New Research Points to Risks of Pradaxa Brain Hemorrhage

Emerging research underscores the potentially fatal consequences of Pradaxa bleeding complications.

The blockbuster anticoagulant was launched by drug maker Boehringer Ingelheim back in October 2010, but the lack of a Pradaxa reversal agent has resulted in hundreds of deaths among recipients, as doctors have few means to stop the effects of uncontrolled bleeding brought on by the medication. This month, two new studies highlight the dangers of intracranial Pradaxa brain hemorrhage among patients who suffered closed head injuries. The research was published in two respected medical journals: Neurosurgical Focus and the Journal of Neurosurgery.

Dr. Brian Walcott, who co-authored one of the studies said, “[Pradaxa] has the potential to provide an important health benefit when used for the proper indications… The lack of an available reversal agent should be recognized as an important current limitation of its use, particularly in patients at a high risk for falls.”

Study reveals dangers of Pradaxa brain hemorrhage

In the Journal of Neurosurgery report, researchers compared case studies among head trauma patients who were on the older blood-thinning medication known as warfarin with patients who took Pradaxa (dabigatran) and others who took no anticoagulants. The study included 15 patients who suffered closed head injuries. Those who were taking warfarin recovered, but of the five patients who were on Pradaxa, two of them died due to brain hemorrhaging that physicians were unable to control, due to the lack of reversal agent. Bleeding events associated with warfarin, on the other hand, can be staunched with a dose of Vitamin K.  The team of researchers concluded that “The development of reversal agents is urgently needed given the growing number of patients treated with this medication.”

Pradaxa bleeding complications in patients have led to uncontrollable gastrointestinal (GI) hemorrhages and strokes, prompting scores of lawsuits around the nation. Plaintiffs and the families of those who died from Pradaxa-related bleeding injuries, claim that manufacturer Boehringer Ingelheim failed to properly test the medication before marketing it, and failed to warn consumers about potential risks. The Food and Drug Administration (FDA) has been flooded with adverse event reports involving Pradaxa bleeding events.

In the first quarter of 2011, the agency reported that some 120 people died on Pradaxa and 500 or more patients suffered complications with incidents of Pradaxa hemorrhage or bleeds. These figures are a stark contrast to those associated with warfarin – a drug that requires patients to undertake more frequent monitoring, but has fewer risks of excessive bleeding.

The other study reported in Neurosurgical Focus examined methods and potential reversal agents that could be used to prevent Pradaxa blood thinning effects.  Researchers discovered that the only viable means to mitigate these effects was to administer dialysis on patients to cleanse the blood and remove all traces of the drug from the system.

Pradaxa bleeding complications spark wrongful death claims

Though still widely prescribed for patients with atrial fibrillation, adverse Pradaxa side effects have prompted a wave of litigation among individuals who suffered life-altering injuries and complications from the blood-thinning medication. Plaintiffs allege that Boehringer failed to sufficiently alert them about the risks of complications such as Pradaxa brain hemorrhage.

To coordinate pre-trial proceedings, all federal cases alleging Pradaxa bleeding injuries were centralized in U.S. District Court for the Southern District of Illinois, where Boehringer Ingelheim faces hundreds of claims.  Judge David Herndon is overseeing the MDL and has scheduled the first trial dates for August 2014. However, both parties will be meeting this August to begin discussions for possible Pradaxa lawsuit settlements.

Metal Poisoning Subject of Stryker Hip Replacement Lawsuit

On May 6, 2013, Louise Bezely filed a Stryker hip replacement lawsuit in the U.S. District Court, Northern District of Illinois (Chicago). In her claim, the plaintiff says that the Rejuvenate system she had implanted in 2010 failed prematurely, causing her to suffer serious complications and injuries that required painful revision surgery. She alleges that the defendant marketed, promoted and sold the Rejuvenate device without disclosing the risks associated with the hip replacement system.

A dual modular hip prosthesis, the Rejuvenate implant was used in patients requiring total hip arthroplasty or replacement due to joint disease caused by degenerative arthritis. The system was cleared for sale by the FDA in 2008, but just four years later, in July of 2012, the defendants issued a voluntary worldwide recall of the Rejuvenate implant along with ABG II components.

