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Ethicon 13/05/15
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J&J blinks in vaginal mesh cases, drops complaint over patient solicitation
May 13, 2015 | Fierce Medical Devices
By Stacy Lawrence
Johnson & Johnson ($JNJ) has already dropped a legal tactic it adopted just a month ago in its defense against lawsuits over the transvaginal mesh devices from its Ethicon subsidiary. -
Boston Scientific settles mesh lawsuit
May 13, 2015 | Mass Device
By Brad Perriello
Boston Scientific reportedly agrees to settle a product liability lawsuit over its pelvic mesh a week into the trial. -
Restore dignity through pelvic floor awareness, treatment
May 13, 2015 | Coloradoan
By Tim Gebhardt and Terry Flynn
The National Association For Continence (NAFC) estimates more than 80 percent of those affected by urinary incontinence can be cured or improved with conservative management. -
Newly funded research effort aims to improve quality of life for women undergoing surgery for endometrial cancer with symptomatic pelvic floor disorders
May 13, 2015 | UAB News
By Tyler Greer
“Finding effective ways to jointly manage endometrial cancer and urinary incontinence provides the opportunity to reduce patient risk, cost and inconvenience, and to prevent the discomfort and recovery from two distinct surgical procedures,” Bevis said. -
Talc-ovarian cancer link sparks growing legal battle
May 13, 2015 | Tuscon Sentinel
By Myron Levin
By J&J’s count, at the end of 2014 it faced 56,300 personal injury claims in the U.S. involving three product lines: hip implants, Risperdal and pelvic mesh devices made by its Ethicon Inc. subsidiary.
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J&J blinks in vaginal mesh cases, drops complaint over patient solicitation
May 13, 2015 | Fierce Medical Devices
By Stacy Lawrence
Johnson & Johnson ($JNJ) has already dropped a legal tactic it adopted just a month ago in its defense against lawsuits over the transvaginal mesh devices from its Ethicon subsidiary. In mid-January, J&J asked the district judge overseeing the federal lawsuit to investigate phone calls urging women with the implant to file suit against the company.
But now it's dropped that strategy, requesting to withdraw that motion to U.S. District Judge Joseph Goodwin in the Southern District of West Virginia, according to a report by Reuters.
Late last week, Goodwin told lawyers that they were not being helpful given some recent motions. The judge encouraged a comprehensive settlement between 7 devicemakers and the plaintiffs in the 70,000 lawsuits they face over potentially dangerous transvaginal mesh. They are alleged to lead to painful problems including bleeding, infection and nerve damage.
The lead plaintiff's lawyer, Bryan Aylstock, told Reuters he is pleased with Ethicon's decision and that both sides have "pledged to work together to attempt to put an end to any wrongful solicitations of clients."
A number of devicemakers have made settlements. In fact, Goodwin said during a hearing that he could not "imagine a corporation facing potentially billions of dollars in verdicts wouldn't find it advisable to try to achieve a settlement for a much lesser sum" and pointed to other "rather large" verdicts from similar cases. These include awards to two sets of four women worth $18.5 million and $26.7 million for suits filed against Boston Scientific ($BSX) for its vaginal mesh product.
Also, J&J has agreed to settle more than 100 product liability lawsuits regarding pelvic mesh products sold by its Mentor subsidiary.
Two manufacturers have already heeded the judge's advice and arrived at a comprehensive settlement. Endo ($ENDP) agreed in October of last year to pay an additional $400 million to settle "substantially all" of the remaining claims related to its vaginal mesh implants. And Danish devicemaker Coloplast paid $16 million to settle lawsuits claiming it injured women with vaginal mesh inserts in March 2014.
The FDA issued a warning against vaginal mesh implants as early as 2008. It stated: "The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia."
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Boston Scientific settles mesh lawsuit
May 13, 2015 | Mass Device
By Brad Perriello
Boston Scientific (NYSE:BSX) reportedly agreed to settle a lawsuit brought by a woman who alleged she was injured by 1 of the company's transvaginal mesh devices, which have been the target of more than 26,000 product liability lawsuits.
