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In response to the circumstances surrounding McNeil Consumer Healthcare’s (McNeil) voluntary recall of multiple well-known pediatric medicines including Children’s Tylenol, the House of Representatives Committee on Oversight and Government Reform opened an investigation into the matter. Reuters reports that the Congressional committee is looking into whether McNeil, a unit of Johnson & Johnson, “failed to investigate consumer complaints that could have identified the contamination problems.”

The committee also plans to scrutinize the adequacy and performance of the U.S. Food and Drug Administration’s (FDA) inspection process following a routine inspection of McNeil’s Fort Washington, Pa. facility in April in which federal health officials found contamination, grime, thick dust and quality control violations.

Committee Chairman Edolphus Towns, a New York Democrat, and the panel's ranking Republican, Darrell Issa of California, had this to say about the committee’s investigation in a jointly filed news release:

“We are deeply concerned about the recall of popular pediatric medications widely used by infants and children across the country. When a recall of this nature occurs, it is our responsibility to bring attention to the issue as a public service and to fulfill our oversight responsibility by asking tough questions about the conditions of the manufacturing plant and controls put in place by the drug company’s management, and about whether FDA’s inspection and recall procedures were sufficient.”

Towns and Issa also noted in the news release that it is important to investigate the circumstances surrounding the recall due to the potentially adverse effects the products could have on children. According to the Washington Post, the recall affects an estimated 70 percent of the market for over-the-counter pediatric liquid medicines.

Towns, Issa Announce Investigation into Recall of Popular Pediatric Medication – Committee on Oversight and Government Reform’s News Release about the Investigation

House committee will look into recall of children's drugs after Tylenol recall – The Washington Post

Congress probing J&J Children's Tylenol recall – Reuters

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A report issued  by the U.S. Food and Drug Administration (FDA) states that federal health inspectors found that Johnson & Johnson unit McNeil Consumer Healthcare (McNeil) knowingly used materials contaminated with bacteria to make certain lots of its infant’s and children’s Tylenol products. McNeil issued a voluntary recall on April 30 of more than 40 different sizes and flavors of seven of its most popular products, including Children’s Tylenol and Children’s Motrin. The company has also suspended production at its Fort Washington, Pa facility. For now, FDA officials are saying that no final product batches contain contamination, but that the agency needs to review the inspectors’ assessments further to rule out any such possibilities.

Following a routine FDA inspection of McNeil’s Fort Washington, Pa. facility in April, federal health officials noted the following:

“The Quality Control Unit (QA) authorities most responsible for overseeing daily operations at the Fort Washington facility did not ensure that the responsibilities of the Analytical, Microbiological, Compliance, and Quality Assurance departments were enforced for rejection and withholding from approval any raw material component that contained known contamination of gram negative organisms. Raw material…lots…had known contamination with gram negative organisms and were approved for use to manufacture several finished lots of Children's and Infant's Tylenol drug products, which remain within expiration date(s) on the market.”

The FDA’s report also indicated that its inspectors found grime and thick dust covering certain types of equipment at McNeil’s Fort Washington, Pa. facility. In addition, the report, dated April 30, notes that the company handled consumer complaints poorly. Reuters reports that consumers filed 46 complaints between June 2009 and April 2010 involving “dark material in the liquid products.” The FDA is urging consumers to use generic over-the-counter medicines in place of the recalled products.

FDA: Drug maker McNeil knew of contamination – USA Today

FDA finds grime at J&J plant, urges use of generics – Reuters

FDA Inspection Report of McNeil’s Fort Washington, Pa. Facility

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McNeil Consumer Healthcare, a division of McNEIL-PPC, Inc. (McNeil) issued a voluntary recall of some of its most popular children’s medicines on Friday, including multiple varieties of the popular Children’s Tylenol and Children’s Motrin. The Johnson & Johnson unit issued the voluntary recall in consultation with the U.S. Food and Drug Administration (FDA) due to “manufacturing deficiencies” and because the products “may not meet required quality standards.” The FDA is urging consumers to stop using the affected products immediately.

According to the FDA, the manufacturing deficiencies have the potential to affect the purity, quality and even potency of the recalled over-the-counter children’s medicines. The New York Times reports that certain lots of the products may contain a larger amount of the active drug ingredient than specified, and that other recalled products could contain ingredients or foreign particles that may not meet McNeil’s testing requirements.

The recall involves more than 40 different sizes and flavors of seven well-known products, including:

•    TYLENOL® INFANTS’ DROPS
•    CHILDREN’S TYLENOL® SUSPENSIONS
•    MOTRIN® INFANTS’ DROPS
•    CHILDREN’S MOTRIN® SUSPENSIONS
•    CHILDREN’S ZYRTEC®  LIQUIDS IN BOTTLES
•    CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES

McNeil’s voluntary recall comes in response to a routine inspection of the company’s Fort Washington, P.a. facility on Friday in which federal health inspectors found multiple manufacturing violations. According to the New York Times, this is McNeil’s second major recall of 2010, the other taking place in January involving over-the-counter adult and children’s medicines manufactured at a plant in Puerto Rico.

Children’s Tylenol and Other Drugs Recalled – New York Times

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products – McNeil Press Release (includes list of recalled products)

FDA News Release about Recall

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Toyota Motor Corporation (Toyota) has suffered another blow to its already tarnished safety record. Following a Consumer Reports “Don’t Buy” warning, the carmaker issued a temporary sales halt on April 14 for its 2010 Lexus GX 460 luxury sport-utility vehicle. Consumer Reports found the popular SUV to be a “safety risk” due to its susceptibility to flip over in certain situations.

Tests of the SUV by Consumer Reports found that the rear of the vehicle was prone to slide out during sharp turns or other emergency maneuvers, despite an electronic stability control system seemingly designed to prevent such occurrences. As a result, Consumer Reports found the SUV susceptible to potentially life threatening rollover accidents.

“We believe that in real-world driving, that situation could lead to a rollover accident, which could cause serious injury or death,” Consumer Reports noted on its Cars Blog about the situation. “As a result, we are urging consumers not to buy the GX 460 until the problem has been fixed.”

Julia Piscitelli, a spokesperson for a division of the Transportation Department, advised drivers of the Lexus GX 460 to "use care and caution. Drivers of all vehicles should avoid excessive speed and aggressive maneuvering in order to maintain control of their vehicles."

The Los Angeles Times reports that the National Highway Traffic Safety Administration is planning to review the findings of Consumer Reports.

