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

New Roof Rule for Rollover Safety

The Federal Motor Vehicle Safety Standards (FMVSS) and regulations with which automobile manufacturers must comply were first enacted by the National Highway Traffic Safety Administration, in March 1967 to provide manufacturers with guidelines regarding minimum safety performance requirements. Since 1967, new standards have been added and existing standards have been amended. These changes have been necessary due to the evolution and expansion of automobile manufacturing.  In 1973, FMVSS 216 was enacted. According to the U.S. Department of Transportation, FMVSS 216 “specified requirements for roof crush resistance over the passenger compartment.” The intent of FMVSS 216 was to provide protection to individuals involved in rollover crashes by ensuring that automobile manufacturers adhered to federal roof standards. In April 2009, FMVSS 216 was amended to provide better protection for those involved in rollover crashes and extended the standards applicability to both heavier trucks and sport utility vehicles (SUV).

The National Highway Traffic Safety Administration (NHTSA) reports that more than 280,000 rollover accidents are reported each year. As a result of these accidents, approximately 10,000 individuals are killed on a yearly basis. Many of these fatal accidents involve SUVs and trucks. Until the 2009 amendment to FMVSS 216, most SUVs and trucks were exempt from federal roof standards. According to the Insurance Institute for Highway Safety’s Status Report the amendment will begin being phased-in in the year 2012, and all automobile manufacturers will be expected to comply with the amendment by the year 2017. This means that all passenger cars, trucks and SUVs up to 10,000 pounds will be subject to federal roof standards. These standards will apply to both the driver and the passenger side of the vehicle’s roof.

The National Highway Transportation Safety Commission reports that only 2 percent of accidents involve rollovers, but these accidents account for approximately 33 percent of all vehicle related fatalities. In Florida, approximately 25 percent of motor vehicle fatalities were the result of rollover crashes in 2007 according to the Traffic Safety Performance (Core Outcome) Measures provided by the NHTSA. In 2007, Georgia (31%), Alabama (40%), and California (29%) all had higher percentages of rollover fatalities than Florida, and New York (17%), Michigan (19%), and Mississippi (19%) had lower percentages of rollover fatalities than did Florida. The Insurance Institute for Highway Safety’s Status Report predicts that 135 lives will be saved each year by the amendment to FMVSS 216.

The changes that FMVSS 216 will require automobile manufacturers to make in the production of vehicles up to 10,000 pounds will mean that the roofs of cars, trucks, and SUVs will be even sturdier than they have been in the past. Not only will the driver side be able to withstand greater impact but the passenger side will be able to withstand greater impact as well. Proponents of the amendment to FMVSS 216 feel that this change has been long overdue and that by updating and improving the federal roof standards individuals will be more likely to survive a rollover crash.
 

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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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According to the FDA users of the psoriasis medication Raptiva (efalizumab), have a new issue to think about. Recently, the FDA issued a public health advisory regarding an increased risk factor for Raptiva patients to develop a rare brain infection, known as Progressive Multifocal Leukoencephalopathy (PML).  According to the FDA, PML is caused by a virus that affects the central nervous system. This brain infection occurs almost exclusively in patients on immunosuppressive medication. Symptoms include: unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. The FDA stated that possibly four known victims contracted this infection while on the medication Raptiva for over three years.  None of the victims were on immunosuppressive medication. Presently, there is no known effective cure or treatment for PML. 

Raptiva, marketed in the U.S. by San Francisco Pharma manufacturer, Genentech, is a once-weekly injection approved for adults with moderate to severe plaque psoriasis.  Approved by the FDA in 2003, the drug showed no cases of PML in clinical trials. Reports indicate that nearly 3,000 patients were treated with the drug during the clinical trials. The medication was administered to 218 people for one year or more, over 900 patients for six months and 2,400 patients for three months. Approximately 46,000 people worldwide have been treated with Raptiva, since 2003.

Late last year, the FDA, approved a Black Box warning label change of the drug Raptiva in October 2008. The new FDA Box warning stated that using Raptiva could increase the risk for infection. Genentech manufacturer of Raptiva, has been ordered by the FDA, to investigate the effects and likelihood of PML being contracted while taking Raptiva.

Since the FDA's recent advisory, Genentech has taken steps to notify users and medical professionals about the risks of taking Raptiva, by outlining specific risks on the website and sending warning letters to patients and health care providers. Unfortunately, all of this is a little too late for the victims that died, possibly due to using Raptiva for treatment of  psoriasis. According to reports, they were using Raptiva for at least three years.

The FDA has vowed to “take appropriate steps” to ensure that the treatment benefits of Raptiva outweigh the heightened potential risk of contracting PML. Further, the FDA is informing health care providers what to look for in PML cases. They have issued a warning to physicians that they may see more cases of PML. In addition, they  are directly informing Raptiva patients of the risks involved with using the psoriasis medication and describing the symptoms of PML. Hopefully, these proactive measures will help prevent more deaths. 

 

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Interesting turn of events today in the U.S. Supreme Court.  The Supreme Court issued a decision  regarding pre-emption in  the Wyeth v. Levine, product liability case. This was an overwhelming victory for Americans. The 6-3 decision explicitly upheld the ruling that FDA  approvals do not provide a defense to pharmaceutical manufacturer Wyeth in product liability tort claims, in the Wyeth v. Levine, No. 06-1249 (slip op., 03/04/09).

According to the 80 page decision that was delivered by Justice Stevens,

Directly injecting the drug Phenergan into a patient’vein creates a significant risk of catastrophic consequences-quences. A Vermont jury found that petitioner Wyeth, the manufacturer of the drug, had failed to provide an Adequate-quate warning of that risk and awarded damages to re-spondent Diana Levine to compensate her for the amputation of her arm. The warnings on Phenergan’s label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth’s new drug application in 1955 and when it later approved changes in the drug’s labeling .The question we must decide is whether the FDA’s approvals provide Wyeth with a complete defense to Levine’s tort claims. We conclude that they do not.

The majority decision, authored by Justice Stevens, unequivocally rejected the pharmaceutical defendant’s arguments that the FDA regulatory scheme preempted state law failure-to-warn claims and outlined the real world limitations of FDA powers. This decision will have implications in pharmaceutical product liability claims for decades to come. Also joining Justice Stevens were Supreme Kennedy, Sorter, Ginsberg, Beyer, and Thomas. It was not surprising that the three dissenters included, Chief Justice Roberts, Ali to and Scalar. 

