The Recall Lawyers

Kawasaki has issued a recall for its Teryx4 Recreational Off-Highway Vehicles. According to the U.S. Consumer Product Safety Commission, the front brakes and the steering gear assembly can fail. The loss of the ability to brake or steer poses a serious risk of injury or death and prompted this recall. Thankfully, no injuries have been reported.

The recalled vehicles (shown below) are the following styles of 2012 Teryx4 4x4: 750, 750 EPS and 750 EPS LE. The vehicles were sold nationwide at Kawasaki dealers from October 2011 through July 2012.

If you have any questions, contact attorney Terrance Massey at Jones Ward PLC. He can be reached by phone at 502-882-6000 or by email at tj@jonesward.com.

Two Congress members have urged the United States Food and Drug Administration (FDA) to revamp databases providing public information concerning the safety of medical devices that rarely are the subject of clinical trials. Representative Edward Markey, a democrat from Massachusetts, and Senator Jeff Merkley, a democrat from Oregan, have spearheaded the request.

The pressure comes in light of pending legislation introduced in February, which would authorize the FDA to reject device applications if the proposed medical devices are modeled after previous devices which have since been pulled off the market for public safety reasons. The bill is currently pending in the House of Representatives.

Specifically, the Congressmens' letter to the FDA suggests that the agency make the following changes to their medical device databases:

• Update the 510(k) database to clearly indicate devices that have been recalled for design flaws that could affect safety or effectiveness;
• Update the database within 30 days after completing a review of a manufacturer's root-cause analysis that concludes a flaw triggering a recall was serious;
• Include in the database clearly marked past recalls for serious design flaws that could affect safety and effectiveness, and
• Revise the 510(k) Premarket Notification database to notify the public that a certain product repeats the same design flaw that caused a predicate's recall.

Although such changes would not prevent the problem entirely, that is, make all medical devices suddenly safer, public access to such safety data puts the right information in the hands of the people who need it most--patients. And far too often are patients left in the dark until the harm has already been inflicted.

The dangerous drug and device lawyers at JONES WARD are dedicated to bringing you the most up-to-date information regarding defective drugs and devices, as it comes out. If you or a loved one has been injured, please give us a call. For more information, contact attorney A. Layne Stackhouse at 502.882.6000 or layne@jonesward.com.

Johnson & Johnson, a leading pharmaceutical and medical device manufacturer, as well as a prominent producer of personal care products, announced last week its plans to remove harmful substances, including formaldehyde from its consumer products.

J&J hopes to meet this goal by the end of 2015. The company's recently-announced goal comes after it already announced it would remove certain chemicals from its baby products, including its famous baby shampoo, by 2013.

J&J's goal appears to be a trend for the corporation, after pledging in July to expand corporate oversight over its drug production and marketing division, which we blogged about in a prior entry. You can read that blog post here.

These commitments, however, also come after a wave of allegations concerning repeated FDA violations and illegal marketing of J&J's FDA-regulated products. Similarly, J&J has faced several recalls of its products in the past several years.

Although J&J's vows are surely a step in the right direction, they are also indicative of a public relations effort to elicit a favorable public image, in light of the trouble they've faced for prior bad conduct.

J&J's commitment to remove harmful chemicals from its consumer products, however, if implemented, demonstrates a rare instance of a drug and consumer products company placing public safety over profits. According to the New York Times, J&J's pledge makes it "the first major consumer products company to make such a widespread commitment."

The company plans on implementing its program to cover popular brands, including Clean & Clear, Neutrogena and Aveeno. J&J representatives report that its recent announcement coincides with increasing concern over safety of ingredients in personal care products, which are not subject to the same stringent regulations that prescription drugs and medical devices face.

In 2009, a report surfaced on the subject, concluding that many consumer products contain harmful chemicals and yet companies have found a loophole in federal regulations to avoid reporting them. After scientifically analyzing several dozen products, the Campaign for Safe Cosmetics reported that many consumer home care products contain formaldehyde, recently identified as a carcinogen, and 1,4 dioxane--both chemicals that can be extremely harmful to human health.

The loophole that allows manufacturers to avoid reporting these ingredients, and others, is that technically, neither are added "ingredients." Rather, both substances can become chemically created and released into the products by other listed ingredients in the products.

Per reports, public interest groups, including consumer safety and environmental organizations have been urging J&J and other like industry leaders to remove potentially harmful substances from their products for years. For those groups and consumers alike, if J&J follows through, it will represent a public safety victory.

In the meantime, however, the personal injury and defective products lawyers at JONES WARD will continue to report on the conduct of major consumer product and pharmaceutical companies, bad or good. The recall lawyers at JONES WARD are dedicated to bringing you the most up-to-date information regarding dangerous products, as it comes out. If you or a loved one has been injured, please give us a call. For more information, contact attorney A. Layne Stackhouse at 502.882.6000 or layne@jonesward.com.

In July forty-one medical products underwent label revisions, with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

The following drugs had modifications to the boxed warnings, contraindications and/or warnings sections:

• Avinza (morphine sulfate) Extended-Release Capsules

• Butrans (buprenorphine) Transdermal System

• Dantrium (dantrolene sodium) Oral Capsule

• Dolophine (methadone hydrochloride) Tablets

• Duragesic (Fentanyl Transdermal System)

• Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules

• Exalgo (hydromorphone HCl) Extended-Release Tablets

• Kadian (morphine sulfate) Extended-Release Capsules

• Methadone hydrochloride Oral Solution and Concentrate

• MS Contin (Morphine Sulfate Controlled-Release) Tablets

• Nucynta ER (tapentadol) Extended-Release Oral Tablets

• Opana ER (oxymorphone hydrochloride) Extended-Release Tablets

• Oxycontin (oxycodone hydrochloride controlled-release) Tablets

• Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) 

