PHARMACEUTICAL (DRUG) LITIGATION
Zyprexa - $700 million settlement
Steven M. Goldberg participated in $700 Million Settlement of Zyprexa Claims:
On June 7, 2005, Eli Lilly announced a $700 million settlement of approximately 8,000 cases that were filed against them for allegations that the atypical anti-psychotic drug Zyprexa caused them to develop diabetes and diabetes-related injuries. Steven M. Goldberg Co., LPA participated in this suit on behalf of hundreds of injured Ohio consumers and worked on behalf of their clients to reach this settlement.
Diabetes is a very serious condition with several serious complications. The lawsuits alleged that Eli Lilly, the manufacturer of the drug, failed to adequately warn patients and their doctors about the drug's known association with diabetes and other injuries.
Steven M. Goldberg Co. LPA and its affiliated counsel have also filed and/or actively participated in Vioxx, Heparin, Bextra, Celebrex, Trasylol, Digitek, and Gadolinium lawsuits.
FDA ADMITS ITCANNOT DO ITS JOB
A year ago, Dr. Andrew von Eschenbach, an U.S. Food and Drug Administration (FDA) Commissioner, requested that the Science Board, which is the Advisory Board to the Commission, form a subcommittee to assess whether science and technology at the agency can support current and future regulatory needs. It has become quite apparent that the FDA has failed to do the job required of the agency in an adequate manner. This special committee recently released its report, and we have summarized some of its major findings:
- The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
- The FDA's inability to keep up with scientific advances means that American lives are at risk.
- The world looks to the FDA as a leader in medicine and science. Not only can the agency not lead, it can't even keep up with the advances in science.
- Due to constrained resources and lack of adequate staff, the FDA cannot adequately monitor development of food and medical products because it is unable to keep up with scientific advances.
- The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
- The lack of a trained workforce means that the FDA is ineffective in fulfilling its mission.
- The FDA cannot fulfill its mission because its information technology infrastructure is inadequate.
- Reports of product dangers are not rapidly compared and analyzed, as inspectors' reports are still handwritten and slow to work their way through the system.
- There are inadequate emergency backup systems in place, which has resulted in the loss of FDA data in the past.
At a time when the Bush Administration and big Pharma are pushing jointly for total immunity from lawsuits for drugs or products that are FDA approved, these findings by the FDA should be enough to eliminate any thought of pre-emption. Previous FDA internal committees have found problems similar to those now identified within the FDA. But, this report clearly proves that the crises warned about in previous FDA reports have now become realities. As a result, American lives are at risk.
Those Americans who were at risk and became victims are typical of the folks that our firm represents in law-suits. Each of the victims has a constitutional right to go to court when he or she is harmed or injured by a product or drug. It's a fundamental truth that none of them should have the court-house door shut in their face by George Bush or by big Pharma. The argument that approval of a product or drug by the FDA, which admittedly cannot perform its job adequately, should immunize those products from scrutiny by a jury, has clearly been refuted by the very organization big Pharma attempts to hide behind. Once the American people became aware of what the Bush White House and big Pharma are trying to do to them, I believe you will see a public outcry against preemption and against a shutting down of the American jury system.
Source: FDA.gov
ONLY DRUGS THAT ARE SAFE SHOULD BE PUT ON THE MARKET
Drug developers are just beginning to come to grips with recent FDA over-sight reforms and how they will affect drug safety. But, it appears that industry and consumer advocates are not together on how well the overhaul will be able to prevent future drug safety scandals. In fact, there is sharp disagreement. Signed by President George Bush in September, the measures give the Food and Drug Administration more authority over and responsibility for the safety of prescription drugs after they hit the market.Although follow-up historically fell under the agency's purview, as a practical matter the FDA focused on monitoring drug development and reviewing treatments for approval. But safety scares in recent years, such as the Vioxx saga, sparked closer scrutiny of both drug makers and the FDA, along with big changes.
Despite a development process before FDA approval, which at best has proved to be seriously flawed, a drug's side effects can go unnoticed or be deemed insignificant in small clinical populations. But once a drug hits the general market and is consumed by millions of persons, fatal risks become apparent. The FDA-simply put-is too dependent on the drug industry and that became most evident in recent years.
