Farah & Farah March 2016 Newsletter

Posted on March 3, 2016

J&J Must Pay $72 Million to Plaintiff’s Family Over its Toxic Talc

It’s used on babies and on anyone wanting to feel “fresh” in the pelvic region but Johnson & Johnson is on the hook for $72 million to the family of a women who used the company’s talcum powder and developed ovarian cancer that killed her last year.   The trial, held in St. Louis, Missouri, was the first state court case over J&J’s baby powder, also known as Shower-to-Shower. 

Jackie Fox, 62, of Birmingham, Alabama died in October of last year of ovarian cancer.   She had alleged that J&J knew the risks and links to cancer, but failed to warn the public and in fact, did the opposite, giving consumers the impression its powders were so soft they could be used on a baby.

Her son took over the case after Ms. Fox died. Marvin Salter of Jacksonville, Florida, told jurors the powder was a bathroom staple for years and just became second nature like brushing your teeth.

There is no requirement by the U.S. Food and Drug Administration that personal care products list their ingredients or conduct safety testing. As a result, companies can essentially do what they want and let the marketing departments take over to make any promises to consumers. 

It took jurors four hours to deliver the award with the jury foreman saying the company’s internal documents were “decisive” in their decision.  “It was really clear they were hiding something,” said Krista Smith of St. Louis.  She added all they had to do was warn consumers in their label, but the company did not.

Shower-to-Shower was marketed to women for feminine hygiene. “Just a sprinkle a day keeps odor away,” was the slogan. The product was sold to Valeant Pharmaceuticals International in 2012.

The problem with talc is it can be contaminated with asbestos fibers. Talc is mined from the soil and can contain magnesium, silicon, oxygen and hydrogen, used to absorb moisture. The talc can travel up the vagina to the ovaries, especially with repeated use.

J&J, the largest US healthcare products company, is no stranger to controversy over its consumer products. No More Tears Baby Shampoo was the focus of The Campaign for Safe Cosmetics which pushed the company to eliminate questionable ingredients from the shampoo including formaldehyde and 1,4 dioxane, a probable human carcinogen. 

J&J sold formaldehyde-free baby products in Europe while they were selling the contaminated versions in the U.S., its primary market.  Congress last year introduced the Personal Care Products Safety Act of 2015 to give the FDA more authority to regulate the personal care industry. 

CBS News reminds us that Johnson & Johnson knows how to recover from a company crisis. Just look at how it handled the Tylenol poisonings.  But J&J is not the same company it was in 1982 and this is just the latest blow to a company that needs a serious make-over in the ethics department. Instead the company issued its credo on Facebook that it, “has no higher responsibility than the health and safety of you and your family.”

Tell that to the women who have filed 1,200 other talc-related lawsuits that are already in the pipeline waiting to be heard. #

Sources: http://www.usnews.com/news/business/articles/2016-02-23/st-louis-jury-awards-72m-in-johnson-johnson-cancer-suit;   http://time.com/4239561/johnson-and-johnson-toxic-ingredients/http://www.ewg.org/skindeep/ingredient/706427/TALC/

FDA Requires Stronger Black-Box Warning Added To Essure Birth Control Device

The U.S. Food and Drug Administration (FDA) promised it would take action in February 2016 on the controversial birth control device, Essure, and the agency has kept its promise.  The FDA wants German drugmaker Bayer AG to further study Essure and to add a strong black-box warning to the label, as well as provide guidance for doctors to provide full informed consent to their patients.

Essure, acquired by Bayer in 2013, was approved by the FDA in 2002.  Since then it has been the target of thousands of complaints to the agency including rashes, pain, chronic bleeding, broken devices traveling in the body and autoimmune disorders such as lupus.

Made of two small nickel-titanium coils, Essure is supposed to remain in the fallopian tubes indefinitely where the coils scar over and prevent the sperm from reaching an egg. The FDA has also ordered Bayer to launch a surveillance to assess the risks of the device by following more than 2,000 women for at least three years. 

