are often found in the homes of consumers for a long period of time.  Consumers who have suffered through the pains of teething with multiple children often use what they have on hand to soothe their baby.

The U.S. Federal Trade Commission issued a statement November 15, 2016 saying that homeopathic products (such as homeopathic teething gels and homeopathic teething tablets) must be held to the same standards as other products that make similar health-related claims, and must have reliable scientific evidence that their products can treat specific conditions and illnesses.

In the U.S. and the U.K., drug manufacturers have to show the effectiveness of their products by performing double blind scientific studies with control groups to establish whether or not the medication is superior to a placebo at treating a condition. Until now, homeopathic remedies have not been held to these standards.

The new FTC policy statement, the Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs states that,

the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy.

If no such evidence exists, companies must clearly state this fact on the product’s label and also state that claims are based only on ancient theories that have been rejected by the majority of the scientific community.

Belladonna Poisoning

According to the National Institute of Health, belladonna poisoning can lead to baby teething seizures and is likely unsafe when taken by mouth. It contains chemicals that can be toxic and side effects can include dry mouth, enlarged pupils, blurred vision, red dry skin, fever, fast heartbeat, inability to urinate or sweat, hallucinations, spasms, mental problems, convulsions, and coma.

So, why is a product widely regarded as unsafe included in the list of ingredients for our most vulnerable citizens – our infants?

Because the FDA does not test homeopathic and herbal supplements for safety or effectiveness. Instead, homeopathic drugs must meet the standards established by the same people who profit from them -– The Homeopathic Pharmacopoeia of the United States (HPUS). Members, who are in the business of homeopathy, govern HPUS.

As long as the HPUS includes belladonna in their “Official Homeopathic Drug” list, it may legally be included in a homeopathic medicine, even medicines given to infants.

Belladonna is a toxic and poisonous plant native to Europe and parts of Asia that has been used as a poison as well as an important ingredient in homeopathic medicine for hundreds of years.   Belladonna has been used as:

  • A sedative
  • To treat asthma and whooping cough
  • As a cold and hay fever remedy
  • For Parkinson’s disease
  • To relieve colic and motion sickness
  • As a painkiller

But, belladonna has never been tested for safety by the FDA. According to the FDA, children less than two years of age respond to belladonna in an unpredictable way, putting them in avoidable danger

Earlier this year, the FDA warned consumers to seek medical attention if they observe symptoms in children given homeopathic teething tablets or gels as it may indicate “belladonna toxicity.”

Do Homeopathic Remedies Really Work?

Scientific studies have repeatedly shown that homeopathic remedies work no better than a placebo, although studies concluding that a homeopathic product is superior are often published in the journal Homeopathy. Scientists refute these claims by saying that these studies have no control group and are not blinded, meaning that the study participants knew whether they were getting the real treatment or a placebo.

Many users of homeopathic remedies have a strong belief that such medicine makes them feel better, which is known as the placebo effect. But with the new regulations, consumers will be explicitly informed about whether the effectiveness of a product has any scientific basis or not.

Teething Tablet Lawsuit Leads to Wrongful Death

The first teething tablets lawsuit was filed on April 21, 2017 alleging that Bryan Morales II and Delyla Sanchez experienced belladonna poisoning as a result of taking hyland teething tablets leading to the wrongful death of Delyla.

The Morales and Sanchez family allege that hyland teething tablets were sold to them in an unreasonably dangerous condition and that they were not warned of the potential risks and toxic effects of the teething products.

Individuals interested in more information on Hylands Teething Tablets Lawsuit 2017, should refer to our blog with details on the teething tablets lawsuit.

Hyland Teething Tablets – Big Profits, Little Regulation

The FDA Adverse Events website tells the story of a company hell bent on ignoring panicked parent’s pleas to discontinue a product that teams of doctors told them harmed their babies.  Seven years of injuries and deaths reported and presented to a company that marketed this product to parents who believed this was the “natural choice” – Hyland’s homeopathic teething tablets.

