On August 10, 2001 a sightseeing helicopter crashed into a cliff in the Grand Canyon killing the pilot and David Daskal and three of his traveling companions.

The only survivor of the crash was Daskal’s wife, Chana, a 29-year-old mother of two.

In a lawsuit against the tour company, the pilot, and the helicopter manufacturer, Mrs. Daskal alleged all of the defendants were responsible in some way for the tragic crash that left her near death.  She is still recovering from her injuries that included a broken back, burns over 80% of her body, and the amputation of both of her legs.
Her attorney, Gary Robb of Kansas City, Missouri, stated that:   "Chana is delighted to have this part of her life over with. She’s pleased she doesn’t have to travel to Las Vegas for trial. The important thing is now she can address her needs."     

The $38 million settlement, approved by Judge Nancy Saitta last week in Clark County District Court, is to be paid in a lump sum within 30 days and is ranked by a jury verdict tracking system as the largest pretrial cash settlement in a personal-injury case in U.S. history. The settlement details are sealed and cannot be disclosed.
The settlement resolves all claims against the defendants that included Papillon Grand Canyon Helicopters in Las Vegas; American Eurocopter Corp. and Turbomeca Engine Corp., of Grand Prairie, Texas; Washington-based helicopter retailer Zuni LLC; and the estate of the pilot.

A study published in the current issue of Archives of Internal Medicine reports that treatment with atypical, but not conventional, antipsychotics raises the risk of venous thromboembolism (VTE) in elderly patients.

Dr. Rosa Liperoti, from Universita Catolica del Sacro Cuore in Rome, and colleagues assessed VTE hospitalization among 19,940 nursing home residents taking antipsychotic agents and 112,078 residents not using these drugs.
The overall VTE hospitalization rate was found to be 0.91 per 100 person-years. That figure was comprised of about 78% venous thrombosis events and around 22% pulmonary embolism events. Relative to nonuse, atypical antipsychotic use was linked to an elevated risk of VTE, ranging from 87% for olanzapine, 98% for risperidone, to 168% for clozapine and quetiapine fumarate.

By contrast, treatment with phenothiazines or other conventional agents did not seem to increase the risk of VTE.
According to the study authors: "It seems advisable to be cautious when prescribing antipsychotic agents to elderly patients. However, the therapeutic choice should be individualized based on a careful evaluation of the benefits and risks of both classes of antipsychotic agents and patients’ risk profiles."

The era of the COX-2 inhibitors appears to be coming to an end. Vioxx was removed from the market worldwide by Merck in September 2004. Pfizer has announced Celebrex is about to undergo new safety testing while the company’s other COX-2 inhibitor, Bextra, was removed from the market in April 2005.

The suspension of Bextra sales was due to safety concerns related to rare but serious skin reactions and cardiovascular problems. At that time, Health Canada issued a stop-sale order which ensured that Bextra (valdecoxib) would not be permitted to return to the Canadian market without further consultation with Health Canada.

The Canadian agency, which is the equivalent of the U.S. FDA, studied all of the available data on COX-2 inhibitors in general and concerning Bextra, specifically. Based on that review Health Canada has determined that “there is an increased risk of heart attack and stroke when these drugs are used for long-term treatment. Studies also showed that these side-effects can occur when Bextra is used for short-term pain relief following high-risk heart surgery. Bextra is also associated with a risk of rare but severe and potentially fatal skin reactions.”

The official announcement on the agency’s Web site (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_134_e.html) states:  “The decision to stop the sale of Bextra is based on information submitted by the manufacturer, Pfizer Canada Inc., and consultations with external experts and the public. Health Canada concluded that there is insufficient evidence to establish the safety of the drug for its recommended use.”

“As a result of this regulatory action, the manufacturer will not be able to bring Bextra back onto the Canadian market under its present conditions of use. Health Canada has sent a letter to inform Pfizer Canada Inc. of the status of Bextra.”

The advisory concludes by stating that: “Health Canada has completed the review and agrees with the panel that available evidence indicates that COX-2 selective inhibitors and all other non-steroidal anti-inflammatory drugs are associated with an increased risk of cardiovascular events when high doses are used for long periods. However, the exact nature of that increased risk may differ from one product to another. The panel also found that the overall risk versus benefit profile for Bextra does not support the marketing of this drug in Canada under its current conditions of use.”