The confidential settlement was reached yesterday, a week after a trial began in U.S. District Court for the Central District of California, according to plaintiff's attorney Jim Perdue of Perdue & Kidd, Reuters reported.
The case, brought by Roseanne Sanchez, is the 6th to go to trial against Marlborough, Mass.-based Boston Scientific over its mesh products, which are designed to treat pelvic organ prolapse and female urinary incontinence, according to the news service.
In April Boston Scientific agreed to a $119 million deal to settle nearly 3,000 of the lawsuits. That same month a federal judge ruled that punitive damages claims against the company can stand in another of the cases.
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Restore dignity through pelvic floor awareness, treatment
May 13, 2015 | Coloradoan
By Tim Gebhardt and Terry Flynn
Admittedly, there are few possessions in our daily routine that we just want to work; computers, cars and much more intimately, our pelvis. Despite multiple anatomy courses earlier in my education, my understanding of the pelvic region was unknowingly limited to key reproductive organs and bones. In physical therapy school, upon a detailed study of our muscles ‘down there,’ I was floored to learn that I had been anatomically shortchanged in prior lessons. The age of selfies and body consciousness lend hyperawareness of our body and self-image; however, understanding of our own ‘downstairs’ is often minimal, at best. The pelvic floor has critical implications for our most intimate processes.
The pelvic floor is a small but mighty group of postural muscles, ligaments, connective tissues and nerves that supports our low back and pelvis. Consider it a hammock stretched between the pubic bone, tailbone and both sit bones at the base of the pelvis. As part of our core muscles, the pelvic floor assists in continence (regulating bowel and bladder function), sexual function and provides stability for the pelvic girdle and spine — a worthy contender for the ‘most under-appreciated’ anatomy award.
When communication of pelvic floor, core muscles and related structures is disrupted, regional unrest can ensue. Pelvic floor dysfunction refers to an array of symptoms, including incontinence, pelvic pain (including painful intercourse) and pelvic organ prolapse (descent of pelvic organs). Onset often varies from gradual to injury, surgery, weakness or infection. These disorders can also create pain in the middle and low back, abdominal, groin, tailbone, hip, sacroiliac or pelvic areas. Such dignity-compromising symptoms often become entwined with emotional distress, shame, difficulty with exercise and body issues and intimacy struggles — not to mention increased healthcare costs if addressed with medical professionals.
Research in 2014 suggested at least 25 percent of non-pregnant women reported one or more pelvic floor disorders, including urinary or fecal incontinence, urgency and pelvic organ prolapse. Additionally, chronic pelvic pain, or pain lasting greater than six months, affects 15 percent of women between the ages of 18 and 50. While all too common, these symptoms are not ‘normal.’ Contrary to popular belief, urinary incontinence and pelvic issues are not inevitable parts of the aging process. For example, if you have leakage with sneezing, laughing or other physical activity, find yourself routinely rushing to the restroom or have pain with intercourse, it is not normal and likely indicative of pelvic floor involvement or dysfunction.
The National Association For Continence (NAFC) estimates more than 80 percent of those affected by urinary incontinence can be cured or improved with conservative management. Incontinence, pelvic organ prolapse, pelvic pain and other symptoms are often due to muscle problems and can be successfully treated with physical therapy provided by a therapist specializing in pelvic health.
In clinic, I describe the role of our musculoskeletal system in pelvic floor disorders with a simple, musical truism of younger years: “The knee bone’s connected to the hip bone.” The pelvic floor is both integral in and influenced by its near next-door neighbors. A tiny group of postural muscles cannot act in mere isolation; these muscles function in a coordinated, integrated system of the deep core and surrounding tissues and joints.
‘Core muscles’ are exceedingly misrepresented as six-pack abdominals, boasting the cover of popular newsstands. Anatomically, we must dig deeper for structures that actively coordinate in support of the spine and pelvic region. Clinically, I depict these muscles with analogy of a house:
· Roof: Diaphragm. Dome-shaped support assisting with breathing and synchronized with pelvic floor motion;
· Basement: Pelvic floor muscles. Support pelvic organs, bowel and bladder control and sexual function;
· Back door: Multifidus muscle. Supports every segment of the spine;
· Front door: Transversus abdominus. Stabilizes lumbar spine and pelvic floor as our deepest abdominal layer and natural corset.
