http://www.yourlawyer.com/topics/overview/Cochlear_Implants Sat, 21 Nov 2009 18:56:19 -0800 pixel-app en http://www.yourlawyer.com/articles/read/15025 Tue, 26 Aug 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/15025 cochlear implant can go forward, a federal judge in Texas has ruled, because a Supreme Court decision  that gave medical device makers protection from product liability lawsuits does not apply to this case.  In her opinion, US District Court Judge Barbara Lynn wrote that  preemption was not warranted in the case because “plaintiffs’ strict liability claims are predicated solely on violations of federal law."

In February, the Supreme Court ruled in favor of medical device makers in  Riegel vs. Medtronic, Inc., granting them protection from product liability lawsuits involving devices that had been approved by the Food & Drug Administration (FDA). Before the High Court, Medtronic had successfully argued that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts.

That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims.  Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

In their lawsuit filed last September against Advanced Bionics and Astro Seal, Scott and Pamela Purcel blamed the companies' cochlear implants for injuries their son received.  The Purcels’ suit centers around a single component of the HiRes90k — a feed-thru manufactured by Astro Seal — that was used to connect the device’s internal electrical circuitry to external components. Advanced Bionics issued a voluntary recall of all nonimplanted HiRes90k devices containing Astro Seal feed-thrus in September 2004 because moisture could get into the internal circuitry, which could cause the device to fail.

The Purcels' lawsuit alleges that Advanced Bionics violated federal law when it made the defective cochlear implant.  That allegation grew out of  an administrative claim filed against Advanced Bionics by the FDA last November. The claim, which was amended in March, accused the company of using components from an unapproved supplier. The company settled with the FDA in July by agreeing to pay a $1.1 million fine, the maximum the FDA can impose on an individual or company. As part of the settlement, Jeffery Greiner, Advanced Bionics’ president and co-CEO, also agreed to pay a $75,000 fine.

Because the plaintiffs' claims involve violations of federal law, the judge wrote that lawsuit does not impose requirements that are additional, or different from, those imposed by the Medical Device Amendments of 1976.   As such  the lawsuit is not covered by the Supreme Court's ruling in Medtronic vs. Riegel, the judge ruled.  

]]> http://www.yourlawyer.com/articles/read/14121 Mon, 31 Mar 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14121 cochlear implant hearing aids, could face a stiff fine from the Food & Drug Administration  (FDA) for manufacturing violations that may have resulted in dangerously defective hearing aids.  The FDA has alleged that Advanced Bionics failed to follow manufacturing standards and wants to fine the California medical device manufacturer $2.2 million.  

Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator in 2007.  The cochlear implant hearing aid is surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children. The hearing aid is considered a Class III device by the FDA—the most stringent regulatory category for devices. The FDA says the hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.

The agency's complaint, originally filed this past November and amended on March 17, seeks penalties against Advanced Bionics and its president and co-CEO, Jeffrey H. Greiner. The complaint alleges that Advanced Bionics shipped hearing aids to customers in the United States prior to filing appropriate supplemental information with the agency, including a notice of changes made to the devices that affected their safety and effectiveness.

The agency says Advance Bionics failed to comply with the FDA's current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products. Advanced Bionic's alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the hearing aid by testing lots under actual or simulated use when the unapproved vendor's component was used. The complaint also states that Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. Two hearing aids shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.

The complaint states that the company's failure to file the required supplement occurred after a 2001 inspection. At that time, Advance Bionics was cited by the FDA for similar failures and made commitments to correct the problems.

]]> http://www.yourlawyer.com/articles/read/13201 Thu, 11 Oct 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/13201 Food & Drug Administration (FDA) after it learned that two children with Cochlear implants had recently died from bacterial meningitis.

A Cochlear implant is an electronic hearing device that works by stimulating nerves inside the inner ear.  It is designed to produce useful hearing sensations to children and adults with severe to profound nerve deafness. The FDA approved the first commercial Cochlear devices during the mid-1980s.

