Antidepressants Linked to Birth Defects
Posted by: Stephen Leshner
February 02, 2012

Antidepressants including Celexa, Effexor, Lexapro, Paxil and Zoloft have been linked to an increased risk of birth defects.  

Antidepressants (SSRIs [selective serotonin reuptake inhibitors]), such as Celexa (citalopram), Effexor (venlaxafine), Lexapro (escitalopram), Paxil (paroxetine) and Zoloft (sertraline), since September of 2005 have been suspected to cause birth defects including:

• Heart (cardiac)
• Lung (pulmonary)
• Brain and spinal cord (neural-tube defects)
• Abnormally shaped skull (craniosynostosis)
• Abdominal wall defects (infant omphalocele)
• Club foot (one or both feet turn downward and inward)
• Complete or partial closure of the anus (anal atresia)

In July 2006 the FDA issued a warning about the increased risk of Neonatal Persistent Pulmonary Hypertension (PPHN) to babies whose mothers had taken SSRI antidepressants such as Celexa, Lexapro, Paxil and Zoloft.  The study (published in 2006 in the New England Journal of Medicine by Christina Chambers of the University of California, San Diego) this warning was based on suggested that PPHN was six times more common in babies whose mothers had taken an SSRI after the 20^th week of pregnancy compared to babies whose mothers did not.  PPHN occurs in babies soon after birth and causes high blood pressure in the lungs and they are not able to get enough oxygen into their bloodstream.  PPHN is a life-threatening disorder in which 10 to 20 percent of infants end up dying even if they receive treatment.

In addition, researchers from Denmark?s Aarhus University published a study on September 25, 2009 in Online First of BMJ that tied the use of SSRI?s with a heart defect involving a piece of tissue that separates parts of the heart.  Zoloft more than tripled the risk of this defect.  Taking more than one SSRI pushed the risk of having a baby with this heart defect to nearly five times more likely.

Women who took Paxil during the first trimester of pregnancy were twice as likely to give birth to children with atrial septal defects (ASD) and ventral septal defects (VSD).  These are holes in the walls of the chambers of the heart.  Other defects that may be linked to Paxil include cardiomyopathy, hypoplastic left heart syndrome (HLHS), hypoplastic right heart syndrome (HRHS), bicuspid aortic valve, tricuspid stenosis, limb reductions, spina bifida, anencephaly, cleft mitral valve as well as those defects listed above.  These findings prompted the FDA to ask GlaxoSmithKline, the manufacturer of Paxil, to strengthen the drug?s pregnancy category from C to D (those that cause danger to the fetus).

A May 31, 2010 study published online in the Canadian Medical Association Journal by scientists at the University of Montreal stated that women who take antidepressants during the first trimester of their pregnancy were more likely to miscarry than women who did not.  The risk was found to be 68 percent higher.  The researches found that Effexor was among the antidepressants that carried the highest risk.  A study in the March 2010 issue of Pediatrics found associations between exposure to antidepressants in late pregnancy and prolonged motor developmental milestones at 6 and 19 months of age.  Effexor was one listed.

Attorney Stephen I. Leshner of Phoenix, Arizona recently filed a case in U.S. District Court in Arizona on behalf of a mother and her child, against the maker of Zoloft, because of the birth defects sustained by the child while his mother was taking Zoloft during her pregnancy.

If your child has sustained birth defects while you were taking Celexa, Effexor, Lexapro, Paxil or Zoloft during your pregnancy, please call or email Steve Leshner for a free consultation.

Permalink

The High Cost of Failing Hip Replacements
Posted by: Stephen Leshner
December 28, 2011

The following article was published in today's New York Times.

The High Cost of Failing Artificial Hips

By BARRY MEIER

Published: December 27, 2011

The most widespread medical implant failure in decades, involving thousands of all-metal artificial hips that need to be replaced prematurely, has entered the money phase.

The case of Thomas Dougherty represents one particularly costly example. He spent five months this year without a left hip, largely stuck on a recliner watching his medical bills soar.

In August, Mr. Dougherty underwent an operation to replace a failed artificial hip, but his pelvis fractured soon afterward. The replacement hip was abandoned and then a serious infection set in. Some of the bills: $400,776 in charges related to hospitalizations, and $28,081 in doctors? bills.

I?m sitting here on a La-Z-Boy meant for someone who is 80 and I?m 55, said Mr. Dougherty, who lives in Groveland, Ill., and works at Caterpillar, the heavy equipment manufacturer. His bills are five times as much as he paid for his home.

The so-called metal-on-metal hips like Mr. Dougherty?s, ones in which a 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, as artificial joints normally do. The wear of metal parts against each other is generating debris that is damaging tissue and, in some cases, crippling patients.

The incidents have set off a financial scramble. Recently, lawsuits and complaints against makers of all-metal replacement hips passed the 5,000 mark. Insurers are alerting patients that they plan to recover their expenses from any settlement money that patients receive. Medicare is also expected to try to recover its costs.

While his insurer has covered his bills so far, Mr. Dougherty said he was preparing to sue his surgeon, who may have implanted the device incorrectly, and Johnson & Johnson, which produced his artificial hip, to help recoup some of the insurer?s money.

All these payers want to be paid back said Matt Garretson, the founding partner of the Garretson Resolution Group, a firm in Cincinnati that manages product liability cases.

Until a recent sharp decline, all-metal implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States. Some 500,000 patients have received an all-metal replacement hip, according to one estimate. A new study found that no new artificial hip or knee introduced during a recent five-year period, implants that included some of the all-metal hips, were more durable than older devices, and 30 percent were worse.