In a press release, Stuart Simpson, Stryker Orthopaedics VP and General Manager of Hip Reconstruction, said “While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action.”

Heavy metal poisoning from Rejuvenate components

According to the plaintiff’s Stryker hip recall lawyer, Bezely began experiencing pain shortly after being implanted with the Rejuvenate system. A subsequent diagnostic workup showed no signs of device malposition, loosening or infection, which may have explained the claimant’s symptoms. Another round of testing that included blood work revealed the plaintiff was suffering from heavy metal ion contamination – a common complication among Rejuvenate recipients.  Her surgeons performed revision surgery in August of 2012 based on Bezely’s worsening symptoms.

The plaintiff is now seeking damages for:

• Pain and suffering
• Disability
• Physical impairment
• Mental anguish
• Aggravation of a preexisting condition
• Loss of the capacity for the enjoyment of life
• Past and future medical expenses
• Diminished earning capacity

Her Stryker hip replacement lawsuit alleges that the defendant failed to provide adequate warnings that the Rejuvenate could cause heavy metal toxicity, and that the manufacturer “failed to adequately test the alloy’s compatibility with chrome cobalt components in an effort to prevent corrosion and fretting at the neck/stem taper neck junction of this modular device.”

Like hundreds of others who are pursuing legal recourse after suffering complications from the Rejuvenate system, Bezely believes the hip replacement was defectively designed. The complaint alleges that Stryker failed to report adverse events with the Rejuvenate in a timely manner and failed to fully inform the FDA of unanticipated complications.

Punitive damages sought by plaintiff

In addition to compensatory and actual damages, the plaintiff is also demanding punitive damages against Stryker Orthopaedics for their alleged reckless, fraudulent and malicious conduct in regards to the now-recalled Rejuvenate device. Her lawyer adopts several counts in the Stryker hip replacement lawsuit including common law negligence, breach of implied and express warranties, design defect, strict liability, failure to warn, and manufacturing defect.

At present, more than 100 lawsuits alleging Stryker Rejuvenate injuries have been filed in courts around the country. The United States Judicial Panel on Multidistrict Litigation (JPML) may soon decide to consolidate claims brought in district courts as MDL in an effort to expedite pre-trial proceedings.  Stryker has agreed that multidistrict litigation for Rejuvanate and ABG II lawsuits may be appropriate given the large number of claims.

SSRI Side Effects May Include Surgical Complications

Zoloft is a commonly prescribed selective serotonin reuptake inhibitor (SSRI), which is a type of antidepressant intended to treat anxiety disorders and depression. Zoloft has long been the subject of complaints that allege significant birth defects when used during pregnancy, but now, recent research suggests that the drug may also raise the risk of surgical complications. In this study, researchers examined the potential for SSRI side effects in patients who underwent various surgeries.

Complications can be life-threatening

The study was published on April 29, 2013 in JAMA Internal Medicine. Andrew D. Auerbach, the lead author, and his colleagues evaluated medical records from 534,416 patients in 375 hospitals in the U.S. All of the patients were 18 years old or older and underwent a major surgery between 2006 and 2008.

The results of the study revealed that patients taking Zoloft and other SSRIs were more likely to be readmitted to the hospital within a month of the surgery. These patients were at an increased risk of life-threatening complications, including a 10 percent increased risk of excessive bleeding.

More research is needed to corroborate these results and to determine the cause behind these SSRI side effects. It is possible that Zoloft interferes with the body’s ability to effectively clot blood following the surgery, which is a problem that is commonly seen with nonsteroidal anti-inflammatory drugs (NSAIDs). Although doctors currently recommend stopping blood-thinning medications like NSAIDs prior to surgery, no such recommendation is yet being made for SSRIs. Auerbach and his colleagues cautioned patients not to stop taking a prescribed medication without speaking to a doctor first.