Don't Buy: Safety Risk--2010 Lexus GX 460 – Consumer Reports

Toyota temporarily halts sale of Lexus GX 460 SUV – Los Angeles Times

Lexus GX 460 Sales HALTED: Toyota Responds To ‘Don’t Buy’ Warning From ‘Consumer Reports’ – The Huffington Post

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Additional fines may be imposed against Toyota Motor Corporation (Toyota) , by U.S. safety regulators, for failure to promptly take action to fix the sticky accelerators. This would be in addition to the historic $16.4 million penalty imposed by the National Highway Traffic Safety Administration (NHTSA) on the automaker, April 5, that we discussed previously on the Injury Law Blog.  The NHSTA noted that the fine would have been $13 billion if not for caps set by U.S. law.

Automakers are required by law to inform regulators about a safety defect within five days of its discovery. Toyota’s records indicate that the automaker issued repair notices for sticking accelerators in Europe and Canada in September, but waited until January to take action in the United States. The possibility of this new penalty comes in response to an ongoing review of Toyota’s documents by NHTSA that indicates there were two separate defects in the recalled pedals.

United States District Judge James V. Selna in Orange County, Calif. will handle the trial, including important pretrial decisions such as deciding what documents and materials Toyota will need to provide as evidence.

According to an investigative Associated Press article, Toyota has a reputation of withholding documents and using evasive legal tactics in previous product liability, personal injury and wrongful death cases. A prime example is a product liability case in Colorado involving a young girl s killed in a 4Runner rollover crash. Court records show that a federal judge ordered Toyota to produce documents about internal roof strength tests. Unfortunately, the jury ruled in favor of Toyota, since they were not privy to important documents that may have helped shape a different opinion.

A former Toyota attorney, Dimitrios Biller and Whistleblower, accuses the automaker of  withholding evidence in former rollover cases. Rep. Edolphus Towns, D-N.Y., chairman of the House Oversight and Government Reform Committee, found many of  Biller's claims to be substantiated after reviewing some of Biller's still-undisclosed records. It is important to note that Rep, Edolphus Towns, had to subpoena Biller's records.

Toyota now must decide whether to appeal the initial fine or not. According to NHTSA Chief Counsel O. Kevin Vincent,

"If Toyota will not agree to pay the demanded penalty, NHTSA will refer this matter to the U.S. Department of Justice with the recommendation that the Attorney General commence a civil action in federal court ."

It is hard to believe that the previous largest fine was against General Motors Company for only $1 million. Surprisingly, this fine was for not promptly recalling  windshield wipers in vehicle model years 2002-2003.

US regulators consider 2nd fine against Toyota – Reuters 

AP IMPACT: In Toyota cases, evasion becomes tactic – Associated Press

Toyota Acceleration Suits Combined in California Federal Court – Bloomberg 

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How can Toyota have actual knowledge of their cars sticky accelerators, give wrong information to the United States National Highway Traffic Safety Administration, and NOT face criminal penalty?

Presently there is a Federal Grand Jury proceeding in New York, which is investigating the “timeliness of Toyota’s reporting of its sudden-acceleration complaints and fixes.” I am betting that the United States Attorney will open an investigation soon for criminal penalties against the company.  Many innocent victims have died because Toyota hid the truth about safety issues.

Human lives are not to be counted on an actuarial chart and compared to the financial impact on a company before making a known defect public.  When you are producing a dangerous product and putting it in the stream of commerce, you must correct know defects; otherwise, you are acting with reckless abandon in harming human life.

The very definition of manslaughter is the unlawful killing of a human being without premeditation or intent through gross negligence.  The difference between this and actual murder is that murder requires actual malicious intent.  Former Toytota counsel Dimitrios Biller said that Toyota had systematically disregarded the law.  He said to CNN that the material he had reviewed was “very, very disturbing.”  Toyota continues to fight the litigation requests to review their most important documents.  They are also not permitting their old lawyer to say what he knows. 

Hopefully, the public will not feel bad for Toyota because tough minded trial attorneys want to hold Toyota accountable for their reckless conduct.

 

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Toyota owners, there is a new problem facing yet another popular Toyota brand, the Toyota Corolla.  Driver complaints of  power steering related problems are causing Toyota to consider a recall of the very popular subcompact Toyota Corolla. 

This potential new recall may come in addition to the Toyota recall of approximately 8.5 million vehicles worldwide due to floor mat hazards, sticking gas pedals, and braking problems. Toyota has yet to disclose the vehicle model year(s) or regions that may be affected.

Reports show that the most recent Data from the National Highway Safety Administration (NHTSA), puts the alleged death toll due to Toyota vehicles at 34 deaths since 2000, with the numbers continuing to rise.

According to Toyota quality controls executive, Shinichi Sasaki, Corolla drivers may feel as if they were losing control of their ability to steer. Sasaki also mentioned that a link between the Corolla’s possible steering problems might involve the vehicle’s braking system or tires.

Word of this new issue comes on the heels of Toyota President Akio Toyoda’s statements regarding the forthcoming U.S. Congressional meeting. During a recent news conference, Mr. Toyoda stated that he does not plan to appear before the Congressional committee scheduled for February 24. Rather, he stated that he wanted to remain focused on improving the quality and image of his company on a global scale.

Toyota owners continue to address complaints to Federal safety officials about the potential problems. With approximately 100 reported complaints regarding the possible steering trouble, Toyota is poised to take yet another blow to its already tarnished image. When will this saga end?

In addition to decreases in the company’s image and stock value, news of this potential new recall, in conjunction with the other worldwide recalls, continues to draw legal woes for Toyota. According to the Financial Times, Toyota is facing a multitude of class action lawsuits in the United States that may cost the automaker billions of dollars. Experts estimate that more than 40 suits have been filed against Toyota under federal and state law. Claims reportedly involve wrongful death, personal injuries, property damage, and more.

Toyota is working to determine the source of the Corolla complaints and has not ruled out the possibility of issuing yet another recall.  Toyota sold roughly 1.3 million Corollas worldwide in 2009, making it the best-selling car in the world.

To read more on Toyota's latest woes regarding the looming Toyota Corolla stering probe and possible recall, click on the following links to New York Times, CNN,  Financial Times (Registration Required) and the WSJ Blog.

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As though it could not get any worse for  Toyota Motor Corp., a new report shows that two former Toyota regulators helped ward off four U.S. investigations of unintended acceleration by Toyota vehicles. This was uncovered in recent court and government records. Who can we trust to make sure that safety standards are being followed for consumer products, especially automobiles?

Two people at the heart of this new revelation are: Christopher Tinto, vice president of regulatory affairs in Toyota's Washington office, and Christopher Santucci, who works for Tinto. Allegedly, these individuals encouraged the National Highway Traffic Safety Administration to discontinue looking into 2002-2003 Toyota Camrys and Solaras, court documents show. The most alarming revelation is that Tinto ans Santucci were former NHTSA employees before joining Toyota.

