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Ethicon 8/4
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Md. Federal Judge Retains Jurisdiction Over Product Liability Claims in Ethicon Transvaginal Mesh Action
Aug 3, 2015 | HarrisMartin Publishing
A Maryland federal judge has retained jurisdiction over claims asserted against Ethicon Inc. in a transvaginal mesh device action and severed and remanded the claims against the healthcare provider defendants... -
Mesh Implant Helpline Goes Live
Aug 3, 2015 | Modern Scotsman
A dedicated helpline for those affected by mesh implants went live today. -
Keeton and the FDA Conspiracy Concerning Pelvic Mesh
Aug 3, 2015 | Mesh Medical Device News Desk
By Jane Akre
Lana Keeton seeks compensatory damages of $7 million and punitive damages of $21 million from J&J, the FDA, its lawyers and employees. -
Top Product Liability Verdicts In The First Half Of 2015
Aug 3, 2015 | Law360
By Sindhu Sundar
Both sides of the product liability bar have won consequential trial victories so far this year, including a $100 million verdict against Boston Scientific Corp. in pelvic mesh litigation — the largest so far — and two wins for Pfizer Corp. in suits over birth defects allegedly caused by Zoloft. -
Surgery believed helpful for women with overactive bladder, Pitt-related study finds
Aug 4, 2015 | Pittsburgh Post-Gazette
By Jill Daly
...Most women seeking surgery for stress urinary incontinence also have overactive bladder symptoms, according to the study, which included both non-mesh and mesh urinary incontinence surgeries...
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Aug 3, 2015 | HarrisMartin Publishing
A Maryland federal judge has retained jurisdiction over claims asserted against Ethicon Inc. in a transvaginal mesh device action and severed and remanded the claims against the healthcare provider defendants, ruling that they are dispensable parties.
In a July 30 order, Judge Peter J. Messitte of the U.S. District Court for the District of Maryland found that resolution of the medical negligence claims would not necessarily resolve the plaintiff’s claims against Ethicon and Johnson & Johnson. As such, the healthcare providers are not indispensable parties, the judge held.
In November 2011, Maryland resident Leanne Sullivan underwent surgery ...
Subscription required, for the full story please see: http://harrismartin.com/article/19770/md-federal-judge-retains-jurisdiction-over-product-liability-claims-in-ethicon-transvaginal-mesh-action/
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Mesh Implant Helpline Goes Live
Aug 3, 2015 | Modern Scotsman
A dedicated helpline for those affected by mesh implants went live today.
The helpline, advertised by NHS Inform, will be supported by an experienced physiotherapist who will give support to women experiencing complications on how to manage their symptoms.
The Scottish Government worked with patient groups to develop the support service for women currently experiencing complications or who may have concerns regarding their condition.
Health Secretary Robison said: “I welcome the launch of the dedicated mesh implant helpline and the support it will give to those affected by the procedure. I have met with the Scottish Mesh Survivors group and recognise the impact mesh implants have had on their lives. We have been working closely with the group to develop the helpline and I am pleased that it will be supported by an experienced physiotherapist who has a background in community practice and holistic care. I am extremely concerned that women have suffered complications following their surgery, which is why we have set up an Independent Review, which is currently considering these issues and will make recommendations shortly. Until then we have requested that all health boards continue to suspend the use of mesh implants, except where clinically advisable and the woman has asked to proceed, is aware of the risks and has fully consented.”
Scottish Mesh Survivor Elaine Holmes, from Newton Mearns said: “We would like to thank the Scottish Government for recognising the overwhelming need for support aimed specifically at mesh injured women. While this new service cannot and will not replace the services provided by doctors and other clinical staff specialising in the treatment of stress urinary incontinence and pelvic organ prolapse, it can provide information and help patients understand the care pathways, support, and practical solutions available to them.Women can feel reassured that they can discuss any mesh related problems or difficulties in confidence, and we urge them to make full use of the service.”The Scottish Mesh Survivors campaign group is also having input in the development of a protocol for health boards to follow when managing patients with stress urinary incontinence and pelvic organ prolapse.
The Chief Medical Officer has written twice to all medical directors to reiterate the request that boards should consider suspending transvaginal mesh implants until the independent review has reported.
