Articles Posted in Product Liability

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Many more Yaz injury plaintiffs are being added to the growing YAZ multidistrict litigation (MDL) against Bayer, but this time it’s not for deadly blood clots or a heart attack.

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Plaintiffs are litigating against Bayer Healthcare because they suffered severe gallbladder disease, one of the many side effects from this oral contraceptive.

Plaintiffs are claiming gallstones, cholecystitis (inflammation) and biliary dyskinesia, as disorders that disrupts the emptying and filling of the gallbladder. Most plaintiffs eventually end up get a cholecystectomy or gallbladder removal.

Is Drospirenone the Culprit?

Yaz was heavily touted as a safe birth control that also helped control acne, premenstrual weight gain and moodiness. But multiple medical studies have shown that the drug often causes problems that includes deadly blood clots, heart attacks, pulmonary embolisms and gallbladder disease.

Like most birth control pills, Yaz is made from a synthetic estrogen and synthetic progesterone. The problem is that this new formulation of synthetic progesterone, drospirenone, is linked to many medical problems, one of which is gallbladder disease.

According to experts, the drug causes gallbladder disease because it is known to raise potassium levels, has a severe diuretic effect and because drospirenone is found to decrease bile flow and impede the gallbladder’s natural functions.

YAZ’s manufacturer, Bayer, denies and defends all research pointing to the Yaz-gallbladder disease connection, that studies have shown the correlation between the two.

YAZ Victims Waiting on Settlement

Most people who have severe gallbladder problems, undergo laparoscopic surgery. While rare, gallbladder surgery can cause fat malabsorption and diarrhea for years to come.

Today, an estimate 11,000 Yaz victims have filed lawsuits against Bayer, in federal court. Many suffered deadly embolisms, heart attacks and blood clots from the drug. The majority of the cases, up tp 75%, suffered from gallbladder disease.

Plaintiffs allege that Bayer was negligent in the design and manufacturing of the drug. They also contend that Bayer failed to warn patients and medical professionals about the Yaz dangers.

The court cases had been scheduled to start earlier this year but the judge overseeing the MDL ordered mediation instead with the hopes of a possible out-of-court settlement. If the cases can not be successfully mediated in the coming weeks, MDL proceedings will continue.

Bayer is in the process of settling the venous thromboembolism cases, deep venous embolism, pulmonary embolism and stroke, but is not offering any settlement or discussion regarding the gallbladder injury cases.

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Natazia (estradiol valerate and estradiol valerate/dienogest), a fourth generation oral contraceptive made by pharmaceutical giant Bayer HealthCare Pharmaceuticals, Inc, was FDA-approved on March 15, 2012, for the treatment of heavy menstrual bleeding.

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In February 2012, the FDA gave Natazia a Black Box Warning regarding “Thromboembolic Disorders and Other Vascular Problems.” The warning states:

“Data from a large, prospective cohort safety study of various COCs (combined oral contraceptives) suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.”

Bayer’s History with Yaz, Yasmin and Ocella

Natazia is a four-phasic oral contraceptive approved by the FDA on May 6, 2010. Bayer’s other controversial contraceptives include YAZ/Yasmin, are the subject of thousands of personal injury lawsuits alleging that YAZ/Yasmin are associated with increased risk of blood clots (deep vein thrombosis (DVT), pulmonary embolism (PE)) and gallbladder problems.

Natazia is associated with many of the same problems. The following safety information was included in a press release from Bayer following the release of Natazia on the US market, in 2010: “The use of Natazia is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, hypertension, ruptured ovarian cyst and uterine leiomyoma. The excess risk of thromboembolic events is highest during the first year of use of COC.”

Bayer became the first company to launch estradiol valerate together with the progestin, dienogest—as the contraceptive Natazia.

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According to a medical study, patients who received metal-on-metal hip replacements are at no greater risk of developing cancer after a seven-year period than the general population.

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The research is published in the British Medical Journal, and recommends that longer-term review is needed of the effect of metal particles released from the implants, because some tumors take many years to develop.

The BMJ and the British Broadcasting Corp. said Feb. 28 that a joint investigation showed patients with the metal-on-metal implants may have been exposed to toxic metals that can cause long-term disability.

According to U.K. researchers in the medical journal The Lancet on March 12, the devices were more likely to fail than others and should be banned,
The study reviewed 40,576 patients with metal-on-metal hip implants and 248,995 patients with alternative bearings and their incidence of cancer based on hospital admissions.

