Articles Posted in Product Liability

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Federal drug regulators are expanding the warnings over the potential heart risks of Celexa, with new dosing instructions for the elderly and people with liver problems.

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The FDA issued a new Celexa drug safety communication on March 28, limiting the maximum dose as 20 mg for patients over the age of 60. The limit is also recommended for patients with liver problems, who are taking the anti-ulcer medication Tagamet, or who are poor CYP2C19 metabolizers or are taking a CYP2C19 inhibitor.

Celexa (citalopram hydrobromide) belongs to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), and is approved for the treatment of major depression. Celexa is often used off-label to treat other psychological disorders. Celexa is available in brand name form or as a generic in 10 mg, 20 mg and 40 mg tablets, as well as a 10 mg/5 mL oral solution.

The new dosing recommendations are an update of an earlier August 2011 FDA warning of Celexa side effects that could affect the heart rhythm. The agency stated that Celexa should no longer be given at doses exceeding 40 mg per day.

The FDA warned patients who are currently taking Celexa, if their dose is greater than 40 mg per day to seek immediate care if experiencing an irregular heartbeat, shortness of breath, dizziness or fainting.

The FDA says it expanded the recommendations because some patients may still need to take Celexa despite the heart risks. The new label change affects people with congenital long QT syndrome, an abnormal heart rhythm condition, and states that the drug is not recommended for them.

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According to federal drug regulators, Merck failed to conduct requested testing on their popular diabetes drugs Januvia and Janumet, which was designed to assess the risk of pancreatis from Januvia and Janumet.

The FDA issued a warning letter to Merck on February 17, and the FDA indicated that Merck failed to comply with proper testing for Januvia and Janumet, and therefore the drugs are now considered misbranded.

Merck promised to conduct the three-month pancreatic safety study when the FDA expanded approvals for Januvia and Janumet.

Merck agreed to have a final protocol for the studies to the FDA by June 14, 2010. The study was supposed to be complete by March 15, 2011, and a final report should have been to the FDA by June 15, 2011.

The letter orders Merck to submit a plan for the study to the FDA within 30 days of the warning letter’s issuance. The trial has to start within six months of the agency’s approval of the plan.

Januvia (sitagliptin) is a medication approved for the treatment of adults with Type-2 diabetes. It is one of the first in a new class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors, Janumet combines Januvia with metaformin.

The FDA made the requirements following increasing concerns over a Januvia pancreatitis risk three years ago.

In September 2009, FDA recommended that doctors monitor patients carefully for signs of pancreatitis from Januvia and Janumet after starting treatment or increasing dosage. The agency found that in 58 of the 88 cases of pancreatitis Januvia and Janumet users required hospitalization, and four required treatment in intensive care units (ICU).

A 2011 Januvia pancreatic cancer study also found indications that the drug may increase the risk of pancreatitis and pancreatic cancer.

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According to new medical research, Byetta and Januvia may cause increased risk of pancreatitis and pancreatic cancer.

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A medical study in 2011 found that users of Januvia and Byetta may be six times more likely to be diagnosed with pancreatitis and three times more likely to develop pancreatic cancer.

Byetta (exenatide) is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. In recent years, FDA adverse event reports have raised concerns about a link between Byetta and pancreatitis, including severe cases of necrotizing pancreatitis and hemorrhagic pancreatitis, which have resulted in several deaths.

Concerns about pancreatitis from Byetta first arose in 2007, when the FDA issued an alert indicating that the drug had been linked to at least 30 reports of acute pancreatitis. In August 2008, the FDA notified doctors about six more cases of severe pancreatitis with Byetta, including two deaths. Following the FDA announcement, the drug makers disclosed that they were aware of at least four other pancreatitis deaths among Byetta users.

Januvia is a newer drug approved for the treatment of adults with Type-2 diabetes. It is one of the first in a new class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors. Januvia has rapidly become a strong selling medication for Merck.

In September 2009, FDA recommended that doctors monitor patients carefully for signs of pancreatitis from Januvia and Janumet after starting treatment or increasing dosage. The agency found that in 58 of the 88 cases of pancreatitis Januvia and Janumet users required hospitalization, and four required treatment in intensive care units (ICU).

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An initial conference has been set for April in the federal multidistrict litigation (MDL) involving all lawsuits over Wright Medical metal-on-metal hip replacements.

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In February, the U.S. Judicial Panel on Multidistrict Litigation centralized the Wright Medical hip replacement lawsuits in the U.S. District Court for the Northern District of Georgia.

According to a Pretrial Order issued March 19, the Court is expected to review issues surrounding the organization of the MDL, a deadline for discovery and pretrial motions, as well as a target date for the conclusion of the MDL.

