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Wright Medical, Inc. ProFemur Total Hip Replacement System Defect Lawsuit Filed in Phoenix, Arizona
Posted by: Stephen Leshner
February 22, 2012

PHOENIX, Ariz. (Feb. 22, 2012):  A Phoenix man filed a lawsuit today in U.S. District Court against Wright Medical Technology, Inc. and Wright Medical Group, Inc. after needing emergency surgery following a sudden catastrophic fracture of the titanium modular neck of the Wright ProFemur Total Hip System as he was dressing for work last July.

                Phoenix attorney Stephen Leshner and defective hip lawyer Joseph H. Saunders of Saunders & Walker, PA in Pinellas Park, FLA. filed the complaint against the Tennessee-based company on behalf of Dale Purcell, who had the device implanted in June 2005 during a total left-hip replacement.  

The Wright ProFemur Total Hip System is comprised of three separate components which are assembled during surgery: a femoral head, a modular neck and the femoral stem.

               There is a design defect in the femoral implant that causes it to fracture just below the neck Leshner said.  When it fractures, you?re on the floor, in extreme pain and you have to have emergency surgery immediately.  The nine-count complaint, which charges negligence, design defect, manufacturing defect, failure to warn and fraudulent misrepresentation, seeks unspecified general, special and punitive damages.

                One minute I?m standing there getting dressed for work and the next I?m on the ground, Parcell said.  At first I thought there was an earthquake that knocked me down, but then the pain hit and I couldn?t move my leg.

                Purcell, 57, underwent revision surgery at Chandler Regional Medical Center on July 7, 2011 when surgeons had to remove the fractured fragments of the ProFemur Z titanium modular femoral neck and noted some mild corrosion at the site of the fracture, according to the complaint.

According to the complaint, the titanium modular neck used in Mr. Parcell fractured and broke very near the femoral stem, leaving a broken portion of the titanium neck wedged inside the stem.  The fracture of the modular neck adapter caused failure of the system, requiring corrective surgery, and made it extremely difficult to extract the fragment.

                The complaint points out that studies have shown that modular neck adapters made from titanium alloy, such as the ProFemur modular neck adapter are more likely to suffer fretting corrosion and fatigue fracture than those made from cobalt-chromium.

                A 2009 report by the Australian Orthopaedic Association showed that the Wright ProFemur Z femoral stem had a high failure rate requiring approximately 11.2 percent of all patients receiving the implant to need revision surgery.

                According to the complaint, in 2009, Wright Medical changed the material in the ProFemur Hip System Modular Necks from titanium to cobalt chrome alloy, but the company took no corrective action in the form of a recall or even an announcement of warning to the medical community or to the public at large concerning its decision to switch from titanium modular neck adapters to cobalt chrome adapters.

               At all relevant times, Defendants knew, or should have known, that the Device which included a titanium modular femoral neck was more prone to fatigue fracture and failure than a device made with a cobalt chromium modular neck, according to the complaint.

                Leshner said this is the first of several lawsuits he expects to file on behalf of individuals who suffered similar failures of the hip-replacement device.

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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.

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