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Ethicon 4/27
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Ad Spending Up, Defense Bar Irked
Apr 27, 2015 | National Law Journal
By Amanda Bronstad
...In cases involving the blood-thinner Xarelto and pelvic mesh devices, ads targeting potential plaintiffs have prompted defense attorneys to seek the court's help in staving off large numbers of allegedly meritless lawsuits... -
Social Media Class Notices Gain Traction But Carry Risks
Apr 24, 2015 | Law 360
By Erin Coe
...particularly if it involves sensitive subjects, such as litigation involving people who had health complications following vaginal mesh surgery or who bought contaminated baby formula... -
Women Who Suffer from Incontinence are No Longer Under Pressure
Apr 25, 2015 | Irish Examiner
...Sling surgery can tackle the problem — the technique involves inserting a sling or hammock-like support for the bladder... -
SIMPLY FIT: Nourishing and nurturing your body back to normal is so important for new mums
Apr 25, 2015 | Lincolnshire Echo
By Lisa Gimenez-Codd
...Is being fitter than someone else more important than protecting yourself from a pelvic organ prolapse in a few years' time?
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Ad Spending Up, Defense Bar Irked
Apr 27, 2015 | National Law Journal
By Amanda Bronstad
Attorneys representing the makers of medical devices and pharmaceutical drugs are turning to the courts to combat what they claim are questionable lawsuits driven by an influx of aggressive advertising.
A new crop of companies called lead generators, which refer clients to plaintiffs law firms, are fueling an increase in spending on advertising. And defense lawyers are joining the refrain of tort reform advocates and their own clients by turning complaints about ads into legal arguments.
In cases involving the blood-thinner Xarelto and pelvic mesh devices, ads targeting potential plaintiffs have prompted defense attorneys to seek the court's help in staving off large numbers of allegedly meritless lawsuits.
"Many of these cases turn out to be not very well investigated and, in many instances, shouldn't have been filed at all," said John Beisner, a partner in Skadden, Arps, Slate, Meagher & Flom's Washington office. "It's just this feeding frenzy that gets started of advertising."
The dollars spent on advertising aimed at pharmaceuticals and medical devices are on the rise. Between 2012 and 2014, about $407 million was spent on 1.6 million TV ads, according to The Silverstein Group, a Washington crisis-management and communications firm. Last year, money spent on ads jumped to $162 million, compared with $113 million in 2013.
Of the top five TV mass tort advertisers in 2014, two were lead generators, said Rustin Silverstein, president of the firm, whose data defense counsel cite frequently in court papers. Lead-generation firms are big business, selling client referrals to lawyers for $500 to $10,000 a piece, said Silverstein, a former associate at Steptoe & Johnson LLP.
The ads are commonplace on television, often using trumped-up news headlines and listing a host of alarming side effects from using a product. The defense bar also cites such ads in emails, text messages and websites. Unlike attorneys, lead-generation firms don't have the same ethical constraints in targeting potential clients.
Plaintiffs attorneys say their law firms are doing nothing wrong and note that it's the lead generators — not plaintiffs lawyers — who are behind many of the ads. But they also insist that advertising is necessary to combat what they say is an increase in defective medical products.
Calls for comment to iLawsuit Helpline and Lead Generation Technologies' The Relion Group, the lead-generation firms cited by The Silverstein Group as the top buyers of ads last year, were not returned.ADVERTISING'S HIGH IMPACT
The fight initiated by the defense bar demonstrates the impact that ads have had on mass tort litigation, particularly in recent years. Ads usually go up soon after a significant event, like a big settlement, verdict or FDA warning, Silverstein said.
In February, for instance, spending on TV ads featuring prescription drug Zofran jumped by 8,211 percent in one month, to $2 million, according to The Silverstein Group's latest report. The ads followed the first lawsuits alleging that the anti-nausea drug had been linked to birth defects.
