Drug Injury Watch

Ortho Evra Recall Requested By Public Citizen Due To Blood Clot Risks

Women Have Developed Serious Side Effects Like Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) After Using This Birth Control Patch

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 8, 2008 Public Citizen's Health Research Group (HRG) sent its "Petition to the FDA to Ban Ortho-Evra" to Commissioner Andrew von Eschenbach.  In this 11-page letter, Sidney Wolfe, M.D., the Director of HRG, discusses the increased risk of blood clots and serious side effects associated with Johnson & Johnson's Ortho Evra birth control patch, sometimes referred to simply as "the Patch".  In summary, Dr. Wolfe points out:

Compared to standard 35 microgram estrogen/progestin oral contraceptives, Ortho-Evra results in:

• 60% more estrogen on average exposure;
• greater variability in estrogen levels;
• a possible two-fold increased risk of venous thrombosis (typically, painful blood clots of the leg which can travel to the lungs and cause death)....

This May 2008 Petition concludes with a request for a "gradual recall" of the Patch:

Public Citizen therefore requests a six-month transition period in which  Ortho-Evra will be available for refill prescriptions to allow women time to meet with their healthcare provider and seek an alternative contraceptive method.

A May 8, 2008 Reuters article, "US Group wants FDA to pull J&J birth control patch", summarily presents the long-standing FDA and drug company positions as regards this allegation by Public Citizen that Ortho Evra is unsafe and, therefore, the Patch should be removed from the market:

The FDA has said the chance of developing a clot is low. For every 10,000 women who use hormonal contraceptives for one year, some three to five of them will develop a clot, the agency has said.

Ortho Women's Health & Urology, the J&J division that makes the contraceptive patch, has said its patch has risks and benefits like all hormonal contraceptives.

We will look for what the FDA and J&J have to say, if anything, about this May 2008 Ortho Evra Petition from Public Citizen in the days to come.

Extent Of Digitek Recall Remains A Mystery Ten Days Later; Patients Are Left In The Dark

Heart Medication Sold By Mylan Was Made In Actavis Plant That Received FDA Letter About Manufacturing Problems Over A Year Ago

(Posted by Tom Lamb at DrugInjuryWatch.com)

News about the April 2008 Digitek recall came first in the form of a brief company press release dated April 25, which was followed by an FDA MedWatch Safety Alert posted April 28 on the agency's web site.

As of May 5, ten days later, there had been little additional information from Actavis Totowa, the drug manufacturer, and none from the FDA, about the possible extent of the Digitek recall. 

Meanwhile, patients are being contacted by their pharmacists who, admittedly, know nothing more about the situation than what was set forth in the April 25 half-page press release about this "Class 1 nationwide recall of Digitek (digoxin pills, USP, all strengths)".

Understandably, patients are asking how far back in time they have been getting and taking Digitek pills that may have contained double the intended dose of active ingredient.

The latest news about the extent of the Digitek recall comes from a May 6, 2008 article, "Double-strength digoxin recalled in US", by Phil Taylor, which is posted online at In-PharmaTechnologist.com ("Breaking News on Pharmaceutical Technology"), of London, UK.

Because we do not want to misconstrue in any manner the intriguing information developed by Mr. Taylor in his May 6 article, we provide this extended excerpt:

A spokesperson for the company told in-PharmaTechnologist.com that the investigation into the problem was still ongoing, but at the moment there was no further information on what caused it and how many tablets were involved.

This is not the first time that there have been manufacturing problems at the Actavis Totowa facility in New Jersey, which was acquired as part of the takeover of Amide Pharmaceuticals by Actavis in May 2005, although the spokesperson said these earlier issues were entirely unrelated to the current incident.

Just over a year ago Actavis Totowa was sent a warning letter by the FDA after an agency inspection revealed that drugs products manufactured in the facility were 'adulterated'.

The quality control unit at the site came under criticism from the agency, which said it failed to reliably establish the identity, strength, quality and purity of drug products manufactured and released onto the market. The FDA inspectors also noticed a general lack of investigation of out-of-specification test results, as well as a lack of sufficient documentation of the results.

It is understood, however, that all these 'Form 483' issues have since been resolved to the agency's satisfaction.

Hopefully Actavis and/or the FDA will be making an official announcement, soon, about how far back in time the Digitek pills sold under the "Bertek" and "UDL" labels may have been double-strength tablets.  Until then, many patients and their families are left wondering if possibly related symptoms were caused by the use of these double-strength Digitek tablets.

