A recent article by MSNBC.com suggests drivers are disoriented and have problems deciding what to do in an emergency with cars that display fancy technology and controls such as keyless ignition. In fact in the BMWiDrive, the control functions for the radio and air conditioning were so baffling that if forced drivers to take their eyes off the road.

Shifting from neutral to drive or reverse isn’t what it used to be. Drivers now have to push a button to start their car and most drivers are unprepared for what to do in the event of an emergency.

According to MSNBC, an off-duty California Highway Patrolman and his family were killed when his rental Lexus ES350 sedan accelerated suddenly and crashed into rush hour traffic at 120 mph. Toyota blames the accident on the accelerator pedal, but the deaths are also a major factor in not being able to control a modern car. We used to be able to shift the car into neutral or turn off the engine. However, the driver of the Lexus was unable to shift the car into neutral or switch off the engine because with the ES350’s engine, you would have to press and hold the “Stop/Start” button for three seconds, an action that is not obvious and could be difficult to accomplish at high speeds. Another problem is that Lexus’s shifter is curved and not the typically expected straight line.

Consumer Reports immediately put into action a five fixes plan for carmakers following this incident. They suggest that auto manufactures:

• Make it simpler to turn off the engine in an emergency;
• Require a minimum distance between the gas pedal and the floorboard;
• Engineer cars so a sustained braking force can stop a car in a reasonable distance even with the accelerator pedal fully depressed;
• Require sufficient brake pedal pressure before a car can be shifted from Park;
• Simplify shifting into Neutral.

Consumer Reports states that “finding Neutral should be intuitive and obvious, but the advent of gated and electronic shifters can make finding Neutral in a panic confusing. You shouldn’t have to read the owners manual to figure out how to use the shifter.”

What can the consumer do until some of these problems are worked out:

• Read your owner’s manual carefully;
• Sit in your vehicle, with the owner’s manual and physically work through the various operations of the gadgets in the car;
• Become very familiar with the shifting mechanism in your car;
• Know how to shift to neutral in the event of sudden acceleration;
• Test your braking system in an empty parking lot — try fast stops;
• Never turn off the ignition in the event of sudden acceleration. In most cars, this locks the steering or makes steering much more difficult;
• Never use your cell phone while driving, unless you have hands free operation;
• Never text while driving.

In a video we produced, Attorney Cal Warriner discussed the practice of pain pump manufacturers promoting the use of continuous flow infusion pain pumps for uses never approved by the Food and Drug Administration. In fact, pain pump manufacturers were, in some cases, told to remove orthopedic use from their written materials.

Tragically, pain pump manufacturers went to what appears to be substantial efforts to market their pain pumps for use directly in the joint space (intra-articular) and went from doctor to doctor; from conference to conference; promoting this unapproved use.

The FDA now has issued another notification, this time in the form of a video, which concludes the manufacturers used the pain pumps in a way not approved and recommended drugs for use in the pumps for which they conducted no testing for the intended their use.

Yet, these same manufacturers continue to argue to judges that they should be dismissed from lawsuits. This is being argued before a jury can hear that their use of the pain pumps was unapproved and their selection of drugs for us in the pumps was untested. Their attitude is typical of trying to pervert the law in the interest of corporate avoidance for their poor judgment and circumvention of federal guidelines.

Japanese auto giant, Toyota, has been under fire in the last few months over recall woes for sticky brake pedals and mats that entrap the accelerator pedal. Twenty deaths have been blamed and linked to the faulty gas pedal and YouTube has videos and 911 recordings of people whose Toyota has sped out of control.

Our faith in a brand that for years has ensured safety and quality is now tarnished. The lack of importance Toyota initially put on the recalls and their quickness to repair these defects has consumers fuming. Toyota is also accused of taking far to long to recall the cars in the first place. Reports on sticky pedals in Toyota’s have been documented back to 2008. It has recently been acknowledged that Toyota has known about customers complaining about sticky accelerator pedals in the UK since late 2008.  Toyota only went public on these complaints after British government safety officials alerted US counterparts who were handling a massive deluge of complaints about the sticking accelerators. This exposure led to Toyota’s recall of 12 of its popular vehicles, with some 2004 models being involved in the recent recalls. Toyota has recalled nearly 8.5 million vehicles since November 2009 around the world.

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Pain pump manufacturers did it wrong. If we are practical, the conclusion is inescapable… pain pump manufacturers have been sued in hundreds of cases because they deserved it. They gambled…they were caught… and they should pay patients who have suffered devastating injuries. Opinion? I suppose, but let’s look at the facts and you decide.