It is important to note that this Br yer and Thomas clarified their vote by also writing an opinion in addition to Justice Stevens.  This solidified their strong belief in their sentiments that manufacturers can't hide behind the FDA approval and not be vigilant in issuing necessary warnings and safety precautions. The Supreme Court held: (1) the FDA’s regulatory scheme exists in harmony with state law failure-to-warn claims; (2) the controversial 2006 FDA preamble regarding preemption is entitled to no deference; and (3) it is the manufacturer, not the FDA, which has the duty to warn consumers about side effects. As the Supreme Court reasoned, “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.” (Slip op., at 23.)

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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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Denture creams such as Super Poligrip and Fixodent may be causing Zinc poisoning in patients. The daily intake of Zinc as part of a normal diet, is 8mg (women) and 11 mg (men), while the daily intake for denture cream users can be an alarming 300mg. According to the National Academy of Sciences, 40mg per day constitutes Zinc poisoning. Symptoms of Zinc poisoning are: weakness in extremities, impaired sense of position, tingling, numbness, burning in extremities, and a feeling of gloves or socks on the hands and feet even when they are bare. Diagnoses related to Zinc poisoning include: Paresthesias, Dysesthesias, Copper Deficiency, Anemia, Bone Marrow Failure, Nueropathy, and Toxic Encephalopathy.

Denture cream manufacturers have done a good keeping this information from the public, by not listing ingredients of denture cream products on the packaging. One can only wonder if the manufacturers hiding this information purposefully? The FDA classifies Denture cream as a “class I dental device” under the Food, Drug, and Cosmetic Act, which does not require the listing of ingredients. In their defense, GlaxoSmithKline issued the following statement, “When someone uses Super Poligrip for their dentures, the vast majority of the zinc in the product remains in the adhesive and is not released into the mouth. Thus the potential for absorption of zinc through the gums is minimal. Although it is expected that a small amount of Super Poligrip would be swallowed when used as directed, the amount of zinc that is released into the stomach and absorbed into the bloodstream is very small. Therefore, the possibility of experiencing adverse effects from exposure to zinc in Super Poligrip is highly unlikely when the product is used as directed.”

How can denture cream cause such adverse effects? Denture creams such as Poligrip and Fixodent contain Zinc as an odor blocker and bonding agent. Zinc from the denture cream can then be swallowed, or can be absorbed through the skin of the gums.

Although GlaxoSmithKline claims the product is safe, several cases have been made against the denture cream manufacturers since 2005. According to one FDA report at least one patient was diagnosed with toxic encephalopathy and peripheral neuropathy as a result of using Poligrip denture cream and the case was deemed as medically serious by GlaxoSmithKline.

With an estimated 35 million people using denture creams, doctors are beginning to wonder if the problem of Zinc poisoning is more widespread. If you are using denture cream and experiencing any of the symptoms of Zinc poisoning, contact your doctor immediately, your daily regimen may be dangerous to your health. 
 
Click here  to read more from the FDA on Denture Cream and Zinc poisoning.

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Interesting news today on the Pharma front. The FDA has issued orders that the "old faithful" painkiller Darvocet should be withdrawn off the market. This drug is somewhat of a household medicine cabinet staple, with over 20 million prescriptions in 2007 alone. A review panel narrowly approved this measure to withdraw this drug  with a vote of 14-12. It makes one wonder after 50 years why is this drug getting the attention of the FDA.  The Consumer Watch Dog Group, Public Citizen, may have something to do with this recent interest. Last year, in June 2008, the Public Citizen Group filed a lawsuit against the FDA over Darvon, Darvocet and all drugs containing propoxyphene , since it has been banned in the United Kingdom, since 2005.  The group brought this revelation to the FDA's attention as far back as 2006. What took the Agency so long to act?

We are delighted that someone in the FDA is finally paying attention to reports from non-biased organizations, such as the Florida Medical Examiners. There is data from the reporting system of the Florida Medical Examiners that show reports from 85 people out of 341 dying with the Darvon drug in their system. It is important to note that all 341 deaths were classified as drug related causes.

Fierce Pharma states that there were 1,452 deaths associated with propoxyphene from 1957 through September 2008.

Click here to read more from the FDA and the Wallstreet Journal on the Darvocet painkiller.

 

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According to a new study, women taking the epilepsy drug valproate while pregnant may significantly increase their child's risk of developing autism.  Valproate is a generic version of the brand drug, Depacon. Further, according to the FDA this drug has a laundry list of side effects. However, the most glaring one is that some patients taking the drug Valproate have experienced life-threatening liver failure. 

The author of the report published in Neurology, December 2, 2008, Professor Gus Baker, of the University of Liverpool, states that women using the drug valproate during pregnancy could lead to a "substantial" risk of children being diagnosed with the condition. Further, they should be aware of this risk and should discuss them with their doctor. 

Preliminary results from this on-going study have shown that of the 632 children being followed, nearly half of the mothers took epilepsy drugs during the pregnancy.  Seven of the children were exposed to valproate in the womb and five of the seven exposed to the drug, developed autism. It is important to note that the mother of one of the five children with autism took a combination of Valproate and Lamotrigine.

The children in the study had no family histories of autism and were tested at ages one, three and six. Most of the children were six years old when they were diagnosed.

Click here to read more from Science Daily on this Epilepsy drug's risk to pregnant women.

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The Supreme Court Case, Wyeth v. Levine  (06-1249), the Supreme Court Justices are sharply divided over whether FDA regulations of labeling can prevent consumers from suing. Wyeth and the FDA presented the case before the Supreme Court involving Diana Levine, an amputee, whose bodily injury resulted from the use of the drug, Phenergan.

The debate among Supreme Court Justices is in the matter of whether consumers have the right to sue drug companies when the FDA has approved a drug for use. The strength of the argument presented by Levine's lawyers is that Wyeth is attempting to use FDA labeling to deny her a Consumer’s right to hold a Pharma company liable.

This is not the first case of involving a Pharma company being sued for harmful and deadly side effects of their drugs. A few notable instances include, Glaxo for their drugs Paxil and Avandia, Purdue Pharma for Oxycontin, Merck & Co. for Vioxx. In some cases, deficient research led to serious risks that was overlooked. In others, misleading advertising that omitted possible risks was the basis of these lawsuits.

