RECALL & SUBSEQUENT (9/27/04) LAWSUIT ON ProHeart 6 Injectable

FDA Recall  September 3, 2004   (go to end of page for related links to Prescription Inserts, Litigation, etc.)

Fort Dodge to Comply with FDA's Request to Recall ProHeart 6 Injectable Heartworm Product from the Market Due to Serious Health Concerns.  Fort Dodge Animal Health, of Overland Park, Kansas, at FDA's request, has agreed to immediately cease production and recall its heartworm medication ProHeart®6 from the market until the FDA's concerns about adverse reaction reports associated with the product can be resolved. FDA is requesting that the firm continue to conduct research to determine the cause of related adverse reactions and develop a strategy to help prevent such problems in the future before the product is marketed again. The FDA will convene an independent scientific advisory committee to thoroughly evaluate all available data.

ProHeart®6 is an approved injectable sustained-release heartworm prevention product for dogs. Heartworm disease is a serious and potentially fatal condition of dogs, cats, and other species of mammals. The parasite that causes heartworm disease is transmitted through the bite of a mosquito.

FDA is also advising veterinarians to avoid administering this product to dogs until further notice. Pet owners should consult their veterinarians regarding their pet's health care needs.

Since the product was approved in June 2001, Fort Dodge Animal Health has cooperated with FDA to investigate numerous adverse event reports. As a result, Fort Dodge has voluntarily changed the label to include post approval safety information including rare reports of death and a caution to practitioners that dogs should have a negative test for heartworm before administration.

Despite these label changes, FDA is still receiving unexplained adverse event reports, some of them severe. FDA's concern is based on voluntary self-reporting to FDA by veterinarians and owners whose dogs have suffered adverse drug experiences (ADEs) to ProHeart®6 (which contains the drug moxidectin) as well as the mandatory reporting of adverse events by Fort Dodge Animal Health.

Fort Dodge Animal Health has agreed to recall any product that has already been distributed to veterinarians.

As of August 4, 2004, FDA's Center for Veterinary Medicine (CVM) had received 5,552 adverse event reports for ProHeart®6. The actual number of adverse events is likely even higher because studies show that only a fraction of actual ADEs are reported.

The Agency has observed an increase in the number of cases associated with liver and bleeding abnormalities followed in some cases by death.

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LAWSUIT FILED 9/27/04

Contact:   Deborah Howard: 970-223-3800    Dennis Dill: 405-359-0600                                               
Lawsuit Filed against Manufacturer of ProHeart®6 Heartworm Medication - Complaint Alleges Fort Dodge Animal Health, a Division of Wyeth, Failed to Warn Consumers of Possible Serious Adverse Reactions, including Death, to Dogs from Sustained-Release Preventative Shot

EDMOND, Oklahoma - September 27, 2004 - Dennis Dill, an attorney with Chris Harper, Inc., a multi-practice law firm in Edmond, Oklahoma filed a lawsuit against American Home Products, Wyeth and Fort Dodge Animal Health in Tulsa, Oklahoma District Court on September 22, 2004. 

The lawsuit alleges that American Home Products, Wyeth and Fort Dodge Animal Health recklessly introduced ProHeart®6, an injectable heartworm preventative medication, to the market without giving consumers proper warning that their product could cause serious health risks or even death to canines. 

On September 3, 2004, the FDA recalled ProHeart®6.  This recall received extensive media coverage.  Fort Dodge, at the request of the FDA, is also ceasing production while continuing to conduct research to determine the cause of related adverse reactions.  The FDA also instructed the company to develop a strategy to help prevent such problems in the future before the product is marketed again. The FDA will convene an independent scientific advisory committee to thoroughly evaluate all available data.

Chris Harper, Inc. has asked the Court for a class action status due to the numerous complaints that have been filed with the FDA Center for Veterinary Care, which is estimated at over 5,000 throughout the United States (around 10 percent are deaths).

The Plaintiff in this lawsuit is June Dill, an 80-year-old grandmother who took her companion, "Baby," an 8-year-old Yorkshire Terrier, to a local veterinarian for a preventative check-up.  After being told that ProHeart®6 was a safe, preventative heartworm medication, she allowed the vet to inject "Baby" with ProHeart®6.  It is alleged in the Petition that due to the injection of ProHeart®6, in just a few short weeks, "Baby" died as a result of complications caused by ProHeart®6.

Chris Harper, Inc. has filed this Petition to assist pet owners, such as June Dill, who have either had their companions injured or watched them pass away due to the complications of ProHeart®6.

