Monthly Archives: February 2009

Bed Bugs on the March Nationally

In Florida, we’ve seen a rash of bed bug complaints. Most experts will attribute to the rise in bed bug complaints to unsanitary conditions in hotels or motels but there’s growing evidence that the problem is spreading and the culprits can be linked to more than dirty mattresses and bedding.
Some experts attribute the rise in bed bug complaints to the lack of an effective chemical agent to destroy the bugs and their eggs. The banning of the toxic chemical DDT, greater travel to third world countries and the bed bugs growing resistance to modern insecticided amounts to more bed bugs.
The most common variety, Cimex lectularius is a hardy, flattened brownish insect that can survive without a food source for up to a year! Female bedbugs can lay up to five eggs a day. Unfortunately, bed bug colonies can also thrive in immaculate homes and aren’t fussy about their food source. They just need a warm-blooded host including pets and humans.
In three years, bed bug complaints in New York City have quadrupled from 1,839 in 2005 to 8,830 complaints in 2008.

Psoriasis Drug Investigated in 4 Deaths

The FDA is investigating a potential link between the psoriasis drug efalizumab, sold under the brand name Raptiva. The drug has been linked to potentially four deaths. The link is associated with a rare degenerative condition of the brain known as progressive multifocal leukoencephalopathy which is characterized by neurological disorders such as mental deterioration, loss of vision, and other unspecified neurological symptoms. The investigation is in its infancy stages and was reported a few days ago on the LA Times health blog.
The disease (PML) is caused by the reactivation of a common virus in the central nervous system in those with compromised or weakened immune systems. It is most common in those with acquired immune deficiency syndrome (AIDS). If not treated with an effective antiretroviral therapy, the disease can be become rapidly fatal.

Medtronic Sprint Fidelis defibrillator leads Bard Composix Kugel Hernia Mesh Patch

With horrific stories of consumers suffering due to defective medical devices, some federal lawmakers are working to overturn the Supreme Court’s fateful Riegel v. Medtronic decision which gave FDA-approved medical devices immunity from state court lawsuits. The results of this court decision have been documented in tragic detail in today’s NY Times.
The decision is even more problematic and injurious for consumers given the FDA’s track record, especially recently, concerning consumer safety. The FDA has been particularly inept at keeping harmful drugs and dangerously defective medical devices off the market and out of the reach of consumers. We only have to look at recent examples such as Vioxx, Medtronic’s Sprint Fidelis defibrillator leads, Bard Composix Kugel Mesh Patch, to name a few.
Hopefully, lawmakers will craft legislation for President Obama’s signature that will ensure a return to consumer confidence and consumer safety. Reversing the effects of Riegel v. Medtronic would go along way to do just that.

Zimmer Bracing for Durom Cup Lawsuits

Zimmer Holdings Inc, the manufacturer of the Zimmer Durom Cup hip implant medical device, has increased its reserves in anticipation of lawsuits being filed as a result of the defective hip implant device. Initially, Zimmer put aside $47.5 million to cover the anticipated lawsuits but increased that amount by 50% in the fourth quarter last year to $69 million.
In July 2008, Zimmer suspended sales of the Durom Acetabular Component after reports of failures began to mount. The complaints involved loosening of the hip implant device requiring revision surgery. The failure rates are estimated to be 5.7% in the United States with approximately 12,000 implants performed prior to the suspension of sales.
However, in August 2008, the Durom Cup was reintroduced with a new warning and a training program for surgeons implanting the device. In spite of this, some surgeons complain that the problem with the device lies with the device itself and not with surgical technique or procedure.

