Drug Injury Watch

Celebrex and Bextra Federal Court MDL Cases Will Go To California

Product Liability and Sales Claims Assigned To Judge Breyer in San Francisco

In Fall 2005 all federal court cases involving Pfizer Inc.'s painkillers Celebrex and Bextra were consolidated into a multi-district litigation (MDL) and assigned to U.S. Judge Charles R. Breyer of the Northern District of California (In Re:  Bextra and Celebrex Marketing, Sales Practices and Products Liability Litigation, MDL Docket No. 1699, JPMDL, No. 05-1699, N.D. Calif.).

The federal court system's Judicial Panel on Multidistrict Litigation ("JPML") had before them and ruled on several competing motions which had filed by some different plaintiffs' lawyers, each seeking creation of a distinct type of federal court MDL:

• a Bextra and Celebrex products liability MDL;
• a Bextra marketing and sales practices MDL;
• a Celebrex marketing and sales practices MDL; and,
• a Bextra and Celebrex marketing, sales practices, and products liability MDL.

Pfizer's attorneys opposed the creation of any federal court MDL for the Celebrex and Bextra products liability cases involving personal injury and wrongful death claims.  Pfizer's attorneys, however, supported the creation of an MDL for all marketing and sales practice lawsuits. 

Pfizer's attorneys had suggested to the federal court's JPML that any Celebrex and Bextra MDL case be sent to the Southern District of New York, where it could be joined with the Pfizer securities, derivative, and ERISA MDL already in existence.

The plaintiffs' lawyers, meanwhile, in addition to the Southern District of New York, had suggested several other possible venues for the Celebrex and Bextra MDL:

1. the Eastern District of Louisiana (which has the Vioxx MDL);
2. the District of Connecticut;
3. the District of Massachusetts;
4. the District of Delaware;
5. the Southern District of Florida;
6. the District of New Jersey;
7. the Southern District of Texas; and,
8. the Northern District of California.

The JPML ultimately selected the Northern District of California for its assignment of this newly created federal court MDL for Bextra and Celebrex cases.

The JPML expressly rejected the several motions filed by plaintiffs' lawyers that would have lumped together Bextra and Celebrex claims in any one MDL.  Rather, the JPML left to U.S. District Court Judge Breyer the seemingly complex issue of how to coordinate (a) the products liability cases alleging personal injury or wrongful death caused by Bextra and Celebrex with (b) the sales and marketing claims filed against Pfizer regarding Bextra and Celebrex.

(Posted by: Tom Lamb)

Hormone Replacement Therapy With Alcohol Use Increases Breast Cancer Risk

November 2005 HRT-Alcohol Study Attempts To Find Out More About Mechanism

Women who use postmenopausal hormone replacement therapy drugs and, at the same time, use alcohol are apparently at an increased risk of developing a specific type of breast cancer.

In the November 2, 2005 edition of the Journal of the National Cancer Institute appears a report by Dr. Alicja Wolk, from Karolinska Institutet in Stockholm, and others which draws upon data from the population-based Swedish Mammography Cohort.  According to their report, hormone replacement therapy (HRT) with alcohol use increases estrogen-receptor (ER)-positive breast cancer.

The researchers acknowledged that a few earlier medical studies had posited some mechanisms for an interaction between alcohol and breast cancer risk.  The purpose of their study was to further investigate the relationship between alcohol consumption and hormone receptor tumor subtypes.  For the details of this new study by Dr. Wolk and her associates we turn to a November 8, 2005 article from Reuters Health:

Dr. Wolk's group prospectively evaluated outcomes for approximately 52,000 Swedish women born between 1914 and 1948 who underwent mammography between 1987 and 1990. A follow-up questionnaire in 1997 included questions regarding alcohol consumption.

By 2004, a total of 1188 invasive breast cancer cases had been diagnosed for which ER and progesterone receptor (PR) status were known.

The highest alcohol intake (10 g/day or more) was associated with a multivariable adjusted risk ratio of 1.65 for ER-positive breast cancers, compared with nondrinkers. There was no significant association for ER-negative tumors, regardless of PR status.

The absolute rate of all ER-positive breast cancers was 232 per 100,000 person-years in the group with the highest alcohol intake compared with 158 per 100,000 among nondrinkers (p for trend < 0.001).

Dr. Wolk and her associates concluded from these findings that "alcohol may affect postmenopausal breast cancer through the ER-signaling pathway".

