Monsanto Sues California Environmental Agency to Block “Probably Carcinogenic” Designation for Roundup

Agribusiness giant Monsanto Corporation has sued California’s Office of Environmental Health Hazard Assessment (OEHHA) to block the agency from adding glyphosate—the main ingredient in its herbicide Roundup—to the list of chemicals known to cause cancer.

The list of carcinogenic chemicals is authorized under California’s Proposition 65, a 1986 law to keep chemicals that cause cancer, birth defects, or reproductive harm out of the state’s drinking-water supply, Law360 reports. Monsanto said the listing was “virtually automatic” after International Agency for Research on Cancer (IARC) of the World Health Organization classified glyphosate as probably carcinogenic. Under Prop. 65, a business must post a warning when its operations or products will expose people to any of the chemicals on the list.  

Monsanto claims it was denied due process, that “OEHHA effectively elevated the determination of an ad hoc committee of an unelected, foreign body, which answers to no United States official (let alone any California state official), over the conclusions of its own scientific experts.” Phil Miller, Monsanto’s vice president for regulatory affairs, said OEHHA’s proposed listing is “contrary to science.” He said IARC’s designation is “erroneous, non-transparent and based on selectively interpreted data,” according to Law360.

Monsanto claims that the portion of the California Labor Code that cites IARC findings as a basis for Prop. 65 inclusion violates the California and U.S. constitutions. Monsanto told the court that during the 40 years Roundup has been in use, regulators and scientists who have not found an associated cancer risk. The OEHHA itself was one of the evaluators. The agency concluded in1997 and again in 2007 that glyphosate is not likely to pose a significant cancer risk to humans, Law360 reports.

Roundup is widely used commercially on crops such as corn and soybeans and also widely used use by landscapers and home gardeners. The Environmental Protection Agency (EPA) says that in 2007 farmers in the U.S. used about 185 million pounds of glyphosate, double the amount used six years earlier.

In 2015, the IARC deemed glyphosate “probably carcinogenic to humans,” the New York Times reported. The agency based its determination on studies of glyphosate exposure in the United States, Canada, and Sweden since 2001. “Probably carcinogenic” is more difficult to refute than the lesser designation “possibly carcinogenic.”

Glyphosate has been linked to the cancers leukemia (multiple myeloma, myeloma), and lymphoma (non-Hodgkin’s, Hodgkin’s), and also to Parkinson’s disease. In addition, glyphosate is associated with health problems including respiratory distress, impaired consciousness, pulmonary edema, arrhythmias, and renal failure, according to a study published in Toxicology Review in 2004. People exposed to glyphosate have also experienced blurred vision, coma, confusion, dizziness, hand tremors, headaches, insomnia, loss of appetite, stomach cramps, diarrhea, and loss of coordination.

After the IARC designated glyphosate a probable human carcinogen, France’s ecology minister, Segolene Royal, banned the sale of Roundup at garden centers. In a town in Argentina’s Entre Rios province, residents are demanding action on the high cancer death rates. They say that nearly half the deaths there in recent years have been cancer deaths. The national cancer death rate is 18 percent. Residents say the heavy use of Roundup on rice and soybean crops is responsible for the high cancer death rate.

Lawsuits filed against Monsanto allege Roundup caused the cancers of a Hawaiian farmer and a California field worker. Both suits mention the IARC probable carcinogen classification in support of the claims. Monsanto is seeking to have both cases dismissed, Law360 reports.

 

 

 

 

from Parker Waichman http://www.yourlawyer.com/blog/monsanto-sues-california-environmental-agency-to-block-probably-carcinogenic-designation-for-roundup/

Class Action Lawsuits Filed over Blistering, Bleeding, and Rashes from EOS Lip Balm

In January 2016, four proposed class action lawsuits have been filed over claims that EOS Lip Balm use leads to cracking, bleeding, and blistering lips.

San Francisco dermatologist Marie Jhin said the rashes could be contact dermatitis caused by a reaction to vitamin E, according to Your Health Magazine. Beeswax, an ingredient in the EOS lip balms, is an allergen, The Inquisitr notes. People sensitive to beeswax need to know if beeswax is in the cosmetics they use. The Inquisitr says EOS (Evolution of Smooth) does not fully disclosure the ingredients on EOS Lip Balm labels.

One of the women who filed a lawsuit alleges her lips felt like “sandpaper” within hours of using the EOS Lip Balm. When she applied more lip balm, her lips began to crack, flake, bleed, and blister, and she developed a rash. Her symptoms lasted for 10 days. The lawsuit seeks damages and corrective advertising indicating EOS Lip Balm may cause mild to severe rashes, dryness, bleeding, blistering, cracking, and loss of lip pigmentation that may last from a few days to a few months, or may potentially be permanent. A California plaintiff alleges violation of the Consumers Legal Remedies Act. A New York woman accuses EOS of false advertising and negligent product design, according to the firm representing the woman. One lawsuit was brought by a mother who bought EOS Lip Balm for her teenage daughter as an “age-appropriate” alternative to lipstick. Her daughter developed rashes and blisters from the lip balm.

Celebrity promoters of EOS Lip Balm include Kim Kardashian, Miley Cyrus, Ann Kendrick, Britney Spears, and Katie Perry. The EOS flavors involved in the lawsuits are Blackberry Nectar, Coconut Milk, Strawberry Sorbet, Blueberry Acai, Pomegranate Raspberry, Summer Fruit, Sweet Mint, Honeysuckle Honeydew, Lemon Drop, and Medicated Tangerine.

EOS posted this statement on social media: “Some of you may have seen reports of a lawsuit filed against our company. We wanted to be sure that you, our valued customers and fans, know that the health and wellbeing of our customers is our top priority. Our products are safe to use, are made with the highest quality ingredients and they all meet or exceed all safety and quality standards set out by our industry. An independent laboratory puts each of our products through a battery of rigorous testing to ensure this is the case. For these reasons, we firmly believe this lawsuit is without merit, and we will continue to create new and exciting products that delight our customers.”