The issue of FDA labeling as insurance to preempt lawsuits by consumers is an important aspect of the Wyeth v. Levine case. The issue of preemption is supported by the current Bush Administration in its attempts to reduce lawsuits by consumers against drug companies. Pharmaceutical companies argue that stiffer regulations and standards inhibit their research of newer, more effective drugs.

In the Levine case, Wyeth's argument reduces the lawsuit to a simple case of medical malpractice. Surprisingly, the FDA stands with Wyeth in the argument. The Federal Agency that is supposed to be on the side of Consumers, feels that once the FDA approved the drug for use, extraordinary risks that may appear as a result of use at some later point should not be a consideration for lawsuits against drug companies that have received FDA approval and are labeled as such. This begs the question: Who should be liable and held accountable if the FDA and the pharmaceutical maker fails to catch something in trials or overlooks a deadly side effects, because of the rush to get a drug on the market?

Another valid point of the argument by Levine’s lawyers is that Wyeth did not advise physicians or consumers of the danger of using the "push" method of injection of Phenergan. It is safe to say, that maybe more people would have had second thoughts about using this drug, if they would have known about the additional dangers. Moreover, in another case, Pfizer's anti-nausea drug, Vistrol, caused gangrene when injected into the arteries and Wyeth should therefore have requested an FDA to change the label warning of this on their Phenergan label.

The State of Vermont awarded Levine $6.8 million. In preemption arguments, federal law supersedes state law. Justices Scalia, Alito and Roberts argued in favor of Wyeth while Bader-Ginsberg argued in favor of Levine.

It would be simple to view Wyeth's position as one of preemption vs. adequacy of disclosure. Ultimately, the Supreme Court must address the potential for future lawsuits of this nature. They must also address the issue of what happens if the drug company gives the FDA false or misleading information about a drug that later proves to be harmful to consumers. Consumer advocates everywhere are following this case closely. Let’s see if the Supreme Court can do the right thing and tell Wyeth and the FDA that they do not get a free pass in this case. They are responsible for the safety of drugs that are put on the market, even if the FDA gives the drug a stamp of approval.

Jacob Goldstein, Writer and Blogger for the WSJ Health Blog, shares a few insightful comments from Diana Levine in his blog post "Wyeth v. Levine: The Mother of All Preemption Cases". He also includes a nice candid photo of the woman who Wyeth is going after for fighting for her rights to hold them accountable for taking their migraine drug that caused her to have her arm amputated. All eyes are on the Supreme Court regarding the decision of this case.  Let's see if they can get it right and hold the Pharmaceutical companies liable for unreported risks and dangers associated with their drugs.
 

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If you or someone you know suffers from osteroporosis and takes bisphosphonate medications, Fosamax  (alendronate) or Zometa ( zoledronic acid), there is something you should know. Doctor Jennifer Miranda, reported findings from a study at a recent scientific conference, that shows  patients taking these medications have an increased risk of  68% for a condition called atrial fibrillation. More specifically these Atrial fibrillation cases can lead to hospitalization or death. Atrial fibrillation is a dangerous condition in which the heart's natural beat and rhythm are disrupted and can lead to severe cardiac malfunction and death. This study was the result of a meta-analysis of more than 16,000 subjects, with a mean age of 69 to 75 years most of whom were female.

Bisphosphonates are a type of drug which inhibit the resorption of bone. They are commonly used to treat osteoporosis and other bone defects because, by reducing the body's natural breakdown of bone, they can help slow the rate at which bones become weak and brittle.

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According to the research article, “Inhaled Anticholinergics and Risk of Major Adverse Cardiovascular Events in Patients With Chronic Obstructive Pulmonary Disease” written by Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg, MD, and published in the Journal of the American Medical Association, people using the Spiriva inhaler possibly face the following risks: cardiac death, heart attacks or strokes. Alarmingly, the risks are greater for the Spiriva inhaler users than inhaler users using a placebo or other drugs. This study published in the September 24, 2008 issue of JAMA denotes that although the risks were small, the popular inhalers could lead to potentially life threatening side effects.

The German Manufacturer, Boehringer Ingelheim Pharmaceuticals Inc. makes Spiriva Handihaler (tiotropium) and the  generic drug for Atrovent, Ipratropium, approved  for treating COPD.  In the United States, they have a joint marketing partnership with Pfizer Pharmaceuticals. In 2004, the inhaler was approved for a daily long-term treatment of bronchospasm, which is linked with COPD, chronic obstructive pulmonary disease.

It is important to note that both drugs have been used by approximately 8 million people worldwide. They are both known for helping to open passages and preventing spasms that decrease airways in the lungs to increase effective breathing.

The JAMA article details how authors, Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg, MD analyzed the data from 17 randomized studies, and compared it to primarily older people on either Spiriva or Ipratropium, to people using placebos or other drugs. Their research found that patients had an increased risk over 50% in developing both fatal and non fatal heart problems, including heart attacks when they used Ipratropium or Spiriva.

Researchers are quick to add that additional studies are required to further evaluate the safety of the drugs. However, they recommended individuals with COPD to take precautionary measure prior to starting drug therapy that includes stop smoking, control blood pressure and cholesterol and the use of oxygen.

There was a statement issued by Boehringer and Pfizer indicating that disagreed with the analysis of the new study. They cited an analysis of 30 clinical trials that confirmed the safety of the Spiriva Handihaler and that showed no increased risk of all-cause death or cardiovascular death to the inhaler users.

However, the Food and Drug Administration, FDA issued an early communication in March 2008, that indicated they are evaluating the potential connection between the side effects of the the Spiriva Handihaler and strokes. The March 2008 FDA communication was quick to point out that their investigation was precautionary and did not mean that Spiriva causes strokes. They encouraged people on the drugs to not stop taking their drug based on the FDA early communication, in March but to wait until they have confirmed conclusions and recommendations.

We can only hope that the FDA’s conclusions will not be too late for some individuals.

 

 

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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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There seems to be a dispute between two studies on risks involving Vytorin. In recent trials, data provided to the Food and Drug Administration on Thursday showed no increased risk of cancer.

However, a recently published study called Seas, disputes these findings and  found an increased risk of cancer and deaths from cancer in patients taking Vytorin, compared with those given a placebo.

According to a WSJ article, the new Seas study, released in July, has surprised investors and the medical community.

