Articles Posted in Product Liability

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Medical side effect concerns about Tekturna, a blood pressure drug sold by Novartis, have arisen after clinical trials were canceled due to a high number of strokes and kidney problems among diabetic patients.

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Novartis was running a trial of the drug to see if it could be useful in the treatment of diabetic hypertension. The drug maker found that Tekturna may increase the risk of non-fatal strokes, kidney problems and other health risks.

Read the Safety Warning from Novartis here. Direct Healthcare Professional Communication on potential risks of cardiovascular and renal adverse events in patients with type 2 diabetes and renal impairment and/or cardiovascular disease treated with aliskiren (Tekturna®) tablets and aliskiren-containing combination products.

As a result of the findings, a safety review of the potential Takturna problems was launched in December in Canada, where the medication is sold under the brand name Resilez.

The cancellation of the clinical trials was announced in a December 20 press release by Novartis. The trial, known as ALTITUDE, involved 8,609 patients from 36 countries. It was a randomized, double-blind, placebo-controlled study of the drug’s use in patients with diabetes and kidney problems.

The study found an increase in Tekturna side effects after 18-24 months that included not only strokes and kidney complications, but also caused hypotension (low blood pressure) and hyperkalemia (high potassium), both of which can cause circulatory problems.

The clinical trial involved the use of Tekturna along with angiontensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). As a result of the bad side effects, Novartis says it will cease promoting the use of Tekturna in combination with those drugs in any patients.

ALTITUDE was cancelled after an independent Data Monitoring Committee (DMC) overseeing the clinical trial became alarmed at the high rate of Tekturna health risks among tests subjects and recommended Novartis pull the plug.

The company has not yet released data from the study, but has told all of the clinical trial’s investigators to remove Tekturna products from their patients’ treatment regimen.

Tekturna (aliskiren) was approved in 2007 for the treatment of high blood pressure. In several countries outside the United States, it is sold under the brand name Rasilez.

In a recent statement released by the Canadian regulatory agency, Health Canada, noted that 329 of the test subjects were from Canada and the agency has expressed concerns over the risks of the clinical trial to its citizens.

Canadian officials say they are looking at available safety data and is considering taking appropriate regulatory action if necessary. The actions could include new label warnings and safety recommendations.

Read more here on Mass Tort Pharmaceutical Litigation and visit our website for more information

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The federal judge overseeing the thousands of Yaz, Yasmin and Ocella venous thrombo-embolism lawsuits, has delayed the first trial scheduled to begin January 9th. The Court ordered the parties to meet with a special mediator in an attempt to negotiate a settlement for the litigation.

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The first Yaz trial was involved a plaintiff who suffered a pulmonary embolism after taking the birth control pill.

Judge Herndon issued the order December 31 and determined that the litigation will be better served by delaying the start of the bellwether trial. This trial was designed to help the parties gauge how juries are likely to respond to evidence that will be presented in many of the cases.

Experienced Mediator Appointed

Professor Stephen Saltzburg of George Washington School of Law was appointed to serve as Special Master for purposes of mediating the entire litigation.

Scope of the YAZ Problem

Over 10,500 women have filed a product liability lawsuit against Bayer alleging that they suffered injuries as a result of the drug maker’s failure to adequately warn about the side effects of Yaz, Yasmin and other drosperinone-based birth control pills.

Is Drospirenone the Culprit?

Drospirenone is a new type of synthetic progestin that is used in combination oral contraceptives pills that includes estrogen. Berlex Laboratories originally manufactured Yasmin. Berlex was acquired by Bayer Healthcare, and newer version of Yasmin was manufactured called Yaz.

Recently, Bayer introduced a third version, called Beyaz, which includes a folate supplement. There are several generic versions of Yaz and Yasmin include Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah.

Medical Studies Reveal the Problem

Several medical studies have found that women using Yaz face an increased risk of suffering a blood clot, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT) and sudden death, a condition known as Venous Thrombo- Embolism (VTE).

FDA Now Involved

The FDA recently released a report that suggested drospirenone-based birth control pills may increase the risk of blood clots by 75% over older birth control pills.

A panel of FDA advisors which met in December called for stricter label warnings on Yaz and Yasmin, but stopped short of recommending a Yaz recall.

