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Ethicon Aug 31
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5 Dos And Don'ts For Employers After NJ's Ethicon Ruling
Aug 28, 2015 | Law360
By Martin Bricketto
A recent New Jersey Supreme Court decision that the state's whistleblower law covers watchdog employees in performing their regular duties could spell more lawsuits from compliance personnel unhappy with management decisions. But clear policies, consistency and extra diligence can protect companies... -
“Transvaginal Mesh Feels Like a Scouring Pad, and My Husband Feels It.”
Aug 30, 2015 | Lawyers and Settlements
By Jane Mundy
Glenda wishes her gynecologist had explained transvaginal mesh to her before she had it implanted back in 1999. Chances are her doctor didn’t know about transvaginal mesh side effects, but it was the same year that one type of TVM was recalled. -
I Had a Kid. Will My Bladder Ever Be Normal?
Aug 28, 2015 | New York Magazine
By Susan Rinkunas
It would be easy to think that incontinence is an old person’s problem. But it affects younger women more than we realize: Two out of five women under 60 have some leakage, says Jill Rabin, M.D., professor of obstetrics and gynecology at Hofstra North Shore-LIJ School of Medicine and author of Mind Over Bladder. -
US Business Groups Call for Probe of Medical Funding Industry
Aug 29, 2015 | Business Recorder
Two business lobbying groups this week called on the Consumer Financial Protection Board to investigate the medical funding industry after a Reuters investigation revealed that private investors are funding operations for women who have sued makers of surgical implants. The American Tort Reform Association ... -
Exercise After Giving Birth Has Many Benefits
Aug 30, 2015 | The Northwestern
By Molly Yatso Butz
Exercise after pregnancy can be one of the best things you can do for yourself and your baby. Exercise after giving birth has many benefits, including: weight loss, improved cardiovascular fitness, restored muscle strength and tone, restored condition of the abdominal muscles, increased energy levels... -
Boy Completes Trek as Gosport Woman’s Target is Reached
Aug 28, 2015 | The News
By Will Luckett
BRAVE seven-year-old Edward Pagett walked 75 miles along Hadrian’s Wall to raise money for his friend’s mum, who is in desperate need of an operation. But there was a double delight in store as Edward completed his nine-day walk as his friend’s mum Suki Mann reached her fundraising target.
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5 Dos And Don'ts For Employers After NJ's Ethicon Ruling
Aug 28, 2015 | Law360
By Martin Bricketto
A recent New Jersey Supreme Court decision that the state's whistleblower law covers watchdog employees in performing their regular duties could spell more lawsuits from compliance personnel unhappy with management decisions. But clear policies, consistency and extra diligence can protect companies if a demotion or firing blows up into litigation.
The court's hotly anticipated decision on July 15 that watchdog employees can invoke the Conscientious Employee Protection Act — and that they can do so without having to first exhaust all internal avenues for trying to fix alleged wrongdoing — has left companies with new questions over how they should manage such workers, according to attorneys.
The plaintiff in the case, Joel Lippman, has accused Johnson & Johnson's medical device unit Ethicon Inc. of firing him for advocating the recalls of allegedly dangerous products, while Ethicon has said Lippman was terminated because of an inappropriate relationship with a subordinate.
“The primary issue resulting from Lippman is that watchdog employees now have the distinct advantage of being able to blunt their employers’ efforts to discipline or terminate them by arguing that such actions are motivated by retaliatory purposes as opposed to legitimate business concerns,” said Kenneth Rosenberg, a partner with Fox Rothschild LLP.
Here are five dos and don'ts for employers in the wake of the court's Lippman decision.
Don't Be Shortsighted
One knee-jerk reaction to Lippman could be trimming optional compliance staff to prevent whistleblower lawsuits. However, that would be a poor business decision, according to Gregory C. Parliman, a partner with Day Pitney LLP.
“Good compliance folks can play an important role and help the company avoid risk and exposure,” Parliman said. “I would not give that up simply to avoid the possibility of a whistleblower lawsuit.”
The better answer is exercising care as part of an adverse employment decision, according to Parliman.
“I'm not prepared to accept the notion that these folks are untouchable,” he said. “They are still at-will employees, and they are still subject to appropriate disciplinary actions. You just need to be extra vigilant about the things that you should do from a human resources perspective before you terminate any employee.”
Do Put Policies in Writing
One striking element of the Lippman case has been the weaknesses that seem to surround Ethicon's stated reason for firing its former vice president of medical affairs and chief medical officer, according to Maxine Neuhauser, a member of Epstein Becker Green.
