Articles Posted in Product Liability

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The judge presiding over all federal Bard Avaulta vaginal mesh lawsuits has asked the parties to develop a list of potential bellwether cases. These bellwether cases would be prepared for early trial dates in the multidistrict litigation (MDL).


More than 250 lawsuits over C.R. Bard vaginal mesh filed in federal courts throughout the United States have been consolidated before Judge Goodwin for pretrial litigation as part of an MDL.

Plaintiff and defense lawyers are to identify eight cases each to be considered for early discovery.

Transvaginal Mesh Injuries

The Bard Avaulta vaginal mesh litigation continues to grow against devices for repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).

The surgical mesh products have been linked to a risk of severe complications, including erosion of the mesh into the vagina, recurrence of urinary problems, pain and disfigurement.

The litigation initially only included Bard Avaulta mesh products, and now includes at least 29 other types of vaginal mesh made by C.R. Bard or their subsidiaries, including Pelvicol, PelviLace, PelviSoft, Pelvitex, Uretex and Align mesh.

Additionally, a number of similar complaints have been filed against Boston Scientific, American Medical Systems (AMS) and a division of Johnson & Johnson, Ethicon/Gynecare.

January MDL Consolidation Hearing

On January 26, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear arguements over whether the vaginal mesh lawsuits involving these other manufacturers should also be centralized as part of three separate MDLs before Judge Goodwin in the U.S. District Court for the Southern District of West Virginia for coordinated handling.

Growing Number of Mesh Lawsuits

Public awareness about the risk of vaginal mesh problems increased following an FDA warning issued in 2011 about an increasing number of adverse event reports associated with the products.

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

Earlier this month, the FDA mailed a letter to several device makers calling for more post-marketing studies into the rate of complications with vaginal mesh systems, which many believe is the beginning of tighter regulations aimed at protecting women from these serious and debilitating problems.

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The FDA is under fire to hold a new hearing to evaluate the safety of Yaz and Yasmin birth control pills, after conflict of interest issues have been raised regarding some of its advisory committee members.


Allegedly several FDA advisory committee members who voted to keep Yaz and Yasmin on the market had worked as consultants for, or received funding from, Bayer, the YAZ Yasmin manufacturer.

Project On Government Oversight Letter

The government watchdog group Project On Government Oversight (POGO) wrote a letter on January 11 to the agency’s commissioner, Margaret Hamburg, requesting that a new hearing be convened.

In December, the committee voted 15 to 11 that the benefits of Yaz, Yasmin and other drospirenone-based birth control pills outweigh the health risks, allowing Bayer to narrowly dodge a Yaz and Yasmin recall.

Subsequently, it has been discovered that at least four of the committee members had financial ties to Bayer.

The number of members who may have had conflicts of interest is the same as the winning margin of the vote to recommend that the FDA keep the drugs on the market.

According to POGO, “We are troubled by the industry ties of some of the FDA joint committee members who reviewed the safety of Yaz and Yasmin on December 8, 2011. Because of the industry ties of these members, the joint committee’s conclusion—which amounted to an endorsement of the safety of these oral contraceptives—should be disregarded.”
Financial Conflict of Interest

According to POGO, committee members Drs. Paula Hillard, Anne E. Burke, and Elizabeth G. Raymond received research funding or were paid as consultants for Bayer or one of its subsidiaries. Internal Bayer e-mails referred to Hillard as a “huge” Yasmin advocate.

These folks voted to recommend that the FDA allow the birth control pills stay on the market, despite research that suggests an increased risk of blood clots, pulmonary embolism, stroke, gallbladder disease, deep vein thrombosis, heart attack and sudden death associated with side effects of Yaz and Yasmin.

Discovery Documents made public

The documents revealing their connections to Bayer became public as a part of the discovery process in ongoing Yaz lawsuits and Yasmin lawsuits. The lawsuits are part of a federal Yaz MDL, or multidistrict litigation, which has centralized and consolidated claims by thousands of women.