Simply, when issues with the pelvic floor arise, we must consider the pelvic muscles as part of a whole-body approach to treatment. To start, diaphragmatic breathing is an effective exercise to coordinate the active walls of this anatomical powerhouse.
Mainstream advice assigns kegels, or pelvic floor contractions, as cure-alls for pelvic woes. As a physical therapist, if a patient walks into clinic with knee pain, I do not send them sprinting to the gym in pursuit of a quadriceps weight lifting routine — I evaluate and treat the patient as appropriate. Similarly, pelvic floor issues first necessitate proper evaluation of these muscles and related structures as a part of an integrated, whole body approach to treatment. Not every pelvic floor needs kegels. Physical therapy’s customized, hands-on techniques, muscle retraining, cognitive-behavioral advice and targeted exercise can restore dignity and control for patients facing pelvic floor disorders.
For additional resources on pelvic pain and incontinence visit our website at www.ColPTs.com.
Dr. Gina Yeager, PT, DPT specializes in pelvic health and was the guest columnist.
Drs. Tim Flynn and Terry Gebhardt are physical therapists and owners of Colorado Physical Therapy Specialists.
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May 13, 2015 | UAB News
By Tyler Greer
A research team in the University of Alabama at Birmingham Department of Obstetrics and Gynecology, in partnership with Brown University, has been approved for a three-year, $2 million funding award by the Patient-Centered Outcomes Research Institute to study better ways to coordinate the care of endometrial cancer patients among gynecologic oncologists and urogynecologists in an effort to improve long-term quality of life for these women.
The impetus for the study, says Kerri Bevis, M.D., principal investigator and assistant professor in UAB’s School of Medicine, is that women with endometrial cancer also often experience pelvic floor disorders, including urinary incontinence and prolapse. In most cases, the surgeries to remove the cancer and to correct the pelvic floor disorders are performed months or even years apart. The grant will give Bevis and others at UAB an opportunity to develop protocols where both issues can be surgically managed simultaneously.
“It will take a lot of coordination between gynecologic oncologists and urogynecologists to make this program effective, but this is a big step forward for endometrial cancer care in general,” Bevis said. “This is a comprehensive approach to cancer care. It is not only about the isolated treatment of endometrial cancer, but about taking that next step toward maximizing the patient’s ability to live her life to the fullest after her cancer therapy is complete. It really is about caring for the whole patient — more than just her cancer.”
Holly Richter, Ph.D., M.D., director of UAB’s Division of Urogynecology and Pelvic Reconstructive Surgery, is supportive of this research effort.
“Coordination of care for these patients is vital to improving long-term outcomes, and the UAB divisions of Gynecologic Oncology andUrogynecology are committed to this partnership in optimizing care of these women,” Richter said.
The American Cancer Society estimates about 54,870 new cases of cancer of the uterus are diagnosed each year. Of those, about 10,170 women will die from uterine cancer. While there is nothing life-threatening about urinary incontinence, it is an important predictor of quality of life after cancer treatment in these patients. Stretching two surgeries out over months or years — one to remove the cancer and one to repair pelvic floor disorders — is not in the best interest of the patient, Bevis says.
“Finding effective ways to jointly manage endometrial cancer and urinary incontinence provides the opportunity to reduce patient risk, cost and inconvenience, and to prevent the discomfort and recovery from two distinct surgical procedures,” Bevis said. “We understand that the risk for mortality in women with early stage endometrial cancer stems primarily from comorbidities like obesity, heart disease and diabetes. Urinary incontinence can be a strong deterrent to physical activity for these women, so effective management of their incontinence may reduce barriers to the critical lifestyle changes needed to improve their future health. Hopefully, we can prove that managing both removing the cancer and repairing pelvic floor issues at the same time is something that is feasible and results in a longtime improvement in quality of life.”