Drug makers and the FDA have been criticized for acting too slowly to add warnings to drug labels or recall medicines in the wake of serious safety findings. Calls for reform go back to diet pill Fen-Phen's removal from the market in 1997, but intensified after Merck & Co. recalled Vioxx because the drug's use doubled patients' heart-attack risk. When Merck agreed to pay $4.85 billion to settle Vioxx lawsuits, that told the story of how ineffective the FDA has been. British drug maker Glaxo-SmithKline is adding safety warnings to its diabetes drug Avandia because it raises cardiac risks.
The bill calls for a broader range of safety-tracking resources, allowing drug makers and regulators to cull information from hospitals, physician groups, and health insurers as well as the Centers for Disease Control. It projects the creation of a data pool of 25 million patients by 2010 and 100 million patients by 2012 for drugs on the market. While that sounds great, the logistics are still under development. How well this will work in the real world is subject to debate.
Source: Associated Press
DRUG RECALLS
A drug recall is an action taken to remove a prescription or over-the-counter drug from the market.
Many countries have a government agency responsible for overseeing the safety and efficacy of pharmaceutical drugs. In the United States, the Food and Drug Administration (FDA) is responsible for a variety of products, including drugs, medical devices and foods. The FDA provides clinical information about safety issues involving prescription and over-the-counter drugs, biologics, medical devices, and special nutritional products, including dietary supplements. The FDA issues and announces recalls, safety alerts, withdrawals, and important labeling changes that may impact the health of consumers.
Drug recalls are often categorized by class.
- A Class I recall occurs where a reasonable probability that the use of or exposure to a product will cause serious injury or death.
- A Class II recall occurs where use or exposure to a product may cause temporary or medically reversible injury.
- A Class III recall are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations.
- A safety alert is a notice or warning issued in situations where a product may present an unreasonable risk of substantial harm.
The FDA expects drug makers to take responsibility for product recalls, including follow-up checks. When a product is discovered to pose a safety risk or defect, drug makers or distributors will often carry out recalls voluntarily. In other instances, the FDA may inform a company of findings that one of its products is defective and suggest or request a recall. If the firm refuses to recall the product, the FDA may seek legal action under the Federal Food, Drug, and Cosmetic Act. Such legal action may include seizure of available product, and/or injunction of the company, including a court request for recall of the product.
The recall of a defective or harmful drug is sometimes publicized in the media. Often the drug maker will issue its own press release. The FDA publicizes a recall only when it believes the public needs to be alerted about a serious hazard.
After a recall is completed, the FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective.
HEPARIN
On April 15, 2008, the FDA announced that the blood thinner Heparin, which has been associated with several deaths and allergic reactions, may have been intentionally contaminated in order to reduce the cost of the drug. The contaminated heparin was manufactured by Baxter International and is commonly used before certain types of surgery and during hemodialysis as a blood clotting preventative.
In addition, the FDA reported last week that there has been a substantial increase in the number of people who have died while taking the blood thinner. Its findings indicated that there have been 103 reports of heparin-associated deaths since January 1, 2007 and 91 of these were reported to the agency on or after January 1, 2008. Baxter and the FDA recalled several dosage types of heparin in February after receiving reports of adverse reactions including breathing difficulty, vomiting, excess sweating and a rapid decline in blood pressure. Baxter subsequently expanded the recall to include all remaining lots of its multi-dose, single dose and flush products.
The Law firm of Steven M. Goldberg Co. LPA is actively seeking referrals of cases that resulted in death or injury of individuals who were administered heparin. If you would like additional information concerning this litigation, please call us toll-free, 1-877-FDA-WARNS
GADOLINIUM LITIGATION
MRI/MRA Contrast Agent and Association with Nephrogenic Systemic Fibrosis (NSF) and Nephrogenic Fibrosing Dermopathy (NFD)
Imagine going in for a diagnostic MRI scan and coming out of with a progressive, irreversible, and potentially fatal disease. That's what has happened to hundreds of people worldwide who have developed nephrogenic systemic fibrosis (NSF), an acquired disorder in renal patients that's been classified only since 2000.
