Despite the continuing high levels of serious injuries sustained by passengers and especially children under 16 involving all-terrain vehicles (ATVs), the U.S. Consumer Product Safety Commission (CPSC) voted to defer a 2002 petition from the Consumer Federation of America (CFA), American Academy of Pediatrics (AAP), and seven other organizations, seeking a ban of the sale of adult-sized ATVs for use by children.

Instead, the CPSC voted to issue an "Advanced Notice of Proposed Rulemaking" (ANPR) regarding the risks of injury and death posed by ATVs.

“The profound increase in injuries and deaths caused by ATVs show how pervasive this national epidemic has become. This tragic problem is in need of an aggressive and immediate solution by CPSC and state governments,” said Rachel Weintraub, Director of Product Safety for Consumer Federation of America.

“Pediatric emergency department physicians have learned to expect devastating injuries when a child crashes an ATV,” said Gary Smith, MD, DrPH, FAAP, Chair of the AAP Committee on Injury, Violence and Poison Prevention.
“In 2004, ATVs killed at least 130 children and injured over 44,000. This is the equivalent of two school buses full of children dying and the entire population of Palm Springs, California being severely injured. For almost 20 years, physicians and consumer advocates have been pressing the CPSC to pass meaningful regulations to reduce the carnage. It’s time for real action," Smith said.

The CPSC 2004 Annual Report on ATV-related Deaths and Injuries announced the following results.

• Serious injuries requiring emergency room treatment increased almost 8% from 125,500 in 2003 to 136,100 in 2004.

• The estimated number of ATV-related fatalities increased from 617 in 2002 to 740 in 2003 another record.

• In 2004, ATVs killed at least 130 children younger than 16 accounting for 28% of fatalities.

• Children under 16 suffered 44,700 serious injuries in 2004, or 33% of all injuries. This is an almost 16% increase from 2003 when children suffered 38,600 serious injuries. This increase in 2004 is statistically significant.

• Between 1985 and 2004, children under 16 accounted for 31% of all injuries.

The risk estimate for 2004 is 187.9 compared with 188.4 in 2003. According to CPSC, this slight reduction is not statistically significant.

CPSC Chairman Hal Stratton has directed Commission staff to issue a broad review as an Advanced Notice of Proposed Rulemaking (ANPR). This could ultimately lead CPSC to take regulatory or non-regulatory action to protect consumers from ATV deaths and injuries, but is just the first step in a multi stage rulemaking process with no definitive timeline for the full process. The public has 60 days to respond to this ANPR.

While the ANPR outlines many issues to evaluate, of particular importance is the development of a “transitional ATV” for children 14 and older. The CPSC, the ATV industry, and many consumer advocates recommend that children 12 through 15 not ride ATVs with engines larger than 90 cc’s. The American Academy of Pediatrics recommends that no child under age 16 ride an ATV of any size.

Despite the continuing high levels of serious injuries sustained by passengers and especially children under 16 involving all-terrain vehicles (ATVs), the U.S. Consumer Product Safety Commission (CPSC) voted to defer a 2002 petition from the Consumer Federation of America (CFA), American Academy of Pediatrics (AAP), and seven other organizations, seeking a ban of the sale of adult-sized ATVs for use by children.

Instead, the CPSC voted to issue an "Advanced Notice of Proposed Rulemaking" (ANPR) regarding the risks of injury and death posed by ATVs.

“The profound increase in injuries and deaths caused by ATVs show how pervasive this national epidemic has become. This tragic problem is in need of an aggressive and immediate solution by CPSC and state governments,” said Rachel Weintraub, Director of Product Safety for Consumer Federation of America.

“Pediatric emergency department physicians have learned to expect devastating injuries when a child crashes an ATV,” said Gary Smith, MD, DrPH, FAAP, Chair of the AAP Committee on Injury, Violence and Poison Prevention.
“In 2004, ATVs killed at least 130 children and injured over 44,000. This is the equivalent of two school buses full of children dying and the entire population of Palm Springs, California being severely injured. For almost 20 years, physicians and consumer advocates have been pressing the CPSC to pass meaningful regulations to reduce the carnage. It’s time for real action," Smith said.

The CPSC 2004 Annual Report on ATV-related Deaths and Injuries announced the following results.

• Serious injuries requiring emergency room treatment increased almost 8% from 125,500 in 2003 to 136,100 in 2004.

• The estimated number of ATV-related fatalities increased from 617 in 2002 to 740 in 2003 another record.

• In 2004, ATVs killed at least 130 children younger than 16 accounting for 28% of fatalities.