"More than a nuisance, these ads are a key component in driving a lot of the litigation — in particular, both in building up cases, rounding up clients, spreading the word about potential harms from drugs and devices and creating fear in the public that might not have been there otherwise," Silverstein said.
And the defense bar says it's gone too far. On Oct. 31, for example, Bayer Corp. lawyer Tripp Haston, a partner at Bradley Arant Boult Cummings in Birmingham, wrote in a motion before the U.S. Judicial Panel on Multidistrict Litigation, which decides whether mass torts should be coordinated into MDLs, that "lawsuits involving Xarelto resulted only from plaintiffs' lawyers' aggressive marketing tactics in the wake of a massive payday." By September, he wrote, Xarelto had become the "top ad target" among mass tort plaintiffs firms, generating $7.4 million in TV ads, according to The Silverstein Group. Haston declined to comment.
Plaintiffs attorney Roger Denton, senior partner at St. Louis-based Schlichter Bogard & Denton, was co-lead counsel in the $650 million settlement last year involving Pradaxa, a similar drug. He countered that Bayer and Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, had themselves spent $11 million in 2013 to advertise Xarelto. The defense argument, he said, was an attempt to "distract the panel" from the issue at hand: whether to coordinate the lawsuits into an MDL, which Bayer and Janssen opposed. Denton did not return a call for comment.
The same defense arguments emerged in a similar argument Cook Medical Inc. made in 2013 and 2014 against coordinating MDLs over two of its products.
Plaintiffs lawyers don't quarrel with the statistics showing an increase in ad spending, but they insist that attorneys in leadership positions over mass torts having nothing to do with most of the ads and, for the most part, don't hire lead-generation firms.
Exactly how many lead-generation ads result in connecting clients with plaintiffs firms is not known. Harry Bell of The Bell Law Firm in Charleston, West Virginia, liaison counsel for the plaintiffs in litigation over pelvic mesh products, said plaintiffs lawyers are experimenting with them. Some have met success, while others haven't.
"There are lawyers who pay these entities and think of them as a sophisticated targeted ad agency," he said. "Sometimes, what you get in return is not what they sold you."
Plaintiffs lawyers also say that the defense bar's complaints about ads are red herrings. "It generates more plaintiffs and ultimately more money they have to spend," said C. Gibson Vance, a principal at Montgomery's Beasley, Allen, Crow, Methvin, Portis & Miles and past president of the American Association for Justice.
So far, the defense arguments presented to the MDL panel have not shown success. In 2013 and 2014, the panel coordinated actions in the Cook Medical and Xarelto cases and punted the advertising debate to the judges later assigned to handle the litigation. In one of the Cook Medical orders, former MDL Panel chairman John Heyburn wrote on Oct. 15 that "if defendants believe plaintiffs' counsel are filing frivolous claims, it is incumbent upon defense counsel to bring that concern to the attention of the transferee court."
Johnson & Johnson did just that earlier this year in lawsuits coordinated over subsidiary Ethicon Inc.'s pelvic mesh products, which are implanted in women to treat urinary incontinence and pelvic organ prolapse. On Jan. 14, the company filed court papers seeking to investigate an uptick in solicitations of women that were behind numerous "baseless lawsuits." Attorney Christy Jones of Butler Snow in Ridgeland, Mississippi, wrote that the cold calls corresponded with an estimated $45 million in TV ads for mesh litigation in 2014.
The American Tort Reform Association immediately called for a government investigation of the claims.
On Feb. 10, however, Johnson & Johnson abruptly withdrew its request. In an emailed statement, spokesman Matthew Johnson confirmed that the company withdrew the motion following an unspecified agreement with plaintiffs attorneys.
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Social Media Class Notices Gain Traction But Carry Risks
Apr 24, 2015 | Law 360
By Erin Coe
A New York federal judge’s recent decision allowing ex-Gawker Media LLC interns to use LinkedIn and Twitter to contact potential collective action members about opting in to their wage dispute shows that courts are warming up to using social media notification programs, but attorneys crafting such plans should be careful not to trample on individual privacy rights and company reputations, experts say.
