May 26, 2011 | by Shirley

Zimmer Nexgen Knee Implants

Zimmer Nexgen knee implants have come under fire.   In the March 2010 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS), Dr. Richard Berger, an orthopaedic surgeon and former Zimmer surgical consultant,  presented a Podium Presentation entitled “The High Failure Rate of a High-Flex Total Knee Arthroplasty Design” .    The presentation began with the following statement,

“This cementless high-flex femoral component reviewed has a high incidence of failure with 36% being loose and 9.3% having had revision or impending revision for painful loosening”

To read the AAOS summary of this presentation, click on the following link:   http://sjlaw.info/DrBergerAAOSPresentation

So who is Dr. Berger and why is his opinion and this study so important?  The March 2010 presentation based it’s data on patients whose knees were implanted between July and October 2005.   During this time period Dr. Berger was a paid surgical consultant for Zimmer Holdings.  The doctor used the Zimmer Nexgen implant.  The New York Times did an article on June 19, 2010 discussing Dr. Berger and his relationship with Zimmer.   The article was titled, “Surgeon vs. Knee Maker: Who’s Rejecting Whom?”.   The article discusses Dr. Berger’s formerly close relationship with Zimmer.  It states,

“For years, Dr. Richard A. Berger designed surgical tools and artifical joints for Zimmer Holdings, trained hundreds of doctors to use its products and talked it up wherever he went.  In return, Zimmer, an orthopedic implant maker, helped enrich Dr. Berger, portraying him as a master surgeon and paying him more than $8 million over a decade.

Those days are gone.  Dr. Berger started complaining to Zimmer a while back that one of its artificial-knee models was failing prematurely, and he went public recently with a study that he says proves it. ”

Zimmer countered Dr. Berger’s accusations with stating that they had data that the implants were fine and the fault was with Dr. Berger’s technique.  That charge is interesting give the fact that, according to the article, Dr. Berger was paid by Zimmer to train other surgeons using his techniques.  To see the complete New York Times article click the following:  http://sjlaw.info/NYTimesZimmerDrBerger 

So much for Dr. Berger and Zimmer.  There are also other things going on with the Zimmer Nexgen knee implant.  Here is a link to a page on the FDA website which searches for medical device recalls:  http://sjlaw.info/FDAMedDeviceRecalls   If you go to the line specifying product name and type in “knee” and then go down to the line designating recalling firm and type in ”Zimmer”,  pages of recalls all connected with Zimmer’s Nexgen knee implant come up. 

If you or someone you care about has had a knee replacement using the Zimmer Nexgen implant contact us.  There may be something we can do to help.

April 21, 2011 | by Shirley

Questions – Johnson & Johnson DePuy ASR Hip Recall

In a previous post we gave a brief overview regarding the Johnson & Johnson DePuy Hip Implant Recall.  Since then, we have gotten several calls regarding this recall.   Some of the questions we have been asked include following:

How do I know I have a Johnson & Johnson DePuy ASR Hip?

Do have have to have issues to make a claim if I do have the Johnson & Johnson DePuy ASR hip implant?

What is the process that I will have to go through to make a claim?

Is making a claim going to involve a lot of time?  upfront money?

There are many other questions we have had in addition to the above.   We are happy to spend a few minutes answering your questions regarding the Johnson & Johnson DePuy ASR Hip Implant recall  - no obligations – no hassle.   Just contact us.

April 19, 2011 | by Shirley

Johnson & Johnson DePuy ASR Hip Recall

On August 26, 2010 DePuy Orthopaedics, a division of Johnson & Johnson, announced the recall of its ASR XL Acetabular System and the ASR Hip Resurfacing System.    The ASR XL Acetabular System was implanted into the pelvis as part of a total hip replacement.   The ASR Hip Resurfacing System was used where the top of the femur is preserved and a metal cap is placed over it.  The top of the femur is then placed into an ASR socket which is implanted into the pelvis.

