Flea and Tick Product Risks and Recalls

Companies that make topical flea and tick products must immediately improve the labeling on their packages to ensure pet safety and prevent misuse of the treatments, according to changes announced Wednesday by the Environmental Protection Agency (EPA). The agency, however, said it is not banning or pulling any topical or spot on flea and tick products off the market at least not yet.

The action comes in response to the EPAs nearly year-long intensive evaluation of spot on flea and tick products. The EPA launched its probe last April amid reports of a significant increase in adverse reactions linked to the treatments, including burns, neurological problems, and even deaths.

The agency confirmed that in 2008 it received more than 44,000 reports of adverse reactions associated with these products, which are applied by squeezing the contents of a vial or tube to the skin between the animals shoulder blades or along the back. That figure represents an increase of about 53% from 2007, the EPA said.

During its 11-month evaluation, the EPA said it discovered the warning labels on many topical flea and tick products are inadequate and do not give pet owners clear information about dosages or even if the treatments should be used on dogs or cats.

We concluded that the existing warning labels are not working and do not provide adequate protection, said Steve Owens, assistant administrator for the EPAs Office of Prevention, Pesticides and Toxic Substances. We found a number of current labels have insufficient warning labels on themthe warnings were buried in the text of the label and not noticeable. They were easily overlooked.

Clearer labeling

To address these labeling flaws, the EPA said it will immediately require companies that make topical flea and tick products to take the following action:

• Make the instructions on the labels clearer to prevent possible misuse. For example, if a product is intended for a dog, the labels will now be required to say something like do not use on a cat, Owens said;

• Have more precise instructions on the labels to ensure the proper amount is applied according to the pets weight. A dogs weight clearly makes a big difference and the doses for small dogs is different than the doses for large dogs, Owens said. We found that smaller pets, cats and dogs, are more susceptible to adverse reactions (to these products). Its not an exclusive thing; we are seeing larger dogs affected, too. But there is a correlation between pets weights and the dose, and all pet owners need to be careful;

• Require clearer markings on packages to ensure consumers can tell the difference between products for dogs and cats. We found that (flea and tick) products for dogs and cats are labeled similarly, Owens said. People have applied the wrong spot on products to the wrong animal. We have to make sure the label warnings make it clear that a dog product should not be used on a cat.

• Prohibit similar brand names for dog and cat flea and tick products. Those similar names have led to product misuse, the EPA said;

• Require labels to clearly state that pet owners should not permit interaction between dogs and cats after the products are applied. Cats are sensitive to these products, Owens said. It is critical for pet owners to keep their cats and dogs apart after these products are used.

Owens said he also wants the new labels to include symptoms of possible adverse reactions to these topical flea and tick products. Asked when pet owners will see new labels on these products, Owens said, "by the end of the years."

Requiring these label changes, however, isnt the only action the EPA said its taking to ensure the safety of dogs and cats the use topical flea and tick products.

Other actions

The agency also announced it will:

• Only grant conditional, time-limited registrations when new products are registered with the EPA. The agency said this will allow for post-marketing product surveillance. If we see a problem, we can take appropriate action, Owens said, adding that action can include pulling a worrisome product off the market;

• Restrict the use of certain inert ingredients that may contribute to adverse reactions. Owens did not specify which inert ingredients if any are on the EPAs radar. If we believe an inert ingredient is causing adverse reactions, we will take action to limit or prevent its use, he said;

• Launch a consumer information campaign to raise public awareness about the new labels. We want to help consumers not make error in cases in which the labels are unclear or hard to read, Owens said.

• Require more standardized post-market surveillance reporting on adverse effects linked to these products;

• Require companies to submit more sales information to the EPA to ensure the agency does a better job of evaluating incident rates;

• Update the scientific data requirements on pre- and post-market testing to make sure they are more in line with the Food and Drug Administrations (FDA) requirements.

First steps

The EPA emphasized these are only the first steps the agency is taking to address growing concerns about topical flea and tick products.

