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Ethicon Media Monitoring 2/12/2018
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Mesh slings for urinary incontinence to remain in use
Feb 12, 2018 | New Zealand Doctor
By Keira Stephenson
Medsafe has clarified its surgical mesh ban statement from last year allaying fears of a ban on mid-urethral slings used to treat stress urinary incontinence. -
Number of victims suing over 'excruciating pain' caused by contraceptive implant device rises to 25
Feb 12, 2018 | Daily Record
By Norman Silvester
Lawyers acting for women who claim they were injured by a contraceptive device say the number of cases has risen to 25. -
Records Clinched Amputee’s $109M Win In Surgery-Error Trial
Feb 12, 2018 | Law 360
By Nathan Hale
... And it all backed up the clear explanations provided by Carter's expert witness, Dr. Bruce A. Rosenzweig, an assistant professor at Rush University Medical Center in Chicago, who has testified extensively in litigation over vaginal mesh incontinence products. Rosenzweig said a cut would not have expanded in the fashion that Glazerman and USF insisted. -
Athens-Clarke, Oconee suing opioid companies
Feb 11, 2018 | Athens Banner 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.
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Mesh slings for urinary incontinence to remain in use
Feb 12, 2018 | New Zealand Doctor
By Keira Stephenson
Medsafe has clarified its surgical mesh ban statement from last year allaying fears of a ban on mid-urethral slings used to treat stress urinary incontinence.
In a press release on 11 December, Medsafe listed 29 mesh products used in urogynaecological surgery for which it was taking regulatory action to effectively remove them from supply and limit their use.
The Medsafe statement explained its response to an Australian review of the safety of mesh would be “effectively a limit on the supply of mesh for the repair of pelvic organ prolapse and stress urinary incontinence rather than a limit on use of surgical mesh for other types of surgery”.
Urological and gynaecological surgeons widely interpreted this as including a ban on the use of mid urethral slings for stress urinary incontinence, as well as transvaginal mesh for pelvic organ prolapse.
However, in a statement released 31 January, Medsafe clarified that its regulatory action had only resulted in 16 transvaginal mesh products used solely for pelvic organ prolapse and one single incision mini-urethral sling for stress incontinence being removed from the market.
Medsafe group manager Chris James says of the 12 remaining products, those with dual pelvic prolapse and stress urinary incontinence use had or would have their instructions amended to stipulate they can no longer be used for pelvic organ prolapse; others will or already have changed their safety information to add risk warnings and emphasise the need for informed consent.
Medsafe will continue to monitor the use of mesh, Mr James says.
Work on a registry of all mesh implants is continuing although, he points out the recent limit on mesh for pelvic organ prolapse throws the cost benefit analysis out.Decision to follow TGA applauded
Urological Society of Australia and New Zealand vice president Stephen Mark applauds Medsafe’s decision to follow the Australian Therapeutic Goods Administration’s process which still allows the use of abdominal mesh for pelvic organ prolapse and mid-urethral slings for stress urinary incontinence.
Dr Mark says New Zealand is in a zone where time is being taken to work out which use of mesh is acceptable, due to an increase in awareness of potential complications and an administration which is willing to listen.
“There is absolutely no question that mesh has created some problems, so there needs to be a process of getting it right,” he says.
While it is frustrating government action on surgical mesh has taken so long, he is happy the new administration is taking complaints and advice on board and acting on it.
Surgical mesh procedures are still taking place, but patients are appropriately hesitant about having those procedures and some are putting them on hold, Dr Mark reports.
He predicts mid-urethral sling use will continue but says the heightened awareness of risk and a better selection process will cause many patients to seek other options.
Dr Mark supports the idea of a surgical mesh registry but cautions it will be expensive and needs adequate funding and support from either government or the manufacturers.Ongoing informed consent
A joint letter to Medsafe from the Royal Australian and New Zealand College of Gynaecologists and the UroGynaecological Society of Australasia, in response to Medsafe's 11 December announcement, rails against the potential pulling of mid-urethral slings for stress urinary incontinence repair.