The CPSC and Advantage Publishers Group, of San Diego, California, are recalling some 41,000 Children’s Books because if the clear plastic container is removed from the book’s back cover or breaks, young children can access the beads in it. This poses a choking hazard to young children.

Consumers should stop using the recalled children’s books immediately and take them away from children who might still be.
The books were manufactured in Thailand and sold at national book chains, discount department stores, wholesalers and distributors, and membership warehouse clubs nationwide from May 2003 through November 2005 for about $16 for the activity books and about $6 for the board book.

To date, Advantage Publishers Group has received one report of a child accessing beads in the books’ clear plastic containers. No injuries have been reported.

The recalled children’s activity books are multi-colored with holes in the pages to touch a variety of fabrics and to push a squeaker toy, flaps to lift, and a clear plastic container with beads. The “Amazing Baby Look and Play” activity book has a yellow star on the cover. The “Amazing Baby Touch and Play” book has a brown bear on the cover.

The activity books measure about 11-inches by 11-inches, and are for children ages 12 months to 24 months. The recalled “Rattle, Rattle” board book has a magenta car on the cover. The board book measures about 5 1/2–inches by 5 ½-inches, and is intended for children ages 6 months to 18 months.

Consumers should immediately take these recalled activity and board books away from young children and contact the company for a replacement book.

For additional information, contact Advantage Publishers Group toll-free at (866) 748-3731 anytime or visit the company’s Web site at www.advpubgrp.com.

In the largest settlement involving a civil administrative penalty under any federal environmental statute in agency history, the Environmental Protection Agency (EPA) has announced that DuPont will pay $10.25 million in fines and $6.25 to fund environmental projects to settle allegations that the company withheld information about the dangers of the toxic chemical, PFOA.

The settlement stems from the EPA’s action against DuPont, for allegedly withholding information about the potential health and environmental risks posed by perfluorooctanoic acid, or PFOA (C8), under provisions of both the Toxic Substances Control Act and the Resource Conservation and Recovery Act.

The EPA charged that the company knowingly withheld information for more than 20 years about the health effects of PFOA and about the pollution of ground water supplies around DuPont’s Washington Works plant near Parkersburg, West Virginia.

As we have previously reported, for  the past two years, there has been a growing concern over the safety of the manmade chemical known as C8 or PFOA which can be found in everything from bread to birds, green beans to ground beef, dolphins to drinking water, and in the blood of up to 96% of the population of the United States.

The acid is used to manufacture Teflon coating for cookware and hundreds of other products like telephone cables, carpets, clothing, computer chips, chemical piping, and automobile fuel systems. Teflon currently nets DuPont a reported $200 million in profit a year.

Because there are no known “natural” sources of C8, scientists are curious as to how the chemical enters the environment. C8 has also contaminated the groundwater in areas where Teflon is manufactured.   

DuPont, which also pioneered the development of PFOA and continues to dominate its use, claims that the chemical is harmless to humans. It also disputes that C8 is released during normal cooking (as opposed to overheating).

Others are not so sure that either assertion is true. Studies have concluded that C8 is one of several toxic gases released by Teflon when it is heated to temperatures which, at their low end, are only slightly above normal cooking temperatures.

C8 has been shown to cause tumors in rats and fumes from Teflon coated cookware can cause what is known as “polymer fume fever,” a condition which has been shown to kill birds even at low temperatures but which DuPont claims is harmless to humans if the cookware is used at a temperature of up to 500F. When Teflon is overheated (above 700F), fatal cases of polymer fume fever in humans have occurred (at 842F).

Last August, DuPont agreed to pay up to $343 million in settlement of a class action arising out of the contamination of drinking water in Ohio and West Virginia linked to its plant near Parkersburg, West Virginia.

Of that amount, most of the $107 million to be paid for damages to the water supply of some 50,000 people living near the plant will be used to fund a detailed scientific review and a landmark community health study with respect to the dangers posed by C8 in the six Ohio and West Virginia water districts covered by the settlement.  

Up to another $235 million is to be set aside for future medical monitoring if the studies find C8 can make people sick.

So far, some 43,000 individuals have signed up for the health study with more than 17,000 having been tested since August. There is a waiting list of about 26,000 people. Eventually, up to 60,000 people are expected to take part in the study. Each person who completes the screening will be paid $400.