U.S. District Judge Alison Nathan on April 10 granted most of the former Gawker interns’ plan to notify potential class members whose mailing or email addresses were unknown about their right to opt in to the proposed collective action alleging unpaid wages through social media, including “following” them on Twitter in order to send a direct private message and sending an “InMail” message on LinkedIn.
But she found that the interns’ request to “friend” potential class members on Facebookwent too far and also ordered the plaintiffs to “unfollow” individuals on Twitter if they don’t opt in to the suit by this month’s deadline.
Social media class notice plans are still the exception, rather than the rule, but courts are becoming more willing to consider notifying potential litigants through this increasingly popular mode of communication as a supplement to more traditional forms of service of process like mail and print publication, according to Steven Richard, counsel at Nixon Peabody LLP.
“The Gawker case is significant because it recognizes that social media can be a useful and effective tool to reach members of a class or collective action, provided that proper protocols and protections are in place by agreement of the parties and with judicial oversight,” he said.
Notice plans with social media components aren’t new and tend to arise in the employment, consumer, antitrust and privacy context. In a wage class action in New York brought by former interns of Conde Nast Publications that settled for nearly $6 million in November, the judge allowed the claims administrator to contact possible class members with an “InMail” message on LinkedIn.
Steven Weisbrot, the executive vice president of notice and strategy at Angeion Groupwho implemented the class action notice plan in the case, said this is a fairly routine operating procedure.
He estimated that about 15 to 20 percent of settlements today have some social media or digital notice component, and he expected that figure to continue to grow.
“I think social media will be an element of settlement notification, and in certain cases, it will be the prevailing methodology as social media gains continued acceptance and as parties and judges recognize its efficiency,” he said.
Notifying individuals via social media has a number of advantages. Social media is far more cost-efficient compared to mailing notices to thousands of potential class members, and it is a quick way to reach out to a broad audience, according to experts.
“Social media is undoubtedly the fastest growing way to effectively communicate with a mass audience,” said Casie Collignon, a partner at BakerHostetler. “If your goal is to reach out to the most amount of people to hear about a class action, social media is an excellent way to expand that reach.”
Notice providers can use social media to target specific groups of potential class members based on age, gender, job classification and other factors, such as shopping behavior and known brand affiliations. Companies like Angeion Group also are able to track who is reading a class action notice in real time and make strategic changes to make sure the notice gets traffic.
“If we see that a class action settlement ad is producing more interest on a sports site, for instance, than a news site, we can have it appear on more sports sites,” Weisbrot said. “In contrast, once an ad is in People magazine, it’s in People magazine.”
Collignon said that over the last five years, every settlement she has handled in her class action defense practice at some point involves a conversation about whether it is appropriate to notify potential class members through social media, and in about half of those cases, social media is added as a component of the notification program.
“I think where we see more social media notices for class action settlement is when the notification channel is tied to the subject matter of the lawsuit,” she said. “For example, if the class action lawsuit involves issues related to social media, it may make sense to at least explore the option of notifying class members about the settlement through a social media channel. Also, when a case involves a younger population or online behavior, those are excellent options for social media notification.”
However, using social media as a notification method also has various risks associated with it that attorneys should be mindful of when developing a notification program, according to experts.
Some individuals may prefer being contacted through social media about pending litigation, but others may be less open to receiving such notice, especially if it could be seen by their Facebook friends and Twitter followers, and particularly if it involves sensitive subjects, such as litigation involving people who had health complications following vaginal mesh surgery or who bought contaminated baby formula.
“While there is an entire generation of people who increasingly rely on social media to communicate, there is the other half of Americans at the other end of the spectrum who don’t want information about their legal rights — or about them at all — out there in the social media space,” Collignon said. “People may not want all their friends to know what products they buy and who they do business with.”
