Drug Injury Watch

June 18 Congressional Subcommittee Meeting About Medical Device Safety Act of 2009

This Bill, If Passed, Would Restore An Injured Patient's Right To Sue A Medical Device Manufacturer By Reversing Riegel v. Medtronic Ruling

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 18, 2009 the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009 (H.R. 1346).

This June 18 hearing has been titled "Medical Devices: Are Current Regulations Doing Enough for Patients?"  It is my understanding that this hearing is intended to be a follow-up to the Health Subcommittee's May 12, 2009 hearing on H.R. 1346. 

At this June 18 hearing I hope the idea of keeping medical device patients safe by maintaining "complementary" systems, i.e., the FDA and our civil court system, is stressed and understood.  In order to insure that our medical devices are effective and safe we need both a rigorous FDA device-approval process and court access when a defective device harms a patient.

Unfortunately, as a result of the United State Supreme Court's decision in the Riegel v. Medtronic case -- which was handed down in the first part of 2008 -- injured patients are currently barred from going into the court system and holding medical device manufacturers legally accountable for an injury caused by a defective device, e.g., Sprint Fidelis lead wire malfunction victims.

From my perspective, this current situation is not fair to injured patients and that is why we need Congress to pass the Medical Device Safety Act of 2009 into law.  Simply put, this bill would prevent medical device manufacturer from receiving total immunity as regards any patient injury claim simply by pointing to the FDA's prior approval of its device.  Instead, if passed, the Medical Device Safety Act would allow an injured patient to recover legal compensation when her injury was caused by a defective medical device.

What do you think about this issue of whether the federal preemption doctrine should be applied so as to prevent injured patients from suing a medical device manufacturer?

Some Reasons To Support The Medical Device Safety Act Of 2009, And A Dissent

May 12 Hearing In Washington Begins The Debate About Whether The Medical Device Industry Should Have Total Immunity From Legal Liability

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 12, 2009 the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009.  This hearing is the first step to legislatively moving this important piece of legislation through the House of Representatives.

In more detail, the Medical Device Safety Act (S. 540/H.R. 1346) would address the Supreme Court’s Riegel v. Medtronic decision and restore the ability of injured patients to hold negligent medical device manufacturers accountable when their products cause an injury or death.

The February 2008 Riegel decision by the Supreme Court serves to give total immunity to device manufacturers who fail to adequately warn patients about device risks.  As a result of the Riegel decision, any patient who is injured by a faulty medical device cannot get legal compensation from the manufacturer who would be legally liable but for the federal preemption defense available to the company.

In Riegel, the device that failed was a Medtronic balloon catheter used in heart surgery.  The patient in Riegel required additional surgery and eventually died.  But the Supreme Court's decision allowed Medtronic to walk away and, accordingly, there was no corporate accountability in that case.

Looking beyond that one case, when patients with serious injuries are unable to hold the negligent manufacturer accountable, the patients and the taxpayers are left footing the bill.  Where a patient has private health insurance, their insurance company would likely cover the additional surgery required, but this raises the cost of insurance for all of us.  For Medicare or Medicaid-covered patients, the costs of the additional medical care are passed onto the taxpayers.  And for patients who can no longer work, they may need additional taxpayer supported programs, such as Social Security disability.  

Not only is this "bad" cost-shifting, this immunity does not encourage the manufacturer of the faulty device to fix the problem(s) with its product -- and the cycle continues.

The Medical Device Safety Act of 2009 would effectively reverse the Supreme Court’s Riegel decision handed down last year.

If ultimately passed by the House and the Senate, and thereafter signed into law by the President, the Medical Device Safety Act would apply to cases brought on or after the date of enactment as well as to any cases that are still pending prior to the date of enactment.

For an article in support of this legislation, see this editorial published by The New England Journal of Medicine (NEJM), titled simply "The Medical Device Safety Act of 2009", which concludes in this manner:

Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts. The critical issue of preemption, which directly affects the disclosure of risks and thus the safety of the nation's supply of medical devices and drugs, should properly be decided by officials elected by the people, with whom the responsibility for the health of the public rightfully resides.

To get a sense of what the medical device manufacturers will be asserting in Washington at next week's hearing, here is a May 6 press release about a brand new report by Ernst Berndt and Mark Trusheim of the Massachusetts Institute of Technology (MIT), which was funded by the Advanced Medical Technology Association: "Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access".