Beginning in 2006, a court-appointed panel of three epidemiologists will begin reviewing the results of the screening project.

Although DuPont continues to claim that there is no confirmed danger posed by C8, the company announced that it plans to dramatically decrease the use of PFOA in Teflon coatings by the end of 2006.

Earlier this year, however, the EPA stated that tests on laboratory animals linked PFOA to liver, pancreatic, and testicular cancer, reduced birth weight, birth defects, and immune suppression.

The agency also found that elevated cholesterol and triglycerides were a risk of exposure to C8. As a result, the EPA stated that low-level exposure to PFOA could pose a “potential risk of developmental and other adverse effects” in humans.   

The EPA has released a draft assessment of the chemical used in the production of Teflon which, based on animal studies, found “suggestive evidence” that the substance may be a human carcinogen.

In May, the Justice Department issued grand jury subpoenas seeking documents from DuPont with respect to PFOA and related chemical compounds. The suspicion was that DuPont withheld critical information concerning possible health risks posed by PFOA.

A 1961 internal document indicated that DuPont scientists had already warned company executives to avoid human contact with PFOA. DuPont faced more than $300 million in fines if it was found guilty of withholding such information.

In August of this year, a draft report released by an independent EPA scientific advisory board which reviewed the earlier EPA assessment and which will now be submitted to the EPA, concluded that PFOA (C8) is “likely” to be a human carcinogen and, as a result, the EPA should conduct cancer risk assessments for a variety of tumors found in rats and mice exposed to it.

Another startling revelation was reported in the Charleston Gazette on July 10. According to an April 2004 sworn statement by Dr. Bruce Karrh, DuPont’s former medical director, the company found similar birth defects in two of eight children born to women who worked at the Parkersburg chemical plant 25 years ago.

The Charleston Gazette also reported that: “A DuPont researcher said the number was ‘significantly greater’ than the expected rate of birth defects in the general population. In April 1981, the researcher proposed that DuPont do a detailed study to determine if exposure to the toxic chemical C8 was to blame. Three months later, DuPont officials dropped the study, a former top corporate doctor has testified.

Dupont officials also decided not to report its preliminary findings to federal regulators, according to the testimony, obtained under the Freedom of Information Act…‘To my knowledge, it was never reported to EPA, and, to my knowledge, I didn’t ask anybody whether it was reported,’ Karrh said of the birth defects data.”   

The study will look for a number of potential links involving C8; however, cancer and heart disease are of the greatest concern. Those results may take up to four years to report. Each sample taken from the test subjects is tested for the presence of C8 and for organ function.

While the EPA declared that the settlement "sends a strong message that companies are responsible for promptly giving EPA risk information associated with their chemicals;" DuPont has not admitted liability and continues to take the position that “there (are) no human health effects that we know about that are caused by PFOA. We’ve seen nothing."

Thus, with strong evidence against it and a downside risk of over $300 million in civil penalties for failing to report the substantial risks posed by PFOA, DuPont made the prudent business decision of settling the entire EPA case for a total of $16.5 million.

DuPont’s general counsel summed up the company’s position on the settlement by stating:  "Frankly, we could have litigated this thing for several years. We wanted to get this thing behind us so we could move forward."

A federal criminal investigation of DuPont’s actions with respect to PFOA is ongoing.

The Consumer Product Safety Commission (CPSC) and Maxim Enterprise Inc. of Lakeville, Massachusetts, have announced the recall of some 12,000 Little Tree Mini Learning Cubes because small wooden pegs in the top corners of the toy can come loose thereby posing a choking hazard to young children.

Consumers should stop using the recalled products immediately.

The toys were manufactured in China and sold at Target stores nationwide from June 2005 through November 2005 for about $15.

Target has received three reports of incidents including two reports of children mouthing pieces of the learning cube. In one incident, an 18-month old girl swallowed a piece of the recalled learning cube after one side came loose. The piece became stuck and she had to have it removed in a hospital emergency room.

In a second incident, a child started choking when she put two of the toy’s wooden pegs in her mouth. In the third incident, a consumer reported the wooden pegs popped out of the learning cube. No injuries were reported in that incident.

The recalled learning cube is an 8-inch square wooden box with a different activity on each side, including an abacus, blocks with apples and bananas, shapes that can be moved in a zigzag cutout, and a blackboard. The wooden cover has spiral bead maze with wooden beads that slide up, down and around.

Consumers should immediately take the recalled cube away from young children and return it to Target for a $15 gift card plus applicable state tax.

For more information, consumers should contact Target at (800) 440-0680 between 8 a.m. and 7 p.m. CT Monday through Friday, or visit Target’s Web site at www.target.com.

The Consumer Product Safety Commission (CPSC)  and Celebrate Express Inc., of Kirkland Washington, have announced the recall of about 21,100 Mystery Drawer and Dice Tunnel Magic Party Favors and 25,500 Costume Shields because the magic party favors and the dragon ornament on the shield could break or crack, exposing sharp points that could cut or lacerate children. Consumers should stop using the recalled product immediately.

The products were manufactured in China and sold through the Celebrate Express’ Birthday Express and Costume Express online and catalog.

The recalled Mystery Drawer and the Dice Tunnel Magic Party Favors were sold as part of the Magic Favor Box from January 2005 through August 2005.

The Magic Favor Box sold for about $3. The recalled Costume Shields were sold from April 2004 through September 2005 as part of various costume sets. The costume sets sold for about $5 to $36.
No injuries or incidents have been reported to date.

The recalled Mystery Drawer is a black plastic rectangular box with a movable drawer. The Dice Tunnel is a blue or red plastic rectangular box with one die. They were sold along with other party favors in an assortment known as the Magic Favor Box (Item #E4696).

The plastic shield is silver and gold and is about 11-inches long. The shield was sold as part of the following costume sets: Sword and Shield Set (Item #7014), Sword and Shield Set – 8 (Item #8006), and the Cape, Helmet, Sword, and Shield Set (Item #E8520). The item number is located on customer invoices.

Consumers should take the recalled magic party favors and costume shield away from children immediately and contact the company for a refund. Celebrate Express has directly contacted all purchasers of the products by mail.
For more information, consumers should call Celebrate Express at (888) 551-3995 between 4:30 a.m. and 10 p.m. PT Monday through Friday, or visit the firm’s Web site at www.celebrateexpress.com.

The consequences of the mistrial in the first federal Vioxx trial may turn out to be extremely serious for Merck in terms of the embattled company’s ability to mount a credible defense in future trials.

As the trial in Houston began, Merck was regarded as the heavy favorite to win the case for a number of reasons. Among the most obvious were: (1) the trial was in the traditionally less plaintiff-friendly venue of federal court; (2) the case involved short-term Vioxx use, which is generally regarded as more defensible than long-term use cases; and (3) Merck had just won a (short-term-use) case in New Jersey state court and so “momentum” was on the drugmaker’s side.

Those clear advantages evaporated, however, when the trial judge ruled that the plaintiff could introduce expert testimony that short-term use of Vioxx carried similar cardiovascular risks to long-term use. In addition, a damaging videotaped deposition of one of Vioxx’ harshest critics, Dr. Eric Topol (renowned cardiologist from the prestigious Cleveland Clinic) was shown to the jury.

Merck, however, presented a serviceable defense that included the credible testimony of Dr. Alise Reicin, a convincing witness who has an intimate knowledge of Vioxx gained through years of working with the marketing of the drug as a high level Merck employee.

Thus, as case went to the jury for deliberation only three possibilities existed; a verdict for plaintiff, a verdict for Merck, or a mistrial. The jury would not be privy to the unexpected turn of events that was about to take place and, thus, would not be basing its verdict on the evidentiary disaster that would irreparable damage Merck’s defense and impugn the credibility of its witnesses.

What Merck needed was to win the case without the jury knowing the facts surrounding the rather shocking revelation by Dr. Gregory Curfman, executive editor of the New England Journal of Medicine (NEJM) that data linking Vioxx to increased cardiovascular risk was deleted (apparently by Merck researchers) from the VIGOR study two days before it was submitted to the NEJM for publication.  

As Dr. Curfman saw it: "I was somewhere between surprised and stunned. They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health."

The federal jury would never know (while deliberating, at least) that two Merck authors on the VIGOR study knew of three additional heart attacks among Vioxx patients in the study, which had not been disclosed to the NEJM. The heart attacks occurred in the final five weeks of the trial and in patients at low risk for heart problems or that a prior version of the manuscript revealed more cardiovascular problems potentially connected to Vioxx than those discussed in the published study.

Thus, what the jury had was defense testimony that dovetailed neatly with the published results of the VIGOR study thereby making Merck’s defense plausible and certainly able to pass the straight face test.

The deleted data, however, not only discredits the results and conclusions reached in the VIGOR study as to the safety of Vioxx, it also renders much of the testimony given by Dr. Reicin, and Merck’s other employee-witnesses highly suspect at best.

Obviously, the accusation by the NEJM that Merck knowingly withheld data on three fatal heart attacks and more, if true, significantly undermines the VIGOR study results as well as the entire premise upon which Merck has built its entire defense.

It would certainly call into question the study’s findings, which have been a central element in the three trials, as well as the testimony of one of the study’s authors, Dr. Alise Reicin, Merck’s vice president for clinical research, who claimed the company never misled doctors or the public about Vioxx studies.

When the NEJM revelations came to light, we asked a number of trial and appellate attorneys to offer their thoughts on what possible legal issues are raised by the Journal’s allegations. Of course, at that time, the jury was still deliberating and could have rendered a verdict despite what was taking place in the court and the media with respect to the NEJM charges.

After the mistrial was declared (based on the inability of the jury to agree on a verdict hung jury), we went back to those same attorneys to see what they thought the significance of that outcome might be in light of the Norm’s claim concerning the manipulation of the VIGOR study data.

Their responses were consistent in that they all saw the mistrial (under the particular circumstances) as being an extremely devastating blow to Merck.

Even though the mistrial was based on a “hung jury,” the attorneys we spoke with believed that Judge Fallon may have declared a mistrial on his own had there been a verdict in favor of Merck.

Plaintiff’s attorney had moved for a mistrial when the NEJM charges became public and Judge Fallon had reserved decision. Although he was free to decide the motion before the verdict, courts usually reserve decision on such motions until after the verdict to avoid the necessity of a new trial if an appellate court determines the motion was decided incorrectly.

Here, the missing data would have strengthened plaintiff’s case and severely damaged Merck’s defense including the testimony of its key witnesses. Thus, a verdict for Merck may have had to have been set aside anyway.

If the verdict is for the plaintiff, however, it would not have to be set aside although the court would then have to decide if the missing data would be admissible in the case for punitive damages.

Certainly, if the verdict had been in favor of Merck and the motion for a mistrial was denied, plaintiff would have the right to seek a new trial on appeal to the Circuit Court of Appeals.

Merck is also faced now with the problem of maintaining its credibility since there is a serious issue of whether any of its employee-witnesses committed perjury in this or either of the prior trials.

Obviously, if Merck employees deleted critical data, someone at Merck knew about it and may have even ordered it. Since a number of key Merck employees have testified about the study, it is impossible to believe no one knew of the deletion.

Moreover, Dr. Reicin, whose entire testimony has been repeatedly based on the accuracy and reliability of the VIGOR study, happened to have been one of the authors of the article in the NEJM. She is certainly one of the people who would have had access to the data files.

Even if she had no knowledge of the actual deletion of data, she may have known of the additional deaths. Thus, her testimony has become highly suspect since it is based on a study she may have known was inaccurate.

In addition, after Dr. Topol and his colleagues analyzed the VIGOR study and other data, they drafted their article and sent it to Merck expecting the company might be able to reconcile several major discrepancies between its data and that kept in the FDA database.

It was then that Dr. Topol got a visit from the very same Dr. Reicin, a Merck researcher and chairman of its Vioxx Commercialization Committee. At that meeting she told Dr. Topol that it was the Cleveland Clinic team that had “gotten it wrong” and would be embarrassed if we published the paper. "I thought it was harsh," he said.
Obviously, if she knew about the additional deaths and/or the omission of data from the study, her meeting with Dr. Topol was disingenuous.

The mistrial also takes away from Merck the ability to “strike while the iron is hot” with respect to the short-term-use type of case it had prevailed upon in New Jersey and to build on its momentum.

More importantly, however, the mistrial may now jeopardize the outcome in the New Jersey trial wherein Merck prevailed. Since the verdict in that case was based solely on Merck’s claim that it did not know Vioxx was unsafe until September 2004, the allegations of withholding data and manipulating the central study Merck relied on in its defense would give Judge Higbee a strong  reason to set aside the verdict in favor of Merck and order a new trial.

In addition the same issue of possible perjury would exist. Even if Judge Higbee did not set aside the verdict, a New Jersey appellate court could based on the NEJM claims should they be proven to be true.

The attorneys we spoke with also believe that the failure of the federal jury to reach a quick and decisive verdict for Merck raises serious questions as to the ability of the company to overcome the mountain of evidence against it even in cases that were once thought to be eminently “winnable.”

Clearly, if the serious allegations involving deleting data are true, Merck witnesses will be the subject of some rather intense and damaging cross-examination at any future trials, In addition Dr. Reicin may have become a major liability to Merck instead of one of its star witnesses. She may no longer have the credibility she enjoyed in the first three trials and her involvement in the VIGOR study scandal may have made it impossible for her to hold her own on the witness stand.

The value of the VIGOR study itself is also in serious doubt now. Instead of being useful in certain ways to both sides, it may have now turned into an albatross for Merck. This is hardly the tone Merck wanted to set after repeatedly announcing its brash strategy of trying each of the remaining 7,000 plus cases to verdict.

As a late story in the Boston Globe points out that “plaintiffs’ attorneys say they will attack the credibility of Merck and its clinical trials leader, Reicin, as nearly 7,000 lawsuits are heard in federal and state courts. ‘As a general proposition, anything that smacks of manipulating studies or data is a potential bombshell,’ said Kendall Coffey, a legal analyst in Miami and a former US attorney. ‘’It’s the rare case where a cover-up is of no concern to a jury. The implications range from only somewhat harmful to potentially devastating.’”

Clearly, Merck cannot point to anything positive in the mistrial. It was a missed opportunity for the company to draw a line in the sand with respect to the thousands of remaining short-term-use cases. It also represents a serious stumble for Merck’s legal team and corporate management, which have steadfastly refused to entertain the idea of settling any case or engaging in talks to resole the litigation in a global settlement.  

According to a report from WWAY News Channel 3 (www.wwaytv3.com) in Wilmington, North Carolina, a former gastric bypass surgeon, who is facing dozens of lawsuits for medical malpractice, has changed his name.

Formerly Dr. Steven Olchowski, Dr. Steven Hawkins made the switch so that he can have a fresh start, his attorney said. Although the attorney claimed that Olchowski has no intention of practicing medicine again under the name Hawkins, WWAY pointed out that there was no guaranty of that.

In the wake of a flood of malpractice lawsuits, Olchowski lost his medical license in both Michigan and North Carolina.

Former patients accused him of lying about the weight-loss procedures he performed on them. They claim that he performed a dangerous short-cut operation that caused life-threatening medical complications.

Olchowski (Hawkins) has yet to go to trial for medical malpractice.

Patients should be able to access accurate information on Dr. Olchowski on the North Carolina Medical Board website, by searching under his new and former names, officials say.

A Possible Mistrial in Houston, a Potential Retrial in New Jersey, Possible Perjury on the Part of One or More of Merck’s Witnesses, and How the Credibility of a Key Defense Witness and the VIGOR Study Will Fare in any Future Trials Have All Emerged as Serious Considerations for Merck.
    
Following the rather shocking revelation by Dr. Gregory Curfman, executive editor of the New England Journal of Medicine (NEJM) that data linking Vioxx to increased cardiovascular risk was deleted (apparently by Merck researchers) from the VIGOR study two days before it was submitted to the NEJM for publication, a number of serious legal issues have been injected into the ongoing litigation.  

First, however, by way of background, the situation as it stands now is that, according to Dr. Curfman: "I was somewhere between surprised and stunned. They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health."

Dr. Curfman did not find out until November 21, 2005, that by July 5, 2000, two Merck authors on the VIGOR study knew of three additional heart attacks among Vioxx patients in the study, which had not been disclosed to the NEJM. The heart attacks occurred in the final five weeks of the trial and in patients at low risk for heart problems. Curfman also learned that a prior version of the manuscript revealed more cardiovascular problems potentially connected to Vioxx than those discussed in the published study.

The editors of the NEJM had assumed that the VIGOR manuscript they were given only contained limited cardiovascular data since that was all that was available. "It turns out that they had quite a bit more already worked up,"

The Journal now contends that "at least two" of the study’s three authors knew of the additional heart attacks for some 4 1/2 months prior to publication. "There was ample time to include the data on these three additional infarctions in the article."