Patient data came from the National Joint Registry of England and Wales, which collects information about hip, knee and ankle joint replacement procedures, and the U.K.’s National Health Service.

Using computer models, the study found that patients with metal implants had a lower rate of cancer than their non-metal counterparts and the general population.

Manufacturers of the devices include Johnson & Johnson (JNJ), Zimmer Holdings Inc. (ZMH) and Smith & Nephew Plc.

According to medical experts, the long-term biological effects of implants made from metals such as cobalt and chromium are unknown. Metal ions, which can cause irreversible damage to DNA in cells, have been found in many organs following hip replacements, including marrow, blood, liver, kidneys and bladder, the study said.

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The blood thinner Pradaxa, (subject of 6 wrongful death US lawsuits), according to a new FDA report, may have been responsible for another 117 deaths during the second quarter of 2011.

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The Institute for Safe Medication Practices (ISMP) published their quarterly report (PDF) earlier this week on adverse event reports between April and June 2011.

Pradaxa (dabigatran) is associated with more adverse reported cases than any other regularly monitored drug, the anticoagulant had been on the market for less than a year at the time.

Pradaxa was associated with 856 reports of serious, disabling or fatal injury in the second quarter of 2011, including 117 patient deaths on Pradaxa and 511 cases of Pradaxa bleeding events.

Most of the reported hemorrhages involved patients over 80 years old.

Pradaxa (dabigatran) was released by Boehringer Ingelheim in the United States in October 2010, as a superior alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillation. It is the first approved anticoagulant from in a new class of medications, known as “direct thrombin inhibitors,” which blocks the enzyme pathway that causes blood to clot.

FDA Investigates

The United States Food and Drug Administration has issued a safety announcement about the anticoagulant drug dabigatran, marketed as Pradaxa®. This information is based on the FDA’s review of post-marketing reports of serious, and even fatal, bleeding events in patients taking Pradaxa®. The possible increased risk of serious bleeding events with Pradaxa® is confirmed by epidemiologic studies. A recent study also found an increased risk of heart attack or acute coronary syndrome with Pradaxa® as compared to other treatments.

No Antidote for Pradaxa

These medications are promoted as superior alternatives to Coumadin/warfarin because they require less monitoring. Users of warfarin who suffer internal bleeding can be treated with Vitamin K injections, blood and fresh frozen plasma infusions to reverse the blood thinning effects. Unfortunately, Pradaxa and the other newer blood thinners in the same class do not have an antidote and bleeding side effects can only be treated by dialysis.

Concerns over deaths linked to Pradaxa has caused alarm and safety investigations in the U.S., Europe and Canada. An increasing number of people throughout the United States are also now pursuing a Pradaxa lawsuit, alleging that the drug maker failed to adequately research the medication or warn about the serious and potentially life-threatening side effects.

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A New Jersey State court will begin the first bellwether trial for NuvaRing lawsuits in February of 2013. These bellwether trials will reach a jury, out of hundreds of cases brought by women who allege the birth control ring increases the risk of blood clot (venous thromboembolism) injuries.

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A group of nine cases are being prepared for trial dates in New Jersey state court, where the NuvaRing litigation has been consolidated for “mass tort” treatment before Judge Brian Martinotti in Bergen County.

According to a case management order, the first trial date is scheduled for February 4, 2013.

There are currently more than 125 NuvaRing cases consolidated in New Jersey state court, and a second group of 10 lawsuits, including five selected by each side, are being prepared for another round of trial dates that are expected to begin in February 2014.

All of the complaints involve allegations that Merck and their Organon subsidiary failed to adequately research the birth control ring or warn that side effects of NuvaRing may increase the risk of blood clots when compared to certain oral birth control pills.

Plaintiffs claim that they have suffered blood clot injuries from NuvaRing, including deep vein thrombosis, pulmonary embolism, heart attack and stroke.

About 800 complaints have been filed in the federal court system, where they are consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Eastern District of Missouri.

No firm trial dates have been set in the federal NuvaRing MDL, it is possible that the first cases could be presented to a federal jury by late 2012 or early 2013. The federal court has asked the parties to submit proposed plans for alternative dispute resolution before any trials, which would be designed to assist the parties in negotiating potential NuvaRing settlements.

These early trial dates, known as bellwether trials, are often scheduled in mass tort litigation to help the parties get a sense of how juries are likely to respond to certain evidence, arguments and testimony that will be repeated throughout many other cases.