NOTE: Around the world, a growing number of women who have turned to transvaginal mesh implants to help rectify stress urinary incontinence (SUI) and pelvic organ prolapse (POP) have experienced a range of physical difficulties including discomfort, painful sex and erosion of vaginal tissues. In a number of instances, the implant has actually eroded vaginal tissue to the point where the implant protrudes inside of the vagina. In the United States, the fast-track approval process allowed companies to bypass human testing and mesh implants were approved by the Food and Drug Administration (FDA) through the 510(k) process. The process allowed the company to claim that they are substantially similar to an already approved device or drug. In the USA, the FDA does not require human testing for drugs or devices approved via this process. – Source: Perdue & Kidd Trial Lawyers
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Keeton and the FDA Conspiracy Concerning Pelvic Mesh
Aug 3, 2015 | Mesh Medical Device News Desk
By Jane Akre
MND, August 3, 2015 ~ Lana Keeton seeks compensatory damages of $7 million and punitive damages of $21 million from J&J, the FDA, its lawyers and employees. This story is continued from Part One.
She’s a tough talking Texan given to accolades to the above, “This is God’s purpose for me. He perfectly prepared me for this,” who occasionally grows impatient with others (including your editor at times).
Lana Keeton, 68 years old, is from Bonham, Texas an hour north of Dallas. The daughter of a cattle farmer who owned a meat packing plant, she helped her father make his own brand of chili. In junior high, Lana would put labels on the bricks of chilled chili, answer the phone and write out invoices for her father’s business.
“He never ate bologna or vienna sausage because he knew what was in it,” she says today. Her father always wore a hat he put on top of the refrigerator every time he came home. The hat would return to his head when he’d leave the house in the morning. Fast forward to South Beach in Miami. Lana took what she learned from working in her Father’s business and turned it into a lucrative profession – brokering steel. Business was good. Keeton had a view of the Venetian Islands of Miami from her South Beach waterfront home. With a reliable supply of trucking companies and suppliers, and an ability to hold her own with steel manufacturers and the construction industry, Keeton looked forward to a rosy future.
Things changed drastically after Keeton received an Ethicon Gynecare TVT Prolene mesh implant in December 2001, she became deathly ill, complicated by an aggressive flesh-eating bacterial infection following a hysterectomy with bladder suspension surgery. Sometime later, Keeton would come to understand why the Ethicon mesh package warned that synthetic Prolene mesh “can potentiate an infection.”
“I didn’t even know I had mesh in me,” she says today.
Today she calls hers a “million dollar bladder” for what the $1,200 bladder surgery has cost her and American taxpayers in the 17 plus surgeries she’s endured to try and get the mesh out.
See MND background story in 2011.
The physical setbacks during recovery cost her financially. In 2003 Keeton filed for bankruptcy, first Chapter 7 and then Chapter 11. She lost her steel business and her home, and for a time was living with friends. She remade herself using her near death experience to broker a new future, learning everything she could about the medical device that had radically changed her life. In the process she created Truth in Medicine, a patient advocacy organization, set up a web site to educate others and became an avid patient advocate.
After years of trying to work cooperatively with the U.S. Food and Drug Administration (FDA) to lift the veil of ignorance from their eyes about the dangers of pelvic mesh, she decided the veil was there to hide what the agency knew. Last February 4, Keeton filed a RICO action asking for $7 million in compensatory and $21 million in punitive damages from J&J, the FDA, its employees, lawyers, Dr. Willy Davila and the Cleveland Clinic he works for, as well as two lawyers who have represented J&J in mesh litigation since 2005 and who currently represent J&J in the MDL in West Virginia.
RICO LAWSUIT
RICO, the Racketeer Influenced and Corrupt Organizations Act, has been U.S. federal law since 1970. Originally it was applied to prosecute diverse groups such as the Hell’s Angels Motorcycle Club, Major League Baseball and the Gambino crime family, who, it was alleged, were part of a money making, criminal enterprise using mail or wire fraud, embezzlement, murder, kidnapping, bribery, or gambling, among other offenses.
In Keeton’s case, criminal charges are alleged in a civil lawsuit. J&J and the FDA, along with the Cleveland Clinic, conspired and abused the legal system to place misbranded and adulterated medical devices into the stream of commerce on an international level through medical professional societies harming her business and her property,” she says. Both the criminal and civil components allow the recovery of treble damages, or the tripling of the damage amount.
“If they didn’t harm my business or property I would not have a lawsuit. I was the target of their conspiracy but they knowingly and intentionally also harmed the U.S. Bankruptcy Court and Medicare, two other federal agencies. The case is not based on physical injuries from the mesh.”