The lawyers at the Steven M. Goldberg law firm are investigating cases involving Gadolinium-containing contrast agents used in patients with kidney failure and a disease known as Nephrogenic Systemic Fibrosis (NSF), also called Nephrogenic Fibrosing Dermopathy (NFD).
Gadolinioum, a chemical used to help treat diseased kidneys, causes a painful and incurable disease known as Nephrogenic System Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD), which hardens the skin. Gadolinium, a heavy metal, is injected into patients to help doctors capture medical images. The drug, manufactured by Bayer Corp., is distributed by McKesson Corp. and other companies. A recent warning from the Food and Drug Administration relates to NSF. The FDA has asked manufacturers of all Gadolinium-based contrast agents to include a new boxed warning on the product label. As more and more people are becoming aware of the dangers of Gadolinium-containing contrast agents, more reports of these serious conditions are surfacing. People who develop NSF or NFD may experience a thickening of the skin and other organs, which can limit their ability to move, extend joints and can lead to significant pain and even death. Other problems may include dark patches on the skin that appear rough and hard with raised plaques or papules, which are elevations of the skin. Joint and bone pain, as well as swelling of the feet and hands have also been reported.
The FDA first warned about NSF and NFD associated with Gadolinium in June 2006 and again in December 2006. As of April 2007, the FDA had received a considerable number of additional cases involving these problems.
FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images
The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).
The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.
"FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "This latest action demonstrates FDA's continuing vigilance about ensuring the safety of drug products once they enter the marketplace."
Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition.
FDA first notified health care professionals and the public about the gadolinium-related risks for NSF in June 2006. Information on the risks was updated in December.
Gadolinium-based contrast agents are commonly used to improve the visibility of internal structures when patients undergo an MRI. Five gadolinium-based contrast agents have been approved for use in the United States:
- Magnevist (gadopentetate dimeglumine)
- Ominiscan (gadodiamide)
- OptiMARK (gadoversetamide)
- MultiHance (gadobenate dimeglumine)
- and Prohance (gadoteridol)
Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. The reports have not always identified a specific agent. Omniscan was the most commonly reported agent, when a specific agent was identified, followed by Magnevist and OptiMARK.
NSF also has developed after the sequential administration of Omniscan and MultiHance and Omniscan and ProHance. Because reports incompletely describe exposure to gadolinium-based contrast agents, it is not possible to know if the extent of risks for developing NSF is the same for all agents.
Patients should be screened for kidney problems prior to receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again.
There have been no reports of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency.
Bayer Schering Pharma, Berlin, Germany, manufactures Magnevist; GE Healthcare, Chalfont St. Giles, U.K., is the maker of Omniscan; OptiMARK is manufactured by Mallinckrodt, Inc., Hazelwood, Mo.; and ProHance and Multihance are made by Bracco Diagnostics Inc., Princeton, N.J.
Gadolinium is an FDA-approved contrast agent for magnetic resonance imaging (MRI). Gadolinium is also called gadolinium-DPTA and gadodiamide, and it goes by various brand names. Gadolinium is non-radioactive and resembles plain water.
Reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). An MRA test uses magnetic resonance imaging to take pictures of blood vessels. The gadolinium contrast agent is injected into a patient's vein in order to distinguish blood vessels from other nearby tissues.
NSF/NFD is typically characterized by swelling and tightening of the skin, usually limited to the extremities. but sometimes involving the trunk. The condition may develop over a period of days to several weeks. In many cases, skin thickening inhibits the flexion and extension of joints, resulting in painful contractures. In the most severe of cases, affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common.
Once a patient contracts NSF/NFD, the skin changes may start as reddened or darkened patches, papules, or plaques. In time, the skin surface may distort to resemble the texture of the peel of an orange. Some patients may experience burning, itching, or severe sharp pains in areas of involvement. Radiography may reveal calcifications of the soft tissue. NSF/NFD patients can report "bone ache" described in the hips and in the ribs.
