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Over a period of four years, there have been 607 serious adverse events associated with the so-called “abortion pill” RU-486 reported to the FDA. These include five deaths, 68 cases of severe bleeding that required transfusions, and 66 cases of infection.

RU-486 was approved in the U.S. by the FDA in September of 2000, for the termination of early pregnancies. Since then, over 460,000 doses have been administered, while the drug has been linked to a total of eight deaths.

The 607 complaints were reported between September 2000 and September 2004. Of these there were 237 cases of hemorrhage reported, with one resulting in death. 42 were determined to be life-threatening.

Of the reported cases of infection, there were seven incidences of septic shock ( when an infection enters the blood stream and endangers major organs) two of which ended in death.

Seventeen of the reported complications occurred because women had an undiagnosed ectopic pregnancy when they took the drug. Ectopic pregnancy occurs when the fertilized egg is implanted in an area outside the uterus, and can be deadly. Eleven cases resulted in ruptures and one in death.

Diagnosis of the potentially deadly compilcations of RU-486 is often delayed by the fact that the initial warning signs of serious illness, like abdominal cramping, nausea and vomiting are also frequent side effects of the drug itself.

The report of the hazardous complications incited a protest by the ant-abortion faction to remove the drug from the market. Researcher Dr. Margaret M. Gary, remarked to WebMD that  in her opinion the instances reported to the FDA make up only a fraction of the true medical problems that actually occur among RU-486 users. (The FDA has estimated that under-reporting can range as high as 90% to 99%).

Dr. Gary and co-author, Dr. Donna J. Harrison, are members of the American Association of Pro Life Obstetricians and Gynecologists, a group that advocates removal of RU-486 from the market.

In contrast, Harvard Medical School obstetrics and gynecology professor, Dr. Michael F. Greene, argued that underreporting of  complications may be less of a concern with RU-486 than with many other drugs because of the controversy surrounding it.

Dr. Greene says based on the current research it is difficult to determine whether RU-486 is safe or not. He says it is not clear if the drug is more dangerous than miscarriage or surgical abortion, or whether the deaths and other reported adverse events were caused by the drug. "I don’t have a dog in this fight. But I do believe very strongly that women should have access to safe pregnancy termination rather than being forced to undergo unsafe pregnancy termination. If the safest way of terminating a pregnancy turns out to be surgical, then so be it. But until we have more compelling data, no one should leap to conclusions."

The manufactures of the drug, also called Mifeprex declined to comment. Federal officials announced that the FDA is currently investigating the deaths and the reported negative events.

In November, considerable attention was focused on Mifeprex because of multiplte deaths among users of the drug from the same deadly bacteria, Clostridium sordellii, which is a rare and lethal bacterium for which there is no known cure once an infection takes hold.

At that time, the FDA as well as the Centers for Disease Control and Prevention (CDC) announced their intention to launch investigations into the possible link.

Mifeprex (RU-486), as an abortion pill, has been shrouded in controversy since 1996 when the federal advisory committee that recommended its approval was forced to meet under the protection of federal marshals.

Until now, no one had ever suggested or suspected that the drug and the infection might be linked in some way. With the confirmation that at least five women had died from Clostridium sordellii infections within days of taking the drug, medical experts were faced with far more than a coincidence. It had turned into a public safety issue that required a satisfactorily explanation.

Since four of the five deaths occurred in a cluster between September 2003 and May 2005 in California, there was speculation that contamination may have played a role in the fatal infections. Testing by the FDA, however, proved negative for any such contamination.

As a result, the decision was been made to convene a special meeting early in 2006 at which officials from the FDA and CDC will examine what has become a perplexing medical mystery. No doubt, the fifth death, which occurred in Canada during clinical testing of the drug in 2001, will now be reexamined.

In each of the deaths, Clostridium sordellii infected the woman’s uterus, flourished, and then entered their bloodstreams. Death occurred in each case within one week of taking the drug.

