Articles Posted in Product Liability

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A Tennessee man has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage.


According to the complaint, Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects may be irreversible.

The plaintiff alleges that he was prescribed Pradaxa, and after 2 months of use, he suffered a cerebral hemorrhage, as well as other severe personal injuries which are permanent in nature.

Pradaxa FDA Approval

Pradaxa was approved by the U.S. Food & Drug Administration (FDA) in October 2010 and is one of a number of new blood thinners that have been touted as a superior alternative to warfarin.

Both warfarin and Pradaxa pose a risk of serious bleeding. But warfarin bleeding can be stopped with the administration of vitamin K or a drug called recombinant factor VIIa. There is currently no practical antidote for Pradaxa bleeding.Pradaxa bleeds cannot be stopped since there is no known reversal antidote for this drug.

Pradaxa 260 Deaths

Last year, Boehringer Ingelheim, acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa.

The Institute for Safe Medicine Practices (ISMP) reported that Pradaxa was associated with a total 856 reports of serious, disabling or fatal injury, including 117 bleeding deaths, in the second quarter of 2011.

FDA Investigates Pradaxa

The FDA launched a review of Pradaxa in December over reports of bleeding-related side effects, while regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa.

Pradaxa the Hits keep coming

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According to Bayer AG, the German pharmaceutical giant has shelled out $142 million so far, in settlements of U.S. lawsuits claiming that its Yaz, Yasmin and Ocella line of birth-control pills caused blood clots.


Bayer, said today in its Stockholders’ Newsletter for the first quarter, that it has resolved 651 cases alleging its Yasmin and Yaz contraceptives caused blood clots that can lead to heart attacks, deep vein thrombosis, pulmonary embolism and strokes.

The company said it paid $142 million in the settlements, for an average of about $218,000 a case.

According to experts, Bayer’s strategy is to avoid the possibility of a large jury award in these clot cases; settlements provide a fixed and determinable amount when it comes to the cost of resolving these cases.

Bayer’s Hit could be as high as $2.65 Billion

Bayer’s update comes after financial analysts estimate that the drugmaker may have to pay more than 2 billion euros ($2.65 billion) to resolve all the cases over the contraceptives.

FDA New Warning Label

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

FDA Drospirenone Blood Clot Triple Risk

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

The FDA examined data on more than 835,000 women who took pills containing drospirenone, including Bayer’s Yasmin line.

Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health.

Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them one of the drugmaker’s biggest-selling drugs.

Federal 11,900 Suits

As of April 18, Bayer faced 11,900 lawsuits over Yaz and Yasmin in the U.S. involving about 14,000 plaintiffs, the company said.

YAZ Gallbladder Cases

Bayer is rejecting women’s claims that the contraceptives damaged their gallbladders or caused them to suffer from gallstones.

Yasmin Bellwether Trials on Hold

The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings.

The Judge David R. Herndon, of the U.S. District Court for the Southern District of Illinois, extended a stay for the bellwether process on April 19, delaying all deadlines for the third time this year.

The bellwether process was established in the Yaz MDL to allow the parties to prepare a small group of cases for early trial dates and help gauge how juries are likely to respond to certain evidence that is presented throughout the litigation. Bellwether trials are often scheduled in complex pharmaceutical litigation to help facilitate settlement negotiations.

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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Today, in Dallas, Texas, my home town, the attorneys involved in the multi-district consolidated federal DePuy Pinnacle litigation, met with Judge Ed Kinkeade, who is overseeing the MDL Court.


The topics that were discussed included the recent Case Management Order that is to provide a schedule for proceeding with the Pinnacle metal on metal hip lawsuits.

From my vantage point in the “peanut gallery,” I counted 6 attorneys from the defense and about 35 plaintiff attorneys and each side made a short presentation on the status of the lawsuits at this time.

The court announced that there were about 1,245 Pinnacle lawsuits on file at this time. Experts believe that number will increase as more victims will require hip revision surgery, over the next few years.