Were going to continue to monitor this situation closely, Owens said. We want to make it clear that were going to continue to gather data and if the label requirements are not working, we will take more significant action.

We will remove products from the market if we have to, he added. Were not banning any products or removing any today, but that is certainly something that we will be more than willing to do as we move forward and gather more data.

Earlier today, the EPA met with companies that make topical flea and tick products to discuss these required changes.

They realize this is serious problem they need to address, Owens said. And they understand we are serious about this. Their reaction was very positive. No one in the room said no way.

Companies that make flea and tick products, however, have routinely downplayed reports of adverse reactions and often blamed the problems on pet owners misuse of the treatments.

The EPAs new labeling requirements refute that argument, Owens said.

I dont know how you blame a victim when the label is not clear. There is not specific language on the labels about the dosage and consumers in many cases are left to guess for themselves on the appropriate amount.

The reforms were announcing today address those problems, Owens added. While there are cases of misapplications, we think the far great problem is the labels are not adequate.

Are they safe?

But are these products safe?

I think in most cases, yes, Owens said. But I want to underscore that these are poisons. These are products designed to kill fleas and ticks and they do their job. We urge pet owners and other to exercise caution and be careful when using them. And read the labels carefully.

Given those risks, pet owners whove contacted ConsumerAffairs.com wonder why the EPA still allows these products on the market.

Theyre pet owners who say theyve witnessed horrific reactions from these products in their dogs and cats, including burns and welts on their skin, drooling excessively, shaking uncontrollably, whimpering in agony, losing control of their legs, or even dying.

Theyre pet owners like Sharee F. of Tennessee, who is convinced Sergeant's Gold Flea and Tick treatment attributed to the recent death of her dog.

We applied it as directed and later that Friday night, my dog started foaming at the mouth and whining as though he was in pain, she said. Around 4 a.m. on what was now Saturday morning, my dog began seizing. His legs were flopping, his head twitching uncontrollably, he was whining and crying, and he was breathing unbelievably heavy.

Everyone in the house was asleep, but (we) were awakened by the banging of my dogs body jerking against the wall, she added.

Sharees family gave the dog some cool water and tried to comfort him until the vets office opened a few hours later.

It was not until 8 a.m. that my dog was driven to the nearest Pet Meds, she said. Unfortunately, by the time my mother and brother walked into the vet, my dog went into cardiac arrest and they couldn't revive him. I am completely heart broken. I can't go a day without tearing up, and every time I replay this traumatic moment over in my head I get nauseous.

I want these products pulled off the market.

Another pet owner in Texas told us his dog experienced a horrible reaction to Sergeants Gold Flea and Tick Squeeze On treatment.

Within an hour she was going crazy, whining, barking, jumping up and laying down, rolling over and running and laying down and back up and running, said R.A. of Whitney, Texas.

The dog also started breathing heavily, drooling at the mouth, and throwing up, R.A. said, adding he used the product according to the labels directions. R.A. bathed the dog four times to try and relieve these problems. She is still going off her rocker, he said. This stuff is dangerous.

Dangerous to humans?

The dangers may not be restricted to dogs and cats.

I even got a little on my finger while putting it on her and I washed my hands, he said. Within a few minutes, my lips started tingling and I started having a hard time breathing myself. This stuff is a danger to (humans) health, not to mention your pet.

ConsumerAffairs.com also heard from a Florida pet owner, who said her 14-year-old dog suffered serious neurological problems from Sergeants Gold Flea & Tick treatment.

Twelve hours later she was drooling, shaking, and could hardly walk, Debra O. told us earlier this month. There were no dangerous side effects listed on the box. I called the emergency number on the box and was told (my dog) was having an adverse reaction to the meds.

I had to give her three baths with dish soap, pour water down her throat, and also give her vitamin E oil, Debra added. I am still watching her behavior closelyshe is still suffering right now.

Debra is outraged that a product linked to so many horrible reactions in pets is still on the market.

I had no idea or I would have never bought (it) and risked the life of my 14-year-old buddy, she said. This product hurts and kills animals. Someone needs to do something.

