Accident and Injury Lawyer Blog

What do you call 1,000 lawyers at the bottom of the sea - A good start. I’ve heard them all. Lawyers often get bad raps due to frivolous law suits that have been filed. Sadly, many of these suits have merit, but the facts get so distorted by groups attacking personal injury lawyers, that the public doesn’t have the opportunity to learn the actual facts of the case, and in turn, they don’t realize that the Plaintiff has a legitimate claim.

On the other hand, there are ridiculous suits that are filed pro se, in which the public automatically assumes that suit was filed by an attorney. The latest story making headlines, which has people calling for the disbarment of a lawyer, one that doesn’t exist, takes place in Kansas. The suit is being brought pro se, by a convicted criminal serving an 11-year sentence.

Continue reading " Man Sues Couple He Kidnapped " »

Ocean Spray Recalls Craisins

Ocean Spray has announced that it is recalling certain production lots of its Original Flavor Craisins, Dried Cranberries product in 5-ounce, 10-ounce and 48-ounce packages, and bulk sweetened dried cranberries in 10-pound packages. The recall was made after it was determined that there may be the possible presence of very small hair-like metal fragments, though they are saying that it is unlikely to cause consumer injury.

• 5 oz Craisins: UPC: 00293-000
Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED): Oct 27 2012 M
• 10 oz Craisins: UPC: 29456-000 and 29464-000
Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED): Oct 27 2012 M; Oct 28 2012 M; and Oct 29 2012 M
• 48 oz Craisins UPC: 00678-318
Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED): Oct 27 2012 M; Oct 28 2012 M ; Nov 3 2012 M; Nov 4 2012 M; Nov 5 2012 M; Nov 6 2012 M; Nov 7 2012 M; Nov 10 2012 M; Nov 11 2012 M
• 10 lb bulk ingredient & foodservice: UPC: 03477-000
Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED): 30 Oct 2013 M; 31 Oct 2013 M; 1 Nov 2013 M; 5 Nov 2013 M

No illnesses or adverse effects have been reported regarding these products, and the company has received no customer complaints.

Giant Eagle has recalled canned pumpkin

Giant Eagle, Inc. has withdrawn all Valu Time brand canned pumpkin purchased on or after August 30, 2011, as well as all Food Club brand canned pumpkin purchased on or after October 28, 2011. These brands are produced by Topco Associates, LLC.

Giant Eagle is not aware of any immediate health concern, but the market withdrawal was performed out of an abundance of caution, as a result of the product not meeting quality standards. An investigation into the situation is ongoing, and Topco will notify customers if any additional actions are warranted as a result of these efforts.

Customers should not consume these products in any way, or consume anything in which they were used as ingredients, and should dispose of the product.

Heck of a time to recall canned pumpkin....just days after hundreds of thousands of pumpkin pies were served with Thanksgiving dinner.

On November 17, 2011, a Georgia jury awarded $9.85 million to the parents of a child who drowned in a pool at an unlicensed daycare in 2009 ($9.8 million in damages and another $50,000 in pain and suffering).

The facts are tragic. While under the daycare provider's care, the toddler was left unattended and fell into an unsecured pool on the property and drowned. The suit claimed that the daycare employees lied to the parents about their operation being approved by the state of Georgia when, in fact, it was an unlicensed facility.

Before enrolling children in any program, especially home-based facilities, parents should check with state agencies for licensing information. If a daycare owner has a pool, it is like having a loaded gun lying around. At a minimum, the facility needs to make sure there is a lock and key on that gun and all county codes for safety and security are being met. Parents should never blindly assume that the daycare provider is following all the rules and regulations required.

• Maryland Family Daycare Licensing Regulations

New Medication Label Changes

Last month brought changes to forty-eight (48) medical product labels (up from 34 changes in September), 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.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following drugs have been effected:

Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension
Evamist (estradiol transdermal spray)
Selzentry (maraviroc) Tablets
Demerol (meperidine hydrochloride)
Oral Hycamtin (topotecan) Capsules
Premarin (conjugated estrogens tablets, USP)
Suprenza (phentermine hydrochloride) ODT
Amturnide (amlodipine/aliskiren/hydrochlorothiazide) Tablets
Avelox (moxifloxacin hydrochloride) Tablets and IV
Byetta (exenatide) injection
Clozaril (clozapine) Tablets
Ciprofloxacin Tablets
Ciprofloxacin IV for Inusion Vial
Ciprofloxacin 0.2 % Solution in 5% Dextrose
Ciprofloxacin Oral Suspension
Cipro XR Tablets
Factive (gemifloxacin mesylate) Tablets
Gallium Citrate Ga 67 Injection
Lactated Ringer’s injection in aviva plastic container
Lactated Ringer’s,
Lactated Ringer’s and 5% Dextrose
Sodium Lactate (M/6 sodium lactate) injections in viaflex plastic container
Levaquin (levofloxacin) Tablets
Lithium Carbonate 150 mg, 300 mg, and 600 mg capsules
Lithobid (lithium carbonate) Extended-Release tablets
Nexavar (sorafenib)
Noroxin (norfloxacin) Tablets
OxyContin (oxycodone hydrochloride) Controlled-Release Tablets
Tasigna (nilotinib) Capsules
Veramyst, (fluticasone furoate) Nasal Spray
Votrient (pazopanib hydrochloride) Tablets
Vumon (teniposide) Injection
Vytorin (ezetimibe/simvastatin) Tablets
Zocor (simvastatin) Tablets

• September 2011 Medication Label Changes
• August 2011 Medication Label Changes

The FDA pulls Avastin off the market

After a lot of handwringing and emotional debate, the FDA has pulled Roche's Avastin drug for breast cancer treatment in the U.S. off the market. The decision stems from research showing that there is no conclusive proof that consumption of the drug extends the lives of breast cancer patients, while it presents dangerous side effects including severe high blood pressure, massive bleeding, heart attack or heart failure, and perforations in the stomach and intestines.