To date, the Companion Animal Protection Society (CAPS), a national animal protection organization based in Fort Collins, Colorado, has gathered around 90 complaints from people whose dogs have become very ill or died after receiving a ProHeart®6 shot.  The most common reactions listed in these complaints are seizures, liver problems, Immune Mediated Hemolytic Anemia (IMHA), Hemorrhagic Gastroenteritis (HGE) and Thrombocytopenia Vasculitis.  CAPS has been generating news stories around the country that feature consumers whose dogs suffered adverse reactions, including death, after receiving ProHeart®6.  You can read more about ProHeart®6 on the CAPS website: www.caps-web.org.
See also:  http://www.caps-web.org/images/Proheart%206%20Press%20Release.pdf

LAWSUIT OVER VETERINARY DRUG "RIMADYL®" SETTLED

 Jean Townsend of Johns Island, South Carolina announced today that a settlement has been reached with Pfizer, Inc. in what appears to be the first lawsuit of its kind in this country - a lawsuit over injuries that led to the death of Ms. Townsend's chocolate lab, George. Ms. Townsend originally brought a class action lawsuit against Pfizer in October of 1999, two years after the tragic death of George. The lawsuit alleged that after initial approval by the FDA, the drug Rimadyl®, which was the subject of an unprecedented multi-million dollar advertising campaign, was marketed without a complete understanding of the serious side-effects that could result from the drug. Ms. Townsend also alleged that neither she nor her vet were adequately warned of the potential side-effects. After administering the drug for only 14 days, George developed severe internal bleeding and ultimately liver failure. George was euthanized on October 13, 1997. In reaching the settlement, Pfizer has admitted no wrong-doing.

 "It was truly horrible," said Townsend of the experience. "But the most troubling aspect of the ordeal was when I later learned that similar side-effects had been reported to Pfizer and the FDA months before I first gave the drug to my dog. Yet even after my pet became sick, I continued to give him the pills because they were supposed to make him feel better. I had no idea that he was suffering from the side-effects of Rimadyl®. It is devastating to live with the realization that I gave my beloved pet medicine to help him when, in fact, it was killing him." After reporting George's death to Pfizer, Ms. Townsend was offered a $249.33 settlement, but the offer came with the condition that the settlement remain confidential. Ms. Townsend refused.

 In the months following George's death, Ms. Townsend began researching this drug on the internet and soon discovered dozens of other pet owners who had similar experiences with Rimadyl®. Fueled by the growing number of people whose dogs had become sick or died after taking the drug, Ms. Townsend, along with other concerned pet owners, started a campaign to raise awareness of the potential for serious side-effects with this and other veterinary medicines. As part of that campaign, Ms. Townsend and others met with FDA officials as well as Pfizer veterinarians, urging them to step-up efforts to more thoroughly inform pet owners of the potential for serious side- effects with veterinary medicines.

 Unsatisfied with the response of the FDA and Pfizer, Ms. Townsend turned to the legal system and filed a class-action lawsuit. In her suit, Ms. Townsend sought reimbursement of the $734.00 in veterinary expenses she had incurred trying to save George, as well as establishing a class action on behalf of the hundreds of other dog owners whose pets had become ill or died.

 In the meantime, reports of adverse reactions to Rimadyl® continued to rise, and in 1998, Rimadyl® accounted for almost 39% of all Adverse Drug Experience Reports received by the FDA. The reports were so numerous that in December of 1999, the FDA took the extraordinary step of issuing a public statement on the drug.

 Within months of Ms. Townsend's suit and the "Update on Rimadyl®" issued by the FDA, Pfizer announced significant changes in packaging, and that it would begin dispensing a Client Information Sheet to be included with veterinary prescriptions of Rimadyl®. The Client Information Sheet, modeled after similar drug information sheets included with many human drugs, was to provide pet owners with easily understandable information about the potential side-effects and what to do if side-effects occur.

Ms. Townsend reports that as part of the settlement, Pfizer made cash offers to over 300 other dog owners across the country to settle claims for death or injury to the dog, veterinary expenses, property damage, emotional distress and punitive damages. These individual offers averaged over $1000.00 per animal and did not include a confidentiality provision.

Speaking about the lawsuit and the settlement, Ms. Townsend said, "I am pleased that through this suit, hundreds of other pet owners will be reimbursed for veterinary expenses and the loss of their pets. Of course, no amount of money would ever replace the loss of my friend George, and the loss of so many other beloved companions." But to Ms. Townsend, (who donated her settlement proceeds to a local veterinarian to perform surgery on a pet whose owners could not afford the surgery) the issue is far more than the money paid by Pfizer. It is the growing public awareness that the medications we give our pets can have serious side-effects. "We, as pet owners, have the right to know as much about the good and bad sides of veterinary medicines as we do the medicines we give ourselves."

For further information please contact:

Jean Townsend - luswinton@aol.com  843.559.2134

Legislative steps are underway in some states to force compliance of  TDP Project #1 Prescription Inserts

Other informative links  Adverse Reactions  Recalls Pro Heart 6 and Rimadyl Settles