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Defective Products

Welcome to the New York Defective Products Law Firm of Leandros A. Vrionedes, P.C. We have offices in New York City, and serve clients in Brooklyn, the Bronx, Manhattan, Queens, Staten Island, Nassau, and Westchester. For over fifteen years, our lawyers have provided legal representation and advice to individuals and their families in New York involved in defective products cases, including consumer products, drugs and medicines, industrial and manufacturing machinery, medical devices, and automobiles and other motor vehicles. This is a firm dedicated to providing the finest legal representation to the injured public throughout New York.

We provide expert and individualized service for your specific defective product law needs. The cornerstone of our success is the quality relationship, which we maintain with our clients and/or their families. Our New York Law Firm focuses on intelligent legal representation and pledge to listen to and communicate with clients. As New York Lawyers, we treat our Clients with integrity and respect for their needs, goals and objectives.

Defective products harm millions of people every year. Manufacturers of products can be sued for design defects, improper safety devices and manufacturing defects. Products Liability cases may involve:dangerous toys, automobile design, sport utility vehicle rollovers, gas tank explosions, seat belt failures, improperly designed consumer and household products, industrial machinery & equipment, farm machinery, tractors and equipment, products causing explosions and burns, and aviation products. In any products case it is important to save the product or have an attorney act quickly to investigate and preserve the evidence.

There are three main categories for defective product cases. They are 1) Design defects, flaws in the design of the product; 2) Manufacturing defects, specific defects that occur during the manufacturing process of a product; and 3) Failure to warn consumers of the potential dangers and risks of the product.

Drugs and Medicines

Drug companies may send to market a drug that has not been adequately tested or may cause unforeseen side affects. Such drugs have been Vioxx, Phen Phen, Baycol, fosamax, celebrex, and crestor. They can cause a variety of side effects, which include heart attack, stroke and death. Please call us if you have suffered any side effects from a prescription you are taking including:

Digitek (also known as digoxin) is used to treat heart failure and abnormal heart rhythms. This drug has been linked to Digitalis toxicity. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. 

FDA link: http://www.fda.gov/cvm/CVM_Updates/DigitekSafetyRecall.htm

Vioxx (Rofecoxib) is a COX-2 nonsteroidal anti-inflammatory drug (NSAID) developed by Merck & Co., which was used to treat symptoms of osteoarthritis, acute pain, and painful menstrual cycles. The use of NSAID's is associated in some patients with serious problems from stomach ulcers, including bleeding. NSAID medications are also associated with liver damage in some patients. For several years, lawyers have been asserting that Merck was aware of problems experienced by patients taking Vioxx, including the previously mentioned problems with stomach ulcers and liver damage, but also including heart problems and kidney damage. They allege that Merck deliberately suppressed information about these side effects from patients and physicians. Two prominent medical journals have published articles which associate Vioxx use with a significantly heightened risk of heart attack. These side effects are believed to be most likely to occur in patients who took Vioxx for fifteen months or longer.

FDA link: http://www.fda.gov/cder/drug/infopage/COX2/default.htm

Celebrex (Celecoxib) is a COX-2 nonsteroidal anti-inflammatory drug (NSAID) developed by Pfizer, Inc., which is used to treat symptoms of osteoarthritis and rheumatoid arthritis, acute pain, and primary dysmenorrhea (menstrual cramping). The use of NSAID's is associated in some patients with serious problems from stomach ulcers, including bleeding. NSAID medications are also associated with liver damage in some patients. Patients taking Celebrex had a significantly increased risk of heart attacks.

FDA link: http://www.fda.gov/cder/drug/infopage/COX2/default.htm

Baycol, an anti-cholesterol drug (also known as a "statin") produced by Bayer Pharmaceuticals, was approved by the Food and Drug Administration in 1997. Cholesterol is produced in the liver, and plays an important role in the health of cell membranes and in the production of certain hormones. Baycol was represented to lower LDL cholesterol ("bad cholesterol") levels, and also to lower triglyceride levels. Baycol use is associated with Rhabdomyolisis, a condition which causes symptoms including atrophy of the muscle cells, particularly skeletal muscles, along with muscle pain, weakness, fever, nausea, and in some cases kidney failure and even death. Release of potassium associated with the breakdown of muscle cells can cause heart rhythm irregularities and even cardiac arrest. Muscle pain from this condition tends to be most severe in the lower back and calves, and can interfere with the ability to walk.