Finally, the authors of this November 2005 HRT-alcohol study found no evidence of an association between HRT use and invasive breast cancer risk among nondrinkers.

(Posted by: Tom Lamb)

Bayer Has Paid $1.143 Billion To Settle 3,058 Baycol Cases

October 2005 Baycol / Lipobay Settlement Update From Bayer

In the first part of November 2005 Bayer AG said that it has paid $1.143 billion to settle 3,058 Baycol / Lipobay cases worldwide.  Further, Bayer said that across those the 3,058 Baycol / Lipobay settlements the drug company paid an average $373,733 per case.  As had been previously reported, as of June 30, 2005 Bayer had paid $1.138 billion to settle 3,017 Baycol / Lipobay lawsuits worldwide.

Consistent with its last status update in July 2005, Bayer repeated that it is aware of less than 50 Baycol cases in the U.S. that "in our opinion hold a potential for settlement."  Bayer also cautioned, again, that it cannot rule out the possibility that additional Baycol / Lipobay cases involving rhabdomyolysis and, perhaps, other serious side effects may "come to our attention". Lastly, like before, Bayer mentioned that there could be further settlements of Lipobay cases outside the U.S.

In contrast, according to this October 2005 update by Bayer, the total number of pending Baycol cases increased to 6,055, up a bit from 5,986 cases at the end of June 2005.

Bayer is clearly taking the position that it does not intend to pay any settlements to thousands of cases that are still pending in the federal court Baycol MDL.

(Posted by: Tom Lamb)

3600 Hormone Replacement Therapy Drug Lawsuits Filed Since 2002 Study

Do Hormone Drugs Cause Cancer? First Federal Court Trial Set For July

On July 9, 2002 a major study of hormone-replacement drugs for menopausal women was halted after finding a possible association between the hormone drugs and breast cancer as well as dangerous blood clots.  Premarin, Prempro, and Provera -- the leading hormone-replacement drugs -- were so widely prescribed that those drugs were usually among the top-selling prescription drugs in the U.S. each year — until the 2002 study was released.

The drug companies responded to the hysteria which resulted thereafter by attacking the underlying study.  They contended the hormone therapy study was flawed for various reasons, including but not limited to: many of the women were in their 60s or 70s; many of the women were smokers; and, many of the women had high blood pressure or other risk factors for cancer and vascular disease. Furthermore, the drug companies alleged that the findings of the 2002 study, in fact, were not new.  According to Wyeth's senior corporate counsel, Mark Lynch, "That information had been on the Prempro label since 1995".

Others, however, disagreed with the drug companies' assertions.  Those critics argued that the drug companies had not disclosed to doctors and their patients how much of an increase there was for breast cancer from using hormone replacement therapy.

In turn, since July 2002, approximately 3,600 hormone replacement therapy ("HRT") lawsuits have been filed against Wyeth, Upjohn, Pfizer Inc. and other companies over the various estrogen drugs which women took to ease menopausal symptoms. The cases allege a link between the hormone pills and serious health concerns.

Most of the 3,000 HRT lawsuits were filed in federal courts around the country and have been consolidated before U.S. District Judge William Wilson Jr., in Little Rock, Ark., by means of the Multi-district Litigation ("MDL") procedural mechanism. Several hundred other HRT cases have been filed in New Jersey state courts and in the Pennsylvania state court system.

The first federal court HRT drug trial is tentatively set to start in July 2006.

Despite this relatively large number of lawsuits alleging injury and death, Premarin, Prempro, and Provera remain on the market, and apparently deemed safe and effective by the FDA.  Moreover, although sales have declined dramatically since the 2002 study-release hysteria, doctors wrote more than 40 million prescriptions for the HRT pills in 2004.

(Posted by: Tom Lamb)

AstraZeneca Proposes Early FDA Review For All Prescription Drug Ads

Direct-to-consumer Advertisements Would Be Reviewed Prior To First Use

The drug company AstraZeneca Plc has proposed that there be a mandatory FDA review of all direct-to-consumer ("DTC") advertisements for prescription drugs before the ad is first broadcast or published.

AstraZeneca made its recommendation during the FDA's November 1-2, 2005 public hearings on DTC advertisements.  In written testimony submitted to the FDA in connection with those hearings, AstraZeneca said it has adopted the Pharmaceutical Research and Manufacturers of America ("PhRMA") guidelines on direct-to-consumer advertisements.