The EPA said its aware of concerns like Debras and will continue to evaluate the safety of these products.

The agency, however, pointed out that most of the reports it received about adverse reactions were minor and included skin issues and gastrointestinal problems. The EPA also confirmed it received some reports of deaths linked to these product, but said they were rare less than 2 percent of the adverse reactions reported during 2007 and 2008.

The agency said pet owners should continue to carefully follow the labels directions when using topical flea and tick products and watch for any adverse reactions in their dogs on cats after applying these treatments.

Pet owners should also talk to their veterinarians about the best methods to protect their dogs and cats from fleas and ticks, the EPA said.

A copy of the EPAs findings on topical flea and ticks products is now available on the agencys Web site.

A lawsuit filed this week alleges that Biospot brand flea and tick spray is responsible for neurological problems in hundreds of animals, resulting in death in some cases.

The suit, filed in federal court in San Francisco, blames the problem on pyrethrins, organic compounds that kill fleas and ticks but that also have a long history of poisoning cats.

Pyrethrins kill fleas and ticks by interfering with their nervous systems, thus paralyzing and killing the parasites, the suit says. However, [pyrethrins] have the same effect on very significant numbers of pets, causing neurological problems which have and often will result in injury and/or death to the animal.

While the Environmental Protection Agency (EPA) is charged with oversight of products like Biospot, the suit says that the agency rarely conducts independent tests and instead depends largely on information provided by manufacturers when determining whether such products are safe.

Biospot, which can be purchased over-the-counter, is significantly cheaper than its prescription counterparts, such as Frontline.

Pet owners represent proposed class

Five named plaintiffs represent a putative class composed of anyone who bought flea products containing pyrethrins, manufactured by the defendants, provided that their claims fall within the applicable statute of limitations.

Sunny Johannson, a plaintiff from California, usually treated her cat Jack O'Punkin with Frontline and Revolution, neither of which ever caused any adverse effects. Earlier this month, Johannson used Biospot for the first and only time. The following morning, Jack bit [Johannson's] hand and collapsed into a seizure that lasted approximately a minute and a half.

Johannson immediately shampooed Jack in an attempt to remove as much Biospot as she could. Her vet's assistant confirmed the likely cause [of the seizure] to be Biospot, having seen similar reactions in other animals. While Jack survived the incident, he continues to be lethargic and uninterested in food, according to the suit.

Plaintiff William Shelby, a Texas resident, wasn't so lucky. On July 1, 2010, he applied Biospot to Waggles, his seven-year-old pit bull. Within days, Waggles's hair began to fall out and she developed bumps on her back and sides. Shortly thereafter, her immune system shut down; her eyesight deteriorated; and she began suffering seizures.

By late July, Waggles had become totally blind, and was not eating because she could not swallow. [She] was running into walls, was disoriented and in great pain. Shelby had Waggles euthanized on July 29, less than a month after he had used Biospot.

The suit alleges that Biospot manufacturers Central Garden & Pet and Farnam Companies know, and have known for many years, that these chemicals will substantially injure and/or kill very significant numbers of dogs and cats.

As evidence, the suit notes that the manufacturers have reported to the EPA a sharp increase in adverse consequences from application of these products to companion animals. According to the suit, [i]n 2008 alone, there were approximately 44,000 reports of adverse events resulting from squeeze-on products containing pyrethrins, a group that includes Biospot.

Problems not limited to Biospot

Consumers should always be careful when using spot-on treatments, a point hammered home by an EPA advisory issued in May 2009. According to the advisory, the majority of consumer allegations detailing adverse reactions from flea and tick treatments dealt with spot-on products.

Last August, ConsumerAffairs.com's Lisa Wade McCormick detailed the nightmare that befell Diane S., a pet owner from North Carolina, when she used Seargeant's, another spot-on treatment. Her dogs immediately began to whine and jerk, and soon developed burns on their skin.

Diane's vet, who examined the dogs the next day, said [the treatment] was pure poison and it's a wonder it didn't kill them.