All federal Yaz and Yasmin lawsuits have been consolidated as part of an MDL, or multidistrict litigation, which is centralized before Judge Herndon in the U.S. District Court for the Southern District of Illinois.

Read more here on YAZ lawsuits and visit my website for more information

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The Judicial Panel on Multidistrict Litigation (JPML) is streamlining litigation for all federal cases alleging injury caused by the diabetes drug ACTOS®. These cases will now be brought under MDL No. 2299.

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On the basis of the papers filed and the hearing session held, the JPML found that eleven current actions involve common questions of fact, and that centralization in the Western District of Louisiana will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.

Each of the actions alleges claims arising from the use of Actos, a prescription medication approved by the FDA, for use in the treatment of type 2 diabetes. Plaintiffs allege that individuals who use Actos face an increased risk of developing bladder cancer. Plaintiffs further allege that the defendants concealed their knowledge of this risk and failed to provide adequate warnings to consumers and the health care community.

Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings, and conserve the resources of the parties, their counsel and the judiciary.

The JPML was persuaded that the Western District of Louisiana is an appropriate transferee district for this litigation.

The eleven cases are transferred to the Western District of Louisiana and assigned to the Honorable Rebecca F. Doherty for coordinated or consolidated pretrial proceedings in that district.

Read more here on the Actos litigation and visit my website for more information.

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The human tragedy of the most widespread medical implant failure in decades continues to unfold. These involve thousands of all-metal artificial hips that need to be replaced. And now as the litigation slowly grinds on, it has entered its most important phase of cost, both in financial terms and the cost of human suffering.

Medical and legal experts estimate the hip failures may ultimately cost billions of dollars in coming years. The metal-on-metal hip device’s ball and joint are made of metal, are failing at high rates within a few years instead of lasting 15 years or more. The grinding of metal parts against each other is generating metal ions that is damaging tissue and crippling patients. This medical condition known as metallosis.

All-metal hip implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States. According to experts, 500,000 patients have received an all-metal replacement hip. According to a new study, no new artificial hip or knee introduced in the last five years were more durable than older devices, and 30 percent were worse.

One all-metal model, the DePuy ASR, implanted in 40,000 patients in the United States, was recalled last year by the DePuy division of Johnson & Johnson.

10 years ago, Sulzer Orthopedics paid a record $1 billion to settle claims by 6,800 patients who received artificial hips and knees that were contaminated with industrial oil during the manufacturing process.

Along with ASR related cases, DePuy also faces over 560 lawsuits in connection with the all-metal version of another hip model, called the Pinnacle.

Now the insurance companies and Medicare are notifying patients that they expect to be reimbursed for the cost of the re-do hip surgery, a process called subrogation.

Any potential settlement is unclear at this time and DePuy has not announced any global settlement like Sulzer did 10 years ago.

Read more on DePuy ASR Recall and Pinnacle litigation and visit my website for further information.

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Three Fosamax jaw decay lawsuits are scheduled to go to trial in 2012, including a new trial on damages in one case that resulted in an $8 million jury award in 2010.

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U.S. District Judge John Keenan issued an order calling for additional Fosamax bellwether trials to take place in May, September and November of 2012.

Experts and legal commentators are most interested in the re-trial of the Boles case. In that case, the jury will only evaluate the damages that should be awarded for Boles developing osteonecrosis of the jaw (ONJ) from Fosamax.

Earlier in October 2010, another jury determined that Boles’s damages were caused by Merck’s failure to adequately warn about the risk of the devastating jaw damage. Judge Keenan determined that the jury’s award of $8 million in damages was excessive, and Boles elected to have a new trial instead of accepting a reduced award of $1.5 million. The Boles damages trial is scheduled for September 10.

All of the plaintiffs claim that side effects of Fosamax caused them to suffer ONJ, where the jaw bone begins to decay. Occasionally, full or partial jaw removal is required as a result of the condition. Fosamax (alendronate sodium), is a member of a class of drugs known as bisphosphonates, which are prescribed for treatment of osteoporosis.

Merck faces about 1,000 ONJ product liability suits over Fosamax that involve similar allegations. All federal cases are consolidated before Judge Keenan in the U.S. District Court for the Southern District of New York as part of an MDL, or multidistrict litigation.