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There is a new warning from the U.K. health officials, that states patients who received combination DePuy MITCH and Stryker Accolade metal-on-metal hip replacement components are experiencing a high failure rate.

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The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert (pdf) on April 2, stating that there is an increased rate of revision surgery among patients who had a DePuy MITCH acetabular cup/modular head used in combination with uncemented Stryker Accolade femoral stems.

The MHRA is advising orthopedic surgeons not to use the components together and to follow up on all patients implanted with the combination of DePuy and Stryker components as part of a metal-on-metal total hip replacement.

The warning was issues, following an analysis of data from the England and Wales National Joint Registry (NJR), which discovered a cumulative revision rate of 8.8% for MITCH TRH hip resurfacing systems.

This is higher than what the U.K. National Institute for Health and Clinical Excellence (NICE) considers acceptable, and when the DePuy MITCH hip is combined with the Accolade femoral stems, the failure rate increases to 10.7%.

MHRA indicated that patients who received the implant combination should be tested annually for signs of elevated cobalt and chromium blood levels from the hip replacement, which could indicate that they are suffering from metallosis.

Patients who have elevated cobalt and chromium blood levels, are recommended that they should get a second blood test three months later. The elevated level of metal ions indicates the potential for soft tissue damage, especially if the number is rising.

In cases where high levels of metal ions are detected, MHRA recommended that the patient undergo an ultrasound or magnetic resonance imaging to look for potential damage.

The MITCH TRH components were manufactured by Finsbury Orthopaedics and distributed by Stryker in the U.K. from May 2006 through October 2011. Finsbury was acquired by DePuy Orthopaedics in 2009, which is a subsidiary of Johnson & Johnson.

The warning is another nail in the coffin for metal-on-metal hip resurfacing and replacement systems, which have been the target for an industry-wide metal-on-metal hip recall.

In August 2010, a recall for the DePuy ASR metal-on-metal hip system was issued after it was discovered that about one out of every 8 of the hip implants were failing within five years of surgery. More than 3,500 people throughout the United States are now pursuing a DePuy ASR hip lawsuit after experiencing problems with the implant.

Similar product liability lawsuits have also been filed over problems with other metal-on-metal hip systems, such as the DePuy Pinnacle, Wright Medical Conserve Plus and the BioMet M2A-Magnum.

In May 2011, the FDA asked device manufacturers to obtain more information about the danger level of the metal particles released by hip replacements, how much metal they actually release and the potential side effects of metallosis.

Last week, the FDA announced that an independent panel of experts will review the safety concerns with metal-on-metal hip replacement and resurfacing systems, and make recommendations about any regulatory actions that should be taken to protect consumers from the risks associated with cobalt and chromium that may be released into the body.

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In December of 2011, The U.S. Food and Drug Administration (FDA) issued a safety announcement, that it was “evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate).

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Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.”
Pradaxa Side Effects

According to an FDA podcast released 12/7/2011 the FDA is studying reports that there have allegedly been hundreds of reports of severe side effects linked to Pradaxa usage, especially in the elderly.

The side effects of Pradaxa include severe bleeding that may result in a heart attack, stroke, death, brain hemorrhage, gastrointestinal bleeding and kidney bleeding.

The FDA has not made any determinations about the future of this product other than issuing other cautionary statements to physicians.

New Anti Clotting Drugs on the Horizon

A new drug shown to be better than warfarin at preventing strokes in patients with atrial fibrillation may reach the U.S. market more quickly after health regulators gave it an expedited review.

Eliquis, from Bristol-Myers Squibb Co and Pfizer Inc, would be the third new U.S. treatment for these patients after Xarelto, from Bayer and Johnson & Johnson, was approved, and Pradaxa from Boehringer Ingelheim.

The U.S. Food and Drug Administration typically takes 10 months or longer to review new drug applications but will give Eliquis a quicker review after clinical trials showed the drug was safer and more effective than decades-old warfarin.

According to Bristol and Pfizer, the FDA is expected to give a decision on approval by June. That would close the gap in the three-way race, as the new treatments compete in an estimated $10 billion market.

Stroke Risk with Atrial Fibrillation

Atrial fibrillation affects more than 2 million Americans. The cardiac arrthymia condition causes blood to pool in the heart and form blood clots, which then travel to the brain, raising the risk of stroke.

There is little safety data with the new drugs on big groups of patients, including the elderly, people with impaired kidney function and patients with significant valvular heart disease.

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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).