In 2008, the FDA’s fast-track approval of Avastin for breast cancer was contingent upon continued studies of the drug’s usefulness, but research did not indicate that users’ tumor growth was slowed or their lives lengthened. The FDA states that they did not come to this decision lightly, and are advising that they are starting a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer. They will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin.

The FDA's action is not an outright ban. The ban leaves doctors with the ability to prescribe the medication, though insurers may not pay for it. A year's treatment for breast cancer is upwards of $100,000. Some insurers already had quit covering the drug’s use in breast cancer after FDA’s advisers urged revoking the approval, once last year and once this summer. The drug will remain on the market to treat colon, lung, kidney, and brain cancers.

This latest FDA decision is one more in a series of ongoing debate about cancer drugs and public expectations of effective treatment of life-threatening disease. The tough this here is, notwithstanding the science, some people believe that Avastin helped or is helping them, pitting science and experience against each other. I don't know what the right answer is.

Ready Pac Foods is recalling a total of 5,379 cases of bagged salad products containing Romaine lettuce, as it has been determined that they may be contaminated with E. coli (E.coli O157:H7).

All bags are marked with the "Best if Used By" date of November 18. The following items have been recalled:

• 10oz. Ready Pac Caesar Romaine 0-77745-00202-6
• 9.25oz Ready Pac Santa Fe Caesar Complete Salad 0-77745-21404-7
• 10oz. Ready Pac Classic Caesar Complete Salad 0-77745-20566-3
• 10oz. Ready Pac Bella Romaine 0-77745-21407-8
• 10oz. Dining In Classic Caesar Salad Kit 0-11225-02530-3
• 10oz. Raley’s Caesar Romaine 0-46567-71642-8
• 10oz. Trader Joe’s Romaine Salad 0013-2145
• 16oz. Trader Joe’s Very American Salad 0020-7225
• 10oz. Safeway Farms Caesar Romaine 0-21130-98350-6
• 9oz. Safeway Farms Hearts of Romaine 0-21130-98358-2
• 10oz. Safeway Farms Complete Caesar Supreme 0-21130-33677-7
• 10.25oz Safeway Farms Complete Southwestern Ranch 0-21130-33679-1

The recall extends only to the listed products with this Use-by Date and sold in the following states: Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nebraska, Nevada, New Mexico, Oregon, South Dakota, Texas, Washington, and Wyoming. No other Ready Pac Foods, Inc. products are included in the recall.

The J.M. Smucker Company has announced a limited recall on 16 oz. Smucker’s Natural Peanut Butter Chunky, as it has been determined that it may be contaminated with Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

The affected Peanut Butter is packaged in 16oz jars, and is marked as follows:

• UPC: 5150001701 (located on the side of the jar's label below the bar code)
• Production Codes: 1307004 and 1308004
• Best-If-Used-By dates: August 3, 2012 and August 4, 2012
• Chunky product only (not creamy)
• Impacted product would have been purchased between November 8 - 17, 2011

This product was distributed in: Arkansas, Colorado, Delaware, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Wisconsin, and the District of Columbia.

No other products of The J.M. Smucker Company are affected by this recall.

Even more contacts are recalled

CooperVision has announced that it is expanding the worldwide recall of the Avaira brand product line of contact lenses. It now includes a limited number of lots of Avaira Sphere contact lenses. The recall has been expanded as certain lots of Avaira Sphere lenses do not meet its updated quality requirements due to the level of a silicone oil residue.

The presence of the residue (silicone oil) on Avaira Sphere contact lenses may cause hazy vision or discomfort, severe eye pain or eye injuries requiring medical treatment. Not everyone experiences the same symptoms.

The company says they are confident that they found the problem and have taken corrective action to fix the problem. “The health and safety of our customers is our top priority.”

If you wear Avaira Sphere contact lenses and experience any symptoms, CooperVision recommends that you stop wearing the lenses immediately.

CooperVision has launching a recall site for wearers to enter the package lot number found on the contact lens carton or blister label to determine if their lenses have been recalled. Alternatively, contact CooperVision on a toll-free consumer hotline at 1-855-526-6737(hours of operation 9:00am-5:00pm EST Monday-Friday).

• CooperVision Recall - Finally
• CooperVision Recall a Bit Hazy?

United Natural Foods (UNFI) is recalling selected types of FoodMatch, Inc. Divina Stuffed Olives, as they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. These items have been recalled due to a lack of temperature control during the distribution process. UNFI inadvertently subjected the recall items to temperature ranges above those directed by the manufacturer.

