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Welcome
to the New York Defective Products Law Firm of Leandros
A. Vrionedes, Esq. We have offices in New York City,
and serve clients in Brooklyn, the Bronx, Manhattan,
Queens, Staten Island, Nassau, and Westchester. For
over eighteen 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:
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.
Vioxx 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.
Celebrex 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.
Baycol 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.
Bextra 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).
Zyprexa 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.
Fen Phen 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.
Ortho Evra Patch FDA link: http://www.fda.gov/cder/drug/infopage/orthoevra/qa.htm
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.
Digitek® FDA link: 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 Trasylol®®. A study, published in the New England Journal of Medicine in January 2006, revealed that patients treated with Trasylol®® have twice the rate of kidney failure and an increased risk of heart attacks, heart failures, strokes and encephalopathy.
Trasylol® FDA link: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01834.html
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, “exposure 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.
The Duragesic® (Fentanyl) patch FDA link: http://www.fda.gov/cder/drug/infopage/fentanyl/default.htm
Zelnorm® is a drug used in the treatment of irritable bowel syndrome (““IBS””) and chronic constipation in individuals under 65 years of age. The FDA has advised patients using Zelnorm®® to seek immediate medical care if they experience severe chest pain, shortness of breath, dizziness or other symptoms of heart attack or stroke. Zelnorm®® 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.
Zelnorm® 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.
Avandia® 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.
Chantix® 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.
Heparin® 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.
FDA link: http://www.fda.gov/cder/drug/advisory/gadolinium_agents.htm
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).
MEDTRONIC SPRINT FIDELIS®
The FDA has reported that some deaths and other serious injuries have occurred after these leads have fractured. Approximately 268,000 patients in the United States have been implanted with the Fidelis lead, including patients with defibrillators made by manufacturers other than Medtronic, such as Guidant, Boston Scientific and St. Jude. The Sprint Fidelis® family of leads includes model numbers 6930, 6931, 6948 and 6949. These four numbers may be followed by additional numbers and letters associated with the length of the leads. By way of example, if a device card reads 694958ID, the lead would be included in the recall. A small number of Fidelis® leads have also been used with defibrillators made by manufacturers other than Medtronic.
FDA link: http://www.fda.gov/consumer/updates/medtronic101507.html
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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Queens County