According to DePuy, 

“New data shows that five years after implantation, approximately 12% of patients (1 in 8 ) who had received the ASR resurfacing device and 13% of patients (1 in 8 ) who had received the ASR total hip replacement needed to have a revision surgery 13% of patients (1 in 8 ) who had received the ASR total hip replacement needed to have a revision surgery.”  

This data only covers the first five post implantation years.  Statistics are not available for years 6 and beyond.   Obviously the percentage of patients adversely affected would increase if additional years were also included in this type of study.  Most hip systems commonly have a life expectancy of 15 or more years.  

The ASR systems which have been recalled have been implanted since July 2003.  It has been estimated that 93,000 of them have been implanted worldwide. 

These defective implants can cause a multitude of symptoms.   DePuy has stated,

“The patients who reported problems in the first five years and had revision surgery reported a variety of symptoms. These symptoms included pain, swelling and problems walking. These symptoms are normal if you have just had a hip replacement. If the symptoms continue or come back, it is a sign that there may be a problem such as:
               • Loosening, when the implant does not stay attached to the bone in the correct position
               • Fracture, where the bone around the implant may have broken; and
               • Dislocation, where the two parts of the implant that move against each other are no longer aligned.
The ASR Hip is made up of ball and socket components that move against each other. These metal components wear over time and generate very small particles that can only be seen with a microscope.”   

The particles released by the metal component wear can cause fluid to collect in the joint and in the muscles around the joint.  This could cause damage to some of the nerves, muscles, and bones around the hip.

Our firm is helping those patients who have the ASR XL Acetabular System and the ASR Hip Resurfacing System in connection with claims against DePuy Orthopaedics.   These patients may benefit from recovery of monies which may assist them with present or future medical treatment as well as other monetary losses associated with the potential disruption of their lives.  If you have questions regarding the DePuy litigation, please contact us.

April 1, 2011 | by Shirley

Hmmmmm – Clinical Trial Questions

Soooo – you test a new medication in a clinical trial on patients who are not the ones who will normally, eventually take that medication?  What good is that!  That is the gist of an interesting article which popped up in the Archives of Internal Medicine this week.   The investigators specifically looked into medications designed to help patients with heart failure. 

The vast majority of patients who develop heart failure are over the age of 65.  However, according to the investigators, clinical trials of new heart failure medications often exclude anyone 65 or older.   The trials also often exclude anyone taking over 1 (just one) prescription medication.   Unfortunately most people who are over 60 years of age use more one prescription medication.  Bottom line is that most folks who would eventually be taking the new medication aren’t even included in some of  these clinical trials!  I repeat – What good is that!

Why is this such a big deal, at least in my mind?   The FDA uses clinical trial data in evaluating whether or not to approve a drug for use in the general population.  If clinical trial data is skewed – well - isn’t it any wonder, if we use this example, there are so many patients out there who have bad experiences with prescription medications. 

Here are some links to more information regarding  the above:

http://sjlaw.info/PharmalotClinicalTrialExclusions

http://sjlaw.info/ExclusionofOlderPatientsClinicalTrials

March 14, 2011 | by Shirley

Topamax and Topiramate Linked to Birth Defects

On March 4, 2011, the FDA issued a safety alert regarding birth defects and the medication Topamax and its generic form, topiramate.  Topamax is prescribed for epileptics as an anti-convulsant medication which can help with certain types of seizures.  The medication can also be prescribed for prevention of migraine headaches. 

The FDA alert was issued as a result of new data reported to the FDA which shows a significant increase in the development of a cleft palate and/or cleft lip in babies whose mothers were taking the medication while pregnant.   

Cleft is a term which means failure to join.  When babies are developing in the womb, the roof of the mouth or palate is initially separated, left and right.   With normal development at approximately 5 – 9 weeks into the pregnancy, these two sections fuse together in the fetus forming the solid, one piece roof of the mouth.   With a cleft palate defect these two sections never fuse leaving a gap in the roof of the mouth which goes up into the nasal cavities.   With a cleft lip, sections of the lip fail to fuse. 

