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Removal of defective medical device and hospital denied request to have it retained.

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trydrnll

Junior Member
What is the name of your state (only U.S. law)? Tenessee

In June 2012, I underwent a wrist arthrodesis where an intramedullary implate was used. Over the next 12-13 months, I continued to experience moderate pain, reduced grip strength and joint endurance. Following a CT scan in October 2013, it was determined that two of four screws were loose/backing out and an intramedullary nail was also backing out. I underwent a surgery to remove the implate and a second wrist arthrodesis. The screws and nail were noted in operative report.


During the preadmission appointment, I requested to have the implate retained for further inspection by the manufacturer. The hospital staff told me that my request was against hospital policy. The implate was removed several days later and immediately discarded. The hospital, orthopedic surgeon and manufacturer were notified that the implate had failed.


I wrote a demand letter to the manufacturer several days after surgery detailing damages. They did not respond within the time allotted. Several months later, I received a letter from their liability insurance company. I complied with their request and provided a HIPPA form allowing them access to my medical records. I provided an expiration date of June 30, 2014. During their review, they requested to review the implate. I informed them that I was told it was against hospital policy. I reached out to the hospital requesting the specific policy to provide to the insurance company.


I also reached out to a family member that is employed at the hospital. After a quick (< 60 seconds) search, they found the policy/form that I should have been provided that would have allowed the implate to be retained. I also received a return call from the hospital risk management the same day (coincidence). The employee stated the only way to have to implate retained was with a court order. I then disclosed I had been provided the policy/form that I should have received. The employee was not forthcoming about the form (a lot of silence) and then requested a copy of it via email.


After two emails and a week, I finally got a response. She said that I didn&#8217;t ask the question in the right way and that the form basically means a court order. She apologized that the device was destroyed and hoped I used the hospital again. The form does not indicate a court order under any circumstance. All I had to do was provide identifying information, my signature and my doctor&#8217;s signature. This form would have allowed the implate to be retained for the statute of limitations period or the duration of litigation.


To make a long story short. The failure to provide the form at my request led to the implate being destroyed. This basically ruined any chance at a product liability case. I signed a retainer with an attorney. He composed demand letter and complaint, but never sent to defendants. He submitted HIPPA requests and a spoliation letter to all parties. Yesterday he decided to withdraw from the potential case. He provided other attorneys names that might be willing to take the case. I have three months left before SOL expires.

I get the impression that I am fighting a losing battle. It seems there is no way to hold the hospital liable. A blanket "against hospital policy" whether true or false is their mantra.
 
Last edited:


Ladyback1

Senior Member
What is the name of your state (only U.S. law)? Tenessee

In June 2012, I underwent a wrist arthrodesis where an intramedullary implate was used. Over the next 12-13 months, I continued to experience moderate pain, reduced grip strength and joint endurance. Following a CT scan in October 2013, it was determined that two of four screws were loose/backing out and an intramedullary nail was also backing out. I underwent a surgery to remove the implate and a second wrist arthrodesis. The screws and nail were noted in operative report.


During the preadmission appointment, I requested to have the implate retained for further inspection by the manufacturer. The hospital staff told me that my request was against hospital policy. The implate was removed several days later and immediately discarded. The hospital, orthopedic surgeon and manufacturer were notified that the implate had failed.


I wrote a demand letter to the manufacturer several days after surgery detailing damages. They did not respond within the time allotted. Several months later, I received a letter from their liability insurance company. I complied with their request and provided a HIPPA form allowing them access to my medical records. I provided an expiration date of June 30, 2014. During their review, they requested to review the implate. I informed them that I was told it was against hospital policy. I reached out to the hospital requesting the specific policy to provide to the insurance company.


I also reached out to a family member that is employed at the hospital. After a quick (< 60 seconds) search, they found the policy/form that I should have been provided that would have allowed the implate to be retained. I also received a return call from the hospital risk management the same day (coincidence). The employee stated the only way to have to implate retained was with a court order. I then disclosed I had been provided the policy/form that I should have received. The employee was not forthcoming about the form (a lot of silence) and then requested a copy of it via email.


After two emails and a week, I finally got a response. She said that I didn’t ask the question in the right way and that the form basically means a court order. She apologized that the device was destroyed and hoped I used the hospital again. The form does not indicate a court order under any circumstance. All I had to do was provide identifying information, my signature and my doctor’s signature. This form would have allowed the implate to be retained for the statute of limitations period or the duration of litigation.


To make a long story short. The failure to provide the form at my request led to the implate being destroyed. This basically ruined any chance at a product liability case. I signed a retainer with an attorney. He composed demand letter and complaint, but never sent to defendants. He submitted HIPPA requests and a spoliation letter to all parties. Yesterday he decided to withdraw from the potential case. He provided other attorneys names that might be willing to take the case. I have three months left before SOL expires.