For example, it doesn't appear that J&J had any policy prohibiting the kind of consensual romantic relationship at issue, Neuhauser said. Former Ethicon Chairwoman Sherilyn S. McCoy couldn't recall any such policy as part of her deposition testimony on why Lippman was terminated, according to the New Jersey Supreme Court's opinion.
“It is difficult to rely on unwritten policies,” Neuhauser said. “If managers are prohibited from having undisclosed romantic relationships with individuals in their chain of command, put it in writing.”
Do Provide More Explanation
Additional attention when fielding the concerns that watchdog employees raise can help blunt whistleblowing allegations down the road and show that the company took such recommendations seriously, according to attorneys.
“If somebody in a compliance position raises an objection or a concern, I don't think that it's safe to simply say, 'No, we're not going to do that,' or, 'I think you're wrong, so I reject your recommendation,'” Parliman said. “I think you need to do a little bit more now, so you create a record as to the reason why the company disagrees with what the compliance person is raising or recommending.”
That can mean getting an outside opinion from an expert on a particularly thorny compliance issue or just providing a more in-depth explanation on why a different course is more appropriate, according to Parliman. Ultimately, a company should be able to show that it treated a watchdog employee in a fair manner, which could be a deciding factor in court, he said.
“Setting aside all the legal issues, it's really a question of fairness — does the jury believe that the employee was treated fairly,” Parliman said.
Don't Be Inconsistent
In another scrap of testimony that the high court noted, McCoy said she was unaware of Ethicon's or J&J's terminating or even disciplining an employee for a consensual romantic relationship with a subordinate.
It doesn't appear that Lippman's partner in the relationship complained, and the notion that she benefited from favoritism could be undercut by the fact that she didn't directly report to Lippman, according to Neuhauser. The overarching lesson is that companies need to be consistent in why they choose to discipline employees, Neuhauser said.
“Acting arbitrarily invites resentment — and litigation,” she said.
Don't Rush
In the wake of Lippman, companies that are considering some kind of action against a watchdog employee for legitimate business reasons will help themselves by showing extra diligence and caution, attorneys suggested.
Employers should think about gathering written statements and objective evidence of potential misconduct, according to Rosenberg, who added that companies should consult with outside counsel to make sure there is enough support for any disciplinary decision. Businesses might also want to consider using an independent investigator to review allegations of bias or harassment against a watchdog employee, Rosenberg added.
“Employers need to take painstaking steps to build a record to discipline/discharge a watchdog employee,” he said. “Failing to do so leaves open the door that the adverse employment action is being taken for retaliatory reasons. Given the status of the law, employers that don’t build a record have no chance of getting out on summary judgment and little chance at trial.”
Employers most at risk are those that follow the adage “hire slow, fire fast,” according to Ford & Harrison LLP partner Mark A. Saloman.
“Disciplining or terminating a member of the judicially created subclass of 'watchdog' requires extreme patience,” Saloman said. “That employee is conceivably blowing the whistle every minute of every hour of every day on the job, so the smart employer can minimize risk by 'firing slow.'"
"Take the time to fully — better yet, exhaustively — document the legitimate business reasons for the adverse action," he said. -
“Transvaginal Mesh Feels Like a Scouring Pad, and My Husband Feels It.”
Aug 30, 2015 | Lawyers and Settlements
By Jane Mundy
Glenda wishes her gynecologist had explained transvaginal mesh to her before she had it implanted back in 1999. Chances are her doctor didn’t know about transvaginal mesh side effects, but it was the same year that one type of TVM was recalled.
Boston Scientific’s transvaginal mesh had never been implanted in a human vagina before it was cleared by the FDA. It took several years before questions about how the mesh was cleared were raised. Meanwhile, women like Glenda were told that there was nothing wrong and to simply get used to it.
“I had problems with the transvaginal mesh sling right away,” says Glenda. It couldn’t get worse: the mesh was implanted to treat pelvic organ prolapse but her condition was much worse with the mesh. She had to wear a catheter for two months because she couldn’t urinate and even had to catheterize herself.
“I told my gynecologist that I couldn’t fully urinate and that the surgery made my POP worse. And I was in pain,” says Glenda. “He just said to be patient and it would get better. I can’t count how many times I complained to him before he referred me to a urologist. I thought there might be answers but the urologist gave the same old story - that it would get better.”