So the stage is set.  You can let us know what you think about the federal preemption of medical device lawsuits by submitting a Comment, below. 

More importantly, you can contact your representatives in Washington and tell them whether or not a medical device manufacturer should have total immunity when its product seriously injures or kills a patient.

P.S.  The Subcommittee on Health held its hearing on H.R. 1346, the Medical Device Safety Act of 2009 on Tuesday, May 12, 2009, as scheduled.  Here is a list of the witnesses who testified:

David Vladeck, J.D., Professor of Law, Georgetown University Law Center
 
William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of
Medicine, Beth Israel Deaconess Medical Center, Boston

Gregory Curfman, M.D., Editor, New England Journal of Medicine

Bridget Robb, Gwynedd, Pennsylvania

Richard Cooper, Partner, Williams & Connolly LLP
 
Michael Kinsley, Seattle, Washington

Transcripts of their testimony and audio from the hearing is available, now.

(5/13/09)

March 31, 2009 Is Medical Device Patient Lobby Day In Washington, DC

This Event In Support Of Proposed Medical Device Safety Act Is Organized By The "Campaign to Stop Corporate Immunity" Group

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Campaign to Stop Corporate Immunity (CSCI) group has arranged for some patients injured by defective medical devices -- such as the recalled Medtronic Sprint Fidelis lead wires that were used in certain defibrillators -- to be in Washington, DC on Tuesday, March 31, 2009 for the purpose of "showing" our Representatives and Senators why they should vote in support of the Medical Device Safety Act (MDSA; HR 1346 / S 540).

The CSCI group is calling their event Medical Device Patient Lobby Day.

I believe that if more people knew the stories of how these patients were injured by their defective medical device and then learned that the company which made that device was shielded from any legal liability, i.e., complete and full immunity, we would hear a public outcry.

Please help spread the word about this March 31 Medical Device Patient Lobby Day in Washington, DC (sorry about the short notice) and, more importantly, let your representatives in Congress know how you feel about the proposed Medical Device Safety Act.

In closing, I thank the CSCI for arranging this Medical Device Patient Lobby Day and I hope this event serves to advance awareness about the tragic effects of federal preemption in the context of legal claims involving defective medical devices.

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.

2008 Emory Law Journal Article Presents Ketek As A Case Study In FDA Regulatory Failure

Discusses The Dire Consequences Of Fraudulent Science, Federal Preemption, And Corporate Deregulation

(Posted by Tom Lamb at DrugInjuryWatch.com)

Thomas O. McGarity, of the University of Texas School of Law, is uniquely positioned to give us a history of the beleaguered antibiotic Ketek in his 2008 article, "Corporate Accountability for Scientific Fraud: Ketek and the Perils of Aggressive Agency Preemption", which was published in the Emory Law Journal, Volume 58, Number 2 (58 EMORY L.J. 287, 2008).

From an introductory footnote we get this background information about Professor McGarity and this 2008 law review article about Ketek:

This Article lies at the intersection of three major projects on which the author has labored for the past several years and will continue to pursue during the next two years. The first, an inquiry with my colleague Professor Wendy Wagner into the strategies that advocates in the private sector employ to “bend science” to support predetermined policy agendas, resulted in a recently published book....  The second project describes and analyzes the efforts of common law defendants, joined more recently by some regulatory agencies, to persuade courts to find that state common law claims against the manufacturers of federally licensed products and activities are preempted by federal regulatory action....  The final project, a forthcoming book, Freedom to Harm, examines the thirty-year project of free market advocates in corporate America, conservative think tanks, and academia to free companies of “unnecessary and burdensome” regulatory responsibilities and common law obligations.

I understand not many of you may have the appetite nor the time to consume all that Professor McGarity has to offer in his 58-page law review article.  Anyone wanting to learn about the various "irregularities" in how Ketek was approved by the FDA, however, should at least be aware that this McGarity article is available as a resource.

To give one a sense of what this Ketek law review article by Professor McGarity has to offer, I have excerpted the following from the Introduction section:

• Part I briefly describes the new drug approval process through which a manufacturer of a prescription drug must obtain approval from the Food and Drug Administration (FDA) for new products and for new uses of existing products.

• Part II provides a case study of the dramatic failure of this process to protect consumers by using recently uncovered information concerning the antibiotic Ketek.

