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Ethicon Media Monitoring 2/21/2018
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Ethicon Prolift Pelvic Mesh Case to Begin Monday in Indiana
Feb 20, 2018 | Mesh Medical Device Newsdesk
The product liability trial of Kaiser v Ethicon is set to begin in Hammond, Indiana next week. It is one of the earliest pelvic mesh cases filed eight years ago in multidistrict litigation in Charleston, WV that has been remanded back to state court to finally be resolved. -
Mentor Awarded Summary Judgment in Maine Federal ObTape Transvaginal Mesh Case
Feb 20, 2018 | HarrisMartin Publishing
A Maine federal judge has awarded Mentor summary judgment in an ObTape transvaginal mesh device action, ruling that the bulk of the claims are untimely and that the remaining failure-to-warn claims fail because the plaintiff's surgeon would not have changed his decision to implant the device had he been presented with different warnings. -
Athens-Clarke, Oconee suing opioid companies
Feb 20, 2018 | The Newnan Times-Herald
By Lee Shearer
.... Blasingame Burch has developed a reputation for expertise in such multi-district litigation in medical cases, in part because of its lawsuits filed on behalf of women who suffered injuries resulting from the use of a kind of plastic mesh for repair in vaginal surgery.
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Ethicon Prolift Pelvic Mesh Case to Begin Monday in Indiana
Feb 20, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, February 20, 2018 ~ The product liability trial of Kaiser v Ethicon is set to begin in Hammond, Indiana next week. It is one of the earliest pelvic mesh cases filed eight years ago in multidistrict litigation in Charleston, WV that has been remanded back to state court to finally be resolved.
Barbara Kaiser was implanted with Ethicon’s Prolift mesh on January 27, 2009. She was being treated for pelvic organ prolapse or POP as well as SUI (stress urinary incontinence) and Dr. Gregory Bales of Munster Community Hospital in Munster, Indiana decided the extra-large Prolift, with its six polypropylene arms should be the mesh of choice.
Bales in his deposition said he was probably one of the early users of Prolift, which came onto the market in March 2005. Bales said he had performed a couple hundred procedures with either total Prolift System or the Anterior Prolift System which incorporates the bladder.
Dr. Bales received some of his training on Prolift by Vince Lucente MD, a urogynecologist who acted as a preceptor, or trainer of new doctors to a procedure or product on behalf of a company.
Lucente’s name has been heard in the previous mesh trials of Linda Gross and Joan Budke. Dr. Lucente trained their doctors as well on the Prolift.
Dr. Bales admitted in his deposition that had he known about the complications associated with the use of Prolift, he “may not have started using the Prolift.”
Dr. Bales admitted that the “majority of the times the reps would be present” referring to sales representatives from various vendors are in the operating room.
Ms. Kaiser later learned from Raphael Albert, MD that her complaints of lower pelvic pain could be related to the Prolift.
REMANDED
The Kaiser case was one of the earliest ones filed in U.S. District Court in Charleston, West Virginia where a pelvic mesh multidistrict litigation consolidated thousands of cases for trial.
The Kaiser case No. 2:12-cv-00887, was remanded to the Northern District of Indiana and will begin February 26th with the Honorable Judge Phillip P. Simon Presiding. The new case no. is 2:17-cv-00114 and it was filed in this federal court on March 15, 2017.
Lawyer Ed Wallace, one attorney for Ms. Kaiser says “This is one of the first cases remanded and yes it will start to happen with others, hopefully.” Tom Cartmell also represents Ms. Kaiser.
Because Ms. Kaiser was implanted in Indiana, the Indiana’s Products Liability Act must be followed. It requires the plaintiff to show a product is defective and unreasonably dangerous through design defect, its manufacturing defect or a failure to warn, all counts in the Kaiser claim along with negligence, strict liability defective product, common law fraud, fraudulent concealment, constructive fraud, negligent infliction of emotional distress, breach of express warranty, breach of implied warranty and gross negligence.
Ethicon claimed that Ms. Kaiser’s claims were untimely under the two-year statute of limitations. Judge Goodwin denied Ethicon’s motion for Summary Judgment.
