Philadelphia Personal Injury Lawyer - All Topics - Most Popular

Cancer Risk for Children Using TNF Blockers

Jamie Sheller — Thu, 06 Aug 2009 22:27:41 GMT

Tumor necrosis factor (TNF) blockers keep down the production of TNF-alpha, which can cause inflammation leading to bone, cartilage and tissue damage. An FDA analysis showed that TNF blockers pose a greater risk of cancer to children and adolescents. Based on that risk, the FDA is requiring stronger warnings on the prescribing information for TNF blockers, which include Remicade, Enbrel, Humira, Cimzia, and Simponi. TNF blockers are used to treat rheumatoid arthritis, juvenile idiopathic arthritis, Crohn's disease, and other chronic inflammatory diseases.

As early as 2006, the FDA knew of a possible general cancer risk with TNF blockers, and a risk of lymphoma in children and young adults. After receiving 30 reports of cancer in children under 18 using TNF blockers, the FDA began an investigation in 2008. The results of the investigation showed that after 30 months of treatment with TNF blockers, there was an increased risk of cancer. Doctors should discuss the risk with families, and patients using TNF blockers should be monitored for malignancies both during and after treatment with TNF blockers.

If you have a child who used TNF blockers and developed cancer, contact Sheller, P.C. to discuss potential legal claims you may have. The Sheller firm has a history of successfully representing people who have been injured by prescription drugs.

Originally posted at InjuryBoard by Jamie Sheller

New Black Box Warnings Ordered For Botox Products

Jamie Sheller — Sat, 02 May 2009 11:07:02 GMT

On April 30, 2009, the FDA announced a requirement that Botox and similar products must carry a black box warning on their labels. The new labels must highlight a warning about the risk of a potentially fatal complication if the effects of the drugs spread far beyond the injection site. Botox and similar products are used medically to treat muscle spasms and involuntary muscle movements. However, if the botulinum toxin spreads, it can cause botulism poisoning. There have been reports of hospitalizations and deaths in children with cerebral palsy who were treated with botulinum toxin. There have also been hospitalizations reported for adults being treated for muscle spasms, but suspected adult deaths could not be confirmed. Some symptoms of distant spread and botulism poisoning in Botox users include loss of bladder control, trouble breathing or swallowing, blurred or double vision, drooping eyelids, and sudden loss of strength or muscle weakness.

Botox and the related product Myobloc are also used for cosmetic purposes to treat frown lines between the eyebrows and excessive underarm sweating. The required doses for cosmetic use are generally smaller than for medical use, and the FDA told reporters that cosmetic use appears to be safe when the drugs are used as directed. Public Citizen, a health advocacy group petitioned the FDA for the black warning. According to Public Citizen, 180 serious adverse events and 16 deaths in the U.S. were attributable to Botox and Myobloc as of early 2008.

The products affected by the FDA black box warning requirement include Botox and Botox Cosmetic, sold by Allergan Inc., Myobloc, sold by Solstice Neuroscience and Dysport, a new product sold by Ipsen.

Originally posted at InjuryBoard by Jamie Sheller

Lawsuits Over Bayer Birth Control Pills

Jamie Sheller — Wed, 15 Jul 2009 23:14:35 GMT

In 2008 Bayer agreed to run a $20 million advertising campaign for its Yaz birth control pill. The purpose of the new ads is to correct some misrepresentations that were in the initial advertising campaign where Bayer downplayed the risks of Yaz and overstated the drugs benefits. The agreement to run the corrective ads followed a warning letter that Bayer received from the FDA about the original Yaz ads.

Now Bayer is facing federal lawsuits about the safety of Yaz and Yasmin birth control pills. According to plaintiffs' lawyers Bayer overpromoted the birth control pills, while failing to warn of their increased risks of injury such as blood clots. Plaintiffs' attorneys believe that the FDA's warning letter is important evidence of their clients' claims. One attorney stated that her firm has uncovered evidence that the FDA has received many more reports of adverse events for Yaz and Yasmin than for other birth contol pills that have been on the market longer. Yasmin was approved by the FDA in 2001 and Yaz in 2006. Many more lawsuits against Bayer are expected to be filed in the coming weeks and months.

Originally posted at InjuryBoard by Jamie Sheller

Synthes Components Recalled

Jamie Sheller — Wed, 18 Nov 2009 21:17:38 GMT

Recently, Synthes, a Swiss medical device company, voluntarily recalled its Synex II Central Body components. According to the company, all surgeons and hospitals with the recalled devices were to immediately stop implanting them. The FDA has classified the recall as a Class I, which means that they could pose an imminent health hazard. The Synthes devices are used to replace damaged or unstable vertebral body in the T1-L5 portion of the spine. The recall was issued after reports of device failure causing loss of vertebral body replacement height. Those problems could lead to neural injury, increased pain and possible need for further surgery.

Originally posted at InjuryBoard by Jamie Sheller

New Defibrillator Warnings

Jamie Sheller — Sun, 22 Nov 2009 15:06:09 GMT

Recently, the FDA warned that about 300,000 defibrillators manufactured by Cardiac Science Corporation have potential malfunctions. According to the FDA, these malfunctions don't show up on device self-tests, but may prevent delivery of life-saving shocks.

The devices affected by the warning include some Powerheart and CardioVive models of AEDs, manufactured between August 2003 and August 2009. Some of the potential problems include failure to recognize pad placement during use, interference from background noise, and interrupted electrocardiography analysis. Though the FDA is not issuing a recall of these devices, it is urging users to take certain precaution if they are currently using affected AEDs. Some of those recommendations include using an alternate AED if available, until the malfunctioning model has been replaced or repaired, for at-home use, only use the device when necessary, in clinical settings, use a manual defibrillator if available.