The following products have been recalled:

• DIVINA 4 OZ OLIVES,FETA CHEESE STUFFED (blue and yellow label) UPC 63172352780
• DIVINA 4 OZ OLIVES,BLUE CHEESE STUFFED (blue label) UPC 63172352790

Divina Olives Stuffed with Feta Cheese were distributed to the Safeway stores identified below:

• #0583 1606 N Ave, Spearfish, South Dakota
• #1577 6520 S Academy Road, Colorado Springs, Colorado
• # 1615 3325 28th Street, Boulder, Colorado
• # 1644 7655 Mclaughlin Rd, Falcon, Colorado
• # 2761 1165 Main St, Lander, Wyoming
• # 2792 27152 Main St, Conifer, Colorado
• # 2910 1632 Hover Road, Longmont, Colorado
• # 0853 7625 Old Georgetown Road, Bethesda, Maryland
• # 0942 12 West Washington St, Middleburg, Virginia
• # 1283 8646 Richmond Highway, Alexandria, Virginia
• # 1606 9596 Old Keene Mill Rd, Burke, Virginia
• # 1668 5510 Norbeck Road, Rockville, Maryland
• # 1956 14939 Shady Grove Road, Rockville, Maryland
• # 2650 43150 Broadlands Plaza, Ashburn, Virginia
• # 4002 5727 Burke Center, Burke, Virginia
• # 4205 415 14th Street SE, Washington, D.C.

Date codes Best Used By: 11 JAN 2012 and Best Used By: 1 FEB 2012 sold at other retail outlets have not been affected because the products were not exposed to a lack of refrigeration controls.

Divina Olives Stuffed with Blue Cheese were distributed to the following states: Alaska, Washington, Oregon, California, Arizona, Nevada, South Dakota, Colorado, Wyoming, Maryland, Pennsylvania, Virginia, and Washington DC through the following retail stores:

• Genuardis
• Carrs
• Safeway
• Pavilion
• Vons

Best Used By: 11 JAN 2012, Best Used By: 15 DEC 2011, Best Used By: 30 DEC 2011, Best Used By: 1 FEB 2012

These date codes sold at other retail outlets have not been affected because the products were not exposed to a lack of refrigeration controls.

No illnesses have been reported to date.

• Recall on Stuffed Bio Gaudiano Brand Organic Olives

Recalled for health concerns

Kimberly-Clark has announced a product recall of a limited number of its Kotex Natural Balance Security Unscented Tampons, as there are related health concerns.

The recall is limited to Kotex Unscented, Regular Absorbency tampons, and includes the 18 count and 36 count only, with the following product SKU numbers:

• 15063 (18 count)
• 15068 (36 count)

The Product SKU numbers are the last five digits of the product’s barcode and can be found on the bottom of the package.

The tampons were manufactured with a raw material contaminated with a bacterium, Enterobacter sakazakii, which may cause health risks, including vaginal infections, urinary tract infections (UTIs), pelvic inflammatory disease or infections that can be life-threatening. Women with serious existing illnesses, cancer or immune-compromised conditions, such as HIV, are at increased risk. There is limited evidence of transfer between individuals with this bacterium.

The tampons affected were shipped to retail customers between October 29, 2011 and November 2, 2011 in specific Wal-Mart stores in Iowa, Kansas, Missouri, Nebraska, New Mexico and Texas; specific Fry’s stores in Arizona; and specific Smith’s stores in Utah and Arizona. Not all stores in these states were impacted. All impacted stores have been alerted to remove the recalled product SKUs from shelves. A listing of stores impacted and the latest information can also be found on the Kimberly-Clark website and the Kotex brand website.

Consumers should contact a physician immediately if they have used the recalled tampons and experience unusual vaginal discharge, rash, fever, headache, vomiting or abdominal pains, particularly if they are HIV positive, have AIDS, cancer, an existing serious illness or may be pregnant.

Diagnosis of malignant pleural mesothelioma is difficult and can often be mistaken for pneumonia, leading to a delay in treatment. But there is a new hope. Diagnosing mesothelioma with a simple breath test may be on the horizon.

A study recently published in September 2011 (e-pub ahead of print), has presented a novel test which analyzes exhaled breath using an electronic nose to detect malignant pleural mesothelioma. The concept for this analyzer was based on previous research that demonstrated electronic devices which could analyze exhaled breath and distinguish constituents in the breath which were characteristic in patients with lung cancer, due to characteristic "breath prints". The recently reported study in malignant pleural mesothelioma patients demonstrated that the breath in patients exposed to asbestos who had malignant pleural mesothelioma, could be distinguished from the breath of patients exposed to asbestos who did not have malignant pleural mesothelioma, and from the breath of control patients who were not exposed to asbestos, with a sensitivity of 92.3% and specificity of 85.7%. Not a perfect test. But a great start.

These results suggest that such an analyzer may be beneficial in diagnosis of malignant pleural mesothelioma or may be used as a screening tool to determine patient groups that may require further diagnostic testing. This preliminary research is very encouraging. Follow up validation tests will be the next steps that will need to be conducted prior to integrating into current diagnostic practices for malignant pleural mesothelioma.

Mesothelioma and Other Asbestos-Related Lung Diseases - Epidemiology
Meso is just a tough disease. The World Health Organization estimates that 90,000 people worldwide die annually from asbestos related disease. Asbestos inhalation can lead to a variety of respiratory diseases including malignant mesothelioma, interstitial pulmonary fibrosis, pleural plaques and asbestos-related lung cancer. Mesothelioma is more common in men than women at a ratio of 5:1. The American Cancer Society estimates that 75% of patients diagnosed with mesothelioma are over the age of 55. Mesothelioma is more prevalent in the elderly due to the long latency of asbestos related disease. The occurrence of asbestos-related diseases is expected to increase over the next 20 years due to the ageing population and long latency of the disease.

Prognosis is dependent on several factors include overall health of the patient, timing of diagnosis, stage of disease, and whether or not it has metastasized to other areas of the body. Patients with late stage disease generally are given an life expectancy of three to six months. The five year survival rate (percentage of people expected to survive 5 years or longer) is approximately 10%. This is in large part due to delays in diagnosis.

