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Jurors Prepare To Mull First Philly Pelvic Mesh Case
Dec 17, 2015 | Law360
By Dan Packel
Philadelphia jurors will begin deliberating Friday in the first pelvic mesh case to be tried in the jurisdiction, after hearing the attorney for an Indiana woman contend the negligence among scientists at a Johnson & Johnson unit is the root cause of her inability to have sex. -
The Biggest NJ Decisions From The Second Half Of 2015
Dec 17, 2015 | Law360
By Martin Bricketto
The New Jersey Supreme Court in the second half of 2015 continued a year of major decisions by making clear that whistleblower protections extend to watchdog employees performing their regular job duties and that the deployment of retired judges passes constitutional muster, which avoided a tsunami of case backlogs. -
American Medical Systems Wins 510(k) Clearance For Transvaginal Sling
Dec 17, 2015 | Mass Medical Device News Desk
By Chris Walker
American Medical Systems Holdings, a subsidiary of Endo Health Solutions (NSDQ:ENDP), landed FDA 510(k) clearance for its RetroArc retropubic sling system. The device was designed for the treatment of stress urinary incontinence. SUI is considered the most common type of bladder leakage, impacting 13 million women in the U.S... -
Poise Impressa Bladder Supports, For The Pee Leakers Among Us
Dec 17, 2015 | Baby Center Blog
By Joyce Slaton
Pregnancy is a particularly moist time, when gestating moms may find they drool more, sneeze more, have more vaginal discharge, and leak a little pee every now and again, particularly when they laugh, cough, sneeze, or exercise. Most moms expect the leakage, a.k.a. urinary incontinence, to go away after birth. Sometimes it does!
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Full Text of Stories Below
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Jurors Prepare To Mull First Philly Pelvic Mesh Case
Dec 17, 2015 | Law360
By Dan Packel
Philadelphia jurors will begin deliberating Friday in the first pelvic mesh case to be tried in the jurisdiction, after hearing the attorney for an Indiana woman contend the negligence among scientists at a Johnson & Johnson unit is the root cause of her inability to have sex.
Closing arguments in plaintiff Patricia Hammons' case against J&J subsidiary Ethicon Inc. finally came to an end Thursday, after being disturbed the previous day because of an Uber protest in Center City Philadelphia at a fire alarm that emptied City Hall, home to the courtroom.
Attorney Shanin Specter of Kline & Specter PC resumed his entreaty to the seven women and five men on the jury, emphasizing the company repeatedly prioritized sales over patient health in its decisions on its Prolift mesh product.
“The unifying theme here is that every time there was a contest between marketing and safety, marketing won,” Specter said.
Hammons had filed suit in Philadelphia in May 2013, alleging that shards of the Prolift mesh, which was implanted between her bladder and vagina in 2009 in an effort to correct sagging of her internal organs, became implanted in her bladder.
Specter argued to the jurors that testimony in the trial, which began over two weeks ago, revealed that Ethicon's data on the product's safety was false and that the success rate of surgeries to implant the mesh was less than the 80 to 90 percent figure the company cited.
He pointed to the pronouncement from Indiana physician Mark Baker, who performed the initial surgery on Hammons, saying that if he knew in 2009 what he knows now about Prolift, he would not have used the product.
“Dr. Baker is an expert in this case,” Specter said. “He's telling us that it's an unsafe product.”
He also stressed the costs of Hammons' condition, known as dyspareunia, saying that as a result of her inability to have sex, “she doesn't feel like a woman.” He also noted that she must deal with the constant worry that her boyfriend might elect to leave her.
“That worry is part of her harm,” Specter said.
He also preemptively warned the jury against the statute of limitations defense that Ethicon raised.
Ethicon's attorney Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP quickly flagged that issue near the start of his presentation, as he proceeded to march methodically through the nine-question verdict sheet.
He disputed Hammons' contention that she was unaware of the connection between the mesh and her troubles until she saw a new doctor in 2012, pointing to a letter that authorized the release of her medical records on implants to personal injury attorneys in August 2011. He suggested that letter showed Hammons failed to meet her burden of proof that she was ignorant of the connection before May 2011 — two years before her suit was filed.
Ismail also defended Ethicon's scientists, calling Specter's attacks on their conduct baseless.
“He hurled a lot of accusations at the men and women of Ethicon, questioning not only how they do their jobs, but also their basic human decency,” Ismail said. “Time after time, the things he said were not supported by evidence.”
Ismail also showed sympathy for the jurors, noting that the trial had been largely built upon video depositions — 25, by his count.
“That's either a record, or it's cruel and unusual punishment,” he said. “I don't know which.”