• Children under 16 suffered 44,700 serious injuries in 2004, or 33% of all injuries. This is an almost 16% increase from 2003 when children suffered 38,600 serious injuries. This increase in 2004 is statistically significant.

• Between 1985 and 2004, children under 16 accounted for 31% of all injuries.

The risk estimate for 2004 is 187.9 compared with 188.4 in 2003. According to CPSC, this slight reduction is not statistically significant.

CPSC Chairman Hal Stratton has directed Commission staff to issue a broad review as an Advanced Notice of Proposed Rulemaking (ANPR). This could ultimately lead CPSC to take regulatory or non-regulatory action to protect consumers from ATV deaths and injuries, but is just the first step in a multi stage rulemaking process with no definitive timeline for the full process. The public has 60 days to respond to this ANPR.

While the ANPR outlines many issues to evaluate, of particular importance is the development of a “transitional ATV” for children 14 and older. The CPSC, the ATV industry, and many consumer advocates recommend that children 12 through 15 not ride ATVs with engines larger than 90 cc’s. The American Academy of Pediatrics recommends that no child under age 16 ride an ATV of any size.

Long-Time Critics of the ‘Patch’ See Warning as Belated and Inadequate and Yet another Vioxx-Like Example of Pharmaceutical Industry Putting Profits above Safety.

After years of debate over the safety of the Ortho Evra birth control patch (“the Patch”), the drug’s manufacturer Ortho-McNeil (a subsidiary of Johnson & Johnson the world’s 4th largest drugmaker) has finally acknowledged the fact that women who use the product are at a significantly greater risk of blood clots, stroke, and death than woman who use other forms of oral contraceptives.

Ortho-McNeil now admits that women who use the patch can be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill instead.

Critics of both the ‘Patch’ and the FDA’s approval and monitoring practices, however, see the warning as simply another example of economics being placed above public safety.

There has been a constant chorus of warnings about the extremely serious side-effects associated with the Patch from a number of experts as well as the consumer watchdog group, Public Citizen (www.worstpills.org) and the Associated Press.

Several lawsuits have already been commenced around the U.S. alleging that serious injuries and deaths have been caused by the Patch.

Only last week, CBS News presented a significant story from Austin, Texas, concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch. She is now a total invalid.

According to that story, Ortho-McNeil’s own records show the company received some 500 reports of serious health problems associated with the patch between April 2002 and December 2004. During that time only 61 such reports were received with respect to all types of existing oral contraceptives.

In addition, there were four times as many strokes in women using the patch as in women using oral contraceptives even though three times as many women were taking those other forms of birth control.

Finally, the evidence indicates, that in medically confirmed cases, the risk of blood clots is 14 times as high with the patch.

An investigative report published by the Associated Press on July 18, 2005 linked the birth control patch, which contains a combination of norelgestromin and ethinyl estradiol, to an increased risk of blood clots and deaths (compared to older contraceptives) in some young healthy women.

Ortho Evra, like the other hormonal contraceptives, has a black box warning about an increased risk of cardiovascular adverse reactions in older women who smoke. This type of warning is the strongest that the FDA can request.

Today’s Associated Press follow-up story is even more damning, however. In that article, the AP stated:

“Documents released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA’s death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.

In addition, an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was ‘too high a chance that study may not produce a positive result for Evra’ and there was a ‘risk that Ortho Evra may be the same or worse than Ortho-Cyclen.’”

This type of calculated avoidance of negative information, or of the very clinical research that would disclose potentially dangerous side-effects, has been a typical method used by the industry to get unsafe drugs approved and kept on the market.

In the case of Vioxx, there were very similar efforts to mask the cardiovascular risks that drug presented.

• Nov. 21, 1996 – Memo by a Merck official shows the company wrestling with the issue of Vioxx’s (Rofecoxib) involvement in increased cardiovascular events. At this early date, Merck avoided a trial to prove Vioxx gentler on the stomach than older painkillers because in such a trial, “there is a substantial chance that significantly higher rates” of cardiovascular problems would be seen in the Vioxx group.

• February 25, 1997 – Internal Merck e-mail warns that if a proposed Merck trial was carried out “you will get more thrombotic events” - more blood clots “and kill [the] drug.”
• March 9, 2000 – Merck’s research chief, Edward Scolnick, e-mailed colleagues that the cardiovascular events “are clearly there” and stated “it is a shame but it is a low incidence and it is mechanism based as we worried it was.”
• Worried about the affect on Vioxx, Dr. Scolnick wrote that he wanted other data available before the results were presented publicly, so “it is clear to the world that this” was an effect of the entire Cox-2 class, not just Vioxx.
• In response, Alise Reicin, later a Merck vice president for clinical research, said in an e-mail that the company was in a “no-win situation.” She went on to propose that people with high risk of cardiovascular problems be kept out of the study so the difference in the rate of cardiovascular problems between the Vioxx patients and the others “would not be evident.”