Other side effects involve newborns

The increased risk of surgical complications is not the only side effect associated with Zoloft. When the drug is taken by a woman who is pregnant, the infant could develop significant birth defects, such as heart defects like ventricular septal defects (VSD) and atrial septal defects (ASD). These birth defects are more common when the drug is used during the first trimester. ASD and VSD both occur when the chambers of the infant’s heart develop holes, which can lead to symptoms such as:

• Abdominal swelling
• Swelling of the feet and legs
• Lung infections
• Heart murmurs
• Tachycardia (rapid heartbeat)
• Fatigue
• Blue tint to the nails, skin, and lips

Another possible birth defect associated with Zoloft is persistent pulmonary hypertension of the newborn (PPHN). This serious medical condition is characterized by restricted blood circulation to the lungs, which results in elevated blood pressure.

Other birth defects that have been associated with Zoloft include:

• Omphalocele (severe hernia)
• Craniosynostosis (premature closure of skull bones)
• Premature birth
• Autism spectrum disorder (ASD)

Lawsuits filed over Zoloft and birth defects

Numerous lawsuits have been filed because of SSRI side effects, including against Pfizer, the manufacturer of Zoloft. In April 2012, federal Zoloft lawsuits were consolidated into a multidistrict litigation (MDL), which is proceeding in the U.S. District Court of the Eastern District of Pennsylvania. The MDL streamlines the litigation process for complaints that share similarities, such as heart defects and other birth defects. Other plaintiffs have filed lawsuits related to birth defects that are proceeding in state courts.

Cape woman to sue after hip replacement

Cape Town – A Hermanus woman is one of 170 South Africans who are set to sue hip replacement manufacturer DePuy in a British court for damages related to a recall of hip implants.

Martha Maria de Kock, 62, says she has lost partial vision in one of her eyes, walks with a limp, and experiences chest pains as a result of her surgery.

Fifty more individuals will join the case in the next few days, said Sunelle van Heerden of CP van Zyl. Medical malpractice attorneys at the law firm are suing the manufacturing company because of health- related issues such as the ones De Kock is experiencing.

De Kock has had three DePuy hip replacements: She received her first in 2005, and another in 2008. This past June she received her third hip replacement, and what her doctor found was disturbing.

“The flesh around the hip was black, they had to cut it out,” said De Kock. “There was a lot of fluid they had to drain.”

De Kock did research online and discovered other recipients of the hip replacement were experiencing similar symptoms of chest pain and loss of vision. Soon after, she was contacted by the legal team at CP van Zyl to join the case against DePuy.

“Not a day passes that you don’t think about this whole story, because you don’t know what is going on inside your body,” said De Kock.

De Kock’s surgeon saw her limping and asked her to come in for an examination. After blood tests, the doctor found that the elderly woman had an extremely high amount of cobalt metal in her blood, she said.

Since she is unable to walk properly, De Kock has been forced to give up her work as a financial manager of her husband’s business. She has had to hire another employee to take on her work, which is an additional expense.

More than 170 South African claimants will sue DePuy in a British court for damages related to a recall of hip implants, their lawyers said.

“Our South African clients were unable to sue DePuy in South Africa, and therefore started proceedings in England instead,” said Sunelle van Heerden.

They intend seeking millions in damages, claiming to have suffered injuries as a result of hip implants manufactured in England by DePuy – the DePuy ASR XL total hip replacement system and the DePuy ASR Hip Resurfacing System.

“The dismissal of DePuy’s jurisdiction objection means that the claims can now proceed,” Van Heerden said.

Wrongful Death Alleged in Granuflo Recall Lawsuit

A wrongful death lawsuit has been filed in California, by a plaintiff who claims his mother’s Fresenius dialysis injury led to her untimely death in May, 2011. The plaintiff, Joseph Thiede, says the use of a Fresenius product during the hemodialysis treatment led to alkalosis and subsequent cardiac arrest and death.

Series of dialysis treatments led to patient’s death

Thiede filed his Granuflo recall lawsuit in Los Angeles Superior Court on April 25, 2013. In the complaint, Thiede states that his mother, Cynthia Lou Thiede, underwent hemodialysis at the Da Vita Ash Tree Dialysis center in Fresno, California. Da Vita was a part of a network of dialysis clinics owned by Fresenius, the manufacturer of the Naturalyte and Granuflo products used during dialysis. Thiede’s treatments spanned from December, 2010, to May, 2011.