Hammons is represented by Shanin Specter, Lee Balefsky, Kila Baldwin and Michelle Tiger of Kline & Specter PC and Adam Slater of Mazie Slater Katz & Freeman LLC.
The defendants are represented by Susan Robinson of Thomas Combs & Spann PLLC, Matthew Moriarty of Tucker Ellis LLP, Molly Flynn of Drinker Biddle Reath LLP, and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
The case is Hammons v. Ethicon Inc. et al., case number 130503913, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.
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The Biggest NJ Decisions From The Second Half Of 2015
Dec 17, 2015 | Law360
By Martin Bricketto
The New Jersey Supreme Court in the second half of 2015 continued a year of major decisions by making clear that whistleblower protections extend to watchdog employees performing their regular job duties and that the deployment of retired judges passes constitutional muster, which avoided a tsunami of case backlogs.
Ultimately, 2015 may be remembered as the year that the justices upheld a $1.57 billion cut that Gov. Chris Christie made to pension funding or returned oversight of towns' affordable housing obligations to the courts because of the state's inability to do so, which were among the decisions that the high court handed down in the first six months of the year.
But attorneys still had a lot to digest in the later half of the year thanks to the court's July 15 decision benefiting watchdog employees in Lippman v. Ethicon Inc. and the approval of the use of recall judges as part of its July 30 decision in New Jersey v. Buckner.
Other significant Supreme Court decisions in the second half of 2015 kept a lid on stores' liability as part of slip-and-fall actions and paved a smoother path for employers to seek the disgorgement of a disloyal employee's salary, while the New Jersey Appellate Division handed down important rulings of its own that created new concerns for companies looking to enforce arbitration agreements.
Here are seven Supreme Court and appellate decisions from the last six months that attorneys say could prove important beyond the specific cases they involved.
Lippman v. Ethicon
In one of several major employment law rulings from the Supreme Court this year, the justices allowed Joel Lippman, a former vice president of medical affairs and chief medical officer with Johnson & Johnson's medical device unit Ethicon Inc., to move forward with claims that he was fired for advocating the recalls of allegedly dangerous products.
The unanimous court found not only that watchdog employees such as Lippman can invoke the Conscientious Employee Protection Act but also that they can do so without having to first exhaust all internal avenues for trying to fix alleged wrongdoing.
The ruling means employers can't rely on a job duty exception in defending against whistleblower claims and that watchdog employees have added protection in their positions, which could create headaches for companies when they want to take action against such personnel for valid business reasons, according to Christine A. Amalfe, who chairs the employment and labor law department of Gibbons PC.
"I don't see those employees as untouchable after Lippman but certainly employers could be placed in a difficult position when trying to terminate or take other adverse action against a watchdog or compliance employee who was not properly perform his or her job duties," Amalfe said. "In those situations, employers may face risk that the employee will claim that it was his or her reporting of a violation of a policy or the law, something they are paid to do by the company, and not their own poor performance that caused the adverse action."
Still, the ruling won't prevent companies from successfully defending themselves against the CEPA claims of watchdog employees, even if they won't be able to strictly rely on an individual's job responsibilities to win summary judgment, according to attorneys.
"I would argue courts are still going to hold claimants' feet to the fire on the issue of whether there's a reasonable belief that the employer was engaged in unlawful activity and also whether the claimant was engaged in whistleblowing activity," said Martin W. Aron of Jackson Lewis PC.
New Jersey v. Buckner
The same month it handed down the Lippman decision, the Supreme Court refused to disrupt a long-standing practice of temporarily filling judicial vacancies with jurists who have reached a mandatory retirement age of 70.
James Buckner tried to shed a nine-year prison sentence for charges including robbery and aggravated assault by arguing that a 40-year-old statute allowing those appointments had breached constitutional language that "justices and judges shall be retired upon attaining the age of 70 years." The recall judge who presided over his trial was 73 at the time.
But Chief Justice Stuart Rabner said for a 5-1 majority of the court that Buckner failed to show that the law was clearly repugnant to the constitution beyond a reasonable doubt. Instead, Rabner pointed to "ample evidence that the recall statute is consistent with both the language and the history of the modern state constitution."
The decision is important because of what the majority didn't do, according to Jeffrey S. Mandel of Cutolo Mandel LLC, who said the recall system that has been invaluable for coping with heavy caseloads at both the trial and appellate levels.
"Had the court not come out the way it did, there would have been an uproar by litigants and lawyers with the slow pace of how things would be proceeding," Mandel said, adding that recall judges' decisions also would have been subject to challenges targeting their validity.
Prioleau v. Kentucky Fried Chicken Inc.
In a closely watched personal injury case, the Supreme Court on Sept. 28 awarded Kentucky Fried Chicken a new trial over a Delaware woman's negligence claims and refused to adopt what it deemed as an overly expansive view of the so-called mode-of-operation rule.
