One more step forward in Hill’s class action lawsuits. Will DSM be next?


The Class Action suit against Hill’s Pet Nutrition, Inc., has taken another step forward in the legal process with the appointment on July 31st of Lead Counsels for the Plaintiffs and the Defendants.

Lead Counsels for the Plaintiffs are:

The Multidistrict Litigation consolidates approximately 20 individual Class Action suits initiated by grieving dog owners whose pets died as a result of vitamin D overdose.

During the first half of 2019, Hill’s Pet Nutrition recalled 33 varieties of canned, wet dog food due excessive levels of vitamin D in the products.

At present, Defendants named in the Class Action include Hill’s Pet Nutrition, Inc., Hill’s Pet Nutrition Sales, Inc., and Colgate-Palmolive Company.

Hill’s is a subsidiary of Colgate-Palmolive.

The toxic concentrations of vitamin D were found to have originated from a formulation error in the vitamin D premix supplied to Hill’s by the Fort Worth, Texas facility owned by DSM Nutritional Products, LLC. 

An employee at the Fort Worth plant added vitamin D to the premix instead of adding vitamin E, resulting in a 2900% excess of vitamin D in the premix.

FDA follow-up discussions with company management established that DSM did not have adequate systems in place to prevent this type of operator error. For example,

  • Although batch records were reviewed and signed off, the ingredient substitution was not caught either by the
  • The vitamin D and vitamin E ingredients were similar in color, and there was no color-code labelling system in place to differentiate the ingredients
  • DSM did not have a bar coding system in place to aid in identification and tracking of ingredients
  • DSM did not provide a Certificate of Analysis for each batch of premix supplied to Hill’s and does not test every finished batch

As of mid-April, DSM was preparing a revised food safety plan, which it promised to provide to FDA by the end of May.

DSM has not yet been named as a Defendant in the Class Action. It will be up to the Co-Lead Counsels to decide whether or not to do so.

The best last word in this saga belongs to Jessica Hensley of FDA, who told DSM representatives, Your products killed life. Be sure that you have a process in place so that an employee can’t screw it up.

 

 

 

Hill’s Vitamin D Catastrophe – A Preventable Tragedy


On August 16, 2018, DSM Nutritional Products, Inc. in Fort Worth, Texas manufactured two production lots of vitamin premix intended for use in dog food.

Due to a manufacturing error, the premix contained vitamin D at 2900% over the target concentration level.

The two batches of premix, comprising a total of 2.7 tons of material, were destined for a single customer – Hill’s Pet Nutrition Inc. in Topeka, Kansas.

The vitamin premix was used over a period of several months to manufacture 86 total lots of 33 varieties of canned, wet dog foods, under the Hill’s Prescription Diet and Hill’s Science Diet brands.

Those 86 lots, which were distributed across the United States and to 65 other countries around the world, contained toxic levels of Vitamin D.

Hill’s recalled the affected products in three separate announcements, the first in January 2019, the second in March 2019 and the third in May 2019.

In February 2019, Hill’s acknowledged to FDA inspectors that the company had received 85 consumer complaints reporting pet deaths associated with their dog food.

Those 86 lots were most probably responsible for hundreds of pet deaths and even more pet illnesses, causing pet owners unimaginable heartache and costing many thousands of dollars in veterinary bills.

DSM COULD HAVE PREVENTED THIS TRAGEDY

Had DSM carried out its responsibilities under the Food, Drugs & Cosmetics Act to evaluate foreseeable hazards and to implement preventive controls, the company would not have produced or supplied the faulty premix.

The Inspection Observations report, issued upon completion of FDA’s inspection in February 2019 and obtained by eFoodAlert in response to a Freedom of Information Act request, identified two deficiencies, quoted in full.

OBSERVATION 1

You did not evaluate each known hazard or reasonably foreseeable hazard for each type of animal food you manufacture, process, pack, or hold in your facility.

Specifically, your Hazard Analysis indicates the likelihood of using excessive Vitamin d in your premix (intended for use in dog food) to have a probability of occurring once in [REDACTED]. Your estimate is too low because your firm produced a super-potent premix on 8/16/2018 containing Vitamin D at a 30-fold excess that resulted in a Class I product recall on 1/31/2019.

OBSERVATION 2

You did not identify or implement preventive controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented.