The patch, like many oral contraceptives, contains two hormones, a progestin and an estrogen. The progestin in Ortho Evra is a new drug (2001) known as norelgestromin, and the estrogen is an existing one known as ethinyl estradiol.

Ortho Evra was approved by the Food and Drug Administration (FDA) in November 2001 and is the first contraceptive product to be approved as a skin patch. It was launched and marketed in a series of “glitzy” television ads featuring “sexy models.” (CBS 11/2/05).

In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million.

Contraceptives are often referred to as second- or third-generation based on their progestin component. Since some experts classify norelgestromin as a third-generation progestin, Ortho Evra is considered third-generation contraceptive.

Public citizen first listed some third-generation oral contraceptives as “DO NOT USE” drugs in 1998 and 1999 because of an increased risk of blood clots compared to the older, second-generation birth control pills. Thus, elevated blood levels of progestin as well as estrogen are possible with the Patch.

The Associated Press used the Freedom of Information Act (FOIA) to obtain adverse drug reaction reports for Ortho Evra from the FDA and reportedly found that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 from last year.

Since the FDA estimates that it receives reports of only between 1% and 10% of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher.

The Associated Press also analyzed the reviews of clinical trial results done by FDA physicians and scientists prior to the drug’s approval. Those results were submitted for review by Ortho-McNeil in support of Ortho-Evra and are available on the FDA’s Web site at: http://www.fda.gov/cder/foi/nda/2001/021-180_ORTHO.htm

Significantly, Ortho-McNeil and the FDA medical officer reviewing Ortho Evra strongly disagreed about whether two cases of blood clots in the lungs (pulmonary embolus) in young women participating in the pre-approval clinical trials were caused by the drug. The FDA medical officer wrote:

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the group” [emphasis in the original].

The FDA medical officer also included the following statement in his comments:

The professional product labeling and information written specifically for women using Ortho-Evra “should reflect the possible increased risk of venous thromboembolism (VTE) [blood clots] associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate).”

In addition, the medical officer expressed concern that 211 out of 3,088 women (6.8%) in the pre-approval clinical trials gained 10 or more pounds in the trials and noted that the contraceptive effectiveness of Ortho-Evra was reduced in women weighing or than 198 pounds (90 kilograms).

The professional product label warns that Ortho-Evra should not be used in the following circumstances:

A history of heart attack or stroke
Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
A history of blood clots in the deep veins of your legs
Chest pain (angina pectoris)
Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous
use of hormonal contraceptives such as ORTHO EVRA, NORPLANT [levonorgestrel], or the birth control pill
Liver tumor (benign or cancerous)
Known or suspected pregnancy
Severe high blood pressure
Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
Headaches with neurological symptoms
Use of oral contraceptives (birth control pills)
Disease of heart valves with complications
Need for a prolonged period of bed rest following major surgery

An allergic reaction to any of the components of Ortho Evra
Women who may be using Ortho Evra should contact their physician if any of the following warning signals develop:

Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
Pain in the calf (indicating a possible clot in the leg)
Crushing chest pain or tightness in the chest (indicating a possible heart attack)
Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
Sudden partial or complete loss of vision (indicating a possible clot in the eye)
Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or health care professional to show you how to examine your breasts)
Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)
Severe problems with sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
Jaundice or a yellowing of the skin or eyeballs accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems).

Since contraceptives are usually prescribed to young, healthy women they should be associated with the lowest possible risk of serious adverse drug reactions.

Blood clots in the lungs were seen in two women given Ortho Evra in clinical trials conducted before the drug was even approved (in addition to several similar cases after the drug was marketed).

There is also no evidence that the patch is a superior contraceptive compared to older second-generation birth control pills. As stated in the September 2005 issue of Worst Pills Best Pills (published by Public Citizen); “Rarely do randomized pre-approval studies, the scientific ‘gold standard’ for proving safety or efficacy, present such strong evidence of a serious problem.”

As a result of what it considers strong evidence of the increased risk of blood clots and death, Public Citizen states: “There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.”

If one reads Ortho-McNeil’s Press Release, the first thing that becomes obvious is that the company has made a concerted effort to present the information in a way that is difficult (if not impossible) for anyone but an expert to understand.

For example, the acronym AUC is used without definition thereby making the references to estrogen concentrations difficult to extrapolate.

AUC, however, is a measure of how much of a drug reaches the bloodstream in a set period of time, usually 24 hours. AUC is calculated by plotting drug blood concentration at various times during a 24-hour or longer period and then measuring the area under the curve between 0 and 24 hours.