That standard has arisen in the context of self-service businesses and entitles an injured customer to an inference of negligence, freeing them from having to show that the defendant business had notice of the alleged dangerous condition that caused the accident, the court explained.
A trial court agreed to a mode-of-operation jury charge because employees may have tracked oil and grease from the restaurant's kitchen to the area near the restroom where plaintiff Janice J. Prioleau fell, which reduced her burden of proof. However, the Supreme Court said the dispute was an ordinary premises liability negligence claim, not a mode-of-operation case.
"The trial record establishes that plaintiff's injuries were unrelated to any aspect of defendants' business in which the customer foreseeably serves himself or herself, or otherwise directly engages with products or services, unsupervised by an employee," Justice Anne Patterson wrote for the unanimous court. "Neither theory of liability advanced by plaintiff involved the limited circumstances in which the mode-of-operation rule has been held to apply."
The ruling maintains a business-friendly approach to the rule, according to Mandel.
"Here, our Supreme Court was saying that it is going to maintain what's already been said about the mode-of-operation rule and not permit crafty lawyers to find ways to expand it," he said.
DeMarco v. Stoddard
Overturning an appellate decision, the Supreme Court on Dec. 1 dealt what some consider a blow to consumers in finding that an insurance entity, the Medical Malpractice Joint Underwriting Association of Rhode Island, didn't have to provide medical malpractice coverage under a policy that was rescinded over a podiatrist's misrepresentations.
In her opinion for a 5-2 majority of the court, Judge Mary Catherine Cuff, who is temporarily assigned, found that the Appellate Division wrongly used the compulsory automobile insurance model as a "guidepost" to allow Thomas DeMarco and his wife to recover from the RIJUA after podiatrist Sean Robert Stoddard's policy was rescinded. The insurance group axed coverage for Stoddard over misrepresentations that at least 51 percent of his practice came from Rhode Island.
The unique facts of the case may limit the decision's reach, but it's significant for what it might say about the court in general, according to E. Drew Britcher of Britcher Leone & Roth LLC.
"Here is a situation where an innocent policyholder is being burned by the actions of a defendant, and so an insurance company who collected premiums and had all the power in the world to investigate gets off," Britcher said. "If you're watching this court, the fact that this was a 5-2 decision in favor of the insurance companies is distressing."
Kaye v. Rosefielde
The second half of 2015 wasn't all rocky news for employers in terms of the Supreme Court's rulings.
In September, the court provided employers with a potentially valuable tool in litigation and presuit negotiations when it explicitly found that swindled companies don't have to show economic damages to win back a disloyal employee's salary.
The justices had tackled a sliver of time-share businessman Bruce Kaye's lawsuit accusing a former general counsel and chief operating officer for some Kaye companies, Alan Rosefielde, of legal malpractice, civil fraud and breaching loyalty and fiduciary duties.
The decision provides new clarity on what some attorneys have said was a previously murky issue.
"Given the court's ruling, even in the absence of economic harm employers may be entitled to the equitable remedy of disgorgement of an employee's compensation for the period of time during which there has been a breach of the duty of loyalty," Aron said. "There is also a valuable deterrent effect secured from making employees aware that they will suffer adverse consequences when they engage in a breach of fiduciary duties.”
New Arbitration Decisions
The New Jersey Supreme Court made waves in 2014 with its decision in Atalese v. U.S. Legal Services Group LP, holding that an arbitration provision in a contract for debt adjustment services was unenforceable because it didn't have clear language stating the plaintiff was waiving her right to go to court
The second half of 2015 saw the Appellate Division add to a tough legal environment for arbitration agreements.
That includes a three-judge panel's September ruling in C.M. v. Maiden Re Insurance Services LLC, which reversed an order sending a disability discrimination suit to arbitration. An arbitration clause in a Maiden employee handbook clashed with other sections of that document that "prominently and unequivocally disclaim the handbook is intended to create a legally enforceable contract between Maiden and its employees," the court found in that unpublished opinion.
"My guess is there are a significant number of arbitration agreements that are in handbooks — that have the disclaimer language without carefully limiting its coverage to exclude the arbitration agreement — that this decision will call into question," said Thomas A. Linthorst of Morgan Lewis & Bockius LLP.
One month later, a different appellate panel refused to compel arbitration in a stockbroker's suit against Bishop Rosen & Co. Inc. over legal costs from a client dispute. The court found in a published decision that language in industry documents couldn't force arbitration because they were not specific enough and spread over too great a time period.