The study is one of 46 proposals that PCORI approved for funding April 21 to advance the field of comparative clinical effectiveness research and provide patients, health care providers and other clinical decision-makers with information that will help them make better informed choices.
“This project was selected for PCORI funding, not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to fill an important gap in our health knowledge and give people information to help them weigh the effectiveness of their care options,” said PCORI Executive Director Joe Selby, M.D. “We look forward to following the study’s progress and working with UAB to share the results.”
Bevis’ study and the other projects approved for PCORI funding were selected through a highly competitive review process in which patients, clinicians and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders and their methodological rigor, among other criteria.
PCORI is an independent, nonprofit organization authorized by Congress in 2010 to fund comparative clinical effectiveness research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health and health care decisions. PCORI is committed to seeking input from a broad range of stakeholders to guide its work.
PCORI has approved $854 million to support 399 research studies and initiatives since it began funding research in 2012. More information about PCORI funding is online.
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Talc-ovarian cancer link sparks growing legal battle
May 13, 2015 | Tuscon Sentinel
By Myron Levin
Deane Berg’s doctor called her in the day after Christmas, 2006, to give her the crushing news. She’d had her ovaries removed, the pathology results were back, and they could not have been much worse. Berg had stage IIIovarian cancer, and her prognosis was poor.
Despite her 25 years as a physician’s assistant, Berg, then 49, knew next to nothing about ovarian cancer. Grappling with the “why me?” question, she studied the risk factors, finding just one that could apply: regular use of talcum powder for feminine hygiene.
Talc powder might be a cause ovarian cancer–who knew? It turned out that some people did. Berg was stunned to learn that since the early 1980s, a slew of studies had found that women who regularly used talc powder for feminine hygiene had higher than average rates of ovarian cancer. Yet the evidence–which fell short of proving causation–was mostly confined to medical journals and had barely made a blip on the public radar.
For millions of women, Berg included, dusting the genitals or underwear with powder was a daily ritual, like brushing teeth. Since her teens, Berg had used Johnson’s Baby Powder and Shower to Shower, another Johnson & Johnson powder marketed to women. “A sprinkle a day keeps odor away,” the ads said. “Your body perspires in more places than just under your arms.”
How could a product meant for babies be dangerous? “This is crazy,” Berg recalled thinking. “Why aren’t they warning women about it?”
So after painful rounds of chemotherapy, Berg filed a first-of-its-kind lawsuit against J&J in federal court in her home town of Sioux Falls, S.D. A mystifying verdict in October, 2013, enabled both sides to declare victory. The jury found Johnson & Johnson Consumer Cos., guilty of negligence for failing to warn of the risk of ovarian cancer, but awarded zero damages to Berg. More on this later.
Yet the case brought a slow-building controversy to a head. Plaintiff lawyers, heartened by a liability finding in arch-conservative South Dakota, have since brought claims for about 700 ovarian cancer victims or their survivors, blaming the disease on exposure to talc powder. More cases are in the pipeline. Along with J&J, the suits name Imerys Talc America, Inc., part of the global mining concern that supplies talc to J&J. Other marketers of talc powder and the Personal Care Products Council, a Washington, D.C. trade group for cosmetics makers, are named in some of the cases.
Lawsuits against Johnson & Johnson contend that women contracted ovarian cancer from using its talc powders for feminine hygiene. The company says there is no causal connection.
“We use this on children … and it had to be a good thing, right?” said plaintiff Deborah Giannecchini, 62, a Modesto, Calif., hospital secretary diagnosed with metastatic ovarian cancer in November 2012.
This is an ugly disease,” she told FairWarning. “I sure would have appreciated being given the chance to say this is worth the risk or it isn’t.”
In J&J, “we’re dealing with a company that has done nothing to inform customers of the risk and, in fact, I believe has taken steps to hide the risk from the public,” said Ted Meadows, a lawyer with the Montgomery, Ala., firm of Beasley, Allen, which is involved in many of the cases.
Imerys and the Personal Care Products Council wouldn’t comment, and J&J refused interview requests, but released a statement: “We have no higher responsibility than the health and safety of consumers who rely on our products. It is important for consumers to know that the safety of cosmetic talc is supported by decades of scientific evidence and independent peer-reviewed studies.”
