Drug Injury Watch

Levaquin Federal Court Cases Already Have MDL; Now "Mass-Tort Treatment" Requested In New Jersey State Court

While Levaquin Is Just One Of Several  Antibiotics In Fluoroquinolone Class, All Of Which Have Been Linked To Tendon Ruptures, Levaquin Has Most Tendon Injury Lawsuits Filed To Date

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late August 2006 the consumer advocacy group Public Citizen filed a petition with the FDA requesting that the agency order certain drug companies to put a "black-box" warning about the risks of tendon rupture that have been associated with a class of antibiotics known as fluoroquinolones.  Some of these antibiotics are Ortho-McNeil's Levaquin as well as Bayer's Cipro and Avelox products.

In January 2008 Public Citizen filed a lawsuit intended to force the FDA to decide whether this stronger warning should be added to antibiotics such Levaquin as well as Cipro and Avelox.

On July 8, 2008 the FDA announced that a so-called "black-box" warning would be added to the package insert, or label, to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture associated with the following fluoroquinolones:

Ciprofloxacin (marketed as Cipro and generic ciprofloxacin)
Ciprofloxacin extended release (marketed as Cipro XR and Proquin XR)
Gemifloxacin (marketed as Factive)
Levofloxacin (marketed as Levaquin)
Moxifloxacin (marketed as Avelox)
Norfloxacin (marketed as Noroxin)
Ofloxacin (marketed as Floxin and generic ofloxacin)

While the tendon rupture and tendinitis side effects have been associated with all of these fluoroquinolone class antibiotics, Levaquin has drawn the most lawsuits, by far, to date.

All Levaquin tendon rupture lawsuits filed in federal court have been assigned to MDL No. 08-1943, which is presided over by the Honorable John R. Tunheim, in the District of Minnesota.  The first test case, or bellwether, trial for the Levaquin MDL is scheduled currently for August 2010.

More recently, there has been a request of so-called "mass-tort treatment" made for a growing number of Levaquin lawsuits filed in the New Jersey state court system.

From a May 13, 2009 Law.com article, "Levaquin Tendon Injury Mass Tort Treatment Sought for Suits Over Ortho-McNeil Antibiotic Levaquin":

Users of Levaquin, an antibiotic linked to muscle ailments, are asking the New Jersey Supreme Court to accord mass-tort treatment to their suits against the manufacturer, Johnson & Johnson subsidiary Ortho-McNeil Pharmaceutical Inc.

Acting Administrative Director of the Courts Glenn Grant made the application public in a notice to the Bar that solicits comments on or before June 5.

We expect that the New Jersey Levaquin litigation will be given the requested mass-tort designation and that the number of Levaquin lawsuits filed in New Jersey will increase -- especially if the New Jersey cases are assigned to Judge Carol Higbee in Atlantic County.  (As some will recall, Judge Higbee was in charge of the NJ Vioxx mass-tort litigation.)

We will continue to monitor developments concerning the Levaquin litigation, both in the federal court MDL and in the NJ state court system.

The Tale Of Merck's Fake Medical Journal As Told At A Vioxx Trial In Australia

Drug Company Paid Scientific Publisher Elsevier To Produce What Was Essentially A Marketing Publication For Vioxx And Fosamax

(Posted by Tom Lamb at DrugInjuryWatch.com)

In early April 2009 we heard that there had been some testimony at an Australian Vioxx personal injury trial about a "medical journal" which Merck had created and distributed to doctors in Australia apparently to tout the benefits of its (now recalled) blockbuster drug Vioxx.

Now an April 30, 2009 article, "Merck publishes fake journal", published online by The Scientist (free site registration required), gives us some additional information about what Merck was doing in Australia back in 2003:

Merck paid an undisclosed sum to Elsevier to produce several volumes of [Australasian Journal of Bone and Joint Medicine,] a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles--most of which presented data favorable to Merck products--that appeared to act solely as marketing tools with no disclosure of company sponsorship.

"I've seen no shortage of creativity emanating from the marketing departments of drug companies," Peter Lurie, deputy director of the public health research group at the consumer advocacy nonprofit Public Citizen, said, after reviewing two issues of the publication obtained by The Scientist. "But even for someone as jaded as me, this is a new wrinkle."