The plaintiff alleges that “repeated and continuous use of Granuflo and Naturalyte on decedent during her dialysis treatments” led to her injuries and sudden death on May 1, 2011. Thiede’s Granuflo dialysis lawsuit also claims that his mother was unaware of the dangers associated with these products, and if she had been properly warned about the risks, she would have chosen not to use them in her dialysis treatments.

Potential dangers of Granuflo and Naturalyte

Granuflo and Naturalyte are both formulas used during dialysis – Granuflo is a powder concentrate and Naturalyte comes in liquid form. The products contain an active ingredient that converts to bicarbonate in the body, a substance necessary for the cleansing process. However, these products have a unique formula that can lead to a buildup of bicarbonate levels in the bloodstream.

When this occurs, patients can develop a medical condition known as metabolic alkalosis. Left unchecked, metabolic alkalosis can lead to a number of severe medical problems, including cardiac arrhythmia, heart attack, cardiac arrest and sudden death. The complaint indicates this was the case for Cynthia Lou Thiede, who suffered a “sudden cardiac event” after receiving the Fresenius products during dialysis for just a few short months.

Internal memos demonstrate knowledge of risks

Thiede alleges that Fresenius knew of the dangers long before his mother underwent dialysis treatment. The Granuflo recall lawsuit states that as early as 2000, an internal memo circulated among Fresenius executives and medical staff, warning that improper mixing of the formulas was occurring. Additional memos were issued from 2001 to 2003 regarding increased bicarbonate levels in some dialysis patients.

The internal memos continued to circulate until 2011, when the company sent a six-page memo to Fresenius medical staff reporting that more than 900 patients had experienced heart attacks at Fresenius clinics during the previous year. The memo was anonymously sent to the FDA a few months later, and the agency launched an investigation into Fresenius-related injuries. In June, 2012, the FDA issued a Class I recall of Granuflo and Naturalyte.

Since that time, the Granuflo recall lawsuit number has continued to grow. Although the exact number of cases filed is unknown at this time, a motion has been filed to coordinate federal claims into a single court as multidistrict litigation. At the time that request was made, 59 federal lawsuits had been filed against Fresenius across the country.

Thiede’s lawsuit joins that number, with counts of failure to warn, breach of warranty, negligence, and fraud. Because Thiede’s mother died after her Fresenius injuries, Thiede has also listed wrongful death and survivorship on his complaint, stating the loss of his mother has resulted in his loss of her companionship, support and love. Thiede is seeking compensatory, consequential and punitive damages in an amount to be determined at trial.

SSRI Antidepressant Side Effects Include Autism, Says Research

The use of antidepressants during pregnancy may double the risk of autism in the child, according to recent research published in the British Medical Journal.

The study adds to the concerns surrounding SSRI antidepressant side effects, which may also include birth defects and malformations. SSRIs (selective serotonin reuptake inhibitors) are the most widely prescribed antidepressants, and are known to be effective at treating severe depression. But the commonly-held perception that SSRI antidepressant side effects are less serious than other types of medication is false, according to the study.

Researchers from Stockholm compared data on 4,429 cases of autism spectrum disorders, using more than 40,000 control studies. The results showed that women using any kind of antidepressant while pregnant were about twice as likely to have a child that would test on the autism spectrum. There was no significant difference between non-SSRI and SSRI antidepressant side effects.

The analysis indicates that 0.6% of all autism cases – or 1 in 167 – may be a result of the mother using antidepressants during pregnancy.

Findings supported by other studies

The Swedish research is at least the second study to link antidepressants with autism spectrum disorders. The Kaiser Permanente Division of Research in Oakland, CA, found a link between SSRIs and in utero damage in 2011. Researchers found a two-fold increased risk of autism, with the most notable effects occurring after first-term usage of SSRIs.

