When Zimmer consultant Richard Berger, M.D. first reported revisions of the NexGen CR-Flex Porous Femoral Component to the company back in October 2006, no one could have anticipated that one of the unintended consequences of that action would be the taming of personal injury lawyers.
Berger followed up with a study presented at the 2010 American Academy of Orthopedic Surgeons annual meeting where he reportedly said the NexGen CR-Flex Knee Replacement failure rate may possibly be as high as nine percent and, “unacceptably high.”
This was followed by a very public divorce between Zimmer and Berger that made national news and was detailed in OTW in June 2010.
A month later, Senator Charles Grassley sent a letter to Zimmer saying he was “troubled” by accounts of the company’s response to allegations of safety concerns raised by Berger and asked for further information. Nothing has been heard from the Grassley’s office since.
Send In The Lawyers
After Grassley’s letter, personal injury lawyers swooped in with websites, letters and television ads seeking patients who had received the NexGen Knee System. The lawyers made claims about the device that Zimmer found objectionable.
So Zimmer went after the pa limited tort lawyers, made them blink and got them remove the objectionable claims. Call this a “Man Bites Dog” story since it’s usually the company that gets sued.
Zimmer filed a lawsuit in the U.S. District Court for the Northern District of Indiana on February 16, 2011 against three personal injury law firms the company says were, “making inaccurate and misleading statements about the Zimmer NexGen Knee System through letter writing, internet and television advertisements and websites that incorporate Zimmer’s name and brand.”
The firms in Michigan and Texas included: Kresch Legal Services; Pulaski & Middleman, and Weller, Green, Toups & Terrell. Three more firms were added to the suit during March and April: Gordon Edelstein Krepack, Rottenstein Law Group, The Moody Law Firm, and Elk & Elk.
The company says it recognizes that it is unusual to take this kind of action against law firms, but believes it is necessary to protect the interests of the company, patients and surgeons who rely on their products. In addition to the lawsuit, Zimmer continue to send cease and desist letters and will pursue other avenues available to them.
Settlements
Zimmer recently reached settlements with three of those law firms. As part of these settlements, the firms are required to post corrective statements on their websites for the next six months. Additionally, the firm Weller, Green, Toups & Terrell LLP sent a letter of retraction to all of the members of the American Association of Hip and Knee Surgeons (AAHKS) whom they had previously solicited.
What exactly was it that the law firms said that sent Zimmer’s lawyers after them?
Weller: “Defective Knee Implants
In the Weller case, it was a letter sent to AAHKS members across the country regarding the NexGen system.
According to Zimmer’s Complaint, the first sentence of the Weller letter reads: “As you may be aware, numerous complaints have been asserted concerning, and Congress is investigating the safety of Zimmer NexGen Knee Implants.” The letter refers to Zimmer as the manufacturer of “defective knee implants.”
The company says the implants are neither “defective” nor the subject of “numerous complaints [and] Congress is not “investigating the safety of” these devices.
Here’s what the AAHKS retraction letter said:
We recently sent you a letter concerning the Zimmer NexGen Knee System, seeking referrals of patients for possible legal action against Zimmer. We have determined that the sources we previously relied upon to make claims about the Zimmer NexGen Knee System do not support the statements or implications that significant numbers of patients receiving the NexGen Knee System as a whole experienced pain or loosening or require additional surgery or that the NexGen Knee System as a whole is otherwise defective.
We apologize for any confusion our prior letter may have caused.
Sincerely,
Mitchell A. Toups
Kresch: “Pain, Failure and Revision Surgery!”
Another defendant, the Kresch firm, said this on their www.1800lawfirm.com website:
- “Research shows that 36% of patients who received NexGen knee replacements experienced joint loosening.”
- “Patients who received the NexGen joints may experience joint failure at a higher rate than other joint types.”
- Physicians presenting at the American Academy of Orthopedic Surgeons (“AAOS”) “argued that 36% of patients who received the NexGen joint experienced pain in their joint.”