TRIAL PREPARATION
In January of last year, Plaintiffs asked the court to exclude evidence related to the FDA and its 510(k) clearance process that allows most medical devices on the market with no review for safety.
Plaintiffs felt any mention of the U.S Food and Drug Administration (FDA) might add legitimacy to the device that had skirted through any safety and efficacy checks through the fast-track 510(10) clearance to sell process. In order to explain how the majority of medical devices make it to market would have required an extraordinary amount of time to delve into the FDA’s requirement to name a predicate device and exchange paperwork. No clinical trials needed.
For its part, the defendant wanted to exclude the “522 letters.” In January 2012, the FDA issued a mandate to mesh makers which required them to show the safety of their POP meshes in order to stay on the market.
What resulted was a mass, yet quiet removal of most POP meshes from the market including the Prolift relieving the mesh makers of the requirement to show their product was safe.
The FDA sent letters allowing Johnson & Johnson and others they no longer had to prove safety of their device. Never mind the thousands of women, Like Barbara Kaiser, who had the larger POP polypropylene meshes residing in their pelvic regions and lived with the consequences.
In January 2016, the FDA moved to reclassify POP mesh as a high risk device, requiring clinical trials to prove safety and efficacy. To date no new POP meshes have attempted to clear that hurdle. ###
LEARN MORE:
MND, February 22, 2017 Documentary: J&J Knew Risks of Prolift
https://www.meshmedicaldevicenewsdesk.com/documentary-jj-knew-risks-prolift/MND, December 21, 2015, Prolift Pelvic Mesh Found Defectively Designed
https://www.meshmedicaldevicenewsdesk.com/documentary-jj-knew-risks-prolift/MND, January 9 2015, The Launch of Prolift Pelvic Mesh- What the Company Knew, Budke Trial
https://www.meshmedicaldevicenewsdesk.com/the-launch-of-prolift-pelvic-mesh-what-the-company-knew/MND, January 23, 2018, Australia Pulls Ethicon TVT Mesh Devices from the Market
https://www.meshmedicaldevicenewsdesk.com/australia-pulls-ethicon-tvt-mesh-devices-market/MND, June 5, 2012, Four J&J Vaginal Meshes Named Will be Removed from Market
https://www.meshmedicaldevicenewsdesk.com/four-jj-vaginal-meshes-named-will-be-removed-from-market/MND, Jan. 2012, Mesh Makers who Received 522 PostMarket Surveillance Orders
https://www.meshmedicaldevicenewsdesk.com/mesh-makers-who-received-fda-letter-requiring-follow-up-tests/https://www.meshmedicaldevicenewsdesk.com/ethicon-prolift-pelvic-mesh-case-begin-monday-indiana/
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Mentor Awarded Summary Judgment in Maine Federal ObTape Transvaginal Mesh Case
Feb 20, 2018 | HarrisMartin Publishing
PORTLAND, Maine - A Maine federal judge has awarded Mentor summary judgment in an ObTape transvaginal mesh device action, ruling that the bulk of the claims are untimely and that the remaining failure-to-warn claims fail because the plaintiff's surgeon would not have changed his decision to implant the device had he been presented with different warnings.
On Feb. 14, Chief Judge Nancy Torresen of the U.S. District Court for the District of Maine held that absent any evidence of how the surgeon would have responded to an additional or different warning, the plaintiff has failed to establish that a genuine ...
Access to full text unavailable – subscription required. For full story:
https://harrismartin.com/article/23196/mentor-awarded-summary-judgment-in-maine-federal-obtape-transvaginal-mesh-case/
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Athens-Clarke, Oconee suing opioid companies
Feb 20, 2018 | The Newnan Times-Herald
By Lee Shearer
Athens-Clarke and Oconee counties have joined a growing number of other governments and hospital authorities across the country in a multi-state federal lawsuit targeting makers and distributors of opioid drugs.