Unfortunately, criticism of NHTSA and Toyota is pretty high right now, for the handling of defects in Toyota and Lexus models tied to 19 deaths between 2004 and 2009. Three congressional committees have scheduled hearings on the recalls Feb. 24 and Feb. 25. The Senate Commerce Committee plans a hearing March 2.

Joan Claybrook, an auto safety advocate and former NHTSA administrator in the Jimmy Carter administration stated the following: "Toyota bamboozled NHTSA or NHTSA was bamboozled by itself. I think there is going to be a lot of heat on NHTSA over this."

Toyota, the once media darling, is facing one of the largest scandals in the history of the automaker.  Years of carefully building a stellar image are being diminished in one fell swoop, each day a new revelation is made in the fiasco over safety issues. The Toyota Motor Corp. stock closed today at 76.01, a continued downward spiral.

In an effort to promote safety, we encourage all Toyota owners to contact their local Toyota dealer to find out if their vehicle is a part of the recall.  It will not hurt to take your car in to the shop, just to make sure. Safety and precaution go hand in hand.  You can also contact Toyota directly to see if your car is on the list. However, taking your car to a local Toyota Dealer for a check-up to be sure, can only help improve your chances of being safe in your Toyota.

Click on the following link to read more on the Bloomberg article: Regulators Hired by Toyota Helped Halt Investigations

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Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions

The U.S. Food and Drug Administration (FDA) announced a Class I recall of certain infusion set needles used in the treatment of chronically ill patients and others. Products included in the recall are the following all manufactured by the Japan-based Nipro Medical Corporation for Exelint International Corporation.

Exel/Exelint Huber needles

Exel/Exelint Huber Infusion Sets

Exel/Exelint “Suretouch+ [plus.”

The recall comes in response to inspections of Japanese Nipro facilities carried out in October 2009. These inspections found that the needles, used to access under skin ports designed for repeated access to veins, “cored” in approximately 60 to 72 percent of tests. According to the FDA, coring means that the silicone cores (or silvers) of the needles were cutting and dislodging the under skin ports when inserted, causing the ports to leak in certain cases.

In a news release about the recall, the FDA stated that:

“At this time, the FDA has not received any adverse event reports related to silicone foreign bodies released in patients from Huber needle coring. The agency received only reports of port leakage. However, because it may be very difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, there may be under-reporting of events.”

Needles involved in the recall were manufactured between January 2007 and August 2009. According to the FDA, this recall includes more than 2 million units in distribution nationwide.

The affected needles have lot numbers beginning with the following, along with a catalogue number of product code:

“07”

“08”

“09”

 For more information, please read the following articles on the Class I FDA recall for Needles

FDA’s New Release about Recall: FDA Announces Class I Recall of Certain Infusion Set Needles
 

CNN Health Article  on Recall: FDA recalls more than 2 million needles used in port implants

 

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Honda Motor Corporation (Honda) issued a global recall of roughly 646,000 units of the models Fit/Jazz and City. The announcement came today and and includes 140,000 Honda Fit units in the United States.

According to Honda, the recall was to correct a faulty master power window switch, which could allow water to enter the switch and cause a fire. New York Times reports that three cases of fire due to the defective master switch were reported, including two in the U.S. and one in South Africa.

A statement released by Honda about the recall indicated that:

"Under some severe operating conditions, water, rain, or other liquid may enter the driver's window and reach the master power window switch, resulting in impaired function of the switch.” The statement went on to add that, "An overheating switch may cause smoke, melting or, potentially, fire."

Honda’s recall involves models sold around the world, including North America, South America, South Africa, and Asia. However, a Honda spokesperson indicated that the recall does not include Fit/Jazz and City units sold in Japan. Honda’s Fit is the company’s best-selling car in that country.

This latest recall by Honda comes just days after rival automaker Toyota halted sales and recalled millions of vehicles worldwide due to the threat of unintentional acceleration.

We strongly recommend all Honda Fit/Jazz or City vehicle owners to contact their dealer, or call Honda Automotive Customer Service at 1-800-999-1009.

For more information on the latest Honda recall, please click on one of the following links:

NY Times Article:  Honda Recalls Cars, Citing Defect

Wall Street Journal article: Honda Announces Worldwide Recall Of 646,000 Fit Cars

Honda South Africa’s Press Release about the recall:

 

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Toyota Motor Sales, U.S.A., Inc. (Toyota) announced the temporary suspension of the sale of eight models, including the popular Corolla and Camry lines. The suspension comes after the Toyota recall on January 21 of 2.3 million cars due to the threat of unintentional acceleration. Toyota is instructing dealers to halt sales of certain vehicles in connection with the ongoing recall until a “remedy is finalized.”

Toyota anticipates stopping North American vehicle production lines for the week of February 1 to “assess and coordinate activities.” This production halt will affect Toyota manufacturing facilities in Kentucky, Indiana, Texas, and Canada.

The accelerator pedal recall and sales suspension affects eight models, including:
 

• 2009-2010 Corolla
• 2009-2010 Matrix
• Certain 2007-2010 Camry
• 2005-2010 Avalon
• 2009-2010 RAV4
• 2010 Highlander
• 2008-2010 Sequoia
• 2007-2010 Tundra

Bob Carter, Toyota Division General Manager and Group Vice President  stated the following:

"Helping ensure the safety of our customers and restoring confidence in Toyota are very important to our company. This action is necessary until a remedy is finalized. We’re making every effort to address this situation for our customers as quickly as possible.”

It is important to note that this recall is in addition to the carmaker’s ongoing recall of certain Toyota and Lexus vehicle lines due to the threat of pedal entrapment caused by “incorrect or out of place accessory floor mats.”

A Toyoya spokesperson reported that no confirmed deaths could be traced to the defect. However, Toyota’s stunning decision to halt sales and production are a clear indication of the serious nature of the situation.

For more information on the most recent Toyota recall click on the following links: Toyota, Washingtonpost,  CNNMoney.com and The New York Times.

We encourage Toyota vehicle owners with the affected models to contact their local Toyota Dealer or to contact Toyota directly at 800-331-4331.

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Toyota Motor Sales, U.S.A., has recalled approximately 2.3 million vehicles to correct sticking accelerator pedals on specific Toyota Division models. This action is not related to the on-going recall of approximately 4.2 million Toyota and Lexus vehicles to reduce the risk of pedal entrapment by incorrect or out of place accessory floor mats. Approximately 1.7 million Toyota Division vehicles are subject to both separate recall actions.

Continue Reading...

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The Medicines Company (NASDAQ: MDCO) has issued a voluntarily recall of eleven (11) lots of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter.

The affected Cleviprex lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. No other lots are affected by this recall.

