Yourlawyer Blog

Health regulators in the United Kingdom were aware of problems with defective PIP silicone breast implants for at least four years before they were eventually recalled from the market in Europe and some parts of South America.

More than 50,00 women in the U.K., and tens of thousands more around the world received the less expensive Poly Implant Prosthese (PIP) silicone gel breast implant after it reached the market in 2006. Five years later, the implants were being recalled as more and more women reported suffering adverse reactions and health side effects they could only blame on the implants. Continue Reading »

by: Jonathan Macri, Esq.

West Coast Nutritionals, a seller of popular dietary supplements and other wellness products, has just issued a voluntary recall of a number of products it markets and sells relating to sexual health. The move comes amidst FDA findings that the products contain an ingredient known as tadalafil. While tadalafil is a drug that has been approved for use by the FDA in certain drugs that are meant to aid erectile dysfunction, there use in West Coast’s products was deemed an unapproved use and thus the FDA has stepped in.

Specifically, the drugs that West Coast has taken off the shelves are Fiminite, Extra Strength Instant Hot Rod and Libidron, all of which are aimed at increasing sexual health and performance. The main issue with the presence of tadalafil in these drugs is that it likely will interact negatively with nitrates that are commonly found in prescription drugs for high blood pressure or heart disease. The interaction between the tadalafil and the nitrates can cause blood pressure to lower to very dangerous levels.

Owners of these products should stop use immediately and pay attention to their blood pressure as well.

by: Michael Werner, Esq.

Inhaled anticholinergics (IACs) are often used in the treatment of unexpected asthma flare-ups and are administered through the common asthma inhaler. However, a University of Illinois study of approximately 7,600 asthma patients ages 5 to 24 years old concluded that the active and regular use of IACs were associated with a 1.56-fold increase in heart arrhythmia risk.

The study’s participants were split into groups based upon their exposure to IACs: active, immediate past, past and never. As expected, the higher concentration of IAC one was exposed to lead to a higher risk of developing an arrhythmia.

In light of the concerning risk of heart arrhythmias to children, the study’s author, Dr. Lee, commented that he “wanted to focus on pediatric patients and young adults because these are the groups that don’t have a lot of risk factors for cardiovascular disease.” Moreover, the study excluded all candidates with a history of or potential proclivity for heart problems or disease.

Dr. Lee concluded that “[i]t’s certainly biologically possible that these medications could increase heart rate and cause arrhythmic events.” He added that researchers have long questioned the effect of inhaled medications on biological systems outside of the lungs.

by: Stephanie Herschaft, Esq.

This week, an administrative law judge (ALJ) issued a cease-and-desist order against Pom Wonderful to stop it from making misleading claims about the health benefits of the pomegranate juice that it sells. The ALJ ruled that the Resnicks, owners of Pom Wonderful, spread deceptive claims implying that their pomegranate juice could treat or prevent ills such as erectile dysfunction, prostate cancer and heart disease.

In September 2010, the FTC filed a complaint that accused the company of false advertising shortly after POM had sued the FTC, alleging that the agency had violated their first amendment rights through their new regulations on the evaluation of deceptive advertising. This decision will be appealed before the full FTC. POM did not lose the whole fight, however.

The ruling also stated that Pom does not have to have its marketing campaigns pre-approved by the FDA nor would they have to conduct placebo controlled tests to reinforce its claims in those advertisements.

Source – huffingtonpost.com

A judge in Brooklyn urged all Orthodox Jews who are aware of sexual abuse against children to report these crimes to civil authorities for proper prosecution.

According to a New York Daily News report Tuesday, Brooklyn Supreme Court Justice Vincent Del Giudice issued this statement as he sentenced Michael Sabo to 20 years in prison for sexually abusing two young children. Sabo is a 38-year-old nurse and father who pleaded guilty to abusing a 5-year-old boy and 6-year-old girl repeatedly since 2001. Continue Reading »

by: Michael Werner, Esq.

Women age 50 and over have been taking Fosamax or Actonel to prevent hip, spine and wrist fractures resulting from the onset of osteoporosis. Ironically, some Fosamax and Actonel patients have suffered fractures curiously similar to those the drugs are meant to protect against—and often through simple, everyday movements.

A study published Monday by the Archives of Internal Medicine in conjunction with the American Medical Associate found a causal connection between the drugs and atypical, particularly rare thigh fractures. The researchers noted that the fracture risk can increase dramatically the longer one uses Fosamax or Actonel.

For example, with less than 2 years of use, users are 35 times more likely to develop a femur fracture. However, that statistic skyrockets to 117 times more likely for the period of 5 to 9 years of use. After more than 9 years of use, one is 176 times more likely to suffer a fracture. In light of these statistics, it is not surprising that one of the study’s authors suggested reconsideration after 3 to 5 years, “[o]therwise, it is possibly causing more harm than benefit.”