Sulzer Redux: Zimmer Durom Cup Hip Implant

The latest defective hip product that’s caught the attention of medical professionals, the media, and the FDA is the Durom Cup hip implant manufactured by Zimmer Holdings Inc. It appears that the same defects found in the Sulzer hip implants have now affected the Zimmer Durom cup. The Durom shell is plasma sprayed pure titanium (PorolockTM –TiVPS) using a vacuum plasma spray technology developed by Sulzer Metco (Surface Technologies), Shanghai, People’s Republic of China. The problems that affected the Sulzer medical devices sprang from the oil residue that remained on the implant preventing the bony ingrowth that provides fixation, strength and stability.
The problems with the Durom cup are eerily similar. Defective Durom cups have been characterized by a lack of bony ingrowth and the ease at which they pop out.
If you’ve had a Durom cup implanted and are concerned about its potential failure, here are the signs to look for:
– start-up stiffness and pain when you rise from a chair or out of a car after the first three months postoperatively
– sharp groin pain when moving from a bent position to an upright position or when lifting your leg straight when lying down
– difficulty climbing stairs
– inability to walk distances
– reliance upon a cane when walking outdoors

Medtronic Lawsuit and Judge’s Potential Conflict of Interest

When US District Court Judge Richard H. Kyle dismissed all of the lawsuits against Medtronic regarding its defective Sprint Fidelis defibrillator five weeks ago, it was not widely known that the judge’s son Richard H. Kyle, Jr. is a partner with the firm Fredrikson & Byron. The firm represents Medtronic (although not in the defibrillator lawsuits) and is listed as their counsel on Medtronic’s own website.
Of course, Judge Kyle as well as Medtronic spokesmen were quick to downplay the significance of the relationshship as well as the conflict of interest. However, plaintiffs attorneys may pursue the conflict of interest matter and seek to have the judge removed from the multidistrict litigation lawsuits.
Judge Kyle’s decision five weeks ago on the Sprint Fidelis lawsuits effectively dismissed all the lawsuits on the basis of preemption ie. the notion that federal regulation (FDA) of medical devices preempts or trumps any product liability lawsuits in in state courts. This was a major victory for Medtronic.
In 2007, some cardiologists began to report fractures in the Sprint Fidelis leads at an alarmingly high rate. These leads connect electrical defibrillators to the heart and ensure proper cardiac rhythm, at least that’s what they were designed to do. In the case of the Sprint Fidelis leads, shorts in the leads caused irregular shocks to the heart or in some cases, no shock at all when the defibrillator was designed to do so.
In this matter, the new revelation of Judge Kyle’s son representing Medtronic is interesting. However, not enough is known to demonstrate a conflict of interest. On the other hand, more often than not in these types of situations the following axiom holds sway: perception is reality.

Drug Marketing and Consumer Safety

There are two news items of interest this morning that concern how pharmaceutical companies’ marketing efforts are dangerous to consumer safety.
First, the FDA has moved to restrict and more closely regulate the prescribing of certain narcotic drugs including Oxycontin, the powerful and popular painkiller. In announcing the new restrictions, the FDA noted that doctors are sometimes too cavalier in the manner in which they dole out the powerful pain drugs. Interestingly, the governmental agency commented that the real culprit was the manner in which the drug companies themselves market these drugs as cure-alls while downplaying their dangerous side effects and the potentially life-threatening effects of misuse and overuse. For years now, I watched as pharmaceutical companies market their products as if they were candy. Finally, the FDA is moving to do something about this problem.
Secondly, Bayer, the manufacturer of YAZ, a popular birth control drug, will limit the way it markets the product. This comes on the heels of Bayer’s settlement with 27 states over Bayer’s marketing claims that YAZ can treat symptoms such as PMS for which it was never approved. As a result of the settlement, Bayer must implement a $20 million marketing campaign to remedy its misstatements in previous marketing campaigns.
Pharmaceutical companies have tons of money to throw at marketing campaigns. The more aggressive the marketing campaign, the more doctors and consumers will demand the drug. If there are no federal regulations concerning their marketing campaigns, drug companies can continue to put consumer safety at risk.