Current Diagnosis and Future Directions

Diagnosis now for meso is not easy. It is estimated that 25% of patients show symptoms of pleural mesothelioma for 6 months or longer before they are diagnosed. Unfortunately symptoms do not occur until the pleural mesothelioma reaches advanced stages. Therefore, earlier detection is key to a more favourable outcome. Various procedures may be used in diagnosing patients, including but not limited to: chest x-rays, CT scans, throracoscopy, bronchoscopy, mediastinoscopy and biopsies. Some of these procedures are very invasive and carry a high risk for complications. As a result, recent research has been focused on finding less invasive, novel tests for more accurate and early detection. Some bodily fluids have been shown to have an association with malignant pleural mesothelioma. It has also been shown that exhaled air contains over 3000 volatile organic compounds which may be used to identify the presence of respiratory disorders.

It is still early, but this test provides new hope for treating a very difficult disease.

Apple will recall its original iPod nano in the United States. The problem precipitating the recall is an overheating problem in the iPod nano. Apple will offer full replacements. This is the first iPod nano recall in the U.S.

Apple is telling customers that although the problem is rare, they should immediately stop using their iPod nanos, and follow along with one of the methods they’ve got available for replacing the device with another model for free from Apple.

To get a new i-Pod nano for this recall, you will have to check with Apple to see if your serial number matches the recalled nanos.

Someone will find a way to file a class action lawsuit about this. I know this because someone sues every time someone drops an iPod in a river. Apple has a big target on its back for consumer class action lawsuits because it makes so many products.

ATVs recalled for steering tie-rod issues

Arctic Cat of Thief River Falls, Minnesota is recalling all 2011 Arctic Cat XC 450 ATVs, and some 2012 Arctic Cat XC 450 ATVs, as it has been discovered that the ATV's steering tie-rod can bend, causing loss of control and a possible subsequent crash.

Recalled Arctic Cat 2012 model year ATVs can be identified by the last six numerals of the Vehicle Identification Number (VIN) in the following ranges: 6V0101 through 6V0178 and 700101 through 700230. The VIN is located on the lower front frame tube below the front bumper. The recalled ATVs are black and orange or black and lime green and display the words "Arctic Cat" on each side of the cowl ahead of the handlebars. The model number "450 XC" is on the front center of the cowl.

Consumers should immediately stop using these ATVs and contact their local Arctic Cat ATV dealer to schedule a free repair. While Arctic Cat has received three reports of bent tie-rods, there have been no reports of injuries.

Toyota is recalling approximately 420,000 of some of its most popular vehicles, as it has been determined that engine issue may cause an unexpected increase in steering effort.

In a news release Wednesday, Toyota said that a problem with the crankshaft pulley could allow the belt for the power-steering pump to come off of the pulley, causing “a sudden increase in steering effort,” though they are not aware of any accidents relating to the problem. The automaker said it would replace the crankshaft pulley on the V-6 engine on the:

• 2004 Avalon
• 2004-5 Camry, Highlander, Sienna and Solara
• 2006 Highlander HV
• 2004-5 Lexus ES 350 and RX 330
• 2006 RX 400h hybrid

In a report to the National Highway Traffic Safety Administration, Toyota said it received its first reports of the problem in 2007, and suspected the cause to be an inadequate use of adhesive on the crankshaft pulley. Toyota continued to "monitor” the issue, and confirmed the cause of the problem earlier this month.

While Toyota described the recall as voluntary, once a manufacturer knows of a safety problem, it has no choice but to inform the safety agency within five working days of its plan for a recall or face civil penalties. That makes sense to me, it just seems like the right thing to do.

Badia Spices is recalling approximately 3,800 lbs. of Pinenuts, as they may be contaminated with Salmonella Enteritidis, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

The pine nuts were sold in retail stores in Florida, New York, Pennsylvania, Maryland, and New Jersey - between June 2011 and October 2011. No illnesses have been reported for any Badia brand pine nuts to date.

Badia Spices is recalling the following lots of Pinenuts:

• (UPC) 033844 00068 – 1 oz Pine nuts in small plastic bags Lot # 84666
• (UPC) 033844 00733 – 2 oz Pine nuts in pet bottles Lot # 83184, 85442

Badia Spices repacked bulk pine nuts which were imported from Turkey and subsequently recalled by Sunrise Commodities. The bulk pine nuts have been linked to an outbreak of Salmonella Enteritidis illness.

• Sunrise Commodities' Pine Nuts Recall
• Wegman's Pine Nuts Recall

The Food and Drug Administration (FDA) is warning consumers not to eat Turkish pine nuts, distributed by Sunrise Commodities, after tests have confirmed the presence of Salmonella.

The FDA is collaborating with the Centers for Disease Control and Prevention (CDC) to investigate a multistate outbreak of Salmonella Enteritidis infections. To date, there are reports of at least 42 illnesses associated with the outbreak in Maryland, New Jersey, New York, Pennsylvania and Virginia.

As part of FDA’s investigation, samples of Turkish pine nuts from a warehouse used by Sunrise Commodities were collected.

Sunrise Commodities has already recalled four lots of the product implicated in this matter, totaling more than 21,000 pounds of pine nuts.

The affected nuts were packed in 22-pound boxes and included the markings:

• Warehouse Lot 27963 with the identifying code “PO#: 50165”
• Warehouse Lot 29628 with the identifying code “PO#: 50558”
• Warehouse Lot 27713 with the identifying code “PO#: 49595”
• Warehouse Lot 27427 with the identifying code “PO#: 50032”

Sunrise Commodities distributed the Turkish pine nuts in bulk to various food vendors in Florida, New Jersey, New York and Canada. A recall notification was issued by Sunrise to its customers on November 3, 2011, alerting them of the test results and of the epidemiologic investigation.