The EPA advisory warns pet owners to carefully follow instructions when using flea and tick products, and advises them to consult a veterinarian before using the products on weak, aged, medicated, sick, pregnant or nursing pets, or on pets that have previously shown signs of sensitivity to pesticide products.

By Lisa Wade McCormick
ConsumerAffairs.com

March 9, 2010
A 72-year-old dog owner has won what may be a landmark decision against the countrys leading maker of pet care products and fueled the ongoing debate over the safety of topical flea and tick treatments.

A Texas jury awarded Frank Bowers $4,440.75 in the small claims court action he filed against Hartz Mountain Corporation. In this David-versus-Goliath court battle -- believed to be the first small claims court action of its kind --- Bowers alleged that Hartz Ultra Guard Pro Flea and Tick Drops caused the death of his beloved Olde English Bulldog, Diesel.

The six-member jury deliberated less than 30 minutes before reaching a unanimous decision in favor of Bowers, who was widely considered the underdog in the case.

"When the bailiff walked in the courtroom and said we have a unanimous decision, I nearly passed out," said Bowers, who represented himself in the court action. The jury said we find Mr. Bowers integrity outweighed what was presented by (Hartz) attorney. He lost an animal of value and all costs hes out are awarded to him."

I just literally went numb, Bowers added. I caught up with three jurors in the hallway after the hearing. All I said to them was: thank you, thank you, thank you. And they just said: we did our job.

Hartz told ConsumerAffairs.com that it believed the case was "without merit," but did not appeal because of the time and cost involved.

Sense of justice

For Bowers, the jurys decision brings closure and a sense of justice to an emotional issue that started at 8:30pm on August 7, 2008. On that warm summer night in Texas, Bowers applied Hartz Ultra Guard Pro Flea and Tick Drops to the 14-month-old, 68-pound, Diesel.

I nipped off the top of the tube and put it on his back, Bowers recalled. I precisely used it as directed nothing more, nothing less than directed. By early the next morning Diesel had become gravelly ill.

I went to my garage to work and I smelled this odor from excretion, Bowers said. Diesel was laying on the floor. He was shaking and having spasms of some kind. And he was passing a horrible odor of diarrhea. Bowers called his daughter, who told him to immediately take the ailing dog to the vet.

Diesels health continued its rapid decline during the ride to his vets office, Bowers said.

He continued to have bowel movements on the way. When we got to the vets office, he couldnt walk. They got one of those stainless steel tables and took him back to an exam room.

The veterinarian asked Bowers a battery of questions about Diesel, including one that caught him off guard.

The vet asked me if Id put any flea treatment on him, Bowers said. And I said: yes, last night. I told him what it was and went back to the store to get a tube to show him.

The vet, he said, took one look at the Hartz Ultra Guard Pro Flea and Tick Drops and shook his head. He said: Oh, my God. Hes going to have kidney failure.

By 4 oclock the next morning, Diesels kidneys had shut down.

He was in total renal failure, Bowers said. The vet wanted permission to euthanize him. I said you know whats best and I dont want any animal to suffer. I picked Diesel up around 7am and took him out in the country and buried him on my daughters 10 acres.

This painful chapter in Bowers' life happened in less than 35 hours from the night he applied the flea and tick drops to the morning of Diesels death.

He wanted answers

Bowers wanted answers. He wanted to know why Diesels health deteriorated so quickly.

The plain-spoken Texan went straight to the source. He called Hartz.

But they did not care to discuss this with me, Bowers said of the companys customer service representatives. They insinuated that I did something wrong. At that point, I said my dog is dead and I need you pay. Its about $4,000.

Hartz balked at his suggestion, Bowers said.

They said we wont pay that, sir. Its a risk you take when you use our products. I asked for this persons supervisor, but she hung up on me.

Bowers then sent the company a letter about Diesels death.

I got no response, he said. This irritated me. They acted like I didnt exist.

About two months later, someone (from Hartz) called me and told me it was my fault (that Diesel died) or neglect that caused the death and they were not responsible.