Babies can have difficulty eating with these birth defects.  With the mouth completely open to the nasal cavities it is hard for these babies to have the ability to suck.  Therefore special feeding procedures may be required to allow them to get enough nourishment.   The children affected can also have issues with breathing, hearing, speech and language.  

Surgical repair of these defects is recommended within a baby’s first 18 months.  Many children need to have additional surgeries as they grow older.  

The FDA alert regarding Topamax and it’s generic, topiramate is based upon data supplied to the FDA by the North American Antiepileptic Drug (NAAED) Pregnancy Registry.  We have attached the link to the FDA Safety Communication below which discusses the actual data submitted to the FDA which lead to their safety alert. 

The use of Topamax and it’s generic, topiramate is widespread.  According to the FDA approximately 32.3 million prescriptions were dispensed for these medications between January 2007 and December 2010.

Links: 

Information regarding cleft palate/cleft lip:   http://sjlaw.info/CDCCleftPalateLipInfo; http://sjlaw.info/AmericanCleftPalateCraniofacialAssociation;    http://sjlaw.info/cleftlippalateinformation

FDA Safety Alert:  http://sjlaw.info/FDATopamaxtopiramateBirthDefectAlert

December 2, 2010 | by Shirley

FDA Recalls Darvon, Darvocet, Propoxyphene Medication Due to Heart Issues

Darvon and Darvocet, are medications which have been prescribed to relieve mild to moderate pain for many years.  Proproxyphene is the active ingredient in these medications.  It is also the generic form of these medications.  There has been concern over the safety of these drugs for quite some time.

The FDA had received requests to have these medications removed from U.S. markets in 1978 and again in 2006 due to ongoing concerns regarding their safety.   In 2009 an advisory committee met with the FDA and discussed these safety concerns.  On January 30, 2009 that advisory committee voted 14 – 12 to remove all drugs containing propoxyphene from the market.  In response to the 2009 request for removal, the FDA asked that a new study be done to address the issues raised by the advisory committee.

Recently the FDA received the results of that study.  Accordingly, on November 19, 2010, the FDA finally asked for recall of all medications, such as Darvon and Darvocet, which contain Proproxyphene.  The FDA states in its press release:

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart.  These changes, which can been seen on electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death.  The available data also indicates that the risk of adverse events for any particular patient (even patients who  have taken the drug for many years) is subject to change based on small changes in the heath status of the patient, such as dehydration, a change in medications, or decreased kidney function.

The FDA is not the first to call for the withdrawal of propoxyphene containing medications from the market.  In 2005 these drugs were withdrawn from the market in Great Britain due to that country’s concern over safety issues.   In 2009 the drug started to be withdrawn from European markets at the recommendations of the European Medicines Agency. 

Darvon, Darvocet and Propoxyphene have been widely prescribed in the United States.   It is estimated that approximately 10 million prescriptions were written for them in 2009.  If you believe you or someone you care about has suffered as a result of taking a propoxyphene medication or you have any questions feel free to contact us.

August 17, 2010 | by Shirley

Chantix and Pfizer – Stealth Advertising

Can there be an ad for a drug where the drug isn’t even mentioned?   Consumers Reports wrote a blog article titled, “Pfizer and Chantix: Stealth advertising at its finest”, on this topic.  In their blog they state,  ”If this sounds a little sneaky to you, well we think it is.  But it’s also totally legal, and representative of a growing trend in direct-to-consumer advertising:  the help-seeking ad.  These are ads that, instead of mentioning a drug by name, address the condition it’s meant to treat – then drive you to a web site or toll free number that offers, among other information, the option to learn about a “prescription treatment option.” 