Courts seem to be concerned about making sure that a social media notice program is not overbroad. Judge Nathan in the Gawker case in March rejected the plaintiffs’ initial social media request, saying that their proposed plan to post notices on Tumblr and on Reddit pages such as “r/OccupyWallStreet” and “r/Progressive” would call the attention of individuals not connected to the Fair Labor Standards Act suit rather than individuals with opt-in rights.
The judge noted that the purpose of FLSA notice is to inform eligible plaintiffs to opt in to the collective action, not to advertise the defendants’ alleged violations.
“Courts are sensitive to the fact that because of the breadth of an Internet or social media posting, if a notice is directed to potential class members, that needs to be balanced with the potential reputational harm of a consumer-oriented company by advertising that any class action exists,” said Shari Claire Lewis, a partner at Rivkin Radler LLP.
Notice must be the primary objective to reach potential members of a class or collective action through social media, and content of the notice shouldn’t unduly prejudice any party’s rights in the litigation, according to Richard.
“Content can’t be used to punish the defendant or publicize the case, but rather to reach individuals and notify them of their rights in a class or collective action,” he said.
Attorneys also should keep in mind that while class action notification is a creature of due process, social media is a creature of a trend, according to Collignon. What may be a popular social media site one moment may be obsolete the next.
"Good notice programs have to make sure they are honoring trends to help notify as many people as possible, but at the same time, attorneys have to be cognizant that they are relying on a trend to convey important legal rights,” she said.
While social media is often one component of notification programs, Lewis said she could envision cases where a social media-only notification plan arises, such as in litigation over cyberintrusion claims and the only relationship between the class members and the defendant is virtual.
Attorneys need to be aware that courts are going to increasingly come down in favor of notice plans that include social media as an element, Lewis said.
“Lawyers can’t ignore what is going on,” she said. “Social media is the equivalent of a virtual street corner for the exchange of ideas, and more and more, we are likely to get notice out through social media rather than print media.”
The case is Mark et al. v. Gawker Media LLC et al., case number 1:13-cv-04347, in the U.S. District Court for the Southern District of New York.
--Editing by Jeremy Barker and Philip Shea. -
Women Who Suffer from Incontinence are No Longer Under Pressure
Apr 25, 2015 | Irish Examiner
Toilet mapping’ and ‘latchkey urgency’ are phrases you’re probably going to hear more about as women increasingly seek help for an embarrassing problem which affects large numbers of them — leaking urine.
There are women who know the location of every public toilet in their local town or city, says Barry O’Reilly, consultant obstetrician and gynaecologist at Cork University Maternity Hospital and the Bon Secours Hospital.
And why?
Because more than one in three mothers-to-be in Ireland report leaking urine in early pregnancy, while half of all new mums say they ‘leak’ for up to three months after giving birth.
It plays havoc with their sex lives and restricts their ability to exercise or even enjoy some fun with their small children, even leaving them fearful even to laugh or sneeze.
That’s according to a study underway by researchers from Trinity College Dublin, who are looking into all aspects of maternal health for first-time mothers.
The MAMMI (Maternal Health And Maternal Morbidity In Ireland) study is following more than 2,600 women through their pregnancy and for one year after birth, recording their experiences.
Women were traditionally deeply reluctant to discuss the problem — but that’s changing, believes Dr O’Reilly.
A year ago, he and other experts addressed an information night at a Cork City venue on the issue of urinary and stress incontinence.
The speakers expected about 40 women to turn up — instead they got an audience of more than 200.
Dr O’Reilly, who founded the Continence Foundation of Ireland (www.continence.ie ) a decade ago to highlight the issue, provide information, develop a strategy to deal with the problem, and carry out research, says urinary continence is a “huge quality-of-life issue” for affected women.
The Continence Foundation recently published the findings of a study into more than 1,000 first-time mothers — it showed that about 40% of women had experienced bladder problems of some kind prior to pregnancy, and that these problems worsened following childbirth.