Bowers contacted a few attorneys to see if theyd take his case. But none wished to be bothering Hartz as there was not enough money, he said. The determined pet owner, however, didnt give up or back down.

He took matters into his own hands and represented himself in court, specifically Small Claims Court, Precinct 3, in Travis County, Texas. Consumers in the Lone Star State can seek damages of up to $10,000 in their small claims court proceedings. Texas also allows jury trials in small claims court actions.

I filed papers in small claims court, said Bowers, who lives in Austin, Texas. But the court called me a while later and said I needed to re-file my case because Hartz did not respond.

Bowers filed his case again on July 28, 2009. And this time, Hartz did respond to the court, he said. The court sent the company a registered and non-registered letter about my case. An attorney contacted the court and said she represented Hartz.

The court wanted Bowers and Hartz to resolve the case through mediation. But that process wasnt too productive, Bowers said.

I looked at the girl (Hartz attorney) square in the eyes and said: do you have a check for this amount -- $4,400? She said no. I said then this mediation is over. At this time, there is nothing to negotiate.

Bowers and Hartz attorney then went back and talked to the judge.

The judge said well have to reschedule for another appearance, Bowers said. But I told the judge that I wanted a trial by jury. She said thats your privilege. The attorney (for Hartz) didnt like it. She wanted to settle this between her and I.

Here I am -- 72-year-olds old. I have a high school education. I dont have a law degree. But I still wanted a trial by jury. The judge asked me if I thought I could get a jury verdict in my favor and I said I wouldn't be here if I didnt.

Day in court

Bowers' day in court finally arrived on January 12, 2010.

Before the trial, each side had a chance to question a pool of potential jurors.

I chose not to ask them any questions, Bowers said. But Hartz attorney kicked a few potential jurors off because they had pets. She also asked the jurors if theyd had any problems in the past with pet medications. She didnt want any pet owners or people who had problems with pet medications on the jury. There were also no vets on the jury.

In the end, a jury of three men and three women heard the case.

The trial took less than two hours, Bowers said. I wasnt able to tell the jury everything I wanted to.

The judge, for example, wouldnt allow Bowers to enter into evidence any of his Environmental Protection Agency (EPA) documents about the adverse reactions dogs and cats have experienced from topical flea and tick products. The vets he wanted to call as witnesses also couldnt make it to court that day.

I had no witnesses, Bowers said. I was riding the brass rail by myself. And he was up against Hartz savvy attorney, who he learned had taken a special course on flea and tick products to prepare her for the case.

Hartz had all kinds of statements about flea and tick products and they had everything notarized so it could be entered into evidence, Bowers said. I didnt know I needed to do that (get documents notarized). Hartz had statements from their vets, too.

During the trial, Hartz also cross-examined Bowers about Diesels death. Hes glad they did.

Thats when I got in the information that they wouldnt let me enter, Bowers said. I entered it by blurting it from the witness box. The attorney asked me a question like how did I know it was Hartz that killed my animal? And I said Hartz has killed many other animals.

The attorney was screaming to get me to shut up and I just kept talking, Bowers added. The judge then told me to shut up. At that point, I looked at the judge and said Im sorry. And then I looked at the jury and smiled.

Used as directed?

Hartz attorney also suggested that Bowers didnt apply the flea and tick drops as directed.

They screamed that over and over, Bowers said. But I precisely used it as directed.

Hartz and other makers of fleas and tick products often cite the misuse of these treatments for adverse reactions. Pet owners, they say, may put a flea and tick product intended for a dog on a cat. Or they may apply too much flea and tick product on their pets.

Last summer, the ASPCAs Animal Poison Control Center also studied its data on topical flea and tick products. That study revealed the likelihood of severe adverse reactions was significantly less when dogs and cats were treated according to directions.

From the data we have collected, the adverse reactions tend to be mild, like skin sensations and stomach upset, the ASPCAs Dr. Steven Hansen said after the organization released its study. We dont have very many cases of true neurological issues when these products are properly used.