The lawsuits allege violations of unfair business laws in different states. One case alleges that EOS breached express and implied warranties, committed consumer fraud, unjustly gained from the sales. Two of the lawsuits claim EOS failed to warn about skin reactions on the product itself or in the advertising material, and failed to commission a study on the adverse effects of its proprietary formula.

 

from Parker Waichman http://www.yourlawyer.com/blog/class-action-lawsuits-filed-over-blistering-bleeding-and-rashes-from-eos-lip-balm/

Class 1 Recall for Brainlab Cranial Image-Guided Surgery System Because of Navigation Inaccuracy

The Brainlab Cranial IGS (Image Guided Surgery) System has been recalled because inaccuracies in the navigation system display could lead to inaccurate medical procedures. This could result in life-threatening injuries or death.

Brainlab Cranial IGS System shows the surgeon the area being operated on and the position of an instrument relative to the patient’s anatomy to enable minimally invasive surgical procedures. The imaging system guides the surgeon through the procedure, helping to keep skull openings small and minimize damage to healthy brain structures, the company says.

The recall includes about 1021 units distributed nationwide from May 1996 to May 2015. All existing versions of the cranial navigation system before Cranial 3.0 are included in the recall. The Food and Drug Administration (FDA) has categorized this as a Class I recall, the most serious recall class. Use of the Brainlab Cranial IGS System may cause serious injury or death.

Brainlab notified customers of the display problem on April 22, 2013 and issued an update on May 29, 2015. The recall notice was updated again on January 15, 2016. Brainlab notified customers of the problem and said customers should adhere to the Instructions for Use supplement document “Measures to Improve Cranial Navigation Accuracy” when using the recalled IGS devices.

Brainlab will provide customers with an updated software version and schedule the update installation starting in September 2015.

Customers can direct questions to the Brainlab Customer Hotline at 1-800-597-5911 or they can send email to support@Brainlab.com.

 

from Parker Waichman http://www.yourlawyer.com/blog/class-1-recall-for-brainlab-cranial-image-guided-surgery-system-because-of-navigation-inaccuracy/

Kidney Problems Related to Heartburn Drugs

Medicines used in the treatment of heartburn, such as Prevacid, Nexium and Prilosec have been reviewed for potential ties to increased risks for kidney disease.

These drugs, in the drug class known as proton pump inhibitors (PPIs) reduce the production of acid by blocking the enzyme in the stomach wall that produces acid. Acid reduction helps to prevent ulcers in the esophagus, stomach, or duodenum. If stomach juice backs up into the esophagus, it would be less irritating and would allow for healing in the event of an ulcer, The New York Times wrote.

Studies in the use of PPIs, especially in long-term use, have linked PPIs to increases in bone fracture; pneumonia, and Clostridium difficile, a serious type of infection. For over 13 years, researches followed 10,482 people comparing those who used PPIs to those who took a non-PPI drug in the class known as H2 receptor antagonists, such as Zantac and Pepcid. The research appears in the American Medical Association’s (AMA) journal, JAMA Internal Medicine.

The study concluded that use of PPIs was associated with a 20 to 50 percent increased risk of developing chronic kidney disease. Use of the mostly over-the-counter (OTC) non-PPI medication was not associated with this risk. A kidney specialist at Johns Hopkins noted that patients using PPIs for a longer period of time, should be routinely monitored for their kidney function, according to The New York Times.

from Parker Waichman http://www.yourlawyer.com/blog/kidney-problems-related-to-heartburn-drugs/

Widely Used Herbicide Roundup Linked to Leukemia, Lymphoma, and Parkinson’s

Monsanto’s Roundup, one of the world’s most widely used herbicides, is linked to health risks, including cancers, Parkinson’s disease, and respiratory issues.

Roundup had been in use for decades in commercial farming, home gardens, and landscaping applications. The weed killer is crucial in the production of genetically engineered corn and soybeans, the New York Times reports.

Roundup’s main ingredient—glyphosate—has been associated with serious health issues such as respiratory distress, impaired consciousness, pulmonary edema, arrhythmias, and renal failure, according to a 2004 study published in Toxicology Review. Exposure to the toxic effects of Roundup has been seen in agricultural workers, nursery workers, landscape workers, and people who work at farm stands.

In 2015, the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO) classified glyphosate as “probably carcinogenic to humans,” according to the Times. IARC’s determination was based on studies of glyphosate exposure in the United States, Canada, and Sweden since 2001. The report said that glyphosate had been found in food, water, and air following Roundup spraying. The IARC recommended that the Environmental Protection Agency (EPA) examine the dangers of glyphosate, but the EPA says it does not have the resources to do the testing.

The EPA reports about that 185 million pounds of glyphosate were used by farmers in the U.S. in 2007, which is double the amount used only six years earlier. And as weeds have developed greater resistance to Roundup, farmers have used more of the herbicide to counteract the resistance.

Glyphosate has been linked to:

• Leukemia: multiple myeloma, myeloma
• Lymphoma: non-Hodgkin’s, Hodgkin’s
• Parkinson’s disease.

People exposed to glyphosate may also suffer other significant heath problems:

• blurred vision with excessive tearing
• coma
• confusion
• dizziness
• fatigue
• hand tremors
• headaches
• insomnia
• loss of appetite associated with nausea, stomach cramps, diarrhea
• loss of coordination
• weakness
• weight loss

In 2011, Parkinsonism Related Disorders published a report of a case of a 44-year-old woman diagnosed with Parkinson’s symptoms after three years of glyphosate exposure in a chemical factory job. In 2014 Rodale Wellness reported a large increase in non-Hodgkin’s lymphoma cases in the last 30 years, and that year the International Journal of Environmental Research and Public Health published a review 44 scientific papers showing the effects of 80 active ingredients in 21 chemical classes on farm workers. According to IARC, exposure to glyphosate doubled the risk of developing non-Hodgkin’s lymphoma.