The letter calls for “ongoing work in the areas of informed consent for patients, the credentialing of surgeons to perform these procedures and the robust monitoring of outcomes and complications from these procedures.
https://www.nzdoctor.co.nz/article/news/mesh-slings-urinary-incontinence-remain-use
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Number of victims suing over 'excruciating pain' caused by contraceptive implant device rises to 25
Feb 12, 2018 | Daily Record
By Norman Silvester
Lawyers acting for women who claim they were injured by a contraceptive device say the number of cases has risen to 25.
Personal injury specialists Thompsons say more Scots patients have come forward claiming to have suffered painful side effects from the Essure product.
Patients say they have been blighted by excruciating pain, bloating, bleeding and infections.
Solicitor Lindsay Bruce, who is acting for the 25 women against manufacturers Bayer, said their complaints are similar to those of women who had problems with vaginal mesh implants.
The patients are also considering taking legal action against the health boards who carried out the procedure on the NHS.
German pharmaceutical giants Bayer announced they would stop selling Essure in September, a month after its safety licence was suspended.
Lothian MSP Neil Findlay, who has campaigned for mesh victims, called on the Scottish Government to do more in the Essure case.
Findlay said: “Here we have young women going through extreme pain and distress because of an implant product.
“I’m concerned that the licence for Essure was suspended a few weeks before Bayer took it off the market.”
Four health boards in Scotland have carried out an estimated 679 Essure procedures since 2007. Between 350 and 375 were done in Lothian, 230 by Grampian, 45 by Dumfries and Galloway, and 29 in Greater Glasgow and Clyde.
Essure was first licensed 14 years ago by the National Standards Association of Ireland (NSAI).
NSAI are one of a network of notified bodies whose safety marks allow products such as Essure to be sold in the EU. They suspended Essure after Bayer failed to respond to a request for product information during a routine review.
Bayer say they announced plans to discontinue Essure last May, before the suspension.
They said it was for commercial reasons and women with Essure “should have no safety concerns based on this decision”.
https://www.dailyrecord.co.uk/news/scottish-news/number-victims-sue-over-excruciating-12002526
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Records Clinched Amputee’s $109M Win In Surgery-Error Trial
Feb 12, 2018 | Law 360
By Nathan Hale
Law360 (February 9, 2018, 5:42 PM EST) -- After six years in a nursing home, three trials and two hung juries, persistence paid off for Lisa-Maria Carter and her lawyers as they secured a potentially record-setting $109 million decision last month in Florida state court over a botched surgery that led to the loss of her hands and feet and half of her abdomen.
Carter's counsel from Tampa-based Dandar & Dandar pulled crucial evidence from the medical records, presented clear expert testimony, and elicited a key concession on the stand to secure a jury verdict that found the University of South Florida and its medical staff negligent in their handling of what was supposed to be a basic outpatient procedure.
The decision and hefty award could not take away the physical pain, anguish and frustration she has endured since the 2010 operation went terribly wrong. And the jury's Jan. 26 verdictdoes not mark the end of her fight; if her claims survive a likely appeal from the state university, a lengthy claims process almost certainly lies ahead that requires persuading the Florida Legislature to approve payment of the damages award.
A Costly Error
Dr. Larry Glazerman, a staff physician at Tampa General Hospital, was slated to operate on Carter to remove an ovarian cyst in time for her to make her next deployment to Iraq two weeks later. At age 45 in November 2010, she was “just shy” of earning full federal retirement benefits for her work as an intelligence analyst with the U.S. Department of Defense, according to the original June 2012 complaint.
Glazerman opted for laparoscopic surgery because it requires only a small incision, resulting in a quicker recovery, but Kennan Dandar said Carter had warned the doctor that she had adhesions, a condition in which organs in the abdominal cavity stick together.
Carter's small bowel was stuck to her abdominal wall, and when Glazerman inserted his scalpel, instead of the 1-centimeter cut he was supposed to make, the doctor made an incision 5 centimeters long that continued nearly entirely through her small intestine, according to the complaint.
