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Home/Legal & Regulatory and Reimbursement/Zimmer and NexGen Go on Trial in October
Legal & Regulatory and Reimbursement

Zimmer and NexGen Go on Trial in October

June 16, 2015 2 min read Premium comments

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Zimmer and NexGen Go on Trial in October
Courtroom / Source: pixabay.com
Secondary

The first bellwether trial over Zimmer Holdings Inc.’s NexGen knee implant will start on October 13, 2015.

Over 1, 300 lawsuits have been filed by patients implanted with knee. The device received FDA clearance in 1995 and more than 5 million implant procedures have been performed since then.

Lawsuit Consolidation

In 2011, the U.S. District Panel on Multidistrict Litigation decided to consolidate the lawsuits to decrease the chances of conflicting rulings with judges and duplicative discovery. Consolidation is also more convenient for the parties, witnesses, and court. The lawsuits were consolidated to Judge Rebecca R. Pallmeyer in the Northern District of Illinois.

Allegations surround the company’s lack of sufficient product testing, manufacturing and selling of faulty products.

Judge Pallmeyer identified six cases that will serve at the “initial tranche” of bellwether trials against Zimmer. Of these six, three were plaintiffs’ picks and the other three were chosen by Zimmer. Plaintiffs in these cases include Ramona Diano, Kathy Batty, Randy Pudwill, Debra Teague, Mertha Shoat, and Ronnie Davis.

Diano is a 72-year-old Philadelphia woman whose implants failed in both knees. According to the plaintiff’s steering committee, hers is the most straightforward and comprehensive one, as she belongs to the most common age range and gender for the procedure and her case has the least individual issues, compared with the two other choices.

Her case also includes false marketing allegations, according to the plaintiffs’ brief, as advertisements for a gender-specific type of femoral component influenced her decision to choose Zimmer’s implant.

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Fighting Lawyers

Last September Zimmer filed a motion with Judge Pallmeyer to sanction the lawyers for the patients. Zimmer claimed that attorneys representing plaintiffs Shoat, Davis and Teague had missed a deadline for producing expert reports without providing advance notice that a deadline was going to be missed, or required an extension. Zimmer claimed that such “repeated abandonment of Zimmer case picks has unreasonable and vexatiously multiplied these MDL (multidistrict litigation) proceedings and justifies sanctions.”

The patients’ lawyers said Zimmer’s actions just proved the company was running scared.

Zimmer Celebrates Milestone

At the recent annual meeting of the American Academy of Orthopaedic Surgeons in Las Vegas, the company announced it was “celebrating a key milestone” in 2015 for its NexGen Complete Knee System. “2015 is the 20th year since Zimmer first introduced the NexGen knee system, with its innovative design and component quality, to the market. To date, more than five million implantations of the NexGen knee have taken place worldwide, ” stated the company.

“The NexGen knee has been—and will continue to be—a significant move forward in knee replacement, ” added Brad Quick, vice president, Knee Marketing for Zimmer.

The case is: MDL 2272 In Re Zimmer Nexgen Knee Implant Products Liability Litigation.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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