France banned Roundup in 2015 after glyphosate was classified as a probable carcinogen. Ecology minister Segolene Royal declared that “France must be on the offensive with regards to the banning of pesticides,” according to The Independent.

In May 2015, residents of a town in the Argentine province Entre Rios demanded an investigation into the town’s high cancer death rates. Nearly half the deaths in the town in recent years were caused by cancer, though the national average for cancer deaths is 18 percent. Residents point to the heavy use of weed killers on rice and soybean fields. Entre Ríos has increased production of rice and soybeans, with a corresponding increase in the use of pesticides and herbicides. The chemicals sprayed on fields are dangerous both to the workers doing the spraying and to nearby residents, who are exposed to drifting spray. There are also reports that discarded pesticide canisters have contaminated ground water in some neighborhoods, leading to residents’ glyphosate exposure.

 

from Parker Waichman http://www.yourlawyer.com/blog/widely-used-herbicide-roundup-linked-to-leukemia-lymphoma-and-parkinsons/

Senate Report Says FDA, Scope Makers Failed to Warn about Superbug Risk

A Senate report says that medical device makers, the U.S. Food and Drug Administration (FDA) and hospitals all share blame in the outbreak of several superbug infections linked to contaminated duodenoscopes. The devices, which are used to treat and diagnose disorders in the pancreas and bile duct, have been under scrutiny in light of the outbreaks, which took place over a three year period. The U.S. Food and Drug Administration (FDA) warned last year that the devices could spread antibiotic-resistant bacteria, even when cleaned according to manufacturer’s instructions. The agency said the complex design of the scopes may prevent them from being sterilized effectively.

Device maker Olympus controls most of the market for duodenoscopes in the United States. Duodenoscopes are also manufactured by Pentax and Fujifilm. In January 2015, Sen. Patty Murray’s office launched an investigation into the scopes. The Senate report stemming from that investigation revealed that Olympus knew its scopes could spread bacteria after cleaning as early as 2012. However, the report states, the company did not notify hospitals, patients or the FDA.

The report also criticizes the FDA for its delayed action. The agency learned of the scope-linked infections in 2013, but took an additional 17 months to warn the public. In the time it took the FDA to issue a safety alert, 68 patients in seven hospitals across the US were infected with antibiotic-resistant bacteria following procedures with a duodenoscope. “The failure of FDA’s device surveillance system to rapidly identify and respond to duodenoscope-related superbug and antibiotic-resistant infections serves as just one example of the fallacy of a system that is primarily reliant on hospitals and device manufacturers to self-report information to FDA,” the report states.

According to the report, hospitals also failed to take the necessary steps to prevent further superbug infections. The scopes were linked to infections at 16 different hospitals, but they failed to notify the FDA. The report states that at least 250 people became ill from 25 different superbug infections between 2012 and the spring of 2015.

The report found Olympus did not alert the FDA about the risk of spreading infection. The company learned of two independent lab reports showing bacteria could still be alive after cleaning in early 2013, but did not inform the FDA until February 2015. Additionally, the report says that Olympus, Pentax and Fujifilm all failed many regulatory requirements. “The duodenoscope manufacturers and Custom Ultrasonics failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues,” Sen. Murray wrote, according to Law360. “This disregard for the spirit, and sometimes the letter, of the law resulted in potentially preventable serious and potentially fatal illnesses in hospitals around the world.”

from Parker Waichman http://www.yourlawyer.com/blog/senate-report-says-fda-scope-makers-failed-to-warn-about-superbug-risk/

False Data Allegedly Reported Concerning Essure Birth Control System

A Yale study has reported that pregnancy was four times more likely in women treated with the Essure birth control system than more traditional laparoscopic tubal ligation.

The U.S. Food and Drug Administration (FDA) approved the Essure birth control system in 2002. Bayer now markets Essure, which was originally developed by Conceptus. Bayer disputes allegations that the product is unsafe.

Meanwhile, several women have died from complications associated with the device; non-fatal adverse events include metal toxicity, headaches, fatigue, and lifelong autoimmune problems.

According to a report from NBC News, several women involved in a clinical trial in 2000, indicated that their records were altered. One woman, after obtaining records related to the device in 2013, said her records were obviously altered. She was also quoted as saying that, when she reported pain, the information was crossed out in the records. Another woman reported that when she cited “sharp pain,” the researchers reported her comfort level as “excellent.” In other cases, patients reported being coached by researchers on how to describe their adverse reactions. There were also reports of women between the ages of 20 and 30 who were implanted with the Essure system who had to undergo total hysterectomies.

The FDA has cited Conceptus for multiple problems in 483 documents, including failure to disclose adverse events. There were a minimum of 41 reports of perforation, mostly of the uterus and fallopian tubes. The dates related to the tests were from July 12, 2012 to December 10, 201. There were 508 incidents of perforation as of January 6, 2010.

The FDA reported that an announcement concerning Essure will be made by the end of February.

from Parker Waichman http://www.yourlawyer.com/blog/false-data-allegedly-reported-concerning-essure-birth-control-system/

Medtronic Uses Preemption in Medtronic Infuse Case, Again

The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While a shallow analysis of the Supreme Court’s action in denying certiorari made it seem as if Medtronic had finally succeeded in preventing the litigation of hundreds of cases across the country claiming serious injuries due to its Infuse® Bone Graft Device, that was not the case at all. 

Medtronic argued in the Caplinger case that federal law and the Supreme Court’s prior decisions in cases such as Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and Buckman Co. v. Plaintiffs’ Legal Committee, 532 U.S. 341 (2001) barred any private right of action against manufacturers of such devices; that they prohibited states from protecting their citizens under the doctrine of “preemption.” But an examination of the Caplinger case reveals that the only issue actually before the Supreme Court was limited to how victims pleaded their cases, rather than the merits of their claims. As the United States Court of Appeals for the Tenth Circuit said (whose opinion was subject to the potential review by the Supreme Court), nothing the Supreme Court has said in the past regarding this area of the law has been especially clear. “How,” asked the Court of Appeals, “are we supposed to apply all these competing instructions [from the Supreme Court]? It’s ‘no easy task.’” Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1340 (10th Cir. 2015).  The Tenth Circuit then limited its ruling in Caplinger, held that preemption would only apply where a plaintiff failed to adequately plead state causes of action which paralleled federal statutory or regulatory violations, something which the plaintiff in Caplinger had failed to do [“It’s where the problems begin,” said the Tenth Circuit.  784 F.3d at 1340.]

