People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

"FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings," said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines."

Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

During the past year, FDA has carefully weighed several complex sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.

At this time, FDA has concluded that there isn’t enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly.

The revision of Avandia’s existing boxed warning – FDA’s strongest form of warning – includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients. GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia.

To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

For more information:
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm

FDA Issues Safety Alert on Avandia
www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html

Issues with the leads was first noted in March and physicians were notified. Data accumulated since has prompted Medtronic to stop producing, selling, and distributing the Spring Fidelis leads. Products currently on shelves should be returned to Medtronic.

The defibrillator leads recall does not, however, necessitate the surgical removal of already implanted devices at this time; an adjustment of the defibrillator’s settings is recommended. While the rate of adverse effects is currently less than 1%, it is unknown if this rate will increase as more time passes and leads have been in place for longer.

Adverse effects may include major complications or even death. Medtronic has identified five cases in which the faulty leads may be responsible or a contributing factor in the death of the patient.

Patients currently implanted with affected devices–approximately 268,000 worldwide–should speak with their physicians. A small number of non-Medtronic defibrillators are also fitted with the Sprint Fidelis leads. Patients with another manufacturer’s device that utilize the faulty leads, or those unsure of their leads’ manufacturer, should contact their doctor.

Medtronic’s decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.

These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.

Defibrillators are life-saving products for patients with a heart rhythm abnormality. We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect. However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.

Background:

Today, Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.

Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today’s action.

Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.

When a defibrillator lead is slightly more prone to fracture, it doesn’t mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.

Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don’t know if this rate of adverse events will remain constant or increase over the life of these leads.

FDA considers Medtronic’s action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action. We recognize that some patients and health care professionals might inappropriately interpret the word "recall" to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.

The leads continue to function properly in the vast proportion of patients. Although there is no test to predict which lead will fracture, FDA agrees with Medtronic’s recommendation that defibrillator settings be adjusted at the patient’s next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed.

Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.

Patients should recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients have reason to believe that they have a Sprint Fidelis lead or if they do not know the model of their lead, they should contact their health care professional.

FDA will continue to monitor information on these devices and will take whatever other actions may be necessary.

The Sprint Fidelis leads are used to deliver therapy in defibrillators only, including Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy – Defibrillators (CRT-Ds). Approximately 268,000 Sprint Fidelis leads have been implanted worldwide. This action does not affect Medtronic pacemaker patients.

The U.S. Food and Drug Administration (FDA) intends to issue a public statement regarding Medtronic’s decision at www.fda.gov.

Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of Medicine, Director of Cardiac Electrophysiology, Washington University School of Medicine and President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis.

This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Based on Medtronic’s extensive performance data, Sprint Fidelis lead viability is trending lower than Medtronic’s Sprint Quattro® lead at 30 months (97.7% Sprint Fidelis vs. 99.1% Sprint Quattro). This difference is not statistically significant; however, if the current lead fracture rates remain constant, it will become so over time. Medtronic believes that given this performance trend and its ability to identify the primary fracture locations, this action is in patients’ best interest.

Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output. Based on current information regarding the 268,000 implanted leads, Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.

“There is nothing more important to us than the safety and well-being of patients,” said Bill Hawkins, president and chief executive officer of Medtronic. “We take all matters of product quality very seriously and believe this action is the right thing to do given currently available information.”

Medtronic Outreach to Physicians and Patients

In conjunction with Medtronic’s Independent Physician Quality Panel, Medtronic today communicated, via letter and direct outreach with more than 13,000 physicians worldwide, the Sprint Fidelis lead performance data and updated patient management recommendations for patients who are implanted with Sprint Fidelis leads. These recommendations include device programming and patient management recommendations that will ensure a patient’s device is set to more effectively monitor for potential problems and provide an audible alert in the event of lead fractures.

“Medtronic has acted responsibly to address concerns about the possibility of lead fractures and to minimize harm to patients,” said Kevin Hackett, M.D. of Columbus Cardiology Consultants and member of Medtronic’s Independent Physician Quality Panel. “The Physician Panel has reviewed Medtronic’s data and believes they are taking the correct action.”

Information for Patients

Medtronic recommends that patients, who believe they may have a Fidelis lead, consult with their physicians. It is important to note that Medtronic pacemaker patients are not affected by this action. Medtronic will communicate directly to affected patients and encourage them to contact their physicians for more information. Medtronic has established the following website – www.medtronic.com/fidelis – and a toll-free number (1-800-551-5544 ext. 41835) for patients seeking information.

In addition to being equally effective (and in some cases, superior), side-effects were considered less severe and costs considerably lower. Glucophage (metformin) is available in generic form at about $100 for a year’s supply; a month’s supply of Avandia or Actos can be more than twice that.

Consumer Reports created a users’ guide to the information presented in the study, naming the metformin generic as a CR Best Buy. Users for whom metformin alone is ineffective or not well tolerated should consider either glimepiride (Amaryl and generic) or glipizide (Glucotrol and generic). Consumer Reports argued that only the small number of people for whom all of the preceeding drugs prove unusable should consider Actos or Avandia.