The companies contend that statistical associations between talc use and ovarian cancer are weak, and may result from bias in the study methods. A causal link is not biologically plausible, they say, since there is no proof that talc particles can pass through the genital tract to the ovaries or that, once there, they could cause malignant growths. There is no causal link, they argue, so warnings were unnecessary.
Most of the lawsuits have been filed in New Jersey, where J&J is headquartered, or in state court in St. Louis, Mo., considered a favorable venue for plaintiffs. The first trials are scheduled for early 2016.
About 20,000 U.S. women annually are diagnosed with ovarian cancer, and more than 14,000 die. Ovarian cancer strikes about one woman in 70. Studies showing a higher rate of the disease with talc use have typically found an increased risk of about 35 percent—which would put the odds at about one in 50.
Talc, the softest of minerals, has a multitude of industrial and consumer product uses, including in the manufacture of paints, paper, rubber, roofing and ceramic materials, and even as a food additive, a filler in capsules and pills and in cosmetics.
Complicating the health question is that talc deposits are often interlaced with other minerals, including asbestos. That means the danger, if any, may be due to impurities, rather than talc itself. Over the years, some groups of talc miners have been stricken with asbestos diseases. Talc suppliers have also paid settlements or judgments to factory workers, such as tire makers, who contracted asbestos-related illnesses following exposure to industrial grade talc.
In 1976, researchers at Mount Sinai Hospital in New York published test results on 20 talc-based consumer products, including baby and facial powders. They found two types of asbestos, tremolite and anthophyllite, in 10 of the 20 products.
That same year, the Personal Care Products Council (then called the Cosmetic, Toiletry and Fragrance Association) issued a standard requiring “a complete absence of detectable asbestos in cosmetic talc.”
J&J vows that its talc is “asbestos free, as confirmed by regular testing conducted since the 1970s.” The ovarian cancer suits take the claim at face value, asserting that talc itself, not impurities, caused the disease.
The suits charge J&J with failing to take the precaution of replacing talc with cornstarch, which has similar skin-soothing properties but has not been linked to health risks. While defending the safety of talc, J&J has offered powders with cornstarch or cornstarch-talc blends.
In October 2012, for reasons neither company would discuss, J&J sold North American marketing rights to Shower to Shower to Valeant Pharmaceuticals.“Inaccurate, to phrase it euphemistically”
Suspicions about talc and ovarian cancer go back decades. In 1971, British researchers analyzed 13 ovarian tumors under a microscope and found talc particles ‘’deeply embedded” in 10.
In 1982, the journal Cancer published the first study showing a statistical link between genital talc use and ovarian cancer. Soon after, lead author Dr. Daniel Cramer, a gynecologist and Harvard Medical School professor, was visited by a senior scientist from J&J. He “spent his time trying to convince me that talc use was a harmless habit,” Cramer recalled in a document filed in court, “while I spent my time trying to persuade him … that women should be advised of this potential risk.”
Altogether, about 20 epidemiological studies have found increased rates of ovarian cancer risk for women using talc for hygiene purposes, though some studies have found no association. One report, published by Cramer and several co-authors in 1999, said talc use could be the cause of about 10 percent of ovarian cancers in the U.S.–or some 2,000 cases per year. “Balanced against what are primarily aesthetic reasons for using talc in genital hygiene, the risk benefit decision is not complex,” the study said. “Appropriate warnings should be provided to women about the potential risks of regular use of talc in the genital area.”
In response to such findings, the Cancer Prevention Coalition, an advocacy group, asked the Food and Drug Administration in 1994 to require warnings against talc use for genital hygiene. The agency said it lacked evidence to require warnings, and J&J refused to issue them voluntarily.
Instead, the company and its allies circled the wagons. In 1992, the cosmetic and fragrance association launched a Talc Interested Party Task Force to develop talking points and find experts to rebut studies linking talc to ovarian cancer.
