Devices law suits in the USA – Litigation costs are rising. – Provision for litigation should be made in every device manufactures budget especially if they trade in the USA.
A large devices manufacturer of ostomy, continence, urology, and wound and skin care products—which has its U.S. headquarters in Minneapolis—had previously provisioned in their budget, 1.5 billion kroner (equivalent to $226.2 million) for law suits. (Related article: The Worst-Performing Medical Device Firms of 2015) however they have now found that their liabilities will be very much higher as their “Mesh” Litigation liabilities are set to rise to an estimated $678.6 million. On top of the vaginal mesh cases the U.S. Justice Department is investigating into their sales practices.
Vaginal mesh devices were developed and marketed to treat urinary incontinence. During 2008 through to 2010 reports of thousands of serious complications, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems were reported to the FDA. Several other companies have been sued as the use of these devices has resulted in litigation.
(Related article:Top 7 Medtech Controversies)
How do you manage your risks in your business, have you a disaster plan? Do you risk asses the products before launch? How would you deal with this situation? Are the benefits of selling in the USA outweighing the potential losses? Is it time to re-assess your route the market? How do you train your sales team to deal with product complaints? Do they know how to report a PV complaint? More to the point who to report them to?