“He should have known that he did that, but he didn't know,” Dandar said. “So that was the first negligence right there — not knowing that you just went through the bowel.”
Recovering in the hospital following the surgery, Carter started to experience shortness of breath.
Later that day, as Carter was returning from the hospital bathroom, the incision opened up and “copious” amounts of blood and bodily fluids poured out, “in such a large amount that the attending nurse had to grab a large bath towel to absorb the bloody discharge as she helped Carter back to her bed,” according to the original complaint.
Carter was transferred to the intensive care unit, but her health continued to decline throughout the night. The complaint alleges that several other lapses in care by various nurses, doctors and medical students at the hospital followed, including failure to properly attach an IV medication needed to restore Carter's blood pressure, and repeated cancellations of orders for abdominal scans.
Medication used in the ICU to maintain Carter's blood pressure around the heart and lungs also had the side effect of cutting off circulation to her extremities, which ultimately led to gangrene and the need for amputating her hands and feet, according to Dandar.
“What they should have done was called for an emergency consult with the surgeon. And we believe that they would've conducted the emergency surgery and she would've come out of the hospital with all of her extremities and everything would have been fine,” Dandar said.
When the attending trauma surgeon arrived the next morning, he decided from a simple assessment of Carter's abdomen that emergency surgery was needed. Inside her abdomen, he found flesh-eating bacteria — necrotizing fasciitis — possibly released from the small bowel or allowed to enter through the burst incision. It was attacking her tissue so aggressively that the doctor had to cut away most of her abdominal wall and muscles and fashion a pouch using skin from her legs and back to hold her intestines outside of her body, Dandar and the complaint said.
The Aftermath
When Carter awoke on Dec. 27, 2010, she saw her hands were black and thought she had on the driving gloves she liked to wear when cruising in her BMW convertible, but then she noticed her mother was in the hospital room and realized something was wrong, Dandar said. The black was from gangrene, her mother explained, and her feet were the same way. They would be amputated soon afterward.
Carter has spent most of the past six-plus years living in a St. Petersburg nursing home. Dandar described the surroundings as depressing, with elderly fellow residents passing away on a regular basis, and said he and his wife bring Carter dinner every night because she doesn't like the food. Carter requires assistance for most tasks. She has high-tech prosthetic arms, but they break down frequently, and her colostomy bag must be maintained regularly to avoid leaks and spills, her lawyer added.
Carter is no stranger to having to persevere. She put herself through college, went through a divorce from her high school sweetheart a few years before the surgery, and suffered the grief of her adult daughter's death in a car accident, Dandar said.
While undergoing rehab at Johns Hopkins in Maryland in 2011, a doctor told her that because of her lack of abdominal muscles, she'd never walk again. A month later, she was up and moving around on prosthetic legs.
“That's why she's survived all these years and why she'll survive in the future, because she makes up her mind to do something — look out, she gets it done.” Dandar said.
She has nearly completed studies for a master's in forensic psychology, but the degree requires performing a residency, which she has not been able to do yet, her lawyer added.
In the Courtroom
In the first trial, which included Tampa General as a defendant alongside USF, the judge decided just before closing arguments to issue a judgment releasing the hospital from the case based on a patient waiver form Carter had signed. That so enraged two of the jurors that they refused to vote, leading to a hung jury. Dandar said he later learned from other jurors that the jury had been prepared to award Carter everything she was seeking.
The second trial — minus the hospital, which won an affirmance of its dismissal on appeal — also ended in a hung jury. An alternate, elevated when the judge struck another juror who appeared to be sleeping through the proceedings, held out, telling the press she could not rule against USF because “everyone makes mistakes,” Dandar recalled. He said he heard rumors, which he never confirmed, that her family owned a company that was trying to secure a contract with USF.
Carter's camp had to feel better about their odds when the jury in the third trial came back during its deliberations to ask the judge to read back a piece of Glazerman's testimony that contained what appeared to be a major concession from the surgeon.