Click here to read more on this Vytorin Study dispute from the Wallstreet Journal. (Note: Subscription required)

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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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Preemption is a huge issue for the average American and I wonder if the public is paying attention. Last week as reported in the LaBovick Injury Law Blog, Congress had a hearing to discuss the issue of preemption. On all accounts, it appears to have been a success. One of the key speakers, Actor Dennis Quaid, discussed his experience with the drug Heparin, which almost killed his twin newborns. His testimony was so moving that even a total tort reformer, like Rep. Tom Davis, was moved to state that if "this had been my kids, I'd be suing everyone in sight. This should not happen."

The public does not seem to get the fact that this is a HUGE separation of powers issue. The right to sue is part of our JUDICIAL system. It is the way America, as a society, permits the common man to address problems he may have with other people including corporations and even our government. The Judicial system replaced the rule of Hammurabi, which was an eye for an eye. We also have a Legislative Branch, which makes the rules, and an Administrative Branch that applies the rules and keeps order (police, fire, army, road crews, etc). We can not allow the Administrative Branch to take away our right to access to the judicial branch. It messes up the balance of our government and our entire social makeup! Do you know how deeply this harms our system of government? I know it feels innocent and easy on the surface, however the implications of a dictatorship rule is scary!

Click here to read the testimony of key witnesses and Chairman Waxman's Opening Statement addressing the legal liability of manufacturers that produce dangerous drugs and medical devices before the Committee on Government Oversight and Reform.

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Medtronic, Inc. voluntarily recalled several Heparin products, According to the U.S. Food and Drug Administration (FDA). One can only wonder what took them so long to get this conviction. On April 8, 2008, the U.S. Food and Drug Administration's recommended that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action. The Medtronic recalled products include disposables used for heart surgeries and the cardiopulmonary bypass, including reservoirs, blood oxygenators, tubing packs, and pumps. It is unclear if exposure to Heparin Carmeda-coated medical devices could cause adverse events similar to those observed with injectable heparin formulations.

In a separate action, Medtronic is advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products. The ultimate goal is to remove all contaminated products from the market.

The Medtronic recall is a precautionary one. Let's all hope the company continues to take measures regarding their products that will help save lives and not threaten them.

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In a widely discussed article on Bloomberg.com, Judge Jack Weinstein, an outspoken U.S. District Judge  from New York, has stated that he does not want to allow patients and insurers who paid for Zyprexa for uses approved by the U.S. Food and Drug Administration, including schizophrenia and bipolar disorder, to sue as a group. Further he does not feel that the purchasers of the Zyprexa drug are entitled to  claim punitive damages. The case ``ought to be settled,'' said the judge to both Plaintiff and Defense lawyers. "I really think that we're not dealing with very much money.''

In a blog post on the Pharmaceutical Blog Pharmalot, the author mentions that a lawyer for Zyprexa purchasers, is pushing for Judge Weinstein to certify classes of individual Zyprexa users and third-party payers, such as insurers. He believes that Zyprexa maker, Eli Lilly exaggerated the effectiveness of the drug; failed to adequately warn about side effects including weight gain, diabetes and other illnesses; and promoted Zyprexa for off-label use, including for treating elderly dementia patients and children.

Drug manufacturer, Eli Lilly has paid over $1billion to settle over 30,000 claims brought by patients stating they were not given adequate warning about the side effects of Zyprexa.

Judge Weinstein is supposed to issue a ruling sometime soon.. Everyone is waiting to see if justice will be served for the purchasers.  Stay tuned...

Bloggers for the Drug and Device Law Blog have some interesting comments on the subject. It is nice to see a healthy discussion between bloggers and readers...

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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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ATV (All terrain Vehicles) are coming under fire for tougher safety and product liability laws from parents of a personal injury victim that died in  ATV related crash.

Ashley Phelps' life was cut short last year when the all-terrain vehicle she was a passenger on struck some mailboxes and rolled over. The driver, Gregory Hebert, then allegedly drove away, leaving the injured 21-year-old behind. Head injuries sustained as a result of the ATV crash caused Ashley's death.

According to the most recent CPSC Annual Report of ATV deaths and injuries for 2006, that was released in February 2008, there have been over 8100 deaths related to ATV crashes or ATV fatalities.  The state of Pennsylvania leads the nation in ATV fatalities with 420 total deaths from 1982 - 2006. The State California  comes in second with 418 ATV fatalities from the same period. In the state of Florida, there were 349 deaths as of result of ATV accidents.

Click here to read more from the AP and the Insurance Journal and Click here to read more from the Consumer Product Safety Commission on ATV Accidents, death and injuries.

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In what is the most anti-tort opinion from the Supreme Court ever to hit the shelves of the Library of Congress Justice Scalia delivered a terrible and scathing opinion creating bonafide Federal preemption to regular tort claims. Here is the low down on Riegel vs. Medtronic: The Supreme Court agrees that the Federal Government has created a pre-emption clause within Federal Statute 21 U.S.C. Section 360. This means that if the Food and Drug Administration (FDA) give "Pre-market Approval (PMA) to any medical device and that device is defective and hurts, kills, infects or otherwise harms human beings (read: United States Citizens), that the human beings have the right to go scream in a bucket, because they can’t do anything about it. The FDA said the device was OK and that is the final word. No joke. The FINAL WORD! Sure the FDA may, eventually pull the product after a few hundred deaths, sure the FDA may fine or otherwise slap with figurative company wrist. However, you, the injured, dead or otherwise harmed individual or family, just need to ... learn to live with it.

The court, in its first few paragraphs, related the story of the Dalkon Shield, an intrauterine device that harmed thousands of women. The court made a broad accusation that the Dalkon Shield created a barrage of tort lawsuits that proved the common law tort system (read: American System of Justice) is defective and unable to properly handle tort claims related to medical devices. The court gave no basis for this opinion, except for the fact that there were many tort claims filed because thousands of woman here harmed by the Dalkon Shield. For most of America the Dalkon Shield cases were proof, similar to Ford Pinto cases, that Corporate profit motives outweigh human safety all too often, even with Federal oversight.

Are medical devices so special that they get special handling or special rules compared to any other "device" produced today. If the court system cannot properly handle medical devices then why it is able to handle front-end loaders that have a "device defect" that kills people. Why can the court properly handle tire defect cases, roof crush, seat belt failures, or any other "non-medical" device that harms people? It is illogical. The only logical position is that medical devices interact with the human body in a more intimate and significant way so they need additional protection from lawsuits. I feel the exact opposite. The fact that a medical device is such an intimate thing leads me to believe that the law should garner the human participant in using the medical device MORE not LESS protection from device defects.