Almost 11,000 women have filed a federal lawsuit against Bayer alleging that they suffered injuries as a result of the drug maker’s failure to adequately warn about the risk of health problems from Yaz, Yasmin and other drosperinone-based birth control pills.

Drospirenone the Culprit?

Drospirenone is a newer type of synethetic progestin that is used in combination oral contraceptives. It was originally introduced by Berlex Laboratories in Yasmin. Berlex was acquired by Bayer Healthcare and an updated version of Yasmin was introduced called Yaz. 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, all of which contain drospirenone.

The FDA released a report in 2011, that suggested drospirenone-based birth control pills may increase the risk of blood clots by 75% over older birth control pills. They also doubled the risk of heart attacks and strokes in users who were new to birth control, with some health problems appearing in less than three months after women started to take the pills.

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Merck & Co. has agreed that all Propecia lawsuits filed in federal district courts throughout the United States by men who experienced sexual problems after using their hair-loss drug should be consolidated before one judge for pretrial proceedings.


Merck Prefers New Jersey

Merck has suggested that the U.S. Judicial Panel on Multidistrict Litigation should transfer all cases to the U.S. District Court for the District of New Jersey, where 41 of the 53 lawsuits over Propecia have already been filed.

Some plaintiffs proposed that the Propecia MDL be centralized in the U.S. District Court for the Eastern District of New York, or, in the alternative, in the U.S. District Court for the Western District of Washington.

Merck’s attorneys claim that moving the cases to the Eastern District of New York, or the Western District of Washington, would be inefficient because the courts lack familiarity with issues already addressed in a number of the cases.

Judicial Panel on Multidistrict Litigation

The U.S. Judicial Panel on Multidistrict Litigation is expected to hear arguments on the consolidation of the lawsuits over Propecia at a hearing scheduled for March 29, 2012 in San Diego, California.

It appears that all parties agree that centralizing the Propecia cases as part of an MDL, or multidistrict litigation, would serve the convenience of the parties, prevent duplicative discovery and avoid conflicting pretrial rulings. However, the MDL panel will have to determine what is the most appropriate transfer jurisdiction.

What is the problem with Propecia?

Propecia (finasteride) is approved for the treatment of male pattern baldness. It is a low-dose version of Proscar, approved in 1992 for the treatment of benign prostatic hyperplasia.

Men who took the hair loss formula say that Merck failed to warn consumers of the risks of long-term erectile dysfunction from Propecia, as well as loss of libido, infertility, anxiety, depression and other problems.

In the United States, Merck has suggested warned that the sexual side effects of Propecia are temporary, indicating that cases observed during clinical trials resolved after users stopped taking the medication.

Merck has different European warning

Merck has been forced to provide additional warnings to men in certain other countries, indicating that post-marketing reports have indicated that some men experience sexual problems that persist.

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A Kansas woman is has filed a product liability lawsuit which was allegedly caused by side effects of Cymbalta. Cymbalta is manufactured by Eli Lilly and Co. She developed a dangerous skin reaction, known as Stevens-Johnson syndrome.


Nanci Matos, filed the Cymbalta lawsuit in the U.S. District Court for the District of Kansas on January 6.

Matos alleges that she developed Stevens-Johnson syndrome from Cymbalta, a popular antidepressant and anti-anxiety medication.

Matos began taking Cymbalta in November 2009. By December, she indicates that she started to show signs of a skin reaction and was hospitalized in January 2010.

Stevens-Johnson Syndrome (SJS) is an auto immune reaction that can be caused by some medications. The medical condition is typified skin blisters, severe rash and the skin may separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as toxic epidermal necrolysis (TEN).

Treatment for SJS or TEN typically involves inpatient care at a hospital Intensive Care Unit (ICU) or Burn Unit, and the conditions can be fatal in many cases.

Matos’ Stevens-Johnson syndrome lawsuit claims that Eli Lilly failed to adequately warn doctors and patients that Cymbalta side effects could cause dangerous skin reactions.

According to the lawsuit, the FDA asked the company as early as 2007 to investigate potential link between Cymbalta and skin reaction problems, but Eli Lilly allegedly ignored that request and a number of other warnings by experts until September 2011, when the Cymbalta label was updated to include a warning of SJS and other skin reaction side effects.

