Drug Injury Watch

April 2008 Accutane Trial In New Jersey Ends With Plaintiff Verdict

Utah Woman Developed Inflammatory Bowel Disease After Using This Hoffman-LaRoche Drug

(Posted by Tom Lamb at DrugInjuryWatch.com)

A 24-year old woman from Utah was awarded more than $10 million in legal compensation by a New Jersey state court jury in a trial involving the allegation that Accutane (isotretinoin), a prescription acne medication, caused her inflammatory bowel disease (IBD).  The case is Kamie S. Kendall v. Hoffman-La Roche Inc., No. ATL-L-8213-05-MT, N.J. Super., Atlantic Co.

From an April 23, 2008 article, "Jury Awards $10.5 Million Over Accutane", by Wall Street Journal (WSJ) reporter Heather Won Tesoriero:

The jury awarded $10.5 million of compensatory damages plus $78,500 for medical expenses. The judge presiding over the case ruled there was insufficient evidence to allow the jury to consider punitive damages or consumer fraud....

Since it was introduced in 1982, Accutane, which is still sold, has been taken by roughly 13 million people in the U.S. A company spokesman said in a statement that "the Accutane labeling has contained a warning about IBD for more than 20 years."

In May 2007 the first New Jersey case against Hoffman-La Roche Inc. for the failure to warn that its acne drug Accutane can cause inflammatory bowel disease (IBD) went to trial; it resulted in a $2.6 million verdict against the drug company.

A second Accutane trial in October 2007 ended with a jury awarding $7 million to the plaintiff.

A Hoffman-LaRoche spokesman said the company plans to appeal all three Accutane verdicts, according to the April 23 WSJ article.

Jaw Bone Decay, Or Osteonecrosis, Is Serious Albeit Rare Side Effect Of Fosamax Use

This Condition Is Referred To Generally As Bisphosphonate-Related Osteonecrosis Of The Jaw (BRONJ)

(Posted by Tom Lamb at DrugInjuryWatch.com)

The April 8, 2008 edition of Journal Watch General Medicine included a brief article titled "Should We Be Concerned About Jaw Osteonecrosis with Oral Bisphosphonates?", by Allan S. Brett, MD, and Peter B. Lockhart, DDS.

The first part of this article provides some background information:

[Bisphosphonate-related osteonecrosis of the jaw (BRONJ)] is defined as exposed, necrotic bone in the maxillofacial region that persists for more than 8 weeks in current or past recipients of bisphosphonate therapy. The condition can occur spontaneously or after invasive dental procedures. These lesions often expand — sometimes involving large areas of the alveolar bone — and no treatment has been proven to be effective. Reports of BRONJ first surfaced about 5 years ago, primarily in cancer patients who had received IV bisphosphonates for hypercalcemia and bone metastases. Experts generally accept the association between jaw osteonecrosis and IV bisphosphonates, which are often given repetitively in high doses. [footnotes omitted].

Next, Dr. Brett and Dr. Lockhart turn their attention to the incident rate of oral bisphosphonates such as Fosamax causing BRONJ, also referred to simply as ONJ.  They point out that such a determination is made difficult due to this fact:

No ICD-9 code exists for jaw osteonecrosis, so the researchers had to use other codes (e.g., diagnostic codes for inflammatory conditions of the jaw and procedure codes for jaw surgery) as surrogate markers for jaw osteonecrosis.

In view of this "important limitation", for their article Brett and Lockhart spoke to dentists with patients treated with Fosamax and other oral bisphosphonates who developed symptoms of ONJ after either invasive dental procedures or, in some instances, even without any apparent jaw-area trauma.  From those discussions, the authors conclude:

Although these anecdotal unpublished observations hardly prove cause and effect, they should not be dismissed out of hand for at least two reasons. First, if we accept that IV bisphosphonates can cause jaw osteonecrosis, we can reasonably assume that oral therapy occasionally might cause the same complication in highly susceptible people. And second, biopsy-proven severe suppression of bone turnover — resulting in spontaneous fractures of the femur, pelvis, and ribs — has been described in several patients after long-term oral bisphosphonate therapy. [footnote omitted]

This April 2008 Journal Watch article is followed by a list of eight source items; each has a link to its free Medline abstract for those who want to delve deeper into this issue.

One recent medical article that is not listed therein is "Osteonecrosis of the jaw.", by NB Watts and RD Marciani, which appeared in the Southern Medical Journal dated February 1, 2008. Its Medline abstract includes the following statement, however, which suggests this article does not add much to the discussion -- perhaps why it was not referenced by Brett and Lockhart:

Although ONJ occurs exclusively or almost exclusively in patients receiving bisphosphonate therapy, a causal association has not been shown, and the mechanism is not clear.