The language of 21. U.S.C. section 360 states as follows:
Except as provided in subsection (b) see below of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (emphasis added) -
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." Section 360k(a).
(The exception noted in subsection (b) allows the FDA some latitude in giving local and State government oversight in some limited instances, which were not covered by the court in the opinion.)

 

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Concerned Citizens, Health Care Personnel, the FDA wants your opinion on the new FDA Proposed Guidance for Dissemination of Information on Unapproved Uses of Medical Products. Public Comments will be accepted for 60 days. 

"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. "This guidance also safeguards against off-label promotion."

Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006.

Comments via the Internet:  go to Docket Number FDA-2008-D-0053 on the Regulations.gov Web site.

Comments via mail:
Submit comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

All comments should be identified with the docket number, FDA-2008-D-0053. For single copies of the draft guidance, call 301-827-3360 or contact: Office of Policy, Food and Drug Administration, 5600 Fishers Lane, Room 14-101, HF-11, Rockville, MD 20857.

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A recent report by the FDA links the multiple sclerosis drug natalizumab (Tysabri) to liver injury. It can occur as early as six days after the initial dose, per reports from the FDA.

The drug's marketers, Biogen Idec and Elan,issued a letter to clinicians,  stating a warning about liver toxicity has been added to the natalizumab label.

The new warning informs the user that signs of liver injury "including markedly elevated serum hepatic enzymes and elevated total bilirubin" not only occurred within six days of initial doses, but also had "been reported for the first time after multiple doses."

One can only wonder how someone can feel safe taking this drug after reading such a warning.  I applaud the manufacturer for at least including the warning on the label now, so that the consumer can be fully aware of risks and side effects of this drug.

Click here to read more from Medpage Today on this new warning for natalizumab or click here to read more on Tysabri.

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A West Palm Beach Jury awarded a couple $11 million in a Product Liability suit. The case involved the death of the couple's 25 year old son in a  2004 rollover crash. According to the Plaintiffs the death was caused by a defective seat belt and front passenger seat of a Mitsubishi Sport Vehicle involved in the fatal rollover.

The Counsel for the Plaintiff argued the seat belt was called an "energy absorbent" belt and was designed with an extra 10 inches of overlapping fabric, that could break and cause the belt to extend. 

The Counsel for the Defense argued the loop of material installed on the front passenger seat was designed to help protect the passenger from head and chest injuries. The Defense attorneys are appealing the $11 million jury verdict.

Thankfully the driver's belt did not have any extra material, therefore he suffered only minor injures.

According to the National Highway Traffic Safety Administration's 2007 report of rollover crashes and outcomes, there were 10,553 fatalities involving rollovers in 2004. Florida came in third in the nation with 627 fatal Rollovers in Florida. Texas came in second in the nation with 876 fatal rollovers in Texas. California led the nation with 1068 fatal rollovers in California. Ironically, Montana led the nation percentage wise with 67% fatal rollovers in Montana.

Click here to read more of this case from the Daily Business Review and Click here to read more from NHTSA on Rollovers

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Lawmakers reached a compromise on a Consumer Product Safety Senate bill. It is the first major overhaul of the nation's consumer product safety system in a generation.

The deal, was a bi-partisan effort, being led by Sens. Mark Pryor (D-Ark.), Daniel K. Inouye (D-Hawaii) and Ted Stevens (R-Alaska). There was a lot of behind the scenes maneuvering, but the congressional members managed to come to a compromise to address last year's product liability claims and recalls for  millions of Chinese-made toys, including iconic playthings such as Barbie and Thomas the Tank Engine. 

Click here to read more from the Washington Post on the Senate Consumer Product Safety bill.

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Toy Manufacturer RC2 Brands agreed in Cook County Circuit Court to pay $30 million to settle a nationwide class-action lawsuit representing hundreds of thousands of families who bought the Thomas & Friends toys -- setting a precedent for other suits filed against toy companies in last year's China manufacturers/lead paint scandal.

Under the settlement agreement, expected to receive final approval in May, class members can receive cash refunds or replacements of the toys based on the PBS children's TV show -- plus a "bonus" toy. Also, RC2 will institute new quality controls to prevent future infractions.

Click here to read more on the RC2 settlement for Thomas the Tank Engine   

 

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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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One of our favorite Bloggers, Blawgletter wrote a post about Tort Reform and the rights of trial by jury. Although his post is re: a securities fraud case against University of Phoenix, it also rings true that jury trials are important for personal injury cases. Without them, who would be held accountable? Ted Frank at Points of Law.com, chimed into the jury trial discussion by adding "trials remain a risky business for both plaintiffs and defendants", in a recent post. 

Pointsoflaw.com, provided an excellent summation of the Vioxx litigation in their  vioxx roundup yesterday. They cited several cases pending trials and gave updates on Merck. All eyes are on Merck. Let's see if their proposed vioxx settlement of $4.85 billion will make the jury trials go away. In a newswire release, Merck indicated that there are 50,000 Vioxx claimants. 

Only time will tell how this saga will end. Stay tuned...

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The Ohio Supreme Court gave their ruling yesterday in the  Arbino vs. Johnson & Johnson, Slip Opinion 2007 -Ohio 6948.  The ruling was 6-2  upholding a 2004 law approved by the legislature that caps jury awards for non-economic (pain and suffering, mental anguish, etc.) to $350,000 unless there is a loss of limb or organ. The court found the law to be constitutional and does not violate consumer rights, right to jury, or separation of powers.  The case before the court was brought by Melissa Arbino for a product-liability suit against  Johnson & Johnson for side effects from using the Ortho Evra Birth Control Patch. Surprisingly,  the patch is still on the market, but with warnings about the serious side effects.

John Michael Spinelli, gives a brilliant outline of both sides of the arguments, in his post on Daily Kos entitled "Ohio Supreme’ Ruling Good for Bad Bills, Bad for Good Juries". One point that he drives home in the post is that the ruling came from an all-Republican Supreme Court. One could gather from his clever intro "the best Republican Supreme Court money can buy" that he has strong feelings on this subject.

Chief Justice Moyer, writing for the majority opinion, states "The decision in this case affirms the General Assembly’s efforts over the last several decades to enact meaningful tort reforms. It also places Ohio firmly with the growing number of states that have found such reforms to be constitutional. However, the issue remains a contentious one across the nation, with several states finding such statutes unconstitutional."