The Athens law firm Blasingame, Burch, Garrard & Ashley filed a complaint in the United States District Court’s Middle District of Georgia Wednesday, and followed up Thursday with a similar complaint on behalf of Oconee County, said James Matthews, a Blasingame Burch partner.
The law firm earlier filed lawsuits against major opioid manufacturers and distributors on behalf of rural Candler County and the Candler County Hospital Authority.
Matthews said he expects the firm to file 25 or more complaints against the opioid manufacturers and distributors for other Georgia governments and agencies.
The more than 20 named defendants in the 176-page complaint Athens-Clarke County filed Wednesday include Cardinal Health Inc., Cephalon Inc., Johnson & Johnson, Ortho-McNeil Janssen Pharmaceuticals Inc, Allergan PLC, and Watson Pharma Inc., among others.
“Plaintiff brings this civil action to eliminate the hazard to publish health and safety caused by the opioid epidemic; to abate the nuisance caused thereby, and to recoup monies that have been spent, or will be spent, because of Defendants’ false, deceptive and unfair marketing and/or unlawful diversion of prescription opioids,” according to the complaint.
Those costs include money for medical care, costs for rehabilitation and related services, and “costs associated with law enforcement and public safety" relating to the opioid epidemic, according to the Athens-Clarke complaint.
“Cities, counties and states are hugely affected by this, so the potential legal damages are very high,” Matthews said.
One rural South Georgia county had to establish a drug court primarily because of opioid-related cases at a cost of $400,000 a year, he said.
The Georgia complaints will be combined with dozens of similar lawsuits across the United States in a process called multi-district litigation. The cases will be grouped with dozens or hundreds of others in the federal Northern District of Ohio.
Fulton and DeKalb counties have also sued companies over the costs of dealing with opioid addiction and overdoses, but those cases were filed in Georgia state courts, Matthews said.
Lawyers sometimes use the same multi-district approach when many claims arise from a defendants' alleged actions.
In the 1990s, most states joined in a lawsuit against tobacco companies over the costs of smoking and tobacco use, eventually reaching a $10 billion settlement with the companies. Lawsuits arising from the massive 2010 Deepwater Horizon oil spill in the Gulf of Mexico were also handled through multi-district litigation.
Blasingame Burch has developed a reputation for expertise in such multi-district litigation in medical cases, in part because of its lawsuits filed on behalf of women who suffered injuries resulting from the use of a kind of plastic mesh for repair in vaginal surgery.
About 95 percent of around 100,000 plaintiffs nationwide - many but not all represented by Blasingame, Burch, Garrard & Ashley - have now settled with defendants in the mesh litigation, Matthews said.
Ohio District Court Judge Dan Polster has appointed a lead counsel for the opioid litigation, but Matthews hopes to be appointed to a plaintiffs’ steering committee, not yet named, according to the Fulton County Daily Report, an Atlanta legal newspaper.
The litigation could take years to resolve, and the judge has told lawyers he wants the first year to be spent on trying to settle the cases, Matthews said.
An eventual settlement or judgment might help pay for future anti-opioid measures now working their way through Georgia and other state legislatures, said University of Georgia law professor Elizabeth Weeks Leonard.
Georgia's state Senate recently approved legislation to establish a commission to study the addiction and substance abuse, for example.
Multi-district cases can also be helpful for the defense side, Leonard said. Like the plaintiffs, the defense lawyers don’t have to defend what is essentially the same case in multiple courtrooms.
The opioid crisis means more work for law enforcement, agreed Oglethorpe County Sheriff David Gabriel.
“It’s definitely a problem,” he said. “I think you’re seeing it everywhere.”
Victims of the drug often begin with a legitimate need for the pain-killers, but become addicted, he said.
“The biggest issue is that opioids are a route to people getting on heroin,” he said. Oglethorpe county had one death last year attributed to heroin, he said.
Opioid pills are expensive, so those who become addicted may turn to heroin as a cheaper alternative, and to crime as a way to pay for drugs, he said.
“It’s down to money at the end of the day,” he said.
http://times-herald.com/news/2018/02/athens-clarke-oconee-suing-opioid-companies
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