This deadly bacterium can cause nausea, vomiting, diarrhea, and weakness. Since fever may not occur, however, victims often succumb to toxic shock without ever realizing how sick they really were. Once the infection has flourished, antibiotics are often ineffective because even in death, the bacteria continue to release deadly toxins.

Many experts are concerned about these revelations for a number of reasons. One is that other similar deaths may be going unreported because the association between the drug and the infection has not been made. A second is the under-reporting issue discussed above.
A third is that some researchers believe the drug itself impairs the immune system and makes patients more vulnerable to infection with Clostridium sordellii. Dr. James McGregor, of the University of Southern California, discussed that theory earlier this year in two medical publications.

As a result, critics of the drug are again calling for its removal from the market pending the outcome of the combined FDA and CDC probe.

Warnings about the drug’s possible link with Clostridium sordellii were placed on Mifeprex’s label in July, and the FDA updated this information on its Web site on November 4, without announcement, after it discovered that all four California deaths involved the Clostridium sordellii bacterium.

The U.S. National Highway Traffic Safety Administration (NHTSA) and Transport Canada have been notified by Michelin North American that the international tire giant is recalling approximately 6,500 Michelin(R) Pilot(R) Sport 255/35ZR20 97Y Extra Load tires in the United States and Canada. The recall is specifically limited to the above mentioned tires only.
 
This decision came as a result of findings by Michelin’s own internal quality control system that the tires in question do not meet the company’s quality standards.

The defect in the affected tires ordinarily appears first as a visible blister on the sidewall of the tire that may produce a noticeable tire vibration, which a driver might detect.

The condition may also result in a rapid loss of air pressure, which could potentially lead to a loss of control and potential vehicle crash.
   
To date, there have been no accidents or injuries reported in North America. The majority of the tires affected by the recall were distributed in the U. S. with fewer than 400 distributed in Canada. Related actions are under way in other countries.
    
The recalled tires were fitted as original equipment on some trim levels of Jaguar XJ8 vehicles and also were available in the replacement market. The affected tires’ DOT markings begin with FHPNEFMX and end with 00, 01, 02, 03 or 05.  

The DOT code can be found on the sidewall right above the rim printed in small type less than half an inch tall. Consumers should first make sure of the tire’s make and model: Michelin(R) Pilot(R) Sport 255/35ZR20 97Y Extra Load.  

Next, the DOT code on the sidewall should be examined. Affected tires have a DOT code that begins with FHPNEFMX and ends with 00, 01, 02, 03, or 05 as the final two digits.   

Consumers who have difficulty identifying a tire’s DOT code should ask for assistance at a local tire dealer or call Michelin Consumer Relations at 1-800-847-3435 (1-888-871-4444 in Canada). A photo of an affected tire can be found online at:   http://www.newscom.com/cgi-bin/prnh/20051229/CLTH002.

The first two characters FH designate the tire’s manufacturer and plant code. The third and fourth characters denote the tire size. The fifth, sixth, eleventh, and eighth (optional) characters identify the brand as well as other significant characteristics.

The final four numbers denote the date the tire was produced with the first two indicating the week and the last two numbers indicating the year (05 indicates the tire was built in 2005).

The company will be replacing all potentially defective tires in a comprehensive commitment to retrieve from the market any tire that does not meet Michelin quality standards. Replacement tires are available at no cost (including mounting and balancing) to consumers through Michelin tire dealers.
    
Any consumer in the United States or Canada who believes they are affected by the recall should not wait to receive notification but should call Michelin Consumer Relations at 1-800-847-3435 (1-888-871-4444 in Canada) or return to their servicing tire dealer for a free inspection and replacement of affected tires

Since the potential defect is one that could cause a serious or even fatal accident, consumers should examine their Michelin tires immediately and not hesitate to have any tire affected by the recall replaced as soon as possible.

It is admittedly an odd connection but there seems to be no real doubt that MIRAPEX, a drug used to treat Parkinson’s disease (PD), is also responsible for turning some of the patients who used it into gambling addicts.