Justice Paul Pfeifer, writing for the dissenting opinion states "Instead of jealously safeguarding the right to trial by jury, the majority opinion in this case eviscerates it by holding constitutional a statute that enables courts to ‘enter judgments in disregard of the jury’s verdict.’ Instead of jealously safeguarding the right to trial by jury, the majority opinion employs shallow reasoning and shoddy logic in concluding that juries can meaningfully determine only facts that do not conflict with predetermined assessments of the General Assembly. Instead of jealously safeguarding the right to trial by jury, the majority opinion "cleans the scalpel for the legislature to cut away unrestrainedly at the whole field of tort redress."

This case sends a resounding message to the legal community that the issue of tort reform will continue to be hotly debated.  The Ohio Supreme Court ruling will no doubt add fuel to the tort reform discussion.  Those in favor of tort reform, just received a check mark in their column with this decision.  One can only hope that this does not give corporations a false sense of security in future product liability cases.

Johnson & Johnson stock is trading at $67.43, yesterday, the day of the Ohio Supreme Court ruling,  it closed at $67.33.

To read more on this story, check out the following articles: Daily KOS, The Toledo Blade, Ohio State Supreme Court Slip Opinion No2007 -Ohio 6948

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I came across an interesting blog by the name of Tort Deform that discusses the public's access to the courts. Hats off to the Executive Editor, Kia Franklin, and team for putting together a great blog. I enjoy reading this blog, topics are always current, timely and thought provoking.  Keep up the good work....

We recently received a comment from a Tort Deform contributor, in response to our blog post "Shedding Light on Attorney Contingency Fees. Executive Editor, Kia Franklin, raises some interesting points in her Tort Deform blog post, "Civil Justice to Fee or Not to Fee".

I really appreciate that there are people in the world, other than Plaintiff attorneys, who understand what we do and the function we serve. The world has a balance to it.

This reminds me of a movie I recently saw,  The Bee Movie. In the movie Jerry Seinfeld portrays a Honey Bee who figures out that humans are using Bees to make honey for human use and that the humans are not paying the Honey Bees anything for their labor or the product (honey). With that knowledge he befriends a human woman and they sue the honey industry.

The remainder of the movie was a mélange of lawyer jokes and silliness. In the end, the Seinfeld character wins his lawsuit against the honey industry and all bees around the world are free to stop working. That, of course, sends the world into a tailspin. Without bees we have no pollination, and without pollination we have no flowers. In the movie they only dealt with flowers, but the truth would be that without bees the world would significantly change. Millions of plant and animal (probably humans as well) species would disappear in the process. One of the movie's lessons is that, within a system, if you take out a step you may change or destroy the entire process because the balance is no longer in check.

Our government system is similar. We have a unique and wonderful system of checks and balances. Our founding fathers developed, through sheer brilliance, a fantastic system. The system works between the executive, judicial and legislative branches. It also works between private and public services as well as between corporate and individual rights. One major component to that system is that individuals and corporations are held accountable for the damages they cause to the social compact. Part of that social compact is that no party or person is permitted to use "self help" to right a wrong. We are not permitted to shoot our neighbor if they put a fence up on part of your property. Instead of self-help we have a finely developed court system. People trust and believe in the general fairness of our entire system. Their belief and trust in that fairness is what keeps society generally peaceful. Most people will sue each other to correct the behavior or damages one party does to the other. Most people will not take JUSTICE into their own hands and use a gun or a knife to right their own wrong.

If we take away the people's right to sue to right their wrongs then we have seriously changed our system of justice. We have taken out a critical piece in the checks and balances system of our society. The people cannot be forced to live with government oversight as their sole method of solace because when something goes wrong they need to feel empowered to do something to "fix" the situation. In our system, we need to have a method of taking action, of taking self-responsibility, to help oneself. That system calls for lawsuits and not guns. If government takes on that responsibility and doesn't do a good job (which is inevitable) then over time the public will feels greater discontent with government. This discontent, historically, has led to revolution.

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Bexis ( co-author of drug and device law blog)

I am sorry this response took so long. (Click here to see response from Bexis).  My life just does not have enough fun things like responding to your great blog post. 

First things first: For those of you not following my intellectually astute commenter, Shay’s Rebellion was the post-revolutionary (1787 or so) clash between the farmer and merchants in the New England states.  It was the first test of our new Democratic Republic and the system passed muster with high marks.  The point of this was to note, that we cannot rely on the government to save us from corporate profiteering at human expense.  I only wish I were such an extremist.  Extremists get loads of press and people are naturally drawn to them.  But, let's put the whole anarchist thing to bed.  Nothing could be further from the truth.   I love our system of Government.  I think government serves a legitimate purpose.  I am just a natural Republican.  When possible, I believe government should be smaller rather then bigger.  I would prefer to see government not intervene when not necessary.  This is especially true of the federal government.  In a contest between the federal government and the state government on who should be passing legislation, I would prefer to leave most things in the hands of the states.  I am, however, (tell Mark Hermann I used however properly again) not an extremist.  I realize the federal government has a legitimate role and a great responsibility to protect the national public from dangerous products.  This is a typical Republican position.  It is not the anarchist position.

What I do NOT believe is that the FDA has the ability to insure that the public is safe from dangerous drugs.  I do not believe that by passing the lowest threshold of government oversight that any company should be released of their responsibility to the end user of their products.  I do not believe that the government can be trusted or expected to guarantee product safety.  This holds true for our prescription drugs, our food supply and our water.  Government is the first line of defense.  It is not the exclusive remedy when a corporation harms its customer(s).

You say that 90% of products are not sued because of a defect.  I don't believe this, but let's pretend it's true.  What about the 10% of defects that you admit cause death, dismemberment or other injuries?  What about those people?  Why should they be prohibited from suing the business that harmed them because the dangerous product was Ok’d by some minimum wage government inspector?  Why, as a taxpayer, do I have to bear the burden of the injured person's medical bills because the business that caused the injury is off the proverbial hook?  Why should I, as a taxpayer, have to bear the burden of the injured person’s unemployment compensation when they can't return to work because of this injury?  Do you think the injured person is going to feel like the American Justice System did the right thing when they are told that there is no case because the FDA or some other government agency simply failed to catch a dangerous defect?  Is it fair that the injured person will have no legal remedy against the offending company?  Of course, all of the above is patently unfair and anti-American.  We are not Russia.  We hold people and businesses accountable for the harm they do, to individuals and to society.  To create an exception for drug companies or any other business is simply wrong.