What was left undecided by the Tenth Circuit, and thus never presented to the Supreme Court was, what happens when an individual injured by the Medtronic Bone Graft Device does plead his case properly, making an appropriate claim that there were no federal requirements covering the device as used or that state law only parallels existing federal law, rather than preempting it? The answer to that question had come earlier in a Ninth Circuit matter, Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013). In Stengel, the Ninth Circuit Court of Appeals, in an unusual en banc proceeding where not just three, but all the judges of the Circuit participated, upheld the amended complaint of a plaintiff against a Medtronic medical device because it did properly plead a state-law duty that paralleled a federal-law duty. The Supreme Court had said that such pleading would be sufficient to avoid preemption. In upholding such a pleading, the Ninth Circuit noted that it joined both the Fifth and Seventh Circuits which had reached the same conclusion. 704 F.3d at 1223. The Supreme Court then refused Medtronic’s request to have it review the Stengel case. Significantly, though, before denying Medtronic that review of Stengel, the Court invited the Solicitor General of the United States to “express the views of the United States.” Medtronic, Inc. v. Stengel, 134 S.Ct. 375 (2013). The Solicitor General urged the Supreme Court to deny any review of the Stengel opinion rejecting preemption (http://www.justice.gov/sites/default/files/osg/briefs/2013/01/01/2012-1351.pet.ami.inv.pdf) and the Court did just that in June 2014. 134 S.Ct. 2839 (2014)

With the Stengel decision firmly in hand, the Supreme Court’s denial of review in Caplinger has limited effect, pertaining only to those cases which have been pleaded incorrectly.  All other cases against Medtronic, whose complaints resemble those in Stengel, will continue unabated.

from Parker Waichman http://www.yourlawyer.com/blog/medtronic-uses-preemption-in-medtronic-infuse-case-again/

FDA Deems Customed, Inc., Convenience Pack Recall a Class I

The U.S. Food and Drug Administration (FDA) has warned health care providers against using Customed, Inc., Surgical Packs and Convenience trays due to their lack of proof of adequate testing. These packs contain items such as instruments, absorbent towels, exam gloves, suture bags, surgical table covers, and drapes. When used in surgery, these items must be germ-free and sterile, in order to protect patients from infection. A voluntary recall was initiated by Customed, Inc. and has been deemed a Class I by the FDA.

The criteria and safety features that must be completed to pass inspection are: Sterility of products; endotoxin, a toxin that is released upon destruction of bacterial cells during sterilization; and ethylene oxide that must be within safety limits. Packaging must be able to withstand stresses during transport; expiration dates must be adhered to.

In 2014, the plastic packaging of one unit stuck to adjacent units during the sterilization process, allowing possible microorganisms to enter and contaminating the contents during separation of the package. The FDA alerted Customed, Inc.in a letter sent on December 9, 2014 citing deficiencies found during inspection.

In November 2014, Customed, Inc., resumed manufacturing without informing the FDA despite the Class 1 recall issued in October of the same year. A Class I recall is deemed by the FDA when a situation involves reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Customed, Inc.’s actions potentially posed a lack of package integrity, as well as a lack product sterility. In early 2015, the FDA became aware that the required corrections had not been made and that Customed, Inc. had continued to manufacture its product, despite the serious potential adverse health risks.

The Puerto Rico Hospital Supply company was cited as one firm that was distributing the potentially unsafe product in Puerto Rico during the time of the recall.

from Parker Waichman http://www.yourlawyer.com/blog/fda-deems-customed-inc-convenience-pack-recall-a-class-i/

New FDA Regulations Would Bar Tanning Bed Use for Anyone Under 18

To reduce skin cancer risks in younger people, the Food and Drug Administration (FDA) has proposed a ban on the use of tanning beds by anyone under 18. Health experts call this a major step toward reducing the risk of skin cancer.

Indoor tanning has not been seen as a significant factor in skin cancer rates, but recent evidence indicates that tanning beds play a greater role in cancer risk than previously thought, the New York Times reports. Research published in the last year estimates that tanning beds account for up to 400,000 cases of skin cancer annually, including 6,000 cases of melanoma, which is the deadliest form of the disease.

The FDA’s proposed regulations—which will be open for public comment for 90 days—also contain provisions to require tanning bed manufacturers to make warning labels more prominent and easier to read and to have an emergency shut-off switch on the tanning bed. The regulations would require indoor tanning facilities to ensure that people using tanning beds use protective eyewear during tanning sessions.

Rates for many types of cancer have been on the decline, but melanoma rates have continued to rise about 3 percent a year in the last twenty years, the Times reports. The incidence rate of melanoma in women under 40 has risen by about a third since the early 1990s, according to data from the National Cancer Institute. Health experts are concerned that tanning beds, which are especially popular among young women, are a significant contributor to the rise.

Some states have already imposed their own bans on indoor tanning for minors, but tanning beds are still widely available to minors in most states, according to the Times. The FDA gives an estimate of 18,000 to 19,000 tanning salons nationwide; tanning beds also available in gyms, spas, hotels, and on college campuses. In Florida, there are more tanning salons than McDonald’s restaurants, CVS stores, or Bank of America branches, University of Miami researchers found.

Dr. Jeffrey E. Gershenwald, a professor of surgery and medical director of the Melanoma and Skin Center at the University of Texas M.D. Anderson Cancer Center, described the proposed restriction as “a tremendous advance.” FDA spokesman Eric Pahon said the agency would enforce the ban through state authorities. Among the enforcement measures the FDA might employ are seizure of tanning beds, civil penalties and fines, or criminal prosecution.