The lead author of the study, Lisa Croen, PhD, said at the time: “Our results suggest a possible, albeit small, risk to the unborn child associated with in utero exposure to SSRIs, but this possible risk must be balanced with risk to the mother of untreated mental health disorders.”

Croen added that further studies were needed. Both the Oakland and Stockholm researchers noted that doctors needed to weigh the mental health needs of the mother against the potential risk to the child.

SSRIs and pregnancy

Autism is not the only risk factor associated with exposing unborn children to antidepressants. Health problems linked to the use of SSRIs and other antidepressants during pregnancy include:

• Septal heart defects
• Skull malformations
• Neural tube defects
• Abdominal defects
• Spina bifida
• Persistent pulmonary hypertension in newborns (PPHN)

SSRI lawsuits

An increased understanding of potential SSRI antidepressant side effects has led to lawsuits being filed against manufacturers up and down the country. One drug, Zoloft, is at the center of multidistrict litigation (MDL), formed in 2012 and presided over by Judge Cynthia M. Rufe. Zoloft is manufactured and marketed by drug giant Pfizer.

In April, a status update submitted to the U.S. District Court for the Eastern District of Pennsylvania – where MDL proceedings are underway – stated that 336 cases had been consolidated, with a further 50+ pending in the federal court system. Additionally, there are several lawsuits relating to Zoloft pending at state courts around the country, including in Missouri, Illinois, New York, West Virginia and Pennsylvania.

Judge Rufe has selected 25 of the Zoloft birth defects cases for bellwether trials, designed to help predict the likely outcome of SSRI lawsuits. The first is set to be heard no later than October 13, 2014.

DePuy ASR Hip Lawsuit Filed in San Francisco

A new product liability suithas been filed against Johnson & Johnson, alleging they were aware of the risks associated with their DePuy ASR hip replacement system before it was implanted into the plaintiff. Filed at the Superior Court in San Francisco County on April 30, 2013, it is the latest DePuy ASR hip lawsuit to question the safety of metal-on-metal hip replacements.

The plaintiff was implanted with device in March 2008. According to court documents, Johnson & Johnson knew prior to this date that the ASR system was “too challenging” and carried an unusually high failure rate compared to other hip replacements. The lawsuit alleges that Johnson & Johnson perpetuated false information that their device did not carry significant health risks. A DePuy hip lawyer representing the plaintiff said that, in all likelihood, the plaintiff would have to undergo revision surgery, and will suffer lifelong residual problems.

Also mentioned in the DePuy ASR hip lawsuit is the patient’s physician, who allegedly had a financial interest in promoting the device. According to the plaintiff, the doctor’s company was responsible for collecting royalties arising from the ASR system.

High failure rate preceded DePuy ASR recall

In August 2010, Johnson & Johnson issued a recall of the DePuy ASR system, after research data indicated a failure rate as high as 1 in 8 devices. Around 90,000 patients around the world had already been implanted with the system.

Some DePuy hip lawyers have cited the product’s controversial route to market as a major contributor its high failure rate. The FDA allowed numerous metal-on-metal implants to be fast-tracked through their safety review process, because they resembled previously approved hip replacements. Manufacturers like Johnson & Johnson were able to bypass clinical trials, which might have demonstrated the risk of metallosis (metal poisoning) and other health problems caused by tiny fragments of metal debris being eroded from the system and entering the bloodstream.

New guidelines laid down by FDA

After an increasing number of DePuy ASR hip lawsuit actions were filed against Johnson & Johnson, the FDA implemented new guidelines for metal-on-metal implants.

The new guidelines advised physicians to use metal-on-metal hip replacement systems only when there was no alternative, and to pay close attention to patients who have already received an implant. They also asked manufacturers to prove the safety of their systems if they wanted to continue selling them. Any metal-on-metal implant produced in future will have to withstand rigorous clinical tests before hitting the market.

Thousands of DePuy ASR hip lawsuits filed

Thousands of lawsuits have been filed against Johnson & Johnson alleging complications arising from the DePuy system. They accuse the company of failing to adequately warn the public about the risks associated with the device.

