On March 3, 2011, the United States District Court for the Northern District of Ohio granted preliminary approval to a proposed settlement reached in a class action lawsuit filed by Chimicles Schwartz Kriner & Donaldson-Smith LLP (CSK&D) against STERIS Corporation (“STERIS”). The lawsuit is related to STERIS’ marketing and sale of the STERIS SYSTEM 1® Sterile Processor (the “SS1 Device”), a tabletop liquid chemical system that provides rapid, low-temperature processing of surgical instruments such as endoscopes and bronchoscopes. On June 6, 2011, the Court granted final approval to the settlement.
Sterilization systems like the SS1 Device must be cleared by the FDA before they can be sold to healthcare providers. The FDA cleared the SS1 in 1988. The lawsuit filed by CSK&D alleges that STERIS made several material changes to the SS1 Device after 1988 without obtaining the necessary clearance from the FDA, and that as a result, the FDA informed healthcare providers that use of the SS1 Device “should be discontinued as soon as practicable,” but no later than August 2, 2011. STERIS subsequently entered into a consent decree with the FDA to implement a transition plan whereby healthcare providers could return their SS1 Devices to STERIS in exchange for a rebate (the “Rebate Program”). There are no allegations in this case that the SS1 Devices create a safety hazard, nor that anyone has been harmed as a result of using the SS1 Devices.
The proposed settlement of the class action lawsuit is on behalf of all domestic healthcare providers that own or owned a SS1 Device that was (a) purchased before January 1, 2009, and (b) in use on December 1, 2009. SS1 Devices purchased after January 1, 2009 are not part of this proposed settlement because they are already eligible for a full refund from STERIS under the Rebate Program. In December 2009, STERIS prepared a list of SS1 Devices then in use — the “Transition List.” All eligible healthcare providers on the Transition List will be sent notice of the settlement. The settlement applies to approximately 20,000 SS1 Devices owned by approximately 6,600 customers. Based on the number of Eligible SS1 Devices and settlement options made available to each, CSK&D estimates that the settlement provides approximately $20 million of benefits to the class.
The benefits that class members can elect to receive differs depending on whether they are members of Sub-Class A, Sub-Class B, or Sub-Class C:
|A||Class Members that (a) purchased or elect to purchase SYSTEM 1E™ (“SS1E”) Device from STERIS on or before December 31, 2012, and (b) either (i) still have the Eligible SS1 Device(s) or (ii) returned the Eligible SS1 Device(s) to STERIS in the Rebate Program. The SS1E is STERIS’ next generation liquid chemical sterilant processing system.||Will receive SS1E Credits in the amount of $1,000.00 per Eligible SS1 Device, which can be applied towards the purchase of any SS1E Accessories, Parts Or Consumables; SS1E credits can be combined, and must be claimed by December 31, 2012.|
|B||Class Members that (a) do not elect to purchase an SS1E Device and (b) either (i) still have the Eligible SS1 Device(s) or (ii) returned the Eligible SS1 Device(s) to STERIS in the Rebate Program.||Will, for each Eligible SS1 Device, have the option to receive either (a) $500 in STERIS Product Credits, or (b) $300.00 in cash. STERIS Product Credits may be redeemed for any STERIS product(s) other than an SS1E Device, service, or service contracts. STERIS Product Credits can be combined and must be claimed by December 31, 2012.|
|C||Class Members that, for any reason other than because the Eligible SS1 Device was returned to STERIS in the Rebate Program, no longer have the Eligible SS1 Device.||Will be entitled to receive a $200.00 cash payment from STERIS for each Eligible SS1 Device.|
In order to receive this settlement consideration, the Court must grant final approval of this settlement and all Class Members (except for those in Sub-Class C) will be required to return their Eligible SS1 Units to STERIS. Class Members will also be required to return to STERIS all open or used SS1 quick connects, parts, trays, containers, filters, sterility assurance products, S20 sterilant, and other parts, accessories, or consumables for their SS1 Devices that are in the Class Member’s possession. If Class Members have already disposed of these open or used items, they will be given the option to sign a certification confirming that these items have been disposed of and are no longer useable.
Class members will be mailed a claim form within ten days after the Court grants final approval to the settlement. Class members have until December 31, 2012 to return their claim form to the address listed on the claim form.
For additional information about the settlement, you may contact the attorneys below, or visit the settlement website, which will be activated shortly: http://www.sterilizersettlement.com.