Not only did Hylands continue to market this dangerous product despite knowledge of the injuries, they also took action to continue to deceive the public by telling them that their products were safe even at large doses and that anyone saying otherwise was promptly dealt with through phone calls and bans from the company’s social media pages.

On October 23, 2010, the FDA warned parents to stop using Hyland’s Teething Tablets because FDA lab testing found varying amounts of belladonna in the tablets.  During 2010, Hylands was informed of four infant deaths that were consistent with belladonna toxicity.  Some of these deaths were previously reported as SIDS.   As a result, Hyland recalled their homeopathic teething tablets but they returned to the market in 2011 when the company stated that they had “identified manufacturing processes of teething tablets that can be improved to ensure uniformity in dosage.”

According to FDA documents, the belladonna poisoning did not stop after the reformulation.  In 2012, the FDA shows the company was warned of several seizing infants, admittance to the ER and one known death.  These events occurred after the reformulation.

Instead of taking action to discover why the belladonna poisoning continued, Hylands took to public relations, making sure that any parents vocally complaining or warning others were banned from the company’s social media pages.

In a post on the Hyland’s Facebook Page, a concerned parent asked about the FDA warning to which Hyland’s replied: “we cannot understand a factual basis for the FDA’s release.”  Furthermore, a Hyland’s executive posted a video response to these inquiries that noted: “even doctors jump to wrong conclusions.”

These are dangerous reactions to an FDA warning and to news that these products may be tied to the death of an infant.   The CEO of Hylands appear to be most concerned about the loss of jobs at his company as a result of these warnings.  In a recent interview with CNN, John P. (“Jay”) Borneman noted that the discontinued sale of these products

sadly resulted in the loss of 24 jobs.

FDA records from 2012 to the present day tell the sad story of seven years of belladonna poisoning that could have been prevented.  Numerous children presented with symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, and some ultimately became dehydrated and several ultimately died.

Studies estimate that injuries are reported to the FDA 10% of the time.  Given the number of injuries that have been reported, we can only imagine how many other infants were continuously given toxic tablets by their family and how many suffered as a result.

In October 2016, Standard Homeopathic finally stopped making and shipping Hylands homeopathic teething gels and tablets in the U.S. but refused to issue a recall of products still on the market.  The company posted mixed messages on social media and on their website noting confidence in these products.

Then in January 2017, the FDA confirmed elevated levels of belladonna in certain homeopathic teething products, most specifically Hylands homeopathic teething products that were manufactured by Standard Homeopathic Company in Los Angeles. The FDA made best efforts to warn the public to throw away any teething products in their possession and to stop using these products because of the inconsistent levels of belladonna despite mixed messages coming from the company.

Standard Homeopathic finally issued a recall on April 13, 2017.

Many consumers held onto Hylands teething gels and tablets long after the medicine was discontinued from manufacturing – this is why it is imperative that a company like Hylands put consumers in their best interest and issue recalls when needed.  Hyland teething tablet lawsuits are being filed on behalf of injured infants whose family believe they should have been warned of these dangers.

Raritans Homeopathic Teething Products

According to the FDA, Raritan teething tablets expose infants and children to

potentially significant safety hazards from belladonna levels far beyond the labeled content.

Raritan Pharmaceuticals announced that it would voluntarily recall all homeopathic products containing belladonna extract in November 2016.  This includes teething tablets and Ear Relief Liquid sold under the CVS label as well as Kid’s Relief Homeopathic Ear Relief Oral Liquid. The products were tested by the U.S. Food and Drug Administration (FDA) and found to contain varying amounts of belladonna.

Although consumers have not been able to purchase these teething products in the U.S., some consumers mentioned finding them online and may have these tablets in their medicine cabinets still – TruLaw advises all parents to discard these homeopathic products.

In an FDA warning letter dated June 27, 2017, the FDA noted that the amount of belladonna in Raritan’s teething products are not of uniform character and quality, similar to warnings issued to Hyland’s Teething Tablets earlier this year.  The cause of the variability appears to be inadequate quality testing and procedures.