Federal multidistrict litigation (MDL 2197, U.S. District Court for the Northern District of Ohio) is set to begin on June 3, 2013.

So far, two cases have gone to trial. One plaintiff received an $8.3 million damage award. The other case resulted in a defense verdict.

The DePuy ASR hip lawsuits are not the only litigation faced by Johnson & Johnson. The company is also being sued by patients who received their Pinnacle hip system. More than 3,000 claims regarding Pinnacle have been included in an MDL in the U.S. District Court for then Northern District of Texas. The first trial is scheduled for September 2014. Johnson & Johnson has reportedly earmarked more than $2 billion to cover Pinnacle and DePuy ASR hip lawsuit actions.

New York Parents Charge Pfizer Actively Concealed True Risks Of Birth Defects To Infants From Zoloft When Prescribed To Mothers During Pregnancy

NEW YORK,  – Wendy R. Fleishman, a personal injury lawyer at the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, and co-counsel Jack Meyerson and Debora O’Neill of Meyerson & O’Neill of Philadelphia, announced that Kori and Jami Wolcott, residents of Rochester, New York, filed a lawsuit against pharmaceutical giant Pfizer, Inc. PFE +1.08% , for the permanent and devastating injuries their minor son suffered from birth defects allegedly caused by Zoloft, an antidepressant prescription drug manufactured and sold by Pfizer, Inc. that was prescribed to the mother during her pregnancy.

Kori Wolcott’s physician prescribed the Zoloft during her pregnancy. In March 2003, the Wolcott’s son, C.W., was born with multiple congenital birth defects and malformations, including severe aortic valve stenosis, which is an aortic valve disorder consisting of a narrowing of the aorta causing obstruction of blood flow from leaving the heart to the body.

Complications of the disease include shortness of breath, fainting, chest pain, and potentially fatal heart failure. In August 2003, baby C.W. underwent surgery to enlarge his narrowed heart valve.

Despite the surgery, C.W.’s aortic valve stenosis is a permanent condition with which he will struggle for the rest of his life. C.W.’s heart has and must be continually monitored by specialists. He is at an increased risk for future heart problems requiring surgery such as valve replacement.

When taken by pregnant women, Zoloft and its generic version Sertraline can enter the fetal bloodstream. Doctors have prescribed Zoloft to women of childbearing age, as well as women already pregnant.

The lawsuit, filed last week in New York state court, charges that Pfizer knew or should have known that Zoloft was linked to serious birth defects, including heart malformations, cranial defects, and abdominal defects, and should have fully informed doctors and the public of these risks.

“We intend to prove that Pfizer knew of the risk of dangerous birth defects associated with Zoloft and other antidepressant prescription drugs when used during pregnancy both from preclinical studies and subsequent published studies,” stated Ms. Fleishman. “Yet, Pfizer took no action to properly study the risk of birth defects linked to Zoloft. Instead, the complaint charges, Pfizer concealed, suppressed, downplayed, and failed to disclose these dangers.”

The complaint seeks to recover damages for the medical and other expenses related to the treatment for C.W.’s birth defects, disorders, and related illnesses. “As early as the 1990′s, scientific studies began to show a relationship between use of antidepressants during pregnancy and serious birth defects,” stated Ms. O’Neill. “Despite this medical research, the complaint alleges, Pfizer failed, and continues to fail, to warn that Zoloft increased the likelihood of serious birth defects.”

“To this day, Pfizer still has not provided an adequate warning on the Zoloft label to physicians, the medical community, and the public about the increased risk of birth defects associated with Zoloft use during pregnancy,” added Ms. Fleishman.

Further Legal Resources for Parents

Parents of a baby with severe birth defects whose mother took Zoloft or other anti-depressant prescription drugs while pregnant may visit www.BirthDefectLegalResources.com to learn about your rights. You may be eligible to file a claim against the manufacturer of the anti-depressant drug prescribed during pregnancy to obtain compensation for the injury inflicted on your baby.