The Medicines company is cooperating with the U.S. Food and Drug Administration on this recall.
The particulate matter comprises sub-visible inert stainless steel particles of around 2.5 microns.
There are no known complaints or reports of adverse events related to this issue regarding Cleviprex ®

For medical inquiries, adverse event reporting or quality issues related to Cleviprex, please contact The Medicines Company Medical Information at 1-888-977-6326 Monday to Friday 8:00am-5:30pm EST or cleviprexrecall@themedco.com

Consumers with any adverse reactions associated with the use of Cleviprex may also report this to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website.

The stock for MDCO closed at $8.04, down .08 shares from previous trading.
 

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Happy New Year!!! Today marks the first day of 2010. Today is a fresh start for the new year.

It is a time of reflecting on one's life and setting new goals.

Unfortunately, two South Florida teens were killed in a fatal rollover crash auto accident on New Year's eve.  They will not have the opportunity to enjoy 2010 and make the most of their lives.  At this time, the cause of the crash is under investigation by the police. According to Police, the teens were traveling at a "high rate of speed" when the driver lost control and the car smashed into a brick sign.  A third victim in the car managed to escape. Our thoughts and prayers go out to the families and loved ones.

To help drivers make the right decision about getting behind the wheel after drinking, AAA offered a FREE TIPSY TOW for drivers that had too much to drink this holiday season. This was a two program to help cut down on deaths and accidents during this time of year. Time will tell, how many lives were lost in car accidents over the new year's holiday.

We can't stress enough that while you are driving a vehicle, caution and safety come first. Texting while driving has become such an important issue that some states have made this a first offense. On Friday,  texting while driving in Illinois will be illegal. The texting ban law also bans checking e-mail, updating Facebook and Web surfing while driving. However, using your phone GPS is okay. It will be interesting to see how this is enforced. More states are looking at making texting while driving illegal, Florida  included.

On another note, if you are looking for relief of pain, before you reach for your Tylenol, check the label. The Tylenol Arthritis Pain Caplet 100 count bottles have been recalled. This product  has a  red colored EZ-Open top. According to the FDA,The recall stems from complaints of a moldy odor which may result in nausea, stomach pain, vomiting and diarrhea for the user. The symptoms are caused by trace amounts of the chemical 2, 4, 6-tribromoanisole resulting from the breakdown of a chemical used to treat wooden pallets that transport and store packaging material.The recall only applies to this exact model and not other products labeled Tylenol Arthritis. Please visit the Tylenol website  for more specific information on the recalled Tylenol Arthritis Caplets.

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Attention all readers, this is a very important blog post. If you are a Toyota driver or know someone that is, please read and share this important information. It could help save your life or the life of a loved one.

The Toyota Motor Corp. has announced that it will recall 3.8 million vehicles in the United States, to address problems with a removable floor mat that could cause accelerators to get stuck and lead to a crash. The recall affects Toyota models from 2004 – 2010. Specific models affected include 2007-2010 Toyota Camry, 2005-2010 Toyota Avalon, 2004-2009 Toyota Prius, 2005-2010 Tacoma, 2007-2010 Toyota Tundra, 2007-2010 Lexus ES350 and 2006-2010 Lexus IS250 and IS350.

Toyota is working with National Highway Traffic Safety Administration to find a solution to the problem. In the meantime, drivers of the named vehicles should immediately remove the mat from the driver’ side and not replace it, until further notified.

According to a Toyota spokesperson in published reports "A stuck open accelerator pedal may result in very high vehicle speeds and make it difficult to stop a vehicle, which could cause a crash, serious injury or death.

There have been reportedly 102 incidents where the accelerator may have become stuck on the Toyota vehicles involved, according to the NHTSA. However, it is unclear how many have led to crashes.

Transportation Secretary Ray LaHood issued the following statement “For everyone's sake, we strongly urge owners of these vehicles to remove mats or other obstacles that could lead to unintended acceleration."

Toyota has warned owners that if they think their vehicle is accelerating out of control, they should check to see whether their floor mat is under the pedal. If a driver can't remove the floor mat, Toyota advises drivers to step on the brake pedal with both feet until the vehicle slows and then try to put it into neutral and switch the ignition to accessory power.

Unfortunately, this recall comes too late for California Highway Patrol Officer Mark Saylor. In August, Officer Saylor and three others were killed in a  fatal car accident involving the crash of a 2009 Lexus ES 350 and a Sport Utility Vehicle. Reportedly, one of the family members called the police minutes before the crash to report the accelerator was stuck and that the car had no brakes. The Officer’s car hit the SUV, rolled several times and burst into flames. Reports from the NHTSA investigators determined that a rubber all-weather floor mat found in the wreckage was slightly longer than the mat that belonged in the vehicle, something that could have snared or covered the accelerator pedal.

This morning, I removed the driver’s side mat from my Toyota Camry and recommend that all Toyota owners of the above mentioned vehicles do the same. If you have questions or want more information, please contact, the National Highway Traffic Safety Administration's hotline at (888) 327-4236, Toyota at (800) 331-4331 or Lexus at (800) 255-3987.

To read more information on the Toyota recall of 3.8 million vehicles due to a driver's floor mat interference with the accelerator pedal, view the following: Toyota Pressroom, Forbes - Runaway Toyota Recall, Fox News and Associated Press.

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Don't let the slick, clever misleadind Hydroxycut ad fool you, there’s no real substitute for diet and exercise when it comes to losing weight safely.  Every year millions of Americans turn to so-called dietary supplements to aid in reducing pounds and inches from their waistlines. In many cases, these supplements are no more than combinations of vitamins and minerals or herbal remedies that, while they may not actually cause weight loss, do no harm to those taking them. The FDA recalled several Hydroxycut products made by Iovate.

Is it worth the risk, taking a supplement touted as a miracle weight-loss aid, that can possibly cause dangerous, and even fatal, health problems? Many consumers taking the widely popular Hydroxycut products marketed and distributed by Iovate and Muscle Tech are faced with this dilemma.

According to a warning issued by the U.S. Food and Drug Administration last month, several Hydroxycut products manufactured by these companies have been linked with 23 reports of serious health problems, including jaundice and elevated liver enzymes, potential indicators of the presence or emergence of more serious liver damage which may, in some cases, require liver transplant. In addition to these health problems, the agency also reported one death due to liver failure linked to these Hydroxycut products.

In addition, Hydroxycut users reported other harmful and serious side effects, including cardiovascular problems, seizures, and rhabdomyolosis, a condition in which an individual’s muscle tissue begins to break down, often resulting in severe kidney damage and even kidney failure.