One troubled all-metal model, implanted in 40,000 patients in the United States, was recalled last year by the DePuy division of Johnson & Johnson. As of October, some 3,500 patients had filed a lawsuit involving that device.

There is no data on the number of all-metal hips that have failed prematurely in this country because the outcomes of orthopedic procedures are not formally tracked by the government or private companies.

But extrapolating from overseas data and the estimate of metal hip use here, tens of thousands of patients in the United States may have to undergo operations over the next decade to replace the implants, said Dr. Art Sedrakyan, a researcher at Weill Cornell Medical College of Cornell University, who is studying the hip problem.

A decade 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. We have been dwarfed by this, said Teresa Ford, a lawyer who worked at Sulzer at the time and is now in private practice.

Device producers have taken differing stances to covering patient expenses. Zimmer Holdings, which says its all-metal implants are safe, has settled hundreds of patient claims, lawyers involved in those cases say. Also, DePuy is covering costs related to the device it recalled last year, the A.S.R., or Articular Surface Replacement.

DePuy would not comment on how much it had paid in recall-related costs. But a spokeswoman, Mindy Tinsley, said in a statement that DePuy was working with patients and insurers.

Things have not gone smoothly for everyone who has taken DePuy?s payment offer. One patient, Paula Laverty, received a hospital bill for $41,578 and a call from the facility warning her that the bill would be turned over soon to a collection agency.

Ms. Laverty, of Cape Elizabeth, Me., said she spent weeks calling the firm handling claims related to DePuy?s A.S.R. She said she eventually learned that the implant maker had paid the hospital $18,000 for her replacement procedure and that the $41,578 represented the remaining charges.

This month, DePuy made an additional payment to the hospital, according to Ms. Tinsley, the company spokeswoman.

Along with A.S.R.-related cases, DePuy also faces over 560 lawsuits in connection with the all-metal version of another hip model, called the Pinnacle, the device that Mr. Dougherty received. Because the company says that the model is performing well, costs for its replacement are being borne by Medicare, insurers or patients themselves.

To recoup their expenses, insurers typically notify patients through lawyers that they expect to be reimbursed from any settlement money that patients receive, rather than pursue their own lawsuits with the device makers. Also, Medicare is expected to enforce new laws next year that will make it easier for the agency to recover taxpayer dollars spent treating patients injured by problem drugs and medical devices, legal experts said.

Still, some patients are weathering some of the financial impacts on their own. While Charmin McCune, a teacher in Wylie, Tex., is recuperating well from a recent replacement operation, she said that she and her husband, also a teacher, have had more than $12,000 in expenses that have not been covered by insurance.

Mr. Dougherty, the Illinois patient, underwent a procedure this month to get a new hip implant. All went well, he said, so he hopes to spend next year back on his feet and at work.

You can?t do anything, he said of his current situation. You see your wife doing everything for you. It is just not right.

Permalink

Metal-on Metal Hips Continue to Fail
Posted by: Stephen Leshner
September 16, 2011

An article in today's New York Times discusses the alarming failure rate of metal-on-metal (MoM) implants.  If you or someone close to you has complaints about a failed DePuy ASR, DePuy Pinnacle, Zimmer Durom, Zimmer NexGen, or Wright Medical hip or knee implant, please call Steve Leshner for a free consultation.

 Metal Hips Failing Fast, Report Says
By BARRY MEIER
A British registry found that all-metal artificial hips failed at a significantly higher rate than those made from other materials.

Permalink

Transvaginal Mesh Patch (TVM) Injuries Noted by FDA
Posted by: Stephen Leshner
August 29, 2011

A transvaginal mesh (TVM) patch is a surgically implanted device that stretches across the vaginal wall (which is also known as the pelvic floor) to add support to tissues damaged as a result of an injury, childbirth or surgery.  Transvaginal meshes have been used in the treatment of pelvic organ prolapse, a condition in which the bladder, uterus, vagina, urethra, bowels or rectum slides out of place due to weak pelvic floor tissues, or stress urinary continence, which is a lack of control over urination, which can cause women to urinate when laughing, sneezing or coughing.

In 2011, the FDA issued a public notice to doctors and TVM patients after 2,875 injuries relation to the mesh were reported between 2008 and 2011.  Reported complications included devices from nine (9) different manufacturers, including the Avaulto support system by C.R. Bard, Gyncare Prolift and Gynemesh Prolene by Ethicon (Johnson & Johnson), AMS Prolapse Repair System by American Medical Systems, Pinnacle Pelvic Floor Repair Kits by Boston Scientific, and Polyform Synthetic Mesh by Proxy Biomedical, Ltd.

Transvaginal mesh systems have been linked to a number of dangerous problems, including reports of infection, pain, urinary problems and bowel, bladder and blood vessel perforations. There have been complaints of recurrences of pelvic organ prolapse, and vaginal mesh erosion.  In fact, a 2009 clinical trial was stopped after 15% of the women implanted with the mesh suffered vaginal mesh erosion after only three months.

If you or someone close to you has suffered damages caused by a transvaginal mesh (TVM), please contact Steve Leshner for a free consultation and case evaluation.

Permalink

Wright Hip Replacement System Failures
Posted by: Stephen Leshner
July 25, 2011

Wright Medical Technology, Inc. has been in the media recently because of alleged problems with its hip replacement implants. Lawsuits have already been filed on behalf of patients who claim their Wright Profemur Hip Systems have failed prematurely.

A plaintiff in a recent lawsuit filed against Wright Medical Technology, Inc. claims that his hip replacement system broke during everyday use.