According to the FDA warning, Raritan failed to test samples of components for conformity with quality specifications.  The FDA tested samples of Raritan’s homeopathic teething tablets at Raritan’s East Brunswick NJ facility between the dates September 29 – October 20, 2016.  The testing revealed that “the material was not homogenous in composition and not of uniform character and quality, it should not have been released for use in the manufacture of drug products.”

The lack of uniformity found at Raritan’s facility exposed infants and children given Raritan teething tablets to a variety of safety hazards, among them contact with dangerous belladonna levels, according to the FDA.

The FDA warning summarizes significant violations of good manufacturing practice (CGMP) regulations for finished pharmaceuticals, including misbranding and inadequate quality testing and procedures.

If you find any Raritan Pharmaceutical Homeopathic products in your home including Homeopathic Infants’ Teething Tablets, Kid’s Ear Relief Liquid, and Diarrhea Relief Tablets, discard them immediately and if you know of any friends or family members who use Raritan teething tablets, please pass this information on to them.

Teething Tablet Lawsuits

Sadly, it may take the filing of a few tablets lawsuit to bring about the awareness that is needed to keep belladonna out of the hands of our infants. A company that chooses to ignore the findings of the FDA and misleads parents about belladonna toxicity and questions medical advice needs to be held accountable for these actions. For that reason, TruLaw is now speaking to families who believe their children were harmed by homeopathic teething tablets.

Adverse Events Linked to Teething Products
Seizures Congestive Heart Failure (CHF)
Difficulty Breathing Lethargy
Excessive Sleepiness Muscle Weakness
Urinary Retention Difficulty urinating
Agitation Death

On April 21, 2017, two victims of belladonna side effects filed a teething tablet lawsuit against Standard Homeopathic alleging that Hyland’s teething products caused the belladonna side effects that caused injury and death to the infants.

The lawsuit alleges that Hylands disregarded known belladonna side effects rand continued to sell these products without informing or warning the public, including the two victims.

While the Baby Teething Tablet Lawsuit moves forward in court, we continue to talk to families who want to know whether their infant was poisoned by Hylands Teething Tablets.  Today, we are unable to say how many more families will come forward.  According to FDA estimates, only about ten percent of all adverse events are actually reported to the adverse event database.  Currently, the FDA adverse event database has information about 400 injuries that are believed to have been caused by belladonna in homeopathic teething tablets.  Therefore, the number of injuries may be ten times that amount, with a number closer to 4,000.

We anticipate the filing of more teething product lawsuits against the manufacturers of both Hylands and Raritans homeopathic teething products.

Hyland’s Teething Tablet Recall Timeline

  • 2010
  • Sep 08, 2010

    FDA Inspects Hyland’s Manufacturing Facility

  • Oct 23, 2010

    FDA warns parents to stop using Hyland’s Teething Tablets because of "varying amounts of belladonna" and inspects Hyland’s manufacturing facility

  • Oct 23, 2010

    Hyland’s issues a nationwide recall of its teething tablets and note that they have identified manufacturing process that could be improved to insure uniformity in dosing.

  • 2011
  • Apr 29, 2011

    FDA sends a warning letter to Hylands identifying significant violations found during inspection of facility.

  • July 2011

    Hyland’s begins selling and marketing a "reformulated" version of the Teething Tablets.

  • 2017
  • Jan 27, 2017

    FDA confirms "inconsistent amounts of toxic belladonna was found in certain homeopathic teething tablets, posing an unnecessary risk to infants and children"

  • Apr 7, 2017

    FDA sends a Class 1 recall to Hylands because "there is a reasonable probability that the use will cause serious adverse health consequences or death."

FDA Warning

FDA Warning Logo

The FDA is warning that homeopathic teething tablets may lead to seizures or even death for infants.

“Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.”

This is the second time that the FDA has issued a safety alert about the risk of adverse events in infants using these homeopathic tablets and gels. In 2010, the FDA issued a similar safety alert, which prompted Hyland Homeopathic (one of the manufacturers of “Natural Teething Relief”) to remove their products from the market temporarily. These products returned to the market and similar adverse events have been reported since the products return. Since 2010, the FDA is aware of 400 reports of seizures, fever and vomiting, as well as 10 deaths.  The FDA continues to investigate these homeopathic medicines.

