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.
The first few settlement payments were made over the last two weeks from the DePuy ASR Settlement Trust. It had been hoped that more payments would have been made by this point. Brown Greer which is the law firm that is administering the settlement listed June on its website as the anticipated starting month for payments. Apparently, reviewing the claims and documents submitted turned out to be more time consuming than they had anticipated.
As of the second week of July, Brown Greer has doubled its team members on this project so that they now have 85 attorneys, project managers, analysis, and claim reviewers. Brown Greer has a good track record, in my experience, in administering large complex settlements such as this one and I am confident that they will be able to speed up the processing and payment of these claims.
Brown Greer reviews the claims submitted and then issues either a Notice of Eligibility or a Deficiency Notice if documents submitted are not complete. If an Eligibility Notice is issued, it provides a detailed breakdown of how much is proposed to be paid on the claim and why. The attorney receiving the Notice of Eligibility can either accept the claim or contest the claim. If the attorney receiving the Notice of Eligibility does not agree that the payment amount is correct he or she can submit a written description of why the claim is not correct and can upload documents to support the contest of the claim.
In yet another clear sign that pharmaceutical companies are manufacturing a cure and have used the media and aggressive marketing to create a market, Clarus Therapeutics announced that they are resurrecting an IPO designed to back the launch of their new low testosterone drug Rextoro.
Clarus first mounted the IPO for Rextoro three years ago but withdrew it due to lack of market interest. Now with Low T clinics opening across the nation Clarus has mounted a bid to raise $86 million in venture capitol to launch Rextoro. In the IPO the company has announced the drug has gone through Phase III studies and was submitted to the FDA in January.
Everyone in Florida is required by law to have Personal Injury Protection (PIP) automobile insurance. PIP is your personal policy for medical coverage for up to $10,000, whether you are at fault or not. Seems simple, but is it?
Not really. If your injuries are not reported by a medical doctor to be emergency-related medical condition, PIP only pays up to $2,500. To make matters worse, if you do not see a medical doctor or go to a medical facility within 14 days of your accident, your PIP claim can be completely denied. We are fighting to repeal this law, but until we succeed, this is Florida Law.