Wegmans Food Markets, recalled the product from their stores on October 26, 2011. As the investigation continues, additional recalls may take place.

This is a time you want your equipment to work

The Food and Drug Administration (FDA) notified health professionals of a Class I Recall of Mizuho OSI Modular Table Systems because of reports of patient injury related incidents. Mizuho previously provided warnings and recommendations for safe use of the Mizuho Modular Table Systems, including performing a verification count of all the T-pins to confirm the stability of the table top.

Mizuho OSI Modular Table Systems are used for patient positioning during a diverse set of orthopedic trauma, thoracic, and spinal surgery procedures. It has been reported that the removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in patients falling to the floor. Another potential concern is unexpected movement/tilting of the table, resulting in unanticipated movement and/or patient falls during surgery.

• 2011 Biologics Recalls
• 2010 Biologics Recalls
• 2009 Biologics Recalls
• 2008 Biologics Recalls
• 2007 Biologics Recalls

On Monday, Health Canada issued an advisory that requires manufacturers of some antibiotics to revise labels to include a warning that use may increase problems in patients with Myasthenia gravis. The advisory applies to a class of antibiotics known as fluoroquinolones, broad spectrum antibiotics, which are commonly prescribed for bacterial infections including respiratory, skin and urinary infections. This group of antibiotics includes Cipro, Levaquin, Avelox and others. A full list of affected products on the market in Canada can be found here.

In 2008, the FDA dealt with these drugs by issuing an alert requiring black box warnings for fluoroquinolone antibiotics, addressing the risk of tendon ruptures and tendonitis (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm). This type of warning is the strongest warning that can be applied to prescription drugs. This was followed by a labeling requirement in February 2011, which required a black box warning advising that fluoroquinolones not be used in patients with a known history of Myasthenia gravis.

Both Health Canada and the FDA have limited labeling changes to oral dosage formats (e.g. tablets) and intravenous antibiotics, stating that eye and ear drops do not seem to pose the same risk.

Myasthenia gravis is a chronic disorder causing muscle weakness that is progressive. Muscle weakness can occur in the face, eyes, neck, throat and limbs. Symptoms are often exacerbated by activity and regress with rest. The prevalence of Myasthenia gravis estimated to be 14 to 20 per 100,000, with an estimated 36,000 to 60,000 cases in the US. It is suggested that these values may be underestimated due to under diagnosis of this condition (http://www.myasthenia.org/HealthProfessionals/ClinicalOverviewofMG.aspx).
Use of fluoroquinolones may worsen symptoms of muscle weakness or respiratory problems in patients with Myasthenia gravis.

Continue reading " Levaquin, Cipro and Myasthenia Gravis " »

Whittington's Jerky is recalling 126 pounds of beef jerky products, as they may be contaminated with Salmonella.

The problem was discovered as the result of routine testing, but the jerky was shipped before testing results were confirmed. To date, there have been no reports of illness, but those concerned about illness should contact a healthcare provider. The most common manifestations of salmonellosis are diarrhea, abdominal cramps, and fever within six to 72 hours. Additional symptoms may be chills, headache, nausea and vomiting that can last up to seven days.

The affected products subject to recall include:

• 2-oz. packages of Whittington's Original Beef Jerky
• 4-oz. packages of Whittington's Original Beef Jerky

Each package indicates the establishment number "EST. 21257" inside the USDA mark of inspection. The product was produced on Oct. 31, 2011 and distributed to convenience stores in West Texas and at the company's retail operation.

• Wegmans - Recalled Pine Nuts
• American Egg Products Recall Frozen Eggs
• Nike All American Sandwich Recall
• Salmonella Illnesses Linked to Organic Eggs
• Spinach - Two Separate Recalls

Approximately 5,400 jackets have been recalled by the Boy Scouts of America, as they pose a strangulation or entrapment hazard to children.

The recall affects Cub Scout Wind Tech jackets that were sold at Boy Scouts of America retail outlets, nationwide and online, from November 2009 through July 2011. The jackets have retractable cords with toggles at the hood and neck area, and at the waist. It has been determined that the retractable cords and toggles can pose a strangulation or entrapment hazard to children.

This recall is for the blue Cub Scout Wind Tech jackets that are nylon with a polyester lining, long-sleeve, and a full zipper front. They have a Cub Scout wolf head emblem embroidered on the upper left chest. The SKU numbers on the affected product are: 73291, 73292, and 73293, and are printed on the hangtag that is attached to the jacket when it was sold.

While no incidents of injury have been reported, guidelines were issued in February 1996 by the Consumer Product Safety Commission (CPSC), which were incorporated into an industry voluntary standard in 1997, to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper garments, such as jackets and sweatshirts.

Consumers are being instructed to remove the cords from these jackets to eliminate the hazard, or return the jacket to Boy Scouts of America for a full refund.

