Rack one up in the win column for a metal-on-metal hip manufacturer.
On February 3, 2016, Corin Group PLC and Corin USA Limited (Corin) prevailed in a lawsuit alleging injuries from Corin’s hip resurfacing system, the Cormet, a Class III medical device approved by the U.S. Food and Drug Administration (Swisher v. Stryker Corporation, et al.).
After full discovery, Corin filed motions for summary judgment and to exclude the plaintiff’s sole liability expert, metallurgist Charles Powell. The U.S. District Court for the Western District of Oklahoma excluded the relevant opinions of Powell and granted summary judgment in favor of Corin on all claims, holding, according to Corin, that there was no evidence of the purported defect in the device nor any evidence of medical causation for the plaintiff’s alleged injuries
The company challenged Powell on Daubert grounds. The Supreme Court has determined that the general standards for a Daubert challenge to expert testimony requires the trial judge to ensure “that any and all scientific testimony or evidence is not only relevant, but reliable.”
Corin claimed that Powell’s prior experience and training were substantially in areas other than medical devices. “The limited experience he does have with medical devices did not involve Class III devices such as the Cormet system. He has no experience or training with respect to the FDA approval process at issue here. He does not have the necessary expertise to express an expert opinion about the nature of the approval process or what the FDA may have viewed as complying, or not complying, with the standards of ASTM F-75. In particular, he does not have the expertise to identify those things that the FDA may have viewed as ‘inherent’ in the ASTM standard. As a result, Mr. Powell lacks the necessary qualifications to express [such] opinions.”
The Court agreed, saying that Powell’s testimonial theory was inventive, “but it wholly lacks a reliable basis in light of the explicit nature of the ASTM F-75 standard and the nature of the process that it is a part of.”
A spokesperson for Crowell & Moring LLP, the company’s law firm, told OTW that the firm believe this case is important to our readers because the Cormet is one of only three metal on metal hip devices fully approved by the FDA under the Premarket Approval (PMA) process for sale in the U.S. Furthermore, any claims regarding the design or other FDA-approved aspects of the device are expressly preempted by the Medical Device Amendments to the Federal Food, Drug and Cosmetics Act.
“Traditionally, courts have dismissed claims regarding the Cormet at the pleading stage, but some plaintiffs have attempted to sidestep preemption by alleging, without a factual basis, that Corin violated some FDA statute or regulation that caused the alleged injury. That was the path taken by the plaintiff in this case, which was the first case against Corin to avoid complete dismissal at the pleadings stage.”
Finally, the spokesperson said the Court’s rulings demonstrated that after full discovery, “Corin’s device was manufactured exactly as intended and that the allegations used to avoid preemption at the pleadings stage were without merit.”
I have to totally disagree with this decision for I have a Cormet Hip Resurface component and ever since I had surgery and recovery time had passed, there has not been a day that I had no pain. More pain than prior to surgery. That was Sept 2011, today 11/28/2016 I now suffer from severe metal poisoning with every symptom and side effect of the metal poisoning.
And now I need revision surgery, I was 36 when they put this in and now 42 and my symptoms have been on going for the last 2 years.
And trying to find a Orthopedic Surgeon to take this God Awful component out of me have been an never ending “Nope Sorry”
Which tells me that the manufactures of this Cormet, The Corin Group is hiding the facts of this malfunctioning product. And Shame on the FDA for approving such a debilitating device.
I feel sorry for those who suffer like me, and I truly hope someone who is doing their research of the Cormet prior to their first surgery comes across this. Beware for this has to be the worst thing I have ever been through in my life.
Carla,
So sorry to hear about your severe pain and agony. I don’t know how your situation could be so different than mine. I have had my hips in for 15 years and have had no trouble with them at all. I have blood work done every year and no metals are in my blood system at all.
I hope you can find a resolution for this
Carla,
I am sorry you are suffering. My resurfacing was done in 2008. In early 2017 my blood levels became dangerously his and I had a revision done in October of 2017. I hope you find someone to help you and I hope we all find legal justice. I have been turned down by multiple lawyers.
Both hips resurfaced with the Cormet/Corin/Stryker. By 2010 a few catches in the R hip did more therapy, but had pneumonia and hospitalized for 2 weeks…another health issue. Then a lot of things over the next few years until Spring of 2016 when I new I had pressure in groin area and some spasms happening. After the day I needed up with a spasm while in my tractor and I couldn’t Get out for 1 1/2 hrs. I knew I had steak some answers. Found to have a puesdotumor, elevated chromium and cobalt blood levels. Revision done, dislocated a month later. I’m still kicking,but slowly. Been having issues with eyes, I had 2 melanoma surgeries in last year. Yesterday I had the IV midline I wore 24/6 weeks with antibiotics removed for a bacterial infection in my blood and don’t know where it came from. Infectious disease doctor knows nothing about metallosis but because of the metal hip appliances was treated for Infectious Endocarditis. And while I was in the hospital for a week was seen by heart doctor for possible heart murmur which I had not had previously and has found damage to mitral valve. I will have blood cultures drawn on June 5 and another TEE to see if there has been additional damage from the bacteria. The PMA was wrong! My parents lived into their mid 90’s, but I don’t think that will be my future. I’m hoping to see 70 cause I’m still farming and want to be active!
I had both hips resurfaced in 2006 2007 and the right hip has had to be replaced in July of 2018. The problem was that the unit failed because it did not adhere to the bone, became dislodged and threatened my pelvic bone. The old unit was removed, a bone graft was performed, and a full hip replacement installed. The surgeon will testify that the unit failed. Is anyone pursuing a class action suite against Corin in Canada?
I had my surgery in March 2005 on the 15th. On the 17th of March 2021 I started to having pain so bad I cry at night.
I can barely walk on my leg. It hurt all day every day. I was sent for lab and mri about 3 and weeks ago They haven’t
Called me yet. I know something is wrong nothing hurt like this if everything is ok . From my groan down is in severe pain it hurts so bad I have to sleep on my back or left side. Even sometimes I can not sit straight I have to shift my weight to the left side. I am in agreement some one need to get a settlement against them.
Mark-I had both hips resurfaced ( Cormet 2000) metal on metal in 2008(R) and 2009(L) Surgeon didnt order metal tests until I presented with minor pain in 2021 (left hip). I got blood test ( very hi Metals) MRI (much tissue damage and psuedo tumors); then total hip replacment; (followed by dislocation 3 days after surgery). Now I am doing just okay , little pain, metal levels a lot lower, Surgeon is not recomending revision of the right Cormet hip at the moment.
The surgeon was remiss in not having blood metals monitored from 2009-2021. I still would have had the revision but might have avoided the extensive tissue damage, pseudo tumors and risk of future dislocations. Im reluctant to go after the surgeon for failing to follow good practice and not ordering blood tests; he is a friend , former coworker and a brillint surgeon. Is Corin liable?
I’m sorry to hear that so many people have had problems with this “Corin” device. I had a resurfacing done in 2013 and has had chronic pain. Along with pain in my inner thigh. Which was said to be a tendon. That may need stretching. At least two years after the implant was inserted. My chromium & cobalt levels were discovered high years later. But the chronic pain, was said to be normal. Due to the shifting of weight from one leg to another. I personally don’t think extensive research was performed. To ensure that metallosis, or chronic pain along with all the other symptoms. Could possibly one day be a problem for a patient.
Still 10 years later chronic pain and inner thigh pain. Lead me back to my doctor. Who removed some type of fluid from my inner thigh area. My VA doctor has started test, for my eyes, liver etc. To ensure the metal has not started to affect other organs. Upon my discovery, it seems if your not fully insured or working. It becomes a problem to be seen. It is shameful how the industry and doctors. Care more about the almighty dollar than the health and welfare of human kind!