TRUTH IN MEDICINE
In the years since, Keeton has taken directly to Washington her fight to have polypropylene mesh removed from the market. She has addressed an FDA expert panel on pelvic mesh, has had sit-down meetings with members of the FDA, hand delivered letters to members of Congress calling for a Congressional hearing. She’s spoken to the Institute of Medicine three times about the dangerous 510(k) loophole that allows medical devices onto the market with a wink and a nod. In June 2008 she formed the patient advocacy group Truth in Medicine and set up a website to raise awareness of the dangers of PP mesh. Implanted women flock to her for advice and she’d been crediting with saving many women’s lives by providing the right doctor in their time of need. “Washington is not a results-oriented culture,” she says. There are so many special interests that it’s muddled, there are no clear goals or clear answers. I’m very results oriented. FDA is like a black hole; things go in and never come out.”
Keeton points to the proposal to reclassify pelvic organ prolapse (POP) mesh to Class III. The comment period ended a year ago and today the proposal sits in limbo. See background story here. As it stands now, surgical mesh, whether for pelvic or hernia use, remains a Class II medical device and is cleared for sale after an exchange of paperwork between the manufacturer and the FDA with no clinical trials required. The whole process takes up to 90 days or less.
Bruce Rosenberg, The Meshoma Foundation
TALE OF THE TAPE
For years she tried to work within the FDA’s regulatory framework. Keeton says she and Bruce Rosenberg were naïve. Keeton with Truth in Medicine and Rosenberg with his Meshoma Foundation, a nonprofit concerned with hernia mesh injuries, thought employees of the Centers for Devices and Radiological Health (CDRH), the division that approves medical devices, didn’t know about “the tape.”
It turns out they were right.
During one meeting with the CDRH, Lana presented a scientific paper she had authored about nonylphenol, an endocrine disruptor that is in mesh. The Environmental Protection Agency and the European Union both ban nonylphenol and she wanted FDA regulators to know it.
Bruce told Dr. Shuren he wanted to come to the FDA to show them a videotape. Made by Ethicon and hosted by surgeon/consultant, Dr. B. Todd Heniford, the tape showed the doctor with a chunk of explanted hernia mesh. It had been removed from someone and was now hardened into the shape of a lamb chop. It was so hard, Dr. Heniford took it by its “handle” and slammed it into the metal table top.
B. Todd Heniford, MD
The Ethicon promotional tape was singing the praises of a newer, softer, more user-friendly type of hernia mesh, ironically the very mesh implanted in Bruce. Hardly an improvement, and in ways it was worse than the old heavyweight mesh because it disintegrates into threads which are nearly impossible to remove.
Still today, the proprietary Prolene hernia mesh that Dr. Heniford hit on the table is used by Ethicon for its pelvic mesh implants.
A series of emails show that the FDA’s Dr. David Krause, whose job it was to authorize 510(k) clearances for medical devices including pelvic mesh, called the head of regulatory affairs for Ethicon, Peter Cecchini, to ask him about the video tape. Bruce had told Dr. Shuren what it showed.
Cecchini replied in an internal Ethicon October 20 email, “According to David K., it seems that Bruce Rosenberg claims to have a DVD that speaks to a mesh that falls apart after 1 year implantation. David would like the details of this and has requested a copy of the DVD. He did state that if this is true the product should be removed from the market and the 510(k) removed.”
Krause calls the consumer groups (Truth in Medicine and The Meshoma Foundation) “serious, irrational and nasty.”
“It was true and they still did nothing,” says Keeton. “That’s the whole point. Bruce and I didn’t know he contacted Cecchini back then. We are like little beavers, we are clueless people in the meeting. It’s been five years now and virtually all the hernia and pelvic mesh kits remain on the market. Nothing has happened.” Around the same time in October 2010, right after a Truth in Medicine conference she hosted in Washington DC, Keeton noted Jeff Shuren, the head of the CDRH, was hosting a Town Hall Meeting focusing on industry in San Francisco. She called him to protest the deference to industry over patients and to ask for a meeting.
Jeff Shuren MD
Shuren called back to assure Keeton the FDA had provided many opportunities for consumer and patient groups to speak to the FDA.
“There is no special preference for industry,” he says in a voicemail she has today. “We have open sessions and people with issues are always welcome to come in the agency. Surgical mesh is an issue we continue to look into. We appreciate issues you’ve raised as well as Truth in Medicine.”