• Part III briefly describes the role that state common law can play in providing a backup for ensuring that manufacturers behave responsibly during the drug approval process and are held accountable when they do not.

• Part IV describes the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Committee, in which the Court held, in a fairly unique factual setting, that the plaintiffs’ common law claims based upon the fraud allegedly perpetrated by a consultant for a medical device manufacturer was preempted by federal law.  [footnote omitted]

• Part V analyzes the arguments for and against preemption of fraud-on-the-agency claims in light of the Ketek experience and concludes that, on balance, preemption is a bad idea because federal enforcement alone provides inadequate incentives to companies that, because they face powerful economic pressures to show large profits to their shareholders, are inclined to cut corners.

• Part VI offers suggestions on how the lower courts should react to Buckman, how the Supreme Court can avoid extending Buckman when it next takes up the issue, and how Congress might go about reversing or limiting Buckman and empowering common law courts to reassume the vital backstop role that they have played in the past.

One may wonder why Professor McGarity chose Ketek as his example for depicting what is currently wrong with the FDA and its drug-approval process.  From the Conclusion section:

Why does Ketek matter? Because FDA broke its own rules and allowed Ketek on the market; because dozens of patients have died or suffered needlessly; because FDA allowed Ketek’s maker to experiment with it on children over reviewers’ protests; because FDA ignored warnings about fraud; and because FDA used data it knew was false to reassure the public about Ketek’s safety.  [footnote omitted]

For those of you who are not familiar with Ketek (telithromycin), it is in a class of drugs called ketolide antibiotics and is to be prescribed only for community-acquired pneumonia. Ketek has been associated with adverse side effects such as liver damage, liver disease, liver failure, and hepatitis.

All Sprint Fidelis Federal Court MDL Cases Dismissed On Federal Preemption Grounds

U.S. District Court Judge in Minnesota Follows Supreme Court's Riegel vs. Medtronic Ruling As Precedent In Making His January 2009 Ruling

(Posted by Tom Lamb at DrugInjuryWatch.com)

All of the Sprint Fidelis cases that are part of the federal court multi-district litigation (MDL) were dismissed in early January 2009 pursuant to a motion to dismiss that had been filed by the defendant, Medtronic, Inc.

From a January 6, 2009 company press release, "Court Rules in Favor of Medtronic in Fidelis Litigation", we get this summary:

Medtronic, Inc. (NYSE: MDT) reported that on Jan. 5, the United States District Court for the District of Minnesota dismissed with prejudice the Master Consolidated Complaint for Individuals and the Master Consolidated Complaint for Third-Party Payors relating to the multi-district litigation (MDL) involving Medtronic’s Sprint Fidelis defibrillator leads on grounds of federal preemption. The Court issued a companion order that each case in the MDL will be dismissed with prejudice unless an individual plaintiff can establish his or her case survives the Court’s preemption analysis based on claims different from those asserted in the master complaints.

In an exuberant January 6 article, "Sprint Fidelis Preemption Decision - Yessssss", the Drug and Device Law blog -- which typically has an unabashed company / defense perspective on issues like this -- trumpeted this January 2009 medical device preemption ruling:

In what will certainly be an early entry for one of the top ten decisions of 2009, Medtronic just won. The short of it:

Medtronic, the Defendant in this multidistrict litigation, asserts the same doctrine here, arguing that Plaintiffs’ claims – sounding in negligence and strict products liability – are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. Having carefully considered the parties’ voluminous submissions, the Court agrees.

In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, slip op. at 2.

The Drug and Device Law blog was kind enough to post the Court's ALL CASES MEMORANDUM OPINION AND ORDER (slip opinion) which was filed for the MDL cases that are part of In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation.

In June 2008 we first reported that the U.S. Supreme Court's Riegel preemption ruling would be negated by legislation sponsored by Democrats in Congress which, in effect, permits U.S. patients to sue medical device companies like Medtronic if their product causes harm, such as the alleged injuries caused by the defective Sprint Fidelis lead wires.

With this federal preemption motion to dismiss being granted by the Sprint Fidelis MDL Court in January 2009, we expect there to be a renewed push to get this type of legislation passed in Congress and then to President-elect Obama later this year.

Over time I have expressed consistently my opposition to any federal preemption of patient lawsuits against medical device or pharmaceutical companies. 

Now we want to hear what you think about this federal preemption issue.