Why would a pharmaceutical company not want to mention their drug’s name?  Well, according to the FDA,  if an ad mentions a specific drug then that drug’s side effects also have to be mentioned.   So, if a drug has some pretty nasty potential side effects, a help-seeking ad makes sense.  The drug company is actually advertising the drug but, because they don’t have to mention the drug’s name, they don’t have to mention the side effects.  Consumers Reports took a help-seeking ad sponsored by Pfizer and went through it in detail in the video below.  

MAKE SURE TO VIEW THE ENTIRE VIDEO

To view the Consumer Report blog titled, “Pfizer and Chantix:  Stealth Advertising at Its Finest”  which is referred to above use the following link:   http://sjlaw.info/ChantixStealthAd

We are interested in what you think about these help-seeking ads and invite you to comment below.

August 6, 2010 | by Shirley

Avandia – The FDA Advisory Committee Vote

So after the FDA Avandia committee’s review of 900 plus pages of documents and two days of presentations, what was the vote?    There were 33 total committee members and the results were as follows:

  • - 12 voted to remove Avandia from the market
  • - 10 wanted stiffer warnings and restrictions
  • - 7 voted to add stiffer warnings
  • - only 3 voted to leave Avandia on the market with the current labeling

So what will the FDA’s next action be regarding this drug?   Popular opinion is that the FDA will end up leaving Avandia on the market but with stiffer warnings and added restrictions.   However,  no one really knows.   Officials at the FDA have indicated they will make a final decision regarding Avandia as soon as possible.

July 30, 2010 | by Shirley

The FDA and Avandia – The Committee Meeting

The FDA 33 member committee meeting regarding Avandia offered some interesting insights regarding the diverse opinions held in connection with this drug.  We found this CBS News report interesting.

July 9, 2010 | by Shirley

The FDA and Avandia – The FDA has decided to…?

Next week is a big one for the pharmaceutical giant GlaxoSmithKline, manufacturer of the diabetes drug, Avandia.  Avandia’s  fate is going to be decided by the FDA following two days of meetings on July 13 and 14.  Avandia, the once blockbuster diabetes drug which accounted for approximately $2.2 billion in U.S. revenue for the company in 2006, is on trial.  Why?

Avandia has had a rocky road since 2006.    Because of reports and studies which linked Avandia to injuries to the heart, in 2007 the FDA  required GlaxoSmithKline to add a strong “black box” warning regarding the heart to the drug’s labeling.  Studies and reviews of Avandia since then have provided additional worrisome findings.   After reviewing these studies, many government scientists began to echo their concerns over the connection between Avandia and heart damage.   Their concern is why the FDA is holding the upcoming two day special meeting on this drug.   

Questions and decisions are expected to be made regarding Avandia’s fate as a result of this meeting.   Should there be an additional, stronger warning on the drug’s label?  Should only certain physicians be allowed to prescribe the medication?  Most importantly, the biggest and most debated question of all is, should Avandia be taken off of the market completely to protect the public?  

What happens if Avandia is taken off of the market by the FDA?  This is of major concern for GlaxoSmithKline.   For even though, per a recent Associated Press article, the Avandia revenue has dropped from its 2006 height of $2.2 billion down to $520 million last year, the drug is still a lucrative U.S. revenue stream for GlaxoSmithKline.   So, at stake in this hearing – approximate $520,000 million a year in U.S. revenue for this pharmaceutical company.    

Both the FDA and GlaxoSmithKline prepared briefing material for those involved with next week’s meeting.  Today on the FDA website, links to this briefing information, the FDA’s 765 Briefing and GlaxoSmithKline’s 166 page Briefing, were posted for public review.

So the $520 million stage has been set.   The major players, the FDA and GlaxoSmithKline, are in place.   The results?  Stay tuned. 

The following link goes to the FDA page where both the FDA and GlaxoSmithKline Briefings can be accessed:  http://sjlaw.info/BriefingInfoAvandia

The recent Associated Press article mentioned above can be accessed using the following link:  http://sjlaw.info/AvandiaAP