Equipment sterilization device altered without FDA approval

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Case in Point

April 5, 2011

Equipment sterilization device altered without FDA approval 

A surgery center sued the manufacturer of the sterilization system on behalf of all purchasers. The class alleged deceptive trade practices, breach of express and implied warranties and other claims, asserting that the changes resulted in equipment that wasn’t thoroughly sterilized. The court has granted preliminary approval of the parties’ settlement. Phys. of Winter Haven LLC v. Steris Corp.

In 1989, the FDA approved the Steris System, a device manufactured by Steris Corp. for sterilization of medical equipment. Between then and 2002, Steris made several changes to the system without seeking approval from the FDA.

In 2008, the agency sent a warning letter to Steris, advising the company that it illegally failed to seek premarket approval. The agency claimed that Steris’s changes had altered the concentration and amount of sterilant delivered, resulting in equipment that wasn’t thoroughly sterilized.

The FDA also informed health care providers that the device was not approved and said that it had received complaints of malfunctions that could cause infections in patients and burns to health care providers who were exposed to the chemicals. The FDA recommended that providers transition to competitor devices “as soon as possible to ensure continued patient safety.”

Steris notified customers that it was seeking premarket approval for an updated device and would discontinue sales of the older Steris System. The company said it would continue to support existing systems for two years and work with customers to transition to the new product, but it didn’t offer customers a refund.

The FDA accused Steris of an inadequate response and told health care providers that the system “should be discontinued as soon as practicable.”

A surgery center filed a class action against Steris Corp. on behalf of all purchasers of an unapproved Steris System. The class alleged deceptive trade practices, breach of express and implied warranties, tortious breach of warranty, negligent design, failure to warn, and unjust enrichment.

After suit was filed, Steris entered into a consent decree with the FDA, agreeing to a rebate program that offered current customers either a pro-rated cash rebate or a trade-in allowance for a new system. The plaintiffs contended the remedy wasn’t enough because it required them to continue doing business with Steris.

The parties reached a settlement,in which class members who still have the device or returned it as part of the rebate program will receive a $1,000 credit for each device; class members who return their devices after settlement will receive either a credit of $500 or a cash payment of $300; and those who no longer have the device for a reason unrelated to the suit will receive $200.

The court has granted preliminary approval.

Citation: Phys. of Winter Haven LLC v. Steris Corp., No. 1:10-cv-00264 (N.D. Ohio Mar. 4, 2011).

Plaintiff counsel: Thomas A. Muzilla, Cleveland; and Nicholas E. Chimicles, Joseph G. Sauder, and Benjamin F. Johns, all of Haverford, Pennsylvania.


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