In the legal arena, at present Merck & Co. faces numerous product liability lawsuits brought by patients who have developed ONJ after using Fosamax.  These lawsuits are based on the allegation that Merck failed to warn doctors and patients in a timely manner about reports of jaw bone decay, or rot, being associated with its osteoporosis drug Fosamax.

Ortho Evra, Preemption, And The New York Times: Another Drug Company Response Letter

And, We Learn About More Of Merck's Vioxx Shenanigans -- Another Benefit Of Pharmaceutical Product Liability Litigation

(Posted by Tom Lamb at DrugInjuryWatch.com)

For the second time in as many weeks, it was the Johnson & Johnson (J&J) company blog that tipped us off that Ortho-McNeil is responding to an item from The New York Times by posting a letter on the Ortho Evra web site.

To start, on April 14, 2008 the Times ran an editorial, "The Dangers in Pre-emption", which begins:

The pharmaceutical industry and its good friends in the Bush administration are working hard to prevent consumers from filing damage suits for injuries caused by federally approved drug products. They may soon get a helping hand from the Supreme Court, which has already barred many suits over faulty medical devices....

Next, here's the same-day post on the J&J blog, titled "ORTHO EVRA and Preemption — Revisited":

Today, The New York Times editorial page commented on the concept of preemption, basing much of their position on an April 6 New York Times article on the same subject and once again featuring ORTHO EVRA®, the birth control patch marketed in the U.S. by our Ortho-McNeil unit. Today, Ortho-McNeil published a letter from David Norton, the Company Group Chairman, Worldwide Commercial and Operations, who is responsible for the Ortho-McNeil business that provides more context from our perspective for those who are interested.

If you prefer, go directly to this "April 13, 2008 Employee Follow-up Communication", written by Ortho-McNeil's David Y. Norton.

Meanwhile, in a convenient coincidence, in the past couple of days there has been a tremendous amount of media coverage given to the discovery that Merck used "ghostwriters" for Vioxx articles and failed to disclose to the FDA an internal analysis which found Alzheimer's patients who were taking Vioxx in a clinical study sponsored by Merck had a three times greater risk of death than patients taking a placebo.

As summarized by Peggy Peck for MedPage Today in an April 15, 2008 online article, "Rofecoxib (Vioxx) Studies on Mortality Were Controlled by Drug Company":

Ongoing litigation about rofecoxib (Vioxx) has provided confirmation that Merck employees or hired ghostwriters were the true authors of manuscripts about the drug published as the work of academic researchers.

That finding was published in the April 16 issue of the Journal of the American Medical Association along with a second study -- also mined from a paper flood uncovered by lawyers -- that suggests Merck manipulated data to hide an increased mortality risk with rofecoxib.

Bruce M. Psaty, M.D., Ph.D., and Richard A. Kronmal, Ph.D., of the University of Washington in Seattle, said Merck told the FDA that an intention-to-treat analysis of data from three trials designed to assess the effects of rofecoxib on the occurrence or progression of Alzheimer's disease revealed an increased mortality risk with the drug....

The underlying study is "Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment: A Case Study Based on Documents From Rofecoxib Litigation (JAMA. 2008;299(15):1813-1817).

For additional detail, we turn to "Merck May Have Misrepresented Vioxx Risks", by Anna Sophia McKenney, and posted April 16, 2008 at Medical News Today: 

The risk-benefit profile of rofecoxib (marketed under the names Vioxx, Ceoxx and Ceeoxx) may be have been misrepresented by the study sponsor, Merck, in clinical trials with patients with cognitive impairment. This was the result of a comparison of internal company documents, data submitted by the company to the Food and Drug Administration (FDA,) and published clinical trial results, according to an article in the April 16 issues of JAMA....

... These documents were made available during litigation related to rofecoxib and Merck, including internal company analyses and information provided by the sponsor to the Food and Drug Administration....

It seems to me that this conduct by Ortho-McNeil and Merck demonstrates that federal preemption is a concept which does not fit the reality of how drug companies "interact" with FDA officials as regards the safety of their products.  Likewise, what we have learned about Ortho Evra and Vioxx as the result of pharmceutical product liability litigation shows why preemption is a bad idea.

Ortho-McNeil's Response To April 2008 NYT Article About Ortho Evra And FDA / Federal Preemption

New York Times Reporters Gardiner Harris and Alex Berenson Bring Attention To How This Emerging Legal Issue Would Affect Drug Injury Cases

(Posted by Tom Lamb at DrugInjuryWatch.com)

To our pleasant surprise, we saw lots of notice and reaction being given to the April 6, 2008 New York Times (NYT) article, "Drug Makers Near Old Goal: A Legal Shield", wherein Times reporters Gardiner Harris and Alex Berenson explore the concept of "federal preemption" as regards some pending Ortho Evra lawsuits. 