Glenda was at her wits’ end. She asked her family doctor for a referral to another urologist. “She brushed me off like my problems with this mesh were all in my head,” says Glenda. “It got to the point where I had nowhere to go. Because I was also suffering from pelvic pain she sent me to a pelvic wall specialist.” Finally someone gave Glenda answers, but it was good news and bad news.
“This specialist said that I had a lot of scar tissue from the transvaginal mesh but there was nothing she could do for me - she didn’t have the expertise to remove it but it had to come out. I now have an appointment on September 4 to see Dr. Bowling, who may be the only doctor in Tennessee qualified to get this mesh mess out of me.”
The damage this mesh has done to Glenda is tragic. And it has been horrible for her husband - they have been married since 1972. “I can’t have sex at all. I have no desire because it hurts,” Glenda explains. “And I had to take early retirement because I can’t stand or sit for any length of time - I worked in receiving for a department store.
"I remember my doctor telling me that he would use a little bit of mesh to tuck up my bladder and everything would be fine. How wrong he was. I also remember a nurse at the hospital - when I had the mesh implanted - tell me that I should get my medical records. I think she knew about transvaginal mesh problems.
“I know my condition is getting worse. Something in my vagina feels rough; it constantly itches and scratches. It feels like a scouring pad, the kind you wash pots and pans with, hard and wiry. I have had countless bladder infections and it has caused a lot of stress in my marriage. How can doctors still put this mesh in women? It’s like they don’t care as long as they get money to do it. And I can’t believe these mesh manufacturers are still standing behind their product. I will get some satisfaction from a transvaginal mesh lawsuit but no amount of money can make my marriage problems go away.” -
I Had a Kid. Will My Bladder Ever Be Normal?
Aug 28, 2015 | New York Magazine
By Susan Rinkunas
It would be easy to think that incontinence is an old person’s problem. But it affects younger women more than we realize: Two out of five women under 60 have some leakage, says Jill Rabin, M.D., professor of obstetrics and gynecology at Hofstra North Shore-LIJ School of Medicine and author of Mind Over Bladder. Often, the problem isn't having to go suddenly (a.k.a. urge incontinence), but situational incontinence caused by movements like coughing, sneezing, working out, or even having sex.
Think of the Friends and 30 Rock jokes about “peeing a little” when laughing. This is stress incontinence, which is about pressure, not being stressed. It’s caused by organs pushing down on your bladder as the result of weakness of the muscle or connective tissue in your pelvic floor. It’s much more common in women than men, since pregnancy and birth can cause the aforementioned weakness or tissue-tearing (even in moms who never wind up pushing, Dr. Rabin says C-sections can also lead to incontinence because there’s cutting across nerves). It's rare in women who haven't had children or pelvic surgery, but it can affect athletes in their teens and 20s who train for several hours daily, according to Victor W. Nitti, M.D., professor of urology and obstetrics and gynecology at NYU Langone Medical Center.
Women who have kids may have some degree of pelvic prolapse, in which organs like the uterus or small bowel are not fully anchored to the levator muscle of your pelvic floor, which Dr. Rabin describes as a trampoline at the bottom of your abdomen. With prolapse, the organs droop and can actually push through the openings in the muscle like a hernia, which can cause stress incontinence. The more children you have, the more likely you are to have a weaker pelvic floor and torn connective tissue — although not all women are affected, Dr. Rabin says.
Depending on the person, stress incontinence can be annoying, or embarrassing, or both, and it may not be something you’ve shared with your doctor. Some women wear tampons when working out because they find they leak less (it does hold up the pelvic floor a little bit). It’s a temporary solution, but Dr. Rabin recommends learning to do good ol’ Kegels, which are like CrossFit for your pelvic floor. She tells patients to pull up like you’re trying not to pee, hold for a count of three Mississippi, then relax for that amount of time. Do that three times an hour, every hour. “The levator muscle will grow thicker, from a veal cutlet to a filet mignon. That stabilizes your bladder so it won’t drop as much, and it will treat small degrees of prolapse.” Then, if you know you’re going to sneeze or cough, you can pull up your pelvic floor beforehand. Eventually, this will become almost reflexive, protecting against the pressure and hopefully preventing leaks.
Kegels are great, but you should still talk to your gynecologist, who can determine whether the leaking is a result of a problem with your nerves, muscles, connective tissue, or a combination of those factors. Your doctor can also recommend a specific treatment plan, which might include pelvic-floor therapy with a physical therapist or using vaginal weights or cones. Talking with your doctor is important because stress incontinence can get worse over time and may not respond as well to first-line treatments, Dr. Nitti says. He says some women may not bring it up because they think it’s just a fact after having kids. “It just doesn’t bother them. Some women have been taught that this is sort of normal. ‘This is supposed to happen. It happened to my mom.’”