The lawsuit accuses Wright Medical Technology, Inc. of a faulty design. The hip replacement system in question has a modular design, which means that the neck component can be adjusted to fit each patients leg length.

The problem, says the lawsuit, is that the modular design causes the neck to bend too easily. The bending can cause the system to fracture and break in only a few years after surgery, says the lawsuit. When a hip replacement system breaks, the consequences are severe. Patients will experience excruciating pain and will need debilitating revision surgery to fix the problem.

Results from a 2009 report by the Australian Orthopaedic Association shows that the Wright Profemur Z femoral stem has a high failure rate. According the report, one in every nine patients who has received a Wright hip replacement system has experienced pain and other serious problems with their implants.

The report also says that approximately 11.2 percent of all patients who have received the implant have needed revision surgery. Patients who have already filed lawsuits against Wright Medical Technology, Inc. say their implants failed during normal everyday use.

Permalink

Zimmer NexGen Lawsuit Filed in Arizona Federal Court
Posted by: Stephen Leshner
July 19, 2011

Phoenix, Arizona personal injury and product liability attorney Stephen I. Leshner, along with Minneapolis attorneys Johnson Becker filed a lawsuit on July 18, 2011 in Arizona Federal District Court for a patient  claiming damages for injuries caused by a failed Zimmer NexGen implant.

Zimmer NexGen CR-Flex Porous Femoral components and Zimmer NexGen LPS-Flex artificial knee replacements have had been associated with high incidences of significant pain and loosening of the replacement knee, leading to the failure of the knee replacement, revision knee surgery or other knee surgery complications.  If you or someone close to you has had pain, loosening or a subsequent surgery caused by a defective Zimmer NexGen CR-Flex or LPS-Flex knee replacement component, please call Steve Leshner for a free review of your potential Zimmer knee replacement product liability claim.

 A study published in the American Academy of Orthopaedic Surgeons Conference in March, 2010 documented the high failure rate of the high flex (CR Flex) total knee design, and studies as early as 2007 have discussed the high incidence of loosening of the NexGen LPS Flex knee replacement system.

 If you or someone close to you has had a revision of a Zimmer NexGen CR Flex or LPS Flex knee replacement, or if you are currently experiencing pain or loosening of these knee replacement systems or components, please call Phoenix Arizona accident injury attorney Stephen I. Leshner for a free consultation and case review.

Permalink

FDA Issues Warning About 80 mg. Dose of Zocor (Simvistatin)
Posted by: Stephen Leshner
June 14, 2011

A highly-popular statin used to help manage cholesterol levels is being hit with a warning label by the U.S. Food and Drug Administration (FDA) due to the fact that it may damage muscles.

The drug simvastatin, which goes by the brand name Zocor in many cases, has been found to actually increase the risk of muscle damage in its users.

The FDA has stated that in two different trials, known as SEARCH and AtoZ, the drug shows that it increased the risk of skeletal muscle damage, known as myopathy.

It appears that the increased risk comes from the 80 milligram doses which are commonly taken daily by patients.

Doctors are being urged not to prescribe the 80-milligram dose of simvastatin to any new patients, as well as to watch for existing patients.

The 80-milligram dose should only continue for existing patients if they have been on the drug for over a year without any muscle issues.

If you are someone close to you has taken 80 mg. Simvastatin-Zocor, and suffered from rhabdomyolosis, myopathy, kidney failure or damage, liver failure or damage, or death, please call Phoenix Arizona Personal Injury Attorney Steve Leshner for a no-charge review and consultation regarding your potential case.

Permalink

Mesothelioma and Asbestos
Posted by: Stephen Leshner
June 06, 2011

Malignant mesothelioma is a rare form of cancer that develops from the protective lining that covers many of the body's internal organs, the mesothelium. Asbestos is the major cause of malignant mesothelioma and has been considered indisputably associated with the development of mesothelioma. The relationship between asbestos and mesothelioma is so strong that many consider mesothelioma a ?signal? or ?sentinel? tumor.  Unlike lung cancer, there is no link between smoking and development of malignant mesothelioma.

Tragically, companies that produced asbestos-containing products during the 1940-1980s  knew of the dangers of asbestos and chose not to inform those working with their products.  Knowledge of the dangers of asbestos was evident even before asbestos was in widespread use. Internal documents found in corporate files reveal that not only did the companies have knowledge of the hazards of asbestos but also took extra steps to prevent publication or mention of asbestos related dangers. One such case is when Sumner Simpson, the president of Raybestos-Manhatten, wrote to Vandiver Brown, head of Johns-Manville's legal department in 1935. He said, "I think the less said about asbestos the better off we are." Brown replied, "I quite agree with you that our interests are best served by having asbestosis (an asbestos caused disease) receive the minimum of publicity." In 1936, officials from asbestos manufacturing companies met in New York City to agree to secretly finance animal experiments at the Trudeau Foundation's Saranac Laboratory in Saranac, NY.  Their intent was to gather data that would support a defense to lawsuits that were beginning to be brought against the asbestos companies. Before the final publication, the Saranac report had made reference to the findings that animals exposed to asbestos developed cancer.  In the final report, however, all mention of the cancer was erased.  In addition, the revised report was silent in its criticism of the asbestos dust threshold limit value (TLV) and previously published studies that linked asbestos with cancer. Later in 1952, discussions from a Saranac symposium that included asbestosis and cancer caused by asbestos were never published. 