When the implications of AUC are considered with respect to the amount of estrogen that can be released in a given period of time, the result is shocking since that amount can easily exceed 50 mg which is well beyond the level already determined to be unsafe.

A previous study conducted with respect to another contraceptive product (the “vaginal ring”) documented these excessively high levels of estrogen associated with the Patch over nine months ago in the journal Contraception.

In addition to the risks already discussed cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. As a result, women who use hormonal contraceptives, including ORTHO EVRA, should not smoke.

Finally, litigation involving Ortho Evra has been gaining momentum in recent months and especially in light of the Associated Press investigation. The litigation focuses on the claim that Ortho-McNeil knew of the blood clot risk and even disagreed with the FDA medical officer who suspected the two incidents that occurred during the clinical trial were related to the drug.

A lawsuit was filed in July 2005 against Ortho-McNeil on behalf of a 30-year-old woman who suffered fatal blood clots thought to be linked to the Ortho Evra risk. The woman was admitted into the intensive care unit shortly before her death suffering from severe headache, visual problems, vomiting, and nausea.

The other deaths reported in connection with Ortho Evra risk factors were the result of heart attacks and strokes. One of the most recent deaths linked to Ortho Evra was suffered by a 25 year old woman who suffered fatal headaches thought to be linked to a surge of hormone release from the birth control patch.

The youngest woman to die, as reported in a recent study, was an 18 year old college student who collapsed in the New York subway. Ten other women ranging in age from 18 to 27 have also sued Ortho-McNeil.

In September, Parker & Waichman, a major New York based plaintiffs’ personal injury law firm that is heavily involved in pharmaceutical litigation announced that it had filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc., on behalf of a 37-year-old woman who suffered a pulmonary embolism after using the Ortho Evra contraceptive patch for seven months. The suit was filed U.S. District Court for the District of New Jersey.

According to the complaint in that lawsuit, from April 2002 through September 2003, the U.S. Food and Drug Administration logged 9,116 reports of adverse events because of the patch, according to the suit.

This is significant since there were only 1,237 adverse reports by women taking the leading oral contraceptive, Ortho Tri-Cyclen, over a six-year period even though that drug was used by almost six times as many women as Ortho Evra in 2003.

Ortho-McNeil has routinely denied the allegations that these deaths and injuries were the result of Ortho Evra risk factors. It claimed that the “unsolicited reports” it received were not reliable evidence of a problem with the drug.

The company also claimed its own investigation had not found any causal factor linking these deaths to Ortho Evra and relied on the absence of any reports of fatal adverse side-effects during the clinical trials as proof of the drug’s safety.

Ortho-McNeil’s reluctance to accept even the possibility that the Patch could be at fault has lead to the drug being kept on the market without adequate warnings. Even today’s press release and FDA advisory regarding new labeling requirements do not satisfy the Patch’s many critics.

In the eyes of those critics, the fact that Ortho-McNeil has notified the FDA that it has undertaken a “much larger study” with respect to the potential problem of blood clots, strokes, and death associated with the Patch is merely prolonging the time in which millions of women are exposed to an unacceptable risk of catastrophic injuries and death.

According to a study published in CANCER (online 10/10/05 – in print 11/15/05), a peer-reviewed journal of the American Cancer Society, certain procedures that are used to test for cancer in body tissue specimens have a relatively high frequency of error which can result in harm for patients.

Researchers at the University of Pittsburgh School of Medicine looked at medical records, tissue samples, and pathologists’ findings from four different institutions to assess the frequency, cause, and effects of such errors in cancer diagnosis.

The study found that up to 9% of Pap test and cervical biopsies studied had an error and 12% of non-gynecologic specimen pairs studied had an erroneous diagnosis.

According to the researchers, most of the errors were caused by inadequate specimen collection. Errors caused by misinterpretation by pathologists ranged from 5% to as high as 50%.

After reviewing medical records, the research team found that non-gynecologic errors led to harming patients in 39% of cases. In gynecologic cases, errors resulted in harm in 45% of cases.

“Harm” could consist of delays in diagnosis or delays in additional testing which would cause healthcare costs to increase. Rarely, however, did unneeded procedures take place as a result of a false positive diagnosis.

Researchers found that pathologists disagreed on the severity of harm that was caused by errors in cancer diagnosis.

Eating a diet high in red and processed meats may increase the risk of pancreatic cancer by an alarming degree.

A new study in the Journal of the National Cancer Institute found that people who ate high amounts of processed meats, such as luncheon meat and sausage, had a 68% higher risk of pancreatic cancer than those who ate far less of these items.