In 2010 this risk was acknowledged by the U.S. Food and Drug Administration, which included a fracture warning on the Fosamax and Actonel label. Notwithstanding, both drugs are the subject of currently-pending product liability lawsuits.

by: Stephanie Herschaft, Esq.

According to new research presented by Dr. Hamed Khalili, a clinical and research fellow of gastroenterology at Massachusetts General Hospital in Boston, the use of oral contraceptives by younger women or hormone therapy by older women may be linked with inflammatory bowel disease (Crohn’s disease and Ulcerative Colitis). Birth control pills, taken mostly by younger women are associated with an increased risk of Crohn’s disease. Hormone replacement therapy taken by some women after menopause is linked to an increase in the occurrence of ulcerative colitis. Both diseases cause diarrhea, abdominal cramping and rectal bleeding.

The link between Crohn’s and birth control usage, particular long term usage, is the stronger of the two associations. Birth control users had almost three times the risk of Crohn’s disease as compared to those women who never took hormonal contraceptives. Those on birth control had no increased risk for ulcerative colitis.

Women on hormone therapy had a 1.7 times higher chance to get ulcerative colitis than those not on the hormones, but there was no increased risk for Crohn’s. The main takeaway from both studies was that they uncovered a link between hormone therapies and digestive issues, though there was no cause and effect relationship that was proven.

Diamond Pet Foods has now included its Diamond Naturals dry cat food to its ever-expanding recall on dry pet foods it manufactured at its plant in South Carolina that may be contaminated with Salmonella bacteria.

According to a report from The Christian Science Monitor, there has been little attention called to the recall on cat food, mostly focusing on the recalled dry dog food that’s caused at least 16 confirmed cases of Salmonella poisoning in the U.S. and Canada. Diamond included cat food unceremoniously in a recall statement posted at its Web site. The statement reads:

“Diamond Pet Foods has voluntarily recalled some brands of dry dog and cat food that it manufactured in its Gaston, S.C. facility between December 9, 2011 and April 7, 2012 due to potential Salmonella contamination.” Continue Reading »

by: Michael Werner, Esq.

Recently the U.S. Food and Drug Administration (“FDA”) for the first time a

Plavix is a blood thinner prescribed for the prevention of blood clots, and is often the preferred treatment for patients particularly at risk of suffering a stroke or heart attack.  The drug has been linked to serious side effects, including gastrointestinal bleeding, bleeding ulcers, thrombotic thrombocytopenic purpura (TTP) and cerebral hemorrhages.

pproved for domestic sale the generic version of ultra-popular blood thinning drug Plavix.

Brand-name Plavix is marketed jointly by Bristol-Myers Squibb Co. (“BMS”) and Sanofi SA (“SS”). Prior to the FDA’s approval of the generic version, BMS and SS were enjoying nearly $9 billion in annual revenue from the sale of Plavix, which ranks as the second most popular drug in the U.S. These exorbitant sales figures come as no surprise when you consider that Plavix accounts for close to half of all prescription drug sales globally.

All in all, the FDA granted generic approval to seven companies: Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxanne Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals. Additionally, Dr. Reddy’s Laboratories and Gate Pharmaceuticals may sell a 300-milligram dose, which is given almost primarily as an emergency treatment for heart attack patients.

In an attempt to retain their pre-generic clientele, BMS and SS are offering Plavix coupons that greatly reduce the otherwise $200 per month cost of the brand-name version. Additionally, Plavix users may sign up for the Plavix Choice Card, which will allow them to secure a 30 day supply each month for the remainder of the year for a total cost of $37 per month.

Nevertheless, with generic forms of Plavix soon to flood the market, BMS and SS will surely see Plavix prescription rates drop.

by: Michael Werner, Esq.

The U.S. Food and Drug Administration (“FDA”) has recently notified healthcare professionals that it is reviewing the results of a New England Journal of Medicine study that suggests that Zithromax (azithromycin) users are at a heightened risk of suffering cardiovascular death.

Zithromax is an antibacterial drug used to treat a variety of illnesses and conditions, including acute bacterial sinusitis, urethritis, genital ulcer disease and some forms of pneumonia. The study found that users of a 5-day course of Zithromax (known popularly as Z-Pak) were at double the risk of developing a fatal heart condition as compared to users of amoxicillin, ciprofloxacin or no drug at all. In March of this year specific warning information was added to the Zithromax drug label relating to potential cardiovascular side effects.

It is important to note that the FDA is not recommending that azithromycin users immediately stop taking the drug. Instead, as in any situation, the FDA is encouraging users to discuss this issue with their doctor and to remain aware of upcoming developments. Moreover, the FDA continues to investigate a connection between Zithromax’s class of drugs and cardiovascular complications.