According to this article by Bob Grant, The Scientist obtained two issues of the Australasian Journal of Bone and Joint Medicine, Volume 2, Issues 1 and 2, both dated 2003.  Those issues were reviewed by Public Citizen's Peter Lurie, and the article some comments by Mr. Lurie about his review:

"I've never seen anything quite like this," he said. "Reviews are usually swimming in references." For example, one article on osteoporosis labeled above the title as a "meta-analysis" cites two references -- one itself a meta-analysis. "To the jaundiced eye, [the journal] might be detected for what it is: marketing," he said. "Many doctors would fail to identify that and might be influenced by what they read."

This April 30 article also draws upon testimony given at the trial of the civil suit filed by Graeme Peterson -- who suffered a heart attack in 2003 while on Vioxx -- against Merck and its Australian subsidiary, Merck, Sharp & Dohme Australia (MSDA):

In testimony provided at the trial last week, which was obtained by The Scientist, George Jelinek, an Australian physician and long-time member of the World Association of Medical Editors, reviewed four issues of the journal that were published from 2003-2004. An "average reader" (presumably a doctor) could easily mistake the publication for a "genuine" peer reviewed medical journal, he said in his testimony. "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for MSD[A]."

He also stated that four of the 21 articles featured in the first issue he reviewed referred to Fosamax. In the second issue, nine of the 29 articles related to Vioxx, and another 12 to Fosamax. All of these articles presented positive conclusions regarding the MSDA drugs. "I can understand why a pharmaceutical company would collect a number of research papers with results favourable to their products and make these available to doctors," Jelinek said at the trial. "This is straightforward marketing."

As mentioned above, there was no disclosure of Merck's funding found anywhere in the two issues of the Australasian Journal of Bone and Joint Medicine obtained by The Scientist.  But reporter Bob Grant established that this "journal" was, in fact, paid for by Merck:

Elsevier acknowledged that Merck had sponsored the publication, but did not disclose the amount the drug company paid. In a statement emailed to The Scientist, Elsevier said that the company "does not today consider a compilation of reprinted articles a 'Journal'."

"Elsevier acknowledges the concern that the journals in question didn't have the appropriate disclosures," the statement continued. "It is worth noting that project in question was produced 6 years ago and disclosure protocols have evolved since 2003. Elsevier's current disclosure policies meet the rigor and requirements of the current publishing environment."

Mr. Grant's article also includes statements by a spokesman for Merck's Australian subsidiary, MSDA, as well as a rheumatologist in Australia who was one of the members of a "Honorary Editorial Board" for this Australasian Journal of Bone and Joint Medicine journal.

Last but not least:  Mr. Grant's article -- "Merck publishes fake journal" (free site registration required) -- provides links for you to view PDFs of the two issues of Australasian Journal of Bone and Joint Medicine from 2003 which were obtained by The Scientist.

P.S.  A new article, "Fresh questions raised about prominent cardiologist's role in "ghostwritten" 2001 meta-analysis of Vioxx trial", published April 30, 2009 by heartwire, is worth a look if this matter intrigues you.  (5/1/09)

Sprint Fidelis Lead Wire Failures May Be On The Rise According To February 2009 Journal Article By Hauser And Hayes

Physicians Must Consider The Pros And Cons Of Surgical Removal Before Heart Device Shocks Unnecessarily Or Fails To Work When Patient Needed Shock

(Posted by Tom Lamb at DrugInjuryWatch.com)

On February 23, 2009 the medical journal HeartRhythm made available online an article by Robert G. Hauser, MD, and David L. Hayes, MD, "The Increasing Hazard of Sprint Fidelis Implantable Cardioverter-Defibrillator Lead Failure", which pits these two prominent cardiologists against Medtronic, Inc., the company that made the Sprint Fidelis lead wires.

As you may recall, Medtronic was forced to recall its Sprint Fidelis lead wires in 2007 following hundreds of reports from patients with defibrillators who were being shocked unnecessarily or having their heart device fail to deliver any shock when one was needed. 

According to the "Class 1 Recall: Medtronic Inc. Sprint Fidelis® Defibrillator Leads" issued by the FDA on October 15, 2007, the particular units that may have defective lead wires are: 

Medtronic Inc. Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007.