The Harris - Berenson NYT "Ortho Evra" article is worth a read, especially if you have an interest in either the preemption issue or this particular drug injury litigation:

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted....

What had not gotten as much attention was Ortho-McNeil's written response to this April 6 NYT article that the drug company published on their website.  One reason for the lower profile might be that the company-statement item is a bit difficult to find: It goes by the obscure title of "April 2008 Employee Communication", and the link is found on what appears to be a new, specially created web page, i.e., it had no page title nor was it listed on the Sitemap when accessed at 4:20 p.m. on April 7, 2008.

Perhaps wanting to make sure that the word got out, however, the Ortho McNeil "retort" was the subject of an April 7 post, "The New York Times, Pre-Emption and ORTHO EVRA", found over at "About JNJ BTW" -- the in-house blog for Johnson & Johnson (Editor: Marc Monseau).

As for the text of Ortho McNeil's retort to this Ortho Evra - federal preemption story, here's the gist:

While the [April 6 NYT] article deals predominantly with the issue of pre-emption, it also questions our commitment to patient safety and scientific integrity. And in so doing, it inaccurately depicts our actions leading up to approval of the patch by the U.S. Food and Drug Administration (FDA) in 2001, and the data reporting procedures we have followed since. I want to make sure you have our point of view, in part because some of the characterizations in the article, including references to internal company documents, are taken clearly out of context.

This April 2008 NYT report demonstrates how important it is to learn more about this issue of federal preemption.  As I wrote recently on this site, in this post, "Issue: Should We Be Prohibited From Filing Product Liability Lawsuits Against Medical Device Manufacturers And Pharmaceutical Companies?":

According to some critics, the prohibition of drug injury lawsuits by operation of the federal preemption doctrine may have some merit in an ideal world where the FDA was performing its drug-safety regulatory functions at 100%.  But that has not been the situation in the past, nor is it the case today.

Our thanks to two of the leading Pharma reporters, Gardiner Harris and Alex Berenson, for shining a light on this critical legal issue of preemption in the context of drug injury claims.

Zyprexa And Diabetes: Is This A Tale Of Company Greed Coupled With FDA Failure?

Alaska v. Eli Lilly Trial: Focus Is On What Was Known About This Alleged Side Effect, And When They Knew It

(Posted by Tom Lamb at DrugInjuryWatch.com)

News reports about the case Alaska v. Eli Lilly & Co., 3AN-06-05630 CI, Alaska Superior Court (Anchorage), have been limited but interesting thus far.

The most prolific news coverage to date has come from Lisa Demer, reporting for the Anchorage Daily News.  Her March 22, 2008 article, "Defense opens in Zyprexa trial", informed us about some interesting comments made by the trial judge during a court session that involved only the lawyers for the parties -- such that jurors did not get this earful:

Without lawsuits like the one the State of Alaska brought against Lilly, claims that drugs cause health problems "might well go unaddressed," Anchorage Superior Court Judge Mark Rindner said from the bench this week....

Rindner was reacting to an assertion by Lilly lawyer George Lehner that drug regulation is a matter for the federal Food and Drug Administration, not any state. Alaska's Unfair Trade Practices and Consumer Protection Act shouldn't apply to drugs, Lehner told the judge.

Rindner disagreed. Evidence presented by the state over the past two weeks established that the FDA "isn't capable of policing this matter," he said.

As background, Zyprexa is Lilly’s top-selling prescription drug, with worldwide sales of $4.8 billion in 2007.  Zyprexa was approved in September 1996 for the treatment of schizophrenia. Starting soon thereafter, doctors began to report to the FDA and to Lilly that some patients using Zyprexa seemed to experience severe weight gain and high blood sugar which seemed to lead to diabetes in some instances.

The State of Alaska has sued Lilly to recover medical costs paid by the State when treating Medicaid patients who have developed diabetes after taking Zyprexa. The jury trial of that lawsuit, which started earlier this month, is being heard in an Alaska state court located in Anchorage.

A March 8 article, "Lilly Waited Too Long to Warn About Schizophrenia Drug, Doctor Testifies", by Alex Berenson, of The New York Times, provided this account of some early expert testimony in support the state's contention that this Lilly downplayed the serious side effect risks associated with Zyprexa in order to make more money:

Eli Lilly, the drug maker, could and should have warned physicians as early as 1998 about the link between Zyprexa, its best-selling schizophrenia medicine, and diabetes, an expert witness told jurors Friday in a lawsuit that claims that Zyprexa has caused many mentally ill people to develop diabetes.