Plavix (clopidogrel) is a prescription anti-platelet medication used to prevent stroke and heart attack in patients with cardiovascular disease. Plavix works by making blood platelets less likely to form clots. It is generally taken in tablet form, once per day by mouth. Plavix is one of the best selling drugs worldwide, with over $8 billion dollars in annual sales. As with many medications, Plavix may cause serious side effects, including:

• hives
• difficulty breathing and swallowing
• swelling of the face, throat, feet, ankles and lower legs
• bloody stools or vomit
• unusual bleeding or bruising
• slow or difficult speech
• weakness or numbness in an arm or leg
• vision loss
• fast heartbeat
• purple patches or bleeding under the skin
• confusion
• yellowing of the skin or eyes

Drugs come with side effects. We all get that. So that is not the question. Instead, the question is whether the maker of Plavix knew that people who are unable to metabolize Plavix adequately were at greater risk for a heart attack. Since Plavix will not work until it is metabolized in the body, these individuals are at a greater risk for heart attack and stroke. This increased risk is so great that in March of 2010, the FDA added what is known as a “Black Box Warning” to Plavix to alert both patients and physicians that the drug can be less effective in those patients who are unable to metabolize it into the active form. It is estimated that as many as 14% of the U.S. population are poor metabolizers of Plavix.

Continue reading " Plavix Lawsuit " »

Serious Concern with Bio Gaudiano Olives

Last week it was recalled smoked seafood that was recalled for possible Botulism, this week it is olives.

The Food and Drug Administration (FDA) has recalled Bio Gaudiano brand Organic Olives Stuffed with Almonds, and is warning consumers not to eat them. All sizes and lots of Bio Gaudiano Organic Olives Stuffed with Almonds are being recalled, as this product has been linked to a botulism outbreak in Europe.

While there are no illnesses reported in the United States, health authorities in Europe have reported two cases of botulism involving hospitalization. The consumption of the affected product, from Italian manufacturer Bio Gaudiano, has been linked to these illnesses.

Botulism is a potentially fatal form of food poisoning, that can cause many different symptoms. Symptoms can include general weakness, dizziness, double-vision and trouble with speaking or swallowing, difficulty in breathing, weakness of other muscles, abdominal distension and/or constipation. Although cases are rare, botulism attacks the nervous system, and in its sever forms, can cause respiratory failure. Symptoms usually begin 18-36 hours after eating contaminated food, but they can occur as early as six hours or as late as 10 days. People experiencing these problems should seek immediate medical attention.

The FDA has asked that anyone finding the recalled Bio Gaudiano Brand Organic Olives dispose them in a sealed contained in the trash, so that people and animals, including wild animals, cannot consume the tainted olives.

According to information FDA has received from Pure Italian LLC, the U.S. distributor of this product, the product was initially distributed only to Massachusetts retailers. The 314 ml glass jars may have been sold at SoWa farmers market in South End, Mass. Additionally, the following stores in Massachusetts may have repackaged and resold the almond-stuffed olives in containers that do not carry the Bio Gaudiano name: Foodies Fresh Market, Boston, Mass.; Russo's, Watertown, Mass.; and Fresh Choice Supermarket, Framingham, Mass.

CONSUMERS, BEWARE!

• Smoked Seafood Recall - Botulism

Rice-A-Roni Recalled

Rice-A-Roni, the San Franscisco Treat....well, not for those with milk allergies anyway! Rice-A-Roni has recalled a small quantity of Rice-A-Roni Rice, Pilaf flavor, due to an undeclared milk allergen.

The affected Rice-A-Roni is limited to the 10.8 ounce family-size boxes, with the UPC Bar Code ending in 43004 and are stamped as Best Before Date of JUL 30 12 B on the bottom of the box. This product was originally distributed to stores in California and Arizona.

People who are allergic to milk run the risk of a serious or life-threatening allergic reaction if they consume this product, and as such, should return it to the retailer where it was purchased for a full refund.

No other Rice-A-Roni or Pasta Roni products are affected. People who do not have milk allergies can eat this product without concern.

The FDA updates on Tumor Necrosis Factor (TNF) blockers

The Food and Drug Administration (FDA) is urging Healthcare professionals to remain vigilant about reporting cases of malignancy in patients treated with TNF blockers to MedWatch. This comes after the FDA has continued to receive reports of a rare cancer of white blood cells, known as Hepatosplenic T-Cell Lymphoma or HSTCL.

HSTCL is an aggressive cancer and is usually fatal. The majority of the reported cases were in patients that are being treated for Crohn’s disease or ulcerative colitis, but also include a patient that is being treated for psoriasis, and two patients that are being treated for rheumatoid arthritis. The FDA is now updating the number of reported cases of HSTCL. Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.

The are stating that the reports should include:

• patient characteristics (age, gender, no patient identifiers)
• risk factors for malignancy
• exposure to other immune suppressing products or products with risk of malignancy
• indication for TNF blocker treatment
• TNF blocker exposure (duration, dose)
• cancer diagnosis (date of diagnosis, stage)
• biopsy results
• outcomes of malignancy (treatments, event outcome)

• 2011 Safety Alerts for Human Products
• 2010 Safety Alerts for Human Products
• 2009 Safety Alerts for Human Products
• 2008 Safety Alerts for Human Products
• 2007 Safety Alerts for Human Products
• 2006 Safety Alerts for Human Products

Recalled for potential contamination

Foremost Foods, International has issued a recall on certain Pangasinan brand smoked seafood products, as they have the potential to be contaminated with Clostridium botulinum ("Botulism"), a bacterium which can cause life-threatening illness or death. The products were manufactured by FITRITE Incorporated of the Philippines.

Botulism is as bad as its name. It is a potentially fatal form of food poisoning. Botulism can cause many different symptoms, including general weakness, dizziness, double-vision and trouble with speaking or swallowing, difficulty in breathing, weakness of other muscles, abdominal distension and/or constipation. People experiencing these problems should seek immediate medical attention.