Included in the studies will be a comparison to tradition surgery to “tie the tubes” as well as the rate of unplanned pregnancy and the difficulty in removing Essure. Women implanted with Essure have a ten times greater risk of requiring post-procedure surgery when compared to laparoscopic sterilization, according to an October 2015 study.

Essure Problems, a social media site made up of about 27,000 outraged women with Essure implants, said they were outraged that the FDA would leave Essure on the market while it takes years to study the problems caused by the contraceptive. 

Previously the FDA reported only five fetus deaths linked to Essure use, but in a report presented to the FDA last week by former FDA contractor, Madris Tomes, who is the founder and chief executive of Device Events, she combed the FDA’s MAUDE database of complications reported to the FDA. There she compiled a report that says there were more than 10,500 adverse events reported.  There were 303 fetal deaths, stillbirths and/or miscarriages, she said. Previously the FDA said there were only five fetal deaths which it upped to 294 this week. Tomes said she believes the 303 number is conservative because some of the women have had multiple miscarriages and she only counted them once.

The report was sent to Jeffrey Shuren, the direction of the CDRH which oversees medical devices.  Fitzpatrick told the FDA that both Essure contraceptive and the power morcellator adverse event reports are not being forwarded by manufacturers and the FDA is falling down on the job in following up. 

U.S. Rep. Mike Fitzpatrick, a Pennsylvania Republican, filed the E-Free Act that would lift the immunity manufacturers enjoy because the device received FDA approval, and it would block the Department of Veterans Affairs from purchasing Essure.

In September 2015, the FDA convened an expert panel on Essure after 5,000 adverse events or complications were found in the FDA’s database.  At that time the FDA announced it would take some action in February 2016 calling the Essure crisis a “high priority issue.”

There are about 750,000 women who have been implanted with Essure with the majority of them, about 70 percent from the US.  #

Sources:  http://essureproblems.webs.com/2-29-16-press-release; http://www.drugwatch.com/2015/12/10/fda-plans-february-essure-safety-review/;    http://www.usnews.com/news/us/articles/2015/11/24/fda-aims-to-publish-essure-safety-review-in-february;
AdvisoryCommittee/ObstetricsandGynecologyDevices/UCM464487.pdf;   http://www.drugwatch.com/2016/02/19/essure-data-reveals-more-fetal-deaths/;  http://webcache.googleusercontent.com/search?q=cache:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm488109.htm; http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM464487.pdf;
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm473946.htm;  http://www.cnn.com/2016/02/29/health/fda-essure-birth-control-device/http://www.nbcnews.com/health/womens-health/new-stronger-fda-warning-essure-birth-control-implant-n528416http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM488020.pdf

Xarelto’s Ties to Incoming FDA Chief and Tainted Research

The FDA is investigating whether a faulty blood-testing device may have altered the positive outcome during a clinical trial of the blood thinner, Xarelto (rivaroxaban).

Xarelto was cleared by the FDA in 2011 as an alternative to warfarin (Coumadin) to treat atrial fibrillation, deep vein thrombosis, pulmonary embolism and the strokes they can cause. While warfarin involves monitoring the blood to assure there is a steady stream of the drug at all times, Xarelto advertises your healthcare provider need not bother. 

The downside, if you experience trauma, warfarin has an antidote. Vitamin k can reverse the bleeding. Xarelto has no antidote to stop bleeding.  That may be why, just a little over four years on the market, there are 3,500 plus lawsuits filed over the allegedly inadequate warnings to the public about uncontrollable bleeding.

The new information, revealed in litigation, shows a tie to incoming FDA head Dr. Robert M. Califf. While at Duke University, he oversaw the Clinical Research Institute that was saturated with private industry funding – 63 percent of its $320 million annual budget.

One clinical trial received funding from Bayer to study Xarelto. The trial was overseen by Dr. Califf and was known as Rocket AF which involved more than 14,000 patients.  During the trial, which took place from 2006 to 2010, medical device INRatio, a test strip, monitored the dosage of warfarin and anticoagulation medication which was being compared to Xarelto. The trial showed 22 strokes for Xarelto patients compared to 6 strokes among patients on warfarin, which has been on the market for 60 years. 