About Lieff Cabraser

Recognized as “one of the nation’s premier plaintiffs’ firms” by The American Lawyer, Lieff Cabraser Heimann & Bernstein, LLP is a sixty-plus attorney law firm with offices in San Francisco, New York, and Nashville founded in 1972. The firm has successfully represented parents across America whose child developed a significant medical condition or was born with birth defects caused by dangerous prescription drugs or food products with undisclosed serious side effects.

The National Law Journal has selected Lieff Cabraser as one of the top plaintiffs’ law firms in the nation. We are one of only two plaintiffs’ law firms in the United States to receive this honor for the last ten consecutive years. Best Lawyers and U.S. News named Lieff Cabraser as their 2012 “Law Firm of the Year” for representing plaintiffs in class actions and mass torts. Learn more at http://www.lieffcabraser.com

About Meyerson & O’Neill

For more than 20 years, Meyerson & O’Neill has maintained a successful and varied practice handling complex civil and personal injury matters for persons who have suffered serious and catastrophic injuries. Based in Philadelphia with an office in New Jersey, the firm’s lawyers have considerable experience in white collar criminal defense cases and an impressive track record in achieving large financial settlements from the successful prosecution of wrongful death cases. Learn more at http://www.meyersonlawfirm.com/

Notice on Attorney Advertising

This press release may be considered advertising in certain jurisdictions. Any testimonial or endorsement does not constitute a guarantee, warranty, or prediction regarding the outcome of your legal matter. Every legal matter is different. The outcome of your claim or case depends upon many factors, including the specific facts of your claim or case. Prior results do not guarantee a similar outcome.

SOURCE: Lieff Cabraser Heimann & Bernstein, LLP

Judge sets aside $6.5M verdict in first Takeda Actos trial

Less than a week after a jury awarded $6.5 million to a man who claimed Takeda Pharmaceutical Co’s diabetes drug Actos gave him bladder cancer, a California judge has set aside the verdict, citing unreliable testimony from the plaintiffs’ expert witness.

Judge Kenneth Freeman of Los Angeles Superior Court on Wednesday granted Japanese drugmaker Takeda’s motion to nullify the verdict, finding that the medical expert for plaintiff Jack Cooper failed to establish that Actos was the specific cause of Cooper’s bladder cancer.

Cooper, 79, suffers from metastatic, terminal bladder cancer, but also has a history of smoking, which Takeda’s lawyers pointed to during a two-month trial, said plaintiff lawyers involved in the litigation.

Cooper’s case was one of over 3,000 lawsuits pending in courts across the country over the medication and was the first to go to trial and reach a verdict.

On April 26, the jury awarded Cooper $5 million in compensatory damages and another $1.5 million to his wife, but it rejected Cooper’s request for punitive damages. At the time, lawyers for other Actos plaintiffs hailed the verdict as a positive bellwether for their other cases.

Takeda asked the judge to reject the verdict and find that the testimony of Cooper’s medical expert, Dr. Norm Smith, was not reliable on the issue of whether Actos was the specific cause of Cooper’s bladder cancer.

Judge Freeman granted that request on Wednesday, calling Smith’s testimony on the issue “inherently unreliable.”

In considering the issue of specific causation, most courts require medical experts to conduct a so-called “differential diagnosis,” considering all possible causes of a disease for a specific patient and ruling them out one by one.

EXPERT’S MANNER ‘NOT RELIABLE’

“It is evident to the Court that the manner in which Dr. Smith conducted his differential diagnosis is based on speculation, is not reliable, not done with intellectual rigor expected of an expert, and is therefore inadmissible under prevailing California law,” Freeman wrote.

He faulted Smith for not reviewing all of Cooper’s medical records, dating back to the 1970s, and not interviewing or examining Cooper. When Smith was asked in a deposition what Cooper did for a living, the doctor said he could not recall, leading the court to conclude that he hadn’t adequately considered Cooper’s exposure to cancer-causing elements in the workplace.

Without Smith’s testimony, Cooper had no additional evidence that Actos caused his bladder cancer, leading the judge to throw out the verdict, declaring a so-called nonsuit.

“We have empathy for Mr. Cooper and his family, but agree with the court’s finding. In granting the motion, the judge ruled that the plaintiffs failed to offer any reliable evidence that Mr. Cooper’s disease was caused by ACTOS,” said Takeda’s general counsel Kenneth Greisman in a statement.