Bowers, however, repeatedly told ConsumerAffairs.com that he used the Hartz flea and ticks drops as directed when he applied them to Diesel. He also told us the court didnt give him the chance to cross-examine any of Hartz witnesses during the trial. I wasnt asked to, he said. I asked the judge why I could ask any questions and she said thats procedure.

The jury, however, wasnt swayed by the witnesses or documents Hartz used in its defense.

After deliberating for less than 30 minutes, the jurors ruled in Bowers favor.

I didnt know what to think when I heard that, he said, adding the $4,440 he won covers the cost of Diesel and the dogs vet bills. I was dumbfounded.

Bowers is convinced the jury sided with him because of one issue that surfaced during the trial: whether the chemical Phenothrin, which is in Hartz Ultra Guard Flea and Tick Drops, is the same or similar to the chemical Permethrin. Bowers said he argued that, according to his carnal knowledge, those two are the same chemical compound.

I kid you not, that is the thing that saved my case, he said.

Hartz vehemently disputes that contention, saying those are completely different ingredients.

The trade name for Phenothrin is Sumithrin, the companys spokeswoman, Anne Isenhower, told ConsumerAffairs.com. Permethrin is a completely different ingredient that Hartz does not use in any of our on-animal products in the United States.

Hartz also downplayed Bowers allegations and the jurys decision. This case was without merit and the allegations werent supported by evidence (presented in the trial), said Isenhower, senior vice president, with GolinHarris, Hartz public relations firm. Hartz, however, did not appeal the jurys decision because of the time and cost involved to pursue such action, Isenhower said.

Asked if Bowers case marked the first time a consumer has successfully sued Hartz over one of its topical flea and tick products, Isenhower said: Yes, we believe so. We are not aware of any verdict against Hartz flea & tick drops.

She had an identical comment when asked if Bowers case was the first small claims court victory against Hartz. Yes, we believe so. We are not aware of any verdict against Hartz flea & tick drops.

Safety defended

In spite of the jurys decision, Isenhower defended the safety of Hartz flea and tick products.

Weve conducted extensive analysis of the adverse event reporting on our products as well as all topic treatments in the market, she said. Although Hartz is the leader in flea and tick retail sales, we are less than three percent of all adverse effects reported to the EPA in 2008 for topical dog flea and tick treatments.

The safety of topical or spot-on flea and tick products has come under intensified scrutiny by the EPA for the past 11 months.

The agency started that probe last April, saying it had received more than 44,000 reports of adverse reactions associated with spot-on flea and tick products.

Adverse reactions reported range from mild effects such as skin irritation to more serious effects such as seizures and, in some cases, the death of the pet, the EPA said.

Data delayed

The agency told ConsumerAffairs.com that it planned to release its findings last fall. The EPA, however, has since delayed that release date.

The EPA will post its findings about topical flea and tick products, and any regulatory action it may take, on its Web site.

In the meantime, animal experts recommend pet owners consult their veterinarians about which flea and tick product to use on their dogs or cats.

Beware

Back in Texas, Bowers warns pet owners to be earthly aware of any topical flea and tick products they put on their animals.

I think Ill utilize just plain soap and water, he said. I use Head and Shoulders shampoo on my dogs now. I bathe them every time I see them scratching. We used to get Myrtle Bush when I was a child growing up in Louisiana, he added. It was a natural killer of fleas.

Bowers is also keenly aware that his legal victory could have ripple effects in courtrooms across the country. He suspects his case may serve as a rallying call for other pet owners whove seen their dogs or cats suffer burns, blisters, seizures, neurological problems, or even die after using topical flea and tick products.

His case, he said, may open the floodgates for similar lawsuits nationwide.

I think this case will make pet owners wonder why they have not gone forward with their cases in small claims court, Bowers said. And if they do, my advice to them if get a trial by jury; I would never accept a non-jury trial.

The amount of money consumers can recover in small claims court varies by state. And some states do not allow trials by jury in small claims court. ConsumerAffairs.com has a comprehensive small claims court guide.