This "sworn secrecy" in the asbestos industry is also shown elsewhere. In 1947, the Asbestos Textile Institute (ATI) sponsored a study of textile factories by the Industrial Hygiene Foundation. The study found that the workers had asbestosis, made recommendations about medical examinations, and recommended a re-evaluation of the industry's threshold limit value for asbestos. However, these findings were never published outside of the ATI. In the 1950s, the Institute rejected funding for further cancer studies because "such an investigation would stir up a hornet's nest and put the whole industry under suspicion."

As more and more information about the dangers of asbestos became known to asbestos manufacturers, the industry feared that the dangers of asbestos would be publicized and would damage profits. Industry members opposed a health and safety booklet because "the booklet creates fear in the minds of buyers, users, and workers without justification. These fears would be damaging to the entire industry." The asbestos companies knew that this was a problem that affected the entire asbestos industry and worked together to keep the dangers of asbestos from becoming well known to the public.

Because of the widespread use of asbestos, and the long period in which mesothelioma is latent, and undiagnosed, many people, in a variety of trades and industries, are now being diagnosed with mesothelioma, decades after they were first exposed.  People who worked in powerhouses, residential and commercial construction, shipyards, steel mills, oil refineries, chemical plants and foundries from the 1940s thru the 1980s are at risk for developing mesothelioma, as are those who were employed during that time as carpenters, ironworkers, plumbers, pipefitters, laborers, machinists, boilermakers, insulators, mechanics, millwrights, plasterers, drywallers and painters, all because of the prevalence of asbestos in many industries and trades.  Family members of those employed in these industries and trades are also at risk because of second hand exposure,

If you or a loved one has been diagnosed with mesothelioma, please call Steve Leshner for a free consultation.

Permalink

Matrixx (Zicam) Loses Summary Judgment Motion
Posted by: Stephen Leshner
June 06, 2011

 An Arizona federal judge on Friday rejected arguments by Matrixx Initiatives Inc., Zicam LLC and others that the remaining plaintiffs in multidistrict litigation over Zicam Cold Remedy had not demonstrated the product could cause anosmia.

U.S. District Judge Frederick Martone denied the defendants' motion for summary judgment on the issue of general causation ? whether the cold remedy had the capacity to cause a loss of the sense of smell. The defendants filed the motion in March, just months after Matrixx and Zicam agreed to pay out $15.5 million to settle with more than 1,000 plaintiffs who claimed Zicam Cold Remedy caused them to lose their sense of taste or smell.

Judge Martone ruled that the personal injury plaintiffs had put forth enough evidence to demonstrate that it was possible that Zicam Cold Remedy can cause anosmia.

"A reasonable fact finder could conclude that ordinary use of Zicam can cause plaintiffs' alleged injuries," the opinion said.

Attorneys for the parties did not immediately respond to request for comment Friday.0

In their motion for summary judgment, the defendants had argued that the plaintiffs could not show general causation because they had not demonstrated exactly how much Zicam exposure was necessary to cause anosmia.

But after considering limited precedent and practical concerns, Judge Martone ruled that plaintiffs did not need to provide such precise information.

"Plaintiffs need not establish the toxic dose of Zicam," the opinion said. "Plaintiffs' evidence of toxicity is sufficient to create a material issue of fact regarding general causation."

In December, Matrixx and Zicam settled the bulk of outstanding cases and claims in the MDL as well as in California and Arizona state courts. The settlement covered about 1,014 plaintiffs and 1,127 claimants, Matrixx said at the time.

The plaintiffs and claimants agreed to dismiss their cases with prejudice in return for participating in the voluntary settlement, which includes $11.5 million after certain contingencies are satisfied and $4 million in subsequent payments within 21 months, the company said in December.

The lawsuits were launched largely after the U.S. Food and Drug Administration released a June 2009 letter to Matrixx saying that Zicam Cold Remedy gel and swabs could not be marketed without FDA approval, and that the products were misbranded because its labeling did not bear adequate warnings regarding the risk of anosmia.

The zinc-containing products are intranasal cold remedies marketed for reducing the duration and severity of cold symptoms. In its letter, the FDA said that the products had not been shown to be effective.

Steve Leshner is a member of the Plaintiffs Steering Committee, and the Negotiation Committee in the MDL, and Lead Counsel for the Plaintiffs in the Arizona state court cases.  He is also a member of the Claims Committee which is in the process of resolving the settled claims.

Permalink

FDA Concerned About Metal-on-metal (MoM) Hip Replacement Systems
Posted by: Stephen Leshner
May 11, 2011

All artificial hip replacement systems have risks related to implant or material wear. Metal-on-metal hip (MoM) replacement systems have unique risks in addition to the general risks of all hip implant systems.

Because the metal ball and the metal cup slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant. Some of the metal ions from the metal implant or from the metal particles may even get into the bloodstream.

Orthopaedic surgeons take several precautions before and during the implantation surgery to try to optimize the way in which the ball and socket rub against each other so that fewer wear particles are produced. However, there is no way to fully avoid the production of metal particles.

Different people will react to these metal particles in different ways. At this time, it is not possible to know who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be. However, it is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint. This is sometimes referred to as an adverse local tissue reaction (ALTR) or an adverse reaction to metal debris (ARMD).  Such a reaction may cause the implant to become loose or cause pain. Ultimately this can require a revision surgery where the old device is removed and replaced with another one.

In addition to these reactions to metal near the joint and implant, there are some case reports in the literature of a small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland.