When the Wright Medical hip replacement MDL was formed in February, 16 cases involved problems with the Wright Conserve hip system or related artificial hips.

All of the complaints involve similar allegations that Wright Medical manufactured and sold a defective metal-on-metal hip replacement system, known as the Conserve hip, which has failed in many patients within a few years.

The Wright Medical Conserve hip features a metal-on-metal design, which consists of cast cobalt chromium molybdenum cup that provides the receptacle for the cobalt chromium molybdenum femoral head. The metal femoral head rotates within the metal monoblock Conserve Cup, which does not have a plastic liner.

Plaintiffs allege that the design results in the release of metal particles, through the grinding actions of the ball and socket, that can cause metal toxicity in the blood, soft tissue and bone. According to the complaints, this can result in metallosis, tissue necrosis, and pseudotumors.

The allegations are similar to those raised in hundreds of DePuy ASR lawsuits and DePuy Pinnacle lawsuits, which involve metal-on-metal hip replacement systems manufactured by a subsidiary of Johnson & Johnson.

In May 2011, the FDA asked the manufacturers of all metal-on-metal hip replacements to provide additional information on the level at which the metal particles released by the hip replacements become dangerous, how much metal they actually released and what the potential side effects of the metal hip replacements are.

On February 28, Britain’s health agency, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued new guidance stating that patients who have received large-head metal hip implants should have blood tests to check for problems from their metal-on-metal hips every year for the rest of their lives.

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As reported in the New York Times, Johnson & Johnson executives in 2009 phased out their ASR hip implant and sold off their inventory just weeks after the Food and Drug Administration asked the company for added safety data about the implant.

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At the same time, the federal regulators told the company that blood tests of some patients who got the all-metal hip showed a “high concentration of metal ions” that it found “concerning.” These concerns were highlighted in the F.D.A. letter, obtained by The New York Times under the Freedom of Information Act.

Officials expressed concern that reports showed that the ASR was performing “somewhat more poorly” than data submitted by the company’s DePuy Orthopaedics unit indicated. By mid-2009, data from the UK and Australia showed that the device was failing at high rates just a few years after implantation, rather than lasting 15 years as expected.

The Food and Drug Administration’s letter notified DePuy in 2009 that it was turning down the company’s application to sell the device in the United States.

DePuy did not recall the device at issue, or another model that was used in this country, until August 2010, a year after it got the administration’s letter. According to company records, in September 2009, shortly after the letter, company executives started a strategy to phase out the devices while selling their remaining stocks for use in patients both here and abroad.

After receiving the letter, Johnson & Johnson’s DePuy Orthopaedics started to phase out the ASR line, while trying to quickly sell remaining stock and convince doctors to begin using other DePuy products. At that time, the manufacturer denied that there were any safety concerns with the hip, and suggested that the product was being phased out because of declining sales. It is unknown how many patients got the hip model, known as an articular surface replacement and sold under the trademarked name ASR, during that year.

Hundreds of ASR patients have suffered crippling injuries caused by particles of metallic debris generated as the all-metal implant surfaces grind against each other. This medical condition is called metallosis.

Thousands of patient lawsuits are proceeding against DePuy in connection with the ASR.

Last month, after an article in The New York Times disclosed DePuy’s receipt of the administration’s letter, the company’s chief executive, Andrew Ekdahl, defended DePuy’s 2009 decision not to disclose the letter to doctors or patients.

The version of the device that the administration declined to approve for the United States was used abroad only in an alternative hip replacement procedure known as resurfacing. Both models were based on the same component, a metal cup replacing a patient’s hip socket, which experts say was flawed in design.

The version used in traditional surgery was cleared by the Food and Drug Administration in 2005 through a regulatory pathway that did not require it to undergo clinical studies. Today, that device is failing prematurely at even higher rates than the one the administration would not approve, according to data from patient registries in Britain.

To phase out the device, DePuy executives started a strategy to end the model’s production and to sell off its existing stocks while persuading orthopedic surgeons to switch to other implants from the company.

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According to a report by Bloomberg News, Johnson & Johnson sold their Gynecare Prolift mesh for several years before obtaining FDA approval. Johnson & Johnson has been subjected to product liability lawsuits brought by women who suffered complications allegedly caused by design defects with the vaginal surgical mesh.

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Johnson & Johnson’s Ethicon unit began selling the Prolift mesh in March 2005, but it was not approved by the FDA until May 2008.

Johnson & Johnson sold the Gynecare Prolift mesh without approval, and claimed that it was substantially similar to the Gynecare Gynemesh, which was already on the market.

The Ethicon Gynecare Prolift mesh is one of a number of surgical mesh products manufactured by Johnson & Johnson, that are the subject product liability lawsuits nationwide.

