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Archive for the ‘Product Liability’ Category

Hopkins

Jeep Grand Cherokee — Evaluating the Value of Life

Published by John Hopkins in Corporate Fraud, Defective Design, Motor Vehicle Catastrophic Accidents, Product Liability

Are 1993 – 2004 model years of Jeep Grand Cherokees killing people?

Is Chrysler’s handling of the potential problem with the Jeep Grand Cherokee eerily reminiscent of Ford’s Pinto?

Did Chrysler also consult the “bean counters” to determine what a recall would cost them as that relates to the total cost of deaths from their product?

Was it cheaper to risk lives than institute a recall?

The National Highway Traffic Safety Administration has instituted an investigation to determine whether the design and positioning of the Grand Cherokee’s fuel tank may be causing unnecessary fires and resulting in deaths by drivers of the 1993 – 2004 Jeep Cherokee.

The Grand Cherokee was on the Car and Driver list of the Ten Best models in 1993 and was Motor Trend’s Truck of the Year for 1993. It also was Peterson’s 4×4 in years 1993, 1996, 1999, and 2001.

In October of 2009, though, the Center for Auto Safety filed a petition with the National Highway Traffic Safety Administration, including a detailed analysis of the design and placement of the gas tank in 1993 – 2004 model Grand Cherokees.

The petition included the following grisly statistics:

  • 172 fatal fire crashes involving the Grand Cherokee
  • 254 fatalities

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Diedwardo

Dietary Supplements — Litigating Unregulated “Drugs”

Published by Alyssa Diedwardo in Defective Design, Product Liability

I am asked quite frequently to evaluate supplements cases and thought I would share some information that I have found to be helpful and provide some things to consider.

The following supplements can be very dangerous and I recommend they be avoided. Supplements, which combine these and other ingredients into multi-ingredient supplements, are even worse.

  • Aconite
  • Bitter Orange
  • Chaparral
  • Collodial Silver
  • Coltsfoot
  • Comfrey
  • Country Mallow
  • Germanium
  • Greater Celandine
  • Kava
  • Lobelia
  • Yohmbe

From a litigation perspective, the insurance companies for manufacturers of these compounds are likely to have meticulously excluded cases involving the supplements contained on this list from coverage. Pursuing shell companies without insurance coverage does not, in any way, benefit a client injured by these products.

Being successful in these cases requires very diligent work and insight into these very specialized products is needed. The research is very time consuming when done by even the most knowledgeable people.

The FDA warning to manufacturers relating to misbranding is much like pursuing Al Capone for tax evasion in order to put him in prison for much worse things. A misbranding announcement is the “siren call” for much bigger problems in most cases.

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Hopkins

Rhino ATV…UTV…By Any Name, it is Unsafe

Published by John Hopkins in Defective Design, Mass Torts, Product Liability

What do you get when you combine a narrow wheel base, a narrow turning radius, a high center of gravity, and a powerful engine? Add to this combination a vehicle that was marketed to be operated on rough, uneven terrain.

You get vehicle rollovers and severe injuries. Not too terribly difficult to predict, right?

A Yamaha Rhino.

System Engineering and Laboratories tested the Rhino on a “completely flat area” at approximately 13 mph, with devastating results:

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The “back story” on vehicles such as the Yamaha Rhino starts with their designation: “UTV” or utility terrain vehicle, as opposed to an “all” terrain vehicle. At the time the Consumer Products Safety Commission had no regulations for this new “utility terrain vehicle”. These vehicles were the first vehicles with side-by-side seating for occupants and designed for off road use. The Rhino design included a high center of gravity and an engine, which propelled occupants at up to 40 mph.

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Brenda Fulmer

Do Medications Sometimes Do More Harm Than Good?

Published by Brenda Fulmer in Mass Torts, Medical Malpractice, Miscellaneous, Product Liability

Every day on TV, we are bombarded with advertisements urging us to purchase numerous prescription and over-the-counter drugs that will cure everything that ails us (and even cure diseases and conditions unknown or non-existent prior to drug company marketing efforts).

Do these medications really work?

Do they cause more harm than good to our well-being?

Do the risks outweigh the benefits?

Are there some bothersome conditions that should be tolerated and accepted rather than treated with medications?

The number of medication-related injuries and deaths in the U.S. are estimated at over 1.5 million per year, making medications one of the leading causes of death according to a 2006 report from the Institute of Medicine of the National Academies.

Dr. Leo Galland, M.D., a practicing physician and noted medical author, says that not all medications are created equal and that many have serious side effects that the manufacturers failed to adequately disclose to the FDA prior to approving them for marketing.