The February 2009 Sprint Fidelis medical journal article by Drs. Hauser and Hayes was picked up quickly by The Wall Street Journal (WSJ) and The New York Times (NYT) as well as other media.

A February 23, 2009 WSJ article by Thomas M. Burton, "New Concern Is Raised About Medtronic Wires", explains the significance of the study underlying this Hauser and Hayes article published by HeartRhythm:

Drs. Hauser and Hayes evaluated patients at both of their hospitals, looking at a total of 3,037 defibrillator leads of varying models. A total of 94 leads failed. Seventy-two of the failures were Sprint Fidelis leads, out of 848 Sprint Fidelis leads implanted....

The doctors said they saw a Sprint Fidelis failure rate of 3.75% a year, compared with 0.58% among other models. At three years after implant, 87.9% of the Sprint Fidelis leads were working, compared with 98.5% for other models studied.

Medtronic says that its "all cause" failure rate for the Sprint Fidelis at three years is 4.6%, meaning that 95.4% of the devices would be working at that point.

In turn, a February 24, 2009 NYT article by Barry Meier, "Study Finds More Failure of Heart Device", provides some additional information from Medtronic and some commentary:

Medtronic released a statement on Monday saying it still believed its own figures were accurate. “It is important to note that data collected from center to center would be expected to vary,” Medtronic said. “We believe that our analyses are representative of overall Fidelis performance.”...

Two experts not involved in the Hauser-Hayes study said it was difficult to explain the discrepancies between the new report and Medtronic’s data.

Dr. Douglas P. Zipes, a cardiologist and the editor of Heart Rhythm, said one possibility for the discrepancy in malfunction rates might reflect the failure of many physicians to report component problems to Medtronic....

Another cardiologist, Dr. Charles Swerdlow of Los Angeles, said that the discrepancy between Medtronic’s data and the new study might be a result of physicians reading patient symptoms as caused by lead fractures when actual fractures had not occurred.

As many of you know, all Sprint Fidelis lawsuits filed against dismissed Medtronic that were pending in the federal court Sprint Fidelis MDL were dismissed on federal preemption grounds in January 2009.  The U.S. District Court judge in Minnesota who made the ruling stated that he was simply following U.S. Supreme Court's Riegel vs. Medtronic ruling as precedent.

Just last week, however, we learned that some Congressmen and Senators are seeking to reverse by new legislation the effect of this Riegel preemption ruling by the Supreme Court.  In his February 19, 2009 article, "Lawmakers Seek to Return Right to Sue Device Makers", NYT reporter Barry Meier informed us that:

Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision.

A similar Senate bill, sponsored last year by Edward M. Kennedy, Democrat of Massachusetts, and Patrick J. Leahy, Democrat of Vermont, is expected to be reintroduced in coming months.

The lawmakers, as well as patient advocates and others, say the Supreme Court’s medical device decision has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.

We will continue to monitor the debate about actual failure rates for Sprint Fidelis lead wires as well as watch for developments in Washington as concerns the preemption of medical device injury lawsuits.  We hope you stay tuned for our future reports on both issues.

Digitek Update December 2008: Actavis Contends No Defective Digitek Pills Were Ever Used By Patients

At About Same Time, Drug Company Accepts FDA Consent Decree In Connection With Justice Department's Injunction Complaint

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late December 2008 investigative reporter Jeanne Lenzer's hard-hitting article about the Digitek fiasco, "Did the FDA Miss Signals on a Troubled Heart Drug?", was published by The Center for Public Integrity (the Center, for short).

The most surprising part of that article, to me, was this contention by the drug company:

Actavis maintains that none of the improperly manufactured Digitek pills ever reached the public, telling the Center that it recalled the drug simply out of an “abundance of caution.”

I suppose this is a predictable corporate position to take in light of the increasing number of lawsuits being filed by people who allege that they ingested the so-called "double-dose" Digitek pills and were subsequently harmed.  The validity of this Actavis contention, however, will certainly be tested in the federal and state court Digitek litigations.

About a week after the Digitek article by Jeanne Lenzer was published, on December 29, 2008, Actavis issued a press release to announce a Consent Decree that the drug company had agreed to enter into with the FDA:

Actavis Inc. today announced that it has reached agreement on a Consent Decree of Permanent Injunction with the Food and Drug Administration (FDA) regarding the company's Actavis Totowa LLC subsidiary. This agreement, in effect, settles the issues identified by the Department of Justice in its previously filed complaint against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe.
 