- “9% of patients who received the NexGen joint had to undergo a second surgery after experiencing pain associated with the loosening of the joint.”
- “In March of 2010 the FDA issued a class 2 recall of the Zimmer NexGen Knee.”
Zimmer claims Kresch made the following similar “false, misleading and defamatory statements” on their www.zimmernexgenkneereplacement.com website:
- “The FDA has issued a class 2 recall of the Zimmer NexGen knee.”
- “March 2010: Data was presented by a group of knee surgeons that indicated almost 9% of patients examined after 2 years required revision surgery and 36% showed signs of a loose knee replacement.”
- (In large letters): “Zimmer NexGen Knee Replacement Lawsuit” and “the Zimmer NexGen knee replacement has been linked to pain, failure and revision surgery!”
Pulaski: “1-800-Bad-Drug”
Pulaski ran television ads throughout the U.S. that solicited potential clients by making statements about Zimmer and the NexGen Knee System.
The Pulaski Spot has flashing red boldfaced letters in front of a knee x-ray stating “Zimmer NexGen Knee Implant WARNING.” It goes on to say “Reports show the ZIMMER NEXGEN KNEE IMPLANT may have a failure rate of 9%.” It tells listeners they may be entitled to compensation and advises them to call 1-800-Bad-Drug for a free consultation.
Zimmer Rebuts
Garry Clark, Zimmer’s director of public relations told OTW the law firms, “Have a right to advertise truthfully. They don’t have the right to lie about our products.”
According to the Complaint, the scientific evidence is that NexGen joints “perform better, not worse, than ‘other joint types’.”
“No doctors ‘argued that 36% of patients who received’ the NexGen Knee System experienced pain, and 9% of patients who received the joint did not undergo a second surgery. The physician presentation mentioned in the Kresch Websites was a non-peer reviewed account of two doctors’ experience with 108 patients – accounting for a tiny fraction of the many thousands of patients who received NexGen Knee System components.”
Continued the Complaint: “The loosening reported in those 108 patients was exclusively of a single type of NexGen Knee System component: the NexGen CR-Flex Porous Femoral Component.
“The advertisements falsely extrapolate the reported result from the 108-case AAOS presentation not only to all NexGen CR-Flex Porous Femoral Components but further to the over three million total NexGen Knee System components sold, all contrary to the published data. The publicly-available data on the NexGen CR-Flex Porous Femoral Component demonstrate that it (like the NexGen Knee System as a whole) has among the lowest revision rates for that product type.”
The company says there has never been any recall of the entire NexGen Knee System, which includes more than 40 different components. Moreover, there has never been any recall of the NexGen CR-Flex porous femoral component.
“These false, misleading and defamatory statements are clearly and intentionally designed to mislead patients into reaching the false conclusion that the Zimmer NexGen Knee System is dangerous and defective. They have frightened patients and have injured Zimmer’s reputation and other interests.”
Clark told us the company is pressing forward with the litigation against the remaining defendants.
Zimmer first learned of these claims by the law firms when some of their surgeon customers alerted their sales rep or the company. “We have established a team to respond quickly to information we hear from our customers, and also monitor advertising ourselves to try to address problems before they impact our customers or unnecessarily alarm patients, ” added Clark.
Correcting the Record
Other than the corrective statements and retraction letter, we asked if there were any kind of financial penalties involved or if the company was counting on promises to “be good?”
Clark said that while the company was not in a position to disclose all the terms of past or possible future settlements, the primary goal has been to correct the record about “the most widely used and trusted knee system in the world.” He added the settlements contain strong financial and other terms designed to deter plaintiffs’ firms from resuming their false and misleading advertising. “We have retained the right to bring each back to Court should they resume problematic activity.”
Maybe it’s just a coincidence, but Zimmer’s leader, Dave Dvorak was the company’s top lawyer before becoming CEO. The message to personal injury lawyers looking for clients is simple. Be careful who you bite and be accurate with your claims because this dog bit back.
