You are here: Home Investigations

Current Investigations

lLose Up of Ear of Boy

Cochlear Implants & Meningitis

Recently, a link was discovered between bacterial meningitis and children with early versions of the Advanced Bionics cochlear implant. In 2002, a study was completed that showed that bacterial meningitis occurred in more children with cochlear implants that other children of the same age group. The FDA continued to receive reports of an increase in bacterial meningitis in children with cochlear implants.

This risk means that children with Advanced Bionics cochlear implants need to be monitored and observed very carefully for this particular infection, which can be fatal.

Cochlear implants are electronic hearing devices which were first approved by the FDA in the 1980s. They work by electrically stimulating nerves inside the inner ear.

The FDA indicated to patients and doctors that children with cochlear implants and a positioner get bacterial meningitis more frequently than those without the rubber wedge positioner or implants at all. Advanced Bionics was the only manufacturer the market the cochlear implants with the small rubber wedge positioners, who then stopper producing implants with the positioners entirely by 2002.

Advanced Bionics Products Recalled

Recall Number Z-0956-2009
Trade Name/Product HiRes90K Platinum Series Headpiece - HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar; CA 91342 USA. The HiRes90K headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
Reason for Recall Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Seriesheadpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communicationfrequency is adjusted to match that of the internal device. Potential clinicalsymptoms include:-No lock-Intermittent lock-Implant locks; but cann

 

Recall Number Z-0956-2009
Trade Name/Product S-Series Headpiece Short Range - S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar; CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
Reason for Recall Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Seriesheadpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communicationfrequency is adjusted to match that of the internal device. Potential clinicalsymptoms include:-No lock-Intermittent lock-Implant locks; but cann

 

Recall Number Z-0958-2009
Trade Name/Product S-Series Headpiece Long Range - S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar; CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
Reason for Recall Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Seriesheadpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communicationfrequency is adjusted to match that of the internal device. Potential clinicalsymptoms include:-No lock-Intermittent lock-Implant locks; but can

 

Recall Number Z-0957-2009
Trade Name/Product Platinum Series Headpiece - Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss
Reason for Recall Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Seriesheadpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communicationfrequency is adjusted to match that of the internal device. Potential clinicalsymptoms include:-No lock-Intermittent lock-Implant locks; but can

What are the signs and symptoms that a HiRes™90K might be starting to fail?

You or your child may experience:

  • a sudden sensation of discomfort or pain
  • a sudden loud noise or popping sound
  • an intermittent functioning
  • a complete loss of sound
  • in children, an unwillingness to wear the external headpiece

Defective Cochlear Implant Attorneys

Those who have been injured by a cochlear implant might be entitled to compensation.

Talking with one of our lawyers might help you answer some of your questions, such as:

  • Am I entitled to compensation for medical bills, disabilities, pain and/or suffering?
  • How would i begin to pursue a defective cochlear implant suit?
  • What are some comparable cases and their outcomes?
  • Should I file and individual or class-action lawsuit?

To speak with one of our attorneys, please fill out our confidential questionnaire.



 
BP Oil Spill

BP Oil Spill

On April 20, 2010, an oil rig owned by Transocean and leased by British Petroleum (BP) exploded, killing 11 and injuring many others. Unfortunately, there are more short-term and long-term consequences that the people living on the Gulf Coast will have to face. The oil spill will cost billions of dollars in clean up, loss of business activity, lost of income, devastation to wildlife and the environment.

The BP Oil Explosion in the Gulf of Mexico has resulted in one of the most significant environmental disasters of all time. The impact of the explosion is much greater than initially thought as it is now believed that up tp 25,000 barrels of oil are leaking into the Gulf of Mexico each day.

If you have been affected by this disaster, speak with a lawyer now to discuss your options.

 

Zocor

What is Zocor?

Zocor is a prescription statin drug used by people who need to lower their cholesterol. Zocor works by inhibiting cholesterol production in the liver. Zocor is the brand name for the drug manufactured by Merck & Co. of Whitehouse Station, New Jersey. Its chemical name is simvastatin.

What's wrong with Zocor?

The problem with Zocor is patients prescribed the 80 mg. pill have an increased risk of developing rhabdomyolysis, a life-threatening form of muscle disease which can lead to severe kidney damage, kidney failure, and death.

Zocor has also been linked to potential increase in major cardiovascular events, such as heart attack, revascularization and cardiovascular death, in patients taking 80 mg. compared to 20 mg. doses.

An estimated 24 million Americans take cholesterol-lowering drugs; it’s big business and good for investor relations. An estimated 12 million women are prescribed statin drugs each year.

In a clinical trial database where 41,050 patients were treated with Zocor with 24,747 (approximately 60%) treated for at least 4 years, the incidence of myopathy was approximately 0.02%, 0.08% and 0.53% at 20, 40 and 80 mg./day, respectively. Myopathy is a muscular disorder that interferes with the proper function of muscle fibers. Depending on the severity, a person suffering myopathy may find the muscles are so weak that performing routine tasks is extremely difficult, if not impossible.
The FDA reviewed results of the SEARCH trial which over a period of 6.7 years, evaluated the number of major cardiovascular events in 6,031 patients taking 80 mg. of simvastatin compared to 6,033 patients taking 20 mg. of simvastatin. Preliminary results show more patients in the 80 mg. group developed myopathy compared to patients in the 20 mg. group.

   

Qui Tam/Whistleblowers

Qui tam (commonly pronounced as “kwày tæm”) is an abbreviation from the Latin "qui tam pro domino rege quam pro sic ipso in hoc parte sequitur" meaning "who as well for the king as for himself sues in this matter."

Black's Law Dictionary defines a qui tam action as "an action brought by an informer, under a statute which establishes a penalty for the commission or omission of a certain act, and provides that the same shall be recoverable in a civil action, part of the penalty to go to any person who will bring such action and the remainder to the state or some other institution."

Qui tam is a provision of federal and state False Claims Acts that allows private citizens to file a lawsuit in the name of the federal and some state governments against individuals and entities who fraudulently obtain government funds while claiming an award in the event of a recovery.

Federal and state qui tam statutes have been enacted in order to effectively identify and prosecute government procurement and program fraud and recover revenue lost as a result of the fraud.

 

Leflaw has teamed up with The Qui Tam Team, a union of experienced and diverse lawyers that have recovered over $2.5 Billion Dollars in qui tam related cases. To share your story with us and receive free legal advice from The Qui Tam Team, please fill out a form.

 

Yaz/Yasmin

What is Yaz?

YAZ and Yasmin are birth control pills, or oral contraceptives, currently manufactured by Bayer HealthCare Pharmaceuticals, Inc. Yasmin was originally made by Berlex Laboratories, which was acquired by Bayer in 2006.

Ocella is the generic equivalent of Yasmin. The Ocella pill is currently manufactured by Teva Pharmaceuticals. Ocella was originally made by Barr Laboratories, which was acquired by Teva in 2008.

What Are We Investigating?

Each of these birth control pills contain ethinyl estradiol and the new "fourth generation" progestin drospirenone (DRSP). Drospirenone is already well-known for increasing the risk for hyperkalemia. However, these DRSP oral contraceptives have also been associated with adverse side effects such as:

  • Blood Clots
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Stroke
  • Cerebrovascular Accidents (CVA)
  • Heart Attack
  • Myocardial Infarction
  • Gallbladder Disease / Injury
  • Gallbladder Removal (cholecystectomy)
  • Kidney Failure or Renal Failure
  • Pancreatitis
  • Death
Related Information

FDA warning letter #1 2008

FDA warning letter #2 2009

Bayer HealthCare Pharmaceuticals Yaz® website