Jacksonville Personal Injury Lawyer - Medical Devices & Implants

Medtronic Defibrillator Lead Linked to 13 Deaths

Eddie Farah — Sat, 04 Apr 2009 01:08:00 GMT

An independent panel of physicians now says the death count from the Medtronic Sprint Fidelis cardiac wire is closer to 13, more than the five deaths the company previously revealed.

Last month, the company told doctors about the increased number of patient deaths and suggested that leaving the lead intact was perhaps the best choice for the majority of patients. Four of the patient deaths resulted from removing the defective lead.

The defective lead was in the heart of about 270,000 patients when Medtronic pulled the device in October 2007.

Patients have filed lawsuits over the Sprint Fidelis lead which delivered either too many shocks or didn’t deliver an appropriate shock to steady a heartbeat. The cases charge product liability, negligence, fraud, and breach of contract, among other charges.

Patients can ensure they are safe from defective medical devices and drugs only when their makers fully and openly disclose the side effects. It sounds simple and reasonable, but unfortunately litigation, or the threat of litigation provides a strong incentive for companies to avoid design defect or failure-to-warn lawsuits.

The Medical Device Safety Act of 2009 returns to consumers the ability to hold a company accountable for a defective product that the company, in some cases, knowingly markets to the public.

The public can sign on to support the Act in an online petition.

Once you’ve been injured, filing a lawsuit helps you recover what it might cost you for a lifetime of medical care, but it does not reverse the harm. Forcing transparency with the threat of a lawsuit might, and let's not forget it's an American right.

It’s too bad that companies don’t just do the right thing and insist on the highest standard of safety to minimize harm, but clearly they don’t.

Originally posted at InjuryBoard by Eddie Farah

$16.6 Million Duragesic Pain Patch Trial Ends

Eddie Farah — Mon, 24 Nov 2008 22:59:00 GMT

The trial of a woman who died from an overdose of the drug delivered through the Duragesic pain-killing patch is over. The jury awarded her husband and three children $16.6 million.

The Chicago area woman, Janice DiCosolo, 38, died in February 2004. DiCosolo was the mother of three children who suffered constant pain from a neurological condition, reflex sympathetic dystrophy for which she used the patch.

The narcotic, fentanyl, is the pain killing main ingredient in the patch, made by Alza Corp, owned by Johnson & Johnson. Fentanyl is 100 times more powerful than morphine. The pain patches are supposed to be worn 72 hours and then thrown out.

DiCosolo was wearing one when she died. The amount of the fentanyl contained in the patch is enough to kill 10 men weighing 300 pounds each, said her lawyer Jim Orr.

One lot of the Duragesic patches was recalled in February 2004 because the adhesive on the back of the device was improperly sealed. DiCosolo died the next day, the patch she wore was from that lot.

This represents the fourth pain-patch loss for J &J in two years.

Duragesic generated $1.16 billion in sales last year, according to Bloomberg.

Her case began last October, one day after a Sanford Florida jury awarded $13.3 million to the family of Susan Hodgemire, a 34-year-old mother of five who was recovering from back surgery. She too died when a Duragesic patch failed in 2002, flooding her system with the narcotic. In the middle of the night Hodgemire began vomiting violently, then lapsed into a coma and stopped breathing.

Last year, a West Palm Beach, Florida man’s family was awarded $5.5 million after dying from an overdose of prescription patch painkiller. Adam Hendelson was 21 and shattered his hip in a car accident in 1996. Because of constant pain, he was prescribed the Duragesic patch in 2003. He died at the age of 28, from an overdose of fentanyl.

Meanwhile there may be as many as 100 of these cases waiting to have their day in court.

J & J says it may appeal the latest case. #

Originally posted at InjuryBoard by Eddie Farah

More Warnings for Derma Fillers

Eddie Farah — Thu, 20 Nov 2008 21:24:00 GMT

An FDA advisory panel believes the cosmetics industry is not coming clean about the potential adverse side effects from dermal fillers, injected to soften facial wrinkles.

Popular brands are Juvederm (Allergan) and Restylane (Medicis Pharmaceutical Corp).

The experts who make up the panel agreed the labeling should include more serious side effects, how long the product has been on the market, and how long it might take before side effects appear,” says a FDA spokeswoman.

More than 1.5 million of these procedures are done a year, so it's about time. During the last six years, the FDA has received 930 reports of adverse effects from the numerous dermal fillers approved. They include:

· Allergic reactions

· Swelling

· Inflammatory reactions resulting in nodule formation, cold sores, arthritis flare-ups, and other problems

· Infection

· Bruising, bleeding, scars

· Blisters and cysts

· Lumps and bumps

· Numbness, including palsy

· Migration, such as the filler material moving to another site on the face

A number of the reports of adverse events involved injections by untrained personnel, the FDA also found.

No deaths have been reported, but the panel is concerned that the long-term effects of some dermal fillers may not be completely understood.

While the current labels do include several potential adverse effects, they do not always list when the events might occur. The panel is advising the FDA to require manufacturers to note that some events can occur months and sometimes years after injection.

Some plastic surgeons and industry representatives say stronger labels are unnecessary, while other experts welcome the labeling recommendations. #

Originally posted at InjuryBoard by Eddie Farah

An American Right In Jeopardy

Eddie Farah — Sat, 28 Jun 2008 23:23:57 GMT

An American Right In Jeopardy

By Eddie Farah on June 28, 2008

We hear it all the time. People tell us, "I'm not the type who sues..." and then they tell us about a horrible injury they or a loved one has endured. We tell them, it’s okay, you are an American and the courts are set up for citizens like you to find a remedy when they’ve truly been injured. It’s an American right.

It was an American right for the widow of Charles Riegel. Riegel died in 1996 when a balloon catheter made by Medtronic burst in his chest after it was inserted during an angioplasty. She sued, but in February of this year, the U.S. Supreme Court sided with Medtronic.

The reasoning is bizarre and frightning, and generated by business interests to protect the bottom line. Here it is - since the medical device was approved by the FDA, the court decided that the states (in this case New York where the suit was filed) don’t have the right impose liability over a faulty product. In other words- FDA approval is the final word on medical devices.

Given the FDA's track record, that is a frightening thought. (Not that there aren't many good people working there, but there is just too much to do and too few resources to do it.)

Now another case, this one against drug maker Wyeth, is going before the Supreme Court and the business community will be using the same argument, called federal pre-emption, to get blanket immunity for drug liability.

A Vermont musician won $6.8 million judgment, awarded by a jury, against drugmaker Wyeth after her arm had to be amputated because a Wyeth anti-nausea drug was improperly injected. Wyeth wants to overturn the case so will ask for blanket immunity before the Supreme Court. The drug and its warning label was approved by the FDA, after all.

The business community will be waiting and watching. The outcome of the Wyeth case may seal the fate for hundreds of other lawsuits, filed by people who are hurt by dangerous drugs. As it stands now, if you are injured by a medical device pre-approved by the FDA, such as a defibrillator or heart stent, you are basically out of luck.

To remedy this situation - legislation is pending called the Medical Device Safety Act of 2008 (HR 8381) that would overrule the Riegel decision, restoring the right for the injured to seek compensation from medical device manufacturers.

It basically says that traditional state common-law remedies that the injured have always turned to should be restored, and that right doesn’t undermine the FDA’s powers to protect consumers.

Product liability lawsuits are intended to compensate people - the kind of people who are truly injured, the kind of people who tell us, “I’m not the sort of person who sues.” #

Originally posted at InjuryBoard by Eddie Farah