Mesh Class Action & International Litigation

/Mesh Class Action & International Litigation
Mesh Class Action & International Litigation 2018-06-12T16:38:13+00:00

Cases of severe personal injury, as described in transvaginal and hernia mesh lawsuits, aren’t usually prosecuted through class action in the United States. In America, survivors of medical device injuries generally file their own individual civil lawsuits. These individual lawsuits can then be consolidated in a single court for more efficient proceedings through a process called Multi-District Litigation.

The Global Fight Against Mesh

Things are different abroad, where class action is a far more common mechanism. On this page, you’ll find all of our stories on the international fight against pelvic mesh manufacturers, focusing on class action litigation in Australia and Canada.

To jump straight to a report, click one of the links below:

Autoimmune Issues To Be Added To AU Women Mesh Claim Against J&J

Mesh Medical Device News Desk, April 11, 2018 ~ The class action lawsuit involving more than 800 women against Johnson & Johnson just expanded in numbers and in mesh claim complaints.

Image: Au Herald

Since July of last year, more than 800 women have been locked in litigation with global healthcare giant, Johnson & Johnson (JNJ) and its Ethicon division. As the transvaginal mesh case comes to a conclusion, the women have added numbers and new grounds to their complaint.

Justice Anna Katzman, Federal court, Sydney, AU

Unlike U.S. courts, Australian courts allow many months for both sides to air their grievances. Then it is up to a judge to conclude the class action. The defendant may offer a settlement to end the action at any time.

Australian Judge Allows More Women To Join Suit

Being held in a Sydney federal court on Monday, Justice Anna Katzmann agreed to expand the numbers of women who had joined in this class action up until July of last year.  Lawyers for the plaintiffs successfully argued it would be unfair if a large number of women were shut out of the case which began six years ago after complications began emerging among mesh-implanted women in that country.

That ruling expanded the class action by more than 100 women.

A newly released Parliamentary report estimates more than 150,000 pelvic mesh devices have been used to treat incontinence and prolapse, distributed throughout Australia over the last 20 years.

Caz Chisholm, campaigner, Newcastle Herald

Australian Mesh Withdrawal

Australia already led the U.S. in taking action against permanently implanted transvaginal meshes used in women to treat incontinence and pelvic organ prolapse.

Last November, Australia’s medical device regulator withdrew from the market all implantable transvaginal meshes, even those called the “gold standard” by J&J and other manufacturers.  The risks outweigh the benefits, concluded the Therapeutic Goods Administration, the Australian version of the U.S. Food and Drug Administration (FDA).

Doctors Stand Behind Mesh

Chrissy Brajcic

Similar to the US, medical societies largely sided with mesh makers. The Australian Medical Association even marketed a mesh as a “medical design breakthrough” despite complication reports coming in, reports The Herald.

The death of Canadian campaigner Christina Brajcic last November, solidified the Australian campaign and push to have mesh removed in that country.

Sen. Derryn Hinch, Au Senate

Senator Derryn Hinch has joined forces with thousands of Australian campaigners against mesh calling it “the greatest medical scandal” against Australian women. The mesh issue has been the subject of a Senate inquiry in Australia.

 

Joanne McCarthy, reporter, The Newcastle Herald

Immune System Response

In another move, Justice Katzmann on Monday gave Ethicon (J&J) until May 31 to respond to the women who claim the company sold its transvaginal meshes without the “proper warning” of alleged consequences and in doing so engaged in misleading and deceptive conduct.

A proper warning might include the chronic inflammatory response to a foreign body implant in the body, as well as “psychiatric injury” to a woman who feels she has been violated by the implant that may be impossible to remove and a medical professional who implanted it.

Discovery, revealed at this trial, has shown doctors suggesting anal intercourse as an alternative for women who can no longer have vaginal intercourse due to chronic pain from their mesh implants.

Failure To Warn

The Guardian (here) reports a failure to warn would also include that mesh presents a particular risk for patients who might have an autoimmune reaction. That would include women with compromised immune systems.

One biomaterials expert at trial, Professor Paul Santerre, testified that any existing immune problems made it more difficult for polypropylene mesh to integrate with the body.

