Product Defect Liability Lawyer Blog

The U.S. Food and Drug Administration has issued a Class I defective product recall for all lots of Synthes USA, Ti Syntex II Vertebral Body Replacement, a medical device used in a portion of the spinal cord to replace a collapsed, damaged or unstable part of the spine. The FDA has received reports of "moderate to severe loss of vertebral body replacement of height" caused by a failure of the central component. This failure is apparently occurring at six to 15 months after the device is implanted.

Continue reading "Defective Spinal Implants Recalled" »

Medtronic has issued a defective product recall for some of its LifePak CR defibrillators because humidity may cause them to malfunction. According to a news report, these defibrillators were manufactured and distributed between July 9 and August 19, 2008. Defibrillators are medical instruments that are designed to fix abnormal heart rhythms by delivering electric shocks. Company officials say the recalled products may break down in humid conditions and may fail to analyze heart rhythm accurately. As a result the defibrillator may fail to send the required electric shocks or delay sending it, which may result in serious personal injury or death to patients. The company has not yet announced the scope of this defective product recall.

Continue reading "Medtronic Recalls Defibrillators for Product Defects" »

The pharmaceutical liability attorneys at BISNAR | CHASE continue to hear heartbreaking stories about individuals who lost their sense of smell after using Zicam cold remedies. In June, Matrixx, the company that makes Zicam, recalled several Zicam cold remedies including Zicam nasal gel from the market after thousands of complaints nationwide that the medications were causing consumers to lose their sense of smell, and in many cases, their sense of taste.

Continue reading "Zicam Class Action Lawsuit Attorney Concerned about Dangerous Drug Effects" »

The pharmaceutical litigation attorneysat BISNAR | CHASE, for the last 30 years, have fought for the rights of injured victims who suffered the devastating consequences of dangerous or defective drugs. Dangerous drug effects are also often the result of misleading marketing by drug companies. We saw an example of such corporate greed when the U.S. Justice Department announced that Pfizer, the world's largest drug maker, has agreed to pay a $2.3 billion civil penalty for trying to sell drugs for uses not approved by federal regulators. Pfizer paid the fines to settle criminal and civil allegations that it illegally sold four drugs for uses not approved by the U.S. Food and Drug Administration (FDA). When a drug is marketed or promoted for non-authorized or "off-label" uses that are not approved by the FDA, there is no question that public health and safety is at risk.

Continue reading "Pharmaceutical Litigation Lawyer Concerned about Illegal Marketing Practices" »

The University of California (UCI) Medical Center in Orange County is using defective products--particularly pain-control pumps--that have caused drug overdoses in patients, according to an Associated Press news report. A complaint filed with California health officials on July 9, 2009, states there have been five accidental drug overdoses as a result of these defective products at the UCI Medical Center since last year. The faulty medical devices resulted in one patient going to intensive care. A hospital spokesman reportedly told AP that nursing errors--not defective products--caused three of those five overdoses. He says no malfunctioning drug pumps are still in use and that safer models are being "phased in."

This is apparently not the first time that the UCI Medical Center has been in trouble. In May, the state fined the Orange County hospital $50,000 for violations, which caused a patient's death. Last year, federal inspectors cited numerous problems regarding patient care and procedures.

Continue reading "Defective Medical Devices Cause Drug Overdoses in Orange County Hospital" »

Raptiva brain damage attorneys have continued to see new causes of the drug's side effects. The U.S. Food and Drug Administration recently recalled the popular psoriasis drug Raptiva because it was linked to progressive multifocal leukoencephalopathy, a debilitating condition, which causes deterioration of the nervous system and irreversible brain damage. This is often fatal and so far three Raptiva patients have reportedly died as a result of these serious drug side effects.

What is PML? According to the National Institutes of Health (NIH), PML is caused by the reactivation of a common virus in the central nervous system in patients with weakened immune systems. The symptoms of PML are the result of an infection that causes the loss of white matter, which is made up of myelin, a substance that surrounds and protects the nerve fibers in multiple areas of the brain. Without the protection of myelin, nerve signals cannot travel successfully from the brain to the rest of the body.