USF's primary argument had been that the surgeon made the proper incision and that the cut had expanded post-operation. But one of Carter's expert witnesses disputed that suggestion and so did certain medical records. Dandar's nephew and co-counsel, Thomas Dandar, pressed the doctor to answer whether, if he had made the alleged cut and had not noticed it, it would constitute a lapse in care. “I don't know if I have an opinion on that. Well, first of all, well, I would agree with that, yes,” the doctor eventually responded, according to a report from local television station Fox 13.
The defense, however, argued that if the court were going to read back any of Glazerman's testimony, it must read back the full six hours. Not wanting to do that, the judge instructed the jurors to return to the jury room and consider whether they needed to take that step. About 40 minutes later, they rang the courtroom buzzer and returned the verdict in favor of Carter, Dandar said.
That errant cut, and the resulting transection of Carter's bowel, was the first and most important breach of care in the case, Dandar said.
“We had to prove that happened during the surgery on Nov. 1 — the very first surgery — because everything else that happened afterward stemmed from that cutting,” he said.
They proved it with the records, Dandar said, but he also said the records that were initially created were “poor and could not be relied upon.” Glazerman had not dictated his report the day of the surgery and filed nothing until more than two weeks later. The attending resident's handwritten notes lacked details.
It wasn't until a fourth-year medical student checked Carter on the third day and took meticulous notes that a notation was made of a 5-centimeter incision on the skin just below her bellybutton, Dandar said.
That corroborated the description from the surgeon who performed the emergency surgery that saved Carter's life, that there was a 5-centimeter “enterotomy” — a cut, not a tear, the lawyer said.
“That contradicted everything the defense said,” Dandar said.
And it all backed up the clear explanations provided by Carter's expert witness, Dr. Bruce A. Rosenzweig, an assistant professor at Rush University Medical Center in Chicago, who has testified extensively in litigation over vaginal mesh incontinence products. Rosenzweig said a cut would not have expanded in the fashion that Glazerman and USF insisted.
“So his testimony, which was supported by all of the medical records — that was the clincher of the case,” Dandar said of Rosenzweig.
The Road Ahead
A spokeswoman for USF indicated in an email to Law360 that the university is likely to appeal the verdict.
“The University of South Florida has great sympathy for Ms. Carter and we recognize the life-changing injuries she has suffered,” said Lara Wade-Martinez, the university’s director of media relations and public affairs. “We also believe that the verdict that was delivered is not supported by the evidence. We will be carefully evaluating several grounds for appeal.”
Glazerman, who was removed as an individual defendant because he was a university employee at the time, could not be reached for comment.
Should Carter ultimately prevail, state law requires that for any amount over $100,000 she must file a claims bill with the state Legislature. It must be submitted by Aug. 1 to gain consideration for the following year's session. The 2018 session is already underway, and the following session starts in March 2019.
How much of the $109 million jury award Carter would be likely to recover is unclear. According to a database maintained by the state Office of Insurance Regulation, the largest medical malpractice payment to come out of the state courts was $28.6 million, and the largest in Hillsborough County was just $2.1 million.
Carter will have to contact her state representative and senator and possibly hire a lobbyist to help navigate the process, Dandar said, adding that he has never been through it himself. He said he is holding out hope that if the process can start soon, the rules could be waived and Carter could gain approval before the current session ends in early March.
“It's all politics then, but I think my client should be standing way above all politics because of who she is and what happened to her,” he said.
Carter is represented by Kennan G. Dandar and Thomas J. Dandar of Dandar & Dandar.
USF is represented by Louis J. La Cava of La Cava & Jacobson PA.
The case is Lisa-Marie Carter v. University of South Florida Health et al., case number 12-ca-009942, in the Circuit Court for the 13th Judicial Circuit in and for Hillsborough County, Florida.
--Additional reporting by Dave Simpson. Editing by Mark Lebetkin and Breda Lund.https://www.law360.com/articles/1009703/records-clinched-amputee-s-109m-win-in-surgery-error-trial
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Athens-Clarke, Oconee suing opioid companies
Feb 11, 2018 | Athens Banner 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://www.onlineathens.com/news/20180211/athens-clarke-oconee-suing-opioid-companies
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