Many obstetricians tell women to do Kegels during pregnancy or right after childbirth, but if you develop stress incontinence and it doesn’t get better with minimal rehab after delivery and it’s affecting your day-to-day, it’s worth discussing. And Dr. Nitti says you don't need a severe problem to consider additional treatment: “Some women that we operate on, they’re soaking multiple pads. Others, it may just be one small pad, but the degree of bother is there. It’s interfering with their life; they don’t exercise because of it.”
It’s important to note that the fix isn’t always surgery. Options range from simple exercises to urethral bulking agents, incontinence rings, and disposable pessaries that work like the aforementioned tampon method. Dr. Nitti says some women see ads on TV about the horrors of vaginal mesh and think, I’m not going to see a doctor because I don’t want vaginal mesh. But, he adds, "Nobody comes into my office with stress incontinence and I say, ‘You have to have surgery.’ It’s, ‘Here are the things we can do. What suits you?’”
Of course, it’s also possible that women would leak less if their bladders weren’t as full. Dr. Rabin recommends going to the bathroom at least every two to three hours while you’re awake. This also applies to women without incontinence problems and women who don't plan to have kids. If you hold it all day, you can overstretch your bladder and affect its ability to empty fully. Years from now, you might have frequent urges to go because your bladder can only empty small amounts each time. And the last thing your future self needs is pee regret.
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US Business Groups Call for Probe of Medical Funding Industry
Aug 29, 2015 | Business Recorder
Two business lobbying groups this week called on the Consumer Financial Protection Board to investigate the medical funding industry after a Reuters investigation revealed that private investors are funding operations for women who have sued makers of surgical implants. The American Tort Reform Association and DRI-The Voice of the Defence Bar told Reuters on Tuesday that medical funders take advantage of the people they claim to be helping.
The US Chamber of Commerce, another proponent of business-friendly tort reform, said in a statement Tuesday that medical funding is "a blatant abuse of the system" that leaves "actual victims with little or no recovery." As Reuters reported, medical funders profit by purchasing bills for the medical treatment of injured plaintiffs at a deep discount from health care providers, then claiming the full amount of the bill as a lien against the patient's legal recovery through a settlement or verdict. [ID: nL1N10T19Y]
At least several hundred women in the sweeping litigation against manufacturers of so-called pelvic mesh, used to treat incontinence and other conditions, relied on medical funders to pay for surgery to remove their implants. Liens by funders in mesh cases, Reuters found, can spiral to as much as 10 times what health insurers would pay for the same procedures. "This is predatory lending - exactly what the CFPB was designed to prevent," said DRI president John Sweeney in an interview.
A spokeswoman for the CFPB, a federal agency established to combat financial industry abuses, declined to comment. Medical lender Daniel Christensen of Austin-based MedStar Funding said in an email that industry participants are subject to certain state commercial or lending laws. He said patients' attorneys also provide oversight. "I am not in favour of regulation," said Christensen, whose medical funding network was described in the Reuters investigation. "I am in favor of a person's right to contract. If they want to take a settlement advance or if they want to obtain medical care on a lien, they should have the right to do so without the government telling them otherwise."
Christensen said funders earn high rates of return because "litigation finance is an extremely risky endeavour." It is disingenuous, he said, for business groups such as the US Chamber to express concern for plaintiffs. The groups oppose his industry "not because they suddenly developed a sense of altruism, but because eliminating litigation funding is in the best interests of those who fund them - big business and insurance." -
Exercise After Giving Birth Has Many Benefits
Aug 30, 2015 | The Northwestern
By Molly Yatso Butz
Exercise after pregnancy can be one of the best things you can do for yourself and your baby. Exercise after giving birth has many benefits, including: weight loss, improved cardiovascular fitness, restored muscle strength and tone, restored condition of the abdominal muscles, increased energy levels, improved mood, stress reduction and prevention of postpartum depression.
Including physical activity into your daily routine also helps set a positive example for your child. If you had an uncomplicated vaginal delivery, and you exercise throughout your pregnancy, it is safe to begin an exercise program as soon as you feel ready. If you had a C-section or extensive vaginal tear, talk to your doctor about when it’s safe to begin an exercise program.