People who had substantial amounts of pork and red meat in their diet had a 50% higher risk of developing pancreatic cancer than their counterparts who had less of these foods in their diet.

The authors found no increased risk of pancreatic cancer linked to the consumption of poultry, fish, dairy products, eggs, total fat, or saturated fat.  The also found no linkage to cholesterol levels.

Although pancreatic cancer is not one of the most common cancers (about 32,000 Americans were diagnosed with pancreatic cancer last year), it is one of the deadliest.  The five-year survival rate is less than five percent.

Known risk factors for pancreatic cancer are smoking, family history of pancreatic cancer, and diabetes.  It is more commonly found in males of advanced age and in Native Americans and African-Americans.  

The study followed 190,545 individuals, 45% of whom were men.  Twenty-five percent of the study group was Caucasian.  All subjects completed a detailed dietary survey prior to the start of the study, and they were followed for a period of seven years.

Over the seven-year period, 482 individuals developed pancreatic cancer.  The mean age of those who got cancer was 65 years, and 21.6% of them were smokers.  

Since fat intake was not found to be linked to an increase in pancreatic cancer, the authors speculate that meat preparation techniques may be responsible for the increased risk.

A new study finds that less than a third of patients at high risk for gastrointestinal bleeding while taking NSAID painkillers are being prescribed medicines to prevent that bleeding.

NSAIDs include over-the-counter and prescription versions of aspirin, ibuprofen and naproxen (Aleve), as well as Vioxx and Bextra, which have been recalled, and Celebrex, which is still sold in the U.S.

According to ABC News, doctors have long recognized that long-term use of NSAIDs can raise risks for gastrointestinal bleeding, and guidelines exist to spot patients at high risk.  However, many doctors are not giving patients the medicines that can protect them against bleeding, according to study author Dr. Neena S. Abraham, a gastroenterologist at Baylor College of Medicine

NSAIDs are the most commonly prescribed drug in the United States, says Abraham, and upper gastrointestinal bleeding occurs in about 4.5 percent of patients who take NSAIDs over the long term.  Those most at risk for bleeding include people over 65, patients who take steroids or anti-coagulants with NSAIDs, and those who take painkillers in an amount exceeding the manufacturer’s recommended dosage.

In their study, Abraham and her colleagues looked at more than 300,000 patients treated throughout the county in 2002.  All were prescribed NSAIDs for pain relief, and would also be considered at high risk for upper gastrointestinal bleeding.  

Among patients with one or more risk factors, only about 27% were given therapy to counter the risk of bleeding, the researchers found.  Among patients with two or more risk factors, the number rose to 40% and therapeutic assistance reached a high of 42% for those with three or more risk factors for bleeding.

The results of the study appear in Gastroenterology 2005.

In a comparison of fluids fed to infants and toddlers, researchers have found that cola, sucrose and honey were the worst for young teeth, and that human milk caused significantly more cavities than cow milk.

The University of Rochester Medical Center research is published in the October edition of Pediatrics.  It warns parents to stop babies from drinking sugary liquids from bottles and cautions them against sweetening water with honey, a practice which has been promoted as good for dental health.  It also discourages parents from letting babies fall asleep on the nipple.

The study’s authors do not advocate switching from breastfeeding to cow milk, but they do advise nursing mothers to provide oral hygiene after feedings, especially when the infant’s first teeth have begun to emerge.

“In families where cavities are prevalent, there’s also an urgent need to avoid feeding all night once the teeth have erupted,” said Ruth A. Lawrence, M.D., professor of Pediatrics at the University of Rochester Medical Center’s Golisano Children’s Hospital.

Lawrence co-authored the cavities study with William H. Bowen, D.D.S., Ph.D., the University of Rochester Welcher Professor of Dentistry, and one of the world’s leading authorities on tooth decay.  

The study was conducted on rats using an approach that mimics the situation among infants and toddlers who are allowed to indulge in protracted feeding.  The authors report that artificial and human nipples may restrict the flow of saliva, which promotes cavities.

The researchers fed the rats a variety of beverages and found that cola produced the most cavities, and cow milk the least.  Human milk was at the lower end, next to cow milk, and the researchers stated that human milk is no worse for teeth than many infant formulas.

Scientists theorized that the cavity-causing difference between human milk and cow milk might be the mineral content in human milk.

GM, Chrysler, KIA and Hyundai recalling 450,000 vehicles for a range of defects reported by the National Highway Traffic Safety Administration (NHTSA).