Fosamax bellwether cases are selected for an early trial to help give the parties an idea of how juries will respond to evidence that may be similar to what will be presented in other cases. Such trials are often useful in gauging the strengths and weaknesses of common claims in complex litigation, and could help lead to an eventual Fosamax settlement.

Merck has successfully defended itself in all cases except for the Boles trial, and Keenan has assigned a settlement master in hopes of reaching an out-of-court settlement on most of the pending claims.

Furthermore, Merck also faces a growing number of lawsuits over femur fractures from Fosamax. Those complaints allege that long-term use of Fosamax can lead to atypical femur fractures, which typically occur with little or no trauma at all. Those cases are consolidated as part of a different MDL, which is centralized in the U.S. District Court for the District of New Jersey.

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The FDA is concerned over new liquid acetaminophen products for infants because of the possibility of accidental Tylenol overdoses and dosing confusion by parents.

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The FDA issued a consumer update on December 22, warning parents that several new liquid acetaminophen products for infants have different potency than older liquid acetaminophen medications.

According to the FDA, caregivers of infants and children may give a child too much of the drug because they are used to the dosing sizes of older brands of liquid acetaminophen drops.

Acetaminophen is used as a pain killer and anti-inflammatory medication. It is found in many over-the-counter and prescription drugs. It is also aggressively marketed for the treatment of fever, aches and pain.

According to the FDA, medication errors with acetaminophen led to 14 deaths and 74 injuries from 2000 to 2010 in children under the age of 13.

In response to concerns raised by the FDA over the high potency of many infant liquid acetaminophen products, a number of drug makers have reformulated their medications to be more diluted.

The change was voluntary and not all drug manufacturers have adopted it. This means that several different concentrations are now on store shelves, this could lead to confusion.

The FDA is recommending parents to carefully read the dosing instructions and medication guides of this and all other drugs, and to use the dosing device included in the packaging.

Furthermore, to add to the confusion, the packaging often changed very little, and if the person bought older version of the drug and then bought the newer version, they may not realize that there was a difference.

The FDA cited as an example; Little Fevers by Little Remedies. Both boxes say “New!” on the front and are very similar in design, but are of different concentrations.

According to the FDA, acetaminophen overdose has been a leading cause of liver failure in the United States, resulting in more than 50,000 emergency room visits, 25,000 hospitalizations and over 450 deaths annually.

Due to the risks associated with receiving too much acetaminophen, an FDA advisory panel was convened in May to make recommendations about new warnings or other regulatory actions. The panel recommended that dosing instructions be based on a child’s weight instead of their age.

Stronger warnings about the potential risk of liver failure from acetaminophen have also been added to all products over the past year, including clearer indications about what products contain acetaminophen as the active ingredient to avoid the risk of overdose.

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A recent Australian study indicates that the newer technology for artificial hips and knees did not perform any better than older, well tested and less expensive designs.

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This week, data was published from Australia’s orthopedic registry, which covered implants introduced from 2003 to 2007. The study’s findings are significant for patients in the United States because many of the new designs, like the metal-on-metal hips, are widely used here and have come under increasing scrutiny.

These metal on metal implants, consist of a ball and cup made of metal, and according to experts are expected to fail prematurely in tens of thousands of patients. The artificial joints were marketed to last 15 years or more and provide better mobility and be more durable for the elderly population.

The Australian study showed that not a single new artificial hip or knee introduced over a recent five-year period was any more durable than older ones. In fact, 30 percent of them fared worse.

The Australian study concluded that both patients and government health care programs were being short changed because orthopedic surgeons were rushing to use the newly designed metal implants. These implants were introduced with little testing, over existing designs that had track records.

The review concluded, “not only has the introduction of this technology been potentially detrimental to patient care, but the current approach may be an important driver of increased health care costs.”
Dr. Stephen E. Graves, the director of the Australian registry and a co-author of the study, said he believed that surgeons, hospitals and regulators should closely look at the review’s results. In the case of the all-metal hips, some experts say they believe that replacing them may cost companies, insurers and taxpayers billions of dollars.

The United States does not have an orthopedic registry, and the Food and Drug Administration is researching to see whether data from sources like overseas databases and registries run by hospitals here can be used to better monitor device performance.