In July, a Mayo Clinic study published in the Archives of Neurology that identified 11 Parkinson’s patients who developed a gambling habit while taking MIRAPEX or similar drugs between 2002 and 2004. Since the study was released, 14 additional Mayo patients have been diagnosed with the problem according to lead author Dr. M Leann Dodd, a psychiatrist at the Clinic.

Previously, in August 2003 in the journal Neurology, Drs. E. Driver-Dunckley, J. Samanta, and M. Stacey published an article entitled “Pathological gambling associated with dopamine agonist therapy in Parkinson’s disease.”   

That study found extreme cases of compulsive gambling in nine (of 1,884) patients using pramipexole (8 or 1.5%)) and pergolide (1 or 0.3%). Both results were well above the overall incidence rate of all PD patients of 0.05%. Both drugs that showed an increased risk were dopamine agonists (DA).

The Mayo Clinic study also analyzed the findings in five prior studies (including the 2003 Driver-Dunckley study) and confirmed that: “All of the commonly prescribed dopamine agonists have been associated with pathological gambling” with pramipexole being “disproportionately represented in both our series (82% of our patients) and in prior reports (59%).”

MIRAPEX (pramipexole dihydrochloride) is in the dopamine agonist class of drugs and is believed to work by mimicking the action of dopamine in the brain to help control the symptoms of Parkinson’s disease. Dopamine also affects brain processes that control emotional responses and a person’s ability to experience pleasure and pain. It is thought to play a role in addictive behavior.

Unfortunately, this is another drug whose benefits come with a very high price tag for some patients. The ones who become addicted to gambling often wind up losing their life savings, fall deeply into debt, and even jeopardize or destroy their marriages or other personal or family relationships.

In the past, the victims of this harsh side-effect had no idea what had come over them. Their brain was literally taken over and their gambling became constant and compulsive. Simply stated, they were out of control and had no idea why. For these people, the situation was frightening and inexplicable.

As a result of this completely bizarre and damaging side-effect, many MIRAPEX users suffered long periods of debilitating and destructive behavior during which they were unaware that the drug was causing the problem and that it would cease if they discontinued taking it.

MIRAPEX is manufactured by German-based Boehringer Ingelheim Pharmaceuticals, the world’s biggest family-owned drug company, in cooperation with New York-based Pfizer, the world’s largest drugmaker. Its sales for 2004 topped $200 million in the U.S. alone.
.Boehringer Ingelheim lists "compulsive behaviors (including sexual and pathological gambling)" as a possible side effect associated with taking MIRAPEX.  That seven-word phrase on page 17 of a 21-page highly technical document is all the warning that is given concerning the potentially detrimental side-effect.

While Boehringer-Ingelheim has repeatedly claimed there is no scientific evidence upon which to base the conclusion that MIRAPEX causes addictive or compulsive behavior, the multiple reputable studies on the subject would seem to indicate otherwise. In addition, the company revised its package insert to include the warning with respect to “compulsive behavior” despite its denial of the connection.

Currently, two major lawsuits against Boehringer Ingelheim and Pfizer have been commenced in federal court in California and in Superior Court in Ontario, Canada. They allege a number of addictive behaviors associated with MIRAPEX including gambling, shopping, having sex, eating, and engaging in other compulsive conduct.

It is likely that additional lawsuits will be commenced in the near future since the problem is as widespread as the locations of people who took MIRAPEX.

Jerrold Parker, managing partner of Parker & Waichman, a law firm with considerable experience in pharmaceutical and medical malpractice litigation nationwide, told us that: “It is difficult to imagine how the manufacturers of MIRAPEX can maintain there is no scientific evidence to support the addiction link when several studies leave little doubt of the connection. In addition, it is rather amazing that when the manufacturers finally decided to add a warning regarding compulsive conduct to the product insert they chose to hide it in the middle of 21 pages of technical data.”