Immune system response was not included in the original complaint in this class action filed by Shine Lawyers of Australia.  Judge Katzmann rejected company claims that expanding the complaint would be unfair to J&J.

Judge Katzmann rejected a request by plaintiffs that more women be able to join until early 2019 when a decision is expected or a settlement is reached.   ###

LEARN MORE:

Report- Number of women in Australia who have had transvaginal mesh implants and related matters, March 28, 2018
https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Report

The Guardian, January 30, 2018, Vaginal mesh complications too severe to be inflicted on patients, court told
https://www.theguardian.com/society/2018/jan/31/vaginal-mesh-complications-too-severe-to-be-inflicted-on-patients-court-told

MND, October 30, 2017, All Mesh High Risk in Australia
https://www.meshmedicaldevicenewsdesk.com/mesh-high-risk-australia/

MND, January 23, 2018, Au Pulls All Mesh Devices from the Market
https://www.meshmedicaldevicenewsdesk.com/australia-pulls-ethicon-tvt-mesh-devices-market/

Canadian Courts Gearing Up For Pelvic Mesh Litigation

Image, Daniel Joseph Petty

Mesh Medical Device News Desk, January 19, 2018 ~ In Canada, there is no multidistrict litigation like there is in the U.S., where many pelvic mesh product liability cases are filed in one federal court for resolution.

The Canadian system of justice concerning pelvic mesh litigation leads the injured to join a class action or to file for an individual settlement.

Is your case individual or a class action?

Even with no multidistrict (MDL) litigation in Canada, the thousands of defective product  pelvic mesh cases are moving toward resolution.

Compare that to the U.S, where 105,000 lawsuits are filed in one court in Charleston, West Virginia, with thousands more pelvic mesh cases filed around the country –  New Jersey, Philadelphia, and Los Angeles. In contrast, in Canada there are only about 2,000 defective product cases filed against five mesh manufacturers.

Since Canada has a considerably larger land mass than the US, with only about one-tenth the population, a general guideline is it will have about one-tenth of any number in the U.S. If so, that means there are many more pelvic mesh cases waiting to be filed.

Class Action Cases

Because there is no MDL system in Canada, a couple thousand women are currently enrolled in class actions, personal injury pelvic mesh lawsuits against AMS (American Medical Systems), Boston Scientific, Coloplast, Cook and Covidien.

Johnson & Johnson (Ethicon) is waiting to be certified as a class following a procedural motion.

Jill McCartney, Partner Siskinds Law

Siskinds law firm of London, Ontario has one of the largest inventories of pelvic mesh cases filed in a class, approximately 1,000 pelvic mesh cases.

A Common Trial

Attorney Jill McCartney, a partner with Siskinds, tells MND that some issues, which are common to the class, can be decided at a common issues trial for the whole group.

“There are common issues that can be decided for the whole group at a common issues trial, such as breaches of the standard of care, including defective design and failure to warn, and general causation. Then the litigation would proceed to individual trials for each class member on specific causation of their individual mesh related injuries and damages, for example, ‘Ms. Brown had her mesh implanted on a certain date and subsequently it caused erosion with infections,’ ….”

Those injuries must also be quantified, she adds.

McCartney says they use a class to promote access to justice since it’s a better vehicle for inclusion of all women with mesh products. For litigation outside of the class action, the class member must have an individual action and may need a trial on all issues for each plaintiff.

“A cost benefit analysis must be undertaken and in Canada the cost benefit analysis may not make sense for an individual action in all mesh implant cases depending on the circumstances and facts of the individual and the potential case.”

That means Siskinds, as class counsel, represents the common interests of everyone in the class unless a woman chooses to opt out and pursue her own individual litigation.

Daniel Bach, Siskinds LLP

Read more about how these cases are conducted here in a MND previous interview with Daniel Bach of Siskinds.

Legal Fees

McCartney adds that the legal fees to cover individuals in the class action generally range from 20 to 33% depending on a number of factors in a case, including the risk, the complexity, and the amount of time the firm puts into the case.

In Canada, class action counsel fees must be approved by the Court.