Contrary to common belief, homeopathic products have been neither evaluated nor approved by the FDA for safety and effectiveness, and the agency is unaware of a proven health benefit from using them, although they are labeled to relieve teething symptoms in babies and young children,

The FDA first issued a belladonna safety alert regarding the teething tablets in 2010, and Hyland’s issued a voluntary recall at that time. After lab testing, the FDA confirmed that it had found inconsistent amounts of the ingredient belladonna in the tablets and also expressed concern that the bottles did not have child-resistant caps.  Reports were surfacing about Belladonna poisoning in infants when the FDA first took action.

After the 2010 alert, Hyland’s reformulated the product to reduce the amount of belladonna, revamped the production process, and claimed to have not seen any trend to indicate that the medicines pose any risk to consumers.

In September 2016, the FDA issued warnings against the use of homeopathic teething products after receiving numerous adverse event reports. In November 2016, Raritan Pharmaceuticals recalled three homeopathic products containing belladonna, two of which were marketed by CVS.

On January 27, 2017, the FDA announced that inconsistent amounts of toxic belladonna had been found in certain homeopathic teething tablets, posing an unnecessary risk to infants and children. According to the FDA, the body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk. “We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

In response to the laboratory findings, the FDA contacted the manufacturer of Hyland’s homeopathic teething products, Standard Homeopathic Company in Los Angeles regarding a recall of its products known to contain belladonna. According to the FDA, the company failed to agree to a recall, but the FDA recommended that consumers stop using and dispose of Hyland’s teething tablets immediately.

On April 7, 2017, the FDA issued a Class 1 baby product recall for Hyland’s Natural Relief Teething Tablets. According to the letter to Jay Borneman, the CEO of Hylands, the teething tablets “represent a serious health hazard” and a recall for all lots of the teething tablet was required immediately.

The FDA again noted that some of the homeopathic teething tablets tested far exceeded the label claim and that Hylands exhibited a “fundamental lack of control over the content of toxic chemicals.”  This April recall follows a January 2017 FDA announcement that warned the public of inconsistent amounts of toxic belladonna present in lab testings of Hylands Natural Remedy Teething Tablets.

It is imperative that all individuals now remove all lots of Hylands Natural Relief Teething Tablets from their homes.  Furthermore, if you notice any symptoms of belladonna poisoning such as fevers, lethargy, agitation, or seizures after giving your child the tablets, call your doctor immediately.

FDA Warning Letter- June 2017 – In June 2017, the FDA followed up the recalls with warning letters for both Hylands and Raritan noting significant violations of current good manufacturing practice (CGMP) which allowed them to produce adulterated products that pose potential toxic effects.  The FDA noted that sampled products were not homogenous in composition and contained high variability in ingredients.  These warnings serve to protect consumers from these companies coming out with new revised teething products without first getting FDA approval.

But, the FDA did not stop with warning letters on violations to Hylands and Raritans.  In August 2017, we learned that the FDA followed the belladonna trail to Quebec.  We learn in a follow-up warning letter that Homeolab, a company located in Quebec,  is the contract manufacturing organization that produces finished homeopathic drug products for the US market.  The FDA made best efforts to learn of the extent of adulterated products at the Homeolab facility in Montreal, Quebec but they were prevented from photographing equipment that contained excess material clinging to the sides of the machines.  Because of this, consumers may not know the full extent of potential adulteration.

Despite efforts to prevent the FDA from doing a full investigation, the FDA was able to determine that the powder blend mixtures that are manufactured at Homeolab are used in Raritan’s Infant Teething Tablet, which was previously cited as “adulterated.”  The FDA notes that Homeolab shipped lots of belladonna-laced powder prior to evaluating whether the manufacturing process was reliable and/or reproducible.  Furthermore, according to the FDA warning letter, there is no testing of these powder blends that are then used in products sold to infants and children.