Many experts argue that such efforts are essential because 700,000 Americans undergo hip or knee replacement every year, and that number is expected to increase sharply as the population ages.

In a medical device registry, information about a patient is entered into a database when he or she receives an implant. Then, when that patient undergoes surgery again to replace that device, more data is added. By looking at large numbers of patients followed in a registry, researchers can tell whether certain device models are failing prematurely at significantly higher rates.

Some experts believe that when an implant problem is detected in a registry, it may be too late. Therefore some experts suggest that there must be greater scrutiny of implants either before or after they go on the market to detect problems earlier.

An Austrian review found that the results of published studies that accompany the introduction of new implants could bear little resemblance to registry findings about a device’s success once it went into broader use.

That review, found that surgeons involved in the original published reports are often involved in its development and may have a financial stake in them. These often created an ethical and moral dilemma for the doctors, which the companies are only too eager to exploit.

This month, bipartisan legislation was introduced in the Senate that could force manufacturers to track the performance of implants like artificial hips after they have been approved for sale.

Both device producers and their allies in Congress have maintained that any additional F.D.A. regulations would slow the development and marketing of innovative products that benefit patients. For his part, Dr. Graves, the Australian official, said he believed that such arguments were misleading.

“The purpose of regulation is not to impede innovation but to ensure safety and effectiveness of medical devices,” he stated. “This protects patients, but it also protects companies.”

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The safety of Bayer’s two blockbuster oral contraceptives, Yaz and Yasmin, have been called into question. These drugs which were the first to contain a progestin known as drospirenone, which is now used in a number of generic versions of the pills.

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Yaz and Yasmin have been implicated in the formation of blood clots, a condition known as venous thrombo-embolism (VTE). The FDA recently found that Yaz and Yasmin side effects increased the risk of blood clots 74% when compared to older birth control pills that use levonorgestrel as a progestin instead of drospirenone. A number of other independent studies have shown an increased risk of blood clots from Yaz and Yasmin as well.

Newly unsealed documents, revealed during discovery in thousands of Yaz and Yasmin lawsuits being pursued against Bayer, indicate that experts believe that the company kept important safety data from federal regulators. Ex FDA Chief, Kessler gave expert opinion testimony that Bayer purposefully mislead the FDA about Yaz and Yasmin’s safety by selectively presenting data on blood clots and other thromboembolic events to make the drugs appear to be safer than they really were.

An Israeli study has found that side effects of Yaz and Yasmin birth control increase the risk of a pulmonary embolism, deep vein thrombosis or another blood clot injury, when compared to older birth control pills. Researchers say they found that drospirenone-based birth control pills increased the risk of venous thromboembolism by as much as 65 percent, in a new study published by the Canadian Medical Association Journal. This is at least the third study in recent weeks to confirm the risk of blood clots from Yaz birth control.

Drospirenone was originally introduced by Berlex Laboratories in Yasmin. Once Berlex was acquired by Bayer Healthcare an updated version of Yasmin was introduced called Yaz. More recently, Bayer introduced a third version, marketed as Beyaz, which includes a folate supplement. Generic versions of Yaz and Yasmin are also now available from other manufacturers. Generic versions of Yaz and Yasmin include Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah.

As a result of Bayer’s failure to adequately warn about the risk of blood clots from the birth control pills, thousands of women throughout the United States have filed a lawsuits against Bayer after suffering serious and potentially life-threatening injuries who on the birth control pills, such as stroke, pulmonary embolism, deep vein thrombosis, gallbladder disease and sudden death.

There are currently more than 10,538 lawsuits filed in federal district courts throughout the United States that have been centralized before Judge David R. Herndon in the U.S. District Court for the Southern District of Illinois. Our law firm is expecting to file 10 Yaz, Yasmin lawsuits this week in time for Christmas.

Currently the Yasmin and Yaz injury suits have been centralized for pretrial proceedings in the federal court system as well as several states. In federal court, all cases filed throughout the country are being handled out of the U.S. District Court for the Southern District of Illinois for coordinated management during discovery, the early bellwether trials and any preliminary attempts to negotiate settlement offers.