In its statement, the FDA noted that it has not yet determined the dosages associated with injury, and asked consumers to immediately stop using Hydroxycut products, and to see their physician if they experience any of the symptoms which may occur as side effects of Hydroxycut use, including the yellow skin and eyes indicative of jaundice, nausea, vomiting, fatigue, abdominal pain, loss of appetite, itching, light-colored stool, and brown urine.

Hydroxycut products recalled by the FDA include:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

If you have taken these products and are experiencing side effects, contact your doctor. It is better to err on the side of caution and discontinue use of the product. This could help save your life and prevent fatal results.

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Mattel Corp. settled the lawsuits brought against the company for bringing and selling unsafe products within the United States. On Friday, June 5th, the U.S. Consumer Product Safety Commission (CPSC) placed a civil penalty against Mattel for violating Federal Ban on the use of lead paint. The company agreed to pay a $2.3 million sum, though both the company and its subsidiary, Fisher-Price, did not admit to any wrong doing. The moneys to be paid out in this settlement are in addition to a previous a previous finding; in 2008, Mattel ended a 15 month legal probe by paying $12 million to 39 states regarding the importing and attempted sale of the contaminated toys.

The lawsuit stemmed from a discovery of unsafe levels of lead paint found in Mattel toy products that were on store shelves between September 2006 and August 2007. According to the CPSC, nearly 100 varied items were included in the lawsuits, representing several million individual pieces. Mattel issued a recall for the products, which included such popular toy brands as Barbie, Doggie Day Care, Dora the Explorer, and Polly Pocket. Other toys that were recalled included items associated with characters from Sesame Street and the movie Cars.

Parents have every right to feel anxiety about high levels of lead in toys. The CPSC says that lead in paint can cause irreversible brain damage, increased blood pressure, decreased muscle coordination, nerve damage, and reproductive harm in both children and adults. Parents who fear that their children may have been exposed to lead based paint should arrange for lead poisoning screening. Early treatments may reverse the effects of lead poisoning, while prolonged exposure to lead or lack of adequate care may cause permanent damage.

Though some parents have vowed to only allow their children to use organic, unpainted toys, this is an effective but unnecessary step at lead exposure prevention. In order to decrease the contact children may have to possible lead based toys, parents should stay abreast of all product recalls. The CPSC keeps an updated list of all recalled toys at on the Consumer Products Safety Commission website under recalls. Parents should check this site regularly if they are at all concerned about possible lead contamination. Parents should also frequently examine toys and remove those that have chipped or peeling paint, as ingested or inhaled lead is the chief cause of damage. Parents should also attempt to keep children from biting or sucking on painted toys.
 

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If you are driving with Cooper CS4 Touring (VR tires) size 215/55 R17 on your vehicle, Cooper Tire Company has recalled your tires. The Cooper tires were manufactured between September 2008 and October 2008. The recall is based on the fact that the tires were not allotted the proper amount of time to cure, which could lead to tire tread separation. In the event of tire separation vehicles can become exceedingly difficult to control often resulting in a crash. Cooper Tires is reportedly contacting customers who purchased the defective tires and offering to replace, mount, and balance the replacement tires at no cost to the customer. Consumers who may have purchased Cooper Tires affected by the recall are encouraged to call toll free at 1-800-854-6288. Surprisingly, the Cooper Tire website, has no link to this recall information on their website. Callers of the toll free Cooper number have been told by Cooper Tire representatives that the only way to determine whether the tires are safe is to acquire the 11 digit DOT number from inside of the tire. What if the car belongs to your senior grandma? Does this mean that grandma would have to climb under the vehicle to insure her tires were safe?

Tire tread separation is extraordinarily dangerous and can lead to a loss of control even when the tire does not lose pressure. Tire defects can yield catastrophic results including personal injury and death. We strongly encourage you to check your tires and see if you have Cooper CS4 Touring (VR tires) size 215/55 R17 on your vehicle. Also, check the tread of your tires while you are at it. They may need to be replaced due to normal wear.
 

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The FDA released new information on the Peanut Butter Plant that shows the company knew about the Salmonella potential, but failed to act on the information. This failure to act could have possibly prevented the deaths of 8 people and the sickness of 500 people with Salmonella. According to a statement from the FDA in the Washington Post, the Peanut Corporation of America found salmonella in internal tests a dozen times in 2007 and 2008 but sold the products anyway, sometimes after getting a negative finding from a different laboratory. This is an outrage that a company would ignore important data and findings. I would like to know their excuse or rationale for not taking these reports seriously.

Federal investigators also said yesterday that they had found four strains of salmonella at the Georgia plant, including one in a sample taken from the floor near a washroom. Only the Typhimurium strain of Salmonella enterica has been linked to the outbreak.

"There is a salmonella problem at the plant," said Robert Tauxe, deputy director of the CDC's division of food-borne, bacterial and mycotic diseases.

It is important to note that the Peanut Corporation of America, based in Lynchburg, Va., was not required to inform regulators about its internal salmonella tests, Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition, said it appears that the company violated federal law. "Foods are supposed to be produced under conditions that do not render them damaging to health," he said.

Only time will tell if there will be any consequences to this company for this mishap that conceivably could have been avoided if they would have acted or informed people sooner.  In the meantime, thousands of people are worried and alarmed at the prospect of getting salmonella from eating one of America's favorite foods "peanut butter".

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A potential for life-threatening blockages has prompted the recall of the Medtronic Infususion Pump. The FDA and Medtronic, Inc. issued a Class I Recall of the Medtronic Infusion Pain Pump, Neuromodulation INDURA IP. This recall includes the following models: intrathecal catheter, the suturless pump, and the intrathecal catheter pump segment revision kit.

Unfortunately, this is a serious recall, since a Class I Recall is the most serious type of product recall issued by the FDA, Food and Drug Administration.  A Class I Recall involves situations where there is a reasonable probability that death or a serious injury will occur from using the product. 

How are the recalled Products used?
The intrathecal catheter revision kits or the intrathecal catheter use a sutureless connector for the final connection to the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The catheter  is a part of an infusion system. The catheter delivers and stores drugs into a specific space. 

What promoted the Recall?
The recall of the Medtronic Infusion Pump was due to the potential misconnections of the Medtronic sutureless connector ("SC") catheters from the catheter port on the pump. Reports have shown these misconnections to have caused a blockage between, the catheter port on the pump, disconnection from the pump connector and the sutureless pump connector.

The following product models are included in the Recall:
Sutureless Pump; Connector Revision Kit, Model 8678; 
Intrathecal Catheter, Model 8731SC; 
Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC
Intrathecal Catheter, Model 8709SC

It is important to note that this recent recall does not include the MiniMed infusion pumps made by Medtronic.

What should you do if you have a Pain Pump?
If you or a loved one have used a Pain Pump since January 22, 2007, contact your physician to ask questions. You can also contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. Central Daylight Time. 