The manufacturers would tell you they are the victims of trial lawyers and that no scientific data exists that will reliably relate use of their pain pumps to a condition called chondrolysis. In fact, pain pump manufacturers across the country have been telling judges, opposing counsel and anyone else they can that any evidence their pumps caused chondrolysis is simple coincidence, happenstance, accident. In other words, do not look at the little man behind the curtain; listen only to the “great and mighty Oz”.

Is this true? Has the mighty Oz spoken? No and yes. The mighty Oz is certainly speaking, but the truth is certainly not found in the Land of Oz.

Pain pumps work, at least as sold by the manufacturers, by the use of a catheter attached to a pump at one end and inserted into the joint space at the other end. Pain medications, typically marcaine or bupivacaine, are inserted in the pump and injected into the joint space over a period of 48 to 72 hours. Based on this design and the use promoted by pain pump manufacturers, what is the one thing, amongst all others, you would want to know? Go ahead, you know, say it — right, you would want to know if it is safe to inject these drugs into the joint for the length of time suggested.

Did pain pump manufacturers conduct studies to determine whether using their pain pumps in the ways they recommended would cause injury to patients? They did not. I know, I was shocked, too. That’s right, they sold the product, recommended to physicians the way to use the product, but they never studied what complications to which patients might be subjected.

In 1985, a study was conducted, which gauged the effect of bupivacaine on articular cartilage. As a result of that study, the investigators determined that increasing concentrations of bupivacaine caused damage to cartilage. They recommended further study. Did pain pump manufacturers know about this study in 2000? Of course they did.

A study was published in June of 2009, Postoperative Chondrolysis of the Knee; 3 Case Reports and a Review of the Literature, by Eric Fester et al. In that study, the authors review all the literature relating chondrolysis to pain pump use and their own findings in (3) patients.

In their study, through their own experience, training, and a review of the available literature, they concluded that chondrolysis suffered by their patients was caused by the use of pain pumps with bupivacaine. The conclusions drawn by these researchers are interesting:

“In summary, there is currently a significant amount of in vitro and in vivo evidence that the use of pain pumps with bupivacaine and epinephrine may lead to significant chondrolysis when placed into a joint. We agree with Bruce Reidel that one contemplating the use of intra-articular medications must be confident with their morbidity. Until this association between intra-articular pain pumps and chondrolysis is better understood and characterized, we do not recommend the use of intra-articular pain pumps. Also, further research is necessary on the potential deleterious effects of single bupivacaine joint injections, as well as other local anesthetics placed intra-articularly.”

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A jury in Oregon state court delivered a verdict of $5.5 million against I-Flow Corporation for causing devastating, permanent injuries to Matthew Beale by promoting the use of I-Flow pain pumps in joints.

The pain pumps, like those used on Mr. Beale, were promoted by manufacturers including Breg, Stryker, McKinley and I-Flow to physicians for use after joint surgeries.  The theory was insertion of a delivery system that would place pain medicine at the area of surgery would allow for greater pain relief for shoulder, knee and other joint surgery patients.

As with drugs and other medical devices, the theory sounded very good, but, as the FDA told manufacturers, testing would be required in order to safely market the devices for placement in the joints.

Pain pump manufacturers ignored the FDA by conforming labels to FDA requirements and then sending their marketing force out to promote the off label use inside joints. So, sales forces were sent out by each manufacturer in a frenzied effort by each to gain market share. What the manufacturers did not do is any meaningful studies on the results of injecting pain medicine directly into patient joints.

Effectively what pain manufacturers decided is to allow the public to be the guinea pigs for testing and not to tell physicians the pumps had not been approved for in joint placement.

When manufacturers were caught and it was clear their untested devices were causing devastating injuries to young, active people, they were slow to pull the devices or to alert physicians. Instead, they spent their energies trying to find ways to bury discredit the findings. Finally, as the result of lawsuits, they were forced to alert physicians and to withdraw their devices from use inside joints.

Sadly, the pain pump manufacturers’ decision to discourage the unapproved use they had previously promoted was far too late for hundreds, perhaps thousands, of innocent victims.

Now, relatively young people in the age group of 20 to 55 will be forced to undergo multiple surgeries in attempts to correct the devastating damage done by the unapproved use of the pain pumps. Many patients will be forced to experience full joint replacements and, because of their young ages, possibly one, two or three additional joint replacements or revision surgeries during their life will be required.