General Motors (GM)

GM is recalling the Chevrolet Corvette (2005 and 2006), TrailBlazer (2006), Tahoe (2006), Express (2006) and Silverado (2005 and 2006), Buick Rainer (2006), Cadillac Escalade (2006), GMC Envoy (2006), Savana (2006), Sierra (2005 and 2006) and Yukon (2006), Hummer H2 (2006 and Isuzu Ascender (2006).

Total 123,592 vehicles: Certain vehicles may have a power steering hose that is not to specification. Under extreme maneuvers, the hose may fracture and leak fluid. This would result in the loss of power steering and, in some vehicles, the loss of power braking also. In addition, the leakage could cause a fire in the engine compartment.  

Recall will begin on October 14 to inspect and replace the hose in question. Customers may call the following numbers for information: CHEVROLET AT 1-800-630-2438, GMC AT 1-866-996-9463, BUICK AT 1-866-608-8080, CADILLAC AT 1-866-982-2339, ISUZU AT 1-800-255-6727, OR HUMMER AT 1-800-732-5493.

GM RECALL NO. 05086. CUSTOMERS CAN ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION’S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153).

Chrysler

These vehicles have a problem that may cause them to roll away while the transmission is in park. Chrysler is recalling nearly 256,409 Dodge Dakota pickups; Dodge Durango, Jeep Liberty and Jeep Wrangler SUVs; and Chrysler 300 and Dodge Magnum cars from the 2005 model year.

DEALERS WILL INSPECT THE TRANSMISSIONS AND INSTALL A BRACKET TO ENSURE THE PARK PAWL ANCHOR SHAFT IS RETAINED IN THE PROPER POSITION. THE RECALL IS EXPECTED TO BEGIN DURING NOVEMBER 2005. OWNERS SHOULD CONTACT DAIMLERCHRYSLER AT 1-800-853-1403.

DAIMLERCHRYSLER RECALL NO. E14. CUSTOMERS CAN CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION’S VEHICLE SAFETY HOTLINE AT 1-888-327-4236; (TTY:1-800-424-9153).

Kia

Kia Motors Corp. is recalling 74,276 Sedona minivans from 2002 to 2004 model years equipped with power seats because the wiring under the front seats could potentially cause a fire.

DEALERS WILL INSPECT AND RE-ROUTE THE WIRES UNDER THE POWER SEATS, IF NECESSARY, AS WELL AS INSTALL PROTECTIVE SEAMING WELTS AROUND THOSE WIRES TO BETTER INSULATE THEM. THE RECALL IS EXPECTED TO BEGIN DURING NOVEMBER 2005. OWNERS SHOULD CONTACT KIA AT 1-800-333-4542.

KIA RECALL NO. SC054. CUSTOMERS CAN CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION’S VEHICLE SAFETY HOTLINE AT 1-888-327-4236; (TTY: 1-800-424-9153).

Hyundai

Hyundai Motor Co. is recalling 12,000 Santa Fe SUVs from the 2005 model year because of problems with the occupant classification system. The occupant classification system in the front passenger seat of the vehicle could mistakenly identify a child seat as an adult passenger.

DEALERS WILL REPROGRAM THE VEHICLE’S OCS ELECTRONIC CONTROL UNIT (ECU) TO REMOVE THE FEATURE THAT MAY CAUSE THE CRS TO BE RECOGNIZED AS AN ADULT. THE RECALL IS EXPECTED TO BEGIN DURING DECEMBER 2005. OWNERS SHOULD CONTACT HYUNDAI AT 1-800-633-5151.

HYUNDAI RECALL NO. 074. CUSTOMERS CAN ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION’S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153.

GM, Chrysler, KIA and Hyundai recalling 450,000 vehicles for a range of defects reported by the National Highway Traffic Safety Administration (NHTSA).

General Motors (GM)

GM is recalling the Chevrolet Corvette (2005 and 2006), TrailBlazer (2006), Tahoe (2006), Express (2006) and Silverado (2005 and 2006), Buick Rainer (2006), Cadillac Escalade (2006), GMC Envoy (2006), Savana (2006), Sierra (2005 and 2006) and Yukon (2006), Hummer H2 (2006 and Isuzu Ascender (2006).

Total 123,592 vehicles: Certain vehicles may have a power steering hose that is not to specification. Under extreme maneuvers, the hose may fracture and leak fluid. This would result in the loss of power steering and, in some vehicles, the loss of power braking also. In addition, the leakage could cause a fire in the engine compartment.  

Recall will begin on October 14 to inspect and replace the hose in question. Customers may call the following numbers for information: CHEVROLET AT 1-800-630-2438, GMC AT 1-866-996-9463, BUICK AT 1-866-608-8080, CADILLAC AT 1-866-982-2339, ISUZU AT 1-800-255-6727, OR HUMMER AT 1-800-732-5493.