FDA link: http://www.fda.gov/cder/drug/infopage/baycol/baycol‑qa.htm

Bextra (Valdecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) produced by Pfizer, Inc. Bextra is prescribed for treatment of adult rheumatoid arthritis, osteoarthritis, and painful menstruation. There are two primary areas of concern for patients who take Bextra: 1) Allergic Reaction - Bextra is alleged to cause severe allergic reactions in some patients, including toxic epidermal necrolysis (TEN), erythema multiforme (EM), and Stevens Johnson Syndrome (SJS). Stevens Johnson Syndrome (SJS) results in extremely painful and severe blistering of the mucous membranes, which may be associated with skin lesions or a rash. Toxic Epidermal Necrolysis (TEN) is a form of SJS. TEN involves similar severe blistering which causes the patient's skin to peel off in sheets. The effect of the blistering caused by SJS and TEN is similar in nature to a severe burn, and carries similar risk of both loss of fluids and infection. Erythema Multiforme (EM) involves a serious, inflammatory skin rash. 2) Heart Disease - Following the results of a study of blood clotting and heart attacks in coronary bypass surgery patients, in December, 2004 the FDA required Pfizer to warn patients of heart disease associated with the use of Bextra. Some consumer advocates believe that the risk of heart attack posed by Bextra is similar to, and may in fact be greater than, the risk posed by other COX-2 inhibitors.

FDA link: http://www.fda.gov/cder/drug/infopage/COX2/default.htm

Zyprexa (olanzapine) In 2000, the FDA approved it for the long-term treatment of schizophrenia, and also for the short-term treatment of acute manic episodes associated with bipolar I disorder. Zyprexa is also prescribed by physicians for other purposes, not yet approved by the FDA, including treatment of dementia and anxiety. Recent research has demonstrated that significant numbers of Zyprexa users contract diabetes, and precursor conditions such as hyperglycemia (high blood sugar) and ketoacidosis, a condition where the body uses fat as an energy source when glucose is not available, resulting in the build-up of ketones in the bloodstream (ketosis).

FDA link: http://www.fda.gov/cder/drug/infopage/COX2/default.htm

Fen Phen - In the late 1990's, the drugs known as Fen Phen, Redux, and Pondimin were frequently prescribed to assist with weight loss. As many as twenty percent of people who took those drugs suffered heart damage, including: 1) Damaged Heart Valves - The drugs Fen Phen and Redux are associated with damage to the heart's aortic and mitral valves; and 2) Primary Pulmonary Hypertension (PPH) - A condition is caused by a narrowing of the blood vessels in the lungs, which can cause high blood pressure and can lead to heart failure. This condition is extremely serious, is usually progressive in nature, and can result in death. It has been associated with Fen Phen and Pondimin. Manufacturer liability is based upon the assertion that it was known for many years that the use of Pondimin and Redux could lead to primary pulmonary hypertension (PPH), but the manufacturers downplayed the health consequences in order to maintain a very lucrative market for their drugs.

FDA link: http://www.fda.gov/cder/news/feninfo.htm

Ortho Evra Patch is the first transdermal (skin) patch approved for birth control. The weekly prescription patch releases norelgestromin (a progestin hormone), and ethinyl estradiol (an estrogen hormone), through the skin into the blood stream to prevent pregnancy. Ortho Evra, an alternative to birth control pills, is a one-and-three-quarter inch square patch consisting of three layers. The hormones are embedded in the adhesive layer and are slowly released when the patch is applied to the skin. Like birth control pills, Ortho Evra is effective for prevention of pregnancy when used as directed. The risks of using this product are similar to the risks of using birth control pills including an increased risk of blood clots, heart attack and stroke. The labeling also carries the warning that cigarette smoking increases the risk of serious cardiovascular side effects from use of combination hormonal contraceptives. In November 2005, Ortho McNeil issued a warning to millions of women revealing that the patch exposes them to significant amounts of estrogen and may put them at greater risk of developing blood clots.

