NOVEMBER 9, 2011 - The first of many more expected lawsuits was filed this week in Canada in the Ontario Superior Court of Justice naming defendant Johnson & Johnson, manufacturer of transvaginal synthetic surgical mesh. See the Complaint here.
Paul Miller of Will Davidson LLP, a personal injury firm in Toronto, Ontario, filed the case on behalf of Jane Dowdall and her family against Johnson & Johnson, Ethicon Inc, a subsidiary of J&J, and Gynecare Worldwide. All three entities were responsible for the development, marketing, and sales of the device implanted in Dowdall, says the complaint.
“We’ve got to stop using women as guinea pigs” Miller told MDND.
Dowdall’s profile, reported on MDND here on October 31 tells the story.
The 55-year-old resident of the city of Kitchener, Ontario says she was implanted with the Gynecare TVT-O made by a division of Johnson & Johnson on May 15, 2009 to treat a bladder prolapse condition.
Six months later she was informed by her doctor that the pain she was experiencing was symptomatic of her body rejecting the TVT implant. Today she is permanently disabled and lives on pain medication, according to the complaint.
The Canadian tort system currently sets a cap on damages for pain and suffering at $337,000, with no cap on the loss of earnings and future care. The main difference between the Canadian and U.S. system is that in Canada a citizen’s health care costs are covered by their province, so any lawsuit will seek to recover the expenses paid by Ontario for the follow-up care and surgery to try and have the mesh device removed which was not successful.
And unlike the U.S., punitive damages are generally frowned upon in Canada where Miller says the mindset is “very conservative, we like to mind our own business and not rock the boat.”
The largest punitive award in Canada was $1 million, however the loser in any lawsuit must pay a portion of legal costs to the successful party.
On February 4, 2010 Health Canada issued a warning (PDF version of notice here) about complications associated with the transvaginal implantation of surgical mesh for both stress urinary incontinence and pelvic organ prolapse. Synthetic surgical mesh made from the petroleum by-product, polypropylene, is used to reinforce tissues and muscles that no longer hold pelvic organs in place. The notice says there are a multitude of complications associated with transvaginal implantation of surgical mesh including “infection as well as perforations and other injuries to adjacent organs including the bowel, bladder and blood vessels.”
The Canadian cases will move ahead as an individual action in each province on the basis of product liability, defective manufacture, design and a failure to warn. “Pure negligence toward the patient,” says Miller not a mass tort or multi-district litigation as in the U.S. Ontario is the only province where a spouse can recover for the loss of consortium.
As in the U.S. there is a statute of limitations so Miller advises against using a lawyer referral service one might seem randomly posted on a website. He’s seen cases where women reveal personal information only to have the case shopped around and eventually dumped because they are Canadian.
Among the 20 plaintiffs who have come forward, Johnson & Johnson and American Medical Systems, another mesh device maker, are the named defendants. Miller expects to see C.R. Bard named as well in Canadian cases which generally amount to about one-tenth of the number of U.S. cases as Canada has one-tenth the population.
That could amount to somewhere around 10,000 Canadian cases he estimates.
“When you put a medical device on the market, the device is implanted for life. This is not a battery dying where you take it out. You’ve got a 30 or 40 year old women getting these implants and when it goes wrong, it goes very badly.” #