Click here to read FDA Recall of Medtronic Pain Pump.

 

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Health writer, KATE BARRETT, wrote a great article for ABCNews.com, entitled: "New Toy Safety Standards Become Law". The article discussed in detail, the new legislation on Consumer Product Safety and how it impacts children's toys.  The article highlighted the addition of tough  new  standards that address lead levels and chemicals in products for children under 12 years old.  According to the new Bill,  safety tests will be required with the efforts of keeping kids safe and preventing recalls. 

This Bill was a Bi-partisan effort on behalf of our legislators in the House and  the Senate. According to Senate Commerce, Science, and Transportation Committee chairman Daniel K. Inouye, D-Hawaii,  "The Consumer Product Safety Commission (CPSC) has been a neglected agency for too many years, but this legislation puts an end to that neglect. Texas Republican, Joe Barton, ranking member on the House Committee on Energy and Commerce panel, stated "One of the roles of government is to get between kids and the sorts of hazards that are well beyond parents who aren't engineers and chemists with laboratories at their disposal". It is nice to see members of the House and the Senate putting their differences aside and doing what is right to protect our children. The last thing that we need is a repeat of the horrors from the recalls from last year for toys such as the Thomas Tank Engine trains and Dora the Explorer/ Diego toys.

Click here to read the ABC.com article on Safety for Children's Toys.

 Click here to read Consumer Safety Protections Bill H.R. 4040

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Basic Information on the Rhino ATV
After all of the accidents and injuries caused by use of the Yamaha Rhino ATV, one can't help but wonder if the product is safe. Studies have shown that poor design of the All Terrain Vehicle cause most rollovers. Such accidents have notoriously resulted in serious injury for both ATV drivers and passengers and in some tragic cases, have even led to the death of children. According to its critics, the Yamaha Rhino ATV has a high center of gravity due to its narrow bottom and top-heavy design, which makes the vehicle more prone to rollovers. The majority of the reported injuries affected the victims’ extremities, such as their legs, feet, arms and hands.

Rhino ATV Design Flaws and Insufficient Model Modifications
Until Yamaha released its newest Rhino ATV model in 2008, the vehicle lacked doors—an oversight that has triggered multiple accidents. Before this updated model of the Rhino was distributed, Yamaha only offered side doors as an accessory option. However, the inclusion of doors on an ATV is not only necessary, but it seems that even with the doors the Rhino may be unsafe. Some people have reported that the doors have unlatched in the case of rollovers—thereby endangering the passenger just the same.

In 2006, Yamaha acknowledged certain defects of the Rhino ATV, and released safety warnings as a result, such as seat belt and helmet recommendations. Then, in 2007, the company offered to install doors and passenger holds on all 2004-2007 models.

Despite the numerous reported rollovers, Yamaha has yet to acknowledge the flaws inherent within the Rhino ATV’s design and has only issued a recall for the vehicle’s brakes.

Click here to read: ATV Safety Tips

Click here to read: ATV Recalls

Click here to read: Florida Statutes for ATV Use

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Heparin Sodium, a drug used to prevent blood clots in patients, was first approved for the market by the FDA in 1972. Its primary manufacturer is Baxter International, and its production is handled by the Wisconsin-based group Scientific Protein Laboratories LLC (SPL). Heparin is an anticoagulant used to thin the blood in surgery, dialysis, and to prevent blood clots in bedridden patients.

Recent Reports Find Negative Side Effects for Heparin
The adverse effects of Heparin first came into light towards the end of 2007. In the beginning of 2008, the FDA reported over 350 instances of adverse effects due to Heparin since the end of 2007. Following this report, Baxter International announced its intentions to recall its multi-dose vials of Heparin. In March of 2008, Baxter expanded its recall to all multi-dose, single-dose, and diluted solutions of Heparin.

According to the FDA reports, approximately 500 patients have suffered from the adverse side effects of Heparin, and at least 21 have died as a result of the drug. One widely-publicized instance of Heparin’s dangerous effects was that of actor Dennis Quaid. In this case, the actor’s newborn twins were accidentally given an excessive dosage of Heparin, a mistake which nearly caused the infants’ deaths. Dennis Quaid and his wife have sued the maker's of Heparin, Baxter Healthcare Corp. for not doing enough. The lawsuit also says the company should have recalled the large-dosage vials after overdoses killed three children at an Indianapolis hospital.


The Blame Game
It is suspected that during the production of Heparin in one of SPL’s Chinese factories, a contaminant was put into the drug’s active ingredient. Additionally, it has been discovered that the production factories in China were not up to sanitation code. The blame for this lack of inspection falls not only on SPL and Baxter International, but also on the FDA, who admitted to breaking its own policy by not inspecting these locations.

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The courts recently reached an unsettling decision for Plaintiffs involved in the St. Jude Heart Valve Class action when the 8th U.S. Circuit Court of Appeals overturned a national class action certification in a defective products case. The decision called for each plaintiff to show a link between any reliance on St. Jude Medical Inc.  (Minnesota Supreme Court decision. St. Jude Medical, Inc., Silzone Heart Valve Prods. Liab. Litig, No. 06-3860, slip op. (8th Cir. Apr. 9, 2008).

According to a National Law Journal Article on Law.com, the lawsuit alleged that three years after their 1997 introduction, the St. Jude Medical Silzone heart valves were found to have a defective silver coating that made people sick. Lawsuits were filed that alleged St. Jude Medical was negligent in research and development of the valve and marketed it without proper research.

One has to agree with the plaintiff's attorney Capretz that "This is a very disturbing decision with several major implications", especially for the plaintiffs.

Stay tuned for more information on this court decision.

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According to recent reports, some Baxter Heparin blood thinners may be linked to more deaths. Baxter International is expanding a recall to include almost all of its heparin products. The New York Times reports that the Food and Drug Administration has linked the number of deaths possibly associated with the drug, made from pig intestines, to be 21 an increase from the initial four reported deaths. But it cautioned that many of those patients were already seriously ill and that the drug might not have caused their deaths. Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the US market.

The FDA website gives a full report of the Heparin by Baxter Healthcare Corporation.  The site states that Baxter has extended its recall of multi-dose vials of heparin sodium for injection to also include single-dose vials of heparin sodium for injection. As a precautionary measure Baxter is also recalling its heparin lock flush products. The heparin source manufacturer for lock flush solutions is the same as that for Baxter’s heparin sodium for injection.