Health experts say the FDA proposal is needed because young people are at greatest risk for serious consequences from indoor tanning. According to the Times, indoor tanning increases the overall risk of melanoma by 20 percent, but the risk increases by 59 percent for anyone who uses a tanning bed at all before age 35. According to a 2013 federal youth health survey, about 1.6 million minors use indoor tanning facilities every year. Government data also shows that those who turn to tanning beds tend to use them frequently. Data on tanning among high school students has been collected only since 2009, but it shows that more than half of those who used tanning beds had used them 10 or more times in the past year.

 

 

 

from Parker Waichman http://www.yourlawyer.com/blog/new-fda-regulations-would-bar-tanning-bed-use-for-anyone-under-18/

Child’s Death Prompts Lawsuit Against Ikea over Unstable Dresser

Parents of a Washington state toddler fatally injured by an Ikea dresser that tipped over on him  have filed a lawsuit against the Swedish furniture retailer.

The suit, filed in the Philadelphia Common Pleas Court, claims Ikea sold the dresser despite knowing it was unstable, Philly.com reports. This is the second lawsuit in a year over a fatal tip-over of an Ikea Malm dresser. A similar suit was filed by the mother of a Pennsylvania two-year-old, who died in February 2014 when a dresser fell over on him.

In July 2015, Ikea and the Consumer Product Safety Commission (CPSC) jointly announced a “repair program” involving 27 million Ikea dressers. The company said the dressers could be unstable if not anchored to the wall, and the company offered purchasers a restraint kit so they could secure the dresser to the wall.

Though a repair program of this type is considered a recall under CPSC regulations, Ikea has avoided using the word recall in its communications. The company stresses that it has not offered to buy back or replace the dressers, according to Philly.com.

Legal documents indicate that the Washington state boy was pinned under a three-drawer Malm dresser on June 11, 2014. The child’s father found him and lifted the dresser off the boy and the mother performed CPR until the ambulance arrived, according to Philly.com. The boy was hospitalized on a ventilator for four days before his parents removed him from life support and he died.

The lawsuit accuses Ikea of designing and selling dressers that do not meet the furniture industry’s safety standard for stability. A lawyer who represents the families of both children who died said Malm dressers are inherently unstable and Ikea has placed the burden for making them safe on consumers. The company has “got it backwards,” he said.

The parents seek unspecified compensatory and punitive damages, including compensation for medical expenses, funeral expenses, the child’s pain and suffering, and the family’s emotional distress.

Swedish furniture retailer Ikea has U.S. headquarters in Conshohocken, Pennsylvania. The company would not comment on the latest lawsuit, citing a policy against discussing ongoing litigation. But in a statement Ikea said, “We continue to work cooperatively with the CPSC on the important issue of tip-over safety,” according to Philly.com.

The CPSC says furniture tip-overs are responsible for more than 38,000 emergency-room visits in the United States annually. A child dies every two weeks in a tip-over accident, the agency says. Tip-over incidents most often involve unsecured dressers and televisions. Two thirds of the injuries happen to children under five.

from Parker Waichman http://www.yourlawyer.com/blog/childs-death-prompts-lawsuit-against-ikea-over-unstable-dresser/

Second Lawsuit Filed in Death of a Child Trapped under Ikea Dresser

In the second such lawsuit in less than a year, Washington state parents have filed a wrongful death lawsuit against Swedish furniture retailer Ikea. Their toddler son died after being pinned under a toppled Ikea dresser.

The suit, filed in the Philadelphia Common Pleas Court, claims Ikea sold the dresser despite knowing it was unstable, Philly.com reports. This is the second lawsuit over a fatal tip over of an Ikea Malm dresser. A similar suit was filed by the mother of a Pennsylvania two-year-old, who died in February 2014 when a dresser fell over on him.

In July 2015, Ikea and the Consumer Product Safety Commission (CPSC) jointly announced a “repair program” involving 27 million Ikea dressers. The company said the dressers could be unstable if not secured to the wall, and offered purchasers a restraint kit so they could anchor the dresser to the wall.

Under CPSC regulations, a repair program of this type is considered a recall, though Ikea has avoided using the word recall in its communications. The company stresses that it has not offered to buy back or replace the units, Philly.com reports.

According to the lawsuit, the Washington state boy was pinned under a three-drawer Malm dresser on June 11, 2014. The child’s father found him and lifted the dresser off the boy. The mother performed CPR until the ambulance arrived, according to Philly.com. The boy was hospitalized on a ventilator for four days before his parents removed him from life support,

The parents seeks unspecified compensatory and punitive damages, including compensation medical expenses, funeral expenses, the child’s pain and suffering, and the family’s emotional distress.

The lawsuit accuses Ikea of designing and selling dressers that do not meet the furniture industry’s safety standard for stability. A lawyer representing the families of both children who died said Malm dressers are inherently unstable and Ikea has placed the burden for making them safe on consumers. The company has “got it backwards,” he said.

Ikea, the Swedish giant furniture retailer with U.S. headquarters in Conshohocken, Pennsylvania, would not comment on the latest lawsuit, citing a policy against discussing ongoing litigation. But the company said in a statement, “We continue to work cooperatively with the CPSC on the important issue of tip-over safety,” according to Philly.com.

The CPSC says furniture tip-overs are responsible for more than 38,000 emergency-room visits in the United States annually. A child dies every two weeks in a tip-over accident, the agency says, and tip-over incidents most often involve unsecured dressers and televisions. Two thirds of the injuries happen to children under five.

 

from Parker Waichman http://www.yourlawyer.com/blog/second-lawsuit-filed-in-death-of-a-child-trapped-under-ikea-dresser/

Nice! Mandarin Oranges in Bottles Recalled Due to Risk of Glass

Milky Way International Trading Corp. has voluntarily recalled Nice! Mandarin Oranges in 8-ounce bottles, sold at Walgreens stores nationwide. According to a company press release posted on the U.S. Food and Drug Administration’s (FDA’s) website, the product was recalled because it may contain glass, posing a risk of injury if ingested.