Topically, the skin lesions are commonly symmetrical, with zones between the ankles and thighs most commonly involved, followed by involvement between the wrist and upper arms. Hand and foot swelling with blister-like lesions has also been reported in patient with NSF/NFD. Some patients have reported yellow papules or plaques on or near the eyes.
A single U.S. District Court in Cleveland, Ohio has been assigned to handle the discovery phase of all patient injury lawsuits filed in federal courts related to gadolinium and nephrogenic systemic fibrosis (NSF). The move is expected to speed up the legal process for the cases, and could lead to either earlier trials or settlement of the litigation.
The U.S. District Court for the Northern District of Ohio under Judge Dan Polster will oversee the discovery process, with discovery for all federal gadolinium/NSF lawsuits centralized to take place in that jurisdiction. The move is fairly common for cases in which multiple plaintiffs have filed suit against a small number of defendants. The MDL it will streamline the litigation process and enable both plaintiffs and defendants to go through the discovery process once per defendant, rather than for every individual case.
If you or a loved one had an MRI/MRA using a contrast agent to enhance the image, and you developed NFS/NFD, we would be pleased to provide a free, confidential evaluation.
BAYER TRASYLOL
The FDA has suspended marketing of Trasylol, manufactured by Bayer Pharmaceutical. Trasylol (aprotinin injection), an anti-fibrinolytic, is administered to patients during cardiac bypass and other complex heart surgeries to reduce blood loss. Trasylol was using hundreds of thousands of bypass surgeries each year. The FDA suspended marketing of Trasylol after preliminary results from a Canadian study suggested an increased risk of death for Trasylol users compared with two other anti-fibrinolytic drugs. There have also been reports linking Trasylol with kidney problems, educations, heart attacks and strokes.
Bayer has previously said it mistakenly withheld a study of 67,000 hospital records suggesting Trasylol may boost the risk of death, serious kidney damage, congestive heart failure, and stroke. Obviously, that is disturbing and is difficult to understand.
The Goldberg Law Offices are investigating cases involving injuries and deaths related to the use of Trasylol. If you or a loved one received Trasylol and suffered an injury, we would be pleased to provide a free, confidential evaluation.
Digitek Digoxin Recall
Digitek (digoxin tablets)
Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient
Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.
The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate.
Digitalis is a medication prescribed to certain heart patients. Digitalis toxicity is a complication of digitalis therapy, or it may be caused by an acute ingestion of digitalis. Digitalis toxicity can be caused by high levels of digitalis in the body, or a decreased tolerance to the drug. Patients with decreased tolerance may have "normal" digitalis levels. Digitalis toxicity can occur from a single exposure or chronic overmedication, or it may occur in patients with normal blood levels of digitalis if other risks are present. Risks include taking digitalis medications such as digoxin or digitoxin, along with medications that interact with digitalis such as quinidine, verapamil, amiodarone, and others. People with heart failure are commonly given diuretics (medications used to pull excess fluid from the body) along with digoxin. Many diuretics can cause potassium loss. Low levels of potassium in the body increase the risk of digitalis toxicity. Digitalis toxicity may also result from low levels of magnesium in the body.Reduced kidney function will cause digitalis to accumulate in the body rather than being excreted normally through urine. Therefore, any disorders that disrupt kidney functioning (including dehydration) make digitalis toxicity more likely.
Digitalis toxicity can cause nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, heart palpitations, and bradycardia. Bradycardia is a slower than normal heartbeat rate. Vision changes such as halos or light rings around objects, seeing lights and bright colors, experiencing changes in color perception, blind spots in vision, and blurred vision can also occur. Patients can also experience decreased urine output and excessive nighttime urination, overall swelling, decreased consciousness, and difficulty breathing when lying down. At its most severe, death can result from excessive Digitalis intake. There have been several reports of illness and injuries related to the recalled medications
The Goldberg Law Offices are investigating cases involving injuries and deaths related to the use of Digoxin. If you or a loved one received Digoxin and suffered an injury, we would be pleased to provide a free, confidential evaluation.