  FDA link: http://www.fda.gov/cder/drug/infopage/orthoevra/qa.htm

Zelnorm is used for the short-term treatment of women who have  irritable bowel  syndrome (IBS) with constipation (not enough or hard bowel movements) as their main bowel problem. Zelnorm has not been shown to work in men with IBS. Zelnorm is also used for chronic idiopathic constipation (frequent constipation of unknown cause) in both male and female patients less than 65 years of age.

Too little blood flow to the colon leading to inflammation (ischemic colitis) and other forms of intestinal blood flow problems have been reported in patients receiving Zelnorm after the drug became available. In some cases, hospitalization was needed and even death occurred. Patients can develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea, or new/worsening stomach pain.

FDA link: http://www.fda.gov/cvm/CVM_Updates/DigitekSafetyRecall.htm

Trasylol (also known as aprotinin) was approved by the FDA in 1993 to control bleeding and limit the need for transfusions in patients undergoing coronary artery bypass grafting surgery (CABG). Several studies have linked this drug to an increased risk of death, cardiac events and renal failure resulting in the need for dialysis. In particular, two new studies published on February 28, 2008 in the New England Journal of Medicine confirmed an increased risk of death in patients given the anti-bleeding drug Trasylol77.  A study, published in the New England Journal of Medicine in January 2006, revealed that patients treated with Trasylol77 have twice the rate of kidney failure and an increased risk of heart attacks, heart failures, strokes and encephalopathy.

FDA link: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01834.htm


The Duragesic  (Fentanyl) patch is used in patients with moderate to severe chronic pain. 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. Fentanyl is an extremely strong opioid pain medication. While the Duragesic product label was modified in July of 2005, it is still available for use today. According to the recall, Aexposure to the Duragesic hydrogel contents could result in an increased absorption of the opioid component, Fentanyl, leading to increased drug effect including nausea, sedation, drowsiness, or potentially life threatening complications.@ Most recently, in June of 2007, a Florida family was awarded $5.5 million dollars in the wrongful death verdict of a 28-year old man following the nation's first Fentanyl patch trial.

FDA link:  http://www.fda.gov/cder/drug/infopage/fentanyl/default.htm

Zelnorm is a drug used in the treatment of irritable bowel syndrome (AAIBS@@) and chronic constipation in individuals under 65 years of age.  The FDA has advised patients using Zelnorm77 to seek immediate medical care if they experience severe chest pain, shortness of breath, dizziness or other symptoms of heart attack or stroke.  Zelnorm77 has also been linked to serious cases of diarrhea, ischemic colitis and death. This prompted Novartis to amend its label in March 2004 to warn against these serious risks.

FDA link: http://www.fda.gov/cder/drug/infopage/zelnorm/default.htm

Avandia was approved by the FDA in May 1999 for use in improving control of blood sugar levels in Type 2 diabetics. Since its approval, Avandia, which is manufactured by GlaxoSmithKline, has been used by more than seven million people worldwide and is, today, being used by over one million Americans.  The FDA is continuing to analyze the data and to investigate the increased risk of heart attack linked to Avandia. Although the FDA has not reached any conclusions and its analysis of the drug is ongoing, on May 21, 2007, the FDA advised patients using Avandia, especially those who have underlying heart disease or who are at high risk of heart attack, to consult with their physicians about this new information.

FDA link: http://www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm


Chantix (Verenicline) has been linked to  serious neuropsychiatric symptoms. Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.

FDA link: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html

Heparin  Serious injuries and deaths have been associated with the use of heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China. The adverse events have included allergic or hypersensitivity-type reactions, with symptoms such as low blood pressure, angioedema, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain.

FDA link:  http://www.fda.gov/cder/drug/infopage/heparin/#recalls

Medical Devices

Defibrillators and Pacemakers

An implantable cardiac defibrillator is a device about the size of a pager that monitors your heart rate. It is positioned below the collarbone. It is typically used to detect tachycardia and deliver a strong electrical shock to restore the heartbeat to normal. However, many defibrillators can also function as pacemakers, delivering a weaker shock to correct bradycardia as well. A defibrillator consists of a pulse generator with batteries and a capacitor that sends a powerful shock to the heart, an electronic logic circuit to tell the device when to discharge and lead electrodes placed in the heart to sense cardiac rhythm and deliver the shock to the heart muscle. There have been certain manufacturer recalls for potential battery shorting mechanism that may occur in defibrillators. Devices have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function.