It seems pretty clear to any informed person that chondrolysis, a relatively rare condition before pain pump use was promoted, has now resulted in significant increases in damaged cartilage. Chondrolysis is a condition in which the cartilage is essentially destroyed and the patient is left with no protection inside the joint. In plain terms, imagine pouring battery acid on the cartilage inside a patient’s joint and you have the damage caused by pain pumps inserted inside the joint. The results are severely damaged joints and hundreds of thousands of dollars in medical care.

According to World Health Organization (WHO) there are one billion overweight adults worldwide and 300 million are categorized as obese. The World Health Organization cited several contributing factors among which are:

“increased consumption of energy-dense foods high in saturated fats and sugars, and reduced physical activity, Economic growth, modernization, urbanization and globalization of food markets are just some of the forces thought to underlie the epidemic.“

The mounting scientific and statistical evidence related to obesity illustrates a number of associated health risks of epidemic proportions. The many complications of morbidity is a head on collision with our current health care crisis.

WHO lists among the adverse effects of obesity including:

• high blood pressure
• high cholesterol
• high triglyceride
• insulin resistance
• respiratory difficulties
• chronic musculoskeletal problems
• skin problems
• infertility
• type II diabetes

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Most parents want the best for their children. We meticulously search labels, check sugar and salt contents, pack balanced lunches, and try to fix healthy meals for our families. But before you pack that applesauce or tuna fish sandwich into your child’s lunch box, you might want to check the bottom of the plastic container or can it comes in to see if it contains BPA, or bisphenol A.

For years’ concerned mothers, environmental groups, and some scientists have been warning that BPA is unsafe, and can lead to cancers, diabetes, and other diseases. The FDA in 2008 claimed that BPA was safe, but offered tips to decreasing exposure, especially to young children and infants. Recently, the FDA has shifted its position and released that it is “encouraging families to limit their children’s exposure to a chemical found in thousands of household products.”

On Friday, the FDA declared that more research was needed and has suggested reasonable steps to limit the amount of BPA exposure. The FDA is now saying that BPA is “of some concern, especially on the brain behavior and prostate glands in fetuses, infants and young children.”

A noted researcher of BPA, Dr. Frederick vom Saal, at the University of Missouri, stated:

“The FDA formally acknowledging concern about BPA and working with NIH to incorporate research from outside of the chemical industry is a huge step forward,” said vom Saal, who is a Curator’s professor of biological sciences in MU’s College of Arts and Science. “The FDA position presented today [January 19} is consistent with the position that the National Toxicology Program made two years ago. Since then, considerable published research reaffirmed the health dangers of BPA. The FDA says they want to respond more quickly. Now, we will see if they are really able to respond to the huge amount of new science showing dangers not recognized two years ago. They should move quickly to restrict the use of by BPA in products used by adults as well as infants."

However, limiting your exposure to BPA isn’t easy and may be hard to avoid because currently, manufacturers aren’t required to label products containing the chemical. The biggest way to decrease your intake of BPA is by limiting your use of canned foods and foods in plastic containers. Baby bottle manufacturers make bottles that are BPA-free and some plastic containers have the number three or seven on the bottom, which means it does contain BPA. Some recycled pizza boxes also contain the chemical, but are not labeled.

The FDA has historically maintained that BPA is safe largely on the basis of two studies funded by the chemical industry. However, more than 100 independent studies linked BPA exposure to health effects in animals and humans. According to a Washington Post article in 2008, a large study on humans and BPA found that “people with higher levels of bisphenol A had higher rates of heart disease, diabetes and liver abnormalities,” a finding that immediately became the focus of the increasingly heated debate over the safety of the chemical. The government has been looking into whether chemical manufactures unduly influenced the FDA’s stance on BPA.

FDA investigations occurred during February to April of 2009 at a drug manufacturing plant.

A drug recall was instituted in July of 2009.

A voluntary nationwide recall of drugs is instituted on December 21, 2009.

In January of 2010, I am just hearing about it.

