PATERSON, N.J. (CN) - A class action claims eight medical distributors sold sterile surgical mesh under the C.R. Bard label that was neither sterile nor made by Bard, but were "counterfeits made in the Republic of China." Bard is one of the defendants.
Named plaintiff Irene Kirk Calo says she had counterfeit mesh implanted in her during a gastric banding operation on Oct. 21, 2009. She claims lead defendant RAM Medical recalled 16 lots of the surgical mesh in March 2010, and in June that year, "the FDA classified defendant RAM Medical's recall as a Class I recall, a designation reserved for the most serious types of recalls."
Calo claims the mesh "was affixed with genuine Bard lot numbers" and represented "as if having been manufactured by C.R. Bard."
Also sued are Amerimed Corp., Henry Schein Inc., Medline Industries, Marathon Medical Corp., MMS-A Medical Supply Co., and Q-Med Corp.
Calo estimates that the class, of "all consumers in the United States who had defendants' counterfeit surgical mesh surgically implanted from September 1, 2007 until the present day," may "exceed one thousand individuals."
"Surgical mesh is regularly used during surgical procedures to reinforce soft tissue in the body where weakness exists, such as in the repair of hernias and chest wall defects," according to the complaint.
It continues: "The FDA has determined that surgical mesh manufactured or caused to be manufactured, marketed, distributed or sold by defendant is counterfeit. The counterfeit products were labeled and sold as 'Bard' brand surgical mesh but, upon information and belief, were counterfeits made in the Republic of China.
"According to the FDA, RAM Medical, Inc., distributed the counterfeit surgical mesh between October 2008 and October 2009, and the counterfeit surgical mesh was affixed with genuine Bard lot numbers."
Calo says the defendants claimed, inter alia, that "the product was sterile," that it had "been approved for surgical use by the United States Food and Drug Administration" and that it was "indicated for a specific surgical use."
But she says the hospital where she had her surgery, the (nonparty) Lexington Medical Center in South Carolina, sent her a letter in July 2010 "informing her that the surgical mesh implanted during her October 2009 surgery was counterfeit surgical mesh."
Calo claims the defendants "were able to and did charge a premium price for their counterfeit surgical mesh - a price higher than that charged for similar products. In the condition in which defendants' counterfeit surgical mesh was sold, the counterfeit surgical mesh was of no value whatsoever to plaintiff or members of the class."
Calo does not specify in the complaint whether she suffered a particular physical injury from the mesh. She says she and the class members "have sustained physical, mental, and/or emotional injuries, fright, inconvenience and interruption of or intrusion into their personal lives, and economic damages including loss of income, and that they continue to suffer harm because of defendants' wrongful conduct in violation of the law, as alleged herein."
She seeks class damages for fraud, unjust enrichment, breach of warranty and product liability. She is represented in Passaic County Court by E. Drew Britcher with Britcher, Leone & Roth of Glen Rock, N.J.
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