While the safety of Avandia is set to be debated before the FDA on July 30th, the drug’s maker GlaxoSmithKline defended the safety and effectiveness of their product in a July 16 press release, arguing that "Avandia is superior in long-term control of blood sugar over five years compared to metformin." However according to a July 16, 2007 article by CNN, the results come as no suprise to diabetes experts:

The conclusions mirror those of an expert panel that leading U.S. and European diabetes groups convened last year, said Dr. David Nathan, diabetes chief at Massachusetts General Hospital. He has received speaker fees from several diabetes drug makers.

Metformin is "an incredibly inexpensive generic drug, which is why we found it so appealing," Nathan said.

Also See:

"Older drugs are the best choice for most people with type 2 diabetes." Consumer Reports. July 2007. <http://www.consumerreports.org/… .htm> (July 17, 2007.)

"Most people with type 2 diabetes should avoid new, heavily advertised drugs–notably Avandia and Actos–because older medications are cheaper, just as effective, and as safe if not safer, according to a new study and a report based on it from Consumer Reports Best Buy Drugs."

"Analysis: Older, cheaper diabetes drugs get high marks." CNN.com. July 16, 2007. <http://www.cnn.com/2007/HEALTH/conditions/07/16/diabetes.drugs.ap/index.html> (July 17, 2007.)

"The clear winner: metformin, sold as Glucophage and generically for about $100 a year. It works as well as other diabetes pills but does not cause weight gain or too-low blood sugar, the analysis found. It also lowers LDL or bad cholesterol."

Press Release: "GlaxoSmithKline Responds to Reviews of Oral Diabetes Medications." GlaxoSmithKline. July 16, 2007 <http://www.gsk.com/media/press-kits/avandia-16july2007.pdf> (July 17, 2007.)

Bolen, et al. "Systematic Review: Comparative Effectiveness and Safety of Oral Medications for Type 2 Diabetes Mellitus." Annals of Internal Medicine. September 18, 2007, Volume 147 Issue 6.<http://www.annals.org/cgi/content/full/0000605-200709180-00178v1> (July 17, 2007.)

“Conclusions: Compared with newer, more expensive agents (thiazolidinediones, α-glucosidase inhibitors, and meglitinides), older agents (second-generation sulfonylureas and metformin) have similar or superior effects on glycemic control, lipids, and other intermediate end points. Large, long-term comparative studies are needed to determine the comparative effects of oral diabetes agents on hard clinical end points.”

Earlier this spring, The New England Journal of Medicine released a study by Dr. Steven Nissen that analyzed the combined results of 42 clinical trials. Their findings indicated that patients on rosiglitazone experienced an increased risk of heart attack by 43% and other cardiovascular-related deaths by 64%.

In the wake of the study results, the FDA requested that Avandia label get a "black box warning," the most serious warning the FDA can request. Additionally, "Safety alert on Avandia" was issued by the FDA which said, in part:

Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

The House Oversight and Government Reform Committee subsequently held a hearing to debate the FDA’s role in evaluating the safety of Avandia. At the hearing, diabetes expert Dr. John Buse testified to feeling intimidated by drug maker GlaxoSmithKline when he expressed misgivings about the drug’s safety as early as 1999.

According to a June 5 article in The New York Times, Buse wrote a letter in March of 2000 to the FDA in which he "criticized [GlaxoSmithKline’s] marketing, saying it employed ‘blatant selective manipulation of data’ to overstate the drug’s benefits and understate its risks."

The drug’s detractors claim overagressive marketing, both to doctors and direct to consumers, despite GlaxoSmithKline’s awareness of the risks will provide for failure-to-warn lawsuits similar to those resulting from arthritis drug Vioxx. Avandia’s supporters, however, cite several studies that do not show a correlating increase in risk.

Debate will likely increase, both over the safety of Avandia and the effectiveness of the FDA’s procedures surrounding drug approval, specifically, the lacking requirement for subsequent safety and effectiveness evaluations by drug makers after receiving approval to market their drug.

In an interview with USA Today, former deputy director of the Division of Drug Risk Evaluation, Rosemary Johann-Liang, the burden of proof required to call a drug’s safey into question is greater than that required to show its effectiveness:

The FDA approves diabetes drugs such as Avandia if clinical trials show they meet the "surrogate endpoint," or goal, of lowering blood sugar, [Johann-Liang] says, but then doesn’t require makers to do follow-up studies of whether patients actually feel better and live longer.

On the other hand, Johann-Liang says, "if there is a safety issue with the drug, it must be confirmed. I just don’t think that that’s appropriate." As a result, "we’re not doing things in a timely way."