Instead, Lilly hid Zyprexa’s risks from doctors to protect the drug’s sales, according to the witness, Dr. John Gueriguian. Lilly waited until 2007 to add strong warnings to Zyprexa’s label to reflect the drug’s tendency to cause severe weight gain and blood sugar changes.

Lilly put “profit over concern of the consumer,” Dr. Gueriguian said Friday near the end of four hours of testimony....

By the fall of 1998, the combination of adverse-event reports, clinical trial data that showed hyperglycemia and weight gain, and problems in animal studies should have been enough for Lilly to warn doctors about Zyprexa’s links to diabetes, Dr. Gueriguian said. Instead, the company did nothing.

Documents from 1999 and 2000 also showed that Lilly was accumulating evidence of Zyprexa’s risks but not sharing it with doctors, he testified.

With this and other similar testimony being heard by Judge Rindner, it is understandable why he is doubtful about the proposition that the FDA is on-the-job and, therefore, federal preemption is warranted.

In closing, if you are interested in learning more about this Alaska v. Eli Lilly trial, you need to visit the Anchorage Daily News online pages with Zyprexa articles by Lisa Demer, such as her March 14, 2008 report, "Japan made Zyprexa labels reflect risk to diabetics".  On these pages there are links to resources that will give you insight to past and present developments, both, that are significant to this ongoing Zyprexa trial in Alaska.

Issue: Should We Be Prohibited From Filing Product Liability Lawsuits Against Medical Device Manufacturers And Pharmaceutical Companies?

Opinion: Patient Lawsuits Are A Significant Incentive For These Manufacturers And Companies To Ensure That Their Products Are Safe For Use By American Patients

(Posted by Tom Lamb at DrugInjuryWatch.com)

First of all, I presume most of you believe – because as Americans we have always looked to our court system to vindicate our rights – that we are allowed to file these lawsuits today. 

With regard to most cases against medical device companies, however, as of February 2008 you are wrong; and, soon, injured patients may not be allowed to get any legal compensation from a pharmaceutical company for serious side effects caused by their prescription drug.

On February 20, in the Riegel v. Medtronic case, the U.S. Supreme Court granted legal immunity to manufacturers of medical devices which had been approved by the FDA.  This  means that in the future, for most instances, the medical device manufacturers will have no financial accountability for their mistakes if and when their products harm a patient. 

To reach this decision, the Supreme Court used the legal doctrine of  “federal preemption”.  Ironically, this doctrine comes from our Founding Fathers’ Constitution, but in recent years it has been used by the current Bush Administration to abolish a person’s right to sue when injured by a company’s product.

As a start, let us focus on the FDA-approval part of the Supreme Court’s Riegel decision. 

During this past year, the Institute of Medicine, the Government Accountability Office, and the FDA’s own science board have all issued reports that essentially reach the same conclusion: The FDA is largely incapable of protecting the public from unsafe medical devices and drugs.

Moreover, the FDA does not do its own testing; rather, the FDA is almost totally dependent on the companies that it is suppose to oversee to provide the agency with data concerning the safety and effectiveness of new prescription drugs and medical devices. 

Further, the vast majority of FDA approvals occur without there being any representation of patients’ interests; and, safety decisions after the drug or device is approved rarely include input from patient advocacy groups.

Meanwhile, the medical device manufacturers and the pharmaceutical companies clearly have an inherent conflict of interest when addressing safety issues concerning their products, which are intended to make them a profit. 

In addition, these business corporations have stronger legal obligations to their stockholders than they do to the patients who use their products.

Let’s return to the question at hand: Should patients have access to our court systems in oder to file lawsuits for injuries caused by unsafe drugs and medical devices?

In October of this year, 2008, the Supreme Court will hear oral arguments in the Wyeth v. Levine case.  The primary issue in that case is whether people who suffered a drug injury should be able to get any legal compensation from the pharmaceutical company responsible for that drug. 

You will probably be surprised to learn that, at this hearing, the drug company’s lawyers will be assisted by the Bush Administration’s Solicitor General in making their argument that an injured patient should not have any legal right to compensation.

In more detail, the drug company Wyeth and the Bush Administration will be arguing in this Levine case that the Food, Drug and Cosmetic Act of 1938 -- under which the FDA regulates prescription drugs -- has "implied preemption" due to the structure of this statute, i.e., the law's actual text does not include any preemption clause. 