But some statements by the trade group were “inaccurate, to phrase it euphemistically,” a consultant for J&J warned. In two 1997 letters to company officials (here and here), toxicologist Alfred P. Wehner attacked statements that “the scientific evidence did not demonstrate any real association between talc use in consumer products and ovarian tumors.”
“There are at least 9 epidemiological studies published in the professional literature describing a statistically significant (albeit weak) association between hygienic talc use and ovarian cancer,” Wehner wrote.
“Anybody who denies this risks that the talc industry will be perceived by the public like it perceives the cigarette industry: denying the obvious in the face of all evidence to the contrary. This would be a particularly tragic misperception in view of the fact that the industry does have powerful, valid arguments to support its position.”“Arrogance and insolence”
As debate continued in scientific circles, the National Toxicology Program, part of the U.S. Department of Health and Human Services, ruled in 2005 that existing data were insufficient to list talc as a cancer-causing agent.
The following year, however, the International Agency for Research on Cancer, part of the World Health Organization, classified talc as a 2B agent–“possibly carcinogenic to human beings,”–based on the “remarkably consistent” results of epidemiological studies. “A positive association was observed,” IARC said, “but chance, bias or confounding factors cannot be ruled out with reasonable confidence.”
Industry officials have downplayed the significance of the IARC action, noting that coffee drinking is also listed 2B for possible links to bladder cancer. But emails produced in the Berg case show industry officials were deeply upset by the IARC ruling.
A senior executive with J&J talc supplier Luzenac America (now known as Imerys), condemned the decision as “a travesty of scientific integrity.”
Rich Zazenski, Luzenac’s director of environment and safety, declared in the Feb. 27, 2006 email to a J&J official: “I can’t believe the arrogance and insolence of this ‘U.N. agency.'”
“Rest assured, we (I) will explore all possible avenues of challenge—not necessarily expecting a retraction—but to see what sort of political heat (with financial ramifications) that could and should be brought down upon IARC and WHO,” the email said. Zazenski died in 2008, and it’s uncertain if there was an effort to carry out the threat.
In 2013, the industry cheered the findings of an expert panel of the Cosmetic Ingredient Review, a group that is funded by cosmetics manufacturers but says its reviews are independent. The panel declared that talc “is safe in the present practices of use and concentration.”A coveted image
J&J was founded in the 1880s by the brothers Robert Wood, James Wood and Edward Mead Johnson. First aid kits, dental floss, sanitary napkins and baby powder were among their first products. Today, J&J is a $74 billion-a-year colossus with a workforce of nearly 129,000, more than 275 operating companies in over 60 countries, and a huge footprint in pharmaceuticals and medical devices, along with consumer health aids.
Yet the Johnson & Johnson name still evokes cherubic infants and adoring moms, burnishing an image that most big companies can only envy. Fortune Magazine’s 2015 list of most admired companies ranks J&J first in the pharmaceutical industry and 11th of 668 companies worldwide. In December, the website CareerBliss.com, ranked J&J number one on its list of the 50 Happiest Companies in America, which honors businesses with the most contented workers.
J&J last year won kudos for vowing to share clinical trial data with researchers, and for announcing it was testing an Ebola vaccine. In December, a 3 1/2 minute infomercial with singer-actor Jennifer Hudson on ABC’s “The View” touted one of J&J’s charitable endeavors.
“What a great company they are!” enthused Rosie O’Donnell, then co-host of The View. “They’re a wonderful company that America’s believed in for so long.”
Legal battles that have engulfed the company leave a different impression, however.
Last month, J&J’s McNeil Consumer Health Care division pleaded guilty to a criminal charge of selling adulterated medicines, including children’s Tylenol and Motrin that were contaminated with bits of metal. The plea deal with the Justice Department, which included a criminal fine and forfeitures of $25 million, capped a series of recalls and enforcement actions stemming from quality control breakdowns at McNeil’s Fort Washington, Pa., plant.
In November 2013, J&J and two subsidiaries, Janssen Pharmaceuticals and Scios, Inc., agreed to pay more than $2.2 billion to the U.S. and 45 states to settle criminal and civil charges of illegally promoting Risperdal and other anti-psychotic drugs for unapproved uses. They had also been accused of paying kickbacks to doctors and a major pharmacy to prescribe the drugs. As part of the settlement, Janssen pleaded guilty to a criminal misdemeanor. J&J settled the remaining civil allegations without admitting wrongdoing.
