|
Alphatec Ponies Up $11 Million Settlement for ‘678 Patent
By Walter Eisner (posted May 9, 2008)
"Alphatec can now achieve some certainty." That's what Alphatec's President and CEO, Dirk Kuyper, told us at the SAS annual meeting in Miami Beach. He was referring to his company's announcement that its 2006 lawsuit with Biedermann and DePuy over the ‘678 pedicle screw patent is settled.
Biologic Bummer for Stryker in Beantown
By Walter Eisner (posted May 5, 2008)
Stryker's stock stopped trading for 16 minutes before resuming on Friday, May 2. The reason was because Stryker was about to announce that its Biotech division, in the Boston suburb of Hopkinton, had received a warning letter from the U.S. Food and Drug Administration (FDA) related to quality systems and compliance issues.
Physician Disciplinary Actions Decline 22% Since 2004
By Walter Eisner (posted April 24, 2008)
With the current hyper-vigilant focus on surgeon and industry relationships, it begs the question: Are disciplinary actions against physicians increasing or decreasing?
Let the Lawyerin’ Begin. Lawsuits Filed Against ArthroCare
By Walter Eisner (posted April 11, 2008)
That didn't take long. Four law firms (and counting) have now announced that they are starting class action lawsuits against ArthroCare Corp. and are currently searching for lead plaintiffs for the case.
 Chan's Sentence, Industry's Lessons
By Walter Eisner (posted April 8, 2008)
Dr. Patrick Chan didn't have to go to jail or pay huge fines, but his role as witness for federal prosecutors and the continuing civil lawsuits may affect orthopedic companies for years. Will it change industry and surgeon relationships? Who is still on the hot seat? Read our take here."
Chan Sentenced To Canada, Probation and Light Fine
By Walter Eisner (posted April 3, 2008)
Dr. Patrick Chan, the Arkansas neurosurgeon who pled guilty to bribery in January for demanding kickbacks for using specific medical equipment, has now been sentenced by U.S. Federal Judge Susan Webber Wright.
Bill Overturning “Federal Preemption” Drafted in Congress
By Walter Eisner (posted March 28, 2008)
When the U.S. Supreme Court ruled in Riegel v. Medtronic in February that Congress intended federal law to preempt state law, we reported that it might be a short-term victory for the medical device industry.
China Announces Draft Recall Law
By Walter Eisner (posted March 28, 2008)
The Chinese news agency Xinhua reported on March 21 that China will “revoke licenses of the producers of unqualified medical devices with disastrous results, according to a draft on the administration of medical device recalls.”
TriMed Wins Round Two v. Stryker
By Walter Eisner (posted March 24, 2008)
Rack up a court victory for the David, TriMed, over the Goliath, Stryker. Stryker and TriMed have been involved in a patent dispute over the last couple of years. Stryker won the first round; TriMed has won the second.
Post-Settlement Era at AAOS ‘08
By Walter Eisner (posted March 18, 2008)
Thirty thousand orthopedic surgeons and industry reps gathered at AAOS for their first meeting in the Post-Settlement Era. Have business practices and surgeon/industry relationships changed? Find out.
Stryker Discloses SEC Inquiry of Foreign Sales
By Walter Eisner (posted March 17, 2008)
In a February 28 10-K filing, Stryker disclosed that the U.S. Securities and Exchange Commission has made an informal inquiry of the company regarding possible violations of the Foreign Corrupt Practices Act (FCPA) in connection with the sale of medical devices in certain foreign countries.
Surgeons for Sale: The Musical
By Walter Eisner (posted March 11, 2008)
The U.S. Senate held a hearing recently about industry and orthopedic surgeon relationships. What do the accused and the accusers have to say? Read our review of the public theater they call congressional hearings here.
The Unintended Consequences of Riegel
By Walter Eisner (posted March 4, 2008)
The Supreme Court ruled that Congress protected device manufacturers from being sued if they have FDA approval for their products. Sounds good for manufacturers, and celebrations broke out. But is it really a victory?
New Jersey Issues Subpoenas Over Synthes’ ProDisc™
By Walter Eisner (posted February 12, 2008)
Dueling prosecutors in New Jersey are competing to see who is tougher on the medical device industry. First the U.S. attorney settles with hip and knee makers, and now the state’s attorney general investigates Synthes Spine and clinical researchers.
TriMed® Patent Lawsuit Against Stryker to Be Reheard
By Walter Eisner (posted February 1, 2008)
TriMed® vs. Stryker. Round one to Stryker, round two to TriMed. The patent lawsuit between TriMed of Valencia, California, and Stryker has been sent back to the U.S. District Court for the Central District of California for a rehearing.
Stryker Responds to FDA Warnings—Recalls County Cork Hip Products
By Walter Eisner (posted February 1, 2008)
They say the squeaky wheel gets the grease. At Stryker the squeaky hip got the President and CEO’s undivided attention.
December 2007 PMAs Approved by FDA
By Walter Eisner (posted January 30, 2008)
Two Zimmer knees and a Synthes cervical disc all had favorable premarket approval (PMA) decisions rendered by the FDA in December.
FDA Homes in on Postmarket Off-Label Marketing in Spine
By Walter Eisner (posted January 22, 2008)
Staff shifting at the FDA from premarket to postmarket offices has raised the agency’s expertise level to monitor off-label marketing of spine devices. What’s it mean for you?
Squeaky Hips Land Stryker in Hot Water With FDA
By Walter Eisner (posted January 21, 2008)
Squeaky hips have gotten Stryker in trouble with the FDA, which has sent the company a series of warning letters. We reported on the squeaky hips in December 2006 from the 23rd annual Current Concepts in Joint Replacement meeting. Three patients, called "Squeakers," were shown and heard in a video with the noisy hips. We know, it made us chuckle, too, as we imagined Uncle Charlie trying to sneak into the kitchen for a midnight snack.
Tentative 2008 FDA Meeting Dates for Ortho Panel
By Walter Eisner (posted January 18, 2008)
Thanks to some of our readers who noticed that we had given you the 2008 tentative meeting dates for the FDA’s Ophthalmic Devices Panel instead of the Orthopaedic and Rehabilitation Device Panel dates for 2008.
FDA Issues New Guidance for Review of Medical Devices. Ortho Panel Tentative Dates Released
By Walter Eisner (posted January 17, 2008)
The FDA’s new informal review process for medical device applications, intended to speed review times, is clarified in a guidance advising applicants of when and how to contact the agency during a review cycle.
|
Orthopedic Decisions Start Here. 