The Levine case involves a Vermont woman who lost a hand and forearm to gangrene after being improperly injected with the drug Phenergan. At the trial of this lawsuit, Wyeth argued that its drug had met FDA’s federal labeling requirements and, therefore, the drug company should not have any legal liability under state law for this patient’s injury. 

The trial court judge disagreed with Wyeth on this issue, and the jury in that case went on to award $6.8 million in legal compensation to Mrs. Levine for her injury. 

The Vermont Supreme Court ultimately upheld the judge’s ruling and the jury verdict; but the U.S. Supreme Court later accepted this case for review – upon the request of the drug company and the Bush Administration.

As stated above, oral arguments regarding the federal preemption issue will be made to the nine Supreme Court Justices in the Levine case later this year, in October 2008. 

Sometime thereafter, and no later than the summer of 2009, our Supreme Court will decide whether the FDA approval of a prescription drug will serve as a prohibition against patients filing their personal injury and wrongful death lawsuits against drug companies.

According to some critics, the prohibition of drug injury lawsuits by operation of the federal preemption doctrine may have some merit in an ideal world where the FDA was performing its drug-safety regulatory functions at 100%.  But that has not been the situation in the past, nor is it the case today.

It is my opinion that the U.S. Congress should move quickly to pass legislation that would correct the Riegel decision by the Supreme Court, and serve to prevent such a ruling against patients’ rights in the Levine case.   

This legislation is needed because, in my experience, the possibility of becoming involved in product liability litigation is a significant incentive for the medical device manufactures and the pharmaceutical companies to ensure that their products are safe for use by American patients.

I would like to hear what you think about this issue as well as my opinion about use of the federal preemption doctrine in this context.  You can do so by submitting a Comment, below. 

Also, I encourage you to share this piece with others by email, bookmarking, etc.  Of course, I understand that not all people will line-up with me on this issue.  I believe, however, that all citizens will agree that this federal preemption issue is too important to remain as low-profile as it has been to this point in time.

(Thanks for reading this issue-and-opinion piece, which is a departure from the usual news and information about prescription drug side effects that is presented here at Drug Injury Watch.)

P.S.  I have posted this issue on the HeyMonkeyBrain! part of Squidoo: 

"What if you were hurt by a drug and couldn't sue?"

That page can be found here:  http://www.squidoo.com/preemption

Perhaps you can help get this debate started?

Thanks for your effort and time.  (3/20/08)

P.S.  Read an interview with Diane Levine which was done by Ed Silverman and posted on his blog, Pharmalot, earlier this year.  (3/24/08)

Sprint Fidelis Recall Showed That FDA's Medical Device Safety System Is Flawed

Dr. Hauser: "Just because a device is FDA-approved does not necessarily mean it is safe."

(Posted by Tom Lamb at DrugInjuryWatch.com)

In his March 5, 2008 article -- "Medical device safety in spotlight; M.D. uses Medtronic recall in critique of FDA, manufacturers" -- reporter Christopher Snowbeck explores how the Sprint Fidelis lead wire recall in October 2007 by Medtronic Inc. showed the medical device safety system as it currently operates here in the U.S. is fundamentally flawed.

For this article about the Medtronic recall last year, Mr. Snowbeck uses as his starting point a "Perspective" piece by William H. Maisel, M.D., M.P.H., which was published in the March 6, 2008 edition of The New England Journal of Medicine (NEJM), "Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices", which he describes as follows: 

Dr. William Maisel, an expert on medical device safety at Boston's Beth Israel Deaconess Medical Center, writes in today's edition of the New England Journal of Medicine that the Medtronic recall is the latest example of how manufacturers and the U.S. Food and Drug Administration have failed to provide the public with timely, critical information about device malfunctions....

Maisel said that five months before Medtronic recalled the Sprint Fidelis lead wire, the company submitted an application to the FDA to change the product's design and manufacturing.

That request was not publicized to physicians or patients, Maisel wrote, even though doctors had received letters from Medtronic in February 2007 stating that there could be a problem with the lead. He noted that after FDA approved the design changes, old versions of the Sprint Fidelis lead remained on hospital shelves for use in patients.

"Often, a flawed product continues to be marketed while the manufacturer submits a revised marketing application to the FDA and awaits approval of the amended product design and manufacturing plan," Maisel wrote. "Manufacturers have repeatedly and knowingly sold potentially defective devices without public disclosure."

Mr. Snowbeck then permits Medtronic an opportunity to respond to these contentions by Dr. Maisel:

Rob Clark, a Medtronic spokesman,... maintained Maisel's editorial omits key details in describing how the company handled the Sprint Fidelis matter.

"The narrative is incomplete and omits facts that are essential to any full accounting or analysis of the events and their ramifications," Clark said.

