Counterfeit Products On The Rise
Product manufacturers, and the attorneys who represent them, must be aware that their products may be copied and later sold as the genuine article. Any product may be a target of the counterfeiters - as long as they can make money from their deception. Medical products are popular with counterfeiters.
While the counterfeiting of medical devices and drugs has been a problem for some time, U.S. Customs and others believe that the import and use of counterfeits is on the rise. According to one medical device web site, most counterfeit products are shipped from China, Russia, Hong Kong and Taiwan and at least 5% of products coming into the U.S. are counterfeit.
Ethicon recently advised healthcare professionals that a counterfeit polypropylene mesh, masquerading as their own Prolene mesh used for the repair of hernias and other fascial deficiencies, was in circulation. The outward differences between the original and the counterfeit were subtle but visible. The counterfeiter even duplicated the Ethicon logo. The counterfeit likely entered the supply chain through distributors.
Procrit, a drug marketed by Ortho Biotech and used to stimulate red blood cell production in severe anemia cases, has also been counterfeited. The counterfeit was contaminated with potentially hazardous bacteria and the stated dosage levels were incorrect.
According to the World Health Organization, more than 2000 kits containing stethoscopes and sphygnomanometers seized during transport several years ago had been counterfeited, including packaging, instructions, devices and standard marks.
The counterfeiting of products is not limited to the inexpensive, seemingly uncomplicated medical product either. Intra-aortic pumps worth approximately $7 million were recalled after malfunctioning components were found to be counterfeit.
The counterfeiting of products, whether medical or otherwise, presents new and unique issues to the product liability arena. The counterfeit may be simply inferior to the original, or it may malfunction. The counterfeit may also differ from the original in a significant, but unknown or unacknowledged way. Warnings and use instructions may no longer be accurate.
The potential consequences of a defective part in a functioning pacemaker illustrate the problem. In the event of discovery of the counterfeit part, who has the ability to quantify and assess the risks from the counterfeit part? Who will undertake and pay for such testing and assessment of the counterfeit? More harm may come to the patient from attempting to remove and replace the suspect pacemaker than from permitting the pacemaker with a counterfeit part to remain implanted.
Attorneys will want to know who is at fault if a patient is injured or dies as a result of using a counterfeit product. The physician who used a suspect medical product and did not notice a problem is one target defendant. The manufacturer and distributor are placed at risk as well. Everyone from the manufacturer, to the distributor, to the hospital, to the physician who performed the procedure, and his staff, are potential defendants.
A rise in product liability suits caused by the use of counterfeit products could lead to increased insurance premiums. The fact that counterfeiters can fake virtually any device is especially worrisome since the potential for liability is not limited to any one product or device.
As an immediate safeguard, manufacturers, distributors and product users should pay close attention to all aspects of the product including its packaging. Any irregularity should be immediately checked with the manufacturer, distributor or, in the case of a medical device or drug, the FDA.
A number of web sites quickly report any new information regarding counterfeit products. Two good ones for breaking news on recent counterfeit products are www.fda.gov and www.devicelink.com.
A long-term strategy for the companies who hold the rights to products could include anti-counterfeiting measures. One possibility is to institute a program where the manufacturer periodically inspects product inventory at distribution houses. Reasonable steps must be taken by a manufacturer who suspects that its products may have been counterfeited.