AstraZeneca's new proposal goes beyond the guidelines adopted earlier in 2005 by Pharmaceutical Research and Manufacturers of America ("PhRMA").  Those DTC ad guidelines, which take effect in January 2006, call for PhRMA's members to voluntarily submit new television ads, but not those intended for newspapers and magazines, to the FDA for review. Ken Johnson, PhRMA's senior vice president for communications, said the industry trade association has not taken a position on AstraZeneca's call for a mandatory FDA review of all DTC drug ads, including print advertisements.  Mr. Johnson did comment that "[w]e certainly encourage our companies to go above and beyond the code, if they believe it will help them better educate and inform consumers".

At present, the drug companies are required by law to submit DTC ads for FDA review at the time of the first broadcast or publication, not before that point. Some drug companies have voluntarily provided their DTC ads to the FDA earlier.  As part of the November 2005 public hearing, the FDA is considering whether the earlier review of DTC drug ads should be mandatory.  Drug companies spent an estimated $4.1 billion in 2004 on DTC ads for their prescription drug products.

Peter Lurie, deputy director of Public Citizen's Health Research Group and a well-known pharmaceutical industry critic, pointed out that AstraZeneca's proposal comes with a caveat that could prevent any mandatory early review of DTC ads from happening. AstraZeneca'a proposal is predicated on the FDA conducting faster reviews of DTC ads submitted to the agency for approval.  The FDA, however, is not able to speed up its DTC ads reviews because it is short-staffed, observed Public Citizen's Lurie.  "In effect, it's an empty promise," Lurie said. "The [FDA's] drug advertising division has been drastically understaffed for decades, and there's no reason to believe that will change anytime soon."

In relevant part, one purpose of the FDA's early November 2005 public hearing was to consider whether the agency should revise its rules about how much risk information should be included in DTC prescription drug advertisements, and whether all consumer-directed advertisements should be reviewed by the agency before public use.

(Posted by: Tom Lamb)

Merck's General Counsel Comments On Humeston Vioxx Verdict in NJ

Kenneth Frazier: Merck's Vioxx Strategy Is To Defend Each Case, Not Settle

On November 3, 2005, Merck's General Counsel Kenneth Frazier commented on the New Jersey Vioxx defense verdict in the Humeston v. Merck case, which the jury handed down just hours earlier.

During a six-minute conference call with reporters on November 3,*** Merck's General Counsel said the Humeston verdict "indicates that we can defend these cases, and we do not intend to roll over in these cases when people bring insubstantial claims into court to collect money from Merck."  Consistent with that message, Mr. Frazier said that Merck will defend itself case-by-case "over whatever period of years" it will take.

While you you are listening to Mr. Frazier give Merck's position on what the Humeston verdict means to the Vioxx litigation going forward (by use of link above), we thought you might want to look at the jury's findings in this New Jersey Vioxx trial.

• Counts regarding failure to warn of Vioxx risks:

1. Did Merck fail to adequately warn physicians of the link between Vioxx and higher risks of heart attack and stroke, which it knew or should have known about before Frederick "Mike" Humeston's heart attack? -- Verdict: NO by an 8-1 vote.

• Counts regarding failure to warn of Vioxx risks:

1. Did Merck commit consumer fraud "by using unconscionable commercial practices" when marketing Vioxx to physicians? -- Verdict: NO by a 9-0 vote.

2. Did Merck "make misrepresentations that had the capacity to mislead concerning the cardiovascular risk of Vioxx" while marketing Vioxx to physicians? -- Verdict: NO by a 9-0 vote.

3. Did Merck "intentionally suppress, conceal or omit material information about an association between Vioxx" and increased risk of heart attack and stroke? -- Verdict: NO by a 9-0 vote.

Technically, in this first New Jersey Vioxx trial the jury did not vote on whether Vioxx was a cause of Mr. Humeston's heart attack, since the jury had decided -- before getting to the medical causation issue -- that Merck acted responsibly in selling Vioxx. There were remarks by several jurors published in news reports about the Humeston verdict, however, which indicated that the jury would have voted "NO" on this aspect of the case, also.

The bottom line, though, is the defense verdict in Humeston does not mean that Merck, in fact, acted responsibly as regards Vioxx.  Rather, the defense verdict for Merck means only that in this particular Vioxx case the plaintiff did not convince the jury that Merck should be held liable for his heart attack in 2001.

*** FREE registration required, and then must use "Back" button in order to get audio.

(Posted by: Tom Lamb)

New Study Suggests Tysabri Not Likely Come Back On Market

FDA Will Determine Whether Risks Outweigh Any Potential Benefit

Serious side effects associated with Tysabri may outweigh any potential benefit, according to a study published in early November 2005, such that the once-promising drug for multiple sclerosis (MS) and Crohn's disease will not likely return to the U.S. market.