.. Clark said the Sprint Fidelis design change sought by the company in May had nothing to do with the problems that ultimately led to the recall. Manufacturers regularly make such design changes as they improve products, Clark said, and those changes don't indicate earlier versions are flawed.

Finally, Mr. Snowbeck goes beyond the NEJM article dispute to get the insight and opinion of a man who helped bring the Sprint Fidelis problem to light. In July 2007 Dr. Robert Hauser, of the Minneapolis Heart Institute, published a medical journal article that suggested patients with implantable defibrillators which had Sprint Fidelis lead wires were being needlessly and repeatedly shocked because those lead wires were fracturing at an unusually high rate. Here's what Dr. Hauser told Mr. Snowbeck as he prepared his March 2008 story:

"When you stand back and look at this, what's so disturbing is that physicians started implanting this lead because it was FDA-approved — they thought, 'Well, it's a nice, small lead, and it's FDA-approved so it must be OK,'" said Hauser. "Just because a device is FDA-approved does not necessarily mean it is safe."

Unfortunately for us, however, Medtronic and other makers of medical devices like implantable defibrillators are now immune from legal liability any injury or death their product might cause as long as it was FDA-approved.  This situation is the result of an opinion issued by the U.S. Supreme Court on February 20, 2008, in the case Riegel v. Medtronic Inc. (No. 06-179).

As explained by New York Times reporter in her February 21, 2008 article, "Justices Shield Medical Devices From Lawsuits":

The 8-to-1 decision [in the Riegel v. Medtronic case] was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.

In 2004, the administration reversed longstanding federal policy and began arguing that "premarket approval" of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.

The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.

The prescription drug injury case referred to in that last paragraph is Wyeth v. Levine and in that case the Supreme Court will decide whether a patient should be able to sue a pharmaceutical company when there is a serious side effect that the company did not fully disclose, amongst other scenarios where currently the patient does have access to the court system here in the U.S.

The short of it is, as seen by this March 5 article about the defective Sprint Fidelis lead wire, just because a medical device was approved by the FDA does not mean it is a safe product.

P.S.  A well-written Opinion article from attorney Thomas R. Kline, "Immunity is a bad medicine for Americans' well-being", was published by The Philadelphia Inquirer on March 7, 2008.  It begins with this paragraph:

On Feb. 20, the U.S. Supreme Court granted legal immunity to manufacturers of medical devices that secure "pre-market approval" from the Food and Drug Administration for their products. The 8-1 decision in Riegel v. Medtronic guarantees medical-device manufacturers will have no financial accountability for their mistakes when their products are simply made according to FDA minimum specifications. Those standards are, in the words of noted Harvard pharmaco-epidemiologist Jerry Avorn, so minimal they "would be unacceptable anywhere else in research."...

Patient Lawsuits Against Pharmaceutical Companies For Drug Injuries Might Be Prohibited In U.S.

Our Tort System Provides A Needed Means Of Accountability; Law Professor: "A lot is lost without these lawsuits."

(Posted by Tom Lamb at DrugInjuryWatch.com)

On March 3, 2008 the U.S. Supreme Court issued its ruling in the Warner-Lambert v. Kent case and, in so doing, declined the invitation of pharmaceutical companies -- and the Bush administration -- to prohibit drug injury lawsuits from being filed by patients who have suffered serious side effects caused by unsafe prescription drugs.

The tie vote by which the Supreme Court arrived at its decision in Warner-Lambert v. Kent, however, means that this ruling does not set any precedent on the federal preemption issue that is the increasing focus of products liability lawsuits that involve FDA-approved prescription drugs and medical devices.   

From the March 4, 2008 article, "Court Allows Suit Against Drug Maker", by New York Times reporter Linda Greenhouse:

This case, Warner-Lambert Co. v. Kent, presented a narrow slice of the broad pre-emption issue that the court will take up in its next term. In that new case, Wyeth v. Levine, the question is whether the Food and Drug Administration’s approval of a drug’s label precludes individual damage suits based on the claim that the label failed to include sufficient information or adequate warnings.

In essence, if the answer is yes, most individual lawsuits for damages caused by approved drugs would be pre-empted. Last month, in Riegel v. Medtronic Inc., the court interpreted a federal law, the Medical Device Amendments, as barring most individual lawsuits against manufacturers of approved medical devices....

The Bush administration, which has embraced a broad theory of federal pre-emption of individual tort suits, entered the case on the manufacturer’s behalf. It argued that “permitting lay juries to second-guess” the adequacy of a drug application would interfere with the agency’s “exercise of its expert judgment.”

