Should the FDA Share Some of the Blame on DePuy?
December 14th, 2010. By Hunter West
Earlier this month it was announced that all pretrial proceedings for lawsuits centered on the recalled DePuy hip replacement system, will be heard before a single judge in Toledo.
While there are about 150 lawsuits so far, those in the know expect that number to grow to well beyond 1,000. More than 30,000 patients in the US received the complete DePuy hip replacement system that is seen to be failing in a large number of cases, since it was approved by the US Food and Drug Administration (FDA) in 2005.
- Surely Billy Joel expects his hip replacements to last more than 5 years…
I’ll get back to the FDA in a moment. But imagine, if you will, the frustration borne by hip replacement patients realizing that medical products designed to last 20 years, are failing after only a few.
Let’s remember that individuals who are getting hips now, are by and large more active than our fathers and grandfathers at a similar age. We’re not ready for the nursing homes at 50, or 60 or even 70. There are people who are running, skiing, even competing in various sports well into their 80s.
For the remainder of us not inclined toward athletic pursuits, we remain by and large much more active than our forefathers.
Look at Billy Joel. He is still a relatively young man at 61, is he not? In the last two weeks he received a double hip replacement. We fully expect to see him dancing up there on the stage in no time, and I’m sure he expects to have that capacity for the next 20 years if he so chooses.
That’s the point—the expectation. Twenty years is the expectation.
Not five.
So pity the patient, in his 50s who receives a hip and rather than the promised 20-year lifespan, is met instead with pain and suffering, together with a second surgery just a few years on.
Little wonder the expectation is for so many lawsuits over the recalled DePuy system.
That said, I hope the FDA gets some of the blame…
Here’s why.
Our country’s great overseer of all things drug and medicinal employs this little-known rule whereby a manufacturer applying to market a device that is substantially similar to devices already used, can fast-track the approval process. Yes, there are designs that have to be studied and hoops that have to be jumped through, but the bottom line remains that manufacturers coming to market with a ‘similar’ device are spared the rigorous testing required for ‘new’ drugs and ‘new’ medical devices that normally delay their introduction for years.
The DePuy artificial hip system was a bit different than existing hip replacement products: metal-on-metal, combined with the expectation that bone would graft to the porous material inherent with the product.
However—rather than a new product, it would have been viewed as an ‘update’ to an existing product already on the market: the artificial hip. Hence, the opportunity for a fast-track approval.
Was the DePuy ASR hip implant system installed into a statistically correct number of patients as a clinical trial? And were those patients monitored for a period of 20 years to see if the new hip replacements lasted as long as those already on the market?
Somehow I doubt it.
And I have yet to hear if the FDA has reformed that practice. The ‘gift’ to manufacturers with a boffo, new product they would understandably like to see on the market as soon as possible.
If the DePuy Acetabular system was substantially different from hip replacements already out there and proven to last, then Johnson & Johnson and DePuy should have done more stringent, long-form testing. It would have delayed bringing the product to market, to be sure.
But it would have saved thousands of patients in the US who received the allegedly defective device, a lot of grief.
That said, if you were a manufacturer looking to bring a new product to market, and the regulator to whom you must answer does not require you to do a full round of clinical trials, what would YOU do?
Do them anyway? I think not.
I hope this comes up at trial. DePuy and J&J manufactured what appears to be, and is alleged to be, a defective product.
But I think the FDA shares some of the blame on this one.
Find us on
Archive by Category
- Accidents (24)
- Airlines (9)
- Asbestos Mesothelioma (262)
- Automotive (25)
- Celebrity (14)
- Class Action (84)
- Complaints/Comments (15)
- Consumer Fraud (84)
- Contest (2)
- Court of Public Opinion (5)
- Crazy Sh*t Lawyers See (61)
- Criminal Law (4)
- Defective Products (111)
- DePuy ASR Hip Recall (2)
- Discrimination (22)
- Drugs/Medical (248)
- Elder Care Abuse (4)
- Emerging Issues (462)
- Employment (54)
- Environment (52)
- Financial (28)
- Food Illness (15)
- Human/Civil Rights (4)
- Insecurities (5)
- Insurance (16)
- Intellectual Property (16)
- Internet/E-commerce (19)
- lawsuits (161)
- Lawyers (20)
- Lawyers Giving Back (43)
- Lex Levity (10)
- Personal Injury (106)
- Pleading Ignorance (53)
- Real Estate (2)
- Recall (6)
- Scam (3)
- Securities (13)
- Settlement (81)
- Tort Reform (2)
- Totally Tortelicious (81)
- Veterans (11)
- Whistleblower (9)
yes they should be responsible for it, i was told mine would last 50 plus years and i have had mine for 7 years and now i am back to limping having trouble walking and having pain and nobody wants to listen to me
I HAVE FILLED OUT FOR AN ATTORNEY TO CONTACT ME AND NOTHING I HAVE TRIED TO GET HELP BUT SURE NOT GETTING ANY
Hi Cheryl, Ugh! I feel your frustration–and I realize working online can have a person feeling in "no-man's land". I did do some digging with the folks over in our claims area and I have learned that your claim is with one of the law firms specializing in depuy lawsuits. My guess is that they're reviewing it, and given the holidays, it may be taking a bit longer than usual for review. I've asked our claims team to look into it further and to tell whoever's got it to "GET MOVING ON IT!!!"….hope this helps…thanks for letting us know. Wishing you all the best we look forward to a new year…
Dear Hunter West,
Great article, but wait, there is more…..I am a victim of the DePuy Pinnacle metal-on-metal. Several lawyers suit on behalf of victims on that device already, supposedly 300 plus patients have reported complaints to the FDA already. My unfortunately true story, better nightmare/calendar of events, down below:
Upfront, here are serial numbers of the cup and bone screws of my
DePuy Pinnacle (metal on metal) ACE Tabular Cup full hip replacement:
a. DePuy Pinnacle ACE Tabular Cup
REF 1217-22-056 LOT C31EF1000
SZ MM 56
b. DePuy Pinnacle Cancellous Bone Screw (2 screws same serial numbers)
REF 1217-30-500 LOT AF 2E6400
DIA MM 6.5
MM LGT 30
Calendar of events:
1. My right hip was replaced using one of the DePuy devices 2 days before Christmas 2008.
2. For the first 3 months after surgery I was unable to lie down straight in bed, only changing certain positions hourly sitting in a recliner allowed me to bear severe and violent pain. Actually, to the day (almost 2 years after surgery), I am not able to sit, stand, or lie down for more than a couple of hours, rather less. Even when I don’t move at all, severe and violent pain kicks in. During that time I also was ordered physical therapy. At the time, my Physical Therapist also wondered why I still was in so much pain.
3. Once I was ordered to walk on full weight, I was never able to walk more than half a mile without severe pain kicking in. Actually, to the day my hip replaced leg starts hurting badly when I walk only very short distances, much shorter than half a mile and often when I don’t walk also. My surgeon always suggested to be patient as recovery from a severe operation like that could take up to a year, or more.
4. The last time I saw my surgeon was in January of 2010. Again, I told him how severe my pains still were. Dr. Cuff discussed a bone marrow transplant with me. A procedure that could help to fasten the stem part of my implanted hip. But Dr. Cuff recommended to stay away from that procedure as he knew of only a couple of cases and they weren’t successful. On top of it I could be on crutches for another 10 to 12 months.
5. During this past spring/summer I tried to see my surgeon again. Mainly because I was suffering more and more. Unfortunately, due to my long tern ‘Leave of Absence’ I had lost my job and all my benefits including health insurance. My surgeon’s front office told me over the phone that I would have to pay a fee of $160 just to see the doctor as an uninsured person. I simply could not afford that at the time.
6. After I learned that I have a ACE tabucular cup hip replacement made by Depuy Orthopedics, I went to the Venice Regional hospital in order to request my Medical Records and Implant Report. It was a kind of odd that the clerks at the hospital said that they can provide my Medical Records, but that it seemed strange that they were unable to find the serial number of my DePuy hip replacement. They told me that they would send me a copy when they would find it. After appr. 2 weeks I received a copy of the implanted system, and it states ‘DePuy Pinnacle ACE tabular’. While this device is not under the official recall, it is also a metal on metal, and many articles/blog posts by doctors, lawyers and patients talk about the same symptoms I suffer from. Supposedely, the FDA has more than 300 patient complaints on that device.
7. My medical condition, personal situation and circumstances get worst and worst.
Furthermore, and after my employer Comcast Cable had terminated me because of extended ‘Leave of Absence due to illness’, I applied for unemployment benefits. Unemployment was denied because the agency was not able to help me because of my illnesses. Since surgery and after I started to sit for extended time, not only severe pain bothered me, also a condition called Edema (excessive swelling of my right food). Both my doctors back then (until January of 2009), Dr. Cuff and Dr. Schulte knew about that additional condition.
Meanwhile I have developed more severe pain in the hip area of my operated hip, also of my left hip, back, and all the way up the neck. My severe and violent pain is causing me a lot of discomfort, my overall medical condition seems to get worst and worst, ie.
-I cannot get in and outside of a vehicle without terrible pain in my right leg and right hip.
-I cannot get up from sitting or laying down positions without terrible pain in my left and right leg and left and right hip.
-I can only walk very short distances without severe pain starting inside my right leg and right hip.
-I move and walk very slowly, because I am afraid to fall with every single step I do.
-I have to sit down in order to get dressed.
-When I turn my neck to the left or to the right a little faster than very slow, I see ‘stars’. Also, when I move my neck, another violent pain stretches out all the way down to my lower back.
-Both my hands and arms developed a tingling sensation that stretches all the way from the tip of my pinky fingers to the ellbows.
-Each time I have to cough or sneeze, I experience a violent pain sensation inside right thigh and hip areas.
-I have Diarrhea almost all the time, no matter what I drink or eat. Many times there is also blood in my stool.
8. At the end of August 2010 I applied for Social Security Disability benefits. My initial claim was denied 11/23/2010. I am in the procedure to appeal that decision and report to the SSA that I am suffering from the DePuy hip replacement.
9. I am also in the procedure to seek legal help on the matter of my failing DePuy hip replacement.
10. At the present time, I believe that I am in urgent need of medical care. Having lost medical insurance due to the loss of my job, and being denied help from the local Senior Citizen Help Center, I am trying to gain eligibility for the County’s Health Department.
11. While I have no complaints about Dr. Cuff’s care and the care I received at the Venice Regional Hospital, I have a problem to see Dr. Cuff again. Reason why:
a) I cannot afford their fees as an uninsured person.
b) When you look up DePuy Orthopedics official website, and search for associated doctors in Venice/Florida, Dr. Noah pops up first. Dr. Noah and Dr. Cuff both work for Suncoast Orthopedics Medical Center, 836 Sunset Lake Blvd., Venice, Florida 34292.
12. On 12/14/2010 I filed complaint with the FDA online.
Regards, Juergen
we know that FDA sets the rules and standards for the classifications of anything associated with food and drugs. So If there are emerging issues about faulty devices like hip implants, it will directly associated with FDA.