In the U.S., law firms lining up cases to settle are charging clients as much as 40% plus additional expenses and a contribution of 5% into the common benefit fees.

See NYT here on fees in Vioxx litigation of 2007.

Individual Pelvic Mesh Cases

Paul Miller files individual transvaginal pelvic mesh cases. Miller joined Toronto’s Howie, Sacks & Henry LLP as a partner one year ago. Previously he was at Will Davidson.

Chrissy and Tony Brajcic

He also represents the estate of the late Chrissy Brajcic who lost her life last November 30th after repeated infections and antibiotic treatment. She had just started another round of antibiotics, “the strong stuff,” she said in one of her last posts, when her death was announced.

Paul Miller, Howie Sacks Henry Law

Miller tells MND that the cause of death has not yet been established and autopsy results are pending. Read MND story here.

Presently he has about 260 clients who have filed pelvic mesh actions with 200 having settled. Those who opt out may be able to go to trial, though there have been no cases that have gone to trial so far.

Settlements vs. Jury Verdicts

And just like the U.S., some clients are unhappy with how settlement dollars pale in comparison to huge jury verdicts at trial.

But even at trial, Miller says pain and suffering is capped in Canada, currently at $367,000, which goes up slightly with the cost of living index.

“By reading the trial verdicts and the big numbers they have to be educated on the law in Canada. We have a cap on pain and suffering and non-pecuniary damages (pain and suffering) that Americans do not. We have almost like a cap on punitive damages. So far the highest amount the Supreme Court has allowed is one million dollars.”

Why Cap Pain & Suffering, Punitive Damages?

With caps on damages, how is a wrongdoer held accountable for injuries, particularly if there is evidence the mesh manufacturer knew, or should have known, that users of the product would suffer injuries?

Miller says, “That’s a question you have to ask the judges.  It’s a serious injustice for those who have serious or catastrophic injuries.  Whether its transvaginal mesh or a horrible car accident or slip and fall, and there are catastrophic damages, I don’t get it but I don’t care about the wrongdoer, I care about my client.”

“When I went through my settlements I had one week where I was calling woman after woman and having to repeat the cap and it really made an impact on me. When you talk about it occasionally, that’s the law, but when you speak to 10 to 15 women a day for a week and keep telling them, Oh my God! You know what their injuries are, it’s horrific and it’s nothing I can change. The Supreme Court has dealt with it so it’s not changing.”

To add to settlement dollars, Miller sometimes gets a nurse or occupational therapist involved to assess the future care costs.

Losers Pay Court Costs

Ontario has a loser pay system (it differs in each province), where the plaintiff could be on the hook for the defendants’ court fees if the plaintiff loses her case before a jury. Miller advises that before clients go to trial they take out adverse cost insurance to cover any possible losses.

His firm is no longer taking mesh cases. After 6.5 years, Miller says it’s time to move on once they are settled.

Canadian courts from, Thejournal.ie

And the plaintiff must understand that by signing a settlement she is forever releasing the company from future liability.

Miller says, “That’s no different than the person who breaks his ankle and settles it and has future problems. There is an end to litigation. I’ve had that discussion with many clients.   People may not like defendants but they are entitled to having their litigation come to an end.”

There is another distinction between Canadian and US courts, for example, what about those wigs?

“No, not wigs but we do have to wear the robes,” says Miller.     ###

All Mesh “High Risk” In Australia

Uphold, Taranakiobgyn, NZ website

Mesh Medical Device News Desk, October 30, 2017 ~ In a quiet but striking move, Australia’s drug and medical device regulator has strengthened the classification of pelvic mesh, increasing the likelihood it will not be used, especially as a first-line treatment.

If you were not paying attention you might not have noticed an announcement last Thursday, October 26.

All pelvic mesh devices in Australia are to be reclassified from moderate to “high risk” over the next 24 months.

Australia Increases Mesh Risk Level

The announcement was made on the Therapeutic Goods Administration (TGA) website (here), the Australian version of the U.S. Food and Drug Administration (FDA).

The reclassification will begin in December 2018, for the larger pelvic organ prolapse (POP) mesh, used to treat falling pelvic organs.   That gives POP mesh manufacturers 14 months to make the change.