In the November 3, 2005 issue of the New England Journal of Medicine ("NEJM") appears an article about a new concerning Tysabri (natalizumab). This Tysabri study was comprised of two trials, and was supported by the drug companies responsible for Tysabri -- Elan Corp. and Biogen Idec Inc. -- as well as the National Institutes of Health.  The November 2005 NEJM article found that there was some positive response for MS patients and Crohn's patients using Tysabri.  The NEJM Tysabri study article, however, pointed out once again that one Crohn's patient died from progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal brain infection.

This is not the first time PML has been related to Tysabri, which has a short but controversial track record. Tysabri was approved by the FDA in November 2004 for the treatment of multiple sclerosis (MS) and Crohn's disease.  Soon thereafter, in February 200 Tysabri was voluntarily removed from the market by Elan Corp. and Biogen Idec Inc. after reports surfaced that three patients taking Tysabri had developed PML.  Two of three (or four, according to some reports) Tysabri patients who developed PML, an opportunistic infection, died as a result.

Dr. John F. Thompson, a professor of pediatrics and director of the Division of Pediatric Gastroenterology and Nutrition at the University of Miami's Miller School of Medicine, gave his opinion about this latest Tysabri study to HealthDay reporter Amanda Gardner:

Response rates weren't overwhelming but they were certainly exciting, particularly for people who had failed other therapies.  It probably would have become another important medication to consider for people with problematic Crohn's disease but the opportunistic infection is going to be problematic. I certainly would be uncomfortable using it in my patients.

Dr. Thompson concluded it did not seem likely that Tysabri would go back on the U.S. market, given the results of the latest Tysabri study.  Ms. Gardner points out that Dr. Thompson was not involved with the latest Tysabri study.

According to Ms. Gardner's HealthDay article, published on November 2, 2005, Tysabri maker Elan was more optimistic.  Davia Temin, an Elan spokeswoman, said:

Both [Elan and Biogen Idec] are extremely positive about its prospects for coming back onto the market.  Obviously, we want to come up with an appropriate risk analysis and patient safety comes first, but there is a huge unmet patient need....  There has been a very stringent and comprehensive risk analysis safety evaluation that's been done and that has been extremely favorable.  For PML, there were no new cases found in any population. It's the exact same three people.

According to Elan's Temin, the FDA is currently reviewing safety data on Tysabri and the agency should be done with its Tysabri review in about six months.

(Posted by: Tom Lamb)

Merck Prevails In Its First New Jersey Vioxx Trial

Humeston Case Ends with Defense Verdict for Merck

Merck & Co. got what it wanted in its first New Jersey Vioxx trial: a defense verdict.

On November 3, 2005, a New Jersey state court jury concluded that the use of Vioxx did not play any role in causing the heart attack of Frederick "Mike" Humeston, the 60-year-old plaintiff in the nation's second Vioxx case to go to trial.  Significantly, Mr. Humeston said he took the painkiller Vioxx for only two months and not a regular, daily basis. 

In this Humeston Vioxx case the jury also found that Merck had not misrepresented the safety of Vioxx, and that Merck did not commit any consumer fraud in how the drug company promoted Vioxx to doctors and patients.

The Humeston jury had to consider the competing evidence which it heard during the seven weeks of testimony.  Somewhat remarkably, the Humeston jury deliberated for just a bit more than one full day before issuing its defense verdict in favor of Merck.

Essentially, as regards Merck's conduct concerning Vioxx, the Humeston verdict means one of two things.  The first possible conclusion is the jury determined that Merck did not know Vioxx posed cardiovascular risks back in 2001, when Mr. Humeston was prescribed Vioxx.  The second possible conclusion is the jury believed that, even though Merck knew about those cardiovascular risks in 2001, the drug company had adequately warned doctors about the risks associated with Vioxx.

On the medical aspect, the Humeston jury determined that Vioxx was not a substantial factor in causing the plaintiff's heart attack in this case.  Consistently during the Humeston trial, Merck made two primary arguments when defending on the medical causation issue. The first defense argument asserted by Merck was that low-dose, short-term use of Vioxx has not been found to cause heart attacks.  In addition, Merck's defense team told the jury that Mr. Humeston's pre-existing medical conditions -- elevated blood pressure, being overweight, and work-related stress -- caused his heart attack, not the limited Vioxx use.