Attention and discussion was given to formulating a standardized short and long form federal petition or lawsuit, an agreed to plaintiff fact sheets (streamlined discovery), confidentiality order, deposition schedules, a protocol for joint production of documents and determining what types of metal on metal hip replacements should be considered a “Pinnacle” lawsuit.

No firm progress had been made regarding these items. The court indicated that it expected that these issues to be resolved within a month, certainly before the next scheduled status update meeting, which is tentatively set for in 6 weeks.

Dallas Texas DePuy Pinnacle MDL

The U.S. Judicial Panel on Multidistrict Litigation centralized pretrial proceedings in the cases before Judge Kinkeade in the in the U.S. District Court for the Northern District of Texas, as part of an MDL, or multidistrict litigation.

DePuy Pinnacle Injuries and Allegations

All of the DePuy Pinnacle lawsuits involve similar claims that the product was negligently designed with defects in the DePuy Pinnacle hip that caused plaintiffs to suffer injuries with their implant within a few years, often resulting in the need for revision surgery.

DePuy ASR Ohio MDL

Johnson & Johnson and DePuy also face over 6,000 lawsuits over their DePuy ASR hip replacement. Those cases are consolidated in a separate MDL, which is pending in the U.S. District Court for the Northern District of Ohio.

Visit the US District Court for the Northern District of Texas and review the case management orders here.

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Approximately 1,000 women across the United States who suffered serious blood clot side effects have filed a Nuvaring lawsuit claim.


What is Nuvaring?

NuvaRing birth control is a third generation contraceptive manufactured by Organon USA. Organon is part of the Schering-Plough Corporation, which is now owned by Merck.

Nuva Ring birth control is a flexible polyethylene ring that contains a combination of the hormones estrogen and etonogestrel which is a synthetic form of the progestin desogestrel. NuvaRing uses a different form of progestin compared to older contraceptives.

NuvaRing birth control was approved by the Federal Drug Administration (FDA) in October 2001. It was first marketed in the United States in July 2002.

How Does Nuva Ring Work?

NuvaRing releases hormones, and the hormones are absorbed through the vaginal wall.

The hormones inhibit a fertilized egg from being implanted. In addition, the cervical mucous becomes thicker which helps prevent sperm from entering the uterus.

Nuvaring Pulmonary Embolism

NuvaRing pulmonary embolism, is a serious side effect reported by women using this third-generation contraceptive.

Venous thrombo embolism events have been linked to NuvaRing. Pulmonary embolism (PE), deep vein thrombosis (DVT), and ischemic strokes are some of the side effects being associated with NuvaRing.

What is a Pulmonary Embolism?

A pulmonary embolism is a sudden blockage in a lung artery. The cause is usually a blood clot in the leg called a deep vein thrombosis that breaks loose and travels through the bloodstream to the lung.

Pulmonary embolism is a serious condition that can cause permanent damage to the affected lung or sudden death in severe cases. 50% of victims who have pulmonary embolism have no symptoms. Typical symptoms include shortness of breath, chest pain or coughing up blood.

What is a Deep Venous Thrombosis?

Venous thrombosis is a blood clot that forms in a vein. This slow or prevent blood flowing through the veins, causing swelling and pain. In most cases, venous thrombosis occurs in the “deep veins” in the legs, thighs or pelvis; this is called a deep vein thrombosis, DVT.

If the blood clot breaks off from the leg, it can travel to other organs; this is called an embolism. If the clot lodges in the lung, it is called pulmonary embolism (PE). PE is a serious medical condition that can cause death.

Victims who have a DVT or PE have a higher risk of developing another blood clot in the future.

Status of Nuvaring Lawsuits

As of April 2012, the NuvaRing litigation has climbed to almost 1,000 individual injury lawsuits filed in state and federal courts throughout the United States. Many more lawsuits are expected to be filed in the upcoming months as the slowing moving litigation begins to heat up, and progesses to the bellwether trial stage.

According to experts, many more severly affected Nuvaring victims are out there waiting to file their claim against Merck.

To date, there have been no reported NuvaRing settlements and the first trials are not expected to begin until early 2013.