“Milky Way International Trading Corp. today announced the recall of Nice! Mandarin Oranges in 8-ounce bottles due to potential glass in the product. The affected product was distributed to Walgreens stores nationwide and displays one of the lot numbers listed below. Consumers could potentially be cut or injured if ingested.” the release states.

There have been three complaints related to this issue so far, with one reported injury, the release states. The recall applies to specific lot numbers: H894K09A, 4200/01039 and 4200/01039. Lot codes can be found on the lid or neck of the bottles. Walgreens has removed the product from its shelves.

from Parker Waichman http://www.yourlawyer.com/blog/nice-mandarin-oranges-in-bottles-recalled-due-to-risk-of-glass/

Lawsuits Mount over Cancer Risks Associated with Power Morcellators

New lawsuits continue to be filed against the manufacturers of the power morcellator, a surgical tool used in fibroid surgeries and hysterectomies that is alleged to spread undetected cancers.

In October 2015, the U.S. Judicial Panel on Multidistrict Litigation transferred more than 20 power morcellator lawsuits into a federal multidistrict litigation (MDL). More than 30 cases were centralized for pretrial proceedings. The lawsuits have been filed primarily against Johnson & Johnson’s Ethicon division. Plaintiffs in these cases allege that the morcellator caused serious complications, including the spread of cancerous tissue.

In one of the cases, the plaintiff alleges that the morcellator used in her surgery exposed and spread previously undetected cancer cells beyond her uterine walls. She needed the surgery to treat painful uterine fibroids. The morcellator procedure was chosen as a less invasive technique than open surgery. After the surgery, the woman was unexpectedly diagnosed with widespread and aggressive cancer.

The laparoscopic power morcellator is inserted through the lower abdomen via a small incision. Rapidly spinning blades cut uterine or fibroid tissue into tiny pieces that can be removed from the body through the incision. But if the uterine tissue contains cancerous cells—which are virtually impossible to detect prior to surgery—the procedure can spread the cancer throughout the abdomen, where it rapidly becomes more aggressive and sharply reduces the woman’s long-term survival chances.

In 2015, twelve members of Congress asked the U.S. Government Accountability Office (GAO) to investigate why the power morcellator was on the market for two decades before the Food and Drug Administration (FDA) issued a warning about the device’s potential to spread uterine cancer. The GAO investigation increases scrutiny into how the FDA has handled issues with power morcellators, some of which date back to 1991, when the device first received clearance for use in the U.S. The FDA now says evidence indicates a far higher risk of hidden uterine sarcomas than many gynecologists previously believed.

While defending the regulatory process used to approve the power morcellator, the FDA has said it is strengthening its surveillance of devices on the market. Johnson and Johnson, the largest manufacturer of morcellators, voluntarily pulled its morcellators from the market, according to the Wall Street Journal.

In November 2014, the FDA amended an earlier morcellator advisory by ordering a black box warning for the device. The black box is the agency’s strongest warning. Despite calls for a complete ban, the power morcellator remains on the market, although many hospitals have restricted its use to carefully screened patients at low risk for uterine sarcomas. A number of health insurers have decided they will no longer cover routine use of the morcellator in fibroid surgery and hysterectomies.

from Parker Waichman http://www.yourlawyer.com/blog/lawsuits-mount-over-cancer-risks-associated-with-power-morcellators/

CDC Documents Show Disagreement about Cellphone Risk Recommendations

Internal documents from the Centers for Disease Control and Prevention show there was debate among scientists and health officials about what recommendations to make for cellphone use and radiation, New York Times reports. The agency issued new guidelines eighteen months ago: “We recommend caution in cellphone use” the agency stated. Several weeks later, however, the CDC revoked this language in light of confusion about policy change. NYT reports that the initial warning was an unusually bold move for the CDC. Beforehand, the agency said radiation from cellphones “likely are comparable to other lifestyle choices we make every day.” The CDC also removed a section that talks about possible risks in children.

When it comes to cellphone use and radiation, most agencies assert that there is little or no evidence linking it to cancer. The study most often cited for this point is the 2010 Interphone study published by the International Agency for Research of Cancer, a branch of the World Health Organization, which found “over all, no increase in risk” but there were “some indications of an increased risk of glioma,” among the heaviest 10 percent of users. However, the study looked usage rates much lower than what is seen today , according to Interphone’s principal investigator Dr. Elisabeth Cardis. In 2014, a study showed that Americans use smartphones more than 34 hours a month on average; this is much higher than the median call time of two to two and a half hours per month in the Interphone study. “I can’t say for sure there’s an effect, but I can’t say for sure there’s no effect.” Dr. Cardis said to NYT.

“If there’s a risk, it’s likely to be greater for exposures at younger ages,” said Dr. Cardis, who is currently conducting a European study looking at the risks of cellphone use in children, “simply because the skull is thinner and the ears are thinner in children than in adults. Basically your phone is closer to your brain.” The IARC called cellphones a “possible” carcinogen in 2011.

According to over 500 pages of records obtained by NYT, there was considerable back-and-forth concerning cellphone use recommendations. After the CDC issued its new language, there was confusion about policy change and questions of liability. The internal documents show CDC officials discussed how to move away from the new language. CDC spokeswoman Bernadette Burden said the guideline was prompted by “a C.D.C.-wide effort to make health information for the public easier to understand” but led many to mistakenly think a new policy has been implemented. “To correct that misperception and to confirm that C.D.C. had not changed its policy or recommendations, C.D.C. posted a clarification statement,” she stated, according to NYT.