Sources & Further Reading

• Rubin, Rita. "FDA scientist says she was reprimanded for warning." USA Today. June 10, 2007. <http://www.usatoday.com/news/health/2007-06-10-fda-insider_n.htm>. June 29, 2007.
• "FDA Issues Safety Alert on Avandia." FDA.gov. May 21, 2007. <http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html>. June 29, 2007.
• Saul, Stephanie. “Doctor Says Drug Maker Tried to Quash His Criticism of Avandia.” The New York Times. June 2, 2007. <http://www.nytimes.com/2007/06/02/business/02drug.html?…ei=5070>. June 29, 2007.
• Nissen, Steven E., M.D., and Kathy Wolski, M.P.H. “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes.” The New England Journal of Medicine. Volume 356:2457-2471; June 14, 2007; Number 24. <http://content.nejm.org/cgi/content/short/356/24/2457>. June 29, 2007.
• Hearing on FDA’s Role in Evaluating Safety of Avandia. Committee on Oversight and Government Reform. June 6, 2007. <http://oversight.house.gov/story.asp?ID=1325>. June 29, 2007.

Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

FDA’s analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug’s sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.

"FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."

Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product’s labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.

Avandia is manufactured by GlaxoSmithKline, which is based in Research Triangle Park, N.C.

Drugs included in the label warning update are the following 13 products:

• Ambien/Ambien CR (Sanofi Aventis)
• Butisol Sodium (Medpointe Pharm HLC)
• Carbrital (Parke-Davis)
• Dalmane (Valeant Pharm)
• Doral (Questcor Pharms)
• Halcion (Pharmacia & Upjohn)
• Lunesta (Sepracor)
• Placidyl (Abbott)
• Prosom (Abbott)
• Restoril (Tyco Healthcare)
• Rozerem (Takeda)
• Seconal (Lilly)
• Sonata (King Pharmaceuticals)

The FDA recently demanded stricter warnings on the labels of various prescription sleep medications in response to some alarming side-effects. Most notably, some sleeping pill patients have been driving in their sleep; in addition to sleep-driving, those on sleep medications are also completing other “complicated activities” while sleeping, including eating, making phone calls, and having sex.

Over a dozen sleep-driving cases have been reported, according to the FDA, and many more could be going unreported. Rep. Patrick Kennedy is perhaps the best-known example: he crashed his car after taking Ambien and Phenergan (which also acts as a sedative). He had no recollection of the accident.

Another side effect included in the updated warning on drug labels is severe allergic reaction, which can be fatal, and facial swelling. Beyond the updated labeling, doctors will be sent letters detailing the updated warnings and patients will soon be supplied with pamphlets explaining the risks of sleeping pills and steps to take to avoid problems.

If you are currently taking a prescription sleep aid, you should contact your health care provider. The FDA does not recommend discontinuing your medication without first speaking with your doctor.

“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,” said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. “However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks.”

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

• Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
• Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.

Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.

Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labeling include the following 13 products:

• Ambien/Ambien CR (Sanofi Aventis)
• Butisol Sodium (Medpointe Pharm HLC)
• Carbrital (Parke-Davis)
• Dalmane (Valeant Pharm)
• Doral (Questcor Pharms)
• Halcion (Pharmacia & Upjohn)
• Lunesta (Sepracor)
• Placidyl (Abbott)
• Prosom (Abbott)
• Restoril (Tyco Healthcare)
• Rozerem (Takeda)
• Seconal (Lilly)
• Sonata (King Pharmaceuticals)

For more information on the sedative hypnotic products and sleep disorders, visit FDA’s Sedative-Hypnotics Information; also see
FDA information on Sleep Disorders and FDA Insomnia information.

Zyprexa Risks

The following are the risks and side effects associated with Zyprexa therapy. This list is not exhaustive. From the FDA web site, Zyprexa’s risks include:

• A life-threatening nervous system problem called neuroleptic malignant syndrome (NMS). NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS can affect your kidneys. NMS is a medical emergency. Call your healthcare professional right away if you experience these symptoms.
• A movement problem called tardive dyskinesia (TD). Call your healthcare professional right away if you get muscle movements that cannot be stopped.
• High blood sugar and diabetes. Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked often.
• Strokes have happened in older patients treated for mental illness from dementia. Zyprexa is not approved for this use. See FDA Alert.
• Other serious side effects include low blood pressure seen as dizziness, and possibly fainting; increased heart beat; seizures; liver problems; increased body temperature; and difficulty swallowing.
• The most common side effects include sleepiness, dry mouth, dizziness, restlessness, constipation, upset stomach, weight gain, increased appetite, and tremor.

Zyprexa Settlement

Eli Lilly has already agreed to a Zyprexa settlement including some $700 Million to those injured by the drug. In September 2003, the FDA required changes to the Zyprexa warning label to clearly alert the risk of diabetes and hyperglycemia associated with the drug.

Zyprexa Lawsuits: seeking a personal injury lawyer

Do you suffer from diabetes or another condition as a result of Zyprexa? Your injuries as a result of Zyprexa may entitle you to legal compensation.

If you think you have a Zyprexa lawsuit, contact GPW for a free, confidential legal consultation, through our web form or call 1-800-471-3980 now.

For over twenty years, the lawyers of GPW have represented people injured by defective products. Learn more about GPW.