The Consent Decree only affects operations at Actavis Totowa in New Jersey.  [Editor's Note: Two of these facilities ("Little Falls" and "Riverview") are oral-dose manufacturing sites, and one ("Taft") is a packaging facility.]  Pursuant to the Consent Decree, Actavis has agreed to not distribute any products from the Actavis Totowa facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with FDA's current good manufacturing practice (cGMP) and has passed follow-up FDA inspections of the facilities. The company anticipates that commercial production in the Actavis Totowa facilities will resume shortly.

As you may recall, the FDA had filed an Injunction Complaint through the U.S. Department of Justice (DOJ) in November 2008.

According to a DOJ press release regarding that Complaint, "U.S. Files Suit Against New Jersey Generic Drug Manufacturer That Distributed Adulterated and Misbranded Products":

...The Food and Drug Administration (FDA) conducted five inspections of Actavis Totowa's facilities over the last three years. Despite written warnings to the company, during its last inspection this year, the FDA continued to find numerous and recurring violations of Good Manufacturing Practice requirements. FDA also found that the company continued to manufacturer and distribute unapproved new drug products.

If you read the December 2008 Digitek article by Jeanne Lenzer as well as the November 14, 2008 COMPLAINT FOR PERMANENT INJUNCTION document filed by the DOJ, it seems that a more realistic position for Actavis to have taken on the issue of whether or not any defective Digitek pills were ever dispensed and used by a patients would have been that -- given the very nature of those numerous problems found at this Little Falls, NJ facility -- "we don't know", rather than its apparent position of denial.

Of course, as the the Digitek lawsuits progress we will find out whether, in fact, there are any double-dose Digitek pills that were used by and harmed patients.

Prescription Oral Sodium Phosphate (OSP) Products Visicol And OsmoPrep Get Black-Box Warning

Related Recall Of Over-The-Counter OSP Fleet Phospho-Soda, Which Is Subject Of Product Liability Lawsuits

(Posted by Tom Lamb at DrugInjuryWatch.com)

On December 11, 2008 the FDA issued by email a MedWatch Safety Alert which was titled "Oral Sodium Phosphate (OSP) Products for Bowel Cleansing: reports of acute phosphate nephropathy, Boxed Warning to be added to labeling".

According to this December 2008 Alert, the FDA was taking action because it had become aware of reports of a type of serious kidney injury, acute phosphate nephropathy, that was associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures.  Further, some of these cases acute phosphate nephropathy cases occurred in patients who had not have any pre-existing, identifiable factors that would have put them at risk for developing this acute kidney injury.

For more information, the FDA directed patients and doctors to the MedWatch 2008 safety summary about this new Boxed Warning (also known as a black-box warning) for Visicol And OsmoPrep -- the only two prescription OSP products available in the U.S.

From there, for those who wanted more details, the MedWatch summary directed one to this FDA Drug Information Page, "Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)".

Taken from that page is what seems to be the FDA's current understanding of this OSP adverse reaction:

Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of OSPs. The occurrence of these events was previously described in an Information for Healthcare Professionals sheet and an FDA Science Paper issued in May 2006. Additional cases of acute phosphate nephropathy have been reported to FDA and described in the literature since these were issued.

Individuals who appear to have an increased risk of acute phosphate nephropathy following the use of OSPs include persons: who are over age 55; who are hypovolemic or have decreased intravascular volume; who have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]).

All of this was followed closely by a drug company announcement about some similar over-the-counter (OTC) products; from their press release, "C.B. Fleet Voluntarily Recalls its Fleet Phospho-soda Product after FDA Safety Alert":

Following the issuance of FDA's Safety Alert on Thursday stating that oral sodium phosphates bowel cleansing solutions should be available by prescription only, C.B. Fleet Company immediately announced a voluntary recall of their over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® BowelCleansing System. The voluntary recall is directed to retailers and wholesalers.

Interestingly, one of these two products, Fleet Phospho-soda, is the subject of several ongoing product liability lawsuits that have been filed on behalf of patients with kidney damage who used this now-recalled C.B. Fleet OSP product.

