Drug Injury Attorney Blog

Back in April, I wrote on this blog about the withdrawal of the drug Raptiva (efalizumab) from the market for safety reasons. That medication, intended for treating psoriasis, was implicated for weakening the immune system and allowing users to contract a rare brain infection called progressive multifocal leukoencephalopathy. Now, PML is back in the news in connection with two other drugs -- Tysabri (natalizumab), a treatment for multiple sclerosis, and Rituxan (rituximab), which is for treatment of arthritis. The FDA is already watching both drugs for cases of PML. Now, the FDA has announced a new and slightly different case of PML in a patient taking Rituxan, and the European Medicines Agency, the EU’s FDA, is reviewing whether additional measures are necessary to make Tysabri safe.

The Tysabri review comes after 23 cases of PML were reported -- about twice as many as were thought to exist before. The U.S. manufacturer, Boston’s Biogen Idec, said it was already considering a labeling change that would tell consumers that their risk of PML increases the longer they take Tysabri. Ironically, PML resembles a much faster form of multiple sclerosis, a degenerative disease that attacks patients’ movement, vision, speech and cognition. In MS, the body attacks myelin sheaths that protect nerve cells, but the sheaths can be replaced, causing the disease to progress slowly over a number of years. In PML, the cells that make the myelin are destroyed. As a result, PML progresses quickly, often killing its patients within a year of diagnosis.

While the effects of PML may be confused with the effects of MS in patients taking Tysabri, the problem is substantially less likely for patients taking Rituxan, which is indicated for rheumatoid arthritis. The FDA announced Oct. 23 that it had received a report of a new case of PML related to Rituxan, its third reported case. In this case, a 73-year-old woman received one course of treatment with the drug, then developed symptoms of PML within four to six months. This case is different from the previous two, the FDA said, because the woman had not previously been treated with a type of cancer drug called a TNF inhibitor. The FDA said “information to date suggests that patients with [rheumatoid arthritis] who receive Rituxan have an increased risk of PML.”

As a drug injury attorney, I hope that doctors are seriously reconsidering writing new prescriptions for Rituxan and Tysabri. Rheumatoid arthritis and MS are both serious, life-altering diseases, but this is a case where the cure may be even worse. Aside from AIDS patients, who can fight PML with newer drugs that restore their immune functions, patients diagnosed with PML are statistically likely to die within a year of diagnosis. Those who survive may live with severe neurological disabilities. This is a terrible fate and a terrible thing to watch a loved one go through. If the manufacturers originally understated this risk-- or they negligently failed to examine it thoroughly -- they could be legally liable in multiple pharmaceutical injury lawsuits from around the U.S. and the world.

Continue reading " European Regulators Review Arthritis Drug Safety as FDA Announces New Case of Brain Infection " »

Posted by Carey, Danis & Lowe | Permalink | Email This Post

Posted In: Dangerous Drugs

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The U.S. Food and Drug Administration is investigating possible defects in power cords used with medical devices from at least two companies, Reuters reported Oct. 19. Abbott Nutrition, a division of Abbott Laboratories Inc., and Hospira Inc., have reported 122 incidents of fires, sparks or charring from power cords used with their devices, which include infusion pumps and adult feeding tubes. This can expose users and health care professionals to injury or even death from shocks, fires, and failure of the device while in use. The FDA is warning hospitals and home users of devices to keep an eye on wear and tear on power cords, and stop using cords with visible damage. It also asked users to report any incidents of sparking, charring or fires.

All of the incident reports the FDA has received are about cords manufactured by Electri-Cord Manufacturing Corp. All of the implicated cords use a black plastic “bridge” connecting the plug’s prongs. The two medical device manufacturers, Abbott and Hospira, found that the prongs may fail or crack, either outside the cord or just inside the plastic covering of the plug. The cords have been supplied to other manufacturers of medical devices as well, and the FDA is tracing the cords to determine where else they may be. The problem has already sparked a recall from Hospira; the company initiated a voluntary recall in August, the same month it received a letter from the FDA criticizing its response to the power cord problem. A spokesman for Electri-Cord denied that defects are the problem, suggesting that most cords involved in reported incidents showed signs of “significant abuse.”

I don’t doubt that cords involved in fires, sparking or charring might look abused. However, as a defective medical device attorney, I applaud the FDA’s recall effort, which I hope will prevent further incidents that could seriously hurt someone. Defective cords on any device can be very dangerous because they can electrocute their users or start a fire. (In fact, defective wiring is among the most common causes of house fires.) This may be especially true in hospitals, where doctors routinely use highly flammable pure oxygen during surgery. But on a medical device that patients depend on for nutrition, medicine or other essential needs, faulty wiring can also have serious medical consequences unrelated to a fire or shock. If the device fails, temporarily or permanently, the patient can be deprived of its life-saving effects -- which can be at least as deadly as a fire.

Continue reading " Suspected Defects in Power Cords for Medical Devices Spark FDA Investigation " »

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Posted In: Dangerous Medical Devices

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As a defective medical device attorney, I was alarmed to read a detailed article on medical device recall problems from the Associated Press Oct. 5. In short, the article exposes the federal government’s dangerous lack of a centralized system to track down people using medical devices that have been recalled for safety reasons. When a device is recalled, the FDA and manufacturers send out press releases and may make it into the news -- but only certain devices are registered and tracked so that patients may be personally notified. As a result, health care providers, medical professionals and patients may continue to use the recalled products for months or years before realizing the problem.

The FDA currently requires comprehensive registries for 14 medical devices, including pacemakers and breast implants, and a registry for artificial joints is in the works. However, thousands of devices are excluded from these registries, meaning patients must rely on medical providers to keep track of which devices have been recalled. Most hospitals note the serial number of a device in paper records, which can be time-consuming to sift through; some health insurers and nonprofit medical organizations are building their own databases. A comprehensive national medical device registry is part of the health care legislation that Congress is currently considering, but the medical device industry says it would be too costly and unnecessary. However, a study of 2,200 hospitals by a hospital umbrella group found that even after one device was recalled, doctors continued to implant it in at least 50 patients.

The article focuses on the sad story of married couple Michael and ShellyAnn King of New York. Michael King agreed to donate a kidney to his dialysis-dependent wife, but after the surgery to remove the kidney, a Hem-o-lock brand surgical clip popped off his renal artery. Before the problem was discovered, he bled to death in the hospital at the age of 29. After the incident, the King family discovered that the Hem-o-lock clips had been recalled about two years earlier out of concerns that they could dislodge from the renal artery and cause deadly uncontrolled bleeding -- precisely what happened to Michael King. The family’s dangerous medical device lawyer said the hospital had been notified of the recall but never took action. They are suing the hospital, the medical center and the surgeon involved.

This is disturbing news. Patients rely on medical devices to sustain or save their lives, or help them live normal, healthy lives. If our doctors and regulatory agencies don’t have the information they need to stay up to date on which devices have safety problems, they can’t give us the information and the excellent care that we deserve -- and that they want to provide. As a defective medical device lawyer and a longtime observer of the pharmaceutical and device industries, I know that both the use of medical devices and the number of medical device recalls have grown rapidly; the article notes a 164% increase in medical device recalls since 2000. Millions of patients are using devices in an industry with a spotty safety record. If even 1% of those devices slip through the cracks, that still leaves thousands of patients with potentially life-altering or fatal problems from devices implanted in their own bodies.

Continue reading " FDA System for Tracking and Announcing Medical Device Recalls Faulted as Recalls Soar " »

Posted by Carey, Danis & Lowe | Permalink | Email This Post

Posted In: Dangerous Medical Devices

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