Baxter Recall Announcement of Heparin Sodium Vial Products - February 28, 2008

Baxter Recall of Heparin 1,000 Units/ML 10 and 30mL Multi-Dose Vials - January 25, 2008
NDC NUMBERS 0641-2440-45, 0641-2440-41, 0641-2450-45 and 0641-2450-41;
LOTS: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111

The FDA is still investigating the cause of adverse events reported for Baxter’s heparin sodium. Investigations are being done by FDA investigators and scientists , the Centers for Disease Control and Prevention, and Baxter to discover the underlying cause of the adverse events. 

Health care providers are encouraged to report all allergic-type reactions to any heparin infusion to FDA’s MedWatch on line at  www.fda.gov/medwatch/report/hcp.htm, by fax to 1-800-FDA-0178, by mail, or by telephone to 1-800-FDA-1088.

After reading the New York Times describe Chinese facilities that make components of Heparin, mucous membrane,  cooked pig intestines and eventually  a dry substance: crude heparin,  I suddenly recalled the 2006 documentary type movie Fast Food Nation. If we stop to think of how how facilities handle and process animals for consumption and medicine, it is easy to see why someone considers becoming a Vegan or Vegetarian.

Yesterday, Baxter stock closed at $59.93

To read more on the Heaparin recall, Click Here for the New York Times, Food and Drug Administration, Baxter Health International.

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There has been a Class 1 Recall for Product: Fire Star™ RX and Dura Star™ RX PTCA Balloon Catheters manufactured by the Florida based Cordis Corporation. The concerned products were manufactured in Mexico from February, 2007 through December, 2007 and distributed worldwide from March 26, 2007 through January 8, 2008. Dura Star™ RX was distributed in the U.S. on August 29, 2007 and Fire Star™ RX was distributed in the U.S. on August 31, 2007.

All Fire Star™ and Dura Star™ lots 13173912 through 13315455, plus 52 additional lots above 13315455 are affected. (No lots above 13329055 are affected).

The Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. 

The product was found to have a potential slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure or death. 

Since Class 1 recalls are serious recalls that involve situations in where there is a reasonable probability that use of the product will cause serious injury or death.

If you are a consumer or Health care professional and find adverse reactions or quality problems experienced with the use of this product, please contact the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Online:www.fda.gov/MedWatch/report.htm

Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

FAX: 1-800-FDA-0178

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Bayer's liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function has been withdrawn from the market. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. The product should not be used by anyone and all unused vials must be returned to the manufacturer.

Bayer letter regarding withdrawal of Leukine

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NATIONWIDE URGENT DEVICE RECALL - Heparin and Saline Flushes by AM2 PAT

The FDA has announced an urgent nationwide recall of pre-filled Heparin and normal Saline Flushes that were manufactured by AM2 PAT, Inc. of Angier, a North Carolina based Company. The pre-filled syringes are contaminated with Serratia marcescens, which has resulted in patient infections. The products can be found under the brand names, Sierra Pre-Filled Inc. and B. Braun. They are sold in 3ml, 5ml sizes for Heparin and 3ml, 5ml and 10ml sizes for Normal Saline. Both products are sold as pre-filled syringes.

One lot under recall of this product 1003-02, Lot 070926H, Heparin IV flush syringes was found to be contaminated with Serratia marcescens, which has resulted in patient infections. The CDC  confirmed growth of Serratia marcescens from several unopened syringes of this product.

This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Consumers and user facilities who have any of these recalled pre-filled syringes, Heparin or Saline Lock Flush Solution USP, should stop using the product immediately. These products should be immediately quarantined in your inventory and returned to your distributor immediately.

The following information for this recall includes:

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina

PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, All Strengths and Sizes

Saline Lock Flush Solution USP, All Strengths and Sizes

LOT # NDC # CATALOG # Product Brand Name
All 64054-1003-02 1003-02 Heparin Lock Flush 100units/ml 5ml
64054-1003-01 1003-01 Heparin Lock Flush 100units/ml 3ml
64054-3005-02 3005-02 Heparin Lock Flush 10units/ml 5ml
64054-3003-02 3003-02 Heparin Lock Flush 10units/ml 3ml
64054-3003-06 3003-06 Heparin Lock Flush 10units/mL 3ml (6ml syringe)
64054-3005-06 3005-06 Heparin Lock Flush 10units/mL 5ml (6ml syringe)
64054-0910-2 0910-12 Normal Saline Flush 10ml
64054-0905-2 0905-12 Normal Saline Flush 5ml
64054-0903-2 0903-12 Normal Saline Flush 3ml

The products were recalled after bacterial contamination in some end user samples of product code 1003-02, Lot 070926H was found.

It appears from an ongoing Food and Drug Administration (FDA) inspection of AM2 PAT, Inc.’s facility that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10am-5pm Eastern Standard Time.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Before I jump on the soap box, let me preface the following thrashing with the fact that I hold Mark Hermann in very high esteem for his analysis on being an effective attorney in Curmudgeon's Guide to Practicing Law (2006) (which sits on my desk.)

Hermann and Beck's clever Drug and Device Law Blog recently praised, as a panacea of defense positions, the benefits of federal preemption in defective products cases. The blog was clearly written to influence the upcoming Supreme Court opinion in Riegel v. Medtronic.

First off, give credit where credit is due: Medtronic defense attorneys have created the state of the art medical device defense practice relying on federal preemption to stick it to injured people across the United States.

So, you ask, “What is my beef?” Here is my beef. While these guys are self laudatory about the "cool-ness" of federal preemption, they fail to take into account the real life affect of defective products. At a legal/theoretical level, the theory of federal preemption sounds like a good thing. In the real world, however, defective products hurt people. Defective products kill people. Defective products create life changing problems for people. Not theoretical people. Not names on an appellate brief. Real people. Live human beings. Flesh and blood. Commonly referred to as families, children, parents.

When a defective product harms one of those real people the company that made the defective product must be held accountable. To rely on an over worked, under paid, bureaucratic government worker to determine if there is a latent product defect is simply unrealistic. Further to permit the company to be exempt from liability because that government inspector places a "stamp of approval" on the product is ridiculous. It is ridiculous regardless of whether that government stamp was a PMA or a 510(k) review. The company should never be able to rely on government approval to escape from their responsibilities especially when the company product’s harm human beings.

Sure, these guys blather on and on about how tough it is to gain FDA approval. They believe a strong FDA can make our world safe. This is simply not true. The government is not as efficient or as strong as a free market tempered by the right of individuals to sue for their damages when a product defect harms them or a loved one. The checks and balances of our present capitalistic system work. If they didn’t work Medtronic, Bristol Myers Squibb, Purdue Pharma, GlaxoSmithKline, Stryker, Ferno and all the rest of the big medical players would be bankrupt from paying spurious lawsuits.

Are they bust? I don’t think so. In fact, the opposite is true. These companies pay huge fines and penalties to the government, pay off huge litigation bills and lawsuits and still pay their upper management millions of dollars per year for keeping them in the multi-millions of annual profitability. Why in the world do they need federal preemption?