Dr. Galland believes that a number of common medications can be hazardous to your health.  For example, nonsteroidal anti-inflammatory drugs (NSAIDs), which include over-the-counter drugs such as aspirin, ibuprofen, and naproxen (also known as Aleve), cause a number of serious injuries and deaths each year.  Dr. Galland’s studies have found that these drugs relieve pain and inflammation by blocking an enzyme called cyclo-oxygenase (COX), but at what cost?

“Although COX activity contributes to pain and inflammation, this enzyme also performs important functions such as protecting the stomach from the corrosive effects of its own acid, regulating circulation of blood to the kidneys, and modulating the activity of the immune system,” says Dr. Galland. “Almost all drugs today are intended to act like biochemical strait jackets which suppress cellular functions that appear to be overactive,” adds Dr. Galland. “They also interfere with the natural and healthy functions of the body. It is like throwing a wrench into a sophisticated machine in an effort to fix it.”

The net result of disturbing this delicate balance in the COX enzymes is that a number of patients suffer life-threatening gastrointestinal bleeding and ulcers as well as renal failure and other significant health problems as a result of ingesting these popular drugs.

The manufacturers of Vioxx sought to build a better mousetrap – a pain killer that was as effective as other popular NSAIDs without blocking Cox-1 enzymes and thereby causing bleeding issues.  In doing so, however, Vioxx caused other disturbances to the COX system that rather than causing ulcers, instead caused pro-thrombotic events that led to heart attacks and strokes.  “What scientists behind the creation of Vioxx failed to recognize is that all forms of the COX enzyme are important for health,” says Dr. Galland.

Many physicians are now recommending proper nutrition, which when used properly, can achieve results that drugs cannot, because nutrients are essential components of the cellular information network in our bodies.

“The regular use of Omega-3 fatty acids in the diet is an excellent example of how the cells of our body use the Omega-3’s to make powerful chemicals that help to maintain normal cell function under conditions of stress,” advises Dr. Galland.

Omega-3 fats provide an alternative to drug therapy for controlling inflammation in the body, a natural process that, when excessive, can lead to cancer and disease.

Patients who change their diets and decrease their consumption of foods that interfere with the anti-inflammatory effects of Omega-3 fats experience less inflammation and therefore have fewer needs for anti-inflammatory drugs.  These dietary changes include reduced intake of red meats and foods that contain certain oils (including corn, sunflower, soybean, safflower or cottonseed oil).  Dr. Galland recommends using olive oil or flax oil as a substitute.

“Making nutrition a cornerstone of everyone’s healthcare has been my longstanding goal and is the first step in real healthcare reform,” adds Dr. Galland. “Moving from a system based on treating symptoms to a system for achieving optimal health will enable healthcare to achieve its true potential.”

One can only hope that our healthcare system takes these maxims to heart, pardon the pun, and seeks to encourage an increase in the healthy foods placed in our grocery cart each week and a decrease in the number of pill bottles placed in our medicine cabinet.

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Deborah Knapp

Kellogg’s Cereal Recalls: Consumers Be Aware

Published by Deborah Knapp in Mass Torts, Product Liability

A substance that most of us cannot pronounce, has caused Kellogg’s to recall more than 28 million boxes of its popular cereals such as Froot Loops, Apple Jacks, Corn Pops, and Honey Smacks. The recall came from consumers complaining of a funny smell, nausea and diarrhea, and a wax-like taste from cereal boxes. Kellogg representatives have found that the compound, methylnaphthalene, has been the subject of major, on-going government and oil industry testing.

“We have identified a substance in the package liners that can produce an uncharacteristic waxy-like taste and smell,” said Kellogg’s spokeswomen J. Adaire Putnam. “Consumers report a variety of tastes and smells, including those that are stale, metal, and soap-like.”

David Mackay, president and chief executive officer for Kellogg’s says that, “efforts have been made to have the products removed from store shelves and we are working diligently to ensure that the affected products are rapidly removed from the marketplace.”

Kellogg chemists have determined that the “off-taste and smell” was caused by methylnaphthalene, which had leached into the cereal from the package liner. Kellogg’s said that the compound is classified by the FDA as “generally recognized as safe,” but was unable to locate it on the FDA’s website.

Methylnaphthalene, which has two forms, is a component of crude oil and coal tar and may also be formed as a pyrolytic byproduct from the combustion of tobacco, wood, petroleum-based fuels and coal. According to the EPA, the petroleum-based compound is produced in enormous quantities in the United States and health agencies know very little about its safety.

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Diedwardo

Consumer Reports: Common Supplements Are Dangerous

Published by Alyssa Diedwardo in Defective Design, Mass Torts, Product Liability

Consumer Reports recently reported that some supplements we take on a regular basis may actually be more harm than good. Consumers may not realize that manufacturers of supplements do not have to demonstrate that they are safe and effective before they sell their products to consumers.

Experts at the Institute of Medicine said this year that, “The FDA needs to use the same strict standards to regulate supplements as it uses for drugs, and should ask Congress for more power to regulate supplements.”

The FDA has repeatedly found hazardous ingredients, including synthetic prescription drugs, in supplements, and some natural ingredients can also be hazardous. There have also been claims that supplement sellers tell consumers that they can cure their sickness or replace their costly prescription medications with their supplements.

According to Nutrition Business Journal, in 2009, Americans spent more than $26.7 billion on supplements and the trend only seems to be growing. You can find a supplement pretty much anywhere that claims to cure any aliment or symptom; from a cold, to weight loss, an edge in sports, or just to stay healthy.

Consumer Reports states that, “We have identified a dozen supplement ingredients that we think consumers should avoid because of health risks, including cardiovascular, liver, and kidney problems. We also found products with these ingredients readily available in stores and online.” The report found that a group of ingredients were linked to serious adverse events by clinical research and case reports. The report also factored in whether the ingredients were effective for their claimed uses and how readily available they were to consumers.

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Brenda Fulmer

Yamaha Not Expected to Rollover Like Their Rhino

Published by Brenda Fulmer in Defective Design, Mass Torts, Product Liability

Utility vehicles are used in many rural and suburban areas for transportation and recreation, with families trusting manufacturers to keep their loved ones safe while riding on these devices. However, there are currently several hundred individual lawsuits pending against manufacturer Yamaha for their Rhino ATV product that is the “poster child” for instability and rollovers under normal usage; resulting in serious crush injuries.

Rhino Utility Terrain Vehicle

These several hundred cases filed against Yamaha, relating to injuries suffered as a result of the Rhino’s instability. These cases are currently pending in federal court in Kentucky, as well as in state courts in California and Georgia. Cases filed in federal court have now been transferred to a multidistrict litigation (MDL) system which is designed to deal with large numbers of individual lawsuits regarding a specific defective product or disaster.

Currently, work is being done to prepare a number of cases for trials later this year.  These cases are known as “bellwether cases” and the trials will be conducted by the MDL judge in Kentucky as a way of resolving issues common to all cases currently filed, as well as streamlining the work that will need to be done by other federal judges to whom individual lawsuits will be referred for trial settings once the MDL’s work is complete. Judge Jennifer B. Coffman is in charge of the MDL and has scheduled a number of trials this year and next, so it is doubtful that the other cases pending in the MDL will be ripe for remands to local federal courts for quite some time.

Yamaha and its retailers are currently defending themselves in these cases with the argument that the vehicles have been misused and that drivers and passengers have ignored warnings and failed to exercise common sense while driving. We have previously written about the Rhino and why the claims of the manufacturer that consumers “misused” the vehicle are simply “smoke and mirrors” and a typical way for product manufacturers to try and delay resolving righteous claims.

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A verdict was recently rendered by a jury in Gwinnett County, Georgia in the amount of $317,000 in favor of a plaintiff who suffered a serious leg injury after his Yamaha Rhino flipped over.  A previous case in another state court was lost by the injured plaintiff.  Additional cases are scheduled to be tried later this year in various state courts where the parties were able to obtain jurisdiction over the manufacturer.

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Hopkins

Updating the Tragedy — BP Deepwater Horizon Gulf OIl Disaster

Published by John Hopkins in Environmental Disasters, Mass Torts, Product Liability, Toxic Torts

Hearings have been occurring in connection with the investigation of the Deepwater Horizon explosion and the Gulf Oil Disaster. Hearings have been held in New Orleans jointly by the Coast Guard and the Bureau of Ocean Energy Management.

Many of the revelations coming out of the testimony at the hearings are interesting, but witnesses who have refused to appear or those who have been reticent to testify on certain matters are also of note.

A BP lawyer testified that the Deepwater Horizon had 390 “past due” maintenance items that should have been corrected and, which were found during a September 2009 audit of the rig. The lawyer testified that the corrections would have required 3,545 man hours to complete. All this data was set forth in a 30 page report submitted to the rig owner, Transocean, long before the tragic explosion on April 20, 2010.

Also testifying was Stephen Bertone, the chief engineer of the Deepwater Horizon rig. He testified that (8) months before the explosion the rig’s propeller that assisted in maneuvering the rig had been “having problems”. Bertone could not recall how many of the 390 deficiencies on the oil rig had been corrected before the explosion and subsequent oil spill.