The same month, J&J’s DePuy Orthopaedics unit announced an agreement to pay about $2.5 billion to compensate 8,000 patients who had surgery to replace allegedly defective DePuy hip joints. Earlier this year, the company reached a similar settlement with another 1,400 patients–yet it still faces thousands of injury claims related to the DePuy implants.
By J&J’s count, at the end of 2014 it faced 56,300 personal injury claims in the U.S. involving three product lines: hip implants, Risperdal and pelvic mesh devices made by its Ethicon Inc. subsidiary.
The talc litigation, on the other hand, wasn’t even get mentioned in J&J’s 2014 annual report. Still, the challenge has not been taken lightly. J&J has retained as lead counsel the firm of Shook, Hardy and Bacon, a go-to corporate defender that has represented tobacco companies, drug and auto makers in high-stakes litigation.
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Deane Berg recalls her sense of shock and dread when she heard her diagnosis. Both she and her husband Jim broke down and wept.
She got chemotherapy through a port in her chest. It was painful, nauseating—”to put it point blank, holy hell … It put my family through a lot, too,” Berg said. Her first husband had died of lung cancer from smoking, and her two daughters now feared they would lose their mom, too. One called Berg from college every day to make sure she was all right.
“Once you get a cancer diagnosis … it never goes away,” Berg said. “There’s always that ultimate fear that it’s going to come back.” So far it hasn’t. Berg eventually returned to work as a physician’s assistant at the VA hospital in Sioux Falls. She figures her ordeal has made her better at the job.
“It has definitely taught me how important it is to take time with cancer patients, to give them concern and caring, and to say ‘I know what you’re going through,” she said in an interview. “I give them a hug and say we’re in this together.”
In studying the risk factors that might have led to her cancer, Berg mostly came up empty. Family history of ovarian cancer? No. Previous cancers? No. Mutations in the BRCA 1 or BRCA 2 genes? No. Use of fertility drugs; never having been pregnant; eating a high-fat diet—no, no and no. But some literature cited another possibility–genital use of talc.
Berg posted a question on the website of the National Ovarian Cancer Coalition, asking if anyone had used talc and contracted ovarian cancer. Soon she was contacted by a Mississippi lawyer named Allen Smith. After checking him out “to make sure he was legit,” Berg said, she authorized Smith to order an analysis of her tumor tissue. Talc particles were found inside. Explaining her decision to file a lawsuit, Berg told FairWarning: “I don’t want other women to suffer like I did if this could be prevented.”
Her case was tried in fall 2013. Medical experts for J&J dismissed the idea that talc caused her cancer as biologically implausible. They explained the discovery of talc particles in the tumor tissue as probably due to contamination, a common problem in hospitals. Berg’s lawyers sought to discredit the defense experts as hired guns, noting that two had testified on behalf of tobacco companies.
In its head-scratching verdict, the jury found the J&J subsidiary, Johnson & Johnson Consumer Cos., Inc., guilty of negligence for failing to warn Berg of the ovarian cancer risk. Though she had suffered losses—months of lost work time, permanent hearing loss and numbness in her hands and feet from chemotherapy; and the endless fear of her cancer coming back–the jury awarded no damages.
Berg said her lawyers were “dumbfounded,” and that she attributed the result to South Dakota being “a very conservative state.”
It tempers her anger to consider the big picture. “I’m lucky to be alive—really, really lucky,” she said. “I count my lucky stars, let’s put it that way, that I’m not gone.”
Contacted by FairWarning, jury foreperson Christina Wilcox explained the compromise verdict. Jurors decided that “the actual medical proof [that talc caused Berg’s cancer] was not there,” she said. “She [Berg] just got handed a bad deal.”
“However, we also felt that Johnson and Johnson should consider putting…something on the product to alert the consumers of the possible injury and the possible risk,” Wilcox said. “Let the consumer decide what they want to do.”
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