Matos accuses Eli Lilly of strict liability, negligence, breach of warranty, misrepresentation, fraud and violations of consumer protection laws. She seeks damages for disfigurement, pain, suffering, mental anguish, embarrassment, shame, loss of enjoyment of life, loss of consortium and other injuries.

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Topamax can result in serious birth defects such as cleft palate or cleft lip. These occur when parts of the soft and hard palate fail to completely fuse together. The defect can result in a notched lip, or in severe cases, an open groove that extends from the nose to the roof of the mouth. Cleft lip and cleft palate birth defects can also cause problems eating and communicating, and can increase the risk of ear infections.


What is Topamax?

Topamax is an anti-convulsant drug used to treat epileptic seizures. In addition, Topamax is also prescribed to help prevent migraine headaches. The chemical name for Topamax is Topiramate, and its generic name is Topiragen.

Topamax Problems

In 2009, the makers of Topamax were charged by the Department of Justice of promoting the drug to physicians for unapproved purposes. Such promotions are called “off label” since they encourage use of the drug for purposes not listed on the packaging, and not approved by the FDA. The manufacturers of Topamax plead guilty and paid $75.37 million for violating the False Claims Act, as well as $6.14 million in criminal fines.

Topamax Lawsuit

A product liability or defective product claim for Topamax is a type of pharmaceutical claim in which a person is injured as the result of taking a medication. The cleft lip and palate birth defects were not originally listed as side effects of Topamax, prompting the FDA to update the pregnancy warnings.

Topamax Medical Studies

Topamax has been shown by numerous studies to cause serious birth defects, such as cleft lip or cleft palate. Serious malformations may require expensive surgery or speech therapy, which can be costly.

The UK Epilepsy and Pregnancy Register, as well as the North American ARF Pregnancy Registry, noted a higher incidence of oral clefts in children whose mothers took Topamax during pregnancy.

What was Topamax prescribed for?

Topamax is prescribed to treat epileptic seizures, as well as for the prevention of migraines. However, Topamax has been applied for many off-label uses, such as bulimia, post traumatic stress disorder, obesity, and smoking cessation.

When did the FDA issue a new warning for Topamax?
In March 2011, the FDA increased the pregnancy warning for Topamax to Category D, which means there is positive evidence of fetal risk.

The FDA required new warnings in 2011 after data from the North American Antiepileptic Drug Pregnancy Registry found that children born to mothers who took Topamax during the first trimester of pregnancy experienced an oral cleft about 1.4% of the time, compared to a prevalence rate of between 0.33% and 0.55% associated with other epilepsy drugs.

When did the FDA approve Topamax?

Topamax was approved to treat epileptic seizures in 1994. In 2004, the FDA approved is for use in the treatment of migraines.

The FDA estimates that approximately 32.3 million prescriptions for Topamax or a generic equivalent were issued from January 2007 through December 2010. In many cases the drug is prescribed for off-label uses.

Is Topamax sold under any other names?

Yes. A generic version of Topamax was approved in 2006, called Topiragen. It is distributed by Mylan Pharmaceuticals.

Who are the manufacturers of Topamax?

Ortho-McNeil Neurologics and Noramco, Inc. discovered Topamax in 1979. Both companies are divisions of Johnson & Johnson.

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According to experts, the new blood thinner Pradaxa has been linked to an increased risk of serious life-threatening bleeding. Now many experts are questioning its safety.



Users of Pradaxa who suffered severe internal bleeding, hemorrhages or other problems may be eligible to pursue a Pradaxa lawsuit. Our lawyers are reviewing potential claims for individuals throughout the United States.


Boehringer Ingelheim


Pradaxa (dabigatran) was released in October 2010 as an anticoagulant, but received more consumer complaints to the FDA’s MedWatch adverse event reporting system in its first three months on the market than 98.7% of the other drugs.

The drug is meant to be a replacement for warfarin and is supposedly easier to use because it requires less monitoring. Warfarin can be quickly counteracted by doses of Vitamin K when a bleeding problem occurs. There is no such remedy available when Pradaxa side effects cause internal bleeding.