Patients who have MoM hip implants should be aware of potential symptoms which may occur after surgery and indicate that their device is not functioning properly. Common symptoms may include:

?         Pain in the groin, hip or leg

?         Swelling at or near the hip joint

?         A limp or change in walking ability

There are many reasons why any of these symptoms may arise or worsen after surgery and it does not necessarily mean that a reaction to the metal particles from the device is taking place. A thorough evaluation by an orthopaedic surgeon is needed to determine the actual cause. Besides a physical exam of the hip, the orthopaedic surgeon may consider several tests to evaluate these symptoms including:

?         Special imaging tests

?         Using a needle to remove fluid from around the joint (joint aspiration)

?         Blood tests, including checking levels of metal ions in the blood

Patients who receive a MoM hip implant should also pay close attention to changes in their general health or new symptoms outside their hip including symptoms related to their:

?         Heart (chest pain, shortness of breath)

?         Nerves (numbness, weakness, change in vision or hearing)

?         Thyroid (fatigue, feeling cold, weight gain)

?         Kidney (change in urination habits)

In April 2010, the United Kingdom's (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert that included specific follow-up recommendations for patients implanted with MoM hip replacements. The recommendations included blood tests and imaging for patients with painful MoM hip implants.

There are several differences between the U.K. and U.S. regulatory systems and some of the U.K. data may not be directly applicable to the experience in the US. For example, some of the devices available in U.K. are not marketed in U.S. Therefore, the frequency of the reactions described above, in the U.S. is unknown. For this reason, FDA is in the process of gathering additional information about adverse events in people with metal-on-metal hip implants.

At the current time, there is no evidence to support the need for checking metal ion levels in the blood or special imaging if patients with MoM hip implants have none of the signs or symptoms described above and the orthopaedic surgeon feels the hip is functioning properly. The FDA is recommending that asymptomatic patients with MoM hip implants continue to follow-up with their orthopaedic surgeon as prescribed.

If patients with MoM hip implants develop any of the symptoms above, it is very important for them to make appointments with their orthopaedic surgeons promptly for further evaluation.

If patients with MoM hip implants develop any new or worsening symptoms outside of their hips, or if they are referred to doctors to evaluate new conditions, they should let the doctors know that they have MoM hips.

Permalink

Failures of DePuy Pinnacle Ultamet Hip Implants Under Investigation
Posted by: Stephen Leshner
March 08, 2011

The DePuy Pinnacle Ultamet is a metal on metal hip implant that appears to have a failure problem similar to the recalled Depuy ASR hip implant. The DePuy ASR is a metal on metal implant that was recalled in 2010 as a result of a high failure rate.

While the failure rate of the Pinnacle Ultamet is not as high as the ASR and has not been recalled, incidences of metallosis toxicity have been reported. Metallsosis is caused by metal ions released from the metal on metal bearing surfaces of the implant. These metal ions are toxic to the soft tissues in the hip joint and may lead to loosening and failure of the implant. If radiologic images show soft tissue reactions, fluid collections, or masses such as pseudotumors then most doctors recommend revision of the implant. Also, if blood tests show high levels of chromium and cobalt a revision may be recommended. Revision is the removal of the implant and replacement with a different implant product.

Not all Depuy Pinnacle hip systems are metal on metal. The Pinnacle hip implant systems allow for insertion   of different types of liners in the acetablular cup.  Only the Ultamet liner has a metal liner that interfaces with
the metal femoral head of the implant prosthesis. Other Pinnacle liners have  bearing surfaces of polymer, polyethylene, or ceramic. Some of the Pinnacle systems have femoral heads that are ceramic.

The 2010 Australian Hip Implant Registry has demonstrated that the metal bearing surface has the highest risk of revision compared to all other bearing surfaces. It also appears that the size of the metal femoral head is a factor in the failures. It appears that the Pinnacle metal on metal system with a femoral head larger than 32 mm pose a greater risk of revision.

Surgeons removing metal on metal implants have found significant damage from the metallosis, or metal toxicity, including necrotic soft tissues, cavities  containing cloudy fluid under pressure, avulsed tendons, and denuded osteonecrotic upper femora.  If metallosis causes significant damage to the tissues and the upper part of the femur it may be difficult for the patient to recover the ability to walk because those supporting tissues are necessary for proper movement of the hip. This type of damage has been found in revision of the DePuy ASR and Pinnacle Ultamet as well as those of other manufacturers of metal on metal hip implants.

The concept of metal on metal implants was intended to address the needs of younger patients who were active and thus more likely to wear out the polyethylene cups that had previously been commonly used. The polyethylene acetabular cups generally last from 12-15 years before replacement was necessary. It had been proposed by the marketing departments of the manufacturers of the metal on metal hips that these bearing surfaces would last longer and that patients would not need as many revisions over a lifetime. However, it now appears that the metallosis risk may not be not worth the benefit of the metal on metal design.  Some surgeons appear to be moving away from recommending the metal on metal designs for their patients.

One of the objectives of the many product liability and class action lawsuits that have been filed involving DePuy ASR will be to find out when Johnson & Johnson and DePuy knew or should have known that the metal on metal implant patients were taking a significant risk of metal poisoning from the implants. The next wave of lawsuits may be directed at the DePuy Pinnacle Ultamet and Ultamet XL hip implant systems.

If you or someone close to you has had to have a revision of DePuy Pinnacle Ultamet or Ultamet XL hip implant system, please call or email Steve Leshner for a free, no obligation review of your potential case.

Permalink

Zimmer NexGen Defective Knee Replacements
Posted by: Stephen Leshner
February 16, 2011

Zimmer NexGen CR-Flex Porous Femoral components and Zimmer NexGen LPS-Flex artificial knee replacements have had been associated with high incidences of significant pain and loosening of the replacement knee, leading to the failure of the knee replacement, revision knee surgery or other knee surgery complications.  If you or someone close to you has had pain, loosening or a subsequent surgery caused by a defective Zimmer NexGen CR-Flex or LPS-Flex knee replacement component, please call Steve Leshner for a free review of your potential Zimmer knee replacement product liability claim.