In 2006, the FDA issued letters to patients and doctors that deaf children who have a Cochlear implant with a positioner are likely get bacterial meningitis more frequently than either children with the implants that don't have the small rubber wedge or those without implants at all.  Only one Cochlear implant has a positioner and that device was withdrawn from the market in July 2002.

In its latest health alert, the FDA said that two children – ages 9 and 11 – with Cochlear implants had died from bacterial meningitis in the past year.  Neither had been fully immunized against the disease, and both had Cochlear implants with positioners.  

Meningitis is an inflammation of the protective covering of the central nervous system.  Symptoms include high fever, headache, stiff neck, nausea, or vomiting, discomfort looking into bright lights, sleepiness, or confusion. Some patients have ear pain or ear infection. Very young children may be sleepy, cranky, or eat less.  Bacterial meningitis is always a medical emergency and can be fatal.  But the disease can be prevented through appropriate vaccination.

Unfortunately a recent study conducted by Johns Hopkins University found that only 29% of parents or guardians of children younger than two with cochlear implant knew whether their children were properly vaccinated. The same survey also found that vaccination status was also unknown for 43% of implant patients older than two.

In addition to recommending vaccinating children with Cochlear implants against bacterial meningitis, the FDA also is advising parents, teachers and caregivers of children with Cochlear implants to become familiar with the signs and symptoms of the disease.  The FDA is also cautioning physicians to treat ear infections in Cochlear implant recipients aggressively, as many children had presented with middle ear infections immediately prior to the development of bacterial meningitis.  And finally, the FDA advised doctors to consider prescribing preventative antibiotics to children who are about to receive a Cochlear implant.

]]> http://www.yourlawyer.com/articles/read/11300 Tue, 07 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11300
The devices are designed to help severely to profoundly deaf adults and children who get little or no benefit from hearing aids. Individuals with severe or profound "nerve deafness" may also benefit from cochlear implants.

On September 25, 2003 (updating original notice of July 24, 2003) the Food and Drug Administration (FDA) notified healthcare providers "about a recent study showing that children with cochlear implants are at greater risk of developing bacterial meningitis caused by Streptococcus pneumoniae than children in the general population."

Bacterial meningitis, a serious infection in the cerebrospinal fluid (CSF) around the brain and spinal cord, can be fatal.

That study was conducted by FDA, the Centers for Disease Control (CDC) and others, and was published in the July 31, 2003 issue of The New England Journal of Medicine. "The focus of the investigation was young children because they account for the majority of known meningitis cases and represent the population that will receive most cochlear implants in the future."

The FDA/CDC study reviewed the medical records of 4,264 children under the age of six at the time of implantation. Of these patients, 26 were reported to have meningitis. Because the number of meningitis cases was small, the FDA stated it was "limited in our ability to determine the risk of developing meningitis with various cochlear implant models."

Although the FDA/CDC study did show "cochlear implants with electrode positioners were associated with a greater risk of developing meningitis than implants without positioners," it was unable to determine how the positioner increased the risk for developing meningitis.

A positioner is a small rubber wedge that helps the physician position the implant during surgery. Only Advanced Bionics Corporation sold an implant that had a positioner, and none were implanted after July 2002.

On Monday, however, the FDA posted an updated advice for patients that "gives the latest information on the risk of bacterial meningitis in children with cochlear implants and recommends steps to reduce the risk."

A new study, published in the February issue of Pediatrics, "which followed the children for two more years, has found that the increased risk for meningitis persists beyond two years after implantation. This study highlights the importance of continuing to monitor children with cochlear implants for signs of middle ear infection and meningitis. Children need to be monitored for as long as the implant is in place."

Based upon the findings in the new study, the FDA published the following recommendations:

"Continue close monitoring for meningitis and middle ear infections for all children with a cochlear implant, but particularly for children whose implants have a positioner. Consult your implanting doctor to determine if the patient has a positioner. It is, however, important to monitor all cochlear implant patients.