Similar centralized management for the cases has been put in place for state court cases filed in New Jersey, California and Pennsylvania.

All of the cases involve similar allegations that Bayer failed to adequately warn about the risk of serious and potentially life-threatening side effects of Yaz and Yasmin birth control.

In October 2010, Judge Herndon implemented a process that calls for a handful of cases to be prepared for a series of three early trials, known as bellwether cases. The first trial, which is expected to begin January 9, 2012, will involve a pulmonary embolism from Yaz. The second trial will involve a gallbladder injury from Yaz and the third trial will involve a venous thromboembolism (VTE), such as a deep vein thrombosis (DVT).

You have been impacted by Yaz, Yasmin side effects and injuries, including deep vein thrombosis, pulmonary embolism, stroke or gallbladder disease, January 9, 2012 is around the corner and finally the jury can decide whether or nor Bayer is liable for your injuries.

Read more on YAZ, Yasmin and Ocella side effects here and visit my website for further information.

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Accutane side effects and injuries have prompted 6,634 people to file an Accutane lawsuit in New Jersey against the manufacturer of the controversial acne drug, Hoffman-LaRoche.

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A master complaint was filed as more plaintiffs joined the Accutane mass tort lawsuit. The purpose of the master complaint is to centralize the plaintiffs’ common allegations, which include Accutane Crohns disease and Ulcerative Colitis. The master complaint alleges that Hoffman-LaRoche created a defective product and negligently marketed that product to consumers.

Furthermore, the complaint alleges that the company failed to warn consumers about the serious side effects associated with Accutane use; inflammatory bowel disease, (IBD). The complaint also alleges that Hoffman-LaRoche failed to take the product off the market once the bowel side effects, birth defects and suicide were known.

A master complaint is intended to streamline the legal process generally, and potentially lead to more timely settlements.

Crohns disease and Ulcerative Colitis are two forms of IBD. Both diseases involve the patient’s digestive tract. Crohns disease can lead to ulcers, incontinence, intestinal blockages, bowel cancer, and removal of the colon and rectum.

The New Jersey court agreed to the Accutane lawsuit mass tort, placing it under the direction of Judge Carol E. Higbee.

Judge Higbee has chosen several lawsuits as bellwether cases. Each Accutane lawsuit identified as a bellwether case will address some of the issues outlined in the master complaint, including whether or not patients were adequately warned about the risks of dangerous side effects like Crohns disease. The bellwether cases will likely set a precedent for future Accutane lawsuit outcomes and settlements.

Click here to visit my website and learn more about Accutane Lawsuits

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St. Jude Medical Inc.’s Riata defibrillator leads, which the company stopped selling last year, were recalled by the U.S. Food and Drug Administration because of their potential to injure or kill patients.

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The devices remain implanted in an estimated 79,000 U.S. patients. The company voluntarily sent a letter to doctors on November 28 informing them that the wires used to connect the devices to the heart have a higher failure rate than was previously known.

According to the company, the FDA issued the Class 1 recall, its most serious designation, because of its potential risk of serious injury or patient death.

The company acknowledged that the wires inside some leads can penetrate the insulation, compromising the device’s integrity. The devices may inappropriately shock some patients and fail to deliver necessary therapy to others.

This potential for device failure, particular for defibrillators or for folks dependent on pacemakers, is worrisome.

Patients who need frequent shocks from their defibrillator to restore a normal heart rhythm and those who are dependent on pacemakers may be at greater risk, the company said. Doctors may design individual treatment plans for those with the damaged wires based on their risk level and options should be discussed with patients, the company said.

FDA notified healthcare professionals of a Class I Recall of the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads. The silicone insulation covering these defibrillation leads is at risk of premature abrasion. When abrasion occurs, the conductors inside the leads can come out (externalized) of the insulation. Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death.

The recall includes the following model numbers:

Riata (8F) Silicone Endocardial Defibrillation Leads
Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
Riata ST (7Fr) Silicone Endocardial Defibrillation Leads
Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042
BACKGROUND: The leads connect an implantable cardioverter defibrillator (lCD) or cardiac resynchronization therapy defibrillator (CRT-D) to cardiac tissue in order to monitor and regulate a patient’s heart rate by providing pacing and delivery of high voltage therapy for ventricular arrhythmias.