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Merck has agreed to pay a fixed amount of $4.85 billion into a settlement fund for qualifying Vioxx claims that enter into the resolution process. This is not a class-action settlement. Claims will be evaluated on an individual basis. According to Richard T. Clark, chairman, president and chief executive officer of Merck, "This is a good and responsible agreement that will allow the Company to concentrate even more fully on its mission of discovering, developing and delivering novel medicines and vaccines."

The conditions in the agreement, is open only to those cases filed or tolled on or before 
November  8, 2007.

Click here to read full release from Merck re: Vioxx settlement.

Click here to read Merck Final Vioxx Agreement Signed for outstanding product liability claims.

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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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Dana Corp announced a settlement of 7,500 Personal Injury Claims involving asbestos-laden gaskets produced by the auto-parts supplier. They want to pay a maximum of $ 2 Million to settle all claims, providing the claimants submit the required proof to support their claims. This will help the company settle approximately 7 percent of the mesothelioma claims and 4 percent of the cancer claims filed against the Ohio based Auto parts supplier.

Dana has said asbestos-related personal-injury claims, which totaled 150,000 as of June 30, will pass through its bankruptcy unchanged.

It is important to note that the necessary supporting documentation is important for the claimants to receive any funds from the $2 Million proposed settlement. If they have any questions or concerns about the settlement or an asbestos related illness, they should contact an Asbestos Attorney or a Mesothelioma Attorney to discuss the case in greater detail.

Click here to read more on the Dana Corp Asbestos settlement from Associated Press

 

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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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Merck  continues to fight against Vioxx Plaintiffs. This week the much anticipated VIOXX® product liability trial started in the Circuit Court of Hillsborough County, Florida. Merck plans to use evidence to show that VIOXX did not cause the heart attack of Refik Kozic.

In Kozic v. Merck & Co., Inc., Mr. Kozic claims that he used VIOXX for approximately nine weeks before suffering his heart attack in April 2001 at age 50.

Merck will handle this case and go on to their additional 27,000 Vioxx cases.  Their legal strategy take each and every case to trial.  Experts though three years ago it would cost Merck approximately $30 billion. However, to this date they have not paid anyone claiming they had a heart attack due to taking Vioxx.  The only thing that Merck has been paying over the years are legal bills to defend themselves against all the individual Vioxx claims. According to Ken Frazier, the company's lead counsel early on, Merck vowed to fight the cases one at a time, in an article on Cnn.com.  I agree  with Bryan Liang, Professor of health law studies at the California Western School of Law in San Diego, that it was "brilliant strategy to tell the world, they were going to fight every case." It definitely, places Merck in the stronger position.

Now on the other side of the argument, Byron G. Stier,  Associate Professor of Law
Southwestern Law School, and a leading Editor for the Mass Tort Litigation Blog, disagrees with Professor Liang's assessment of the Merck strategy. He candidly weighs in giving two strong arguments.  Professor Stier said: First, "the strategy of holding off settlement is only working for Merck because Merck is winning the individual cases."  Second, "the strategy of holding off settlement is only working for Merck because Merck is winning the individual cases."  Both professors make valid arguments, however, they lead to additional questions:  "Why is Merck so successful with their Vioxx cases?  What makes this drug bullet proof in the courtroom on appeal?  Is Ken Frazier and his legal team, that much better than all of the brilliant trial lawyers they are going up against in Court?

Time will tell if Merck and Vioxx will continue on lucky streak in these trials or if their luck runs out

Click here to read more on Vioxx litigation updates from Merck or Vioxx article from Cnn.com 

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In a recent Press Release from The American Association for Justice, the organization praises a report by the nonprofit Center for Progressive Reform. The report  "The Truth About Torts: Using Agency Preemption to Undercut Consumer Heath and Safety" suggests that the Administration has forced federal agencies to claim their regulations preempt state laws, despite lacking any constitutional authority. These actions contradict Congressional intent and, frequently the agencies’ own policies. According to the new report,  state laws are preempted through regulatory rulemaking authority. The preemption provisions are often slipped in at the last minute without any chance for public comment. 

Among the preemption measures:

• The National Highway and Traffic Safety Administration (NHTSA) declared its rules on seat-belts and roof-crush resistance would preempt state common-law claims, despite previously rejecting the concept.
  
• The Food and Drug Administration (FDA) declared a rule on drug labeling preempted state tort law despite the fact that the agency had long held the opposite view.
  
• The Department of Homeland Security (DHS) also adopted preemption provisions, despite the fact that the Senate Homeland Security and Governmental Affairs Committee had expressly rejected such an approach just a year earlier.
  
• The Consumer Product Safety Commission (CPSC) and Federal Railroad Administration (FRA) have been criticized for trying to preempt state law.

Click here to read the report: "The Truth about Torts: Using Agency Preemption to Undercut Consumer Health and Safety".

Key figures testifying at the Senate Judiciary Committee hearing this week on “Regulatory Preemption" were Georgetown Professor David Vladeck, attorney Collyn Peddie and Donna Stone, state representative from Delaware and the current President of the National Conference of State Legislatures.

Testimony from State Representative Donna Stone

Testimony from Professor David Vladeck

Testimony from Attorney Collyn Peddie

Click here to read more from the AAJ on the Judiciary Committee Hearing.

Agencies such as the Consumer Product Safety Commission (CPSC), Food and Drug Administration (FDA), and The National Highway and Traffic Safety Administration (NHTSA) set out to protect the health and safety of Consumers. Let's hope that the Judiciary Committee meetings help to prove this point loud and clear so that we can all work together towards the fight for consumer justice.

 

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Ford Motors announced Friday that it was voluntarily recalling 3.6 Million vehicles due to safety concerns with the cruise control switch. According to the Associated Press, the cruise control, was reportedly linked to fires. Owners will receive notices on August 13, and are encouraged to bring in their vehicles and have the cruise control deactivated until the parts arrive, which should be in October for a few vehicles. 

The Ford models affected by the recall are: Bronco 1993, Crown Victoria 1992-1997, Explorer 1999-2001, Explorer Sport 2001-2002, Explorer Trac 2001-2002, E150-350 Vans 1992-1993, E 150-350 Vans 1997-2002, F series pickups 1993, F-150 Lightening 2003-2004, F53 motor homes 1995-2002, Ranger 1998-2002, Taurus SHO 1993-1995, Lincoln Mark VIII 1993-1998, Town Car 1992-1997, Mercury Capri 1994, Grand Marquis 1992-1997, Mountaineer 1999-2001.