The affected Pangasinan brand smoked seafood products were distributed in the States of California, Nevada, and Washington through Seafood City and Manila Seafood retail stores. This recall involves products sold between March, 2010 and October, 2011. The products are sold in a clear vacuum packed plastic package and marked with the specific descriptions:

• UPC Code: 2239257451 PANGASINAN Roundscad Smoked Galunggong 60 6 oz
• UPC Code: 2239257470 PANGASINAN Mackerel Smoked Hasa Hasa 60 6 oz

The recall was initiated after the FDA sampled the product and found it to be partially uneviscerated. Consumers are warned not to use the product even if it does not look or smell spoiled. I think that, ah, anyone that learns of this recall will comply.

Another toy - recalled

The U.S. Consumer Product Safety Commission (CPSC) and Battat announced a recall of Toulouse-LapTrec magnetic sketchboards. Approximately 95,000 units are affected by this recall, as well as another 4,300 in Canada.

The magnetic sketchboards, manufactured in China by Rainbow Force Plastic Products, contain a drawing pen. It has been discovered that the magnetic tip of the drawing pen can dislodge from the pen, posing a choking hazard to children. To date, there have been nineteen reports of the tip separating from the pen, though no injuries have been reported.

The Toulouse-LapTrec magnetic sketchboard has a white plastic writing surface, bordered by either a red or brown plastic frame, and has a bean bag type backing. The sketch board has four animal shapes across the top – a rabbit, dog, cat and duck. The multicolored magnetic pen is affixed to the front of the sketchpad. The model number can be found on a paper wrapper that comes with the product at the time it was purchased.

• BX1026 (red frame)
• BX1027 (brown frame)

The Toulouse-LapTrec magnetic sketchboard was sold at Target stores nationwide, as well as other various online retailers from March 2010 to March 2011, and retailed for approximately $16.

Consumers should immediately take recalled sketchboards away from children and contact Battat to receive a free replacement sketchboard. Realistically, few people will actually do this, making it a very inexpensive recall for Battat.

• Recalled Disney Toy Trike
• Target Frog Costume Recall
• Aqua Dots - Settlement
• Pottery Barn Doll Recall

Tygacil has strengthened its warning label. The new Tygacil warning tells doctor and patients that alternatives to Tygacil should be considered in treating serious infections due to Tygacil's increased risk of mortaility, in comparison with other antibiotics in treating infections.

Tygacil (science name: tigecycline) is an antibiotic that fights bacteria in the body. Tygacil is used to fight a variety of different bacterial infections than the digestive system and infections of the skin. Doctors also use Tygacil to fight pneumonia.

The increased mortality risk was most prevalent in those being treated for hospital acquired pneumonia, for which Tygacil is not FDA approved. Tygacil is FDA approved for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired pneumonia.

Not for nothing, this drug was "fast tracked" to approval six years ago. I'm always skeptical of any medication that was fast tracked.

A kid's toy - causing lacerations!

Kiddieland Toys and the U.S. Consumer Product Safety Commission (CPSC) have announced the recall of the Disney-branded fairies plastic trike, due to laceration hazard.

Approximately 12,000 fairy trikes are being recalled (9,000 Disney Princess Trikes were recalled in April 2011) as the plastic fairy figures on top of the handle bar pose a laceration hazard if a child falls on them.

The trike affected by this recall is the Disney-branded Fairies Plastic Racing Trike, which is green and purple, with a white seat and yellow wheels. On the top of the handlebars, there is a Tinkerbell figure and three other rotating fairy figures. "Disney Fairies" is printed on the label in front of the trike just below the handlebar. The trike was sold at Target stores nationwide from July 2009 through December 2009, and retailed for approximately $50.

This recall came after CPSC and Kiddieland received a report of a 3-year-old girl from Ohio who suffered a facial laceration near her right eye. Consumers are urged to contact Kiddieland immediately for a free replacement handlebar with an enclosed rotating display.

With the holiday shopping season upon us, it is rather obvious for consumers to stay aware of these types of recalls, and to make wise decisions when purchasing toys. But really, shouldn't somebody have foreseen a problem with protruding plastic figures BEFORE somebody actually go hurt?

• Toy Recalls: Little Tikes and Toy Cars
• Target Frog Costume Recall
• Aqua Dots - Settlement
• Pottery Barn Doll Recall

Metal-On-Metal Hips - Hidden Dangers

Total hip arthroplasty is one of the most successful surgeries of the past several decades, as it has relieved pain and restored movement to hundreds of thousands of people, but growing technology brings growing concerns.

The U.S. Food and Drug Administration (FDA) has ordered twenty-one (21) artificial hip manufacturers to conduct studies of the Metal-on-metal (MoM) hip replacement devices, and how they can adversely affect patients, after having received close to 11,000 reports of defective hip failures from January through September of 2011.

A recent study revealed that the metal-on-metal hips failed three times more often than other artificial hips. These artificial hips include models manufactured by DePuy (Johnson & Johnson), Wright, Stryker, and Zimmer. Crazy as it seems, artificial hips were approved under less stringent regulations, regulations that did not require human testing. Despite the fact that these devices have been implanted into hundres of thousands of people, many of the devices where never tested IN humans.

All artificial hip replacement systems have risks related to implant or material wear, however metal-on-metal replacement systems have unique risks. While it is reported that the MoM implants wear much less than metal and plastic implants, the wearing that does occur with MoM implants causes the release of metal ions into the body. As designed, the metal ball and the metal cup slide against each other during walking or running, which can cause tiny metal particles to wear off of the device, and enter into the space around the implant. These metal ions can be detected in blood and urine samples, and the levels tend to increase as time passes. The metal particles, cobalt and chromium, enter the blood stream and can be distributed to other areas of the body, and have effects on the heart, nervous system, and thyroid gland.

