Advanced Bionic Recall of HiRes 90K Implant

Image via CrunchBaseAdvanced Bionic has advanced a recall of its  cochlear implant systems, announced today that it has notified the US Food & Drug Administration (FDA) that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation.

These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.

There are three companies in the world that manufacture cochlear implants: Med-El, Cochlear Corporation, and Advanced Bionics.  Advanced Bionics is based in the Los Angeles, California area, and Advanced Bionics was recently acquired by Sonova, a Swiss corporation.  Advanced Bionics was previously controlled and owned by Boston Scientific Corporation. Over the course of its history, Advanced Bionics has manufactured three types of cochlear implants: (1) The Clarion / Clarion 1.2 / C1.2, (2) The Clarion II / CII, and (3) The HiResolution 90k / HiRes90k.

In 2004, Advanced Bionics issued a worldwide recall of all unimplanted Clarion and HiRes90k devices. The company was issued a Warning Letter by the United States Food and Drug Administration (FDA) in February 2005. Later, in March 2006, the company issued a second recall of all unimplanted HiRes90k devices containing a feedthrough manufactured by AstroSeal, Inc. / vendor B. Almost 4,500 persons around the world were implanted with HiRes90k with vendor B feedthrough components.

Talk with us if you believe that you have a defective or recall implant. Call
404-451-7781.

Darvon and Darvocet/Propoxyphene Recall News November 19, 2010

The FDA  has asked that propoxyphene, (brand names Darvon and Darvocet, Xanodyne Pharmaceuticals) be removed from the US market. The decision will also affect generic manufacturers and the makers of propoxyphene-containing products.

The FDA has told medical professionals to stop prescribing propoxyphene. Patients who are taking the stated medications should not sinply stop taking it, ut should contact their doctor soon as possible to discuss switching to another pain-management therapy.

 

Propoxyphene is an opioid typically used to treat mild to moderate pain. It was first approved by the FDA in 1957. It is sold by prescription under various names alone or in combination with acetaminophen. Since 1978, the FDA has received two requests to remove propoxyphene from the market.

 

In January 2009, an FDA advisory committee voted 14 to 12 against the continued marketing of propoxyphene products. At that time, the committee called for additional information about the drug's cardiac effects.

 

From Public Citizen:

Dr. Sidney Wolfe of the Public Citizen's Health Research Group said it was too little, too late, noting that Britain banned the drug six years ago.
"Due to FDA negligence, at least 1,000 to 2,000 or more people in the United States have died from using propoxyphene since the time the U.K. ban was announced," Wolfe said in a statement.
"Our February 2006 petition to the FDA to ban the drug, following the U.K. ban announcement, did not even result in an FDA advisory committee hearing until we had sued the agency in 2008 to force them to respond to our petition."

An FDA advisory committee split on whether to ban the drug in 2009. The European Medicines Agency pulled it from the market in June 2009.

 

 

Tech, The Web, and Being Told what Lawyers Should Do

The way lawyers do business is changing rapidly, which is obvious to just about every attorney in the business. That may not be news. It is also not news to have non lawyers who do not run an office, seek clients, counsel clients, pay bills, or handle 'bet the company' litigation trying to tell lawyers how to do all of some of those.
Today was no different. A webinar was hosted today by a company that from its site provides services like software to lawyers. The webinar dispense free information to attorneys. Some of it was helpful, some - not so much.
First a little about our office - we have a very diverse clientele. It is not uncommon for us to send emails with updates. For some of the younger, mobile generation, many of those clients only have a cellphone. More than a handful will move at least once during the course of a case that lasts two years or more.
With that being said, here is the first bad advice this company (through a speak) gave in its webinar:
1. Bad advice #1: Don't text with clients. Then later, "Never text message your clients."
In my offices, texts are common but limited in subject matter. When we call on the phone and leave a client a message, it is short. "Please call us when you have time." Same for texts - it is to ask the client to call. We never give advice, or simply remark on a pending case. 
We have a policy in place for texts. No one in the office but a law partner may text, and that person may only leave a msg to call us back, or to give an address for a meeting or deposition, or to confirm that the attorney is at a meeting place. 
It's overly simplistic that "never" is the rule. It once again shows how non lawyers, without clients - especially injury clients - lack an understanding of how an office operates now. 
2.  Minimize mobile emailing as well. It's very reactionary..
I'm in court or on the road - a lot. It does take discipline to limit emails. If like me you are in a courthouse, or another office, or on the way to/from either, it's just a way of life to address and prioritize what you may respond to while 'mobile.' 
3.Don't answer the phone simply because it's ringing.
I saw this one from the vendor on twitter. It's a head scratcher. May need better context. For a call into my office, I may let it ring to VM. For the office as a whole, they get answered. After 5PM lawyers may answer. 


A story - it was after 8 PM one night. A new call came to my cell. I answered. It was one of the most significant cases for us that year, a fellow lawyer who needed help on a legal case (his own) and he was impressed that I took the time not only to answer but to talk for an hour. 


My advice - we are all busy. Answer. 

Finally, not bad advice, just not sure how real this one is: "Work with a clean desk" 

I worked with a clean desk. My first day in the practice of law. Never again since.