Personal Injury Law Update

Study Links Flomax Use to Cataract Surgery Complications

As reported on the ophthalmology blog, EyeDocNews, a recent study has shown that that taking tamsulosin (a drug better known as Flomax) for certain prostate conditions within two weeks of cataract surgery poses an increased risk of serious postoperative complications.

Specifically, according to researcher Chaim Bell, M.D., Ph.D., of St. Michael’s Hospital in Toronto, and colleagues, patients who filled a prescription for Flomax shortly before cataract surgery were 2.33 times more likely to receive postoperative treatment for retinal detachment, lost lens or fragment, or endophthalmitis than men with no exposure to the drug.

If you or a loved has been taking Flomax and experienced complications after cataract surgery, the medication error lawyers at our Portland offices can help you evaluate your legal options.

Genentech and FDA Announce Withdrawal of Psoriasis Drug Raptiva From the U.S. Market

In February 2009, the FDA issued a public health advisory that patients taking the psoriasis medication Raptiva manufactured by Genentech were at risk of developing a potentially fatal condition known as PML, or progressive multifocal leukoencephalopathy. As explained on Wikipedia, PML

"is a rare and usually fatal viral disease that is characterized by progressive damage or inflammation of the white matter (a/k/a myelin) of the brain at multiple locations. It occurs almost exclusively in people with severe immune deficiency."

The effects of Raptiva decrease the function of the immune system and increase susceptibility to infections (incidentally, PML is the same disease that has been linked to the multiple sclerosis drug Tysabri, sold by Biogen Idec and Elan).

Earlier this week, the FDA announced that Genentech had begun a voluntary, phased withdrawal of Raptiva from the U.S. market due to the potential risk to patients of developing PML from using the medication. By June 8, 2009, Raptiva will no longer be available in the United States.

The FDA also said it had asked prescribers not to initiate Raptiva treatment for any new patients, and immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies for psoriasis.

Radon in Granite Countertops - Is There a Risk for Oregon and Washington Homeowners?

The popularity of granite countertops in kitchens has soared during the last decade — a tenfold increase, according to the Marble Institute of America, a trade group representing granite fabricators. Unfortunately, so have reports of granite countertops emitting radon and other radiation in excess of levels considered safe, according to a July 2008 story in The New York Times.

To be sure, health physicists and radiation experts agree that most granite countertops emit radiation and radon at extremely low levels, and say these emissions are insignificant compared with so-called background radiation that is constantly raining down from outer space, seeping up from the earth’s crust, or emanating from manmade sources like X-rays, luminous watches and smoke detectors.

Nevertheless, according to The New York Times article, the Environmental Protection Agency ("EPA") has been receiving an increased number of calls from radon inspectors and concerned homeowners nationwide about granite countertops with radiation measurements several times above normal levels.

The EPA's website offers a helpful resource called A Citizen's Guide to Radon, which explains how radon can get into your home, how to test for radon, and what the test results mean.

To test your home, you can call a local laboratory that performs radon testing. The EPA recommends taking action if radon readings in your home exceed 4 picocuries per liter of air (a measure of radioactive emission), which is about the same risk for cancer as smoking a half a pack of cigarettes per day.

The Oregon product liability lawyers at D'Amore & Associates represent consumers in class action lawsuits filed as a result of injury from environmental and toxic torts such as chemical spills, defective products, and pharmaceuticals, medical and other devices that cause injury.

What's Behind Taser Gun's Success Defending Product Liability Lawsuits?

Came across this interesting article on Law.com that analyzes the legal arguments behind the success of Taser Gun International - makers of the well-known electronic stun guns - defending product liability lawsuits. According to Taser, it has never lost a lawsuit. Most recently, the company won two summary judgment motions dismissing plaintiffs' claims in product liability lawsuits in the West Virginia federal court in Martinsburg and in Arizona state court in Maricopa County (Molina v. Stanley, Civ. Action No. 3:06-CV-79 (N.D. W. Va.) and Bellemore v. Taser International Inc., Arizona Super. Ct., Maricopa Co).

The article reviews each of the claims asserted by the plaintiff in the Molina case, and the defenses raised by Taser in its successful motion for summary judgment. It seems the primary defect in the plaintiff's case was a failure to produce expert testimony to support the claims asserted. See the full article at the link above for a complete analysis.

Families of Victims of Contaminated Heparin Testify Before Congress

Heparin is used in medicine as an anti-coagulant; that is, it stops blood from clotting. Because of this effect, the drug is often used to prevent blood or plasma clotting in or on medical devices such renal dialysis machines. 