GM RECALL NO. 05086. CUSTOMERS CAN ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION’S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153).

Chrysler

These vehicles have a problem that may cause them to roll away while the transmission is in park. Chrysler is recalling nearly 256,409 Dodge Dakota pickups; Dodge Durango, Jeep Liberty and Jeep Wrangler SUVs; and Chrysler 300 and Dodge Magnum cars from the 2005 model year.

DEALERS WILL INSPECT THE TRANSMISSIONS AND INSTALL A BRACKET TO ENSURE THE PARK PAWL ANCHOR SHAFT IS RETAINED IN THE PROPER POSITION. THE RECALL IS EXPECTED TO BEGIN DURING NOVEMBER 2005. OWNERS SHOULD CONTACT DAIMLERCHRYSLER AT 1-800-853-1403.

DAIMLERCHRYSLER RECALL NO. E14. CUSTOMERS CAN CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION’S VEHICLE SAFETY HOTLINE AT 1-888-327-4236; (TTY:1-800-424-9153).

Kia

Kia Motors Corp. is recalling 74,276 Sedona minivans from 2002 to 2004 model years equipped with power seats because the wiring under the front seats could potentially cause a fire.

DEALERS WILL INSPECT AND RE-ROUTE THE WIRES UNDER THE POWER SEATS, IF NECESSARY, AS WELL AS INSTALL PROTECTIVE SEAMING WELTS AROUND THOSE WIRES TO BETTER INSULATE THEM. THE RECALL IS EXPECTED TO BEGIN DURING NOVEMBER 2005. OWNERS SHOULD CONTACT KIA AT 1-800-333-4542.

KIA RECALL NO. SC054. CUSTOMERS CAN CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION’S VEHICLE SAFETY HOTLINE AT 1-888-327-4236; (TTY: 1-800-424-9153).

Hyundai

Hyundai Motor Co. is recalling 12,000 Santa Fe SUVs from the 2005 model year because of problems with the occupant classification system. The occupant classification system in the front passenger seat of the vehicle could mistakenly identify a child seat as an adult passenger.

DEALERS WILL REPROGRAM THE VEHICLE’S OCS ELECTRONIC CONTROL UNIT (ECU) TO REMOVE THE FEATURE THAT MAY CAUSE THE CRS TO BE RECOGNIZED AS AN ADULT. THE RECALL IS EXPECTED TO BEGIN DURING DECEMBER 2005. OWNERS SHOULD CONTACT HYUNDAI AT 1-800-633-5151.

HYUNDAI RECALL NO. 074. CUSTOMERS CAN ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION’S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153.

Instead of a dignified legal proceeding, the latest Vioxx trial has became a street fight between Merck’s attorneys and Judge Carol Higbee on Friday.

The defense team’s frustration with the court’s rulings has been building since the week before the trial. At that time, Judge Higbee denied Merck’s motion to adjourn the trial on the ground that publicity from the $253 million Texas verdict against the company would have a prejudicial effect on the jury in New Jersey.

Merck had also tried to change tactics by advancing a defense built around the idea that Merck obviously believed Vioxx was safe since many of its top scientists took it. So did the marketing chief, his mother, and even the CEO’s wife.

Judge Higbee, however, would have none of that and ruled such testimony inadmissible because employees’ personal use of Vioxx actually proves nothing about the drug’s safety.  

Once the trial started, however, the relationship between Judge Higbee and Merck’s attorney Dianne Sullivan rapidly degenerated. Early in the trial, Judge Higbee reprimanded Ms. Sullivan and even threatened to declare a mistrial for violating an order barring disparaging remarks about plaintiff’s lawyers in front of the jury.

Once that battle had ended, Sullivan went on the attack making six different motions of her own for a mistrial claiming the court improperly allowed or failed to bar certain evidence. Judge Higbee denied each of those motions.

When the plaintiff’s attorney, Christopher Seeger, rested his case, Merck moved for a directed verdict arguing that the plaintiff had failed to make out a case against the company thereby entitling it to a dismissal of the claim in its entirety. That motion was likewise denied.

None of these skirmishes prepared anyone for the explosion that occurred yesterday, however, when Judge Higbee struck all of the testimony of Merck’s first, and key, witness.

In a shocking turn of events, the judge struck the testimony of Briggs Morrison, a vice president for Merck Research Labs, because it went "way beyond" his role as a purely “fact” witness as promised by Merck’s defense lawyers.

Judge Higbee ruled that Merck had misled the court in two ways. She said Morrison had testified on matters outside his areas of expertise and the defense team had failed to give sufficient notice about the contents of his testimony. She then barred Dr. Morrison from taking the stand again.

