Durom Cup Problems Subject of New Zimmer Hip Replacement Lawsuit
An Oklahoma woman has filed a Zimmer hip replacement lawsuit, claiming the company’s Durom Acetabular Component is defective. Plaintiff Linda Masteller’s product liability lawsuit relates to the design, development, manufacturing, testing, marketing, promotion, distribution, and sale of the device.
The Durom Cup was surgically implanted in Masteller on March 21, 2008, to replace her left hip. She claims she now requires revision surgery due to a variety of physical injuries, including pain and discomfort.
Counts listed in Zimmer hip replacement lawsuit
The plaintiff is suing Zimmer on 12 counts, including:
- Count I: Strict Liability ─ Failure to Warn
- Count II: Strict Liability ─ Design Defect
- Count III: Strict Liability ─ Manufacturing Defect
- Count IV: Negligence
- Count V: Breach of Implied Warranty
- Count VI: Breach of Express Warranty
- Count VII: Negligent Misrepresentation
- Count VIII: Intentional Misrepresentation
- Count IX: Constructive Fraud
- Count X: Negligent Infliction of Emotional Distress
- Count XI: Unjust Enrichment
- Count XII: Punitive Damages
Zimmer pulls Durom Cup off market temporarily
Zimmer stopped selling the Durom Cup on July 22, 2008, because the instructions for use/surgical technique were insufficient. The company issued a letter to surgeons noting the following stating the following:
“The results of our in-depth investigation have led us to conclude that additional surgical technique instructions and training are necessary in the United States, and we strongly recommend that U.S. surgeons stop implanting the Durom Cup until receiving such training. Zimmer will suspend marketing and distribution of the Durom Cup in the U.S., while we update product labeling to provide more detailed surgical technique instructions and implement a surgical training program for U.S. surgeons. The Durom Cup will continue to be marketed and distributed without interruption outside the U.S.”
In their internal investigation, Zimmer examined more than 3,100 cases. In the letter, the company notes that the overall rate of revision surgery is approximately 0.6% of all the Durom Cups that had been sold to date in the U.S. However, they also noted that this number may be inaccurate.
“Due to difficulties in gathering data and our review of the above mentioned sites, we believe this may underestimate the actual revision rate,” states the letter. Of the U.S. sites investigated (where every patient — more than 1,300 — was reviewed) that employed the above described techniques, the combined revision rate is 1.5%. Conversely, the revision rate for other sites is 5.7%.”
Durom Cup multidistrict litigation
Zimmer hip multidistrict litigation was established on June 9, 2010 in the U.S. District Court for the District of New Jersey, under Judge Susan D. Wigenton. Federal lawsuits were consolidated under MDL 2158 to conserve resources and avoid disparate rulings. However, all plaintiffs retain their individual rights to Zimmer hip settlements or trial verdicts.
Plaintiffs cite many common allegations, including the belief the Zimmer should have issued a permanent recall for the Durom Cup. Other collective accusations include convictions that Zimmer was negligent in testing and marketing the product, that the Durom Cup has manufacturing and design defects, that the manufacturer failed to warn patients and the medical community of risks posed by the product, and more.
Plaintiffs have experienced a variety of complications, as a result of the defective implant. Issues reported by plaintiffs include premature implant loosening, metallosis, tissue damage, premature failure, and the need for early revision surgery.
Zimmer has reportedly allocated $270 million to settle the remaining Durom Cup lawsuits by the end of 2014.
- U.S. District Court for the Western District of Oklahoma, Masteller v. Zimmer Inc. et al http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2158-Tag-Along_Transfer-01-13.pdf
- Zimmer, Surgeon Letter http://www.zimmer.com/content/pdf/en-US/DUROM-SURGEON-LETTER-07-22-08.pdf
- U.S Food and Drug Administration, Recalls http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants/ucm241770.htm
- CNW, Appeal Court upholds Zimmer Durom Cup hip implant class action http://www.newswire.ca/en/story/1102917/appeal-court-upholds-zimmer-durom-cup-hip-implant-class-action