Dr. Christopher J. Portier, who served on the IARC and is former director of the CDC branch that issued the cautionary language, supports the initial warning. “I would not have removed it,” in a NYT interview. “I would have been in support of a recommendation that parents look carefully at whether their children need cellphones or not.” He also said parents should be provided “with enough information to say caution isn’t ill advised, because we really don’t know, and there are enough indicators to say we should be cautious.”

from Parker Waichman http://www.yourlawyer.com/blog/cdc-documents-show-disagreement-about-cellphone-risk-recommendations/

Disturbing Report on Nursing Home Employees Posting Inappropriate Resident Photos and Videos on Social Media

In a disturbing report, ProPublica, the nonprofit investigative news organization, says it has identified 35 instances since 2012 in which nursing home and assisted-living center employees have posted embarrassing photos or videos of residents on social media sites. The residents were sometimes partially or completely naked and some were using the toilet.

At least 16 cases involved the service Snapchat, where photos appear briefly then disappear with no lasting record. ProPublica says some of the incidents have resulted in criminal charges. Posting photos of patients or residents without their permission may violate the Health Insurance Portability and Accountability Act (HIPAA), the federal patient privacy law that carries civil and criminal penalties.

While abuse and neglect in nursing homes, assisted living centers, and rehab facilities is not new, posting explicit, sometimes embarrassing, photos or videos is a new kind of mistreatment, according to ProPublica.

In February 2014, a nursing assistant at Prestige Post-Acute and Rehab Center in Centralia, Washington shared a Snapchat video with a coworker of a resident sitting on a bedside portable toilet with her pants below her knees. The following month, an assistant at Rosewood Care Center in St. Charles, Illinois, recorded another assistant slapping the face of a 97-year-old woman with dementia with a nylon strap. On the video the woman could be heard crying out as she was being struck and the employees were heard laughing. Also in 2014, at Gridley Healthcare and Wellness Centre in California, a nursing assistant reported a co-worker for using Snapchat to send pictures of residents who were “inappropriately exposed” or who appeared to be dead. The assistant said she was “absolutely disgusted” by the lack of respect for human life and for a person who has died, according to ProPublica.

ProPublica uncovered these incidents by searching federal inspection reports, court cases and media accounts, but says such incidents are likely underreported. Many of the victims have dementia and may not realize what has happened or their claims are dismissed because they are “confused.” Inappropriate social media postings have come to light mostly through tips from other staff members or members of the community, ProPublica says.

ProPublica says the Office for Civil Rights in the Department of Health and Human Services, has not penalized any nursing homes for violations involving social media or issued any recommendations to health providers on the topic. Deven McGraw, the deputy director for health information privacy, expressed outrage about the incidents. “If we don’t have pending investigations on any of these cases … they would be candidates for further inquiry from our end,” she said, adding that the office also should issue guidance on social media and the privacy law.

The Centers for Medicare and Medicaid Services, which regulates nursing homes, has cited individual facilities for deficiencies related to privacy. CMS will more explicitly address the issue more explicitly when it revises definitions of “abuse,” “neglect,” “exploitation” and “sexual abuse” in updated regulations governing nursing homes.

 

 

 

 

from Parker Waichman http://www.yourlawyer.com/blog/disturbing-report-on-nursing-home-employees-posting-inappropriate-resident-photos-and-videos-on-social-media/

Viekira Pak and Technivie Label Updated to Include Risk of Liver Injury

The warning labels of AbbVie’s hepatitis C treatments Viekira Pak and Techivie have been updated to include the risk of serious liver injury, the U.S. Food and Drug Administration (FDA) said in a safety notification. The agency stated that the treatments were linked to cases of hepatic decompensation and liver failure in a review of the agency’s Adverse Event Reporting System (FAERS) database and in cases reported to AbbVie, mostly in patients who already had underlying liver cirrhosis. “These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.” the FDA said.

There have been 26 worldwide cases of liver injury that are possible or probably linked to the treatments since the approval of Viekira Pak in December 2014 and Technivie in July 2015. The FDA says liver injury occurred between 1 and 4 weeks of starting treatment in most cases.

According to the Centers for Disease Control and Prevention (CDC), hepatitis C becomes a long-term, chronic infection occurs in 70 to 85 percent of people infected. Hepatitis C is caused by a bloodborne virus that leads to liver infection. Viekira Pak and Technivie are used to treat patients who have chronic hepatitis C.

Patients taking Viekira Pak or Technivie should contact their health care professional if they experience “fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury” the FDA states. Patients should not stop taking their medications without first discussing it with their health care professional, the agency says.

from Parker Waichman http://www.yourlawyer.com/blog/17392-2/

Citgo 2006 Oil Spill Penalty Raised to $81M from $6M

A Louisiana federal judge has reconsidered his previous ruling for a 2006 Citgo oil spill in the Lake Charles area. Law360 reports that U.S. District Judge Richard T. Haik has found the company guilty of gross negligence and imposed a penalty of $81 million. In 2011, Haik imposed a $9 million penalty, including $3 million for state violations, and found that there was not enough evidence for gross negligence or willful misconduct. That ruling was vacated by an appeals court in 2013. “The court recognizes its error in originally penalizing Citgo only $6 million, the equivalent of approximately one day’s profit,” said Judge Haik in the most recent ruling. “Given the seriousness of this incident, the long term impact it had on the Lake Charles area, and all of the factors outlined above, an appropriate penalty belongs in a significantly higher range.”

One of the biggest onshore spills in the nation’s history occurred in 2006, when millions of gallons of oil leaked into the Indian Marais stream. Heavy rain had caused storage tanks to overflow at Citgo’s Lake Charles refinery. Although the tanks were emptied, oil spilled from a secondary holding pond. In June 2008, a lawsuit was filed on behalf of the U.S. Environmental Protection Agency (EPA) alleging Citgo was liable for billions of dollars in damages for violations of the Clean Water Act.

In 2011, Haik said evidence was not enough to find gross negligence. The judge said that Citgo built an adequate system in 1994 but only maintained it sporadically and that the company was intending to remove the excess oil but did not work quickly enough to prevent the incident. He imposed a penalty of $111 per barrel for the 54,000 barrels spilled. The U.S. appealed the penalty to the Fifth Circuit in December 2011, arguing that $6 million was not enough.