An incision from a C-section takes several weeks to heal, but walking at an easy pace is encouraged because it helps promote healing and helps prevent blood clots.
For either situation, when you are ready to start exercising, start with something low impact and simple, such as walking. Dr. Jeremy Bell, doctor of obstetrics and gynecology with Affinity Health System, said, “I usually advise patients begin aerobic exercise two weeks after a vaginal birth and six weeks after C-section. It is always a good idea to start walking right away. I also encourage them to ease back into an exercise routine gradually.”
The Department of Health and Human Services recommends at least 150 minutes a week of moderate-intensity cardiovascular activity. The Mayo Clinic recommends the following guidelines for new mothers: consider taking time to warm up and cool down, begin slowly and increase your pace gradually, wear a supportive bra, avoid excessive fatigue and stop exercising if you feel pain. Remember that joints and ligaments will be loose for about three to five months, so be careful during walks to avoid falling.
Some women may develop a gap in their abdominal muscles as their stomach expands during pregnancy; this gap is called diastasis recti. This condition takes four to eight weeks for th3 gap to close after giving birth. If a woman begins to exercise before this gap closes, she increases the risk of injuring those muscles.
The best postpartum exercises to do are a pelvic tilt and Kegel exercises. The pelvic tilt is done by lying on your back on the floor with knees bent. Flatten your back against the floor by tightening the abdominal muscles and bending your pelvis up slightly. Hold this position for up to 10 seconds and work up to repeating the movement for 10 to 20 repetitions. Kegel exercises help tone the pelvic floor muscles, which support the uterus, bladder, rectum and small intestine. To do a Kegel exercise, contract the muscle that is used to stop urine flow when using the bathroom. Hold this contraction for up to 10 seconds and relax between contractions for about 10 seconds.
Bell said, “With Kegels, the goal is for prevention of future incontinence and pelvic organ prolapse by strengthening the pelvic floor muscles. An aggressive protocol would be sets of 10 three times per day.”
Weight loss of one to two pounds per week is the maximum recommended for a new mom in order to keep up strength and bone density. Daily exercise helps improve circulation and boosts metabolism, helping get back to pre-pregnancy weight much quicker. “If weight loss is a goal postpartum, nothing burns calories better than breastfeeding. Also, remember to drink lots of water,” Bell said.
About 50 percent to 75 percent of new mothers experience “baby blues” in the first few days after giving birth. These “blues” can trigger crying, restlessness, irritability and anxiety. Exercise can help decrease these symptoms.
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Boy Completes Trek as Gosport Woman’s Target is Reached
Aug 28, 2015 | The News
By Will Luckett
BRAVE seven-year-old Edward Pagett walked 75 miles along Hadrian’s Wall to raise money for his friend’s mum, who is in desperate need of an operation.
But there was a double delight in store as Edward completed his nine-day walk as his friend’s mum Suki Mann reached her fundraising target.
Edward took his family – 10-year-old brother Daniel, and parents Amanda and Roy – on the hike in aid of Suki, from Gosport, who needs an operation in America after a mesh implant for a pelvic organ prolapse went wrong, which left her in constant pain and prevents her from walking.
They finished their heroic endeavour last week, just as news broke that Suki has reached the £16,800 she needs.
Edward raised £8 a mile, totalling more than £600, with more donations coming in.
The Pagetts began their journey in Newcastle and hiked all the way across the top of England, parallel to the Scottish border, until they reached the end of the wall in Bowness-on-Solway.
Edward said his favourite day was the day they walked 13 miles.
‘It was really good,’ he said.
And the views were really good, too.’
The family spent their days hiking and nights in bunk-rooms, hostels, and tents.
Edward and Daniel spent their days running and playing, waiting for their parents to catch up.
‘They spent a lot of the time in front,’ said mum Amanda.
Suki, 48, said she was taken back by the gesture.
‘I have been touched by Edward’s efforts,’ she said.
‘Edward’s actions have had a deep impact on my son Jakob and I, and I still get choked when I think about it.’
Suki’s son Jakob, 10, said: ‘Edward’s walk is so inspiring.
‘He wasn’t asked to do this, he just came up with the idea and that is pretty heroic. I’m so glad that Edward is my friend.’
Suki, from Beauchamp Avenue, is due to leave for her operation on September 12.
She said: ‘It is a huge relief that we’ve been able to raise the money needed.
‘There was a point when I didn’t think we were going to make it.
‘Edward completing his challenge at the same time was the icing on the cake.’
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