Shuren knew who Keeton was. He knew Keeton had testified at The Institute of Medicine (IOM) meetings on the 510(k) law in March and June of 2010. And she had had a meeting with others at the FDA on March 2, 2010, a day after the first IOM meeting.
During a meeting with the FDA on November 3, 2010, they met again. Dr. Shuren was sitting three feet away from Keeton as she addressed the FDA and said, “With all due respect, the FDA is a black hole for information.”
“I had the floor. They said nothing,” she says today.
DEFENDANTS SPEAK
In its March 5, Motion to Dismiss, defendant Johnson & Johnson calls Keeton “a serial product liability plaintiff,” and point to this as her third pro se product suit for damages against J&J and Ethicon. (See Doc 13) Johnson & Johnson’s spokesman, Matthew Johnson, (no relation) did not respond to a request for a comment to this story. J&J says her complaint should be dismissed because the judgments and orders in her prior suits bar her complaint and she lacks standing to assert a RICO claim and she fails to state one. In her first lawsuit filed pro se, she alleged design defect, a failure to warn, and negligent manufacturing claims Keeton v. Gynecare Worldwide, et al., No. 1:06-cv-21116-UU (S.D. Fla.) The claim was dismissed by the Eleventh Circuit Court. Keeton then filed a product liability lawsuit in the MDL in West Virginia adding fraudulent concealment. 2:13-cv-24276, MDL 2327.
Judge Goodwin ruled that Keeton’s first judgment barred her second suit, but he did not prevent her from moving forward. Instead he dismissed her claim in the MDL without prejudice and advised her that the proper venue for her claim was in the Southern District of Florida, based on Fraud by Omission claims she made on her short form complaint in the MDL.
Pro se plaintiffs are supposed to be given wide latitude because they are not lawyers but are entitled to their day in court equal to the rights of a represented person.
In it its Motion to Dismiss, the FDA makes the argument that there is no waiver of sovereign immunity and therefore Dr. Krause is protected by his qualified immunity. The RICO violations occurred after Keeton’s surgery in 2001, it says, therefore it’s impossible that any RICO claims could have caused her injuries. Instead, the FDA says the Federal Tort Claims Act (FTCA) is the statute that provides jurisdiction over tort claims against the government. The interaction between Dr. Krause and Peter Cecchini occurred in late 2010, nine years after her surgery. And the Plaintiff has not established an injury to her business or property.
Keeton believes the FDA’s attorneys are defending their client as if this is a personal injury claim, which it is not. Although not an attorney, Keeton argues the conspiracy began in 1997, not on the date of her surgery. She points to a signed contract with Dr. Ulf Ulmsten, the Ethicon consultant who invented the TVT and collected millions if his studies reached certain benchmarks. Not surprisingly, they did.
Keeton says that act alone caused every Gynecare TVT pelvic mesh kit to be misbranded and adulterated, a violation of the FDCA of 1938.
PATTERN OF CONSPIRACY
The TVT, transvaginal tape, used to treat stress urinary incontinence (SUI) was cleared by the FDA for use in the U.S. in 1998. By March of the following year they had their first death, points out Keeton, then subsequent deaths continued, 12 in all from 1999-2007.
Prolift, MedTech Marketing
In 2005, the Prolift Pelvic Mesh Kit made it to market. Ethicon never sought FDA approval. The company just started selling the Prolift kit to treat pelvic organ prolapse (POP) along with its prepackaged stainless steel implanting arms known as trocars.
Keeton says within the FDA that between it, industry and doctors, there was an overall fraudulent scheme with an assortment of players that eventually led to the loss of her property and business.
“The law says if there is a corporation and Peter Cecchini is responsible for regulatory affairs, he knew about that videotape and he was in a position to change it and he didn’t, he becomes a responsible corporate officer who knew about the people dying. Krause told him. Krause was making decisions for government that were not in the interest of public health. Attorneys Leslie and Shapiro had a responsibility to give me the discovery and they did not.”
Ethicon had the Heniford tape, which she says was not provided to her in the discovery of her first case.
And while the video was being made at Ethicon, Krause supervised clearance of the Prolift M+, a newer version of Prolift in May 2008. At that time, the Prolift was discovered and cleared with no sanctions imposed by the CDRH. “Shapiro is representing Ethicon. Ethicon knows all this stuff and they say nothing.”