FDA Says It Doesn't Know How Long Defective Digitek / Digoxin Pills Were Sold

Activas Says They Have Received 11 Complaints About Digitek Side Effects That Date Back To 2006

(Posted by Tom Lamb at DrugInjuryWatch.com)

The facts surrounding a late April 2008 recall of Digitek (digoxin) pills that may have twice the usual active ingredient are becoming less clear as we learn more in the days following the FDA's April 28 announcement.

In a May 1, 2008 Newsday.com article, "Pharmacists will call you: Digitek recalled", by reporter Kathleen Kerr, we learn that the defective Digitek tablets may have been sold for more than a year:

"We had some concerns about the process," [Actavis Totowa spokesman John] LaRocca said. He said the company knew of no deaths linked to Digitek use but Actavis and the FDA had received 11 complaints about side effects since 2006.

As reported previously, this improperly manufactured generic digoxin medication could lead to digitalis toxicity; patients with renal insufficiency are especially at risk.

According to Californian staff writer Emily Hagedorn, in her May 1, 2008 article "Recall of heart drug worries Bakersfield family", the FDA is still trying to get a handle on the magnitude and ramifications of this Digitek recall:

Considering it was voluntarily recalled Friday afternoon, it’s too soon to tell how many people have suffered adverse reactions, said Sandy Walsh, spokeswoman for the Food and Drug Administration. She didn’t know how long the defective pills were sold....  The FDA has inspected the manufacturer’s facility since the error was discovered, she said....  While Actavis has 50 percent of the digoxin market, the FDA does not foresee a shortage from other manufacturers, Walsh said.

Going back to the Newsday.com May 1 article, we get some pharmacy perspective on the Digitek recall:

Joel Bassuk, pharmacist at Raindew Pharmacy in Manhasset, said he received the recall notice yesterday....  "They said to immediately examine your inventory and discontinue all lots," Bassuk said....  CVS spokesman Mike DeAngelis said the chain had removed all Digitek from its stores. "We went back to see which patients had prescriptions over the past 12 months and contacted them," DeAngelis said.

As always, we welcome information about emerging drug safety issues:  druginjury@gmail.com.  This situation, in particular, calls for such assistance from anyone who may know more about the extent of this apparent manufacturing problem whereby some digoxin pills may be too potent.  At this juncture, at least, it seems we are not getting much in terms of "specifics" from Actavis, the drug manufacturer, nor the FDA about this Digitek recall.

Digitek Digoxin Recall: Tablets May Be Double The Normal Dose

So-called "Digitalis Toxicity" Is Possible, Especially In Patients With Renal Failure

(Posted by Tom Lamb at DrugInjuryWatch.com)

In an April 28, 2008 MedWatch Safety Alert about Digitek (digoxin tablets), the FDA informed doctors and patients that this prescription medication is the subject of a nationwide Class I recall because of the possibility that some tablets were manufactured such that they contain twice the approved level of active ingredient.

In more detail, according to this Digitek MedWatch Safety Alert:

• The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label.
• The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure.
• Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia.

This April 28 MedWatch Safety Alert came several days after a press release about this Digitek manufacturing problem was issued by Actavis Totowa LLC (formerly known as Amide Pharmaceutical Inc).  Therein, the manufacturer said it is recalling all strengths of Digitek because it may have accidentally released pills that are double the normal thickness, carrying twice the normal dose.

Digoxin is used in the treatment of arrhythmias and heart failure.

Patients taking Digitek tablets should contact their doctor if they have any concerns or questions.

P.S.  According to a brief newspaper article dated April 25, 2008, "Digitek heart drug recall":

[Actavis Totowa LLC spokesman] John LaRocca said 11 people have reported getting sick after taking the drug, but the Morristown, N.J., company is not aware of any deaths.

We will keep you informed about the number of patients injured by Digitek (digoxin) tablets that were defective, i.e., manufactured with a double-dose, as well as anything that we learn about the dates when these recalled Digitek tablets were being dispensed at pharmacies across the country. 

My law firm has been contacted already by several people who have had family members hospitalized with serious side effects apparently caused by the defective Digitek tablets.  We are in the process of investigating possible Digitek cases where the patient was hospitalized or that involve a death that may be related to the person's use of Digitek tablets.  (5/1/08)

FDA's 2007 Report On Outstanding Post-approval Studies: No Progress Made By Big Pharma

After Their Medications Get Approved By FDA, Many Drug Companies Have Not Yet Started The Studies Which They Promised To Do

(Posted by Tom Lamb at DrugInjuryWatch.com)

Each year the FDA issues what could be called a "report card" on how the pharmaceutical companies are doing as regards post-approval studies for their products that have been approved for sale in the U.S.  As was the case the year before, in 2007 these companies are doing poorly in getting done what they said they would do.

