FDA warning Archives - Carey Danis & Lowe

Zimmer Issued Warning from FDA Regarding Hip Replacement System

By | Defective Medical Device litigation, Hip/Knee Replacement, Uncategorized

Zimmer Issued Warning from FDA Regarding Hip Replacement SystemIn a letter from the U.S. Food and Drug Administration (FDA) dated September 19, 2012, Zimmer Holdings Inc. was issued a warning regarding their hip replacement device known as the Trilogy Acetabular System. The letter of warning followed a recent FDA inspection of a Zimmer Holdings Inc. plant located in Puerto Rico.

The FDA observed while at Zimmer’s Puerto Rican plant that the medical device manufacturer had not established proper testing methods for the hip replacement device. The FDA requires that measures for testing be pursued in order to determine if medical devices conform with design mandates and manufacturing requirements.

The FDA letter also noted that Zimmer had neglected to thoroughly inspect and test the impact of manufacturing methods on their Triology hip replacement devices featuring metallic spikes, which are used as anchoring devices in cases where the use of more traditional materials such as screws and cement is unavailable.

Furthermore, the FDA’s warning letter to Zimmer specifically targeted the medical device manufacturer’s inability to provide test data regarding porosity and pore size in their Trilogy Acetabular Cup hip replacements. Zimmer’s design, according to the manufacturer, is intended to promote adherence of the hip replacement device to the adjacent bones without having to use cement, and this adhesion is aided by the porosity and pore size of the hip replacement medical device. However, as the FDA has stated, there is no evidence from testing that these design criteria meet existing standards for porosity and pore size in hip replacement medical devices.

If Zimmer fails to make efforts toward correcting these FDA violations, they could face severe punishment, including regulations, seizure, and fines.

Zimmer has run into complications with another of their hip replacement systems, the defective Durom Acetabular Component, or Durom Cup. The Durom Cup features a metal-on-metal design for use in a total hip replacement surgery. In 2008, Zimmer voluntarily pulled the Durom Cup off of the U.S. market due to increased reports from patients and surgeons about defective acetabular cups, and an elevated need for revision surgery.

The failure rate of Zimmer’s Durom Cup hip replacement devices are abnormally high. If you or someone you love has suffered physical, emotional, and financial losses due to a total hip replacement surgery involving the defective Zimmer Durom Acetabular Component, or Durom Cup, please contact an experienced defective hip implant device lawyer at Carey Danis & Lowe today to discuss your case.

Diabetes Drug Actos Connected to Bladder Cancer

By | Actos, Pharmaceutical litigation, Uncategorized

Diabetes Drug Actos Connected to Bladder CancerResearch demonstrates a strong connection between the development of bladder cancer and the use of Actos, a drug prescribed to patients with diabetes. Actos is known generically as pioglitazone, and is categorized within the drug class thiazolidinedione (TZD). Actos is manufactured by Takeda Pharmaceuticals.

The U.S. Food and Drug Administration (FDA) made a decision in June 2011 to deliver a warning about the link between Actos and and increased risk of developing bladder cancer. The FDA released this warning based on information gathered from an examination of Takeda’s own ongoing study of Actos.

As a result of the FDA warning, the Actos packaging has been updated with a warning about the increased risk of bladder cancer. Furthermore, the Actos patient medication guide was also updated in a similar manner with information regarding the risks of bladder cancer.

After reviewing data collected from a French study of the drug Actos, two European countries have since banned Actos. France no longer prescribes the diabetes medicine as a result of the findings from the French  epidemiological study. The diabetes drug Actos is also banned in Germany.

The French study was conducted by the French Medicines Agency from 2006 – 2009. The Actos research study looked at the health of 1.5 million patients. During the study, the French scientists discovered a strong link between the use of Actos and the development of bladder cancer.

Another Actos study which saw data linking Actos to bladder cancer is a 10 year study of the drug undertaken by Kaiser Permanente Northern California. Starting in 2002, The Kaiser Permanente data demonstrates an 40% increased risk of developing bladder cancer from the use of Actos for more than 1 year.

Takeda Pharmaceuticals developed Actos for the purpose of intensifying the body’s ability to use insulin in order to regulate blood sugar levels in patients with diabetes. Those patients more at risk of developing bladder cancer are individuals who have been using Actos for the longest duration, and those who are prescribed high doses of the drug.

Signs of bladder cancer include the following:

  • Blood in urine
  • Red-colored uring
  • Frequent urination
  • Pain while urinating

Patients already suffering from bladder cancer, or other bladder health issues, should not take the drug Actos. Also, patients currently taking Actos should discuss stopping the use of the drug with their doctors.

If you or someone you love has suffered from bladder cancer due to use of the diabetes drug, Actos, you may be eligible to receive compensation for your suffering and losses. For more information about filing an Actos lawsuit, contact Carey Danis & Lowe. Our pharmaceutical product liability lawyers work hard to win our clients the justice they deserve.