The smaller “tape” or “slings” used to treat stress urinary incontinence (SUI) will be upgraded to high risk by December 2020, a full 26 months away.

A three-year transition period to December 2021 is proposed to apply for other surgical mesh devices such as hernia mesh.

The TGA is part of the Australian Government Department Of Health and it regulates medicine, vitamins, med devices and blood products.

TGA Requires Higher Level Of Evidence

The change is significant.

After the dates above, mesh manufacturers must provide a “higher evidentiary requirement” before they are approved for sale.  If they fail to, the devices cannot be marketed.

Patient cards for implantable medical devices will be required for all new urogynecological mesh devices from Dec 1, 2018.  At that time, manufacturers of new permanently implantable devices will need to have a patient information leaflet in the TGA approved format.

The changes were approved by Health Minister Greg Hunt and follow an Australian Senate inquiry where women testified they felt like “guinea pigs” after their implants.

Biggest Class Action In Australia’s History

At the same time, the largest class action lawsuit in Australia is underway. Seven hundred women are suing Ethicon, a division of Johnson & Johnson, for defective mesh implants, both POP mesh and SUI mesh.  The class action trial began in July and is expected to take six months. See MND story here.

The founder of the Australian Pelvic Mesh Support Group, Caz Chisholm, told The Herald (here) that the problem has always been a lack of information to women considering an implant.

Caz Chisholm, Newcastle Herald photo

“No woman that I know in the support group of more than 1,000 women was told by her surgeon that her device was high risk, or medium to high risk,” Ms. Chisholm said.  “Once these devices are re-classified, are specialists going to tell women the device they are about to be implanted with is high risk? I don’t think so.” 

Ms. Chisholm has pushed for an Australian Senate report due in late November. She slammed the TGA for “quietly announcing” the changes on its website after her group’s sustained criticism.

In US, Mesh Remains “Moderate Risk”

The U.S. FDA still classifies SUI mesh as moderate risk or Class II, despite the fact that it is a permanent implant and the subject of thousands of defective product lawsuits filed in the U.S.

In January 2016, the FDA reclassified POP mesh as high risk Class III (here) but gave the manufacturers 30 months to prove its safety or stop marketing the devices.   See MND story here.  ###

Largest Class Action In Australia Blames J&J For Hundreds Of Pelvic Mesh Injuries

Outside federal courthouse, Sydney, News.com.au

Mesh Medical Device News Desk, July 5, 2017 ~ As the U.S. celebrated its Independence Day, more than 700 Australian women joined in a pelvic mesh trial blaming Johnson & Johnson for their mesh-related injuries.

The largest class action in Australia may only take up to six months.

It’s estimated as many as 100,000 Australian women may have been implanted with pelvic meshes made by Johnson & Johnson, C.R. Bard, Boston Scientific and AMS (American Medical Systems).

Tuesday, July 4, hundreds of those women took Johnson & Johnson (J&J) and its Ethicon medical device division to court in the largest class action in recent memory in Australia that’s expected to last up to six months.

First Pelvic Mesh Case In Australia

This is the first legal action in Australia naming a defendant pelvic mesh maker. Australia fashions its regulatory approval of transvaginal mesh after the U.S. Food and Drug Administration (FDA) and the meshes named have all had FDA clearance for use.

This trial is headed by Shine Lawyers of Australia and will be held in federal court in Sydney.

Attorney Jan Saddler tells CTV News that the women involved have experienced chronic pain, mesh erosion, chronic inflammatory response, as well as an inability to have intimate relations.

Nine pelvic meshes are named, five are off the market, voluntarily recalled by J&J.

See MND story on J&J pelvic mesh voluntary recalls here.

Allegations Of Injury

Allegations are that while J&J aggressively marketed its meshes, it was negligent for failing to warn doctors and inform patients about the risks associated with transvaginal mesh.  Testing was inadequate before marketing and the transvaginal mesh was defective in its design, not fulfilling the purpose for which it was created, says the plaintiffs’ complaint.

