Florida Injury Lawyer & Attorney : LaBovick & LaBovick Law Firm: Serving West Palm, Boynton, North Palm, West Palm Beach, Jupiter

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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