The Injurious Link Between SSRI Antidepressants and Birth Defects

By | Antidepressant, Pharmaceutical litigation, Uncategorized

Published September 13, 2012 on Carey & Danis

The Injurious Link Between SSRI Antidepressants and Birth DefectsA grave conundrum is presented to women who suffer from depression during pregnancy. There are significant mental and physical health issues that must be considered in regards to medicating with a selective serotonin re-uptake inhibitor (SSRI) antidepressant such as Celexa, Lexapro, Luvox, Symbyax, Paxil, Zoloft, or Prozac while pregnant. Ending use of an SSRI antidepressant during pregnancy poses a risk to the mother’s mental health as well as to the unborn child, depending on when discontinuance of the medication occurs.

If an SSRI antidepressant was taken by the pregnant mother into the third trimester, it has been discovered that these antidepressant medications leach through the placental sack, thus exposing the unborn child to the drugs, often causing a chemical attachment resulting in withdrawal upon the child’s birth or the mother’s sudden termination of SSRI use.Signs of withdrawal in the newborn child are irritable mood, breathing complications, trembling, feeding problems, and hypoglycemia.

In recognition of these withdrawal symptoms in newborn children, the U.S. Food and Drug Administration (FDA) in 2004 released a warning in regards to the use of SSRI antidepressants by pregnant women in their third trimester. In their statement, the FDA made the recommendation that pregnant women medicating with an SSRI antidepressant be placed on a schedule which over time would gradually lower their dosage of an antidepressant.

Though this FDA warning and recommendation was targeted at the prevention of withdrawal symptoms in the newborn child, such near termination of SSRI antidepressant use by the pregnant mother was seen to cause serious mental health issues including a severe episode of postpartum depression. Drug withdrawal is not the only source of suffering inflicted on an unborn child exposed to SSRI antidepressants.

Epidemiology magazine examined in their May 2012 issue a recent study on the health of pregnant mothers using SSRI antidepressants. The study found that there is a significant link between the use of an SSRI antidepressant and pre-term delivery. In this specific study led by the Yale School of Public Health, the SSRI under examination was Paxil. Use of Paxil and other SSRI antidepressants while pregnant have also been linked to a number of other birth defects that cause an undue amount of suffering for a newborn child. These SSRI-linked birth defects include Persistent Pulmonary Hypertension of the Newborn (PPHN), omphalocele, craniosynostosis, atrial septal defects, and ventricular septal defects.

If an SSRI antidepressant was used during pregnancy and a newborn child suffered from a birth defect, compensation for such unfair suffering is due. Contact a knowledgeable pharmaceutical product liability litigation attorney at Carey Danis & Lowe for more information about filing a lawsuit against the manufacturers of Celexa, Lexapro, Luvox, Symbyax, Paxil, Zoloft, or Prozac.

Attorney Jeff Lowe Speaks about Paxil Birth Defects

By | Paxil, Pharmaceutical litigation, Uncategorized

Posted April 27, 2010 

St. Louis, MO: Women who took Paxil during the first trimester of pregnancy and whose children were born with birth defects should consider speaking with an attorney about their options. Jeff Lowe, a partner at Carey Danis & Lowe, says serious birth defects have been linked to the use of Paxil during pregnancy.

Attorney Jeff Lowe Speaks about Paxil Birth Defects “The cases that we’re handling are birth defects that occurred primarily for woman who took Paxil during the first trimester,” Lowe says. “The primary birth defects are Persistent Pulmonary Hypertension of the Newborn (PPHN) and cardiac defects. Those cardiac defects are mainly atrial or septal defects—holes in the heart.”

That does not mean that babies born with other birth defects are excluded from a potential lawsuit. Pregnant women who took any antidepressants from a class of drugs known as selective serotonin reuptake inhibitors (SSRIs, a class that includes Paxil) or serotonin-norepinephrine reuptake inhibitors (SNRIs, a class that includes Effexor) and whose babies were born with birth defects may want to consider speaking to an attorney about their options.

So far the medical literature has made the strongest link between use of certain antidepressants during the first trimester and an increased risk of PPHN or cardiac defects.

“There were studies looking at SSRIs and the early literature didn’t see a connection [between SSRIs and birth defects],” Lowe says. “Then some studies began finding a connection between Paxil and birth defects such as PPHN and cardiac defects. GlaxoSmithKline [Paxil’s manufacturer] had a database they were keeping that was based on their own studies. In 2006, they published their online database, which demonstrated a higher risk in major malformations for infants exposed to Paxil in the first trimester. Additional independent peer reviewed studies confirmed the link.

“Paxil’s warning was changed in 2005 [to include the risk of birth defects]. There was an FDA warning letter issued on December 8, 2005 and a Dear Doctor letter issued in September 2005.”

The good news for potential plaintiffs is that the statute of limitations is not as much of an issue in Paxil birth defect cases as in other situations, because the person most affected by the Paxil is the child. In all states, according to Lowe, “the statute of limitations doesn’t begin to run for a minor until the minor is either 18 to 21 years old, depending on state law, so there isn’t a statute of limitations issue for most children born with birth defects as a result of their mothers taking Paxil.”