Dr. Willy Davila, Cleveland Clinic, FL
Dr. Willy Davila of the Cleveland Clinic was treating Keeton for mesh complications following the original implantation in 2001. In 2005 he was deposed. In 2009, he testified under oath at her medical negligence trial against the implanting doctor and again omitted the fact he ever was a paid consultant to Ethicon. He never ever told her of his association with Ethicon, she says.
“I still didn’t know until last year Willy Davila had worked for them since 2001. Twelve years later. He had been examining me, cutting on me, lying in a deposition and at trial. I was completely violated. It was not on the Cleveland Clinic website anywhere. No one at Cleveland Clinic can do this unless signed off by the Cleveland Clinic. His CV had nothing about his consulting.”
Meanwhile women continue dying and their reports are submitted to the FDA.
Keeton says nothing in life had educated her for this. She was not trained in the law, on how to be apro se complainant, or an expert in this particular medical device. “I made the choice to be better not bitter. I feel much better when I take action rather than waiting for someone else to do something because it’s not happening. This is ugly stuff and it’s a crime.” #
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Top Product Liability Verdicts In The First Half Of 2015
Aug 3, 2015 | Law360
By Sindhu Sundar
Both sides of the product liability bar have won consequential trial victories so far this year, including a $100 million verdict against Boston Scientific Corp. in pelvic mesh litigation — the largest so far — and two wins for Pfizer Corp. in suits over birth defects allegedly caused by Zoloft.
Here, Law360 looks at the top product liability verdicts of 2015 and the firms that won them:
Boston Scientific Hit With $100M Mesh Verdict — Motley Rice LLC, Murphy & Landon
Plaintiff Deborah Barba in May won a $100 million award in a state jury trial in Delaware against Boston Scientific over claims arising from injuries allegedly caused by the device maker's Advantage Fit and Pinnacle mesh products. Her award, the largest so far in mesh trials, comprised $25 million in compensatory damages and $75 million in punitives, according to court documents.
Boston Scientific indicated at the time that it planned to appeal the verdict. The device maker is currently also fighting a $34.5 million judgment resulting from a different mesh trial that concluded in September.
Outcomes in early bellwether trials are not necessarily strong predictors for the outcomes of future trials, even if they may sometimes set the tone for the litigation. The mesh implant trials, for instance, started to go to trial in 2012 and resulted in mixed outcomes and smaller verdicts, attorneys observe. The first suit to go to trial over vaginal mesh injuries went to trial in July 25 and ended in a $3.6 million judgment against C.R. Bard Inc.
"Whether one side wins the first two or three trials doesn't mean it will continue winning, and over time you'll see how the trend shakes out," he said. "The mesh trials have proven that point, and the size of verdicts seems to be growing."
The plaintiff is represented by Fidelma Fitzpatrick and Fred Thompson of Motley Rice LLC and Philip T. Edwards of Murphy & Landon.
The defendant is represented by Colleen D. Shields of Eckert Seamans Cherin & Mellott LLC and Matthew D. Keenan and Eric Anielak of Shook Hardy & Bacon LLP.
The case is Deborah Barba v. Boston Scientific Corp., case number N11C-08-050 MMJ, in the Superior Court of the State of Delaware in New Castle County.
Pfizer Wins First Zoloft Birth Defect Trials — Quinn Emanuel Urquhart & Sullivan LLP, Paul Weiss Rifkind Wharton & Garrison LLP, Thompson Coburn LLP
Pfizer Inc. this year won the first two trials, both in state courts, over the alleged cardiac birth defect risks of its antidepressant Zoloft, giving the drugmaker an edge before the federal bellwether trials scheduled for next year in the Zoloft birth defect multidistrict litigation in Pennsylvania.
In April, Pfizer defeated claims by 31-year-old mother Kristyn Pesante, who claimed her son Logyn, now 11, was born with several cardiac defects. The Missouri state jury did not rule on the plaintiff's causation or failure-to-warn claims, finding simply that "on the claim by plaintiff Logyn Pesante for compensatory damages for personal injury against defendant Pfizer, we the undersigned jurors find in favor of Pfizer," according to the verdict.
In June, a Philadelphia state jury cleared Pfizer in a $2.4 million suit by Mia Robinson and her mother Rachel, who claimed that Rachel's treatment with the medication during her pregnancy had resulted in Mia's heart problems. Mia was born with a condition called transposition of the great arteries, in which the two main blood vessels exiting the heart are in the wrong position.
