Boston Scientific recalls device after pieces broke off in patients – Boston Business Journal

The Marlborough-based medical device giant said the recall is voluntary, but that the Food and Drug Administration has classified it as Class 1, the most serious type.

Source: Boston Scientific recalls device after pieces broke off in patients – Boston Business Journal


FDA warning on uterine device draws opposition from doctors | Newsday

Nearly 50 doctors across the United States sent an open letter to the U.S. Food and Drug Administration on Monday calling on the agency to “revise or rescind” its position on a controversial device that had been used on more than 50,000 women annually until the agency cautioned against it last year.

The device, known as a laparoscopic power morcellator, had been widely used to remove benign growths known as fibroid tumors from the uterus or to completely remove the uterus itself in a hysterectomy.

Serious concerns arose, however, when deadly cancer cells harbored in the fibroids of some women were dispersed throughout the abdomen once shredded by the blades. Some fibroids hide rare and dangerous leiomyosarcomas, an aggressive cancer that can prove difficult to treat.

Source: FDA warning on uterine device draws opposition from doctors | Newsday

FDA Alert: Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication – FDA Cautions about Dose Confusion and Medication Errors

To my pharmacist and doctor friends – you might want to to take a look at this article. The FDA studied 7 cases and found that confusion was resulting because the strength of individual ingredients displayed on Zerbaxa’s vial labels and carton labeling was different. Some of the cases studied showed that this was resulting in a 50% over-administration of the drug. 

FDA Alert: Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication – FDA Cautions about Dose Confusion and Medication Errors.

Providing Local Representation to Out-of-State Motorists

As summer fast approaches, many see this time of year as an opportunity to escape the cold weather being suffered in the northern states, squeeze in a vacation, or are burdened with traveling for work as business begins to increase. Unfortunately, this also means that our state highways and interstates are packed with such travelers. Increased traffic plus high speeds can often lead to disastrous results. The coastal region of Georgia in not only unique in that it attracts a healthy portion of those travelers, but it is also home to a stretch of interstate 95 that has unfortunately earned a reputation for high speeds and tragic accidents.

Often those accidents involve out-of-state motorists who now find themselves injured and away from their home venue. This feeling can be quite uncomfortable, leaving some feeling helpless and questioning what they can possibly do to be made whole again. Fortunately, the laws of the state of Georgia provide that an injured party can seek to bring a claim in the venue in which they were injured. However, an injured party is unlikely to be familiar with some of the local customs, laws, and surroundings areas. Seeking out local representation is beneficial because more often than not, the majority of witnesses, medical providers, critical evidence, and possible parties involved in the accident are located in that venue.

This is where our firm can help. We pride ourselves in not only providing excellent legal representation to our local community, but also representing out-of-state parties injured locally. We seek to provide representation that allows you to return to your regular life at home, while we take care of your interests here in Georgia.

If you are involved in an accident in Georgia, but are unsure how your out-of-state residency effects your case, please give us a call.

Think Twice Before Giving Your Child Probiotic Medicine!! Infant Death Linked to Probiotic ABC Dophilus Powder


The FDA issued a warning to parents and medical personnel that the probiotic ABC Dophilus Powder has been linked to the death of an infant. The FDA warning states, in part, that:

“A premature infant administered a dietary supplement, ABC Dophilus® Powder (Solgar®), as part of in-hospital course of treatment, developed gastrointestinal mucormycosis caused by the moldRhizopus oryzae and died.”

The FDA further cautions parents and medical personnel about the use of dietary supplements containing live bacteria or yeast in infants and adults that have a compromised immune system. Parents should be aware that the FDA does not monitor these types of drugs in the same manner as most pharmaceuticals. The FDA also does not ensure that these types of drugs do what the manufacturer claims.

I know that my wife and I frequently gave our children probiotic medicines when they were infants. I also know that I would have never done this had I known the risks associated.

Want to read the FDA’s warning letter? Click on this link:

FDA Alert: RegeneSlim Appetite Control Capsules: Recall – Presence Of DMAA

 FDA Warning

ISSUE: Regeneca Worldwide a division of VivaCeuticals, Inc., is conducting a voluntary nationwide recall of its appetite controldietary supplement, lot # EX0616R15814 and lot #11414RE5516, because FDA analysis confirmed the presence of DMAA. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. FDA has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.

via FDA Alert: RegeneSlim Appetite Control Capsules: Recall – Presence Of DMAA.

J&J’s Pinnacle Hips Face First Trial on Poisoned Patients – Bloomberg

Bloomberg news just reported that Johnson & Johnson’s first trial concerning its “Pinnacle” hip replacements will begin today.  There are a total of approximately 6,000 cases alleging that the Pinnacle hip replacements were defectively designed causing metal debris to be absorb into patient’s blood stream.

We are currently handling both these cases and other similar cases involving J&J’s “ASR” hip replacements. Please let us know if you have received either hip implant, as you may be unknowingly suffering from metal poisoning.  If you or a loved one has received a hip replacement between the years of 2005 – 2013, I would strongly advise you to contact your doctor to determine the exact make and model of the implant. Let us know if you need help finding this out. All initial consultations are free.

Johnson & Johnson JNJ, which set aside $2.5 billion last year to resolve claims that 8,000 of its artificial hips were defective, faces a new round of lawsuits over another line of hip implants blamed for poisoning patients.J&J’s DePuy unit is starting its first trial of allegations that the metal-on-metal version of the Pinnacle hip was defectively designed and caused metal debris to leech into patients’ bloodstreams. The cobalt-and-chromium material caused an infection that forced Kathleen Herlihy-Paoli to have her artificial hips surgically removed, she said in court filings.

via J&J’s Pinnacle Hips Face First Trial on Poisoned Patients – Bloomberg.

Hysterectomy Device Tied to Spreading Cancer Recalled by Johnson & Johnson

Power Morcellators

Image Credit: Wall Street Journal

J&J just announced that it is voluntarily pulling its power morcellators globally. J&J’s decision comes in the wake of the FDA’s April 2014 warning to doctors that this device may spread, and consequently accelerate, the growth of undetected cancer cells in women. The FDA found that as many as 1 in 350 woman who undergo this procedure may have cancer that this machine could spread outside the uterus.

Power morcellators are robots that are used to preform minimally invasive robotic hysterectomies. The American Medical Association estimates that as many as 20,000 woman have these types of procedures preformed on an annual basis.

Our firm is currently reviewing cases where woman have had robotic hysterectomies and experienced injuries or the spread of cancer.

Bloomberg News published a good article on this: