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The Law Firm of Leandros A. Vrionedes, P.C.

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Defective Products

According to the Consumer Product Safety Commission, millions of people each year require hospital care for injuries suffered due to the use of products.  The Law Firm of Leandros A. Vrionedes, P.C. represents consumers injured by dangerous or defective products.

Product Defects

Product defects generally fall into the following categories:

  • Defective warning: A failure to provide proper and clear warnings of foreseeable dangers linked to the intended use of a product. This failure also occurs when reasonable efforts to issue warnings of defects discovered after the sale of a product are not taken. For example, a drill that does not include detailed instructions might result in a defective warning claim.
  • Manufacturing defect: A failure to follow design specifications during product fabrication. For example, a vehicle not being assembled according to specifications is a manufacturing defect.
  • Design defect: A product is fundamentally and dangerously flawed from its point of origin. If a product has a design defect, every product manufactured according to this design will have the same flaw or defect.

Types of Products Liability Cases

Products liability could involve some of the following goods that consumer’s encounter on a regular basis:

If you suffer an injury because of a product, it is important to save the product if possible and immediately seek the advice of an experienced product liability attorney.

Drugs and Medicines

Drug companies may release a drug for patient use which has not been adequately tested or may cause unforeseen side affects. The following are examples of drugs that have recently been found to cause side effects, such as heart attacks, strokes or even death:

If you or a loved one suffers an injury after taking a drug, it is highly recommended that you seek the advice of experienced legal counsel to determine your options and to preserve your rights.

Avandia

Avandia (also known as rosiglitazone) improves blood sugar control in adults with type-two (non-insulin-dependent) diabetes. Generally, Avandia, which is made by GlaxoSmithKline, is used in conjunction with other drugs, as well as diet and exercise, to control blood sugar. While Avandia has been shown to greatly assist in treating type-two diabetes, it has also been associated with some dangerous side effects.

The FDA warns that individuals at risk for heart failure, fluid retention, or active liver disease should avoid taking Avandia. Patients taking the drug may also be at risk of developing primary pulmonary hypertension (PPH), a cardiovascular disease.  Most doctors associate PPH with a higher-than normal blood pressure in the pulmonary artery. PPH has also been associated with the development of heart valve disease and heart valve defects. In fact, the FDA reports that existing data suggests that patients receiving short-term treatment with Avandia may have a 30% to 40% increased risk of heart attack and other adverse heart-related events. The FDA also warns that individuals with type I diabetes (juvenile diabetes) or diabetic ketoacidosis (dangerously high levels of ketones) should not take Avandia. Moreover, women taking Avandia have been found to face a greater risk of bone fracture.

Baycol

Baycol (also known as a cerivastatin) is an anti-cholesterol drug produced by Bayer Pharmaceuticals. Baycol is in a class of drugs called statins, which lower cholesterol levels by blocking a specific enzyme involved in the synthesis of cholesterol. Baycol use is associated with fatal rhabdomyolysis, a condition which causes symptoms such as atrophy of the muscle cells (particularly skeletal muscles), as well as with muscle pain, weakness, fever, nausea, and in some cases kidney failure and even death. Muscle pain from this condition tends to be most severe in the lower back and calves, and can interfere with the ability to walk. The FDA issued information on a recall of Baycol on August 8, 2001.

Bextra

Bextra (also known as valdecoxib) is a non-steroidal anti-inflammatory drug (NSAID) produced by Pfizer, Inc. Bextra is used to treat adult rheumatoid arthritis, osteoarthritis, and painful menstruation. Allergic reaction and heart disease are the two primary risks associated with taking Bextra. Bextra is believed to cause severe allergic reactions in some patients, including the following:

  • Erythema multiforme (EM) – serious, inflammatory skin rash
  • Stevens Johnson Syndrome (SJS) – extremely painful and severe blistering of the mucous membranes (similar skin lesions or a rash associated with a severe burn)
  • Toxic epidermal necrolysis (TEN) – (a form of SJS) severe blistering which causes the patient’s skin to peel off in sheets (similar skin lesions or a rash associated with a severe burn)

Bextra users are also believed to face an increased risk of heart disease, based on a FDA study on blood clotting and heart attacks in coronary bypass surgery patients. Based on the above risk, the FDA issued information on a withdrawal of Bextra from the market on April 7, 2005.

Chantix

Chantix (also known as verenicline) is used as a smoking cessation drug. However, it has been linked to serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, and suicide. Patients may have experienced these types of symptoms as a result of nicotine withdrawal, but some patients taking Chantix who experienced these symptoms had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in other instances, symptoms developed following withdrawal of Chantix therapy. The FDA issued a health advisory notice regarding Chantix on February 1, 2008.

Digitek

Digitek (also known as digoxin) is used to treat heart failure and abnormal heart rhythms. This drug has been made available to patients in doses containing twice the active ingredient and this coincided with the drug being linked to digitalis toxicity. This can result in nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. In severe instances, death has also been reported from excessive digitalis intake. The Food and Drug Administration (FDA) released information on a recall of this drug on April 25, 2008.

Duragesic

The Duragesic (also known as the fentanyl transdermal system) patch is used by patients with moderate to severe chronic pain, who have been taking a regular narcotic pain medicine for longer than a week. Each patch contains a three day dose of fentanyl gel which is designed to release a steady dose of the analgesic through a rate controlled membrane. Patients must avoid exposing the patch to excessive heat because this exposure promotes the release of fentanyl from the patch. This increases the absorption of fentanyl through the skin, which can result in nausea, sedation, drowsiness, or a fatal overdose. The FDA issued an alert regarding the use of Duragesic on July 15, 2005, which was updated in December 21, 2007. As recently as June 2007, a Florida family was awarded $5.5 million dollars in the wrongful death verdict of a 28 year old man following the first United States Duragesic patch trial.

GranuFlo

GranuFlo is a dry acid mixture manufactured by Fresenius Medical Care that is used in creating the medication for dialysis, a medical procedure for cleansing the blood in people whose kidneys are not properly performing this task naturally. GranuFlo was recalled by the FDA in 2012 after it was discovered that the product may contribute to metabolic alkolesis, which could lead to heart attack, stroke or even death. In fact, a study conducted by FMC in their own dialysis clinics revealed nearly 1,000 cases of cardiac arrest in 2010. While FMC sent an internal memo about GranuFlo to the directors of their clinics, they did not send the memo to the thousands of clinics not owned by FMC but nevertheless serving 125,000 dialysis patients across the country.

Heparin

Heparin is a blood-thinning drug that contains an active pharmaceutical ingredient (API) from China. The drug has been known to cause allergic or hypersensitive reactions, with symptoms such as low blood pressure, angioedema, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain. The FDA issued a recall of Heparin on February 11, 2008.

Ortho Evra Patch

The Ortho Evra Patch is the first transdermal (skin) patch approved for birth control. The patch releases norelgestromin (a progestin hormone), and ethinyl estradiol (an estrogen hormone), through the skin, into the blood stream to prevent pregnancy. Ortho Evra contains hormones that are embedded into the adhesive layer of the patch, that are slowly released when the patch is applied to the skin. This product carries similar risks to the use of birth control pills, such as an increased risk of blood clots, heart attack and stroke. Another risk is that cigarette smoking, while using the Ortho Evra Patch, increases the risk of serious cardiovascular side effects. On November 10, 2005, the FDA approved an additional label for the patch, warning women that it exposes them to significant amounts of estrogen and may put them at greater risk of developing blood clots.

Pradaxa

Pradaxa (dabigatran etexilate) is a blood thinner manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. that has been prescribed by cardiologists for use in patients with irregular heartbeat or atrial fibrillation (AFib) or who are otherwise at risk for stroke, blood clot or embolism. Like Coumadin and other blood thinners, Pradaxa use increases the risk of bleeding in certain patients. However, the risks associated with Pradaxa have been considered to be much more severe, leading to bleeding in the stomach and brain and causing injury or death from internal bleeding or blood loss. In 2011, The FDA reported on over 500 deaths of patients using Pradaxa, and in 2012 the FDA said that patients with artificial heart valves should not be prescribed Pradaxa due to the increased risk of internal bleeding.

Reglan

Reglan (also known as metoclopramide) is used to as a short-term treatment of gastroesophageal reflux disease and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines), as it increases the rate at which the stomach empties into the intestines. Reglan has been linked to tardive dyskinesia, which can include involuntary and repetitive movements of the body, such as lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. Often these symptoms are irreversible once they manifest themselves. The FDA has imposed a warning regarding the long-term or high-does use of Reglan on February 26, 2009.

Trasylol

Trasylol (also known as aprotinin) is a drug that is manufactured by Bayer, which comes from bovine lung tissue. It is used to reduce the risk of bleeding in patients during open heart surgery. Trasylol is often used when a patient is undergoing Coronary Artery Bypass Grafting (CABG), using cardiopulmonary bypass. A 2006 New England Journal of Medicine study, determined that patients given Trasylol had an increased risk of renal (kidney) failure, myocardial infarction (heart attack), and stroke, than patients who received no medication. In addition, a 2008 Canadian study, which published its findings in 2008, indicated that Trasylol increased the risk of death, as compared to other drugs that were used to decrease the risk of bleeding. As a result, Trasylol has been removed from general use on patients, as noted in a in a May 14, 2008 release from the FDA.

Zelnorm

Zelnorm (also known as tegaserod maleate) is used to treat irritable bowel syndrome (IBS-C) and chronic constipation (CIC) in women younger than 55 years of old. The FDA has advised that patients with the following characteristics not use Zelnorm:

  • Prior history of heart attack or stroke
  • Unstable angina
  • Hypertension
  • Hyperlipidemia
  • Diabetes
  • Age greater than 55 years
  • Smoking
  • Obesity
  • Depression
  • Anxiety
  • Suicidal ideation

In 2007, the FDA announced restricted use of Zelnorm because of the risks associated with it.

Zyprexa

Zyprexa (also known as olanzapine) is used for the long-term treatment of schizophrenia and short-term treatment of acute manic episodes associated with bipolar I disorder. Although not approved by the FDA, Zyprexa is also prescribed by physicians for treatment of other disorders, such as dementia and anxiety. However, research has determined that a large number of Zyprexa users contract diabetes, and precursor conditions such as hyperglycemia (high blood sugar) and ketoacidosis (the body uses fat as an energy source when glucose is not available, resulting in the build-up of ketones in the bloodstream or ketosis). The FDA provides warnings of the above risks on this website.

Medical Devices

DePuy, Stryker & Biomet Hip Replacements

The use of metal-on-metal components in the artificial ball and socket joints found in several artificial hips, including the DePuy ASR XL Acetubular System, DePuy ASR Hip Resurfacing System, Stryker Rejuvenate, Stryker ABG II, and the Bioment M2-a Magnum, has been linked to high early failure rates and painful and harmful adverse effects. The wear of metal on metal parts causes metal debris to lodge in tissues and enter the bloodstream. The presence of toxic metals such as chromium and cobalt can lead to tissue necrosis and blood poisoning. Other harmful effects include painful swelling, hip dislocation, fractures, limited mobility, and permanent nerve or neurological damage. Rather than lasting the expected 20 or 25 years, these hip replacements often fail after only five years, requiring painful revision surgeries with long, painful recovery periods. These products have been recalled by their manufacturers, but thousands of people already have these devices implanted in their bodies.

Mirena IUD

The Mirena IUD is an intrauterine device that releases a low dose of a synthetic progestin hormone known as levonorgestrel into the uterus as a method of birth control. The device is supposed to be able to stay in place for up to five years, but it has been known to leave its insertion point and migrate to other areas of the abdominal cavity, where it could cause perforations, abscesses, ectopic pregnancy or infertility. Punctures or perforations of the uterine wall can cause severe abdominal pain, heavy bleeding and other symptoms and could lead to scarring, sepsis, damage to other organs, and the need for a hysterectomy.

NuvaRing

Like the Mirena IUD (see above), the NuvaRing is a contraceptive device that works by releasing hormones into the body to prevent pregnancy. The NuvaRing is inserted into the vagina and is meant to stay inserted for a month at a time. Risks associated with use of the NuvaRing include heart attack and stroke, breast cancer, gallbladder disease and high blood pressure. Blood clots are another serious potential side effect of the NuvaRing. Blood clots in the legs can be particularly dangerous, because they have the potential to travel to the lungs and cause serious adverse effects. The device may also lead to clotting of the blood vessels in the eye, which can cause serious vision problems.

Shoulder Pain Pump

A shoulder pain pump is a small catheter, which is inserted into a shoulder after shoulder surgery to reduce pain after arthroscopic shoulder procedures or other similar surgeries. The pump is connected to a container that is filled with a long-lasting local anesthetic. The pump gradually and continuously releases the anesthetic for up to five days or until the patient removes the pump.

Postarthroscopic Glenohumeral Chrondrolysis (PAGCL) is a painful and permanent condition that arises when the cartilage separating and protecting the shoulder’s ball and socket deteriorates partially or completely. This breakdown causes bone to meet bone, leading to excruciating pain, inhibited movement, and a reduction in functionality. In some instances, the patient requires surgery to completely replace the shoulder joint. Common symptoms of PAGCL include:

  • Shoulder weakness
  • Clicking, popping or grinding of the shoulder
  • Shoulder stiffness
  • Limited range of motion in the shoulder
  • Constant shoulder pain

Many orthopedic surgeons believe that one of the most common causes of PAGCL is the intra-articular placement of the pain pump catheter in shoulder where an arthroscopic surgery has been completed. Recent studies suggest that the insertion of the pain pump catheters released a level of anesthetic concentrated in one place, which was toxic to cartilage. A 2006 study by the American Academy of Orthopedic Surgeons and an October 2007 study by the American Journal of Sports Medicine each suggest a strong link between intra-articular use of pain pumps in the shoulder and individuals developing PAGCL.

Defibrillators

Implantable Cardioverter Defibrillator (ICD) is an implanted device that continuously monitors an individual’s heart rhythm. The device delivers shocks to the heart when it detects life-threatening arrhythmias. Certain ICDs can also pace the heart back into rhythm without having to shock the heart muscle. ICDs are used in patients who have a risk of ventricular tachycardia (a fast rhythm of the heart that begins in the ventricles of the heart). Typically, an ICD is used in patients who have ventricular fibrillation, which is a condition where the cardiac muscles tremble, instead of properly contracting.
Individuals who have ICDs implanted should not engage in sports that can damage the ICD. Nor should patients place severe strain on the shoulder and arm area where the ICD is implanted, because the ICD or the wires leading to the heart can be damaged. ICDs can also be affected by devices that use large magnets or that generate magnetic fields, such as microwaves.

 

ICDs, according to the American Heart Association, have been helpful in preventing deaths of patients suffering from ventricular tachycardia or fibrillation. However, ICDs can malfunction, which can have life-threatening consequences. For example, ICDs can short circuit, which means that the patient does not receive the necessary shock to put the heart back into proper rhythm, or the battery can prematurely deplete.

Pacemaker

The pacemaker is a small, battery-powered device that monitors the heart’s electrical impulses after it is implanted into the body.  It delivers electrical stimuli to the heart, to induce the heart to beat or contract in a more normal rhythm. A pacemaker is used when a patient’s heart has other abnormal rhythms (arrhythmias), beats too slowly (bradycardia), or even to treat heart failure. A pacemaker is made up of two basic parts, a generator and wires (leads). Pacemakers can serve specific purposes, according to the FDA, based on the needs of the heart:

  • Single-Chambered Pacemakers use only one insulated lead placed into the right lower chamber (right ventricle) or the right upper chamber of the heart (right atrium).
  • Dual-Chambered Pacemakers use two leads, with one in the right ventricle and one in the right atrium.
  • Cardiac Resynchronization Therapy Pacemakers use three leads, with a lead in the right ventricle, right atrium and the heart’s veins to the left ventricle.
  • Rate-Responsive Pacemakers increase or decrease heart rate to match an individual’s activities (such as walking or sleeping).

Pacemakers have generally been proven effective in treating people with heart conditions. As a result, it is especially difficult for patients who suffer harm from pacemakers that do not function properly. Manufacturers of pacemakers must recall a product if defects have been proven responsible for causing injuries. Some recent recalls listed by the FDA have been made by two of the largest producers of pacemakers, Guidant and Medtronic.

Gadolinium

Gadolinium (or gadodiamide) provides contrast between normal and abnormal tissue in the brain and body, and it is a clear, non-radioactive substance. It is used to make abnormal tissue appear brighter in Magnetic Resonance Imaging (MRI) because it accumulates in abnormal tissue after it is injected into the blood stream. Patients with normal kidney function are able to excrete gadolinium from the body through the kidneys. However, individuals with poor kidney function often cannot process gadolinium and its use has been linked to a debilitating and incurable condition known as Nephrogenic System Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).

NSF is a disorder causing fibrosis or increased formation of the connective tissue in the skin. The skin typically reveals the most visible effect. The FDA reports that victims of NSF observe some of the following symptoms:

  • Limited range of motion in the arms, hands, legs, or feet
  • Burning or itching of the skin
  • Reddened or darkened patches of skin
  • Swelling, hardening or tightening of the skin
  • Joint stiffness
  • Pain deep in the hip joints or ribs
  • Muscle weakness

Patients may have to wait more than one year for some of these symptoms to appear. Unfortunately, there is no known treatment for NSF. As NSF advances, it can cause fibrosis of the eyes and internal organs symptoms, and even lead to death.
Gadolinium is marketed under several names. Common brand names include: Magnevist, Omniscan, OptiMARK, Multihance and ProHance. As of now, the FDA has mandated a warning on the boxes of gadolinium-based contrast agents. The warning states that patients with kidney malfunction or advanced renal failure, who receive gadolinium-based agents, face the risk of developing NSF. Moreover, patients before or just after a liver transplantation, or those with chronic liver disease, who have kidney insufficiency, also face a greater risk of developing NSF.

Automobiles and Other Motor Vehicles

Motor vehicle defect claims may be based on defects to the many different components that make up a vehicle. A vehicle manufacturer or seller’s liability for a car defect is dictated by the legal doctrine of strict liability. Regardless of what steps a manufacturer or dealer takes to design or assemble a vehicle, a victim can make a strict liability claim based on a vehicle defect (without showing negligence) if the following conditions are met to show that a vehicle was “unreasonably dangerous”:

  • The product was defective at the time that it left the control of the manufacturer or for a dealer when the product left the dealer’s control.
  • The product was used for its intended purpose or in a reasonably foreseeable manner.
  • The defect contributed to the injury or death.

Motor vehicle defects could include any of the following:

  • Body and frame
  • Crashworthiness (Ex. design that exposes gas tank to risk of explosion in a crash)
  • Brakes
  • Cooling and temperature control system
  • Electrical system
  • Engine assembly
  • Exhaust system
  • Fuel system
  • Lubrication system
  • Steering system
  • Suspension systems
  • Transmission and drive-train (Ex. sudden, unexplained acceleration)
  • Seatbelts (Ex. passenger ejection in a crash or causing serious injury to occupants in an accident)
  • Airbags (Ex. deploy with too much force or in minor accidents)
  • Tires (Ex. tread separation)
  • Windows
  • Overall design (Ex. sports-utility-vehicle design subjective to rollover)

Electronic Goods and Appliances

Consumers could encounter defective electronic goods at any time in their every day activities. Manufacturers have been known to rush defective electronic goods for sale to the public resulting in injuries to consumers. For example, there have been numerous instances of laptops being available for sale, which are powered by batteries which represent a fire hazard. A variety of electronics could be harmful to consumers if defective, such as the following:

  • Laptop
  • Batteries
  • Televisions
  • Heaters
  • Lamps
  • Wash machines
  • Dryers

Regardless of the type of product that has caused an injury to you or a loved one, the Law Firm of Leandros A. Vrionedes, P.C. provides consumers with skilled representation. Please contact our office for a consultation on your case.

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