Thousand of Lawsuits

Thousands of women are filing lawsuits, claiming that they suffered painful and debilitating complications after the vaginal mesh was implanted, such as pelvic pain, infection and erosion of the mesh through the vagina.

All vaginal mesh lawsuits involve similar allegations that the manufacturers failed to adequately research and test their products. Furthermore they claim, rushing the products to the market through the FDA’s controversial fast-track approval system, known as the 510 (k) process, which allows the agency to approve medical devices without rigorous pre-market testing when they feature a substantially similar design to other previously approved products.

FDA 510 (k) Process

Johnson & Johnson reportedly failed to obtain 510(k) approval before marketing the Gynecare Prolift mesh.

FDA Warning

In July 2011, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.

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Canadian health regulators have added new label warnings to Pradaxa, the new blood thinner. In Canada it is known as Pradax. The regulators are warning that the risk of bleeding events may be increased among patients with kidney problems.

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The Pradaxa warnings were announced on March 16, and recommend that all patients should have their renal function assessed before starting Pradaxa, and that doctors should assess any changes in renal function while on the treatment, especially among patients over 75 years old.

Health Canada indicated that use of Pradaxa was not recommended for patients with rheumatic valvular heart disease, especially mitral stenosis, or patients with prosthetic heart valves, as the safety and efficacy of Pradaxa has not been studied among those patients.

Pradaxa (dabigatran) is a new blood thinner, which was touted by Boehringer Ingelheim as a superior alternative to Coumadin (warfarin) for prevention of strokes among patients with atrial fibrillation.

There are concerns about the risk of serious and potentially fatal bleeding events from Pradaxa among the medical community in the United States. Since the medication was introduced in the U.S. in October 2010, hundreds of deaths have been reported among Pradaxa users who experienced internal bleeding or hemorrhages that doctors were unable to stop.

No Antidote for Pradaxa

There is no antidote to the bleeding side effects of Pradaxa, short of dialysis.

Institute for Safe Medication Practices Report

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of Pradaxa hemorrhages were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group. At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin/Coumadin, which was second on the list.

FDA Investigates

In December 2011, the FDA announced that it was evaluating post-marketing reports on the Pradaxa bleeding events to determine if there is anything abnormal about the side effects of Pradaxa, and whether the anticoagulant may pose an unreasonable risk for certain consumers.

Pradaxa Lawsuits

Some lawsuits have been filed throughout the United States after patients have experienced severe bleeding problems. The lawsuits allege that Boehringer Ingelheim failed to adequately research the side effects of their medication. When it became apparent that the risk of bleeding events were causing a number of serious injuries throughout the United States, the drug maker should have provided stronger warnings or issued a Pradaxa recall, according to many of the complaints filed.

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New medical research suggest that the popular diabetes drugs Byetta and Januvia could increase the risk of pancreatitis and pancreatic cancer.

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In a study published this summer in the medical journal Gastroenterology, researchers from the University of California, Los Angeles (UCLA) found a nearly threefold increase in reported cases of pancreatic cancer and a sixfold increase in reported cases of pancreatitis among Byetta and Januvia users.

Researchers also found an increase in thyroid cancer among Byetta users.

The study used data from the FDA’s adverse event reporting system from 2004-2009 to find reports of problems with Januvia and Byetta submitted by doctors and patients who took the drugs.

Prior studies done on rats have also suggested a potential link between the two drugs and pancreatitis, which is an inflammation of the pancreas. Severe cases, involving necrotizing pancreatitis or hemorrhagic pancreatitis, can cause severe bleeding, multi-organ failure or death.

Byetta (exenatide) is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. In recent years, FDA adverse event reports have raised concerns about a link between Byetta and pancreatitis, including severe cases of necrotizing pancreatitis and hemorrhagic pancreatitis, which have resulted in several deaths.

Concerns about pancreatitis from Byetta first arose in 2007, when the FDA issued an alert indicating that the drug had been linked to at least 30 reports of acute pancreatitis. In August 2008, the FDA notified doctors about six more cases of severe pancreatitis with Byetta, including two deaths. Following the FDA announcement, the drug makers disclosed that they were aware of at least four other pancreatitis deaths among Byetta users.

Amylin and Eli Lilly currently face a number of Byetta lawsuits involving allegations that they failed to adequately research their medication and warn about the risk of pancreatitis or other side effects of the diabetes drug.

Januvia is a newer drug approved for the treatment of adults with Type-2 diabetes. It is one of the first in a new class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors. Januvia has rapidly become a strong selling medication for Merck.