Dr.Curfman now questions his own diligence in pursuing the obvious manipulation of the scientific data in the VIGOR study since the missing information would have dramatically changed the results.

The accusation by the NEJM that Merck knowingly withheld data on three fatal heart attacks and more, if true, significantly undermines the VIGOR study results as well as the entire premise upon which Merck has built its entire defense.

It would certainly call into question the study’s findings, which have been a central element in the three trials, as well as the testimony of one of the study’s authors, Dr. Alise Reicin, Merck’s vice president for clinical research, who claimed the company never misled doctors or the public about Vioxx studies.

Based upon the facts as they now stand, we asked a number of trial and appellate attorneys to offer their thoughts on what possible legal issues are raised by the NEJM’s allegations. Their responses center on four very serious problems that must now be dealt with by the courts and Merck. These include:

1. Plaintiff’s mistrial motion in the case now being deliberated by the jury in U.S. District Court in Houston has been held in abeyance for now by Judge Fallon. Although he is free to decide the motion before the verdict, courts usually reserve decision on such motions until after the verdict to avoid the necessity of a new trial if an appellate court determines the motion was decided incorrectly. Here, the missing data would have strengthened plaintiff’s case and severely damaged Merck’s defense including the testimony of its key witnesses. Thus, a verdict for Merck may have to be set aside. If the verdict is for the plaintiff, however, it would not have to be set aside although the court would then have to decide if the missing data would be admissible in the case for punitive damages. Certainly, if the verdict is in favor of Merck and the motion for a mistrial is denied, plaintiff would have the right to seek a new trial on appeal.

2. There is a serious issue of whether any of Merck’s witnesses may have committed perjury in this or either of the prior trials. Obviously, if data was deleted, someone knew about it and may have even ordered it. Since a number of key Merck employees have testified about the study, it is impossible to believe no one knew of the deletion. Moreover, Dr. Alise Reicin was one of the authors of the VIGOR study article in the NEJM and is certainly one of the people who would have had access to the data files. Even if she had no knowledge of the actual deletion of data, she may have known of the additional deaths. Thus, her testimony has become highly suspect since it is based on a study she may have known was inaccurate. In addition, after Dr. Topol and his colleagues analyzed the VIGOR study and other data, they drafted their article and sent it to Merck expecting the company might be able to reconcile several major discrepancies between its data and that kept in the FDA database. It was then that Dr. Topol got a visit from the very same Dr. Reicin, a Merck researcher and chairman of its Vioxx Commercialization Committee. At that meeting she told Dr. Topol that it was the Cleveland Clinic team that had “gotten it wrong” and would be embarrassed if we published the paper. "I thought it was harsh," he said. Obviously, if she knew about the additional deaths and/or the omission of data from the study, her meeting with Dr. Topol was disingenuous.

3. The New Jersey trial wherein Merck prevailed has also been called into question now. Since the verdict in that case was based solely on Merck’s claim that it did not know Vioxx was unsafe until September 2004, the allegations of withholding data and manipulating the central study Merck relied on in its defense would give Judge Higbee (not a big Merck fan to begin with) every reason to set aside the verdict in favor of Merck and order a new trial. In addition the same issue of possible perjury would exist. Even if Judge Higbee did not set aside the verdict, a New Jersey appellate court could.

4. The final point raised by the attorneys we spoke with had to do with the future. Clearly, if the serious allegations involving deleting data are true, Merck witnesses will be the subject of some rather intense and damaging cross-examination at any future trials, In addition, Dr. Reicin may have become a major liability to Merck instead of one of its star witnesses. She may no longer have the credibility she enjoyed in the first three trials and her involvement in the VIGOR study scandal may have made it impossible for her to hold her own on the witness stand. The value of the VIGOR study itself is also in serious doubt now. Instead of being useful in certain ways to both sides, it may have now turned into an albatross for Merck.  

It would appear that as the trials have progressed, Merck has been steadily losing ground in terms of evidentiary rulings, scheduling of upcoming trials, and, most importantly, credibility. This latest fiasco has only added to Merck’s legal woes and may very well have spelled the end of the company’s brash strategy of trying each of the remaining 7,000 plus cases to verdict.