Check the patient's record of vaccinations against CDC's recommendations (www.cdc.gov/nip/issues/cochlear/cochlear-gen.htm), which show what vaccines cochlear implant patients should receive and when the vaccines should be given. The CDC Immunization Center telephone number is 800-232-4636. The TTY number is 888-232-6348.

Contact your doctor immediately if the patient has any symptoms of meningitis or middle ear infection. These may include: high fever; headache; stiff neck; nausea; vomiting; irritability; confusion; ear pain; hearing loss; loss of appetite; sleepiness or tiredness; or discomfort when looking into bright lights.

Follow your doctor's prescription for antibiotics very carefully. It is very important that you make sure the patient takes the antibiotic as often as prescribed and for as long as prescribed, so it can work properly."

The latest FDA advice notes that the new study "followed children from the original study for an additional two years. Six children with positioners developed meningitis after two years. Of these six, three developed meningitis between three and four years after implantation.

Children in the study without a positioner did not develop meningitis, but this group of children was so small it is hard to predict the risk of their developing meningitis. The study also concluded there is not enough information now to recommend surgical removal of devices with a positioner."]]> http://www.yourlawyer.com/articles/read/11294 Mon, 06 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11294
The increased risk means the young implant patients should be monitored as long as the electronic devices are in place for signs of the sometime fatal infection of the fluid surrounding the brain and spinal cord.

Deaf children fitted with the implants and a positioner get bacterial meningitis more often than either children with the implants that don't have the small rubber wedge or those without implants at all, the FDA said in separate letters to patients and doctors.

The rubber wedge originally was used to help doctors position the implants during surgery. Advanced Bionics Corp. was the only manufacturer to sell implants with positioners. None has been implanted since July 2002.

An original study found 26 of 4,264 children with the implants developed meningitis during the first two years following surgery, with those with positioners at greater risk. Now, a new study that followed the same children for an additional two years found another six; all with positioners developed meningitis. The results appear in this month's issue of the journal Pediatrics.

It remains unclear how the positioner increases the risk, the FDA said. Nor does the agency have enough information to recommend surgically removing the devices, given the risk of postoperative infection.

Beyond monitoring cochlear implant patients for signs of meningitis, which include high fever and a stiff neck, the FDA recommends the children receive the proper vaccinations.]]> http://www.yourlawyer.com/articles/read/11297 Mon, 06 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11297
This is to call your attention to updated information on the risk of bacterial meningitis in children with cochlear implants, and to provide recommendations for decreasing the risk. A new CDC/FDA study has shown that children with cochlear implants with a positioner remain at increased risk of bacterial meningitis caused by Streptococcus pneumoniae beyond 24 months post-implantation. Cochlear implants with a positioner were manufactured only by Advanced Bionics Corporation. None have been implanted since July, 2002.

The new study, published in Pediatrics, (February 2006, Vol. 117, Issue 2, http://pediatrics.aappublications.org/) followed the same cohort of children identified in an earlier CDC/FDA study for an additional 2 years. After 24 months post-implantation, children with cochlear implants with a positioner continue to be at greater risk of developing bacterial meningitis than children with cochlear implants with no positioner or children in the general population. Six children developed meningitis after 24 months post-implantation. All of those children had cochlear implants with a positioner.

These findings underscore the importance of continued monitoring and prompt treatment of bacterial infections in children with cochlear implants beyond two years post-implantation, particularly among children whose implants have a positioner.

It is still unknown whether the risk of meningitis in patients whose implants have a positioner might be reduced if the implant were removed or replaced by a model that does not have the positioner. Any potential benefits of explantation surgery must be weighed against the risks for operative complications, including perioperative meningitis. The present study concludes that there is currently insufficient information to support a recommendation for elective surgery to explant devices with a positioner.

Recommendations to decrease the risk of meningitis in cochlear implant recipients

These recommendations have not changed from the 2003 recommendations.