There are two main issues, says Dr O’Reilly — one of which is the overactive bladder that has women constantly running to the loo.
“They experience a sense of urgency, and they will have an accident if they don’t make it to the loo on time.
“Such women will know every public loo in Cork City if they are going out,” says Dr O’Reilly, explaining that this has been dubbed ‘toilet mapping’.
“They are so worried about it that it takes over their life.”
Affected women can be prone to ‘latchkey urgency’, which, he explains, “is about coming home and putting your key in the lock and then dropping everything and running to the loo”.
Such women may also have to rise several times during the night to visit the toilet.
“The quality of life issues include lack of self-esteem, missing work because they are embarrassed, avoiding social functions or visiting people — for fear they may have an accident on someone’s couch,” says Dr O’Reilly.
It can result in serious lifestyle changes, warns Shirley McQuade, medical director of the Dublin Well Woman Centre.
“The estimate is that at least one in five women over the age of 40, if not more, can develop urinary incontinence issues over time,” says Dr McQuade.
“It can change your lifestyle and make you more isolated if you’re not going out and meeting other people in walking groups or in the gym — a lot of women avoid social contact which can cause depression.”
Managing the problem includes lifestyle modification — being aware, for example that caffeine is a potent stimulant to the bladder and only using decaf, restricting intake of liquids to one and a half litres daily and trying to train the bladder by trying to ‘hold on’ for longer before running to the loo.
Dr McQuade urges women to seek medical treatment.
“A lot of women are embarrassed to talk to the doctor about this problem, but there are lots of good way to treat it and improve or even eliminate it through a range of different exercises,” she says.
“Bladder retraining and pelvic flow exercises are successful in the vast majority or about 80% of cases.
“Get yourself checked out and ensure there is nothing medically wrong like a urinary tract infection. This problem is very common and there are lots of ways of dealing with it.”
Urinary incontinence has an “insidious” way of affecting life, warns Michele Pippet, psychotherapist and counsellor with the Well Woman centre in Dublin.
“It impacts on daily activities,” she says, explaining that while some women experience minimal leakage, others can have a severe problem which can make them reluctant to participate in everything from exercise to social life and which may cause anxiety, isolation, and low mood.
“It can impact on your confidence and your social interaction,” says Ms Pippet.
For those who do not find relief as a result of physiotherapy and pelvic floor exercises, medication can also be prescribed and is reasonably effective, say the experts.
However, where medication doesn’t work, says Dr O’Reilly, doctors may inject Botox into the bladder to paralyse the muscles.
“The bladder is a muscular bag and injecting Botox into the bladder relaxes the muscles and soothes the irritable contractions of the bladder — it lasts for up to six months.”
Another type of urinary incontinence is stress urinary incontinence, where women ‘leak’ as a result of coughing sneezing, laughing, jumping, or exercising.
“This is a problem that most women who have had babies would be familiar with — it’s caused by a looseness of the pelvic floor muscles,” says Dr O’Reilly.
The problem intensifies with exercise, so women may stop exercising. This can result in weight gain which not only exacerbates the problem but can cause depression, as well as lack of self-esteem and embarrassment.
Social isolation can also result from non-interaction with friends and family — some women may not even feel able to play with their children.
Sling surgery can tackle the problem — the technique involves inserting a sling or hammock-like support for the bladder.
“That has been a fantastic revolution in the treatment of stress incontinence but it is done under anaesthetic and requires an overnight stay in hospital,” says Dr O’Reilly.
However, he believes a recently developed method — trans vaginal laser therapy — will revolutionise the treatment of stress incontinence.
Dr O’Reilly offers the procedure, which is office-based and requires the patient to lie on a couch while a laser probe, an erbium laser, is inserted into the vagina.
“Basically it heats up the walls of the vagina,” says Dr O’Reilly. “The walls contain collagen. Heating allows the collagen to re-form and new blood is attracted to the area.” This strengthens the support structure around the bladder.