Granted, meritless product liability cases are filed every year. Those cases are disposed of with pre-trial motions from a capable defense bar, like Hermann’s or Beck’s firms. They also know that there are far more valid cases filed than the few meritless matters that make their way into their offices to defend. Federal preemption is like throwing the baby, the family and the bathroom all out with the bathwater. It simply goes too far.

There is also the “mindless American lack of juror intelligence” argument within the Drug and Device Law Blog. The fact that the American public is ill equipped to handle the hard technical issues within a medical device case is another theme in the argument for federal preemption. That is a pretty typical white shoe/big firm analysis. It goes like this “We are all trained at the best schools and we have a hard time understanding this stuff, your lowly jurors certainly can’t fairly judge this case, you don’t have the training or expertise.” The American juror is by and large pretty bright. Certainly the group dynamic allows jurors to rise to the occasion and make a fair determination of whether the product was or was not defective. Juror’s also have the assistance of numerous experts presented by both sides at a products liability case. Therefore, the stupid juror argument simply doesn’t fly. Americans deserve better from their legal system.

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Cargill Beef issued a massive recall on November 3, 2007 for more than 1 million pounds of ground beef that is suspected to be contaminated with E. coli bacteria. This is the second voluntary recall of beef in less than a month. The earlier Cargill recall was issued October 6, 2007 for 844,812 pounds of frozen ground beef patties because they may be contaminated with E. coli O157:H7.  This recall included products that were produced on Aug. 9, 10, 15, 16 and 17, 2007, and were distributed nationwide. Each package bears the establishment number “Est. 924A” inside the USDA mark of inspection. The products include:

Products distributed at the retail and subject to recall are:

• 6-pound boxes of “American Chef's Selection Angus Beef Patties 18-1/3 Pound Patties.” Each package bears a case code of “7703100” and various package codes of Best If Used By dates of “02/05/08,” “02/06/08,” “02/12/08,” and “02/13/08.”

A few prevention and safety measures include:

1.  cooking any ground beef to an internal temperature of 160 degrees F., or until the meat is no longer pink and the juices run clear.
2.  Avoid contaminating other foods with any E. coli bacteria that may be present in meat.
3. Wash Hands, utensils and cutting boards after they touch raw meat.
4. Place cooked meat on a clean platter, not one that was used to hold raw meat.

Consumers with food safety questions also can “Ask Karen,” the FSIS virtual representative available 24 hours a day at ASKKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 a.m to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

The Ecoli Lawyer at the Marler Blog, provides excellent commentary on the history of Cargill Food Recalls dating back to the early 90's. Amazing they have been having problems this long. One would think that with new technology, the company would master how to prevent E. coli outbreaks. If you look at the great historical chart, the Marler Blog gives in their post on Cargill, getting reacquainted with the Enemy, it is hard to avoid the massive growth and expansion efforts of the Cargill company. My question to Cargill is "While you were growing and acquiring new companies were you looking into best practices of preventing food-borne illnesses?"

Blogger Jane Genova includes an excellent Blog Post entitled Cargill, ConAgra et al. Need to Follow Oprah Crisis Management 101on measures Cargill should take in dealing with the PR Crisis nightmare. Oprah is my hero and role model. No one is a master PR like Oprah. Jane's list is one that all executives and PR people should keep and hold onto, in case a PR Crisis should arise on their watch.

• Acknowledge the situation is serious
• Be visible where the trouble is or could be
• Follow up sincerity with concrete action. Be a responsive human being
• Be part of the reform effort. This is not about committees or delegation. The message is: This will not happen again, at least not on our watch.
• Be totally accessible. Use technology such as personal email addresses, blogs, and live media conferences

According to the Regional Beef President, John Keating, no illnesses have been reported. Now that is what makes me wonder if the public is fully aware of the meat recalls. There have been so many recalls over the past three months. Every time you look on the news, you hear of  another recall  that many have become desensitized by them. The ten states that are included in the recall are: Connecticut, Maine, Maryland, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania and Virginia.

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Medtronic issued a press release on a voluntary recall of the Sprint Fidelis® family of defibrillation leads, due to the potential for lead fractures. Medtronic is recommending that Doctors do not use implants of the following  Sprint Fidelis Model leads: 6930, 6931, 6948, 6949. Approximately 268,000 Sprint Fidelis leads were implanted worldwide. They are used to deliver therapy in defibrillators only, including Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy – Defibrillators (CRT-Ds). This action does not affect Medtronic pacemaker patients.

According to Medtronic there are approxomately five deaths linked to lead fractures. A lead wire  connects an implantable defibrillator to the heart. If it breaks, the defibrillator can cause a massive and painful shock. A  fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. It is risky to replace a lead, since it requires invasive surgery that can cause the tissue of the blood vessels and heart to tear. Itt is recommended that defibrillator leads are not to be replaced due to the risk it may cause patients, unless they fracture.

According to FDA reports, "the FDA will continue to monitor information on these devices and will take whatever other actions may be necessary."

To read more on the Medtronic Sprint Fidelis Lead Recall
FDA Medtronic Sprint Fidelis Lead Recall Info
Medtronic Sprint Fidelis Lead Recall News Release

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According to an associated press story,  Dole has recalled packages of Dole Hearts Delight salad mix  with "best if used by" date of September 19, 2007, and a production code of "A24924A" or "A24924B," according to Dole officials. This voluntary recall came after package of Dole salad mix that tested positive for E. coli that was purchased in Canada.

The latest recall affects Dole Salad mix packages sold in in nine states Illinois, Indiana, Maine, Michigan, Mississippi, New York, Ohio, Pennsylvania, Tennessee and Ontario, Quebec and the Maritime Provinces in Canada. Unfortunately, this does not mean that people in neighboring  states are free from worry. The recalled salad mix may have been distributed to other states because the product was distributed by a wholesaler. Word of caution, if you have this product in your home, check the dates and production codes and discard the product. It is always better to err on the side of caution.

The strain of E. coli associated with this recall can cause life-threatening illnesses. Symptoms include severe abdominal pain and bloody diarrhea; some people can have seizures or strokes and some may need blood transfusions and kidney dialysis, while others may live with permanent kidney damage.

Almost one year ago, Dole recalled fresh bagged spinach that claimed the lives of at least three people. 

According to Dole, if you still have any of the “Dole Hearts Delight” salads with a "best if used by date" of September 19 and a production code of "A24924A" or "A24924B" consumers should dispose of the product. And always discard products after the best if used by date.  This information is on the product for a reason.

For more information, consumers can visit the following websites FDA or Dole  or can call Dole Consumer Center toll-free at 800-356-3111.

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