In September 2009, FDA recommended that doctors monitor patients carefully for signs of pancreatitis from Januvia and Janumet after starting treatment or increasing dosage. The agency found that in 58 of the 88 cases of pancreatitis Januvia and Janumet users required hospitalization, and four required treatment in intensive care units (ICU).

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A medical study published in the British medical journal, Lancet, has identified that all-metal on metal artificial hips fail more often than other designs. This confirmation has increased concerns about the implants and the researchers are calling for a ban.

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British experts at the world’s biggest artificial joint registry said doctors should stop using metal-on-metal hip replacements, citing an analysis showing they have to be fixed or replaced more often than other implants.

The medical analysis in The Lancet, was published recently after Britain’s medical regulators said nearly 50,000 Britons with metal-on-metal hips needed annual check-ups to monitor for problems, including exposure to toxic metals.

Metal on Metal Hips were supposed to be more durable

Metal-on-metal hips were designed to be more durable than traditional implants, which consisted of a ceramic or metal ball with a plastic socket.

But medical investigation suggests they may actually do worse, leading to the recall of the ASR device made by Johnson & Johnson that experts argue should never have been allowed on the market in the first place.

Women with higher failure rates

According to the researchers, data from the study now reveals that there is a 6.2 percent chance patients with all-metal hips will need a replacement within five years – some three times greater than the revision rate seen with older implants.

And to complicate matters further, the rate was particularly high with larger-head implants and those used in women, in whom failure rates were up to four times higher.

Stringent Regulation demanded

Art Sedrakyan of Cornell University said the problem revealed weaknesses in the regulatory systems in both the UK and US due to “outdated and low-threshold regulatory pathways”.

New monitoring guidelines in UK

Under the new guidelines from Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA), doctors are being advised to consider removing and replacing implants if patients have abnormal MRI scans or if metal ion levels in the blood reach worrying levels.

The study follows findings reported last month that hundreds of thousands of people worldwide may have been exposed to high levels of toxic cobalt and chromium ions that can seep into tissues and destroy muscle and bone, leaving some patients with long-term disability, according to an investigation by the British Medical Journal and the British Broadcasting Corp.

Other companies that make metal-on-metal hip implants include Zimmer, Wright, Stryker, Corin and Biomet.

Read more here and visit our website for more information.

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Federal lawsuits against Wright Medical Technology, a manufacturer of metal-on-metal hip-replacement is now being consolidated in Multi district Litigation (MDL). Wright Medical Technology’s Conserve Plus implants are under assault for causing injuries similar to those produced by the DePuy ASR and Pinnacle metal on metal hip system.

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This is one of three MDLs organized to consolidate pre-trial proceedings for plaintiffs suing over dangerous and defective metal on metal hip implants. The Wright Conserve MDL has been consolidated in the U.S. District Court for the Northern District of Georgia.

DePuy ASR MDL

In the United States, more than 3,500 lawsuits have been filed over DePuy ASR hip metal on metal replacement systems, and litigation has been underway over the past 18 months in the U.S. District Court for the Northern District of Ohio. The DePuy ASR hips were recalled by Johnson and Johnson in August 2010.

DePuy Pinnacle MDL

In the Northern District of Texas, Dallas, another MDL has been organized for more than 900 patients filing suits over the DePuy Pinnacle hip replacement metal on metal systems. These DePuy Pinnacle metal on metal hips have yet not been recalled. Johnson and Johnson considers the DePuy Pinnacle to be their flagship product.

Wright Metallosis and Early Replacement

Plaintiffs allege that they were not warned about the real risk of early failure of the medical devices. Additionally, they have suffered from metallosis, a medical condition of high blood levels of chromium and colbalt. This occurs as a result of metal particles produced when the metal ball and metal socket of the hip implant grind against each other. The metal particles also damage local muscle and tissue, and may lead to cancer.

The National Joint Registry for England and Wales released its Eighth Annual Report in September 2011 and found that Wright Conserve’s revision rates were second only to the ASR devices manufactured by DePuy.

Types of Wright Hips Affected

The Wright Conserve hip-replacement system includes the Conserve Femoral Surface Replacement, the Conserve Plus Total Resurfacing Hip System, the Conserve Total A-Class Advanced Metal and the Conserve Total Hip System.

The system was approved by the U.S. Food and Drug Administration (FDA) through its 510(k) process, a fast track to market process.

Concerns over Metal on Metal Hips

Several thousand metal on metal hips have been implanted over the past 10 years and only a fraction of those defective hips are seeing the light of litigation. This means that there are many thousands of defective hips out there, with folks unaware of the litigation, who are having problems. And the manufacturing companies and their implanting doctors are not letting the patients know of these problems. I get calls every day from folks who did not realize that there was a recall with the DePuy ASR or about metallosis in general. The message needs to get out.

Read more here and visit my website for more information.