Articles Posted in Product Liability

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According to a report in Bloomberg News, Bayer AG will pay at least $110 million to settle about 500 lawsuits over claims that its Yaz, Yasmin, Ocella lines of birth-control pills caused blood clots, in the first round of case settlement.


Bayer, is based in Leverkusen, Germany, and agreed to pay an average of about $220,000 a case to resolve the claims that its Yaz, Yasmin, Ocella drugs caused venous thrombo-embolism that can lead to heart attacks, deep vein thrombosis, pulmonary embolism and strokes.

The settlements came after federal judge Herndon overseeing the MDL litigation in Illinois postponed Jan. 9 bellwether trials. The complaints alleged that Bayer and some of its units mislead women about the health risks of its birth-control pills.

Stronger FDA Label Change and Warnings

The settlements come as the U.S. Food and Drug Administration April 10 ordered Bayer and other contraceptive makers to strengthen the blood-clot warnings on their products.

Bayer’s Yaz, Yasmin and Ocella, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.

Prior Bayer Settlements

Bayer officials said in a Feb. 28 U.S. Securities and Exchange Commission filing that the drugmaker has settled 70 cases over the Yasmin line of contraceptives.

Those settlements included “terms and conditions which Bayer views to be reasonable,” officials said in the filing. “Bayer will continue to consider the option of settling individual lawsuits in the U.S. on a case-by-case basis.”
In 2011, the U.S. FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives.

The FDA examined data on more than 835,000 women who took pills containing drospirenone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report.

The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).

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An Arkansas judge fined Johnson & Johnson and a subsidiary more than $1.1 billion for downplaying and concealing risks associated with the antipsychotic drug Risperdal.

Judge Tim Fox ruled that Janssen Pharmaceuticals Inc. and its parent company must pay $5,000 for each of 240,000 Risperdal prescriptions the state Medicaid program paid for during a 3½-year period. He also fined the companies $2,500 for more than 4,500 letters Jannsen sent to Arkansas doctors, about $11 million.

Arkansas sued the companies alleging they misled doctors throughout the state in a letter that downplayed Risperdal’s side effects.

Risperdal, introduced in 1994, is a “second-generation” antipsychotic drug that earned Johnson & Johnson billions of dollars in sales before generic versions became available several years ago.

The U.S. Food and Drug Administration in 2004 forced the company to revise the drug’s labeling to reflect increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar.

Dozens of states have since filed lawsuits making claims similar to those in Arkansas. A South Carolina judge upheld a $327 million civil penalty against Johnson & Johnson and Janssen in December. Texas reached a $158 million settlement with the companies in January in which the company didn’t admit fault.

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Tylenol is the most popular pain killer in America, with billions of the tablets and capsules sold each year.


Acetaminophen is the generic name for Tylenol, and is found in well over 200 commonly available over the counter medications, including DayQuil® and Tylenol®.

Acetaminophen-related liver injuries (Acetaminophen Injury) result in over 56,000 emergency room visits each year, 26,000 hospitalizations each year, and over 450 deaths.

Acetaminophen is the number one cause of acute liver failure in the United States. New data and studies reveal that Tylenol (generic names acetaminophen and paracetamol) is associated with varying degrees of liver damage and liver failure.

Acetaminophen Uses

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever.

Acetaminophen may also be used to relieve the pain of osteoarthritis.

The result of an Acetaminophen or Tylenol overdose (and sometimes even from normal dosage) can be devastating. More such cases are being reported in the United States each year.

According to the U.S. Food and Drug Administration (FDA), acetaminophen may be linked to liver damage, liver failure, or death from liver disease.

The FDA has issued limits on the amount of Acetaminophen allowed in any medication as well as mandating that a “black box” warning label be applied to the packaging.

Acetaminophen overdose is the most common form of acute liver failure in the United States today. The US Food and Drug Administration (FDA) currently recommends that anyone consuming more than 3 alcoholic beverages per day should not take acetaminophen or other over-the-counter pain medications.

The Tylenol warning was issued after a research report published in the Journal of the American Medical Association found numerous adverse health effects including:

Liver damage can occur after taking Tylenol for only 4 days
44% of Acetaminophen patients show signs of liver enzyme abnormalities
To prevent liver damage, individuals should take no more than 2 grams of Acetaminophen within 24 hours
Acetaminophen may account for up to 50% of liver injury cases
Risk of overdoses occurring when dieting, drinking alcohol, or mixing medications
Dangers of Tylenol

Tylenol/Acetaminophen was approved as a pain medication in the United States in 1950, and the drug was allowed to go over-the-counter in 1959. Recently the Advisory Committee to the FDA voted that the single adult acetaminophen dose should be reduced from 1,000 mg (two extra-strength Tylenol) to 650mg. The advisory committee expressed concern because many people may unknowingly take multiple combinations of drugs that each contains acetaminophen when they are sick.

In 1975, an extra-strength version of Tylenol was approved by the FDA. Extra Strength Tylenol contains 500 mg of acetaminophen per tablet. When an individual takes two tablets as instructed, he is ingesting 1000 mg or 1 gram of acetaminophen per dose. The maximum daily dose is 4 g or 8 Extra Strength Tylenol.

The label for Extra Strength, states that the individual should take “two Extra Strength Tylenol every four to six hours, but should not exceed eight tablets in a 24-hour period.” If an individual is taking Tylenol every four hours as instructed, they will reach the maximum daily dose in 16 hours, which can lead to potential liver injury. Medical research indicates that the vast majority of people receive pain relief with just the 325 mg Regular Strength Tylenol.

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The FDA made a safety announcement today regarding birth control pills containing Drospirenone and the new label change, that these products may be associated with a higher risk for blood clots.


FDA indicated that it had completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. According to the FDA, drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.

What is Drospirenone

Drospirenone is a synthetic version of the female hormone, progesterone, which also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.

New Warning Label for Drospirenone

The revised drug labels will state that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, and other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.

The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

Bayer Now Settling YAZ Lawsuits

Bayer Healthcare reports that it has reached agreements to settle Yaz and Yasmin deep vein thrombosis and pulmonary embolism lawsuits brought by at least 70 women.

The YAZ product liability lawsuits have been consolidated in the Southern District of Illinois. The judge overseeing he MDL litigation, ordered that the bellwether trials been postponed, the bell-wether trial were scheduled for April and now are moved out to June 2012.

Bayer continues to face about 11,300 additional claims in federal court by women who have suffered serious and fatal injuries, allegedly caused by their popular birth control pills.

Bayer has indicated that they are continuing to consider settling lawsuits on a case-by-case basis. Women injured by the drugs are pursuing compensation from Bayer through a Yaz lawsuit or Yasmin lawsuit, alleging that the drug maker failed to adequately warn about the increased risk of blood clots and other serious injuries.

Drospirenone was first introduced in Yasmin birth control by Berlex Laboratories, which was later acquired by Bayer. Yaz is an updated version of the birth control pill, and Bayer recently introduced a third variation, marketed as Beyaz, which also includes a folate supplement.

Earlier this year, the federal judge presiding over all lawsuits filed in U.S. District Courts throughout the United States ordered Bayer and plaintiffs’ lawyers to engage in Yaz settlement negotiations before the first cases are submitted to a jury.

Known as bellwethers, those early trial dates are often used to facilitate discussions to settle other lawsuits, and may help the parties gauge how juries are likely to respond to evidence that is likely to be introduced in multiple cases.

Generic versions of Yaz and Yasmin are also now available from other manufacturers, including Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah.

FDA Recommendation

The FDA recommends that women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

The FDA recommends that healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online:
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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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.


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.


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.


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.


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.


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.


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.