 A study published in the American Academy of Orthopaedic Surgeons Conference in March, 2010 documented the high failure rate of the high flex (CR Flex) total knee design, and studies as early as 2007 have discussed the high incidence of loosening of the NexGen LPS Flex knee replacement system.

 If you or someone close to you has had a revision of a Zimmer NexGen CR Flex or LPS Flex knee replacement, or if you are currently experiencing pain or loosening of these knee replacement systems or components, please call Phoenix Arizona accident injury attorney Stephen I. Leshner for a free consultation and case review.

Stephen I. Leshner, P.C. and the content of this website is not affiliated with, endorsed by, associated with, or sponsored by Zimmer.  Stephen I. Leshner, P.C.'s use of the trademarks, service marks, trade names, or design marks of NexGen or Zimmer are protected under the trademark doctrine of fair use, the Lanham Act, the anticybersquatting Consumer Protection Act, and the Uniform Domain Name Dispute Resolution Policy. This disclaimer is intended to provide visitors with notice of Stephen I. Leshner, P.C.'s good faith compliance with the nominative fair use doctrine under the trademark law of the United States.

Permalink

Zicam Personal Injury Lawsuits Settled
Posted by: Stephen Leshner
December 14, 2010

Permalink

Darvon and Darvocet Linked to Fatal Cardiac Events and Recommeded to be Withdrawn
Posted by: Stephen Leshner
November 29, 2010

Darvon and Darvocet, two long time popular painkillers have been linked to cardiac episodes causing death, and have been recommended to be withdrawn in the United States.

The Office of New Drugs (OND) and the Office of Surveillance and Epidemiology (OSE) recommend that propoxyphene products be removed from the U.S. market.

Propoxyphene is an opioid medication, initially approved by FDA in 1957. Since 1976 this agent, either as a single ingredient or in combination with acetaminophen, has been marketed in the U.S., under Schedule IV of the Controlled Substances Act, for the treatment of mild to moderate pain. Since 1978, two Citizen Petitions ¹ have been submitted to FDA seeking rescheduling of propoxyphene from Schedule IV to Schedule II, or removal of propoxyphene products from the market. Until now, based on all evidence available to the agency, FDA concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risk when used as directed in the approved labeling.

In recent years, postmarket data have been suggestive, but inconclusive, about the risk for propoxyphene-related cardiac toxicity when this agent is used at therapeutic doses. To address these concerns, in 2009, under authority granted by FDAAA, FDA required the sponsor (Xanodyne Pharmaceuticals, Inc.) to conduct a Thorough QT (TQT) Study to formally evaluate the adverse effects of propoxyphene on cardiac electrophysiology.

FDA has now reviewed the results of the sponsor?s preliminary pharmacokinetic study, conducted to determine appropriate dosing for the TQT study, and concluded that the data demonstrate a clear, dose-related effect on cardiac electrophysiology. The results of the new TQT study in conjunction with the postmarket signals, including expanded epidemiological analyses, provide evidence that propoxyphene can have an adverse cardiotoxic effect at therapeutic doses.

It follows then that an individual patient may be at increased risk of cardiotoxicity even if she or he follows the directions for use in the approved labeling. Furthermore, an individual patient?s risk for cardiotoxicity on propoxyphene may change as a result of even a small change to the patient?s metabolic status, concomitant drug use, or renal function. Although the other commonly prescribed analgesic drug products for use in chronic mild-to-moderate pain have toxicities that are also potentially lethal (e.g. respiratory failure and addiction with opioids), the risk of these toxicities occurring can be mitigated with proper use, appropriate risk management strategies, and monitoring. However, it is not possible to monitor for, or mitigate, the risk of a fatal cardiac arrhythmia that may occur within the recommended dosing range for propoxyphene.

As a result, we conclude that the weight of evidence has shifted and the overall balance of risk and benefit can no longer be considered favorable. It is the conclusion of OND and OSE that propoxyphene-containing products should be withdrawn from the market.

If you someone you know has died from a cardiac event while taking Darvon or Darvocet, in which an electrical heart rhythm disruption was fatal, please contact Steve Leshner for a free case review.

Permalink

DePuy ASR Hip Implant Recall Update
Posted by: Stephen Leshner
September 23, 2010

Since the last time I posted on this subject, I am currently handling several cases involving defective DePuy ASR Hip Implants.  

In regard to the status of the litigation, a motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation to consolidate and centralize all federal DePuy ASR hip recall lawsuits in one court for coordinated pretrial proceedings. The motion was filed on September 3 by a woman who filed a lawsuit in the U.S. District Court for the Northern District of California and, if approved, could eventually impact thousands of cases that are likely to be filed throughout the country on behalf of individuals injured by a recalled DePuy ASR hip replacement implant. A DePuy ASR hip recall was issued last month after DePuy Orthopaedics, a subsidiary of Johnson & Johnson, acknowledged that their metal-on-metal artificial hip system may be prone to fail within a few years after it is implanted. Approximately 93,000 DePuy ASR hips have been sold, and new data suggests that about one out of every 8 may fail within five years, potentially resulting in pain and the need for additional hip surgery to replace the artificial hip. While a handful of lawsuits over the hip implant were filed prior to the recall, the litigation is expected to increase dramatically as individuals learn about the problems with DePuy ASR hip implants. Although the recall does not mean that all implants must be replaced, doctors are encouraging all patients to return for an examination to determine whether the hip replacement is functioning as it is supposed to. In addition, patients will likely require additional treatment to monitor for problems in the future.