In July 2013, the appeals court vacated the $6 million verdict, stating that Judge Haik failed to consider how much Citgo profited by failing to act on the deficiencies for over a decade. It also asked the judge to reconsider the gross negligence finding and statutory penalty factors. Judge Haik reconsidered the case and came back with a gross negligence finding. He set a penalty of $1,500 a barrel, totaling $81 million.

“Upon second review of the evidence and arguments presented, this court could not agree more with the opinion of the Fifth Circuit, which stated ‘In our view, though, almost winning a highly risky gamble with the environment does not much affect the egregiousness of having been gambling in the first place,’” Judge Haik said, according to Law360. “In a state like Louisiana, where heavy rains are a common occurrence, failing to take adequate measures to prevent a tragedy such as this, with the knowledge Citgo had in its possession, rises to the level of gross negligence.”

from Parker Waichman http://www.yourlawyer.com/blog/citgo-2006-oil-spill-penalty-raised-to-81m-from-6m/

Recalled Bauer Hockey Goalie Masks Linked to Serious Eye Injuries

Bauer Hockey Corp., in cooperation with Health Canada and the U.S. Consumer Product Safety Commission (CPSC), has recalled hockey goalie masks with cages that have broken and caused serious eye injuries.

In March 2015, the manufacturer and the two government agencies issued a joint recall of three Bauer goalie masks and cages after the sporting-goods company found a potential quality issue in some of the titanium wire used in the cages, according to CBC News. The CPSC says the recalled goalie masks and cages do not provide adequate protection to the goalie in the event of impact from a puck and could pose a facial-injury hazard.

At the time of the recall, Bauer had received a report of the titanium wire cage cracking or breaking on impact with a puck, resulting in minor facial injuries. Health Canada has recently updated the recall to say that it has received two reports of serious injuries related to the products. Bauer has now received 11 reports —10 in Canada and one in the United States — of breaks or cracks that resulted in four minor and two major facial injuries.

An 18-year-old goaltender from Bay Roberts, Newfoundland, required emergency eye surgery after a piece of wire snapped from the cage of his Bauer mask, slicing into his face and cutting off a piece of the iris of his left eye, CBC News reports.

The recall covers about 1,300 units sold in Canada and about 1,200 units sold in the United States from April 2013 to February 2015. The recalled masks and cages are:

• Bauer Concept C1 Goal Mask with Certified Titanium Oval Wire
• Bauer NME 10 Goal Mask with Certified Titanium Oval Wire
• Bauer RP NME Ti Titanium Cage

The recalled equipment was manufactured in Thailand and China.

The Concept C1 and NME 10 goalie masks were sold in black or white with a titanium wire cage that attaches to the mask with two screws on each side of the mask.  The Concept C1 mask is a Senior mask in sizes S/M and M/L. Concept C1 is printed at the top of the shell.  A sticker inside the shell at the jaw also lists the model and size. The NME 10 Goal Mask is a Senior mask in sizes Fit 1, Fit 2, and Fit 3.  NME10 is printed at the top of the shell.  A sticker inside the shell at the jaw also lists the model and size. The RP NME Ti Titanium Cage is a replacement cage intended for the Concept C1 and NME 10 goalie masks.  A side plate reads Bauer Titanium Oval Wire and RPNME Ti Sr.

The CPSC advises anyone who has the recalled masks and cages to immediately stop using them and contact Bauer Hockey for a free replacement wire cage and complimentary throat protector.

from Parker Waichman http://www.yourlawyer.com/blog/recalled-bauer-hockey-goalie-masks-linked-to-serious-eye-injuries/

Educator, Feminist Activist Highlights Child Abuse in Orthodox Jewish Community

Dr. Elana Sztokman, an educator, sociologist and activist, recently emphasized the prevalence of child abuse in the Orthodox Jewish community. The Jewish Chronicle Online reports that Sztokman recently spoke at a session at the Limmud conference in Birmingham, stating that the Jewish community has a “rampant epidemic” of rabbis who commit sexual abuse. Dr. Sztokman frequently focuses on the topic of Orthodox Jewish feminism.

She said, “We have a epidemic of abuse and it is rampant in the Jewish community,” according to the The Jewish Chronicle. “A disproportionate number of abusers seem to be rabbis or quasi rabbis.”

In July, a Jewish teacher and son of a rabbi was sentenced to 13 years of jail for molesting two teenage girls. The judge who sentenced him, Mr. Justice Timothy Holroyde, called Todros Grynhaus “an utter hypocrite” for “cynically condemning his victims to suffer” while proclaiming his religion. ““I have no doubt that you felt able to rely on a prevailing attitude of insularity which you hoped would prevent these allegations from ever coming to the attention of the police. You hoped that, at worse, you might have to pay a form of financial penalty as directed at the Beth Din.” the judge said, according to The Jewish Chronicle.

According to Sztokman, who is a former executive director of the Jewish Orthodox Feminist Alliance, cases such as Grynhaus’ are all too common. At the conference, she discussed reasons why abusers are often never punished for their actions; victims are frequently ostracized. “We have seen it time and time again a victim comes forward and the community shuns them. Their lives are made impossible, kosher shops ban them, people in shul push past them and their families. And people come out in defence of the abuser.”

“This pattern of behaviour needs to change and as a community it needs to be challenged.” she said.

Abusers are “too often” shielded by community leaders and peers, Sztokman said. “People don’t like to think of their charismatic rabbi as an abuser or capable of such acts. They come out in defence of them and say ‘oh I only know him to be nice’ But what they are doing is silencing victims.”

Additionally, victims are often dissuaded from reporting the abuse, Sztokman said. She pointed out that rabbis encourage victims to seek them out before going to the police. “How can a victim who is being abused by a rabbi then go to a rabbi to report it?” she said. “People at the top in the Orthodox community tend to be male and it makes it hard for female victims to come forward or have an even playing field. Victims are dismissed and not believed. If you come forward against a abusive rabbi you will loose.”

from Parker Waichman http://www.yourlawyer.com/blog/educator-feminist-activist-highlights-child-abuse-in-orthodox-jewish-community/