The discovery that these metal ions can slowly accumulate in the body have people concerned about higher rates of cancer and allergy-like reactions to the metal. Manufactures are trying to point their fingers at the DuPuy ASR (Johnson & Johnson) as the primary problem, as it contains a shallow cup; however, many believe that the same risk of problems caused by metal poisoning exist with other types of metal-on-metal hip replacements. While this may be true, it is Johnson & Johnson that is on the hook for failing to correct or warn patients of the apparent problem.

Continue reading " Metal-On-Metal Hips - A Colossal Failure? " »

Saying that Tylenol is widely used is an understatement of "Kim Kardashian had a relatively short marriage" magnitude. Tylenol is ubiquitous. Usually, it serves its purpose of reducing pain and discomfort of fever without incident. But in a minority of cases, Tylenol has been linked to serious and sometimes fatal complications invovling liver damage.

Over the counter medications contain dosage strengths between 325mg and 500mg, with a recommended single dose up to 1000mg. Though toxicity is generally reported at dosages greater than 4g/day, cases have been reported at lower dosages. There are other factors that may increase the risk of liver damage including liver disease and alcohol consumption.

In 2009, the FDA required that manufacturers of acetaminophen revise packaging to ensure that labels prominently display the potential risk for serious liver injury. The FDA’s “Boxed Warning” is the strongest label warning mandated by the FDA. It is applied to drugs that have serious and potentially life-threatening risks.

In January, the FDA took further action by limiting the amount of acetaminophen in combination prescription drugs to 325mg. The requirement will be phased in over the next three years and mandatory compliance is set for 2014. Though this ruling addresses combination drugs, it does not apply or address the concerns faced with over the counter medications.

With so many multi-ingredient products on the market, especially for cold and flu symptoms, it can be difficult for a person to calculate their total intake of acetaminophen. This may be especially true of elderly persons who may be taking acetaminophen already for joint pain relief. A survey conducted in 2002, showed that 11% of people do not read product labels, which make this group of people extremely vulnerable to toxic effects of Tylenol and acetaminophen containing products, as they may not be aware of the risk. Symptoms of overdose include nausea, tiredness, sweating, loss of appetite, vomiting, stomach pain, unusual bleeding or bruising, and/or flu-like symptoms.

It is often left up to the consumer to be vigilant about the other medications they are taking to properly tally acetaminophen usage. Often, patients prescribed medications containing acetaminophen are not aware that they should not take over the counter products containing acetaminophen at the same time, as they are not always informed by their doctor or pharmacist.  With many products on the market now that contain multiple ingredients, it is important to be aware of the ingredients, amounts, and total daily intake of certain products such as acetaminophen in order to avoid potential toxic and fatal effects. This can be extremely difficult in situations where patients may be taking acetaminophen from multiple sources for multiple indications (ie. taking a cold and flu medication with acetaminophen when also using Tylenol daily for joint pain relief). 

Continue reading " Tylenol Liver Damage Lawsuit " »

Recall - Incorrectly Labeled Filter

The Food and Drug Administration (FDA), along with Fenwal, Inc of Illinois, has announced a recall of their Blood Component Infusion Set, as Fenwal has identified a labeling issue with Product 4C2223.

It has been determined that the package label for the Blood Component Infusion Set incorrectly states 80 Micron filter, when the actual filter size is a standard blood filter of 170-260 micron in size.

Fenwal is recommending that customers immediately discontinue the use of this product and return the product to Fenwal.

• 2011 Biologics Recalls
• 2010 Biologics Recalls
• 2009 Biologics Recalls
• 2008 Biologics Recalls
• 2007 Biologics Recalls

The U.S. Consumer Product Safety Commission (CPSC) and IKEA have announced a voluntary recall of their PAX AURLAND wardrobe mirror doors. The recall affects approximately 1,700 units in the United States and about 500 in Canada.

It has been discovered that the mirror doors, imported and sold by IKEA North America Service, can detach unexpectedly from the wardrobe door, and fall and shatter. Obviously, this poses a laceration hazard to consumers.

This recall involves a wardrobe door with full-length glass mirror with model number 101-604-51, supplier number 12650 and production weeks 1039 through 1048 (YYWW). The product name "PAX AURLAND" and "IKEA" and production week are printed on the rear of the mirror door on the lower edge. The mirror door is made of foil-coated particleboard and the mirror of glass. The mirror is secured with metal fastenings at top and bottom. The mirror door measures about 19 and 1/2 inches wide, 93 inches high and 7/8 inches thick.

IKEA has received reports of 14 incidents. Customers are urged to conact their local IKEA store for instructions on returning the mirror wardrobe door for a free replacement door.

BMW will recall 32,000 of its most powerful vehicles because of a fire hazard. The recall is for 2008-11 model years of the 5 Series, 5 Series Gran Turismo, 7 Series, X5 and X6 equipped with turbocharged 8- or 12-cylinder engines.

What is the problem with these highfalutin luxury cars? BMW says the problem is with the water pump that helps cool the turbocharger. An electronic circuit board could fail and, “in an extreme case,” lead to the “smoldering of the water pump.”

BMW says that usually the driver would get a warning on the instrument panel of the problem. But you might not want to take that theory to the bank.

• 2002-2005 BMW recall from September
• 2010 BMW Recall