Personal Injury Law Update

Medtronic Voluntarily Recalls Infusion Sets Used to Deliver Insulin from an Insulin Pump to a Diabetes Patient

We reported recently about Medco's pacemaker recall. Earlier this week, the FDA announced another Medco recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps.

An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days.

The affected Medco infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number "8." Medtronic recently discovered that approximately two percent of "Lot 8" Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.

Patients should discontinue using "Lot 8" Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website to view the labels of "Lot 8" Quick-set infusion sets.

Medtronic Recalls Kappa and Sigma Pacemakers With Wiring Problems

Medtronic and the FDA recently announced a Class 1 recall of approximately 21,300 Kappa and Sigma pacemakers manufactured primarily between November 2000 and November 2002. Patients can enter the serial number of their device at this Web site to find out whether it is included in the recall.

The reason for the recall is that the "devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery." In rare cases, patients who are pacemaker-dependent may experience serious injury or death resulting from the defect.

See further details on MedPage Today.

FDA Announces Recall of Fun Express Water-Based Face Paints for Children Due to Adverse Skin Reactions

Earlier this month, the FDA notified consumers and healthcare professionals of the recall of cosmetic “Face Paint” items distributed by Oriental Trading Co., of Omaha Nebraska, due to reports of skin reactions in children using the face paint, including rashes, itchiness, burning sensation, and swelling. All exposures occurred on the same day at an organized event in children exposed to various colors of the face paint. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory. These items were distributed nationwide.

See the release for further details.

Crib Safety Now a Focus of the Consumer Product Safety Commission

The Crib Information Center of the Consumer Product Safety Commission (CPSC) says that more than 5 million cribs, bassinets and play yards have been recalled in the last two years, and that products involved in the recalls have been linked to at least five infant deaths and 16 cases in which babies were trapped by parts of a crib. Particularly problematic have been entrapment hazards associated with drop-side cribs (in which one side of the crib slides down to make it easier for a parent to pick up a baby). Here's a link to a list of recent drop side crib recalls (note: the last page of the document provides a detailed explanation of the risks associated with drop side cribs).

The safety concerns associated with drop side cribs recently led Toys R Us to stop ordering drop side cribs for their stores. As Toys R Us CEO Jerry Storch explained in an interview:

"There are enough concerns raised about drop-side cribs that we're moving forward and we're going to phase them out . . . It seems that the strongest cribs are ones where the four sides attach to each other and have less complicated hardware."

On April 22, 2009, the CPSC held a roundtable on cribs and other sleeping environments for infants to solicit input regarding the adequacy of the current voluntary and mandatory standards. Attendees presented relevant information, ideas, proposals, or concerns about current or future standards as they relate to the infant sleep environment.

Oregon and Washington Firms Recall Products With Pistachios Due to Salmonella Scare

Consumers have undoubtedly heard about the nationwide recall of pistachio nuts by Setton Pistachio (the nation's second largest pistachio processor) due to fears of salmonella contamination. In recent days, the pistachio recall has affected Oregon and Washington firms.

On April 2, 2009, Harry and David, of Medford, Oregon, announced it was voluntarily recalling three Harry & David products, a Mendiant Assortment, a Capiz Chocolate Tower containing Mendiants, and Fruit and Nut Mendiants, because these products contain pistachios that may be part of the recall by Setton Pistachio of Terra Bella, Inc. due to contamination with Salmonella.

On April 3, 2009, Chukar Cherry Co. of Prosser, Washington, announced that it was voluntarily recalling from nationwide distribution specific best before dates of Chukar brand and Norm Thompson brand packaged products containing pistachios from Setton Pistachio of Terra Bella, Inc. sold directly to consumers or resellers due to potential contamination with the Salmonella organism. Chukar Cherry Co. said it had received no reports of illness related to their products containing pistachios; but the company is issuing this recall as a precaution.

Parents Sue Manufacturer After SlyDog Retractable Leash Injures Eye of 12 Year Old Girl

In September 2008, the U.S. Consumer Product Safety Commission and Worldwise voluntarily recalled about 223,000 SlyDog retractable leashes with metal clasps after the company received reports of serious injuries to users of the leash, including facial cuts, a broken tooth, a displaced eye lens and a bruised collarbone.

Last week, it was reported that the Texas parents of a 12-year old girl filed a lawsuit against Worldwise after the retractable leash popped while the daughter was walking her puppy and a piece of metal lodged in the young girl's pupil. The girl has already undergone three surgeries to close the laceration and remove the piece of metal, and could face further operations.

Delphina's Bakery of Portland, Oregon Recalls Peanut Butter Bars and Hippie Cookies

In recent months, there have been thousands of product recalls due to potential salmonella contamination from tainted peanut butter sold by the Peanut Corporation of America.

In our own backyard, the Neighborhood Baking Co., dba Delphina's Bakery of Portland, Oregon, announced today that it is recalling all Peanut Butter Bars and Hippie Cookies, because they may be contaminated with Salmonella. The Peanut Butter Bar and Hippie Cookies were manufactured using peanut products recalled by Peanut Corporation of American because it has the potential to be contaminated with Salmonella.

The Peanut Butter Bar and Hippie Cookies subject to the recall were distributed during the period January 1, 2007 through February 27, 2009, in Oregon and Washington through direct delivery to coffee shops, delis, farmers markets, and in the Delphina's Bakery's retail Café and Bakery outlet on NE. 42nd Avenue, Portland, Oregon.

FDA Urges People to Avoid Products Containing Peanut Butter

On Saturday, Federal health authorities urged consumers to avoid eating cookies, cakes, ice cream and other foods that contain peanut butter as an ingredient until investigators can learn more about a deadly outbreak of salmonella contamination. While most peanut butter sold in jars at supermarkets appears to be safe, the peanut paste that is the subject of the investigation (produced at a Georgia facility owned by Peanut Corp. of America) is an ingredient in cookies, cakes and other products that people buy in the supermarket. Kellogg is among the companies that have recalled cookies and other food products containing peanut butter.

So far, more than 470 people have gotten sick in 43 states, at least 90 had to be hospitalized, and at least 6 have died.

U.S. Department of Agriculture to List Retail Stores Selling Tainted Meat

Earlier this month, Secretary of Agriculture Ed Schafer announced that beginning in August, the U.S. Department of Agriculture (USDA) will begin publicly identifying retail stores that received meat and poultry products involved in Class I recalls. The USDA defines Class I recalls as involving "a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death." 

According to Schafer, "the identity of retail stores with recalled meat and poultry from their suppliers has always been a missing piece of information for the public during a recall," said Schafer. "People want to know if they need to be on the lookout for recalled meat and poultry [at] their local store and by providing lists of retail outlets during recalls, USDA's Food Safety Inspection Service will improve public health protection by better informing consumers."

The list of retail stores that received products subject to Class I recalls will be listed on the website of the USDA's Food Safety Inspection Service (FSIS), generally within three to ten business days after the recall was issued. The website offers summary data on open and active recall cases.

Read the full release here.

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.