Cooper’s lawyer Timothy Litzenburg said his client would appeal the judge’s ruling to the California court of appeals. He said the ruling was highly fact-specific, questioning what year the patient quit smoking and whether he had renal failure in the past. Such factual issues are for a jury to weigh, not the judge in disqualifying an expert, he said.

Litzenburg also defended Smith as one of the leading bladder cancer experts in the world, noting that the judge had previously found him well qualified to provide an opinion on the topic generally, if not on the question of specific causation.

Marc Bern, a leading lawyer for plaintiffs in Actos litigation under way in Cook County, Illinois, said even though the judge threw out the verdict in Cooper’s case, the jury’s verdict bodes well for the other Actos plaintiffs.

“Even when the case is not a strong case for the plaintiff, even when the plaintiff’s expert may not be the best, he still prevailed against all odds,” Bern said.

Kansas Woman Files Mirena IUD Lawsuit

On April 16, Kansas resident Jessica Caruthers filed a Mirena IUD lawsuit against Bayer Healthcare Pharmaceuticals, alleging severe injuries. The plaintiff claims that Bayer designed, manufactured and marketed a defective product and failed to warn about its latent dangers. Her Mirena lawyer filed the case in the U.S. District Court of Kansas (Wichita), and also names as defendant Berlex Laboratories, Inc.

Approved by the Food and Drug Administration (FDA) in 2000, the intrauterine device is used as a primary form of birth control by more than 15 million women throughout the world. Since its market launch, however, the IUD has been linked to severe complications, most of which stem from device migration. The 27-year old Kansas plaintiff is suing Bayer and Berlex Labs for debilitating injuries after the Mirena IUD migrated from its original position and punctured through her abdominal cavity.  According to court documents, Caruthers sustained significant medical expenses as her physicians had to surgically remove the IUD.

Plaintiff argues Bayer failed to warn about Mirena side effects

As detailed in her Mirena IUD lawsuit, Caruthers was implanted with the device by her physician in January 2007.  She tolerated the procedure well, and neither she nor her doctor had reason to suspect she would experience future complications. In October 2011, the plaintiff returned to the hospital for surgical removal of the device after it migrated, perforated her uterus, and then punctured through her abdominal cavity. Such horrific complications are commonly cited in other Mirena lawsuits against Bayer, prompting hundreds of women to label the IUD as both “defective and unreasonably dangerous.”

The Kansas plaintiff says that due to her significant pain and suffering and debilitating injuries, she has lost wages and potential earning capacity. She further claims that her injuries are physical, emotional, and economic, and seeks to hold Bayer liable for her losses. Her attorney levels several counts against the defendants including product liability – defective design, failure to warn, manufacturing defect, negligence, and breach of implied and express warranties.

Caruthers’ allegations mirror those of at least 40 other women who have also filed a Mirena IUD lawsuit in court rooms across the nation. They all contend that Bayer acted in a deceitful and fraudulent manner and despite evidence as to the IUD’s defective characteristics, continued to market their product without adequate warnings concerning risks.

Mirena side effects and complications alleged in claims against Bayer include:

• Abscesses
• Adhesions and internal scarring
• Embedment in the uterine wall
• Uterine perforation
• Infertility
• Bowel and intestinal perforation
• Pelvic Inflammatory Disease (PID)
• Ectopic pregnancy
• Need for surgical removal

Federal lawsuits coordinated as multidistrict litigation

In an effort to economize pre-trial processes, all Mirena IUD lawsuits brought in the federal court system have been centralized in multidistrict litigation. The products liability MDL No. 2434 has been assigned to the U.S. District Court for the Southern District of New York, which is close to the defendant’s corporate headquarters. The judicial panel established the MDL on April 8, 2013, in order to “promote the just and efficient conduct of this litigation.” Cases such as Caruthers may be transferred to the MDL as a potential tag-along action, as the docket contains lawsuits involving common issues of fact and allegations, mostly resulting from device migration.