"It's all in the vein of New Jersey courts, I think, taking a cue from the New Jersey Supreme Court in Atalese and really being critical and closely scrutinizing these agreements on traditional unconscionably and contract formation grounds," Linthorst said. -
American Medical Systems Wins 510(k) Clearance For Transvaginal Sling
Dec 17, 2015 | Mass Medical Device News Desk
By Chris Walker
American Medical Systems Holdings, a subsidiary of Endo Health Solutions (NSDQ:ENDP), landed FDA 510(k) clearance for its RetroArc retropubic sling system.
The device was designed for the treatment of stress urinary incontinence. SUI is considered the most common type of bladder leakage, impacting 13 million women in the U.S., according to a press release.
"FDA Clearance of the RetroArc retropubic sling system rounds out the AMS family of slings," women’s health general manager Steve Blum said in prepared remarks. "It underscores our commitment to physicians and patients for the treatment of female stress urinary incontinence, and builds on our leadership in women’s health."
This is another win for the Minneapolis-based medical device company. The RetroArc was cleared for use in Europe earlier this month.
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Poise Impressa Bladder Supports, For The Pee Leakers Among Us
Dec 17, 2015 | Baby Center Blog
By Joyce Slaton
Pregnancy is a particularly moist time, when gestating moms may find they drool more, sneeze more, have more vaginal discharge, and leak a little pee every now and again, particularly when they laugh, cough, sneeze, or exercise.
Most moms expect the leakage, a.k.a. urinary incontinence, to go away after birth. Sometimes it does! Often, it doesn’t. Postpartum urinary incontinence, which is more common amongst women who have delivered vaginally, had multiple deliveries, or are obese, can linger for weeks, months, even years after giving birth, severely stressing out the moms who suffer from it.
It’s so embarrassing! You’re terrified other people will notice. It’s gross and weird and uncomfortable to wear underwear with a wet patch; it’s awkward and expensive to keep using pads. Just try being dynamic at work when you’re worried you’re emitting a crotch fugue.
So when Poise Impressa Bladder Supports, which, by the way, did not pay for this post, offered to send over some samples, I was willing to give it a try.
Poise Impressa interested me, because unlike every other over-the-counter incontinence product, it’s focused on stopping leaks rather than sopping them up — it’s supposed to keep you from peeing, instead of absorbing pee. The box looks like a tampon box, and the supports themselves look like super-sized tampons.
And was soft, flexible silicone, not scratchy plastic. I wore it during one long day when I was helping with an elementary school winter performance; it was comfortable, no leaks. Well, that wasn’t much of a surprise, actually — I’ve written before about my own problems with incontinence, which has improved a lot since I wrote about it. I took my leaky self to the doctor; he diagnosed flabby pelvic muscles and told me to do 10 Kegels (how it annoys me that that exercise is named after a dude, I feel the same about Braxton-Hicks contractions, but I digress) every time I thought about it.
So I did. And it’s better! Thus, even though I purposely filled myself up with known pee-inducers coffee and tea while I was wearing the Impressa, I was unable to replicate my former lack of control.
Besides, upon perusing Poise’s literature, I found that it wasn’t right for my type of incontinence, anyway. I had (have?) Urge Urinary Incontinence: gotta go right now, and if I had to go really badly, I might actually start the performance before the curtain has gone up, so to speak. Poise is meant for people with Stress Urinary Incontinence: the pee-when-you-laugh (cough, sneeze, dance, jump around) type.
Not wanting to leave any stone unturned or any bladder weeping for that matter, I gave the rest of my Poise package to my pal to try. She’d been leaking several times a week.
It worked, she reported back. She wore the supports for four days running, and didn’t leak while she was wearing them, and planned to continue using them.
Not every day — at about $14 to $18 for a package of 10, Poise Impressa is pretty expensive, and each support can be worn for a maximum of 8 hours a day. You can buy maxi-pad-like “incontinence pads” for $15 for 45; or leak-absorbing undies for $20 to $40 a pop. But for long days when it would be inconvenient to change, my friend said the Poise Impressas would come in handy.
It’s worth noting that bladder supports are not a new thing; there are a variety of medical devices that go into your vagina for various therapeutic reasons. My great grandmother wore a pessary, a doughnut shaped thingy made of God-knows-what-in-her-day because she had vaginal prolapse, and doctors have treated urinary incontinence with them too. Flexible devices that fit inside the vagina to support the bladder are newer, but had to be fit by a doctor, sometimes caused urinary tract infections, and had to be taken out and cleaned every time you peed. Good times. Enjoy doing that in your office bathroom.
Also worth noting that if your incontinence lingers longer than a few months, you should go see a doc to make sure everything’s okay up there. You want your kids to seek health? Model it. Go see a doctor. Then, if everything’s okay, maybe Poise Impressa can be another tool in your pee-leak arsenal.
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