All of the lawsuits involve similar allegations that the manufacturer failed to adequately research the side effects of the birth control ring or warn woman that they may face an increased risk of blood clots compared to older birth control pills.

Federal Nuvaring MDL

The majority of NuvaRing personal injury and death claims throughout the United States have been consolidated for pretrial federal proceedings as part of a multidistrict litigation or NuvaRing MDL.

All lawsuits filed in federal courts throughout the U.S. are automatically removed and centralized in the U.S. District Court for the Eastern District of Missouri to avoid different rulings and speed up discovery proceedings. This is known as the Federal MDL.

Some Nuvaring injury cases have been selected for early trial dates, this process is known as “bellwether” trials. Bellwether trials help the plaintiffs and the defense assess how juries are going to respond to the blood clot and alleged lack of warning evidence that will be introduced in the litigation.

State Nuvaring MDL

Some Nuvaring personal injury and death lawsuits have been filed in New Jersey. Merck’s corporate headquarters is in New Jersey. The New Jersey NuvaRing litigation has been centralized as a “Mass Tort” in Bergen County.

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Federal regulators at the Food and Drug Administration (FDA) have issued a warning about the combination of blood pressure medication Aliskiren (Tekturna) with ACE inhibitors and angiotensin receptor blockers (ARBS) in diabetics or kidney patients.


Novartis, the maker of Aliskiren, announced that the TekturnaR labels have been updated in the US, following the FDA’s review of the preliminary findings from the ALTITUDE study.

Altitude Study

The ALTITUDE study, found an increased risk of adverse events in patients who were taking the direct renin inhibitor as an add-on to other anti-hypertensive medications such as ARBs and ACE inhibitors.

The FDA said that diabetic patients who mix the drugs are at risk of renal impairment, hypotension, and hyperkalemia.

Novartis, has decided to cease marketing in the US of ValturnaR (aliskiren and valsartan, USP), a single pill combination of aliskiren and the ARB valsartan. Valturna will no longer be marketed after July 2012.

Medications that contain aliskiren include:

Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
Tekturna (aliskiren hemifumarate)
Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
Tekamlo (aliskiren hemifumarate and amlodipine besylate)
Valturna (aliskiren hemifumarate and valsartan).

FDA Medwatch

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
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

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Wrongful death and personal injury lawsuits are being filed against Intuitive Surgical, Inc., the maker of the da Vinci Robotic system. These lawsuits are alleging that patients are being injured following the use of a da Vinci robot during a hysterectomy and other surgeries.


Recently a case was filed by Gilmore McCalla in the U.S. District Court for the Southern District of New York on April 4, alleging that the death of his daughter, Kimberly McCalla, was caused by problems with the device used during her robotic surgery.

What is the da Vinci Robotic System?

The da Vinci surgical robot is a medical surgical machine that features four remote controlled arms and a camera, allowing surgeons to operate through a small incision with a joystick-like control.

The device is touted as less invasive surgery and shorter recovery times, but there have been a large number of serious and fatal complications and problems associated with the da Vinci surgical robot.

da Vinci Surgical Robot Background

Intuitive Surgical received clearance from the U.S. Food & Drug Administration (FDA) to market the da Vinci Surgical Robot in 2000.

The robot, which can cost hospitals as much as $2 million, is controlled remotely from a console, while the robot’s arms are placed into the patient for burning away tissue in order to remove the diseased organs.

Da Vinci Lawsuits

The da Vinci surgical robot lawsuits allege that the manufacturer, Intuitive Surgical, failed to adequately research the device or warn patients and the medical community that use of the robot carries a substantial risk of complications and injuries, including burns, tears, dehiscence, bleeding, hematomas, sepsis and fistulas.

The complaints claim that the Da Vinci surgical robot is defective, that relies on use of monopolar energy to cut, burn and cauterize tissue, although safer methods are available that would reduce the risk of complications.

The device also has inadequate insulation for the arms, allowing electrical current to pass into the tissue outside of the operative field. The injuries do not always appear immediately during the actual operation, which can further increase the seriousness of the complications.

