Sunday, September 18, 2011

Other Hip Recalls: Sulzer in 2001 (2 of x)

In 2001, Sulzer voluntarily recalled a lot of  its acetabular shell (aka, socket.)  This was a manufacturing defect whereby  during the manufacturing process, a small amount of mineral oil-based lubricant leaked into the machine coolant, and even after the cleaning process, the lubricant remained as residue on the shell.

Sulzer Hip Implant Recall


Sulzer Orthopedics, a subsidiary of Sulzer Medica, has recalled certain lot numbers of its Inter-Op acetabular shells. Most of the recalled hip replacement products were manufactured during or after October 1999 but a limited number were produced as early as June 1997. The affected lot numbers of the Inter-Op acetabular shell included approximately 25,000 units of which 17,500 were implanted.
In September 2000, Sulzer Orthopedics of Austin, Texas, the manufacturer of the defective implant, began receiving adverse reports from doctors. Following an 8-week investigation of patient records, surgical techniques, and the product itself, the recall was ordered. It was ultimately found that during the manufacturing process a small amount of mineral oil-based lubricant leaked into the machine coolant, and even after the cleaning process, the lubricant remained as residue on the shell. No other implant manufactured by Sulzer, other than the Inter-Op acetabular shell, was affected. Since the problem was identified, steps in the manufacturing process have been either eliminated or modified to prevent a recurrence of the problem.

Designed so that the acetabular component snaps into place and bone grows into it, the oily residue interfered with the bonding. Some people who have received the defective implant have reported loosening and have required further surgery to revise the failed hip replacement. Patients who had the acetabular component cemented in place are unaffected by the recall.

Sulzer Recommendations at the time


Although the FDA has not required it, Sulzer Orthopedics has recommended that surgeons contact patients who received the Inter-Op shells from the affected lots. To recognize if there is a problem with an Inter-Op shell implant, Sulzer recommends patients and surgeons be aware of the following symptoms:

  • Sedimentation rate, C-reactive protein, and aspiration show no evidence of infection preoperatively.
  • All cultures at surgery are negative and an arthrogram does not show dye around the shell.

Up to 6 weeks post-op

  • The patient may be progressing well, or may be reporting pain in the groin or anterior trochanteric area.
  • Patient may have increased thigh pain.
  • Patient may have significant pain when starting to walk, or buttock pain after rising from seated position.
  • X-ray may show possible migration of the component

Hip Implant Class and Sulzer Will Settle Case for $1 Billion

The revised settlement, approved by the Court in May 2002, provided patients with defective implants almost twice the cash payment as under an initial settlement.

by Jahna Berry
THE RECORDER

The settlement checks are in the mail.

On Friday, Sulzer Orthopedics Inc., the company that was mired in national litigation over thousands of recalled hip and knee implants, approved a $1 billion settlement. The announcement means that many patients and lawyers will begin to get payments from Sulzer some time before the end of the year, a lawyer said.

Typically, a person who had one surgery to replace a bad implant would get $260,000, plus medical expenses. His or her attorney would get more than $40,000 in fees out of the patients’ gross award.
As the litigation neared its conclusion there was widespread fear that the deal would fall apart if many of the rank and file plaintiffs decided to try their luck in trial. Lead plaintiff attorneys warned that too many opt-outs would force the company under — narrowing the chance that all patients would be compensated.

“It was a real nail-biter,” said Orinda attorney Luke Ellis (Gillin, Jacobson, Ellis & Larsen), who represented 35 plaintiffs. “It went down to the wire.”

In fact, at one point 132 plaintiffs opted out; 35 were patients with serious claims who could have waged deal-busting legal battles. Lawyers from the plaintiffs team worked the phones and whittled that number from 35 to 16.

A little more than 3,000 people so far have had surgery to replace the defective hip and knee implants. Sulzer has said that about 4,000 people will be covered by the agreement. Not all patients who got the implants will develop problems, and some implant recipients are medically unable to undergo surgery.
In the upcoming months, U.S. District Judge Kathleen O’Malley also will decide which plaintiffs lawyers will share in the $50 million fee award for lawyers who played a big role in the settlement.

xxx

Sulzer  also established a $100,000,000 Extraordinary Injury Fund, that will provide compensation for serious complications arising from the defective implants.

Ellis said that because the average age is over 60 in these cases, there were some pretty serious complications: dislocations or fractures as a result of the defective part, stroke, heart attack -all those things happened, which isn't surprising, given the age group. People with these extraordinary injuries are eligible for up to one million.

Sulzer, he added, estimates that maybe a quarter of the 3,800 [who required additional surgery] might be eligible for the fund."

xxx

[ from connie:  there are several things I noted from this case:
  1. The "injuries" seemed to be one time issues with no residual potential of long term impairment such as cancer as a result of the injury as there clearly is in the Depuy case.
  2. There seemed to be nothing to study in terms of the potential long term effects of this lubricant on the future health of the patients.
  3. There seemed to have been no potential for organ damage such as exists with the Depuy case in the Kidneys and other areas.
These are big issues which MUST  be addressed in the settlement with the Depuy case.  That is:
  • Funds must be allocated by Depuy to study the long term affects of the metal on the patient population
  • a extraordinary injury fund needs to be established to cover the potential cancer issues that have been studied and linked to this metal effect long term on the organs of patients who will inevitably affected.
As patients who might have long term complications from this metal issue, it is imperative that any settlement MANDATE that Depuy fund longer term studies on this issue.  What good will be served by paying out patients a few hundred thousand dollars if no one clearly understands the long term effects of cancer work that has been done to date on this issue?

The lawyers on this case need to be cleaver and utilize other options to look at the long term affects of this problem.  If I see any law firms who have put the long term systemic issues front and center along with the idea of mandating long term funding to study the issues further, I will let you know.

I have not engaged a law firm yet.  I have up to two years in NY since I was made aware of this problem until the statue of limitations runs out.  BE CAREFUL GUYS THAT YOU CHECK WITH A LAWYER TO ENSURE THAT IF YOU CHOOSE TO FILE A CASE, YOU DO SO PRIOR TO THE STATUE OF LIMITATIONS EXPIRE FOR YOUR STATE OR PARTICULAR SITUATION.  the statues seem to vary from state to state.

 Once I have some kind of assurance that these two issues will  be key issues ADDRESSED in a settlement, I would sign up.

If Depuy wants to settle this case, they should provide some assurances that these issues will be addressed. If the lawyers don't ask for these to be a part of the settlement, shame on them.   No patients should settle for anything less.]

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