Gai Thompson tells CTV News in Canada,  “No amount of compensation, money, could ever replace what we’ve lost with our lives, with our families, our health, our emotional health,” Thompson told reporters outside court. “My prayer is that this mesh would be banned and that no woman would suffer what we suffer.”

In a statement, Johnson & Johnson said the use of mesh to treat pelvic organ prolapse and urinary incontinence has successfully helped millions of women worldwide, and said the majority of women who undergo the surgery have had a positive result.

The New Jersey-based healthcare giant says it’s only aware of 200 complication reports in Australia, reports Reuters.

“It is always a concern to us when a patient doesn’t get the outcome they had hoped for, or believes they have experienced an adverse event,” spokeswoman Meshlin Khouri said in a statement.

News.com.au

No Recalls

In the U.S., an estimated 140,0000 women have filed defective product actions against mesh makers, many in multidistrict litigation (MDL).

Johnson & Johnson and its Ethicon division represent the largest number of U.S. actions filed, with 38,921 lawsuits filed in the federal MDL court as of today, July 5. Among those, 7,420 are listed as closed.

Australian Committee Investigates Mesh Injuries

An Australian Parliament Committee is holding an inquiry into transvaginal mesh implants and a report is expected to be issued in November.

Australia has not recalled any pelvic meshes, following in the footsteps of the U.S. Food and Drug Administration, which also has not recalled or banned use of transvaginal mesh.

U.S. companies regularly send their medical devices overseas, including Australia. It’s estimated at least 100,000 transvaginal mesh medical devices have been sold in Australia.

Joanne Maninon tells The Guardian, “It can’t go on. There’s too many women who have gone through the pain, the complications; it’s lifelong.”

Women in Australia have not found doctors who can remove the mesh which is intended to be a permanent medical device. A few doctors in the U.S. have had some success at full mesh removal, best known among them is UCLA’s Dr. Shlomo Raz.

Opening Day – Valuable Market

In the opening day of this class action, Tony Bannon spoke for the plaintiffs. He said the risks were either minimized or not communicated to the surgeon or patient by J&J.

“[They were] overwhelmed by a tidal wave of aggressive promotion, designed to persuade both surgeons and patients of the quick, easy operation able to resolve the particular difficulties,” Bannon told the court.

Prof. Bernard Jacquetin, TVM patent

He said the company saw a “valuable market” to be gained and convinced doctors it would be easy and quick to implant a pelvic mesh device.

Bannon quoted one of the French Ethicon team, Bernard Jacquetin, who said he wouldn’t like his wife to undergo that treatment and, “I don’t think I’m alone.”

Jacquetin was a consultant to J&J who received royalties from the healthcare giant.

Read about him from the Linda Gross trial held in New Jersey in 2013 here.

More Class Actions Ahead

News.com.au reports another 300 women in Australia have enrolled in a second class action lawsuit against American Medical Systems (AMS). The AMS Apogee was developed in Australia and cleared for use in the U.S. by the FDA  in 2004.

It was quietly removed from the market by AMS.  Read MND about AMS recalls here. 

No Australian Ban Yet

Australia’s regulatory authority, the Therapeutic Goods Administration (TGA),  has not banned mesh devices in that country, similar to the U.S. Food and Drug Administration which, despite a Safety Communications that implant injuries are “not rare,” has taken no action to curtail pelvic mesh implantation.

In the U.S., there are approximately 140,000 lawsuits pending against seven mesh makers and an unknown number of cases have been prepared for settlement but have not been filed.

Besides Australia and the U.S., J&J/Ethicon is facing defective product lawsuits over its pelvic mesh in Canada, England, Israel, Italy, Belgium, the Netherlands, Scotland and Venezuela. ###

LEARN MORE

Mesh News Desk, June 2012- J&J Will Remove Four Meshes From the Market
https://www.meshmedicaldevicenewsdesk.com/four-jj-vaginal-meshes-named-will-be-removed-from-market/

 MND, Day 20 Linda Gross Trial , February 8, 2013
https://www.meshmedicaldevicenewsdesk.com/day-20-linda-gross-v-ethicon-medical-director-mesh-exposure-15/


MND, Australian Inquiry into TVM leads to Inquiry and Trial, March 16, 2017
https://www.meshmedicaldevicenewsdesk.com/australian-investigation-transvaginal-mesh-leads-trials-senate-inquiry/

CTV Reports On Canadian Transvaginal Mesh Class Action Lawsuit

CTV story on mesh lawsuits

Mesh Medical Device News Desk, April 17, 2012 ~ CTV National News on Tuesday, April 17 ran a taped story of two women who are involved in a multimillion dollar class action lawsuit in Canada over vaginal mesh. The women are now disabled and unable to work as a result of being implanted with synthetic surgical mesh as a treatment for incontinence.