Da Vinci Health Benefits?

Both the American College of Obstetricians and Gynecologists and the Kaiser Foundation have raised questions over the widespread adoption of the robot at many hospitals.

In addition to failing to adequately research the device, Intuitive Surgical has allegedly failed to reveal through publications or reports to the FDA the true extent of complications and injuries that have occurred. The complaint also alleges that the company has suppressed reports of complications and performance errors.

Research suggests that hundreds of cases may be necessary before a surgeon becomes proficient at use of the device, Intuitive Surgical only provides hospitals with a two-day course operating on human and pig cadavers, followed by four live cases supervised by a proctor.

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According to Merck & Co., Inc. form 10-K annual report for the fiscal year 2011, published on February 28th, approximately 950 NuvaRing lawsuits were pending as of Dec. 31st 2011.


This critical information is buried deep in the financial disclosures, pages 118, 119.

The plaintiffs are alleging damages for personal injuries sustained from NuvaRing, including deaths, venous thromboembolism, deep vein thrombosis, pulmonary embolism and strokes.

One of many injuried plaintiffs is our own client, Dawn Kregel, from Denton Texas, who has filed a $10 million lawsuit against the manufacturers of NuvaRing, claiming she suffered a massive deep vein thrombosis shortly after using the birth control device.

Dawn Kregel, a nurse, filed suit against Organon USA Inc., Organon Pharmaceuticals USA Inc., Organon International Inc., Schering-Plough Corp. and Merck & Co. Inc. on Jan. 9 in the Eastern District of Texas, Sherman Division.

Kregel used the NuvaRing, for just over a month in 2010. She states she was subsequently diagnosed with an extensive whole leg deep vein thrombosis, that required emergency surgery to prevent a massive potentially lethal pulmonary embolism.

Kregel argues that the defendants failed to warn that that the ring product was associated with more thrombotic events than the pill. The defendants are accused of marketing, promoting and advertising that the ring product had a relatively low amount of estrogen in an effort to hide that it had a high level of dangerous third-generation progestin.

Nuvaring Lawsuit Status

As of December 31, 2011, there were approximately 950 NuvaRing cases. Of these cases, approximately 820 are or will be pending in the NuvaRing MDL in the U.S. District Court for the Eastern District of Missouri before Judge Rodney Sippel, and approximately 125 are pending in coordinated discovery proceedings in the Bergen County Superior Court of New Jersey before Judge Brian R. Martinotti. Four additional cases are pending in various other state courts.

Pursuant to orders of Judge Sippel in the NuvaRing MDL, the parties originally selected a pool of more than twenty cases to prepare for trial and that pool has since been narrowed to eight cases from which the first trials in the NuvaRing MDL will be selected.

Pursuant to Judge Martinotti’s order in the New Jersey proceeding, the parties selected ten trial pool cases to be prepared for trial. The parties have completed fact discovery in the originally selected trial pool cases in each jurisdiction and Merck anticipates expert discovery to be
completed in those first trial pool cases by the summer of 2012.

What is Nuvaring

NuvaRing is a birth control vaginal ring placed around the cervix, that slowly releases female hormones of estrogen and a 3rd generation progestin, that inhibits ovulation.

NuvaRing was approved by the FDA in October 2001 and it is marketed and sold by subsidiaries of Merck, Organon USA Inc. and Schering-Plough.

FDA Study

In 2011, the FDA published a birth control study revealing that the NuvaRing raised the risk of blood clots including DVT and PE by 56% when compared to older birth control pills.

Approximately 820 cases are or will be pending in a federal multidistrict litigation (MDL 1964) in Missouri and approximately 125 are pending in coordinated discovery proceedings in the Bergen County Superior Court of New Jersey.

Plaintiffs Complaints

The plaintiffs contend that Organon and Schering-Plough, among other things, failed to adequately design and manufacture NuvaRing and failed to adequately warn of the alleged increased risk of venous thromboembolism (“VTE”) posed by NuvaRing, and/or downplayed the risk of VTE.

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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.