These lawsuits filed against Fleet allege that the drug company marketed Phospho-soda at dosages higher than the FDA permitted for OTC oral laxatives containing sodium phosphate -- up to twice the permitted daily amount according to these lawsuits. 

In turn, use of the higher dosage of Fleet Phospo-soda can leads to deposits of calcium and phosphate in the kidneys, a condition known as nephrocalcinosis. This damage to the kidneys is often permanent, and requires dialysis or even a kidney transplant.

Returning to the FDA's information, above, it seems that the risk of developing an OSP-induced kidney injury is increased in certain patients, such as those taking certain blood pressure medications or diuretics, and that the risk of this adverse reaction kidney damage increases with a patient's age.

We will continue to monitor this emerging drug safety issue, and we welcome any insight you may have about these several different OSP products causing kidney problems like acute phosphate nephropathy or nephrocalcinosis.

Risk Of Digoxin Toxicity / Digitalis Poisoning Higher In First Two Months Following A Hospitalization

Researchers Looked For Possible Digoxin-Related Adverse Drug Events In Older Patients From Pennsylvania

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the wake of the generic digoxin pill Digitek being recalled in the spring of 2008, there has been an increased interest in determining the incidence of digoxin toxicity, also known as digitalis poisoning.

In the November 28, 2008 edition of Pharmacoepidemiology and Drug Safety there is an article, "Increased risk of digoxin toxicity following hospitalization", which is helpful in this regard.  This medical journal article reports the findings of several researchers from the University of Pennsylvania's Program for the Reduction in Medication Errors, which is part of the Department of Biostatistics and Epidemiology as well as the School of Medicine.

From the Abstract for this November 2008 digoxin article we get this synopsis:

PURPOSE: ... The objective of the study was to identify health care system factors that affect the risk of digoxin toxicity for older adults on digoxin.

METHODS: We conducted a prospective cohort study of older adults within the Pennsylvania Pharmaceutical Assistance Contract for the Elderly (PACE) program.... Trained abstractors reviewed discharge summaries of possible digoxin related [adverse drug events, or ADEs]....

RESULTS: We enrolled a total of 2030 adults on digoxin from May 2002 to June 2003. A total of 34 hospitalizations due to digoxin toxicity occurred, equivalent to 1.12 hospitalizations per 1000 person-months of exposure. Adjusting for hospitalization in the past 2 months, age, total number physicians prescribing any medications in past 3 months, total number of pharmacies filling medications in past 3 months, and number of unique prescriptions filled in the past month had a 4.25-fold increased risk of subsequently experiencing digoxin toxicity (IRR 95%CI 1.95, 9.27).

CONCLUSIONS: The risk of digoxin toxicity-related hospitalization, while low, is higher in the post-hospital period.

First, we point out that this study concerned the use of digoxin during a time before the March 2006 to May 2008 period of time implicated by the Digitek recall.

We also emphasize that the medical records reviewers were looking not only for instances where there was a stated diagnosis of "digoxin toxicity" or "digitalis poisoning", but also for medical conditions that were consistent with having taken too much digoxin. 

This second point is significant for patients who took Digitek during the 2006 to 2008 recall time range and experienced possible side effects that required hospitalization.  Even if there was no digoxin toxicity diagnosed -- in part because doctors would not have imagined the scenario that the Digitek pill was possibly too potent, i.e., "double dose" -- it may be that their hospitalization was due to digitalis poisoning.

In fact, my law firm has seen situations like this in the process of investigating possible Digitek cases where the patient was hospitalized following the person's use of Digitek tablets.  While these possible Digitek cases are less obvious than those where a diagnosis of digoxin toxicity is noted in the medical records, these cases may be viable -- especially where the patient or their family still has some of the remaining suspected-to-be defective Digitek pills available for testing in order to determine the dosage.

FDA And DOJ File Court Papers In November 2008 To Shut Down Actavis Totowa LLC

Federal Government Seeks A Permanent Injunction Against This Drug Company That Produced Defective Digitek Pills

(Posted by Tom Lamb at DrugInjuryWatch.com)

A November 13, 2008 Bloomberg article, "Actavis Sued by U.S. Regulators to Shut Heart Drug Manufacturer", got our attention due to the fact that this drug company, Actavis Totowa LLC, was responsible for the April 2008 Digitek recall as well as an August 2008 recall of all other generic drugs made at its Little Falls, New Jersey facility where the defective Digitek (digoxin) pills had been manufactured.