“It’s painless, currently requires two applications of 20 minutes each and so far has proved 90% efficacy a year after treatment,” he says. The treatment is ideal for women who are between babies, and experiencing severe leakages.
“Generally we would reserve the sling surgery until a woman’s family is complete and the youngest is mobile,” he says.
Women are increasingly willing to discuss the problem and seek treatment.
“Women are discussing the issue with their friends more and more, whereas previously it was not something that you would talk about.”
n A comprehensive overview on how to identify the pelvic muscles, pelvic floor exercise and bladder re-training such exercises is available on the Well Woman centre at www.wellwomancentre.ie
Eileen began to ‘leak’ while walking with group
In 2012 Eileen* started to experience ‘leakage’ during outings with a group of women from her regular aerobics class.
“It came out of the blue,” she says.
“There was no reason for it, but generally after I had been walking for about half an hour or more it would happen.”
The women in the group were extremely fast walkers, she recalls, and eventually she noticed that the leakage only seemed to occur when she was with them.
“I found that when I was keeping up with them it would happen.”
Embarrassed, she let it go for nearly two years, but eventually sought medical advice in 2014.
The GP recommended that she have a scan, which came back negative.
“Once I found that there was nothing wrong, I didn’t see any point in taking it further,” says Dublin woman.
She simply stopped walking with the group in September 2014 she experienced no further trouble.
She now walks alone, and at her own pace, every day and never drinks coffee before going out anywhere because she finds she experiences a sense of urgency.
“However I still wear pads every day, just in case. Once you have had one accident, you will never again take a chance.”
*Name has been changed
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SIMPLY FIT: Nourishing and nurturing your body back to normal is so important for new mums
Apr 25, 2015 | Lincolnshire Echo
By Lisa Gimenez-Codd
Spring! A time of rebirth, of blossoming and blooming plants, with little lambs skipping in fields.
This article is not about spring though, it's dedicated to new mums.
Whether you are six days, six months or six years post-partum (after childbirth) nurturing your body should be sacrosanct… so why are so many new mums in a dash to get back to the gym?
Talking of the number six, there's that six week post-natal check with your GP/midwife that gives you the "all-clear to return to exercise".
Let's just consider what that actually means as I receive queries from ladies who, only four or so weeks after giving birth, are asking whether they can go back to spinning, zumba and/or the gym.
What's the rush?
Healing
Is being seen to be "bouncing back" more important than allowing your body to properly recover?
Is fitting back into those skinny jeans within X weeks of giving birth more important than making sure your abdominals heal fully?
Is being fitter than someone else more important than protecting yourself from a pelvic organ prolapse in a few years' time?
I'd say no, no and never!
Our bodies adapt to pregnancy over the course of nine months with tidal changes in our hormones, differences in our alignment and muscle tone and, not forgetting, the impact of childbirth.
Whichever birthing method your baby arrived by, there is a whole lot of healing needs to go on in your tissues – externally and internally.
Being a parent is a tough job. If it's your first, you're on a learning curve like no other.
Sleep deprivation has a huge impact on how your body responds to different stimuli.
Your uppermost layer of abdominals may have separated and/or weakened.
Your alignment may have changed to counteract the weight of baby during pregnancy.
Your pelvic floor will most definitely have been affected by the weight of baby, uterus, placenta and all that amniotic fluid during pregnancy alone. All of these factors, among others, need to be taken into account when considering how you are going to "regain your pre-baby body".
To be honest, I don't like that phrase. Your body has just done something truly amazing – why would you want to erase that?
You are not the you that you were pre-baby so why strive so hard to regain that body?
Why not focus on the body you have now. Nourish and nurture it. Allow it time to recover, heal and blossom... just like the spring.
If you'd like more information on returning to exercise after childbirth, healing Diastasis Recti or addressing pelvic floor issues get in touch with me at Custom Fitness or at: www.custom-fitness.co.uk org
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