Following the Humeston verdict, Jim Fitzpatrick, a spokesman for Merck, was quoted by The Wall Street Journal ("WSJ") as follows:

• "We're very pleased with the jury's verdict."
• "I think the science is very clear that there is no short-term risk."
• "This confirms our strategy" to fight each case individually based on the science.

When the dust settles, it will be interesting to see whether Merck reaches out to plaintiffs' lawyers in an attempt to settle those Vioxx cases which involve eighteen months or more of Vioxx use followed by a heart attack or ischemic stroke.

(Posted by: Tom Lamb)

FDA Announces New Digital Drug Package Inserts / Labels Project

Drug Companies To Submit Digital Versions For All Drugs In Coming Year

On November 2, 2005 the FDA announced a new project which will involve drug companies submitting digital versions of drug package inserts, or labels, for posting on a new web site for doctors and patients to use.

The FDA's digital drug label project is intended to allow for the creation of a new online database which will serve as a centralized source where patients can find up-to-date package inserts, or labels, for all prescription drugs marketed in the U.S.

To start, the FDA's digital drug label project will require the drug companies to submit all new or changed prescription drug labels in a format suitable for use on an online database. Going forward, the drug companies will be required to submit in digital versions the labels for each of their prescription drugs already on the U.S. market.

As the digital labels are submitted to the FDA they will be placed online at web site which will be called Daily Med -- a public online archive maintained by the National Library of Medicine.  The FDA plans to eventually establish its own web site that will post all of the digital drug labels submitted by the drug companies.

According to Andrew von Eschenbach, acting commissioner of the FDA, the goal of this new digital drug label project is to make available to doctors and patients a "timely, user-friendly, available format" by which to learn about the uses and risks of a prescription drug.

In the bigger scheme of things, the FDA's new digital label requirement is the first part of a broader effort to "improve" the usability of package inserts for prescription drugs.

We know that most patients never see the actual package insert, or label, from the drug company -- whether it be the folded-up copy in the pill box, the Physicians' Desk Reference ("PDR") print-out, or viewed drug company's web site.  If and when a patient does see the actual drug label, it is far from easy to read.  Even doctors often find the current lay-out of drug labels difficult to use, as they can go on for dozens of pages and highlight relatively obscure information, e.g., a diagram of the drug's chemical structure.

It is anticipated that later this year the FDA will announce a plan that would completely change the layout and content of the drug labels to make them easier to use and understand.

(Posted by: Tom Lamb)

Wyeth Wins Latest Three Fen-Phen Diet-Drug Cases

Several Hundred Fen-Phen Cases Still Pending and Headed to Trial

On October 31, 2005 the drug company Wyeth announced that it had won the latest three fen-phen diet-drug cases: Lee Ann Brunson v. Wyeth; Colleen Rondas v. Wyeth; and, and Lonnie Zimmerman v. Wyeth.  These three fen-phen cases had alleged that Wyeth was liable for heart-valve injuries caused by the diet drug Pondimin, a product once marketed by Wyeth.  The three cases had been consolidated for a single trial in the Philadelphia Court of Common Pleas.  The trial began on October 18, 2005 before The Honorable Stephen Levin.

The defense verdict for this set of three fen-phen cases made October 2005 a good month for Wyeth and its lawyers.  According to news reports, of the 10 plaintiffs originally scheduled to have had their fen-phen case heard in one of the two October 2005 trial groups, five voluntarily dismissed their cases before trial, four cases resulted in verdicts for Wyeth, and one resulted in a verdict of $88,000 for the plaintiff.

As background, nearly six million people took Wyeth's diet drugs Redux and Pondimin, which were one-half of the diet-drug combination known as fen-phen, before Wyeth withdrew those drugs from the market in 1997.  Since that time, Wyeth has faced thousands of lawsuits alleging heart-valve damage from the use of Redux and Pondimin.  To date, Wyeth has set aside about $21.1 billion to cover its legal defense costs as well as settlements and trial verdicts.

At the same time as announcing the October 2005 fen-phen trial wins, a Wyeth spokesman said there are several hundred fen-phen cases still pending and, seemingly, headed to trial.  These remaining fen-phen cases were ones which plaintiffs' lawyers had "opted-out" of the multibillion-dollar settlement fund called the American Home Products ("AHP") / Wyeth fen-phen Trust, which has been besieged by allegations of fraud.

(Posted by: Tom Lamb)