In March 2008, the FDA announced major recalls of heparin imported from China due to contamination. Today, families of victims who died from exposure to contaminated heparin while undergoing dialysis testified before a Congressional subcommittee investigating the recall. The subcommittee also heard from Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, who indicated that initial evidence shows the contamination was intentional, and not a manufacturing mistake.

The Washington and Oregon medication error lawyers at D'Amore & Associates help clients and their families obtain compensation for injury resulting from being prescribed the wrong drug, or from drug side effects.

FDA Video Series Covers Recalls and Safety Alerts for Prescription Drugs and Medical Devices

The FDA's Patient Safety News (PSN) is a series of monthly video news shows addressing significant approvals, recalls, and safety alerts for prescription drugs and medical devices. Some of the videos contain footage and demonstrations relevant to protecting patients from serious side effects and other unwanted consequences from taking or using these products.

For example, consumers may want to watch the video concerning the recent FDA warning against giving cough and cold medicines to young children.

Click here for access to the full list of currently available videos (note: the videos are primarily targeted at doctors and other healthcare professionals and thus may be somewhat technical in nature).

FDA Advises That Cold Medicines Too Risky For Children Under 2

Last Thursday, the FDA issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. The side effects reported include death, convulsions, rapid heart rates, and decreased levels of consciousness.

OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds. The FDA's study of side effects of these medicines in children ages 2-11 is continuing.

Read the full FDA release here.

FDA Announces Class 1 Recall of Medtronic Sprint Fidelis® Defibrillator Leads

On October 17, 2007, the FDA issued a Class 1 recall of Medtronic's Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949, manufactured from September 2004 through October 15, 2007. Defibrillator leads are thin wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to a patient's heart. ICDs and CRT-Ds are devices that monitor heart rhythms, and deliver an electrical shock or rapid pacing to restore normal rhythm when life-threatening, irregular heartbeats are detected. These devices are surgically implanted into patients who are at risk of sudden cardiac arrest.

The Medtronic leads are being recalled because of a risk of fracture. If a lead fractures, it can have serious consequences: some patients can receive unnecessary and massive shocks, sometimes compared to the jolt of sticking a fork in a light socket. Other patients don't get the shock when they do need it to save their lives after cardiac arrest. Overall, five patients so far have died in cases Medtronic says may be related to the flaw.

Consumers with implanted defibrillators are urged to contact their cardiologists immediately. A list of commonly asked questions and responses prepared by the FDA concerning the recall can be accessed here.

A post on the Drug Industry Watch blog by Tom Lamb observes that warning signals about flaws in Medronic's leads surfaced as far back as March 2007 when Medtronic sent a "Dear Doctor" letter to cardiologists. Lamb questions whether the FDA moved quickly enough to issue a recall.

Lamb references a helpful article in the Wall Street Journal article outlining patient options in connection with the recall.

New Jersey Supreme Court Denies Class Action Status in Vioxx Litigation

Interesting development in the ongoing Vioxx litigation against Merck.

The plaintiff in the New Jersey case was a union whose health-care plan spent $200,000 on Vioxx prescriptions for its members and now seeks reimbursement from Merck following the withdrawal of the medicine three years ago. Two lower courts had ruled the union could join forces in a class action with other health-care plans and insurers seeking as much as $15 billion in reimbursement from Merck.

However, in a 5-0 ruling, New Jersey's highest court found the plaintiffs are not entitled to a class action under New Jersey's Consumer Fraud Act. The ruling bolstered Merck's view that each Vioxx lawsuit contains a different set of facts and must be considered separately. 

Read more about the ruling here and here.

Supreme Court to Consider Whether Federal Regulatory Approval Shields Medical Device Manufacturers from State Product Liability Suits

As reported in the Chicago Tribune, the U.S. Supreme Court agreed earlier this week to consider whether federal regulatory approval of medical devices shields manufacturers from most product liability lawsuits in state courts. In the underlying lawsuit at issue, a New York couple, Charles and Donna Riegel, sued Medtronic Inc. when its Evergreen balloon catheter burst during Charles Riegel's angioplasty.

The growing consensus in federal appeals courts has been that the Food and Drug Administration's regulation of medical devices, particularly the agency's stringent pre-marketing approval process, generally does protect the companies from lawsuits.

Thanks to the Products Liability Prof blog for the tip.