Johnson & Johnson is once again in the crosshairs of another medical device investigation. Ethicon, a division of J&J, is the largest maker of a highly controversial surgical instrument known as a power morcellator. The FBI has launched an investigation to determine if J&J continued to market the devices even after it was discovered they could spread a type of cancer.
The power morcellator was designed to be used in minimally invasive surgeries and is often used to remove the uterus. The tool has rapidly spinning blades that cut tissue into small pieces that can be removed from the body through small slits made during surgery. But it has been discovered that when the morcellator is used in women with undetected cancers, during removal of the uterus malignant cells are sprayed around the abdomen and can actually speed the progression of the disease. Continue reading
There was little fanfare in the business world earlier this year when Valeant Pharmaceuticals International acquired the rights to two drugs made by Marathon Pharmaceuticals. However what happened after that acquisition is raising serious concern.
With the deal, Valeant gained the rights to a pair of lifesaving heart drugs, Nitropress and Isuprel. The Wall Street Journal reported that on the same day bought the rights to these heart drugs, their list prices rose by 525% and 212% respectively. more
This week the iconic Texas Ice creamery Blue Bell announced a mandatory recall of all it’s frozen dessert products over concerns of contamination by the potentially deadly bacteria Listeria. This is the second recall for Blue Bell in less than a month. It follows an initial March recall due to Listeria found in half-gallon containers of chocolate chip cookie dough ice cream produced March 17 and March 27.
Publix, our regions largest grocery chain with 763 stores in Florida alone, issued immediate orders to all its stores to destroy all Blue Bell ice cream. Other grocery chains across the southeast have issued similar orders to destroy all products produced by Blue Bell, the Nation’s third-largest manufacturer of ice cream. Continue reading
Serious concerns about the possible increased risk of heart attacks and strokes in patients using “low-T” products, have led the Food and Drug Administration to issue a new ruling requiring the makers of these dugs to alter labeling to reflect the dangers associated with them.
The FDA will now require the makers of “low-T” products, to make clear that using these products carries the possible increased risk of heart attacks and strokes. The new labeling will also state that these drugs are only approved to treat low testosterone levels caused by disease or injury, not normal aging. Continue reading
Last month, after little outside input, the Food and Drug Administration swiftly approved Vyvanse — originally marketed as an attention deficit hyperactivity disorder drug — to treat Binge Eating Disorder (BED), calling it “an effective option to help curb episodes of binge-eating.”
Days after Vyvense was approved, retired professional tennis player Monica Seles coincidentally began appearing on popular television talk shows and was featured in People magazine sharing her struggle with binge eating. The timing wasn’t coincidental; Seles is a paid spokesperson for Shire, the makers of Vyvanse, and the face of the BED drug’s marketing campaign. Along with Seles, Shire also launched a website to spur social media and began providing funding for patient groups. Continue reading
Johnson & Johnson has been ordered by a Philadelphia jury to pay $2.5 million to a 20-year-old autistic man from Alabama – who developed size 46 DD breasts as a young teenager – because the company failed to adequately warn of that potential side effect from his use of the antipsychotic drug Risperdal.
This was the first Risperdal case to go to jury that was related to the condition gynecomastia – which causes abnormal development of breasts in males. The lawsuit claimed that J&J had knowingly hid the risks of gynecomastia, and came after several other similar cases were settled in recent years. Continue reading
The Topeka Capital Journal reported that the Better Business Bureau warned consumers of the dangers of ignoring product recalls. According to the Better Business Bureau, every product created is a possible recall candidate. Consumers who do not check whether or not their product has been recalled, could be placing themselves and others in harm’s way.
We, here at Saunders and Walker, P.A., try to keep you updated on product recalls. However, it is not possible to report on every recall of every product. For that reason, we strongly urge consumers to be proactive in researching products before and after purchases. Continue reading
In Dallas, Boston Scientific Corporation was just ordered to pay $73 million to a woman who claimed she suffered serious injuries from a transvaginal mesh device made by the company, the Obtryx sling, which had been implanted in her to treat incontinence.
The jury’s verdict in this case marks the first loss for Boston Scientific and comes amid tens of thousands of suits being mounted nationwide against manufacturers of these dangerous devices.
Massachusetts based Boston Scientific is facing 23,000 of these lawsuits over its vaginal mesh implants. The suits all contend that their mesh slings erode in the body and cause innumerable painful complications that require surgery to remove the device.
All the cases come after the makers of these devices were ordered by the FDA in 2012 to study rates of organ damage and complications linked to the mesh products. Since then a wave of lawsuits has been filed against companies who make mesh implants. Thousands of the federal lawsuits have been consolidated in West Virginia and the first trial there is scheduled to begin next month.
Only a handful of mesh cases have gone to trial so far and this award is the largest to date. The jury returned the verdict against Boston Scientific after only a few hours of deliberation and, according to the court filing, the defendant was awarded $23 million in compensatory damages for her actual and future suffering and $50 million in punitive damages after finding the company was grossly negligent.
While the makers of these dangerous mesh products continue to deny responsibility for the horrible problems experienced by women who have received the devices, justice is slowly catching up with them. This verdict in Dallas is an early shot across the bow and the manufacturers, like Boston Scientific, will eventually have to take responsibility for the dangerous mesh products they sold.
“Would you drive the length of a football field at 55 mph with your eyes closed?
That question was posed by TimesDaily.com. According to the online publication, the National Highway Safety Administration states that is what it is like to take your eyes off the road for five seconds.
Hand-Held Versus Hands-Free
Cell phone technology is expanding at a rapid rate. Android and Apple smart-phones have the capability to surf Facebook, the internet, read emails, stream news, watch movies and videos, and take pictures at the touch of a finger. The technology is expected to expand to screens that bend, self-charging phones, and NFC chips that allow people to use their phones as boarding passes, hotel room keys, and payment cards.
New Jersey trial Judge Carol Higbee denied Johnson & Johnson and subsidiary Ethicon’s motion to throw out the 11 million dollar jury verdict from last February’s trial. The jury in the Linda Gross v. Ethicon trial awarded $3.35 million in compensatory damages and $7.76 in punitive damages after finding that the manufacturer of the transvaginal mesh was negligent and that the product was a defective product under products liability laws.
The jury trial which took four weeks involved the Gynecare Prolift Pelvic Mesh Kit. This type of mesh is marketed to treat pelvic organ prolapse and stress urinary incontinence in women. In 2012, the United States Food and Drug Administration (FDA) became concerned the high rate of injuries and adverse outcomes from transvaginal mesh products and issued a number orders that medical device manufacturers increase post market surveillance of adverse events for these products.