In more detail, the Bush administration will be arguing in Wyeth v. Levine (No. 06-1294) that the Food, Drug and Cosmetic Act of 1938 -- under which the FDA regulates prescription drugs -- has "implied preemption" due to the structure of this statute, i.e., the law's text does not include any preemption clause. 

The Levine case involves a Vermont woman who lost a hand and forearm to gangrene after being improperly injected with the drug Phenergan. At the trial of this lawsuit, Wyeth argued that its drug had met FDA labeling requirements and, accordingly, the drug company should face no liability under state law.  The trial court judge disagreed, and the jury in that case awarded $6.8 million in legal compensation to Levine for her injury.

According to some critics, federal preemption of drug injury cases may have some merit in an ideal world where the FDA was performing its drug-safety regulatory functions at 100%.  But that has not been the situation in the past, nor is it the case today.

In his March 3, 2008 article, "Patients' ability to sue at risk", Los Angeles Times reporter Daniel Costello presented these facts which tend to show why federal preemption of drug injury cases is a bad idea:

The FDA "doesn't have the ability at this time to oversee in a comprehensive fashion everything it regulates," said David A. Kessler, a former FDA chief and a professor at UC San Francisco.

A trio of recent reports, including one by the FDA's own advisory committee, has raised serious questions about the agency's recent performance.

Last fall a yearlong study by the FDA's advisory committee found "the agency is so underfunded and understaffed that it's putting U.S. consumers at risk in terms of food and drug safety."

In an unusual public departure from the view of the Bush administration, the current FDA commissioner, Andrew C. von Eschenbach, said in an interview last week that the agency needed a systemic overhaul that could take years....

Some legal experts and attorneys are concerned that without such lawsuits, regulators and the public may never hear of evidence that manufacturers knowingly marketed products they knew were unsafe.

In recent years, documents and e-mails uncovered in court cases have shown that some companies kept safety issues involving their products from the FDA.

"Without the tort system, what reasonable assurance do we have we will learn about the bad actors?" asked David Vladek [sic], a law professor at Georgetown University.

"A lot is lost without these lawsuits."

Oral arguments in the Levine case are scheduled for October 2008.  Sometime thereafter the Supreme Court will decide whether FDA approval of a prescription drug prohibits the filing of personal injury and wrongful death lawsuits against drug companies.

No doubt we will continue to hear a lot about this important policy issue in the months to come.

P.S.  Dr. David A. Kessler, Dean and Vice Chancellor for Medical Affairs at the University of California San Francisco and former FDA Commissioner, and David C. Vladeck, Professor of Law at Georgetown University Law Center, explore the legality and wisdom of this continuing effort by the FDA and the Bush administration to persuade lower courts, including the Supreme Court, to preempt most failure-to-warn claims asserted by patients against drug companies in this recent law review article:

David A. Kessler & David C. Vladeck, A Critical Examination of the FDA’s Efforts To Preempt Failure-To-Warn Claims, 96 GEO. L.J. 461 (2008).

Dean Kessler and Professor Vladeck explain how the FDA’s position, if ultimately adopted by the Supreme Court, 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.  The authors explain, also, why the FDA’s view that the agency, alone, is capable of regulating the safety of prescription drugs in the U.S. is unrealistic. 

This 35-page scholarly article is compelling and insightful as to why federal preemption of drug injury cases is a bad idea.  (3/5/08)

Dr. Dennis Mangano Says On 60 Minutes In February 2008 That Trasylol Should Have Been Recalled As Early As January 2006

Delay By Bayer And FDA Until November 2007, When Trasylol Sales Were "Suspended", Caused 22,000 Excess Deaths Per CBS Report

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to interviews broadcast by CBS Television's 60 Minutes program about Trasylol on February 17, 2008, an estimated 22,000 patient lives could have been saved if the FDA had acted quicker to recall Trasylol, Bayer AG's drug used to stem bleeding during open heart surgery.

Trasylol (aprotinin injection) sales in the U.S. and Canada were suspended by Bayer in early November 2007. Trasylol was used to reduce blood loss during coronary artery bypass surgery.

As background, in mid-February 2006 the FDA announced it was evaluating the safety of Trasylol after new studies had linked this heart surgery drug to higher risks of kidney problems, heart attacks, and strokes.  At the end of February 2006 a "Dear Doctor" letter from Bayer regarding Trasylol was posted on Health Canada's MedEffect web site.

Later, the FDA held an advisory committee meeting in September 2006 and, thereafter, convened another such meeting on September 12, 2007 to further discuss Trasylol. 