Originally posted at InjuryBoard by Jamie Sheller

Emergency Alert Regarding MTD Snow Throwers

Jamie Sheller — Tue, 20 Oct 2009 19:32:37 GMT

Winter is quickly approaching, and snow has already fallen in parts of the country. Along with snowfall, comes the use of snow throwers. However, some snow throwers should not be used. In 2006, there was a recall of snow throwers manufactured by MTD. The snow throwers were recalled due to the risk of injury from bursting wheel rims when the tires are inflated. Exploding plastic wheel rims have caused numerous injuries, including lacerations and fractures. The snow throwers involved in the recall are two-stage compact snow throwers with Troy-Bilt, Yard Machines or Craftsman printed on the snow thrower's housing. Yard Machine and Troy-Bilt brand snow throwers were sold at independent dealers, home improvement and hardware stores. Craftsman brand snow throwers were sold at Sears and Kmart stores. Snow throwers involved in the recall were sold between July 2004 and March 2006. The MTD snow thrower recall was done in cooperation with the Consumer Product Safety Commission.

Despite the fact that the recall was done in 2006, people are still using the recalled machines, and being injured. Anyone who has one of the recalled MTD snow throwers should not try to inflate the tires. There is a risk of injury caused by the tire rim exploding.

If you have been injured by an MTD snow thrower, contact Jamie Sheller, at Sheller, P.C. to discuss your potential legal rights. The Sheller firm has a long history of successfully representing individuals and classes of individuals who have been injured by defective products.

Originally posted at InjuryBoard by Jamie Sheller

Patients Suffering After Using Shoulder Pain Pumps

Jamie Sheller — Thu, 23 Apr 2009 14:55:54 GMT

Pain pumps are used after surger to help manage post-surgical pain. Recently, pain pumps used in the shoulders following arthroscopic surgery have been linked to postarthroscopic glenohumeral chondrolysis (PAGCL). Some patients are questioning the use of shoulder pain pumps by their doctors, in light of the extreme difficulties they have experienced. For instance, one woman can no longer perform her job as a home health aide. Due to her pain and continuing shoulder problems, she cannot help clients bathe and get dressed. In July 2008, Julie D. had surgery to repair torn cartilage in her shoulder. Her doctor sent her home with a pain pump, but after it was removed, Julie had continuous aching, with limited mobility, and she still had popping, clicking and grinding in her shoulder. Six months later, an MRI showed that the cartilage was re-torn and Julie had another surgery, with a pain pump being used for a longer amount of time. Since the most recent surgery, Julie has suffered with a constant ache from her shoulder to her wrist, and still has popping and clicking. Also, the pain medication has not taken care of the pain that she has. Julie is now questioning whether her post-surgical problems have been caused by the pain pumps that were used after both of her surgeries. She also wonders why her doctors used the pump in her shoulder when it is not approved for use in the joint. Her injuries have significantly impacted her day-to-day life. She is always in pain, and can no longer do many of the activities that she used to do. Julie also can't sleep comfortably. There are many people with similar suffering after use of shoulder pain pumps.

Originally posted at InjuryBoard by Jamie Sheller

Bacteria In Vicks Nasal Spray

Jamie Sheller — Sun, 22 Nov 2009 10:41:44 GMT

Vicks Sinex nasal spray has been recalled in the United States, Britain, and Germany. Proctor & Gamble announced the recall after discovering that some of the Vicks nasal spray was contaminated with bacteria. According to Proctor & Gamble, the bacteria was found during routine quality control at a manfacturing plant in Germany. The company states that, so far, the contamination is limited to a single batch of raw material mixture. Three lots of the product, sold in the United States, Britain, and Germany are affected by the recall. Proctor & Gamble asserts that the bacteria does not pose a great risk to healthy people, but that people with weakened immune systms or chronic lung conditions could develop serious sinus infections from the bacteria.

If you have the recalled Vicks nasal spray, you should discard it and contact Proctor & Gamble for a replacement coupon or refund. In the United States, the affected product is Vicks Sinex Vapospray 12-hour Decongestant Ultra Fine Mist, with lot number 9239028831.

Proctor & Gamble is based in Cincinatti, Ohio.

Originally posted at InjuryBoard by Jamie Sheller

Deadly Multi-Car Crash On I-95

Jamie Sheller — Fri, 30 Jan 2009 20:47:18 GMT

A multiple car accident on I-95 left 3 people dead, and another person in extremely critical condition. The accident happened in Claymont, Delaware, apparently when the driver of a Ford Explorer lost control of the SUV and crossed from the northbound lane into the southbound lanes of the interstate, and hit a Mercury sedan. The 47-year old passenger in the Explorer, and the 72-year old driver of the sedan, died at the scene. The 50-year old man driving the SUV died at a local hospital, and the 78-year old passenger in the sedan was taken to the hospital in critical condition. Delaware State Police are investigating the cause of the accident, with speed being a possible cause.

Originally posted at InjuryBoard by Jamie Sheller

Philadelphia Personal Injury Lawyer - All Topics - Most Popular

Cancer Risk for Children Using TNF Blockers

New Black Box Warnings Ordered For Botox Products

Lawsuits Over Bayer Birth Control Pills

More Problems For Acne Drug Accutane

Synthes Components Recalled

New Defibrillator Warnings

Emergency Alert Regarding MTD Snow Throwers

Patients Suffering After Using Shoulder Pain Pumps

Bacteria In Vicks Nasal Spray

Deadly Multi-Car Crash On I-95