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Talc-Ovarian Cancer Link Sparks Growing Legal Battle
Apr 29, 2015 | Fair Warning
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. -
Boston Scientific Corporation Reports Q1 Loss On Strengthening Dollar, Rising Litigation Costs, Lowering 2015 Sales Forecast
Apr 29, 2015 | Bidness ETC
By Hannah Ishmael
The recent decline in revenues has also been largely affected by the ever rising litigation expenses. The medical device maker, as reported on Tuesday, will be paying almost $119 million for the settlement of as many as 3,000 claims and lawsuits that it currently faces regarding its transvaginal surgical mesh products. These allegations have come from over 25,000 women who have accused the company’s devices for leading to serious problems like urinary incontinence and pelvic organ prolapse. -
Pharmalot.. Pharmalittle.. Good Morning: We’re Catching up on Gilead, Merck and Lots More!!
Apr 29, 2015 | The Wall Street Journal
By Ed Silverman
Boston Scientific agreed to pay about $119 million to resolve 2,970 lawsuits over claims that its transvaginal mesh products to treat urinary incontinence were defective and caused harm, Reuters informs us.
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Talc-Ovarian Cancer Link Sparks Growing Legal Battle
Apr 29, 2015 | Fair Warning
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 hadstage III ovarian 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.[/caption]“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.
“We have no higher responsibility than the health and safety of consumers … 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.”
- Statement by Johnson & JohnsonIn 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.
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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Apr 29, 2015 | Bidness ETC
By Hannah Ishmael
The world’s leading device maker, Boston Scientific Corporation (NYSE:BSX), announced its first quarter financial results for 2015 before the opening bells on Tuesday, signifying loss at the back of rising litigation costs and higher than expected negative impact of the currency fluctuations.
Boston, for the first quarter of 2015 (1QFY15), reported a loss of $1 million, or $(0.00) per share, signifying a decline of 100% Year-over-Year (YoY) when compared to profit of $133 million, or $0.10 per share reported in the first quarter of last year. This loss figure reported for the recent quarter was also much lower than the profits of $206 million reported for the preceding quarter, thus signifying a fall of almost 100%.
Adjusted earnings per share (EPS) for Boston Scientific in the latest quarter, after excluding items like amortization, acquisition and divesture-related charges and pension termination costs, in contrary, saw a rise; reported to be $0.21 per share, adjusted EPS for the latest quarter signified an increase of 5% YOY as compared to last year’s first quarter figure which came in at $0.2 per share. The adjusted EPS figure reported for 1Q of 2015, proved to be in line with the analysts’ expectations of $0.21 per share, as per data compiled by Bloomberg.
Sales for the first quarter of this year, further added to the gloomy performance of the company. Revenues reported for the recent quarter, stood at almost $1.77 billion, signifying a decline of 0.34% YoY when compared to the first quarter revenues of 2014 which were reported at almost $1.77 billion; these revenues, however, also fell short on the Street estimates of $1.8 billion. However, when measuring revenues on a constant currency basis i.e. after excluding the negative impact of currency fluctuation, the recent quarter’s revenues saw a growth of 6% YoY.
The recent decline in revenues has also been largely affected by the ever rising litigation expenses. The medical device maker, as reported on Tuesday, will be paying almost $119 million for the settlement of as many as 3,000 claims and lawsuits that it currently faces regarding its transvaginal surgical mesh products. These allegations have come from over 25,000 women who have accused the company’s devices for leading to serious problems like urinary incontinence and pelvic organ prolapse.
In addition, the company’s revenues have also been largely affected by massive impact of currency fluctuations which led to a reduction in recent quarter’s sales by almost $117 million. However, when adjusted for these effects, the revenues did show considerable growth, as discussed before. This growth was the result of rising sales of the company’s cardiovascular stents, which is used to open up blocked arteries, and also from increasing sales of implanted defibrillators, which are used for treating irregular heartbeats.
Overall, the sales of the company’s largest division, formed of cardiovascular devices signified revenue growth of a significant 10% to a level of $712 million, on adjusted basis. Another major sales growth factor was the rise in sales of its neuromodulation devices unit, which saw a rise of 6% to $114 million, again on an adjusted basis.
Michael Mahoney, the Chief Executive of Boston Scientific, seemed very positive of the company’s recent quarter’s results, citing the fact that most of its business units reported growth which was much higher than the overall market, he stated: "We achieved strong results in the first quarter, and we continue to build global momentum. In particular, our Interventional Cardiology business, including structural heart, delivered excellent results. We are also excited about bringing new innovation to patients with the recent Food and Drug Administration approvals of the WATCHMAN™ Left Atrial Appendage Closure Device and the EMBLEM™ Subcutaneous Implantable Defibrillator System," as per the press release made by the company on Tuesday.