Continue reading "Raptiva Brain Damage Attorneys: PML is Fatal and Irreversible" »

Hydroxycut recall lawyers have been notified of the recent dietary supplement defects. The recent recall of dietary supplement Hydroxycut, which has been linked to serious liver damage among users, has prompted the call for a review of regulations governing dietary supplements in the United States. According to a recent news report, an anti-obesity group called Reality Coalition is asking Congress to protect consumers by taking a closer look at the current Dietary Supplement Health and Education Act (DSHEA). The group would like to increase the regulatory bar for weight loss supplement manufacturers to be accountable for the safety and efficacy of their products. Apparently, Hydroxycut is the latest in a string of problematic weight loss supplements that have caused adverse side effects.

Earlier this month, 14 different products in the Hydroxycut line were recalled by the supplement's manufacturer, Iovate Health Sciences, after a number of reports from consumers stating they suffered serious liver damage as a result of using Hydroxycut. So far, one death has been linked to Hydroxycut use. Hydroxycut has been aggressively marketed and has found millions of buyers worldwide. In the United States alone, more than 9 million packages of the product were sold in 2008.

Continue reading "Hydroxycut Recall Lawyers: Better Regulation of Dietary Supplements Necessary" »

Hydroxycut recall attorneys are seeing more dietary supplement recalls.The manufacturer of the dietary supplement Hydroxycut has agreed to recall 14 of its defective products amid complaints that the widely sold supplement has caused serious liver damage, other health complications and at least one death. According to an Associated Press news report, Food and Drug Administration (FDA) officials said at least 9 million packages of this popular diet supplement were sold just in the last one year.

The FDA so far has received 23 reports of liver problems, including the death of a 19-year-old boy as a result of taking Hydroxycut. The teenager died in 2007, but the fatality wasn't reported to the FDA until March. Other patients experienced symptoms ranging from jaundice or yellowing of the skin to liver failure. One patient received a liver transplant and another awaits a liver for transplant.

Hydroxycut's U.S. distributor is Iovate Health Sciences headquartered near Buffalo, N.Y. It is manufactured by a Canadian company and is commonly available in drug stores and grocery stores nationwide in the United States. Hydroxycut is used by people who are trying to lose weight and by body builders who want to sharpen their muscles. Unfortunately, dietary supplements don't come under the same scrutiny as other prescription drugs. They are not as tightly regulated by the FDA. These dietary supplement manufacturers do not need to prove to the FDA that their products are safe and effective before selling them to consumers.

Continue reading "Hydroxycut Recall: Dietary Supplement Linked to Liver Damage" »

In a landmark decision the U.S. Supreme Court this week ruled against drug manufacturer Wyeth holding that pharmaceutical companies can be held liable for harmful medicines that carry warnings approved by federal regulators. According to the Reuters news report, the high court ruled that the U.S. Food and Drug Administration (FDA) labeling approvals do not pre-empt state laws and shield these companies from damages as part of liability claims.

The issue came before the Supreme Court after Wyeth appealed a Vermont jury’s decision to award $7 million to Diane Levine, a guitarist whose arm had to be amputated after she was improperly injected with the anti-nausea drug Phenergan. Levine got the injection to treat a migraine.

With this ruling, the Supreme Court has flatly rejected Wyeth’s argument that a drug company cannot comply with both state law duties and federal labeling requirements. It has also thrown out Wyeth’s argument that requiring a drug company to comply with a state-law duty to provide a stronger warning label interferes with Congress’ purpose in establishing the FDA’s authority.

Continue reading "Wyeth Liability Case" »

Actavis Totowas LLC., manufacturer of the recalled defective heart drug Digitek, has announced a voluntary recall of all drug products manufactured in its Little Falls, NJ facility. According to an alert posted by the U.S. Food and Drug Administration, the drug manufacturer took this action after an inspection conducted by the FDA earlier this year, found the conditions at the facility to be less than satisfactory.

Hundreds of heart patients around the country have filed complaints against Actavis alleging that its heart drug, Digitek, also known as Digoxin, caused severe side effects because of its dangerous drug dosage. The company recalled the drug after finding out that the tablets contained twice the approved level of the active ingredient.