According to the Motion for Transfer filed earlier this month, the plaintiff has requested that the DePuy ASR recall litigation be centralized in the U.S. District Court for the District of New Jersey as part of an MDL. The motion references at least five lawsuits currently pending in different five states, including at least one DePuy ASR class action lawsuit. However, that number is expected to climb dramatically in the coming months as attorneys investigate and review additional claims.All of the lawsuits over DePuy ASR hip implants involve similar allegations of design defect, which caused the plaintiffs to incur additional medical expenses, suffer pain and, in some cases, require additional surgery to revise or replace the hip implant. The complaints allege that DePuy failed to adequately test the metal-on-metal hip system and failed to immediately issue a recall when it became apparent that that the DePuy ASR was linked to a high failure rate.The DePuy ASR is a metal-on-metal hip replacement system developed in 2005. Health care professionals have increasingly been warning about problems with metal-on-metal hip implants, which can shed metal particles into the body. The particles can damage soft tissue, cause inflammatory reactions and lead to bone loss. The DePuy ASR hip failures appear to be linked to a defective design of the acetabular cup, which is shallower than acetabular cups made by other companies, making it prone to problems.According to data from the National Joint Registry of England and Wales, the ASR Hip Resurfacing System fails in about 12% of recipients within five years and the ASR XL Acetabular System fails in about 13% of recipients, with the failure rate even higher among women and those with heads smaller than 50mm.If a multidistrict litigation is formed for the DePuy ASR recall lawsuits, all of the cases will be transferred to one judge to oversee during pretrial proceedings. This will allow the parties to avoid duplicative discovery, inconsistent rulings from different judges and serve the convenience of the witnesses, the parties and the court. During the pretrial litigation, the MDL judge will coordinate discovery and likely select a group of cases for early trials, known as bellwether cases, which may help the parties reach an agreement to settle the DePuy ASR suits.The motion calls for the cases to be consolidated before U.S. District Judge Susan D. Wigenton in New Jersey, which is the corporate headquarters for Johnson & Johnson, the parent company of DePuy. Any responses from the defendants or other plaintiffs who may oppose the motion are due before September 24, 2010. It is expected that the MDL Panel will hear arguments on the motion in November.

If you or someone close to you is experiencing any problems as a result of a potentially defective DePuy ASR hip implants, please call Steve Leshner for a free consultation.

Permalink

Avandia: GlaxoSmithKline agrees to settle before FDA vote
Posted by: Stephen Leshner
July 14, 2010

   The move comes as the Food and Drug Administration votes today whether or not to withdraw Avandia from the market over its heart attack risks.

   GlaxoSmithKline will settle about ten-thousand lawsuits for an average payout of $46,000 apiece.

   Avandia's U.S. sales comprised only a tiny one-and-a-half percent of the British drugmaker's 2009 sales.

   Its withdrawal from the market could spur more lawsuits, however.

   The FDA could choose to keep Avandia on the market but beef up its black-box warning about the risk of heart attacks.

   The other option would be to further restrict Avandia's use.

  Glaxo moved quickly after two U.S. Senators ratcheted up the pressure yesterday by releasing documents underscoring safety concerns with the drugs.

   The documents showed Glaxo had tried to brush off scientific concerns about the increased risk of heart attack in users.

   The FDA is also under pressure of its own, coming from consumer groups eager to test the Obama administration's promises of a more activist watchdog role for the agency.

   If you or someone close to you has been injured as a result of taking Avandia, please call Steve Leshner.

Permalink

Zimmer Duron Cup Hip Replacement Cases
Posted by: Stephen Leshner
June 24, 2010

   The U.S. Judicial Panel on Multidistrict Litigation has decided that all federal lawsuits involving the Zimmer Durom hip implants which involve allegations that the hip replacement device caused problems such as loosening of the hip joint and the need for additional surgery, should be consolidated for pretrial litigation in the U.S. District Court for the District of New Jersey.

   The Panel's order, issued June 9, 2010 will result in 45 Zimmer hip replacement lawsuits currently pending in seven different federal courts across the country being transferred to Judge Susan D. Wigenton in New Jersey. The Panel determined that the cases should be consolidated as part of a multidistrict litigation, or MDL, since they involve sufficiently common questions of fact. Since most of the cases were already pending in New Jersey federal court, the Panel determined that was the most reasonable location for centralization.

   The product liability claims involve allegations that problems with Zimmer Durom Cup hip implants were caused by defects in the design and manufacture of the components and due to Zimmer's failure to provide adequate warnings about the device.

   The Zimmer Durom Cup was first introduced in the United States in 2006, as a more advanced form of an artificial hip. The hip resurfacing system is designed out of a single piece of material and is supposed to avoid problems associated with traditional hip replacement components, such as instability, limited range of motion and wear of the bearing.

   Shortly after Zimmer introduced the Durom Cup in the United States, concerns emerged about a high number of hip replacement failures involving the hip implant, where the component loosened and required revision surgery. A temporary Zimmer Durom Cup recall was issued in July 2008, so that revisions could be made to the product's warnings and instructions to ensure that doctors were properly trained on the surgical techniques needed to implant the artificial hip correctly.

   Approximately 12,000 individuals had the Zimmer Durom Cup system implanted in their hip between 2006 and 2008. While Zimmer's own estimates suggested that some doctors have experienced failure rates as high as 5.7%, the plaintiffs claim that about 14% of those who have had the Durom Cup hip replacement implanted have required hip revision surgery.