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Pharmalot.. Pharmalittle.. Good Morning: We’re Catching up on Gilead, Merck and Lots More!!
Apr 29, 2015 | The Wall Street Journal
By Ed Silverman
Rise and shine, everyone, the middle of the week has arrived. And this calls for a celebratory cup or two of stimulation. How so? Well, you made it this far, which can be an accomplishment, after all. Moreover, there is always good reason to forge ahead, given that there is so much more to do and the effort just might pay off. With this in mind, we have assembled the usual menu of tidbits for your perusal. Hope you have a smashing day and do drop us a line when you run across something interesting…
With Merck poised to disrupt competitors with new hepatitis C drugs, rivals are scrambling to get ahead the best way they can figure: make a medicine that works faster, Bloomberg News tells us. This is high stakes for drug makers like Gilead Sciences GILD -1.35%, which earned more than $12 billion in sales last year from Sovaldi and Harvoni. Along with Achillion Pharmaceuticals ACHN +0.22% and others, Gilead is trying to get treatment time down to six weeks or less, from 12 weeks or more offered by current drugs. Experts say it won’t be easy.
Wockhardt plans to recall some drugs made at its two plants in central India before the FDA banned those sites due to quality concerns, The Hindu Business Line reports. The FDA banned U.S. exports from Wockhardt’s Waluj and Chikalthana plants in 2013, citing manufacturing quality lapses. The facilities were re-inspected early this year following remediation measures taken by the drug maker. During the inspection, the FDA found batches of select drugs, which were exported prior to the FDA import alert, did not conform to stipulated quality standards.
Globus Medical asGMED -1.79%ked a federal judge in Delaware to overturn its $16 million patent infringement loss to Johnson & Johnson 'sJNJ -0.35% DePuy-Synthes unit because a key witness for Synthes lied on the stand about his credentials, MassDevice says. A jury decided in June 2013 that Globus infringed on three Synthes spinal implant patents, but in December 2014, Synthes learned that its witness did not have a Ph.D., as he testified to under oath, according to court documents.
Drug makers are racing to develop the first medicines to treat celiac disease, which researchers say is much more common than previously thought, according to The New York Times. Most of the drugs in development would not eliminate the need for a gluten-free diet, but would help alleviate symptoms when some gluten does leak into food and are being developed mainly by small companies, although some larger drug makers are also showing interest. Treatments are not expected to reach the market, however, until 2018.
Emboldened by its takeover of domestic rival Ranbaxy Laboratories, bankers tellReuters that Sun Pharma 524715.BY -0.47%ceutical is willing to spend as much as $7 billion on further acquisitions. On the Sun Pharma radar screen are U.S. and European companies that develop biosimilars and complex generic medicines that offer better margins than the simpler copycat drugs Indian drugmakers usually make and sell. With a cash balance of $1.5 billion and a debt-to-equity ratio of 0.13, Sun Pharma would find it easy to take on debt to fund any large acquisition, the bankers say.
Merck says the FDA again declined to approve Bridion, its drug to reverse the effects of muscle relaxants used in surgery, until the agency receives more data on allergic reactions to the product, according to Reuters.
Takeda Pharmaceutical confirmed reports that it agreed to pay up to $2.4 billion to settle U.S. lawsuits charging that the drug maker hid the cancer risk of its Actos diabetes drug,The Wall Street Journal says.
Amgen has begun hiring about 100 more research scientists and production engineers as part of an expansion at its office in Cambridge, Massachusetts at the same time as laying off more than 2,000 employees at other sites, InPharma Technologist confides.
Boston Scientific agreed to pay about $119 million to resolve 2,970 lawsuits over claims that its transvaginal mesh products to treat urinary incontinence were defective and caused harm, Reuters informs us.
The FDA will fast track a new use of the Brilinta heart drug sold by AstraZeneca reducing risks for patients who had a heart attack one to three years previously,Reuters writes.
Sanofi’s next-generation long-acting basal insulin Toujeo, which is a follow-up to the best-selling Lantus insuling, was approved for diabetes in the European Union, Pharma Times reports.
Celgene will acquire Quanticel Pharmaceuticals for up to $485 million, exercising an option to acquire the firm that was included in a cancer drug discovery collaboration they previously launched, Genetic Engineering & Biotechnology News says.
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