A pacemaker is a small, battery-operated device that helps the heart beat in a regular rhythm. It is the treatment of choice for patients with bradycardia (slow heartbeat), but is less commonly used for tachycardia (fast heartbeat). Pacemakers can be permanent (internal) or temporary (external). A pacemaker sends electrical impulses to the heart when needed to aid in the proper pumping of blood. Pacemakers are composed of two parts: the generator and the leads. The generator stores the battery and regulatory information for the heartbeat. In an internal pacemaker, the generator is typically located beneath the collar bone. The leads are wires that extend from the generator through a large vein to the heart, delivering electrical impulses that tell the heart when to beat. Certain pacemakers have been recalled for the malfunction of a switch inside which would prevent the devices from providing the electrical pulse needed for proper pacing.
Gadolinium

Gadolinium is a contrast agent for MRI. Gadolinium, or gadodiamide, provides greater contrast between normal tissue and abnormal tissue in the brain and body. Gadolinium looks clear like water and is non-radioactive. After it is injected into a vein, Gadolinium accumulates in the abnormal tissue that may be affecting the body or head. Gadolinium causes these abnormal areas to become very bright (enhanced) on the MRI. This makes it very easy to see. Gadolinium is then rapidly cleared from the body by the kidneys.

New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents. Nephrogenic fibrosing dermopathy (NFD) causes thickening and hardening of the skin, often in the extremities, and occurs in patients with underlying renal disease.
The FDA has learned of cases of NSF/NFD in patients with kidney failure who received gadolinium-containing contrast agent. The FDA is actively investigating whether exposure to a gadolinium-contrast agent is associated with the development of NSF/NFD.

Bard® Composix® Kugel® Mesh Hernia Patch

The Bard® Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a "memory recoil ring" that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

The "memory recoil ring" that opens the Bard® Composix® Kugel® Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Automobiles and Other Motor Vehicles


Motor vehicle defect claims may be based on defects in the body and frame, brakes and braking system, cooling and temperature control system, electrical system, engine assembly, exhaust system, fuel system, lubrication system, passenger compartment, steering and suspension systems, transmission and drivetrain, and other parts and accessories.
A vehicle manufacturer or seller's liability for a car defect is controlled by the doctrine of strict liability. Regardless of what steps a manufacturer or dealer says it takes in designing, assembling, or handling a motor vehicle, you can make a strict liability claim based on a motor vehicle defect -- without making any showing as to negligence-- if all three of the following conditions exist: 1) The vehicle or one of its components had an "unreasonably dangerous" defect that injured you. The defect can come into existence either in the design of the vehicle, during manufacture, during handling or shipment (i.e. delivery from the manufacturer), or through a failure to warn consumers of a dangerous aspect of the vehicle. 2) The defect caused an injury while the vehicle was being used in a way that it was intended to be used. 3) The vehicle had not been substantially changed from the condition in which it was originally sold.

Motor vehicle defects include:

Airbags - Defective airbags include those that deploy with too much force, deploy in minor collisions when they are not otherwise needed, or fail to deploy under circumstances in which they should.

Sudden unintended acceleration - occurs when a vehicle uncontrollably accelerates when a vehicle is shifted into drive or reverse.

Tires – Poor tire shoulder design can lead to tread separation causing a serious accident.

Rollovers - The high center of gravity and relatively narrow wheelbase of SUVs increase their susceptibility to rollover.

Seatbelts - Some automatic shoulder belts are poorly designed and have been known to decapitate or otherwise seriously injure occupants when not used properly. Some seat belts have even been known to separate from their base upon impact, thus providing no protection to the occupant.
Passenger ejection – A passenger can be ejected due to faulty seat belts, collapsing seat backs and rollovers.

Crashworthiness and design – Several examples are exploding gas tanks and design flaws that fail to properly protect passengers during a crash.

See monthly motor vehicle recall reports from the National Highway Traffic Safety Administration.

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