We have a number of clients who have suffered serious side effects as a result of this defective drug. We are in the process of gathering the medical evidence to support their pharmaceutical litigation cases before filing our own lawsuits. An overdose of this drug, which is normally used to treat heart conditions, may cause nausea, vomiting, dizziness, high blood pressure, cardiac instability or even death. The most recent drug recall includes all products manufactured at that facility that have been supplied to retail outlets, wholesalers and hospitals.

Continue reading "Digitek Manufacturer Issues Yet Another Major Recall" »

Zimmer Holdings, which is the country’s largest producer of orthopedic devices, has said it will suspend sales of a potentially defective medical product, the Durom cup, which is an artificial hip component that some doctors have said is failing in patients at a high rate. According to an article in the New York Times, the Durom cup has been implanted in more than 12,000 patients since it was first sold in the United States in 2006. Zimmer’s own data and interviews with doctors shows that hundreds of patients might need early replacement of this component in the coming years because it is failing and not working the way it was supposed to.

Zimmer is not admitting that their product is defective. Of course not. But they concluded in their own investigation that even some experienced surgeons are finding it difficult to implant because it calls for a higher degree of precision. Blame the problems on the doctors. Company officials say they plan to resume sales of the Durom cup once specialized training for doctors has begun. We’ll see.

The issue with the Durom cup came up in April when Los Angeles surgeon Dr. Lawrence Dorr, issued a public warning to other orthopedists about the cup failing in his patients and the problems they were experiencing. Dr. Dorr has said that the cup is simply a badly designed defective product and that he wouldn’t consider reusing it on his patients.

Continue reading "Potentially Defective Medical Device, ‘Durom Cup’ Has Production Suspended" »

Several hundred patients have experienced serious problems and injuries after receiving Durom Cup hip implants in the United States since 2006. But it was a prominent Los Angeles surgeon, Dr. Lawrence Dorr, who created this awareness among other doctors and patients that the problem with this defective medical implant was widespread.

Now, patient advocates are calling for the creation of a joint registry, a national database that tracks how patients with artificial hips and knees are doing, according to this news report. Such a database, they believe, will alert doctors and federal regulators quickly when such devices have a high failure rate and possibly spare numerous patients from severe, painful injuries.

Dr. Dorr’s patients reportedly were back in his office soon after they received the implants, suffering from crippling pain. According to Dr. Dorr, x-rays of patients who received defective Durom Cups, showed that the hip socket was separating from bone rather than fusing with it. Patients were given assurances with the Durom Cup that they won’t need another replacement for 15 to 20 years. But to them, this product defect means they will have to undergo another painful surgery to have their defective implant replaced.

Continue reading "Defective Durom Cups Have Injured Thousands Of Patients" »

In the case of Riegel v. Medtronic Feb. 20, the Supreme Court delivered an 8-1 decision stating that the Medical Device Amendments of 1976 (MDA) to the Food, Drug, and Cosmetic Act (FDA) prevents the filing of any future state liability suit against a medical device manufacturer. According to an editorial in The Los Angeles Times, this means any consumer injured or harmed by a “medical device marketed in a form that received premarket approval from the FDA” such as a stent, defibrillator, artificial knee and many others cannot file a personal injury lawsuit against the manufacturer.

This is a huge decision for the current administration and the medical device industry. By barring any pre-emptive litigation this ruling pushes forward the administration’s agenda of securing pre-emption for federal agencies. Manufacturers and insurance companies are obviously pleased knowing they will have to defend fewer product liability cases.
In 1999, Charles and Donna Riegel had sued Medtronic in New York alleging the firm's Evergreen balloon catheter used on Mr.Riegel during a coronary angioplasty procedure, was defective in design and the manufacturing, and labeling were negligent. The catheter had burst while being inserted on Mr.Riegel. This case challenged the Supreme Court to finally interpret whether the FDA’s reach as the foremost medical device regulatory agency as mandated by the Medical Device Amendments meant that injured patients could not sue for damages in state courts.
A regulatory report republished in the Medical Design Technology Web site reveals some of the Supreme Court majority’s reasoning for their decision. Justice Antonin Scalia, writing the majority opinion states "The solicitude for those injured by FDA-approved devices . . . was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations," Or they believe it was Congress' intention in 1976 to pre-empt state lawsuits by passing the Medical Device Amendments.

Continue reading "Supreme Court Bans Lawsuits Against Medical Device Manufacturers" »