Effexor Recall Underway Due to Wrong Drug in Bottle

PillsI have already written about the anti-depressant drug Effexor and its dangerous and deadly potential effects on pregnant women and their unborn children.

A further hazard with the drug just surfaced this last week when Effexor’s manufacturer Phizer issued a recall on March 6th. The recall came about because a pharmacist discovered that a bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn® (dofetilide) in addition to the regular Effexor XR capsules. Tikosyn has serious adverse health consequences that could be fatal per the FDA.The most prominent and deadly side effect of Tikosyn is that it starts an abnormal heartbeat that can be fatal. Signs of an abnormal heartbeat include dizziness, fainting and a racing heart rate.

The FDA has issued a news release on the recall.

Effexor already has a long list of potentially deadly health problems associated with its use during pregnancy.

  • Miscarriage
  • Preterm birth
  • Stillbirth
  • Cleft Palate
  • Anencephaly
  • Omphalocele
  • Craniosynostosis
  • Primary pulmonary hypertension of the neonate
  • Transposition of the great arteries and other heart defects
  • Feeding and swallowing problems
  • Aspiration and vomiting
  • Seizures
  • Coma
  • Sedation
  • “SIDS”

If you or a loved one has been affected by taking Effexor, contact The Barrera Law Firm, PC at 956 428 2822 to find out if your case can be pursued against Pfizer, maker of Effexor.

Antipsychotics Linked to Sudden Cardiac Death

Doctor with RX prescriptionAntipsychotic drugs have proven to be one of the most profitable commodities of Big Pharma. In fact, Zyprexa has made Eli Lilly over $70 billion. It is sold at $12 a pill and is used by many state institutions and state foster care programs, at a steep cost to the tax payer.

However, a recent study has shown that Zyprexa, Risperdal, Haldol, and other antipsychotics dramatically increase the risk of sudden cardiac death (SCD). In fact, the Oregon Sudden Unexplained Death Study conducted by Dr. Audrey Uy-Evanado of Cedars-Sinai Medical Center in Los Angeles found that individuals on these drugs tripled their risk of sudden cardiac death and that there is a direct link between these drugs and this fatal condition.

No one should have to die as the result of treatment with these drugs and families who have had a member do so should seriously consider bringing a legal suit against the drug manufacturer.

In order to be successful against Big Pharma in such a lawsuit concerning, one would need to show that the medication was the cause of death and other factors must be ruled out or shown not to be the cause of death. Medical research now appears to back up such a claim.

Consumers need to be protected and drug manufacturers who allow such dangerous products to be on the market should be punished.

The False Claims Act and Qui Tam Lawsuit

The False Claims Act ( FCA) was originally enacted during the Civil War with the purpose of protecting the Union Army from unscrupulous suppliers. More recently, the FCA has been a powerful tool to fight fraud on the part of government defense contractors and since 1999 there have been an ever growing number of prosecutions concerning the sales, marketing and pricing practices of pharmaceutical companies.

The FCA combats fraud by imposing civil liability on individuals or entities that “knowingly presents or causes to be presented, a false or fraudulent claim for payment or approval” to the federal government. 31 U.S.C. § 3729.

Essential to the effectiveness of the FCA is the ability of whistleblowers to sue on behalf of the United States. This provision known as a “qui tam” provision allows the individual with evidence of fraud against the federal government, referred to as the “relator” to sue the perpetrator to recover the stolen funds. Qui Tam is an abbreviation of the Latin phrase “qui tam pro domino rege quam pro sic ipso in hoc parte sequitur” meaning “he who as well for the king as for himself sues in this matter.”

The FCA provides for up to treble damages, and the relator is entitled to receive between 15 and 25 percent of the amount recovered by the government through the qui tam action.

Prosecutors and whistleblowers have made headlines using the FCA to fight virtually every kind of healthcare fraud from billing for procedures that were not performed to off label marketing of pharmaceuticals. The New York Times reported on the largest FCA settlement to date in June 2012, “the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug. . . . The agreement also includes civil penalties for improper marketing of a half-dozen other drugs.”

However, liability extends well beyond the marketing of pharmaceuticals and into the R&D process. There is a growing trend in prosecutions associated with the falsification of data in laboratory studies and clinical trials. Should a pharmaceutical company outsource a portion of this function to a Contracted Research Organization (CRO), it is clear that pharmaceutical companies remain liable for the CRO’s actions.

Clinical and medical trial fraud occurs when a pharmaceutical manufacture provides false data to the FDA, withholds or alters negative data regarding the safety and efficacy of a drug, violates the recognized norms of research in order to influence trial outcome or fails to follow study protocol. An example of R & D fraud would be a defective pharmaceutical causing birth defects or suicidal behavior, where the manufacture concealed the risks and continued to market the drug falsely promoting the efficacy and miscoding side effects.

Clinical and medical trial fraud is actionable under the FCA as a form of healthcare billing fraud when Medicaid and Medicare (or other federally funded health program) make payments for drugs whose FDA approval was based on false information. With fraudulent FDA approval, the drug in question would not necessarily be safe or effective. And an unsafe and/or ineffective drug would not be reasonable or necessary—a requirement to be reimbursed under any federal healthcare program. Thus under the FCA, a whistleblower with knowledge of clinical trial fraud or falsification of data used in the FDA approval process, is able to bring a qui tam action against the pharmaceutical manufacturer.

Pharmaceutical Litigation Lawyer

Birth defectsMillions of people swallow prescription drugs daily in the U.S., and many have lost their lives as a result. At the Barrera Law Firm, we are well-versed in what it takes to get justice for those harmed by pharmaceutical products and we have the dedication it takes to see your case through to the finish.

Infant Death and Birth Defect Cases

At the Barrera Firm we are continually helping more and more clients who have had a baby or child injured or killed by certain psychoactive medications. Birth defects, seizures, problems with pre-term labor, delayed infant development, increases in “SIDS” and heart defects and PPHN or Primary Pulmonary Hypertension of the Neonate are all becoming increasingly common among today’s children as the number of women taking psychiatric drugs during pregnancy has risen.

Tragically, many mothers were not given access to accurate risk information from drug companies before their doctors prescribed what was once considered “safe” for nursing moms to help with Post-Partum Depression or Anxiety. These medications can seriously put nursing infants and babies from future pregnancies at risk. It has even become common for doctors to try to prevent certain psychiatric conditions by giving prescription psychiatric drugs to pregnant mothers, and it is the babies who have suffered the most.

Yet, drug makers have known longer than they have let on that these risks existed and they chose not to tell the public about many of the dangers.

Even if your case seems impossible you should investigate until you get answers. No child’s death or birth defect should be excused where the multi-billion dollar drug companies are concerned. We will help you obtain justice for your child.

Suicide and Wrongful Death

In 2004 the FDA began warning patients that certain antidepressants can cause suicide. A warning about homicidal ideation was later added to some drug labels. If you have lost a loved one to suicide or violence you feel may have been caused by a psychiatric drug, you may have a case. Call us at (956) 428-2822 to have your situation evaluated.

Having trouble finding a lawyer?

Many attorneys won’t take a case against a drug manufacturer unless it is an open-and-shut, easy win that will bring a quick settlement. Even if you’ve been turned away by other lawyers in the past, that does not mean your case has no merit. It could be that the lawyer you consulted was looking for a very specific type of client, or did not have adequate knowledge of drug side effects to understand the theories necessary to win your case. Do not give up! Call us for a case evaluation at (956) 428-2822.