Senators Max Baucus and Charles Grassley are asking the commanding general of Walter Reed Army Hospital probing questions about its doctors’ use of an experimental medical device. The medical device, Hydrosorb Mesh, has not received FDA approval for use in spinal surgeries. While surgeons may use drugs and/or medical devices in ways not approved by the FDA, the two Senators believe the Army should have received permission before conducting a study that included spinal surgery.
According to a NY Times article, The Army doctors had implanted Hydrosorb Mesh in spinal fusion procedures for 35 patients in an 18-month period, according to a study published in the journal Neurosurgical Focus in 2004. The study covered 22 patients, including 15 active duty soldiers, to determine whether the bio-absorbable Hydrosorb was possibly preferable to similar titanium mesh. The study concluded, in glowing terms, that Hydrosorb might be “ideally suited” to spinal use. Medtronic has also made payments for consultancy or other services to the three doctors — Timothy R. Kuklo, Michael K. Rosner and David W. Polly Jr., all then with Walter Reed.”
The fact that the three doctors have been remunerated by Medtronic and that after six years Hydrosorb has yet to receive FDA approval has caused concern about safety issues and conflict of interest questions.
Today’s article in the Business section of the NY Times underscores the fundamental flaws and failures in the US medical device regulatory system. The article notes that DePuy Orthopaedics, the world’s manufacturer of artificial hip components in the world, created a faulty product and then convinced the market that the DePuy ASR XL hip replacement was performing as well as other comparable hip replacements even though it was aware of numerous complaints from patients and physicians alike who said the hips were failing frequently and prematurely. When it was introduced to the marketplace the DePuy ASR (Articular Surface Replacement) XL was supposed to be a revolution in technology and design. It was supposed to be a hip that lasted 15 years or more in patients. Not only did it fail in that regard, some DePuy patients are now suffering from severe metallosis or metal poisoning as a result of the metal-on-metal hip joint grinding together and leaving tiny particles of cobalt and chromium to be released into the bloodstream.
While we have documented the DePuy failures in this blog, the NY Times article takes a slightly different view of the issue. The Times’ article focuses on the failed US regulatory system that allows such a faulty medical device onto the marketplace in the first place. According to the Times, unlike a pharmaceutical drug which must endure a series of critical clinical trials before approval, a medical device faces no such scrutiny. If a particular medical device, such as the DePuy ASR XL resembles a previously approved device, it can skip the trials and proceed to the marketplace. Most experts agree this is a huge problem with the regulatory system. Until such problems are fixed, patients will continue to suffer as they are now with the failed DePuy hips.
Matrixx Initiatives and Lead Plaintiffs’ Counsel in the Federal Multi-District Litigation in the District of Arizona and the consolidated proceedings pending in state courts in California and Arizona, Charles S. Zimmerman, Steven Skikos, and Stephen Leshner, respectively, announced the parties to product liability suits against Matrixx Initiatives and Zicam LLC pending nationwide have reached agreement to resolve the bulk of outstanding cases and claims on mutually satisfactory terms. Under the settlement agreement, approximately 1,014 plaintiffs and 1,127 claimants who allege loss of smell and/or taste arising out of their use of Zicam Cold Remedy and other products will be eligible to participate in a voluntary Settlement Program. In return, plaintiffs and claimants will dismiss or release their cases with prejudice. The company will pay a total of $15.5M, including $11.5M after satisfaction of certain contingencies and approximately $4M in subsequent payments within twenty-one months
Johnson & Johnson has announced the recall of 13 million units of its antacid chewable tablets. Its popular antacid Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews and Rolaids Multi-Symptom Plus Anti-Gas Softchews are all being recalled because they may contain metal and wood particles. Potential adverse health consequences include gum and tooth injury and vomiting.
The Rolaids recall is the latest in a slew of bad news for the pharmaceutical and medical device manufacturer. The company has been plagued by recalls this year including pharmaceutical products such as Tylenol and its hip replacement medical device the DePuy ASR XL hip replacement. The DePuy hip replacement issues may affect all patients who’ve had the hip implanted due to the potential for metal poisoning. All those with DePuy ASR XL hip implants may ask their doctor for a specific blood test to determine if they have suffered metal poisoning as a result of the hip product defect. Essentially, the metal-on-metal hip implant allows metal particles to flow into the bloodstream. These cobalt and chromium metal particles may cause metallosis or metal poisoning in those who’ve had the hips implanted.
Dr. Midei, a Baltimore surgeon, is facing numerous lawsuits for implanting cardiac stents in patients who didn’t need them. The Senate Finance Committee, which has begun investigating the doctor as well as the hospital where he implanted the stents, notes that Dr. Midei may have implanted some 585 stents which were medically unnecessary from 2007 to 2009.
According to media reports, Midei was given millions in salary and perks for implanting more of the Abbott Laboratories stents than any other Baltimore doctor. The Senate report finds fault with Abbott’s actions as well as the doctor. “The serious allegations lodged against Dr. Midei regarding the medically unnecessary implantation of cardiac stents did not appear to deter Abbott’s interest in assisting him,” the report states.
The 5 member judicial panel on MultiDistrict Litigation has ordered DePuy hip implant lawsuits be consolidated under Judge David A. Katz, a federal judge appointed by President Bill Clinton in the 1990’s. In their decision, the judicial panel noted that Judge Katz “is an experienced transferee judge with the time and experience necessary to steer this litigation on a prudent course.” The 5 member panel consists of Judges David R. Hansen, Acting Chair, W. Royal Furgeson, Jr., Barbara S. Jones, Frank C. Damrell, Jr., and Paul J. Barbadoro.
Judge Katz has prior experience handling complex MDL cases since one of his most recent MDL’s concerned litigation involving the contraceptive Ortho Evra.
The panel also explained why the Northern District of Ohio (Toledo) was an appropriate venue for the MDL. The judges cited the city’s accessibility as well as several potential “tag along” actions already pending in the court.
DePuy Orthopedics Inc.’s ASR hip implant lawsuits will be consolidated in a MultiDistrict Litigation in the Northern District of Ohio. The MDL docket number is 2197 and will be styled DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation, MDL Docket No. 2197. . .Products Liability Litigation, No. 03-17000, MDL 1535, N.D. Ohio.
Last month a DePuy court hearing took place in North Carolina in order to determine the feasibility of a consolidated litigation for all DePuy hip implant lawsuits as well the location of such an MDL.