Follow CDC’s vaccination recommendations. CDC has issued recommendations about which vaccines cochlear implant patients should receive and when the vaccines should be given. These vaccine recommendations continue to apply to all children with a cochlear implant, with or without a positioner, and all potential implant recipients. Healthcare providers and families should review vaccination records of current and prospective cochlear implant recipients to ensure that the patient is current on all the CDC recommended vaccinations. These recommendations are available on the CDC’s website at www.cdc.gov/nip/issues/cochlear/cochlear-gen.htm.

Recognize the signs of meningitis early. Cochlear implant recipients, along with their families, educators, daycare and healthcare providers, need to be aware of the signs of meningitis. This can help ensure early detection and treatment of this life-threatening illness. Early intervention is vital in successfully treating the infection and minimizing permanent neurological damage. Early signs of meningitis include high fever, headache, stiff neck, nausea or vomiting, discomfort looking into bright lights, and sleepiness or confusion. A young child or infant with meningitis might be sleepy, cranky, or eat less.

Diagnose and treat middle ear infections promptly. In some of the meningitis cases reported to FDA, cochlear implant recipients had signs of middle ear infection (otitis media) prior to surgery or before the meningitis developed. For this reason, healthcare providers should diagnose and treat otitis media promptly in patients with cochlear implants.

Consider prophylactic antibiotics. Healthcare providers should consider prophylactic antibiotic treatment perioperatively in children receiving cochlear implants.

Advice to Patients with Cochlear Implants can be found at http://www.fda.gov/cdrh/medicaldevicesafety/atp/020606-cochlear.html.

Background information

The original CDC/FDA article on this topic was published in the July 31, 2003 issue of The New England Journal of Medicine (http://content.nejm.org/cgi/content/full/349/5/435). The original FDA Notification on the Risk of Bacterial Meningitis in Children with Cochlear Implants, which was last updated on September 25, 2003, can be found at http://www.fda.gov/cdrh/safety/cochlear.html. The 2003 Notification includes additional information on the background of this issue not included in this update.

The 2003 CDC/FDA study assessed the risk of meningitis among 4,264 children under the age of six at the time of implantation. The focus of the investigation was young children because they account for the majority of known meningitis cases and represent the population that now receives a large proportion of cochlear implants. The study showed that children with cochlear implants are at greater risk of developing bacterial meningitis than children in the general population and that cochlear implants with electrode positioners were associated with a greater risk of developing meningitis than implants without positioners. The study was unable to determine how the positioner might increase the risk of developing meningitis.

Reporting cases of meningitis in cochlear implant recipients

We encourage you to report cases of meningitis in cochlear implant recipients. You can report cases directly to the device manufacturer or you can report them to MedWatch, FDA’s voluntary reporting program. You may submit reports to MedWatch one of four ways: online at http://www.fda.gov/medwatch/report.htm; by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787.

Contacting FDA

If you have questions about this notification, please contact Nancy Pressly, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 301-594-2968, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 301-594-0650 and we will return your call as soon as possible.

FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the Notification is released by subscribing to our list server. To subscribe, visit: http://list.nih.gov/archives/dev-alert.html.

Sincerely yours,

Signature of Dan Schultz

Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health

]]> http://www.yourlawyer.com/articles/read/11298 Mon, 06 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11298
Previous Information

A study published in 2003 (NewEngJMed, 349.5: 435-445) (http://content.nejm.org/cgi/content/full/349/5/435) by FDA and the Centers for Disease Control and Prevention (CDC) followed children with cochlear implants for two years after the device was implanted. The study showed that children whose implants have a positioner get bacterial meningitis more often than children with implants that don’t have positioners or children without implants. A positioner is a small rubber wedge that helps the physician position the implant during surgery. Bacterial meningitis, a serious infection in the cerebrospinal fluid (CSF) around the brain and spinal cord, can be fatal. Only Advanced Bionics Corporation sold an implant that had a positioner, and none were implanted after July 2002.

New Information

Now a new study (Pediatrics February 2006), which followed the children for two more years, has found that the increased risk for meningitis persists beyond two years after implantation. This study highlights the importance of continuing to monitor children with cochlear implants for signs of middle ear infection and meningitis. Children need to be monitored for as long as the implant is in place.