I get the impression that I am fighting a losing battle. It seems there is no way to hold the hospital liable. A blanket "against hospital policy" whether true or false is their mantra.
these sort of orthotic devices fail. It is a known problem. It is a known complication of any surgery where they implant parts/screws/rods/etc. into the human body.
 

trydrnll

Junior Member
these sort of orthotic devices fail. It is a known problem. It is a known complication of any surgery where they implant parts/screws/rods/etc. into the human body.
Do I have any leg to stand on with the hospital refusing to let me have it retained to be inspected by manufacturer. The device had only been approved by FDA less than 15 months.
 

Dave1952

Senior Member
The problem that you face is that you were informed that the hospital would not save this device and you decided to use this hospital for your surgery. This was not an emergency. Why didn't you find another hospital?
 

trydrnll

Junior Member
The problem that you face is that you were informed that the hospital would not save this device and you decided to use this hospital for your surgery. This was not an emergency. Why didn't you find another hospital?
It was a result of a WKC injury and this was the approved hospital. The surgeon only uses this hospital due to contract. In our area we have two health systems and they do not "play" together. There is a great divide in who uses what facility. There is very little cross usage. If it is, it is an independent physician that is not part of a medical group.

Also the other facility is not approved by my out of state WKC claim. Enrollment takes months. It took six months to get this hand surgeon enrolled with WKC. Being an intramedullary device, surgeon wanted it removed expeditiously.

If that makes any sense.
 

Zigner

Senior Member, Non-Attorney
It was a result of a WKC injury and this was the approved hospital. The surgeon only uses this hospital due to contract. In our area we have two health systems and they do not "play" together. There is a great divide in who uses what facility. There is very little cross usage. If it is, it is an independent physician that is not part of a medical group.

Also the other facility is not approved by my out of state WKC claim. Enrollment takes months. It took six months to get this hand surgeon enrolled with WKC. Being an intramedullary device, surgeon wanted it removed expeditiously.

If that makes any sense.
It does...but it doesn't change the fact that you KNEW they weren't going to retain the device prior to undergoing the surgery.
 

Ladyback1

Senior Member
It was a result of a WKC injury and this was the approved hospital. The surgeon only uses this hospital due to contract. In our area we have two health systems and they do not "play" together. There is a great divide in who uses what facility. There is very little cross usage. If it is, it is an independent physician that is not part of a medical group.

Also the other facility is not approved by my out of state WKC claim. Enrollment takes months. It took six months to get this hand surgeon enrolled with WKC. Being an intramedullary device, surgeon wanted it removed expeditiously.

If that makes any sense.
so are you saying that this is Work Comp related?

If so, what monetary damages did you sustain?
 

trydrnll

Junior Member
I am confused by your interpretation. I appreciate your opinion.

I am a commercial airline captain that has not worked since 2012. This figure includes a credit for WK payments. These figures include lost payments guaranteed/designated by a collective bargaining agreement. They also include out of pocket expenses for medical coverage premiums, medical expenses not covered by WK as well as expenses to attempt to regain a flight medical following the second surgery which has been unsuccessful. The medical director of the FAA has cited damage from second surgery that was not present prior to second surgery as reasoning.
 

Ladyback1

Senior Member
I am confused by your interpretation. I appreciate your opinion.

I am a commercial airline captain that has not worked since 2012. This figure includes a credit for WK payments. These figures include lost payments guaranteed/designated by a collective bargaining agreement. They also include out of pocket expenses for medical coverage premiums, medical expenses not covered by WK as well as expenses to attempt to regain a flight medical following the second surgery which has been unsuccessful. The medical director of the FAA has cited damage from second surgery that was not present prior to second surgery as reasoning.
FYI--even if you are successful in bringing a suit against the manufacturer for a defective product (and that is a big IF...I'll explain further down), your work comp carrier may be entitled to a portion of any monies you are awarded.

As far as "defective product": What you described happening (surgery, implanting device(s), screws backing out, etc.) happens ALL THE TIME! I cannot tell you how many times, as work comp adjuster, I had to pay for hardware removal and subsequent surgeries under the EXACT same circumstances. Just because surgery did not "cure" you, and may have made the situation worse, does not mean that there were any defects in the hardware, doesn't mean that the doctors did anything wrong.

As far as your monetary damages: If the initial surgery was indeed work comp: Would you have been eligible for all the guaranteed bonus and incentive payments guaranteed by your bargaining agreement? Or is the loss of income due simply because DUE TO A WORK COMP INJURY you were off of work?
What I'm getting at is this: You are speculating that had the device "defect" is what caused your losses and had the hardware not been defective you would have had no losses/fewer or less losses; When in fact the work comp injury is what caused the need for surgery and use of hardware, and the treatment was medically appropriate--thus all of your alleged losses are from the work comp injury. I don't think you have a leg to stand on, but that's my opinion. Feel free to consult a med mal attorney and/or a work comp attorney, though!
 

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