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.

The Florida Attorney General’s Office has announced that it will expand its investigation from 5 to 8 for profit colleges operating in Florida. Initially, the AG’s office said it would investigate five schools including Everest University, Kaplan University, Medvance Institute, Argosy, and the University of Phoenix. The three new schools that will be investigated are Keiser University, Concorde Career Colleges, and Sanford-Brown Institute.
The Florida AG probe began after the federal government’s Government Accounting Office went undercover to investigate complaints about the schools’ marketing practices, financial aid packages, and their recruiting practices.
If any of the school’s are found to be in violation of Florida’s consumer protection laws, they face fines of up to $10,000 per infraction. In addition to the state fines, the schools face possible action concerning the student loans offered to students by the federal government. In one video excerpt of the GAO investigation, the recording reveals a Medvance Institute recruiter telling a prospective student not to worry about paying back the student loans. “It’s not like a car note, where if you don’t pay they’re gonna come after you,” the recruiter told the unsuspecting student.
The investigation may jeopardize the school’s ability to obtain federal and state grant money as well as offer student loans. According to the St. Pete Times, “At stake is billions of dollars in federal student aid — $20 billion in loans last year, plus another $4 billion in Pell grants for low-income students. That’s about a quarter of all federal aid to college students.
In Florida, for-profit schools also receive state money from students with Bright Futures scholarships. Last year, for-profits received $2.7 million through Bright Futures, with more than $571,000 going to the eight schools under investigation.”

Last week the FDA released the results of a new inspection report of a Johnson & Johnson manufacturing facility in Puerto Rico that had failed quality control inspections in January 2010. Yesterday, November 26, 2010 an FDA spokesperson stated:
“Clearly, this inspection shows that the company continues to have serious quality control issues at its plant and that it is not in compliance with current good manufacturing practices required by federal law”.
This statement by the FDA was about the Johnson & Johnson McNeil Consumer Healthcare unit that recalled millions of bottles of Tylenol and other over the counter drugs. However, this is the same company that recently recalled its DePuy ASR XL hip implants made by its DePuy division. It is apparent that Johnson & Johnson and DePuy had knowledge for several years that these hip implants were failing at an unacceptable rate and left them on the market.
Johnson & Johnson used to be a company with the highest standards for conduct. In fact, the Tylenol recall over two decades ago involving Tylenol on shelves that may have been tampered with is still taught in business schools around the country as the textbook example on how an ethical company should properly handle a recall.
Recently, with regard to the over the counter products, J & J was accused of a “stealth recall” in which they hired private firms to go to drug stores and purchase all the product off the shelves without disclosing a recall. This stealth recall involved children’s Motrin products as well as other popular Johnson & Johnson over-the-counter medicines.
There do not appear to be any injuries or deaths reported from the recalled over the counter products. The DePuy ASR XL hip implants, on the other hand, have subjected many hip implant patients to additional surgeries to remove the implants and exposure to cobalt and chromium poisoning that could have long lasting health effects.
It is apparent that the Johnson & Johnson Credo of quality which was like scripture within the company for so many years is not being followed by current management. Such repeated failures in the protection of public health by Johnson & Johnson would make the founders of the company roll over in their graves.
One wonders if the company suffers from a systemic failure in quality control as well as research and development. Johnson & Johnson is suffering from failures in both its medical device division as well as its pharmaceutical division. If this trend continues, consumers will start associating the brand with bad products and dangerous medical devices. No company can survive that reputation.

Now that the FDA has recalled Darvon and Darvocet, manufactured with propoxyphene, an opiod painkiller, attention and criticism have been focused on the slow response of the governmental agency to remove the painkillers from the US marketplace. It’s well-documented that the advocacy group Public Citizen has been calling for the drugs’ removal from the marketplace since 1978. Other countries have removed the drugs much more quickly, including the entire European Union. Dr. Sidney Wolfe told the FDA that the drugs were relatively weak and weren’t effective especially given their potential serious adverse consequences which include fatal abnormal heart rhythms, arrhythmia, bradycardia, cardiac/respiratory arrest,congestive arrest, congestive heart failure (CHF),tachycardia,
and myocardial infarction (MI).
In response to the recall, Public Citizen released the following statement, “Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since time the UK ban was announced,” the group said in a statement. “The best forensic data, the kind relied upon in those countries for the UK and European bans, come from Florida where, because of routine drug testing required by the state medical examiner as part of many autopsies, deaths are categorized as being ’caused’ by certain drugs if the levels found are to be above a certain level. From 2005 through 2009, in Florida alone, 395 deaths were “caused” by propoxyphene. If data from 2007 are representative, in that year, 78 percent of the Florida deaths caused by propoxyphene were ruled accidental.”
There is little doubt in the medical and scientific communities that these are dangerous drugs. Yet, because of the FDA’s inaction, thousands have been prescribed these painkillers in the United States. Little to no information is available as to what caused the years of inaction by the FDA. Because of this delay, consumer safety and consumer confidence have been dealt another blow.
Darvocet Recall

Archbishop John John Nienstedt of the Catholic Archdiocese of Minneapolis-St. Paul has asked the judge in a recently dismissed priest abuse lawsuit for $64,000 in legal fees. The lawsuit was dismissed on the judge’s determination that the suit was not filed in a timely manner. Nienstedt’s attorneys want to recoup their legal fees from the survivor which a legal maneuver normally sought in frivolous lawsuit cases. Is it the position of the Archbishop that this survivor’s claims are frivolous and without merit? This is a tough argument to make since the priest in question, Fr. Thomas Adamson has been accused before and admitted as early as 1980 to sexually abusing minors.
The local Survivors Network of Those Abused by Priests has protested the Archbishop’s action and has released the following statement: “We in SNAP believe it’s immoral for a bishop to exploit legal technicalities and hide behind an archaic and predator-friendly statute of limitations,” said David Clohessy, director of SNAP, referring to Archbishop John Nienstedt. “A profit-making secular businessman might do this. But it’s just wrong for a professed spiritual figure to do so.” While it may not be moral, the Archbishop must view it as an effective means of intimidating other sexual abuse survivors from coming forward and seeking justice through a sexual abuse lawsuit.
The suit was not dismissed because the victim’s allegations were found not to be credible. The suit was dismissed because of the restrictive statute of limitations which prevents many victims from pursuing justice. If this is the Archdiocese’s idea of good pastoral practice, all of us should be alarmed.
One has to wonder if other dioceses and archdioceses around the world will soon follow the lead of this Archdiocese. I doubt if this is an isolated, aggressive strategy to deal with sexual abuse victims only within the Archdiocese of Minneapolis-St. Paul. It would be interesting to ask the newly appointed president of the US Conference of Catholic Bishops Archbishop Timothy Dolan his thoughts concerning this hardball tactic. His own handling of sexual abuse survivors in the Archdiocese of Milwaukee left much to be desired. However, Dolan seems to be sensitive to the potential adverse public relations consequences of these aggressive tactics. According to most press reports, Dolan’s ability to deal with the press (the NY Times a notable exception) was one of the principal reasons he was elected over Bishop Gerald Kicanas, a former Chicagoan who was felled by his mishandling of Chicago pedophile priest Rev. Daniel McCormack.
Perhaps the NY Times will ask Archbishop Dolan about his fellow archbishop’s actions toward a priest abuse survivor. It would be interesting to see what he says.