   As of the end of last year, more than 500 adverse event reports have been filed with the FDA regarding Zimmer Durom Cup problems and many experts anticipate that the rate of hip cup loosenings could increase as time passes after the surgery.

   Although there are only 45 currently pending federal lawsuits over problems with Zimmer Durom Cup hip implants, it is expected that the number of cases will increase in coming months.   Zimmer opposed centralization of the cases, arguing that the cases involve multiple individualized fact issues and that creation of an MDL might derail their attempts to reach Durom Cup settlements without the expenditure of substantial time and resources. The MDL Panel disagreed, indicating that centralization was appropriate to eliminate duplicative discovery, prevent inconsistent pretrial rulings on discovery and to conserve the resources of the parties, attorneys and the courts.

   "Centralization should pose no realistic obstacle to Zimmer's settlement efforts," wrote Judge John G Heyburn, Chairman of the Panel on Multidistrict Litigation, in the order. "Should the parties to one or more actions believe that early resolution through mediation or other means is possible, they are free to approach the transferee judge to adjust the pretrial schedule accordingly."

   While the pretrial management of the cases in an MDL is in many ways similar to how a class action lawsuit would be handled, each claim will still remain an individual lawsuit that would be returned back to the jurisdiction where it was originally filed for trial if it does not settle or otherwise resolve during pretrial litigation.

  Steve Leshner is currently handling a Zimmer Durom Cup case in Maricopa County Superior Court in Phoenix, Arizona, and successfully prevented the case from being transferred into the federal court MDL.  If you or someone you know has been injured as a result of a Zimmer Durom Cup hip implant, please call Steve Leshner for a free consultation to review your case.

Permalink

DePuy ASR Hip Replacements
Posted by: Stephen Leshner
June 24, 2010

    In March of this year, the New York Times published an article about the high early failure rate of DePuy's ASR hip replacement. Since that article was published, many more reports of failures of ASR hip replacements have been received by both DePuy and the United States Food and Drug Administration. In its article, the New York Times quoted orthopedic experts critical of the design of the ASR hip replacement. Experts were also critical of DePuy's failure to stop sales of the device sooner.

   The evidence suggests that that the DePuy ASR hip replacement was defectively designed, and that DePuy knew that their ASR hip replacements were failing at a higher than expected rate, yet  did not pass that information on to consumers or orthopaedic surgeons. As a result, a diagnosis that the ASR hip replacement implanted in patients failed were needlessly delayed as their physicians were unaware of the prevelance of other failures. During patients' surgeries to replace failed hip replacements, orthopedic surgeons discovered that the cup portion of the ASR hip replacement were extremely loose. The ASR hip replacement was designed so that a patient's bone grows into the back of the cup to secure it. However, loosening because of a lack of bone in-growth into the cup is the critical aspect of DePuy ASR hip replacement failures.

   If you or someone you know suffered from a DePuy ASR hip replacement failure, please call Steve Leshner for a free case review and consultation.  Several years ago, Steve Leshner successfully handled over 50 Sulzer Orthpaedic hip failure cases which were also caused by a manufacturing defect that prevented adequate lack of bone-ing growth, and the consequent loosening of the cup.

Permalink

FDA Refuses to Withdraw Zicam Recall
Posted by: Stephen Leshner
March 09, 2010

PDATE 1-Matrixx: FDA declines to withdraw warning letter

Stocks

* Says FDA reaffirms original position

Stocks | Regulatory News | Healthcare

* Co says evaluating options

March 9 (Reuters) - Matrixx Initiatives Inc (MTXX.O) said U.S. health regulators declined to withdraw the warning letter on the company's nasal versions of Zicam cold remedy.

Last June, the company voluntarily withdrew two of its existing Zicam products after the U.S. Food and Drug Administration issued a warning letter that the products could cause a loss of smell. [ID:nN24151638]

In October, the company had said that the FDA had indicated that it was unwilling to reverse its position.

In a regulatory filing with the U.S. Securities and Exchange Commission Tuesday, the company said it had filed in November a response to the warning letter but the FDA reaffirmed its original position.

Matrixx said it was evaluating its options.

Permalink

Matrixx Says FDA Won't Budge on Recalled Zicam Products
Posted by: euser
October 28, 2009

It looks like federal health regulators aren't backing down when it comes to recalled Zicam Nasal Cold Remedies. According to a Reuters report, Matrixx Initiatives Inc., the maker of Zicam products, said the Food & Drug Administration (FDA) is "unwilling to reverse its position regarding the warning letter" it issued over Zicam nasal remedies earlier this year.

In June, the FDA said it had received 130 reports of anosmia-loss of sense of smell-in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

At the same time, the FDA issued a warning letter to Matrixx. In the letter, the FDA said Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that its legal counsel advised it was not required to forward those reports to the agency. In the Warning Letter, the FDA warned the firm that the products cannot be marketed without agency approval and also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.

According to Reuters, Matrixx said in a regulatory filing with the Securities and Exchange Commission (SEC) that the FDA will not reverse its stance that the recalled Zicam products could not be marketed without agency approval. The filing said the company is currently evaluating its options. Matrixx also said it was reviewing the FDA's contention that it should have filed adverse event reports on several individual Zicam loss of smell cases, and that it would be responding soon.

Since the Zicam nasal cold remedy recall, Matrixx has been hit with several class action lawsuits filed on behalf of people who claim the products caused them to suffer anosmia. Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation consolidated the Zicam litigation for pretrial proceedings in the District of Arizona for coordinated handling.

According to Reuters, the recent SEC filing also disclosed that two shareholder derivative lawsuits were filed in September against current and former Matrixx officers related to the recall.

Permalink