In an April 23, 2008 Bloomberg article, "Drugmakers Didn't Begin 1,044 Promised U.S. Studies", reporter Justin Blum presents the facts and gets some relevant reactions.

Let's start with the continuing dismal performance by Big Pharma:

The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA.

As background, the drug companies often agree to perform additional clinical trials evaluating the efficacy and safety of their medications in order to get the FDA's approval  -- but, seemingly, their agreement is more of a promise than it is an actual commitment.

This apparent failure to get these studies done in a timely manner can be viewed in various ways, according to who you talk to about this situation.  Quoting from the April 23 Bloomberg article, we consider these three "perspectives":

• Peter Lurie, deputy director of the Health Research Group at Washington-based Public Citizen, an advocacy organization: "'Drugs often come on the market with an expectation that studies will be conducted.  In fact, many of these studies begin late or do not begin at all.'"
• Alan Goldhammer, deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, an industry group:  "Studies can take a long time to begin because of discussions with the FDA over how they should be conducted and difficulties enrolling patients."
• Susan Cruzan, a spokesperson for the FDA: "The FDA is considering how to 'integrate' its new power to require studies with commitments that have been made by drugmakers.  The FDA will work to ensure that studies previously promised 'are completed in a timely manner.'"

Unfortunately, like earlier versions, this 2007 FDA report does not specify the number of drugs covered by the various outstanding studies -- Mr. Blum points out in his article that "[d]rugmakers sometimes agree to complete multiple studies for a single product" -- nor does the annual report identify the specific companies involved with the many outstanding post-approval studies.

Maybe next year we will be able to tell you that the "class" has done better on this report card about their post-approval studies.

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.

April 2008: FDA Web Site Adds Two New Pages For Learning About Drug Safety

Some Important Terms Are Defined And Various Research Resources From FDA Are Listed

(Posted by Tom Lamb at DrugInjuryWatch.com)

On April 11, 2008 the FDA added to its web site one page that gives short definitions for some important terms used in the realm of prescription drug safety, and another page that is intended to assist one when researching medication safety issues. 

We look, first, at "A Guide to Drug Safety Terms at FDA", which begins with this introduction:

The Food and Drug Administration (FDA) approves a drug for marketing after determining that the drug's benefits of use outweigh the risks for the condition that the drug will treat. But even with a rigorous evaluation process, some safety problems surface only after a drug has been on the market and has been used in a broader population. This guide offers descriptions of some of the drug safety terms commonly used by FDA throughout the life cycle of a drug.

The drug safety terms defined on this FDA web page are organized by the different stages of a drug's history.  Here is a summary of the stages and terms found on this page:

1.  FDA REVIEW

• Pre-Clinical Data
• New Drug Approval Process
• Adverse Drug Reaction

2.  TAKING MEDICATION

• Medication Guides
• Consumer Medication Information (CMI)
• Prescription Drug Labeling
• Nonprescription Drug Label ("Drug Facts")
• Boxed Warning

3.  MONITORING AFTER APPROVAL

• Post-Market Surveillance
• Adverse Event Reporting System (AERS)
• MedWatch

4.  REMOVAL FROM THE MARKET

• Drug Recall
• Drug Withdrawal

5.  TYPES OF SAFETY ANNOUNCEMENTS

• Early Communication About an Ongoing Safety Review
• Public Health Advisories
• Letters to Health Care Professionals ("Dear Doctor" letters)
• Information for Health Care Professionals

The second new page at the FDA site has to do with researching the safety of prescription medications; it is titled "Find the Latest Drug Product and Safety Information".

Here are some of the FDA resources for drug safety research provided on this page:

Index to Drug-Specific Information
www.fda.gov/cder/drug/drugsafety/DrugIndex.htm

Public Health Advisories
www.fda.gov/cder/news/pubpress.htm

MedWatch Alerts
www.fda.gov/medwatch/

DailyMed
http://dailymed.nlm.nih.gov

Drugs @ FDA
www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

FDA Drug Safety Podcasts
www.fda.gov/cder/drug/podcast/default.htm

FDA Drug Safety Newsletter
www.fda.gov/cder/dsn/default.htm

FDA Consumer Health Information
www.fda.gov/consumer/default.htm

Recalls, Market Withdrawals and Safety Alerts
www.fda.gov/opacom/7alerts.html

We thank the FDA for posting these two new drug safety-related web pages -- both of which can be downloaded in an attractive brochure-like PDF for distribution.  Furthermore, we encourage you to share these FDA materials with family and friends who may have an interest in learning more about the safety of medications that they have been prescribed or are currently using.

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.