Since Raritan recalled the products that were using Homeolab powder blend mixtures containing belladonna, the FDA also acknowledges that Homeolab is no longer selling adulterated belladonna products.

Frequently Asked Questions

Sometimes you need a lawyer near you and sometimes its best to hire a lawyer based on the lawyer’s resources and experiences. The right lawyer for mass-tort litigations may not be your local lawyer. Mass tort cases filed all over the country are often consolidated into a single courtroom in order to move the many lawsuits through the courts in the most effective and efficient way. A lawyer experienced with the multidistrict litigation process with the ability to represent clients in all 50 states, is likely to be a good fit for mass tort litigation.

TruLaw is not afraid to take on companies like Standard homeopathic/Hylands. We work with trusted legal affiliates to make sure that TruLaw clients have the resources and experiences needed to hold big business accountable when they put profits over people.

The goal of your teething tablet lawsuit is to help your family financially recover from injuries that were caused by someone else. We hope putting your trust in TruLaw will take away your concern of protecting your legal rights, but it is most important to us that your child stops taking the teething tablets if they are still in the home and that you attend to his or her medical needs.

Your child’s lawsuit should assist in covering any medical bills that occurred as a result of the belladonna toxicity, the amount of income and benefits that you lost as a result caring for your child and, if your child’s injuries are permanent, we will look to recover for these permanent injuries as well.

In addition, it is always our hope that your lawsuit will help us to remove dangerous products from the market. We are not only lawyers, but also safety advocates that believe in getting information out to the public so no more people are injured. We hope you will join us in the role as a safety advocate to make sure that individuals understand that Hyland’s homeopathic teething tablets are dangerous and should be removed from use.

There have been no discussions of teething tablet lawsuit settlements as the first cases were filed in April, 2017 and we are early in building these cases. We understand the frustration in waiting to hear about settlements in product liability lawsuits. TruLaw lawyers building our cases with an eye on winning in court as well as settlement, when we believe that is the best result for our clients. We will never settle without advising you of your options, and we will keep you posted on our progress, to the extent we are legally able.

We often hear injured people refer to their personal injury case as a “class action” because their case was grouped together in a lawsuit with other injured people. This is most often NOT the case. Often, individual cases are grouped together so the attorneys and judge can address common procedural issues initially, saving time for the injured parties and the court, but this is very generally referred to as a “mass tort.”

A Mass tort refers to civil actions involving numerous plaintiffs against one or a few corporate defendants in state or federal court. Class actions are mass torts that are generally used on financial losses and multidistrict litigations (MDL) are generally used on personal injury claims, often in product liability cases. MDL is a procedural tool used when plaintiffs have incurred injuries from products manufactured by the same defendant(s). Even when plaintiffs incur injuries from the same defendant(s), the amount of damages they may recover for those injuries are often substantially different from other plaintiffs included in the same lawsuit.

It is important to understand that mass tort cases are an effective tool to getting the attention of the large drug and device companies. MDLs assist lawyers in determining exactly what the drug and device companies knew about the risks their products caused and whether or not they should have warned consumers. Too often, consumers believe that they can file a single lawsuit and get the attention of big drug companies. This is very hard to do.

Technically, MDLs do not happen until a judicial panel transfers individual cases to a single court. Depending on when your lawsuit is filed, you may find yourself automatically transferred to the MDL court or you may wait to learn when and if the JPML believes an MDL is the proper venue for the mass tort.

But, rest assured, even if your case is included in an MDL, TruLaw lawyers will treat your injuries, your medical history and your financial needs separately. We are aware that not all cases are the same.

A corporation, by definition is profit seeking. There is no requirement that a corporation act morally. Unfortunately, too often we see dangerous drugs, devices and products, even homeopathic products, remain on the market when corporations prioritize profit over people. If these same corporations warn consumers of these risks, there is no case. We only pursue lawsuits on behalf of individuals who were not warned of the risk associated with the dangerous drug, device or product on the market. TruLaw is pursuing Hylands Teething Tablet lawsuits because we believe consumers were not properly warned of the risks of injury from belladonna poisoning.