Fen-Phen’s Dangerous Successors

It’s been almost 12 years since the FDA asked to have fen-phen, the popular diet drug, to be removed from the diet drug. Fen-phen, a mixture of fenfluramine and phentermine, was causing valvular heart disease as well as pulmonary hypertension. Years of litigation and destroyed lives later, the FDA is now going after another set of diet drugs. This time the problem concerns the unknown or “hidden” ingredients in diet drugs that are marketed as natural. In spot inspections, the FDA has cited 69 weight loss supplements such as StarCaps, Sliminate, Superslim, ans SlimUp to name a few. The problem with these products is that the FDA has no real regulatory authority over their approval prior to their entering the marketplace. The FDA can step in and do spot checks which they are doing on a limited basis but the proverbial barn door is already open. The NY Times quoted Michael Levy as saying, “A large percentage of these products either contain dangerous undeclared ingredients or they might be outright fraudulent on the ingredients and have no effect at all,” said Michael Levy, the director of the F.D.A.’s division of New Drugs and Labeling Compliance. “We don’t think consumers should be using these products.”
This could be a more dangerous consumer product safety issue than fen-phen. At least with fen-phen, those who used the product knew what was actually in the drug. Now, with the prevalence of these new supplements, the consumer has no real idea what they are ingesting into their system. Furthermore, if something happens to the person using such supplements, a doctor will have trouble diagnosing the issue correctly because he or she will be in the dark as to what’s in the supplement. The federal government needs to change the law concerning these supplements and ensure some sort of regulatory approval process PRIOR to these products entering the marketplace. Right now, if you take these so-called natural supplements you’re playing Russian roulette with your health and quite possibly your life.

FDA Medical Device Approval Process Flawed

Wyeth Lawsuit Supreme Court Ruling March 2009
Wyeth Lawsuit Supreme Ruling March 2009
According to a January 15, 2009 GAO (Government Accountability Office) report, the FDA’s process for reviewing and approving the sales of medical devices is severely flawed. In reviewing potential medical devices for market here in the US, the FDA uses an antiquated process that dates back to 1976, which categorized medical devices into three groups or tiers depending upon their risk level to consumers.
Between 2003 and 2007 228 medical devices were found to have passed through an insufficient medical review process including about 24 high-risk devices such as heart defibrillators, artificial hip joints and electrodes for pacemakers, according to the government report.
In spite of the flawed FDA system, the Supreme Court denied consumers the right to sue medical device manufacturers for faulty and dangerous medical devices, arguing that if the device received FDA approval, the device company was immune from product liability lawsuits in state courts.
Wyeth Pharmaceuticals, one of the country’s largest manufacturers of prescription and over-the-counter drugs, has brought suit in order to extend this same legal protection for drug manufacturers. Last November, the case was brought before the Supreme Court. If the Court extends this benefit to drug companies, it will prove to be another loss for consumers.

Priest Abuse Scandal: Why the Church Insists on Shooting the Messenger

In the last few weeks we’ve witnessed some extraordinary events in the long, tragic saga that is the Catholic Church’s priest abuse scandal. Thomas O’Brien, the US Attorney in Los Angeles is undertaking a federal probe of the Archdiocese of Los Angeles’ actions and lack thereof regarding its handling of priest abusers. Just this past week, the deceased founder of the Legionaries of Christ, Rev. Marcial Maciel, is reported to have fathered a child. The child, now in her early 20’s wants to write a book about her infamous father and her mother’s relationship with him. Even the Legionaries have stopped disputing the allegation as spurious.
Yet, we still have bishops attacking the media for reporting on the scandals. Bishop Jenky of Peoria Illinois claims that the media’s intense hatred for Catholics is fueling the stories. Jenky is distributing a letter to all parishes of the diocese this weekend complaining about the church’s unfair treatment in the courts and in the press. An excerpt of the letter reads as follows: ““Amid all the tensions of our nation’s culture wars and in the face of the media’s intense hatred for our Catholic faith, I am increasingly concerned that our Church in effect no longer enjoys equal justice under the law.” In his tirade, Jenky did not spare lawyers either.
“Attorneys representing some claimants and some “victims groups” obviously have a significant financial stake in trying to overturn our Diocesan policies.”
Jenky claims, abundant evidence to the contrary, that these “attacks” are an attack on the faith and not a matter of justice, truth, or protecting victims (whose credibility he questions by putting the words in quotation marks).
This defensive, reactive posture will not resolve the scandal nor will it restore credibility to the Church whose own members have suffered as a result of these scandals.