Another lawsuit was added to the avalanche of litigation that DePuy Orthopaedics Inc. is facing over one of its hip implants, after a Tennessee woman sued the company over an allegedly faulty hip implant.
Kathern Hensley was implanted with a DePuy ASR XL Acetabular hip replacement system, according to a statement from the law firms representing the plaintiff.
Hensley alleges that she has been in "constant pain" from her DePuy hip replacement, and accuses Depuy of being aware of the device’s tendency to fail and cause the discomfort she experienced, the firms said. The lawsuit, Hensley v. DePuy Orthopedics Inc., et al., was filed March 4 in state court in San Francisco.
The Johnson & Johnson (NYSE:JNJ) subsidiary has fielded numerous lawsuits about its ASR metal-on-metal hip replacement since a complaint was filed by Florida resident Kathleen Margenau in June 2010 on the device. Margenau also alleges that the company was aware of the device’s problems when it was still selling and marketing it.
The Warsaw, Ind.-based company in August 2010 pulled the ASR XL Acetabular and ASR Hip Resurfacing systems from the market "due to the number of patients who required a second hip replacement procedure, called a revision surgery," according to a prepared statement from the company.
Here’s a roundup of recent legal actions associated with the medical device industry.
- Steris to pay $20 million over sterilization system suit
The U.S. District Court for Northern Ohio last week granted preliminary approval to a proposed settlement reached in a class action lawsuit filed by Chimicles & Tikellis LLP against Steris Corp. (NYSE:STE). The lawsuit is related to Steris’ marketing and sale of the Steris System 1 Sterile Processor (the SS1), a tabletop liquid chemical system that provides rapid, low-temperature processing of surgical instruments such as endoscopes and bronchoscopes. The Food & Drug Administration cleared the SS1 in 1988. The lawsuit filed by C&T 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. 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. 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. Based on the number of eligible SS1 Devices and settlement options made available to each, C&T estimates that the settlement provides approximately $20 million of benefits to the class.
- Ex-Cyberonics CEO battles backdated options reports
Robert Cummins, who stepped down as Cyberonics Inc. (NSDQ:CYBE) CEO in Nov. 2006 after allegations surfaced that he was the beneficiary of backdated stock options, is back in court claiming that he was defamed by reports from Suntrust Capital Markets Inc. analysts who mischaracterized options he had been granted as improperly backdated. Last December, Cummins and Cyberonics reported that he received a letter from the Securities and Exchange Commission that exonerated him. The letter stated that the SEC had completed its investigation of Cyberonics’s stock option practices commenced on June 9, 2006 and that it does not intend to recommend any enforcement action against Cummins, according to the company.
- Swedish court says Occlutech implants don’t violate St. Jude patent
Occlutech GmbH received a favourable court ruling from Stockholm in the on-going patent litigation with St Jude Medical Inc. (NYSE:STJ) and its recent acquisition, AGA Medical. In the ruling by Stockholms tingsratt , the district court of Stockholm, the court does not see any basis for AGA-St Jude’s claim that the Occlutech ASD and PFO occluders violate any patent brought forward in the litigation. The Stockholm court decision thus is similar to the first instance ruling in the United Kingdom that was confirmed by the appeal court in the U.K., the last one received mid 2010. The U.K. ruling is final as the country’s supreme court did not allow an appeal requested by AGA. The favourable Stockholm ruling is also similar to first instance as well as appeal court decisions in The Hague, the last one obtained in the end of 2010. The rulings in Sweden and The Netherlands are subject to appeal by AGA-St Jude Medical.
- Allergan attempts to have Texas court toss breast implant marking suit
Allergan Inc. (NYSE:AGN) asked the U.S. District Court for Eastern Texas to toss plaintiff Kilts Resources LLC’s false marking suit on grounds that it was no longer valid due to a recent decision that the statute governing the matter — a provision of the Patent Act — is unconstitutional. In the a qui tam action, Kilts alleges that Allergan falsely marked unpatented "CUI Brand Tissue Expanders," also known as breast implants, with expired patent numbers with the purpose of deceiving the public, according to court documents.