Personal Injury Law Update

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.

Centralized Government Product Recall Web Site

To provide better service in alerting the American people to unsafe, hazardous or defective products, six federal agencies - the U.S. Consumer Product Safety Commission, the Food and Drug Administration, the National Highway Traffic Safety Administration, the U.S. Environmental Protection Agency, the USDA Food Safety and Inspection Services, and the U.S. Coast Guard - have joined together to create a "one stop shop" website for to alert citizens to U.S. Government product recalls.

The site provides links to obtain the latest recall information, to report a dangerous product, or to learn important safety tips.

Chinese Toys Being Recalled at Alarming Rate

According to a June 18, 2007 article in The New York Times, China manufactured every one of the 24 kinds of toys recalled for safety reasons in the United States so far this year by the federal Consumer Products Safety Commission. The latest recall, announced last week, involves 1.5 million Thomas & Friends trains and rail components, which were coated at a factory in China with lead paint, which can damage brain cells, especially in children.

Another scary example: a ghoulish fake eyeball toy made in China that was recalled after it was found to be filled with kerosene.

The string of toy recalls has led to demands for stepped-up enforcement of safety by United States regulators and importers.

Thank you to the Torts Professor blog for making us aware of this news item.

FDA Limits Warning on Suicide Risk from SSRI Anti-Depressants to Adults up to Age 24

On May 2, 2007, the FDA announced that pharmaceutical companies selling selective serotonin reuptake inhibitor (SSRI) antidepressants would be required to revise the current black box warning of an increased risk of suicidality in children and adolescents to include adults, but only young adults ages 18 to 24.  It's been noted with some sarcasm that apparently the risk of suicide no longer exists once a person hits 25.

An FDA advisory committee had held a public hearing on December 13, 2006 to review drug company data that show SSRIs to be associated with suicidality in adults. Commonly prescribed SSRIs in the US include Prozac, Paxil, Zoloft, Celexa and Lexapro.

See here for further discussion of the debate of the suicide risk present by SSRI anti-depressants, and the adequacy of warnings provided by drug makers.