In the first year Pradaxa was on the market, there were more than 360 deaths attributed to internal bleeding from Pradaxa and some experts have raised questions as to whether the drug’s pre-approval clinical trials were valid.

Complaints of Pradaxa problems have included hemorrhages, especially among the elderly and those with impaired kidney function. Other reports suggest that the drug has proven ineffective in some cases, leading to deep vein thrombosis and pulmonary embolism due to blood clots Pradaxa failed to treat.


In December 2011, the FDA announced it was launching a safety review of Pradaxa, after only 14 months on the market. The agency will evaluate post-marketing reports of serious bleeding events. The investigation came about a month after the manufacturer announced it was investigating Pradaxa death reports.


As a result of the drug makers’ possible failure to adequately warn about the risks associated with their medication, Pradaxa lawyers are evaluating whether users may be entitled to compensation through a product lawsuit.

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SSRIs are a widely prescribed class of drugs most often used as antidepressants to treat depression and anxiety disorders. Since September 2005, scientific information has been emerging that certain SSRIs, such as Celexa (citalopram), Lexapro (escitalopram), Prozac (fluoxetine), and Zoloft (sertraline), and SNRI antidepressants, such as Effexor (venlafaxine) may cause birth defects.


SSRI Birth Defects

Cardiac (heart)
Neural-Tube (brain and spinal cord) – spina bifida
Cranial (skull) – craniosynostosis
Abdominal Wall – omphalocele
Cleft Lip and/or Palate
Limb – club foot and other limb abnormalities
Anal Atresia (complete or partial closure of the anus)
The FDA also issued an alert in July 2006 warning about the increased risk of Neonatal Persistent Pulmonary Hypertension (PPHN) to babies born to mothers taking SSRI antidepressants.

What type of Heart Birth Defects?

The FDA issued a Public Health Advisory on December 8, 2005 based on U.S. and Swedish studies showing that exposure to certain antidepressants in the first trimester of pregnancy may be associated with an increased risk of heart birth defects.

Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed, and leads to a condition otherwise known as a “hole in the heart.”

Exposure to antidepressants may also cause other types of heart defects, including pulmonary stenosis and atresia, tricuspid atresia, aortic stenosis, hypoplastic left heart and conotruncal defects, such as transposition of the great arteries, double outlet right ventricle and Tetralogy of Fallot.

What is PPHN – Persistent Pulmonary Hypertension?

PPHN is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream.

On July 19, 2006 the FDA issued a Public Health Advisory for SSRIs, including Celexa (citalopram), Lexapro (escitalopram), Prozac (fluoxetine), and Zoloft (sertraline) based on a study that suggests there may be additional risks of SSRI medications during pregnancy.

In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.

FDA Pregnancy Warning

All antidepressants, except for one, are currently classified as Category C medications, meaning that animal reproduction studies have indicated an elevated risk of adverse events on the animal fetus and should only be used if the potential benefits outweigh the potential risks.

According to some experts all SSRI and SNRI antidepressants should be classified as Category D medications – “positive evidence of risk-studies in humans” which means fetal risk has been demonstrated.

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Following the lead of the Federal Court ordered mediation in the Yaz/Yasmin litigation, the Pennsylvania state court judge has entered a similar order.


Judge Moss, who is managing thousands of cases in Philadelphia state court, required mediation in an order published on January 6, 2012. Judge Moss’s order comes just one week after a federal judge entered a similar order.

Both judges appointed Professor Stephen Saltzburg of George Washington School of Law, Washington D.C., to assist in the mediation.

Plaintiffs are hopeful that this is good news for women across the country who have been injured by Yaz, Yasmin and Ocella birth control pills and they are hoping that this mediation paves the way for a global Yaz settlement.

The parties have been ordered to negotiate in good faith, but this does not mean that they will be able to come to an agreement.

See the Order below, click here to review the Philadelphia Mass Tort Docket in re YAZ/YASMIN/OCELLA LITIGATION


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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.


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.


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