The reliability of INRatio was already questions in two previous FDA warning letters, even before that trial began.  In 2014, INRatio was the subject of a recall notice warning that INRatio sometimes delivered false test results that could result in a false low reading and “life-threatening injuries, including death.” Duke Clinical Research Institute said in a statement to Project on Government Oversight (POGO) it is conducting an independent analysis of the trial data, sort of like investigating oneself. 

Despite that outcome, FDA reviewers approved Xarelto, and since there have been an increased number of patients who have experienced internal bleeding, gastrointestinal bleeding which is irreversible, stroke and death.  One of the FDA advisory committee members brought in to review Xarelto in 2011 told POGO that is information that should have been made available to the FDA reviewers.  Cardiologist, Vasilos Papademetriou, voted to approve Xarelto.

There are now 3,500 plus plaintiffs that have filed defective product lawsuits against the blood thinner. They are consolidated in multidistrict litigation in the Eastern District of Louisiana and the first trial should begin in about one year before The Honorable Judge Eldon Fallon.  One of the most recent lawsuits from South Florida was filed by a woman on behalf of her late husband. He was given Xarelto to treat atrial fibrillation but instead experienced an uncontrollable bleed out. He died from a subdural hemorrhage.  #

Sources:   http://www.pogo.org/blog/2015/11/drug-problems-duke-reassessing-data-drug-trial.html?referrer=http://www.legalreader.com/califf-appr/;
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm075594.htm;  http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000944/WC500120735.pdfhttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000944/WC500120735.pdfhttp://www.digitaljournal.com/pr/2848837;   http://www.thepharmaletter.com/article/bayer-reports-another-record-year;   http://www.prleap.com/pr/243966/xarelto-lawsuit-attorneys-at-bernstein-liebhard;   https://mail.google.com/mail/u/0/#search/xarelto/153199f0a01918f6;    http://www.digitaljournal.com/pr/2846998http://www.bizjournals.com/triangle/news/2016/02/23/duke-u-robert-califf-fda-commissioner-step.html;   http://www.pharmacist.com/fda-asks-if-faulty-blood-monitor-tainted-rivaroxaban-approvalhttp://www.imt.ie/clinical/2016/02/safety-status-of-rivaroxaban-remains-unchanged-ema.htmlhttp://www.thepharmaletter.com/article/novel-oral-anticoagulants-will-recover-from-slow-initial-uptake-says-analyst;   http://www.nytimes.com/2016/02/23/business/fda-asks-if-faulty-blood-monitor-tainted-xarelto-approval.html?_r=0

Still Ahead:

FDA Considers Reclassifying Surgical Pelvic Mesh Instruments

Feb 26, 2016, the FDA convened a special panel to consider whether the trocars or stainless steel instruments used in the blind passage of implanting pelvic mesh should be considered of “moderate risk.” Presently the Food and Drug Administration has they in the category of little to no risk or class I, the same classification for wheelchairs and band aids.  Trocars are used internally, and sometimes by doctors who have attended a weekend cadaver clinic hosted by the mesh manufacturer to learn how to place the polypropylene ribbons of mesh. Trocars have been found to gouge the bladder, the urethra, the colon. There was such a learning curve that we’ve seen from documents obtained during discovery of pelvic mesh trials, that the more experienced doctors were complaining that the  lesser doctors were “not getting it” and were having all sorts of problems injuring a cadaver.  Imagine what they could do on a human living patient. The Gastroenterology-Urology Devices Advisory Panel will give recommendations regarding the reclassification of the instrumentation. 

Parmesan cheese and Pulp
Some brands of 100 percent Parmesan may actually contain wood pulp or cellulose, according to Bloomberg. Look at the product sold in Target and other stores.  Caste President will plead guilty to criminal charges.

HPV Girl Vaccines
Girls are not receiving their HPV vaccines unless they are from Hispanic communities.

JAMA on bicycle injuries
More Americans want to bike on city streets and elsewhere but hospital admission rate, especially among those 45 and older, shows it’s not always a safe alternative transportation.

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