Specifically, Vitamin D is an ingredient used in your premixes intended for use in dog food. You made two batches of the premix on 8/16/2018 (total of [REDACTED lbs) that proved to contain Vitamin D at 2900% concentration over the target level. These batches were shipped from your facility in Fort Worth, TX to your customer in [REDACTED]. A preventive control such as reconciliation of Vitamin D usage at a specified frequency could have prevented the contamination of these batches. (emphasis added)

HILL’S IGNORED ITS OWN SAFETY PLAN

If Hill’s had carried out the preventive controls specified in its own food safety plan, the company would have detected the toxic level of vitamin D present in the DSM premix batches.

As previously reported by eFoodAlert, Hill’s own written procedures called for vitamin D testing of the premix. However the company was unable to provide any evidence to FDA inspectors that those tests had been carried out.

Hill’s did not verify vitamin D levels either the premix or in their finished product until after receiving a consumer complaint on December 28, 2018.

THE BOTTOM LINE

The story is not yet done.

The race is not yet run.

The lawsuits have just begun.

FDA reveals name of Hill’s vitamin D premix supplier


DSM Nutritional Products Inc. (DSM) was the supplier of vitamin D premix to Hill’s Pet Nutrition.

DSM is an international corporation that is “…a world leading supplier of vitamins, carotenoids and other nutritional solutions…”, according to the company’s website. Its US headquarters are in Parsippany, New Jersey.

According to the FDA Weekly Enforcement Report released this morning (June 19, 2019), DSM was notified by Hill’s Pet Nutrition (Hill’s) that a dog had become ill after consuming Hills Prescription Diet W/D canned dog food, manufactured using the DSM vitamin premix.

On January 30, 2019, DSM initiated a recall of 2217 Canned Canine PMX Product Code: NP15268025, net weight: 25 Kg per package, package type: Woven polyethylene bag.

The recall encompassed two production lots – 9100058130 and 9100058131 – comprising a total of 2500 Kg (~2.75 tons) of premix.

The premix was produced on August 18, 2018.

DSM notified Hill’s of the recall by telephone. There were no other consignees, and no public recall notice was released.

Hill’s first notified FDA about potentially toxic levels of vitamin D in its canned dog foods on January 31, 2019 and initiated a recall of 25 products manufactured during the months of September 2018 through December 2018.

On March 20, 2019, Hill’s expanded the initial recall to include additional products and lot codes. A second expansion was announced on May 20, 2019.

The recalled products were distributed in the USA and around the world.

FDA initiated an inspection of Hill’s manufacturing facility in February 2019. According to the inspection report, Hill’s blamed a manufacturing error by its premix supplier (DSM) for the toxic levels of vitamin D in its canned dog foods.

Although the Hill’s written procedures called for testing of vitamin D levels in the premix, the company was unable to provide any evidence to FDA inspectors that those tests had been carried out.

Subsequent tests conducted on a retained sample of the premix revealed a level of vitamin D that was roughly 30 times the target range for this ingredient.

As of February 11, 2019, Hill’s acknowledged having received 85 consumer complaints reporting pet deaths.

More than 20 civil lawsuits have been filed against Hill’s Pet Nutrition by grieving pet owners.

FDA offers the following information regarding vitamin D toxicity to pet owners and veterinarians.

  • If your pet is having symptoms of vitamin D toxicity, contact a veterinarian immediately. Provide a full diet history to your veterinarian. You may find it helpful to take a picture of the pet food label, including the lot number.
  • Don’t feed the recalled products to your pets or any other animal. Contact the company listed on the package for further instructions or throw the products away in a way that children, pets and wildlife cannot access them.
  • Consumers can report suspected illness to the FDA electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. It’s most helpful if you can work with your veterinarian to submit your pet’s medical records as part of your report. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.
  • The FDA encourages veterinarians treating vitamin D toxicity to ask their clients for a diet history. We also welcome case reports, especially those confirmed through diagnostics. You can submit these reports electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.
  •  Veterinarians should also be aware that vitamin D toxicity may present as hypercalcemia, similar to dogs that have consumed rodenticide. In these cases, FDA suggests that veterinarians confirm diet history to verify whether the dog has been eating any of the recalled products.

For a comprehensive list of Hill’s Pet Nutrition canned pet foods recalled due to excessive Vitamin D, please visit Hill’s Pet Nutrition recalls: Country-by-country breakdown on eFoodAlert