Bertone also testified that he did not recall whether the general alarm had been bypassed, but did not recall hearing it go off. Bertone said he did not know whether the system for purging gas from the drill shack had been bypassed. This system was the one that kept gas from accumulating and what ultimately ended up igniting the massive explosion that did occur.

Stephen Bertone does recall that hours before the deadly blowout at BP’s Macondo well, a larger than normal number of crew members was gathered in the drilling control room on board the Deepwater Horizon.

“At that point I knew there was something going on, but I didn’t know what it was,” Bertone said.

The visit to the rig’s drill shack, where it was “standing room only,” took place about 5:30 pm, he said.

Later, shortly before 10 p.m., Bertone was reading in his bed when he heard what sounded like a freight train running through his room, then a boom. He felt thumping and saw the lights go out. That set up a chain of events that eventually led to a frenzied exit from the fiery rig.

Wouldn’t it be interesting to inquire with Bertone whether he may have asked, “gee, what is everyone here about” or “what’s the problem”, or hey, guys, what’s up”? Instead, all we know is he went to bed to read.

Bertone said he does recall reviewing an audit before the accident that found larger maintenance issues requiring Deepwater Horizon to go to the shipyard in early 2011 for work on thrusters, engines, seawater systems, ballast systems and drilling equipment.

Mike Williams, a subordinate of Stephen Bertone’s, suggested that some key safety functions on board the rig were set to bypass when the accident occurred.

BP’s well-site manager, Donald Vidrine, declined to testify at the hearings; reportedly due to health concerns.

So far, what we have in the testimony seems to be a frightening inventory of neglect and carelessness on at least the part of the rig operator, BP and the rig owner, Transocean. There seems to be at least some scintilla of suspicion that any of the neglected problems on the Deepwater Horizon may have cause d or contributed to this tragedy. There also seems to be some concern that memories are not as sharp as maybe we had hoped or honesty is in short supply.

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Jack Hill

Hospital Errors and the “July Effect”

Published by Jack Hill in Hospital Infections, Medical Malpractice, Product Liability

New studies show that hospital deaths increase sharply in July causing a “July Effect”. The study illustrates the need for patients to practice caution while accepting medical care in that month or over the weekend days.

A recent study by the University of California at San Diego demonstrates that fatal medication errors rose 10 percent in July at teaching hospitals in the United States. This “July Effect,” doesn’t seem to mean that hospital staffs are running amok, but that more medication errors seem to be the culprit in teaching hospitals. The study investigated more than 62 million U.S. death certificates between 1976 and 2006. Of those, 244,388 deaths were caused by medication errors in hospitals such as dispensing the wrong medications, overdoses, and accidents involving drugs or biological agents.

The researchers examined certificates of inpatients, outpatients, and those who died in the emergency department, in which medication error was recorded as the primary cause of death. Counties containing teaching hospitals experienced a 10 percent rise in fatal medication errors in July, whereas counties lacking teaching hospitals did not experience that spike.

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Brenda Fulmer

FDA Concerned About Cancer Risks of Hypertension Drugs

Published by Brenda Fulmer in Defective Design, Mass Torts, Product Liability

The FDA announced yesterday, July 15, 2010, that a class of drugs known as ARBs (Angiotensin-receptor blockers) is being reviewed after a recent study found an increased risk of cancer associated with their use.

ARBs (Angiotensin-receptor blockers) are regularly prescribed for the treatment of hypertension (high blood pressure), diabetic nephropathy (kidney damage due to Diabetes) and congestive heart failure. Some of the more common brand names of ARBs include Diovan (valsartan), Cozaar (losartan), Avapro (irbesartan), Benicar (olmesartan) and Micardis (telmisartan).

The study cited by the FDA was conducted by a team of researchers, led by Dr. Ilke Sipahi, from the University Hospitals Case Western Medical Center in Cleveland. The team synthesized newly available data from other large scale clinical trials to look for a correlation between cancer development and the use of these drugs. The study concluded that “patients randomly assigned to receive ARBs had a significantly increased risk of new cancer occurrence compared with patients in control groups… Among specific solid organ cancers examined, only new lung-cancer occurrence was significantly higher…”[1] showing the possible cancer risk that could follow the use of this class of drugs.

The FDA plans to continue their review of these studies to determine additional information about any increased risks associated with the use of these medications.  They will release any additional information to the public as it becomes available.  At this time, they recommend that healthcare professionals and their patients continue to use these medications as their respective labels advise, but caution the community to stay alert to the possibility of the associated risks.  It is important that anyone using these medications continue with their use unless otherwise advised by their physician.

Healthcare professionals or patients taking these medications are encouraged to any report adverse events or side effects related to their use to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

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