Carol Kouyoumjian had the Johnson & Johnson mesh made by Ethicon inserted around her bladder to treat incontinence six years ago. Since then she’s developed chronic leg pain she says is a “12” on a ten scale.  She can no longer work as a nurse because she can’t stand for any period of time.

Diane McLaughlin says the mesh, inserted in 2006, solved her bladder problem but it left her with severe leg pain. Both women say they were never warned about the long-term and debilitating problems either by their doctor or in the product literature.

Canadian Doctors Still Unaware Of Mesh Warnings

There has been one warning about transvaginal mesh complications issued by Health Canada, however many doctors remain unaware of the warning. Synthetic meshes to treat pelvic organ prolapse, (POP) and stress urinary incontinence (SUI) are still on the market.

In July 2011, the FDA issued its second, stronger warning about complications.

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare,” the agency wrote to health care providers.

“Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

CTV reports the mesh complication rate may be 15 percent, however the actual number of complications is unknown because patients are not tracked after surgery. In the States, the FDA database of  ‘adverse events’ is thought to represent about ten percent of actual injuries. Mesh is still in wide use with thousands of implants put into unsuspecting women every year.

Ethicon’s Statement vs. Permanent Injuries

Ethicon, the mesh manufacturer and a subsidiary of Johnson & Johnson, told the network:

“We are convinced the evidence will show we acted appropriately and responsibly in the research, development and marketing of these products.”

Both women in the CTV story have been told they will have to live with the mesh and the pain because it has now become part of their body.

The Canadian law firm, Siskinds LLP says they want better warnings for women considering mesh.

What Did J&J Know About Risks?

The Statement of Claim alleges that Johnson & Johnson failed to adequately warn patients and physicians of the magnitude of the risk of serious side effects when using one of their transvaginal mesh products compared to alternative treatments.  Possible side effects include mesh erosion through the vaginal wall, infection, pain, bladder perforation, vaginal scarring, pain during sexual intercourse, and other problems which may lead to a significant decrease in quality of life due to discomfort and pain.

Matthew Baer, a lawyer with Siskinds LLP, describes the purpose of the proceeding as:

 “We believe that through this lawsuit Johnson & Johnson will be required to explain to Canadians what it knew about the risks associated with using their transvaginal mesh products and when they first became aware of those risks.  In this case, as with all of these types of cases, we are concerned about whether Canadians were adequately warned of the risks associated with using the products in question. These products are alleged to have high failure, injury and complication rates which could result in frequent and often debilitating re-operations and potentially cause severe and irreversible injuries, conditions and damage.”

Learn More:

CTV- Top Story

http://www.ctv.ca/CTVNews/TopStories/20120417/transvaginal-mesh-women-lawsuit-incontinence-120417/

Health Canada warning, February 4, 2010

http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/surgical-mesh_nth-aah-eng.php

“Health Canada is concerned about Canadian and international reports of various intraoperative and postoperative complications associated with the use of these medical devices.”

Canadian News Wire on Transvaginal Mesh Class Action, April 17, 2012

http://www.newswire.ca/en/story/956349/transvaginal-mesh-class-action-commenced-in-canada

First Canadian Transvaginal Mesh Case Filed

Jane Dowdall

Mesh Medical Device News Desk, 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.

Paul Miller Will Davidson LLP

Dowdall’s profile, reported on MDND here on October 31 tells the story.

Jane Dowdall

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.

Canadian Tort System

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.

Health Canada Warning

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, are 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.”

Individual Personal Injury Lawsuits

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 woman getting these implants and when it goes wrong, it goes very badly.” #