A February 15, 2008 Reuters article, "22,000 died amid delayed Bayer drug recall: doctor", provided these details based on a review of this 60 Minutes report about Trasylol that had been posted on the CBS News web site in advance of the February 17 broadcast:

Dr. Dennis Mangano, the study's researcher, said during the program that 22,000 lives could have been saved if Trasylol had been taken off the market when he first published his study in January 2006....

He said in the broadcast that Bayer failed to disclose to the FDA during an FDA advisory panel meeting in September 2006 -- at which Mangano's negative findings were discussed -- that the German drugmaker had conducted its own research which confirmed the same dangers established by his study.

The chairman of the FDA advisory panel, Dr. William Hiatt, told 60 Minutes he would have voted to remove Trasylol from the market had he been informed about Bayer's study, according to the CBS report.

As acknowledged by company spokeswoman Meredith Fischer in the February 15 Reuters article, product liability lawsuits have been filed against Bayer on behalf of patients who had died or been seriously injured following the use of Trasylol during their heart surgery.

P.S.  In advance of the September 2006 advisory committee meeting about Trasylol, FDA reviewers asked Dr. Mangano for his group’s data in order to see if Trasylol should be withdrawn based on the new evidence.  Read what happened thereafter in Merrill Goozner's November 27, 2006 article, "CABG from NEJM on Thanksgiving", which he posted at Gooznews.com  (2/19/08)

Video Of January 2008 Vioxx Settlement Panel Discussion Is Available Online

Lawyers And Law Professors Discuss The Good, The Bad, And The Ugly Of Merck's Proposed "Global Settlement" Of All U.S. Vioxx Lawsuits

(Posted by Tom Lamb at DrugInjuryWatch.com)

We learned from a January 9, 2009 post, "Webcast of Vioxx Settlement Panel" -- which we found when taking our daily look at the Drug and Device Law blog -- that you can now view online for free C-SPAN's broadcast of "The Vioxx Settlement" panel discussion which took place in Washington, D.C. on the afternoon of January 7, 2008 at the American Enterprise Institute (AEI).

In addition, on the AEI web page for this January 2008 panel discussion of Merck's proposed Vioxx settlement there is a link to the video, at top of right side bar.  (One small advantage to using this means of viewing "The Vioxx Settlement" event is that you don't have to watch some of those people in attendance eat their lunch at the start, as you do on the C-SPAN webcast.)

From that the AEI "The Vioxx Settlement" web page we get this introduction to the panel members:

At this event cosponsored by AEI and the Federalist Society, a panel of experts will explore these and other questions. Speakers include Vanderbilt law professor Richard Nagareda, author of Mass Torts in a World of Settlement; Virginia legal ethics professor George Cohen; author and leading pharmaceutical mass torts defense attorney Mark Herrmann; Andy Birchfield, a member of the Vioxx Plaintiffs’ Steering Committee; and Ted Frank, director of the AEI Legal Center for the Public Interest. AEI resident scholar John E. Calfee will moderate.

A January 7, 2008 post on "The BLT: The Blog of Legal Times" entitled "AEI on Vioxx" provides this same-day report on what was said about Merck's Vioxx Settlement Program by some of the panel members:

In November of last year, Merck & Co. negotiated a settlement proposal with plaintiffs attorneys that, if 85 percent of the claimants agree to it, will give $4.85 billion to the thousands of claimants and their lawyers. But as the AEI panel showed, opinions vary greatly on the settlement.

Mark Herrmann, a defense attorney with Jones Day in Chicago, said the settlement “made sense. It was logical, and it, in fact, was predictable from the start.”

But George Cohen, a law professor at the University of Virginia, had some ethical concerns with the proposed settlement. The terms of the agreement could stand in the way of lawyers giving their clients adequate advice. “The temptation will be, I fear, that lawyers will want to recommend this to people even if it’s not in their best interest,” says Cohen.

Andy Birchfield, an attorney at Beasley Allen and co-lead counsel on the Plaintiffs’ Steering Committee for the federal Vioxx litigation, countered that the settlement had been designed so that plaintiffs attorneys couldn’t “game the system” or cherry pick the best cases to leave out of the settlement.

As a caveat, we point out that this "The Vioxx Settlement" webcast weighs-in at just over two hours in duration (according to the C-SPAN site).  While we understand that most of our readers will not have sufficient curiosity about Merck's proposed Vioxx Settlement Program to sit in front of their computer that long, we wanted to make these webcast links available to those of you who do have the requisite interest and time.

P.S.  A January 10, 2008 article, "Vioxx Settlement Plan Heads for Key Deadlines", published by The Wall Street Journal, provides additional details about Merck's proposed Vioxx Settlement Program and its current status.  (1/10/08)