The defense verdicts could bode well for the drugmaker in federal bellwether trials scheduled for 2016, attorneys have said, amid a vigorous dispute between the parties over whether plaintiffs' causation experts pass muster.
Pfizer is represented by Mark Cheffo of Quinn Emanuel Urquhart & Sullivan LLP, Beth Ann Wilkinson and Alexandra M. Walsh of Paul Weiss Rifkind Wharton & Garrison LLP, and Booker T. Shaw of Thompson Coburn LLP.
Pesante is represented by Shelley Hutson of Clark Love & Hutson.
The cases are Tracey Foster et al. v. Pfizer Inc. et al., case number 1222-CC02441-01, in the 22nd Judicial Circuit Court of Missouri, and Mia Robinson et al. v. Wolters Kluwer Health Inc. et al., case number 110700778, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
Sunbeam Told To Pay $59M For Fatal Fire — The Homampour Law Firm
Plaintiff Kenneth Aaron Shinedling won a $59.3 million award after a California federal trial over a fire that killed his wife and was allegedly sparked by a Sunbeam Products Inc. space heater. The jury found Sunbeam was mostly to blame for the fire, concluding that the manufacturer was negligent because it knew of the fire risks posed by its defective product.
The family received $13.6 million in wrongful death damages, and the remainder of their compensation was for the emotional distress they’ve experienced. One daughter — 4 years old at the time of her mother’s death — was awarded another $13.4 million for her past and future suffering.
Sunbeam is represented by Anne Marie Ellis and Gary A. Wolensky of Arent Fox LLP, David J. O'Connell of Goldberg Segalla LLP, Manuel Saldana of Gordon & Rees LLP, Elizabeth V. McNulty of Archer Norris PLC and Dani Helene Rogers.
The Shinedlings are represented by Arash Homampour and Corey C. Arzoumanian of The Homampour Law Firm.
The case is Kenneth Aaron Shinedling et al v. Sunbeam Products Inc et al, case no. 5:12-cv-00438, in the U.S. District Court for the Central District of California.
Yamaha Beats $17M Suit Over ATV Injury — Bowman and Brooke LLP
In March, a California state jury found for Yamaha Motor Corp. in a $16.7 million trial over claims by plaintiffs Elizabeth Ault-Smietana and her husband Jayson Smietana that alleged defects in a Yamaha Rhino off-road vehicle caused a serious accident that resulted in the amputation of Ault-Smietana's leg.
The case was the eleventh around the country to go to trial in the Yamaha mass tort involving its Rhino utility vehicle, and the last active case in the California Judicial Council coordinated proceedings, which once had more than 275 cases, according to Yamaha's attorneys.
Despite Yamaha’s win, defense attorneys say product liability trials continue to pose challenges, particularly in cases where the injuries are especially serious or graphic.
"Any significant product liability case is invariably a sympathetic, emotionally charged case, which because of human nature tends to cause juries and judges to side with the plaintiffs, even where the claims may not be supported by the law," said Terry Budd of K&L Gates, national trial counsel for a number of companies.
The plaintiffs in the current case were represented at trial by Fredric G. Levin and Virginia Buchanan of Levin Papantonio Thomas Mitchell Rafferty & Proctor PA, Ryan Bright of Klein DeNatale Goldner Cooper Rosenlieb & Kimball LLP, and Ian Pancer of the Law Offices of Ian Pancer.
Yamaha was represented by Paul G. Cereghini, Timothy J. Mattson, Jenny A. Covington and Travis Wheeler of Bowman and Brooke LLP and Brian Gabel of the Yamaha Motor Corp. U.S.A. legal department.
The case is Elizabeth Ault-Smietana v. Yamaha Motor Corp. U.S.A., Case No. 37-2011-00086006-CU-PO-CTL, in the Superior Court of California, Orange County.
Halal Food Co. Founder Convicted For Mislabeling Meat — U.S. Attorney’s Office for the Northern District of Iowa
William Aossey, the founder and former owner of Cedar Rapids, Iowa-halal foods company Midamar Corp., was convicted in July for mislabeling meat bound for export to Malaysia and Indonesia. The jury's guilty finding, relatively uncommon in food labeling suits, related to the company's export of meat that was labeled as coming from a Nebraska plant, when it actually came from a Minnesota plant, according to court documents.
The Minnesota slaughterhouse wasn't certified to export beef to Malaysia and Indonesia from 2007 to 2010, while the Nebraska-based slaughterhouse was. Midamar said at the time that the conviction didn't relate the halal certification of the meat.
Aossey is represented by Haytham Faraj of The Law Offices Of Haytham Faraj PLLC and Jason R. Klinowski of Wallace Jordan Ratliff & Brandt LLC.
The government is represented by U.S. Attorney Kevin W. Techau and Assistant U.S. Attorneys Richard L. Murphy and Timothy L. Vavricek.
The case is U.S. v. William B. Aossey Jr., case number 1:14-cr-00116, in the U.S. District Court for the Northern District of Iowa.
--Additional reporting by Jody Godoy, Joe Van Acker, Matt Fair and Lance Duroni. Editing by John Quinn and Philip Shea. -
Surgery believed helpful for women with overactive bladder, Pitt-related study finds
Aug 4, 2015 | Pittsburgh Post-Gazette
By Jill Daly
Although it is relatively common in adult women, loss of bladder control is a serious situation to those who experience it most frequently and go to their doctors for help. In addition to exercises that improve the pelvic floor muscles, there are drug and surgical options.
Halina Zyczynski, specialist in urogynecology and pelvic reconstructive surgery at the University of Pittsburgh, recently published research reporting that out of a group of 1,600 women most found “significant improvement” from their overactive bladder symptoms after surgery for stress urinary incontinence. She said the unexpected finding is good news for women and their doctors, adding confidence in expecting relief from overactive bladder symptoms after surgery.
Stress incontinence surgery addresses the type of unintentional urine leakage women might have when they exercise, laugh hard, cough or sneeze. Overactive bladder comes with a frequent urge to urinate, sometimes coming with a loss of urine.
Dr. Zyczynski is lead author of a study that analyzed data from three multicenter urinary incontinence surgical trials, published in the August edition of Obstetrics & Gynecology. The study included four primary forms of surgery that construct support for the urethra and the area of the urethral sphincter, the muscle that opens and closes to control the flow of urine from the bladder. Weakness in the muscle — with an assortment of possible causes — leads to urine leakage. Along with relief from stress incontinence, all four types of surgery also relieved a bothersome urge to urinate in a majority of the women.
Most women seeking surgery for stress urinary incontinence also have overactive bladder symptoms, according to the study, which included both non-mesh and mesh urinary incontinence surgeries.
After one year, each surgery group of women reported improvement in their symptoms (amounting to 57 percent to 71 percent of the total number), and five years later about half to two-thirds (46 percent to 65 percent) of participants still reported a 70 percent decrease from their baseline urine loss/urge symptoms.
There is no proof that the surgeries themselves reduced the symptoms, according to the study. But the measurement of the patients’ satisfaction with fewer urgency symptoms is significant, Dr. Zyczynski said. Highest satisfaction was when symptoms were relieved by 70 percent.
“It’s an achievable goal to strive for; that is the bar we have set,” she said.
“In one study, 90 percent of the women [who] came in for surgery had overactive bladder symptoms that were moderately to severely bothersome,” Dr. Zyczynski said. “As clinicians we have become more aware that patients are not in categories; we need to see the whole person.”
She said there have been surgeons reluctant to offer stress incontinence surgery on women who also say they are bothered by the urgency symptoms.
“They are afraid they will make the symptoms worse,” she said. “Through the ’70s, ’80s, ’90s they were very sensitized to this. They would give these patients pharmaceuticals, give them physical therapy, advise lifestyle and diet changes. [But] unless you address the weak sphincter, it’s frustrating to the women. They don’t get satisfying results.”
The recent study could not measure the benefit of the surgery for the small number of women who were already taking medicine for overactive bladder before surgery. And up to 30 percent, depending on type of surgery, had a worsening of their urgency symptoms.
The only factor that seemed to make a big difference in a woman’s chance of finding relief after surgery was obesity — a BMI of 30 or above.
“Obese patients were 43 percent less likely to report relief in overactive bladder symptoms,” Dr. Zyczynski said. “Obesity has an impact … but if you are in this category, you can either lose weight before surgery, or realize there’s a reduction in outcome, directly attributable to weight.”
“This is really an emancipating finding for clinicians,” Dr. Zyczynski said. “Having good data to reflect upon in a counseling session — This is what women want. As we seek to be more functional in work, at home, while we’re exercising, we need to know what can we expect to happen after the surgical experience.”
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