The court admonished Sullivan; “It’s not a free-for-all. “You don’t get to just throw in anything you want into the pot. You have to inform the court and notify your adversary.'’

In unusually harsh language the judge stated: “Quite frankly, I felt sick yesterday afternoon and last night when I realized how I had gotten sucked into this. I feel that I was misled repeatedly yesterday during that testimony.

It doesn’t even make me angry. It makes me sad.” The judge ordered that all of Morrison’s testimony be ignored by the jury and cautioned defense counsel that if Merck wants to use him as a witness at all after this point it would only be by relying on his pre-trial videotaped deposition.

Higbee did not mince words as she sternly admonished Merck’s attorneys for what the judge clearly regarded as misleading behavior on their part. Higbee said Morrison’s testimony about animal testing and its implications regarding the safety of Vioxx was impermissible as he was never claimed to be testifying as an expert on that topic.

Merck had opened its defense with the likable Dr. Morrison in an attempt to give Merck a less corporate image. He was there to attack the central theory of plaintiff’s case, namely that Merck had information from a 1997 study that raised questions about the role Vioxx might play in blood clotting, which can lead to heart attacks and strokes.

Dr. Morrison testified that Merck did several animal studies to test the hypothesis. However, he conceded that he only first reviewed one set of studies in preparation for the trial itself, and that he reviewed the other set after Vioxx was put on the market.

Since Morrison had been called as a “fact” witness these revelations were troubling to the court since he was now offering opinions or expertise on matters with which he did not have direct experience.

Plaintiff’s attorney had objected throughout Morrison’s testimony, questioning the doctor’s qualifications to offer certain opinions and asking that some of his testimony be stricken from the record. Judge Higbee, however, went even further, ruling that all of Morrison’s testimony be disregarded. "Not only did he not do [the studies], he had never seen them until 2005," the judge said. The testimony "strikes at the very heart of the plaintiff’s case; it’s critical."

Higbee observed that Morrison never saw the animal studies when they were conducted yet he had given the jurors the impression that he had seen the studies years ago. “If this is the key study that proves that Vioxx is safe, wouldn’t you think that the Vioxx project team would know about it?'’ Higbee told Merck’s attorneys. “I was told that he was involved.”

Once the damaging ruling had been made, Merck’s attorney, Ms. Sullivan, should have taken an exception and moved on since there was little else to do at that point. The law provides for appellate review of these trial rulings, it does not provide for hand-to-hand combat to settle the disagreement between counsel and the trial judge.

As Judge Higbee attempted to leave the bench, Sullivan, clearly upset and agitated, flailed her arms and loudly challenged the court’s ruling as well as its conduct of the trial. “What’s going on here is not fair,” Sullivan yelled. Higbee directed Sullivan seven times to “sit down” and further warned, in a raised voice; “Ms. Sullivan, sit down or I will have you taken out of the courtroom. Once I rule it’s over, then you can make your record to the Appellate Division.”

Outside the courtroom another of Merck’s attorneys said the company was considering whether to seek a mistrial or file an emergency appeal. "We think keeping this testimony out really strikes at the fundamental fairness of the proceedings."

Following lunch, Sullivan did move for a mistrial, which Higbee denied. The judge also denied Sullivan’s request to delay the ruling while the company filed an emergency appeal.

While the court acknowledged the ruling would hurt Merck’s defense, Higbee stated: “There’s more prejudice to Mr. Humeston. I really don’t think I have any other option at this point other than to strike the testimony.'’

The court then instructed the jury to disregard Morrison’s testimony. “You should not use his testimony in your deliberations any or your thought processes. You should not consider why.”

All litigation lawyers are well aware of the fact that extensive pre-trial discovery takes place in every case in order for there to be no surprises or ambushes and so that both sides are equally prepared to represent their clients as completely as possible at trial.

When discovery is improperly withheld or one side attempts to gain an advantage by changing the position it advanced during discovery, bad things can happen. Courts frown on such tactics and do not appreciate being misled.

After the ruling Merck’s general counsel, Kenneth Frazier, released a statement that said the ruling “goes to the heart of the company’s defense of this case and effectively denies Merck its fundamental right to a fair trial. We will continue to defend these cases and consider this further proof that the plaintiffs know the science does not support their claims.'’

Although the trial will now continue, the calm has been broken and it is unlikely to return. An uneasy truce, at best, will prevail between Judge Higbee and Ms. Sullivan until the verdict is rendered. The court may also be considering sanctions against Sullivan for her conduct.

There is also no guarantee that the type of fireworks that occurred yesterday will not flare up again if Merck is stung by additional unfavorable rulings in this “do or die” trial.