• AzaSite (azithromycin ophthalmic solution)

• Biaxin (clarithromycin) 

• Diovan (valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide)

• Caduet (amlodipine/atorvastatin) Tablets

• Eraxis (anidulafungin) Powder for Injection 

• Mirapex (pramipexole dihydrochloride)

• Natrecor (nesiritide) for Injection

• Prograf (tacrolimus) Capsules and Injection

• Sanctura (trospium chloride)

• Strattera (atomoxetine hydrochloride) capsules

• Zinecard (dexrazoxane) for injection

The attorneys of JONES WARD PLC represent hundreds of persons all across the country who have been injured by defective products, prescription drugs and medical devices. If you have any questions about one of the above prescription drugs or any other type of product, contact attorney Terrance Massey. You can reach him by phone at (502) 882-6000 or by email at tj@jonesward.com.

Gerber Legendary Blades has recalled its Bear Grylls Parang Machetes due to a defect with the machetes handles. According to the U.S. Consumer Product Safety Commission, a weakness in the area where the handle meets the blade can cause the handle or the blade to break during use. This defect with the handle poses a laceration hazard to both users and bystanders.

The recalled machetes (shown below) have a curved blade with an overall length of 19.5 inches. The handle is a dark grey textured rubber grip with orange trim. The machetes were sold separately or as one of the products in Gerber's Apocalypse Survival Kit. The model numbers may be found on the package. The model numbers for the recalled products are: 31-000698, which has "Survival Series" printed on the package; and 31-001507, which was sold only at Walmart. Model number 30-0006010 is for the Apocalypse Survival Kit, which includes a Parang machete, among other items.

To avoid injury, consumers should stop using the recalled machetes immediately. For more information, contact attorney Terrance Massey at Jones Ward PLC. He can be reached by phone at 502-882-6000 or by email at tj@jonesward.com.

PBteen, a division of Williams-Sonoma Inc. has issued a recall for its Beadboard Bunk Beds. Reports indicate the front upper horizontal panel on the bunk beds can break or crack. This faulty panel can cause a user to potentially fall from the bed. Although breaking and cracking panels have been reported, none of them have resulted in injuries.

The recalled bunk beds were sold in chestnut, dark espresso, honey and white. Consumers should immediately stop using the upper bunk and contact PBteen for a free replacement panel. If you have any questions, contact attorney Terrance Massey at JONES WARD PLC. He can be reached by phone at 502-882-6000 or by email at tj@jonesward.com.

Babylicious Products Inc. has issued a recall of its Babylicious Cloth Crib Fringe. The fringe is a narrow fabric strip connecting several individual fabric triangles. According to reports, the narrow fabric strip connecting the individual fabric triangles presents a strangulation hazard to young children. Thankfully, no injuries have been reported, but parents and caregivers should immediately remove the recalled product from cribs.

The product (shown below) was sold online and at specialty children's stores from January 2006 through May 2012 for approximately $24.

For more information, contact attorney Terrance Massey at Jones Ward PLC. He can be reached by phone at 502-882-6000 or by email at tj@jonesward.com.

A recall was recently issued for approximately 870 Emerson Corsair Ceiling Fans. According to the U.S. Consumer Product Safety Commission, the fan's hanger bracket can spread apart due to heat from the motor, causing the fan to fall from the ceiling. Obviously this defect causes a serious risk to bystanders.

The recalled fans were sold in two finishes, oil-rubbed bronze (shown below) and antique pewter. The Corsair model fans were sold at fan and lighting stores nationwide from January 2009 through June 2012.

If you have any questions, contact attorney Terrance Massey at Jones Ward PLC. He can be reached by phone at 502-882-6000 or by email at tj@jonesward.com.

In October 2007, more than one million Bumbo baby seats were voluntarily recalled by the company Bumbo International Trust, of South Africa. The recall was issued because babies were able to maneuver out of the seats or fall from the chairs.

We have posted blogs HERE and HERE about the dangers of these chairs for children.

Now, Bumbo has announced that it has designed a repair kit that includes a restraint belt. Consumers are asked to immediately stop using the seat until they install the free repair kit.

Regardless, seats should never be placed on surfaces other than the ground.

And children should always be supervised while in the seats.

The attorneys of Jones Ward PLC have experience representing even the youngest victims of defective products. If you wish to speak with an attorney, please email Corey Ann Finn at corey@jonesward.com.

The lawyers at Jones Ward PLC have filed lawsuits on behalf of three additional people who have been seriously injured by metal-on-metal hip implants. The lawsuits, filed in federal court in Kentucky, are linked to the Biomet M2A Magnum hip implant. When the product's parts rub against each other inside the patient's body, particles of cobalt and chromium are sometimes shed into the bloodstream, causing a dangerous condition known as metallosis. The only solution is to have the hip device surgically removed during a painful operation called revision surgery.

Complaints about metal-on-metal hip implants continue to grow at an alarming pace, and lawyers representing plaintiffs are working to merge dozens of similar lawsuits together in a single action against Biomet. A similar merged lawsuit, called multi-district litigation, has been underway for more than a year against Johnson & Johnson, the giant health-products company whose subsidiary makes the DePuy ASR hip implant that was recalled in August 2010. Unfortunately, patients with the Biomet M2A Magnum appear to be headed in the same direction. So far, Indiana-based Biomet seems unfazed by the legal scrutiny. A recent report by the Reuters news agency noted that Biomet has $200 million in annual free cash flow, and predicted that the company would continue to develop new products to make up for its movement away from the metal-on-metal line of hip implants. It's too bad that patients with the M2A Magnum can't move away from their own hip implants that easily. If you or a loved one has a Biomet hip, call Alex Davis for a free case evaluation at 502-882-6000.