The drugs that were recalled were manufactured in a facility, which the FDA cited for violations, including:

1. Failed to monitor and implement quality systems; noted to be a “repeat deficiency”.
2. Drug products failed to meet standards, specifications and quality control criteria.
3. Liquid drugs found to contain foreign particles.
4. Tablets found with “unexplained spots”, but still released to market for sale.
5. Drugs released to the market with unapproved specifications.
6. Various flaws found in the internal investigation process and unqualified person(s) conducted the risk assessment investigation.
7. Effective corrective and preventative actions were not taken by the manufacturer.
8. Water used for manufacturing injection is also used for cleaning, vial washing, and is an ingredient in every product produced in the facility.
9. Violations in incident reporting and investigation were found.
10. In-process control procedures did not include examination of weight variations for tablets and capsules.
11. FDA investigators were required to use flashlights in the “visual exam rooms” due to poor lighting. These are the rooms supposedly used for review of products.
12. The FDA set forth that:
13. “Determinations of conformance to appropriate written specifications for acceptance are not made for drug products.”
14. “Specifically…there are lots of Epinephrine and lots of Xylazine 100 mg injection on the market which have not been tested for particulates. There are…other lots of intravenous products on the market that have never had particulate testing. The Vice President of Quality Management stated they have never conducted the particulate matter test for injectable products including Epinephrine and Xylazine.”

This is an investigation by the FDA, which culminated in a 20 page report of violations; a July 2009 consent decree; and a September 2009 recall.

The press release related to the consent decree set forth, among other things:

In the event of future violations, the consent decree also subjects Teva …Health to payments of $20,000 for each day the defendants fail to comply with any provision of the decree and an additional $25,000 for each shipment of…drugs in violation of the decree, up to $7.5 million per year.

Pretty scary, huh?

I told someone about this today and their response was, “well it is only involving animal drugs, so no big worries”.

I can read. I can research. I can speak up for my self. My animals can do none of these things. So, for all of you who are health advocates for your significant pets, the recalled drugs include:

Ketamine:

• Ketaset (Fort Dodge/Pfizer)
• KetaVed (VEDCO), KetaThesia (Butler)
• VetaKet (LLOYD Laboratories)
• Ketaject (Phoenix)
• Keta-Sthetic (RVX)
• AmTech Group, Inc.

Butorphanol:

• EQUANOL (VEDCO)
• ButorJect (Phoenix)
• TorphaJect (Butler)

And for those of you who are not pet advocates, here is something to worry about. The manufacturer of all these “animal drugs”, Teva Pharmaceutical, also manufactures many drugs for humans as well.

So, no worries?

The Food & Drug Administration has recently notified Eli Lilly & Co. and Bayer Healthcare that it has objections to ads used for some of their drugs.

For Eli Lilly, it was print advertisements for its depression drug, Cymbalta. Print ads used on WebMD Little Blue Book; a publication to assist patients in locating physicians and other medical services. The FDA set forth that “…the main body of the print ad entirely omits risk information, including the contraindications, warnings and precautions, and the most frequently reported adverse reactions from the [product labeling]” This required information was set forth in a box on an adjacent page, but the FDA felt that it was not “sufficient to provide appropriate qualification or pertinent information for the claims made in the body of the ad or to mitigate the overall misleading presentation,”. An Eli Lilly spokesman responded:

“Lilly remains confident in Cymbalta’s efficacy and safety in its approved indications…”

I am not sure that Eli Lilly really gets the point the FDA is trying to make and one might argue their TV ads are less about the drug and more about “spin”:

For Bayer Healthcare it is their advertising for the drug, Mirena. The FDA’s concerns expressed are very familiar and similar to those already expressed to Bayer and involving its birth control products, Yaz and Yasmin. In the case of Mirena, the FDA set forth that:

“These claims misleadingly overstate the proven efficacy of Mirena,” the letter said. “Mirena has been proven to be an effective intrauterine contraceptive device. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance or intimacy with their partners.”

It would seem that Bayer cannot seem to grasp that marketing prescription drugs to the consumer is about providing complete and adequate information so consumers can make informed decisions and ask their physicians relevant questions about drugs. What marketing prescription drugs directly to consumers is NOT about is “Broadway show” types of productions or the sort of misdirection one can expect from a “three card Monte” carnival huckster.

Drug manufacturers, such as Bayer and Eli Lilly, have been selling over the counter, prescription drugs for a long time. They certainly should fully understand the regulations governing advertising and they certainly appreciate the FDA’s need for good information to unsophisticated consumers. It is one thing to use “sleight of hand” advertising with a sophisticated audience such as physicians, but to be more interested in dramatic, glitzy, productions as opposed to accurate, solid information in the case of direct to consumer advertising, is simply wrong.

Do the manufacturers have trouble understanding the FDA regulations?

Of course not. They pay good money to people who are particularly skilled at understanding the advertising regulations. Perhaps the manufacturers are simply testing the extent to which they can push the limits of regulations in order to ramp up sales? Perhaps drug manufacturers have come to believe that regulations are made to be broken; at least long enough to give a product a solid and quick boost in public recognition before they are caught breaking the rules?