Some of these implants had an unacceptable level of mineral oil-based lubricant on the product and it was determined this residue may cause adverse reactions in the body that could lead to the shell becoming loose.
"My doctor received a letter in December saying that there was a long list of Sulzer hips to be recalled, but it was too late for me. Just five weeks after it was implanted, it became loose. I went into physical therapy and the activities may have pulled it loose but I think it was migrating before then. Instead of going back to my doctor, and because I had suffered orthopedic problems before, I was able to make it home with my cane. Every time I tried to put any weight on my left leg, the pain was excruciating.
I managed to get home and called the doctor but the receptionist told me I couldn't get an appointment for a few days - I didn't have much choice. He called someone from Sulzer Orthopedics and they brought another hip replacement. I told him that I didn't want another Sulzer hip but they reassured me that the problems were corrected.
But I had lots of complications. It dislocated again and I was just about immobile so I had to go into a nursing home. Thank goodness that was temporary because my son came from North Carolina and took me to stay with him. After a few months I seemed to be doing OK and was able to move back into my own place by myself. Wouldn't you know it, the hip dislocated again! This time I was in the bathroom when it happened and I had to drag myself to the phone and call 911. The fire department also came - they had to break the door down to get me.
When this part flipped out, I could feel the ball running around on the rim then I got shooting white pain. One doctor said I needed a metal brace on it but that made my back hurt so bad. Another doctor thought it was unnecessary. What was I to do? By this time I had a total of four hip dislocations and it was impossible to live alone. And I am only 65 years old.
I got a cellular phone and now my grandson lives with me. I had one more surgery and it had better be the last. This time they put in a constrainer, around the outside of the shell to keep the ball in so it would dislocate again.
This has taken years off my life and I limp severely on my left side. I know there is a statute of limitations to collect on this current lawsuit but when you are ill you don't think about it - you are just in survival mode. When I had my third surgery, the Sulzer reps came to the hospital. Apparently they brought a different ball with zimmer screws and charged $14,000 for it. I have had chronic problems ever since."
Why was Virginia fitted with another Sulzer hip? Because the manufacturer pressured the doctors? She was told nothing about the recall by her doctors.
Sulzer Orthopedics recalled its Inter-Op acetabular shell for hip implants on December 8, 2000. Approximately 25,000 products and 17,500 hip implants already in patients are subject to the recall. When you think of recalls, cars or toasters usually come to mind. But what happens when it is a defective product in your body?
Due to Sulzer's negligence, the recall of this hip joint has caused even more pain and suffering to patients that have already undergone a difficult surgery.
According to Sulzer, approximately 17,500 defective hip replacement parts have been implanted since 1997. Sulzer hip replacement implant products are used in about 10% of all hip replacement procedures.
Surgery to replace an artificial hip can take twice as long as putting one in due to usually much more scar tissue. And then there are all the risks from another surgery: the potential for blood loss, and infection, and complications.The company has offered to cover medical costs not paid by Medicare or other health insurance, but some patients have filed lawsuits for lost wages and what they see as unnecessary pain and suffering.
In February 2002, a settlement proposal for nearly $1 billion was reached with Sulzer.
Starting a Product Liability Suit
To instigate a products liability action, the plaintiff should charge not only the manufacturer but all other entities responsible for placing the unreasonably dangerous article in the market. Other responsible parties may include distributors, retailers, repairers, assemblers, component suppliers and testing laboratories. All such entities may have played a significant role in placing the defective product in the market and all such entities have profited from their product.
It is very important that the injured consumer should also be advised to preserve the allegedly defective product because, in some cases, if the item is lost, the consumer may be left with no proof of the product's defect and the possibility of a successful lawsuit could be wiped out completely as a result. And just as important, get all your medical records. Keep a journal.
Negligence
A negligence theory requires the plaintiff to prove four elements. First it must be shown that the defendant owed a duty to the consumer. In fact manufacturers do owe a duty to the users of its products and to bystanders likely to be injured. The manufacturer also has a duty in making its product, to guard against injuries likely to result from reasonably foreseeable misuse of the product.
(Take the Ford Pinto, for example. In the late 60s, Ford engineers tested and determined that a safety feature was needed to the gas tank, but it would increase the price of the car. The added cost would have been under $8.00 per car and it was predicted that, if it wasn't added, several hundred people will burn to death or suffer serious injury. Ford decided not to add the safety feature which resulted in more than a hundred products liability suits for unnecessary fires. In one case, Ford paid punitive damages of $3.5 million.)
The plaintiff must also show that the manufacturer breached its duty, (by applying the above design defect, manufacturing defect or failure to warn theories). In showing breach, the reasonable manufacturer standard applies, i.e., would the reasonable manufacturer, with knowledge or constructive knowledge of the product's defect, have produced the product. If the answer is "no", then the manufacturer has breached its duty. Of course, the plaintiff need also prove he or she was injured and that the defendant's breach caused the injury.