Recommendations

Continue close monitoring for meningitis and middle ear infections for all children with a cochlear implant, but particularly for children whose implants have a positioner. Consult your implanting doctor to determine if the patient has a positioner. It is, however, important to monitor all cochlear implant patients.

Check the patient’s record of vaccinations against CDC’s recommendations (www.cdc.gov/nip/issues/cochlear/cochlear-gen.htm), which show what vaccines cochlear implant patients should receive and when the vaccines should be given. The CDC Immunization Center telephone number is 800-232-4636. The TTY number is 888-232-6348.

Contact your doctor immediately if the patient has any symptoms of meningitis or middle ear infection. These may include:

• high fever    
• discomfort looking into bright light
• headache    
• sleepiness or tiredness
• stiff neck     
• confusion
• nausea        
• ear pain
• vomiting       
• hearing loss
• irritability      
• appetite loss

Follow your doctor’s prescription for antibiotics very carefully. It is very important that you make sure the patient takes the antibiotic as often as prescribed and for as long as prescribed, so it can work properly.

Additional Background Information

The original CDC/FDA study reviewed the medical records of 4,264 children under the age of six at the time of implantation. The study was undertaken because of increased concern about the risk of meningitis associated with cochlear implants. The study focused on young children because they account for most known meningitis cases, and they represent the population that now receives a large proportion of cochlear implants

In the original study, 26 of the 4,264 children developed meningitis during the first 24 months after implantation. Children who had cochlear implants with electrode positioners developed meningitis more often than children who had implants without positioners. The study was unable to determine how the positioner increased the risk for developing meningitis. Because the number of meningitis cases in the original study was small, it is hard to predict the risk of developing meningitis with various cochlear implant models.

The new study followed children from the original study for an additional two years. Six children with positioners developed meningitis after two years. Of these six, three developed meningitis between three and four years after implantation. Children in the study without a positioner did not develop meningitis, but this group of children was so small it is hard to predict the risk of their developing meningitis. The study also concluded there is not enough information now to recommend surgical removal of devices with a positioner.

Information for health care providers appears on the web at http://www.fda.gov/cdrh/safety/020606-cochlear.html.

For general information on cochlear implants visit: http://www.fda.gov/cdrh/cochlear/]]> http://www.yourlawyer.com/topics/overview/Cochlear_Implants Mon, 06 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/Cochlear_Implants Cochlear Implants On February 6, 2006, the FDA cautioned that children with an early version of the cochlear implant face an increased threat of bacterial meningitis beyond just the first two years following implantation of the hearing devices. This newly announced risk means that young implant patients must be monitored the entire time the implants are in place because infection of the fluid surrounding the brain and spinal cord can occur.  This infection is sometimes fatal.

A Cochlear implant is an electronic hearing device that works by electrically stimulating nerves inside the inner ear.  It is designed to produce useful hearing sensations to children and adults with severe to profound nerve deafness who get little or no benefit from hearing aids. The FDA approved the first commercial Cochlear devices during the mid-1980s.

The FDA said in separate letters to patients and doctors that deaf children who have a Cochlear implant and a positioner get bacterial meningitis more frequently than either children with the implants that don't have the small rubber wedge or those without implants at all. This specific rubber wedge was at first used to help doctors position the implants during surgery. Advanced Bionics Corp. was the only manufacturer to market the implants with positioners.  None of these devices have been implanted in patients since July 2002.

An initial study found that 26 of 4,264 children with the implants developed meningitis during the first two years following surgery and that those with positioners were at greater risk. A recent new study that followed the same children for an additional two years found another six with infections.  All with positioners had developed meningitis. The results appear in the February 2006 issue of the journal Pediatrics. Beyond monitoring cochlear implant patients for signs of meningitis, which include high fever and a stiff neck, the FDA recommends that the children receive proper vaccinations.

If you or a loved one suffered injuries from a Cochlear implant, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>