But the November 13 Bloomberg article did not have much information about this U.S. Department of Justice (DOJ) - FDA court action apart from what parent company Actavis Inc. stated in its November 13 press release, "Actavis Comments on Filing of DOJ Complaint".  Therein, the Actavis version of this situation is set forth:

"We have taken a comprehensive approach to correcting all deficiencies within the Totowa business, and we've communicated regularly and candidly with the FDA, the public, our employees and our customers," said John LaRocca, Actavis Inc.'s Chief Legal Officer. "Last month, we asked FDA to return to the Totowa facilities, conduct an inspection, and observe the substantial progress we have made. To this point, the FDA has not acted. Our company takes these matters very seriously, and we remain focused on quality, innovation and product safety. We look forward to a quick and satisfactory resolution to these issues for the benefit of consumers, the agency and ourselves."

Of course, we will watch for additional news about this government shut-down of Actavis Totowa operations in the U.S., especially the FDA's reason for filing this lawsuit, now.

P.S.  On November 14, 2008 the U.S. Department of Justice (DOJ) issued a Press Release concerning the court papers that were filed against Actavis Totowa LLC, "U.S. Files Suit Against New Jersey Generic Drug Manufacturer That Distributed Adulterated and Misbranded Products", which tells the FDA side of this emerging story.  (11/14/08)

P.S.  If you are interested in knowing more, read the November 14, 2008 COMPLAINT FOR PERMANENT INJUNCTION document filed by the DOJ.  (11/17/08)

P.S.  In a November 26, 2008 article, "Reps attack FDA; call for Obama to 'clean house'", Representative Bart Stupak said the Complaint for an injunction stopping Actavis from manufacturing generic drugs at its Little Falls, New Jersey facility is “posturing” by FDA political appointees who have initiated actions like this, now, in an attempt to retain their positions under the new Administration.  (12/1/08)

Transcript Of Wyeth v. Levine Supreme Court Oral Arguments On November 3, 2008

Read What The Attorneys For Diana Levine And Wyeth Argued, And What Questions Were Asked By The Justices Regarding Possible Federal Preemption Of This Drug Injury Case

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Drug Injury Lawsuits Are Not Preempted By Federal Law (3/4/09)

On March 4, 2009 the U.S. Supreme Court, in a 6-3 decision, found that FDA approval was not a complete defense to plaintiff Diane Levine’s claim that Wyeth failed to adequately warn against a risk involved with the anti-nausea drug Phenergan. 

As stated by Justice John Paul Stevens: 

Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.

Wyeth v. Levine, No. 06-1249 (U.S. Sup. Ct.)

For background information and materials regarding the Wyeth v. Levine case, visit the Federal Preemption of Drug Injury Lawsuits page over at the Drug Injury Law web site.

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In the run up to the November 3, 2008 oral arguments in the Wyeth v. Levine case, there was an increasing amount of attention paid to the issue of whether or not the legal doctrine of federal preemption should be applied to drug injury lawsuits.

For those of you who are interested in what was said by the attorneys as well as the Supreme Court Justices during the Wyeth v. Levine oral hearing, we want to make available this information from the Argument Transcripts page of the Supreme Court's web site:

The Court's current Courtroom reporter, Alderson Reporting Company, provides transcripts of oral arguments that are posted on this Web site on the same day an argument is heard by the Court. Same-day transcripts are considered official but subject to final review. The following transcripts are for the cases argued during the October Term 2000 and subsequent Court Terms. These transcripts are permanently archived on this Web site. Persons wishing to purchase bound copies of individual transcripts should contact Alderson at (202) 289-2260, or www.aldersonreporting.com.

As of 12 noon, eastern time, on November 3 the Wyeth v. Levine transcript was not available, yet.  We will add a postscript, here, with the internet URL for this transcript as soon as it is available.

P.S.  The transcript of the November 3, 2008 Wyeth v. Levine Supreme Court hearing is now available on the Arguments Transcript page of Court's web site.  (11/3/08, 4:00 p.m.)