Owners with questions can call Ford at 888-222-2751.

Click here to check your Ford vehicle status.  Click here to read more from Associated Press.

Click here for the National Highway Traffic Safety Administration (NHTSA).

This Personal Injury blog is brought to you as a service of LaBovick & LaBovick, Civil Justice Prosecutors, A Plaintiff's Private Law Firm.

 

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Toy-maker Fisher-Price and parent company Mattel is recalling 83 types of children's toys including the popular Big Bird, Elmo, Dora and Diego characters, citing paint containing excessive amounts of lead.    

The Fisher-Price recall involves plastic preschool toys made by a Chinese vendor and sold in the United States between May and August. The problem was detected by Fisher-Price after an internal probe. Afterwards, the company  reported it  to the Consumer Product Safety Commission.

Owners of recalled products can exchange it for a voucher of the same value. Mattel has an excellent site that gives information on all the recalled products. The site is: www.servicemattel.com. There is also a Toll Free number for the Mattel Recall Hotline:  800-916-4498. For a list of recalled toys: Click Here.

If all corporations were this responsible with handling product liability and safety measures, we would more good corporate citizens. Companies that put  Consumer Safety first before profits. Kudo's to you Mattel, for doing what is right and recalling your faulty product. I applaud your efforts and commitment to your customers.

Click Here to read more from Associated Press and Bloomberg on the Mattel Fisher Price Recall.

 

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According to recent reports from Bloomberg News, Medtronic Inc.,maker of electronic heart devices, has agreed to pay more than $75 million to settle 2000 lawsuits claiming it hid defects in its defibrillators. Surprisingly enough, the shareholders did not perceive of this as bad news, because the stock only dropped .13 per share. I am sure that management in the company is not happy, because this affects their bonuses and stock portfolio, but it could have been a lot worse. They only lost money, but think of the lives that have been harmed because of the defect.

Another major rival of Medtronic, Boston Scientific Corp., Guidant's parent, agreed last week to pay $195 million to satisfy about 4,000 claims that its defibrillators were defective. According to a published report in the Palm Beach Post, Guidant set aside $732 million to cover the costs of settlements and litigation, if the trial would have continued that was scheduled for July 30th.  Last year, the company made about $7.21 billion in net sales for 2006, this is not bad at all.

If you have a case involving product liabilty or a defective product that caused a personal injury, contact the Civil Justice Prosecutors of LaBovick & LaBovick. They have Personal Injury Attorneys in West Palm Beach, Boynton Beach, Jupiter and Port St. Lucie and help victims throughout the state of Florida. 

The Private Law Firm, LaBovick & LaBovick, Civil Justice Prosecutors, is a Plaintiff’s firm. The firm focuses on fighting for personal injury victim’s rights in Florida and on qui tam (whistleblower claims) nationwide.  Visit our firm website at www.LaBovick.com for more injury information

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Home Depot along with five other companies are facing litigation for the grout product Stand 'N Seal that was exclusively sold at Home Depot. Over 160 people across the country  have brought 31 product liability suits against The Home Depot and five companies tied to the manufacture and distribution of Stand 'N Seal, claiming that using the product permanently damaged their health. The lawsuit claims are ranging from loss of lung, respiratory breathing problems to death.

The interesting part of this litigation is that Home Depot was notified about the defective product, however, did not remove all of the product from its shelves, until 19 months after the Consumer Products Safety Commission issued a recall on 300,000 cans of cans of Stand 'N Seal. The litigation has a lot of finger pointing of who is to blame.  Is the retailer, Home Depot responsible, since it sold the product to the consumer? Is the manufacturer, tile perfect, a division of the Roanoke Companies, a leading manufacturer and private label company? Is it the company SLR, Inc that produced the product for Tile Perfect? Is it the Georgia-based Innovative Chemical Technologies or the South Carolina based company, Ortec Inc. that is responsible because they allegedly were involved with the formulation of Flexipel?  Time will tell, which of these five companies will ultimately bear the blame of the unfortunate injuries to the consumers of the Stand N Seal grout product. 

Click Here to read more about this story from Law.com and the Fulton County Daily Report.

The Law Firm, LaBovick & LaBovick, Civil Justice Prosecutors, is a Plaintiff’s firm. LaBovick & LaBovick focuses on fighting for personal injury victim’s rights in Florida and on qui tam (whistleblower claims) nationwide.  The firm handles all serious injuries, car accidents, boating  accidents, wrongful death, slip & fall, toxic torts and product liability cases. The firm has office locations in Boynton Beach, West Palm Beach, Jupiter and Port St. Lucie, Florida. Visit the firm website at www.labovick.com more injury information.

 

 

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Superior Court Judge, Bryan Garruto, made a significant ruling when he agreed that federal law does not prevent state lawsuits against drugmakers over sufficient warning on a product's risks. The drugmakers were trying to hide behind the U.S. Food, Drug and Cosmetic Act.

Since 2006, drugmakers have been trying to convince the courts that product liability suits are pre-empted, or barred, because federal law gives the Food and Drug Administration the exclusive right to determine whether a drug's label, or detailed package insert, contains adequate warnings about any health risks. 

According to one plaintiff lawyer, "A drug being approved by the FDA does not protect the drug companies from being sued,''  "The FDA regulations are a floor, not a ceiling,'' and drug companies can strengthen warnings or add new ones.

The patient, Deutsch, took Prempro (made by Wyeth) from 1996 through 2002 and also took an older Wyeth drug before that, alleges the drugs caused breast cancer. The New Jersey plaintiff is in treatment for the cancer, which has spread to her bones. 

Wyeth has several thousands of suits pending nationwide, involving Prempro. All eyes will be on the Deutsch trial beginning July 9th.  The outcome will be interesting.  Stay tuned...

Click Here to read more about the case in an Associated Press aricle and from the New Jersey Courts online.

The Law Firm, LaBovick & LaBovick, PA., Civil Justice Prosecutors, is a Plaintiff’s firm. The firm focuses on fighting for Plaintiff’s personal injury victim’s rights in Florida and on qui tam (whistleblower claims) nationwide.  We handle all serious injuries, car accidents, maritime accidents, wrongful death, slip & fall, toxic torts and product liability cases. We have locations in Boynton Beach, West Palm Beach, Jupiter and Port St. Lucie, Florida. Visit our firm website at www.labovick.com more injury information.

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