Live Web Chat With Diana Levine, of Wyeth v. Levine, November 18, 2008, At 3 PM EST

Also, Alliance For Justice (AFJ) Has New Documentary Film, "Access Denied?: The Fight for Corporate Accountability", Which Covers Ms. Levine’s Drug Injury Situation

(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.

**********

I received an email earlier this afternoon from Kyle Murphy, Communications Specialist for the Alliance for Justice (AFJ), in Washington, D.C., that informed me about two items concerning Diana Levine -- named plaintiff in the relatively well-known Wyeth v. Levine case, for which oral arguments were heard by the U.S. Supreme Court on November 3, 2008.

The first item is a live web chat with Diana Levine on Tuesday, November 18, 2008, at 3 p.m. EST, on the FireDogLake.com site.  According to Mr. Murphy's email, "in order to have full commenting rights, you must register your email account (free of charge) with FireDogLake".

The second item is a new documentary film from the Alliance for Justice, "Access Denied?: The Fight for Corporate Accountability", which tells Diana Levine's powerful and sad story regarding how this musician lost her arm to a drug injury that was preventable.  This recently released AFJ film was produced in conjunction with 12-time Emmy award-winning producers/directors Jon Alpert and Matt O’Neill.

Mr. Murphy suggested in his email that the November 18 live chat with Diana Levine would be a good opportunity for people like you and me to ask Diana Levine questions about this new AFJ documentary film which delves into her drug injury situation, including the looming federal preemption issue.

Because there is not much lead time, I urge you to do your part in spreading the news about this November 18 live chat with Diana Levine to anyone who might be interested in listening or participating.  Thanks.

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.

**********

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.

**********

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 Is Accused Of Withholding Or Altering Drug Study Results About Neurontin That Were Not Favorable

If Drug Companies Put Sales Above Efficacy And Safety, Should They Get Legal Immunity By Means Of Federal Preemption Doctrine?

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the first part of October 2008 we learned of yet another instance where a drug company chose to put profits over people.  Yet in the near future our U.S. Supreme Court may decide that the legal doctrine of federal preemption gives legal immunity to Big Pharma for drug injury lawsuits.

An October 8, 2008 Wall Street Journal article, "Suit Alleges Pfizer Spun Unfavorable Drug Studies", explained what is new as far as bad conduct goes in the pharmaceutical sector:

Documents and emails released this week in the case in U.S. District Court in Boston suggest Pfizer's marketers influenced the drug's scientific record to boost sales at least until 2003 by declining to release or altering the conclusions of studies that found no beneficial effect from Neurontin for various off-label conditions....

According to documents in the Boston case, a European study done in the late 1990s by Warner-Lambert to measure Neurontin's use for diabetic nerve pain produced consternation at Pfizer after it failed to find a significant effect. "I think we can limit the potential downsides of the ... study by delaying the publication for as long as possible," wrote Michael Rowbothan, then Neurontin's marketing team leader, in a 2000 email sent after Pfizer bought Warner-Lambert. He added that "it will be more important to how WE write up the study."

A second October 8 article, "Experts Conclude Pfizer Manipulated Studies", published by the New York Times, added some commentary and then put this latest incident in context:

One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings.” ...

The expert reports, unsealed Monday in a federal court in Boston, add to accusations that the pharmaceutical industry has controlled the flow of clinical research data, blurring the lines between science and marketing.

In April, for example, a group of academic doctors questioned the validity of drug industry research after finding that Merck had hired ghostwriters to produce scientific articles about Vioxx, then recruited prestigious doctors to serve as their official authors. Vioxx, a painkiller, was withdrawn from the market in 2004 after research indicated it could cause strokes and heart attacks.

Last winter, Merck and Schering-Plough were criticized for delaying the release of a study on their best-selling cholesterol medication Vytorin that showed the drug did not slow the growth of plaque in arteries. In the case of Pfizer’s Neurontin, the negative studies would have increased doubts about the drug’s value for several unapproved uses — treating bipolar disorder, controlling certain types of pain and preventing migraine headaches, according to the expert opinions.

What is even more remarkable, in light of this type of misconduct, is that the U.S. Supreme Court, in the Wyeth v. Levine case, may soon give these drug companies immunity to drug injury lawsuits by application of the federal preemption legal doctrine to those cases.

It seems to me that this legal immunity is a get-out-of-jail-free card that the drug companies cannot and should not be trusted with for the sake of American drug safety.