Learn More About Possible Federal Preemption of Drug Injury Lawsuits And Wyeth v. Levine

Get Background Information, Opinions, And Resources For This Important Legal And Public Policy Issue

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Drug Injury Lawsuits Are Not Preempted By Federal Law (3/4/09)

On March 4, 2009 the U.S. Supreme Court, in a 6-3 decision, found that FDA approval was not a complete defense to plaintiff Diane Levine’s claim that Wyeth failed to adequately warn against a risk involved with the anti-nausea drug Phenergan. 

As stated by Justice John Paul Stevens: 

Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.

Wyeth v. Levine, No. 06-1249 (U.S. Sup. Ct.)

For background information and materials regarding the Wyeth v. Levine case, visit the Federal Preemption of Drug Injury Lawsuits page over at the Drug Injury Law web site.

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On November 3, 2008 the U.S. Supreme Court will hear oral arguments from both sides in the case of Wyeth v. Levine regarding whether the fact that prescription drugs are regulated by the federal government should shield drug companies from being sued by injured patients in state courts.

It is my position that any application of the federal preemption doctrine to drug injury lawsuits would effectively eliminate a significant incentive for the drug company to ensure that its drug labels reflect accurate and up-to-date safety information, i.e., the possibility of failure-to-warn product liability litigation.

At our Drug Injury Law web site we have developed an information and news page called "Federal Preemption of Drug Injury Lawsuits".

There you will find some background about the the Wyeth v. Levine case, which involves Diana Levine, a Vermont musician and migraine sufferer who lost part of one arm due to side effects from Wyeth’s nausea drug Phenergan.

On the Drug Injury Law preemption page we also have:

• the October 2008 Wyeth press release concerning the Levine case and the issue of federal preemption;
• the U.S. Supreme Court docket and statement of issue for Wyeth v. Levine as well as the various "friend of the court", or amicus curiae, briefs that have been filed; and,
• several opinion articles about the federal preemption doctrine in the context of drug injury cases from various sources, ranging from The England Journal of Medicine to several blogs, including Ed Silverman's Pharmalot and Doug Bremner's Before You Take That Pill, as well as a piece by Henry Greenspan on the collaborative Tort Deform site.

If you want to recommend some additional items that we should make available on the Federal Preemption of Drug Injury Lawsuits page over at our Drug Injury Law site, you can let me know by submitting a Comment to this post, using the link below.

Of course, you can also use the Comment feature to let people know what you think about the possible application of this federal preemption legal doctrine to drug injury lawsuits -- the issue that is before our Supreme Court in the Wyeth v. Levine case.

Pfizer Settles Most Bextra And Celebrex Drug Injury Cases

Company Will Pay $745 Million In Settlements To Conclude 90% Of These Lawsuits

(Posted by Tom Lamb at DrugInjuryWatch.com)

An October 17, 2008 Wall Street Journal (WSJ) article, "Pfizer to Settle Celebrex and Bextra Suits", broke the news and provided the details:

Pfizer Inc. has agreed in principle to pay $894 million to settle litigation related to its painkillers Celebrex and Bextra.

The bulk of the settlement, $745 million, will resolve 90% of the known personal injury suits that allege the painkillers caused heart attacks and strokes, according to Pfizer, which will take a third-quarter pre-tax charge to earnings of $894 million, a statement provided by the company said.

Attorneys General in 33 states and the District of Columbia, who have filed suits relating to Pfizer's promotion of Bextra, will receive $60 million of the settlement; the remainder, $89 million, will resolve class actions alleging fraud in connection with the promotion of Celebrex and Bextra.

The settlement does not cover securities fraud litigation that has been filed in connection with Celebrex and Bextra.

Pfizer's Celebrex is the last among a group of painkillers called Cox-2 inhibitors that is still sold in the U.S.  From the October 17 WSJ article:

"Pfizer stands by the safety and efficacy profile of Celebrex," said Joe Feczko, Pfizer's chief medical officer.

Bextra was recalled in April 2005 by the FDA and Pfizer.  At the time, the FDA said it was the increased risk of serious skin reactions that was the reason for Bextra being pulled off the market.

Vioxx was recalled in September 2004 by the FDA and Merck due to cardiovascular side effects.  In late 2007 Merck agreed to pay $4.85 billion in a so-called "global settlement" of all personal injury and wrongful death cases involving Vioxx use in the U.S.