Drug Injury Watch

Do You Want To Sign The "FDA Preemption = Bad Medicine" Online Petition?

This Petition Is Sponsored By A Group Of Concerned Citizens Called "Americans for Drug and Device Accountability"

(Posted by Tom Lamb at DrugInjuryWatch.com)

In several earlier posts I have advocated 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.

If you tend to agree with this position, you may be interested in signing an online petition titled "FDA Preemption = Bad Medicine".  This petition is sponsored by Americans for Drug and Device Accountability, which describes itself as "a group of concerned citizens interested in protecting the civil rights of the American people".

The online petition form allows you an opportunity to add a Comment along with your signature.  Please know that the voluntary contribution form which pops-up after you click the "Sign Petition" button can be closed and your signature will still be recorded for the petition.  (Of course, you can contribute to the online form company, which is where the money would go, if you want.)

Finally, you should feel free to express your opinion about federal preemption in the context of drug injury cases here by submitting a Comment to this post.

August 2008: NuvaRing MDL Created In Federal Court System, Eastern District Of Missouri

Ruling By Judicial Panel on Multidistrict Litigation Will Result In Transfer Of All NuvaRing Federal Court Cases

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  Our Focus Page on NuvaRing has a complete collection of our articles about this birth control device / method as well as selected news reports about NuvaRing.

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On August 22, 2008 the Judicial Panel on Multidistrict Litigation (JPMDL) granted a petition filed by plaintiffs in 11 NuvaRing federal court lawsuits seeking creation of a NuvaRing multidistrict litigation (MDL). 

These NuvaRing lawsuits involve blood clot-related injuries such as pulmonary embolism (PE), deep vein thrombosis (DVT), strokes, and heart attacks allegedly caused by use of the NuvaRing birth control product. 

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Free NuvaRing Case Evaluation
Strictly Confidential, No Obligation.

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By means of this August 2008 NuvaRing MDL order -- giving rise to In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML -- these pending NuvaRing cases and all future NuvaRing filed lawsuits filed in the federal court system will be centralized for discovery purposes in the Eastern District of Missouri before Judge Rodney W. Sippel.

We will continue to monitor the NuvaRing MDL litigation and report significant developments, here, as they become known.

P.S.  Learn more about NuvaRing and its serious side effects by visiting the NuvaRing Information page over at our Drug Injury Law site.  (9/16/08)

FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility

Inspection Found Sandoz Failed To Properly Validate Manufacturing Process For Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL) Before Distributing Pills

(Posted by Tom Lamb at DrugInjuryWatch.com)

There is yet another apparent quality-control problem in the generic drug manufacturer sector.  This one involves Sandoz, the generic drug unit of Novartis AG (NVS), and its metoprolol succinate ER tablets, which is a generic form of AstraZeneca's Toprol XL.

An August 26, 2008 Reuters article, "UPDATE 1-US warns Novartis generic unit on plant problems", provided this information from an FDA letter about the problems found by inspectors at a North Carolina Sandoz manufacturing site:

"We question the continued distribution of this product until better process controls are implemented and process validation is completed," the FDA letter said.

"We are also concerned that the problems noted in the metoprolol validations could be indicative of problems and poor decisions made with other product validations," the agency said.

Novartis sought to downplay this August 2008 FDA warning letter to Sandoz, according to the August 26 Reuters article:

Novartis spokesman Eric Althoff said the FDA's concerns were "primarily about documentation and validation."

"We are working together with the FDA to solve the problem," he said.

It is unclear as of August 26 whether Sandoz will cease distribution of its metoprolol succinate ER tablets (generic Toprol XL) and/or issue a recall of this medication.  We will be watching for these possible related developments.

In addition, we will post a link to the Sandoz warning letter regarding its metoprolol succinate ER tablets (generic Toprol XL) when this letter is available on the FDA web site.

P.S.  This August 12, 2008 FDA Warning Letter (08-ATL-13) concerns the Sandoz manufacturing facility located at 4700 Sandoz Drive, Wilson, North Carolina.  (8/26/08)

August 2008: FDA Issues Its Final Version Of A New Rule Which May Give Complete Immunity To Drug And Medical Device Companies

FDA Rule Could Serve To Defeat Lawsuits Alleging Failure To Warn About Potentially Harmful Effects Of Prescription Drugs And Medical Devices

(Posted by Tom Lamb at DrugInjuryWatch.com)

Back in February 2008, in a post titled, "FDA Proposed Rule About Drug Label Warning Changes Will Lessen Agency's Power To Protect Us", I told you about a proposed rule that was issued in mid-January by the FDA.  In essence, it said that a drug company would only have to revise the package insert, or label, for its prescription drugs and add an increased warning about a serious side effect where there was “sufficient evidence of a causal association” between a a drug and a serious side effect.  Notably, this determination would be made not by the FDA but by the drug company, itself, i.e., the same entity that sells its medications for profit.  In that earlier post I set forth the three main things which I thought were wrong with this new proposed rule issued by the FDA.

More significant than my opinion, eight Representatives and Senators wrote a January 23, 2008 letter objecting to this FDA proposed rule.  Two fundamental points made in that letter were: (1) The proposed rule set a higher standard for when drug and medical device companies could make changes to a product label to alert doctors and patients about new safety information without waiting for FDA approval; and (2) The proposed rule would have the practical effect of protecting drug and medical device companies from being sued by injured patients for failing to disclose risks associated with their unsafe products.

Well, it seems that the FDA did not listen to me nor did the agency take the guidance offered to it by those eight lawmakers. 

In an August 21, 2008 Bloomberg article, "Drugmakers Given Legal Shield By Rule, Lawyers Say (Update1)", by reporter Justin Blum, we learned the the FDA has issued in final form this rule that had been only "proposed" previously, and that this new FDA final rule is now posted on the agency's web site.

What this new FDA final rule means depends on who you talk to or, more exactly, who Mr. Blum interviewed.  From his August 21 article we get these several different perspectives:

• Randall Lutter, the FDA's deputy commissioner for policy: "This action should reduce confusion about what our policy is, clarify it and provide additional confidence to patients and doctors that information on medical product labels has a sensible scientific basis."
• Ken Johnson, the Pharmaceutical Research and Manufacturers of America's senior vice president:  "[Doctors and patients] look to the FDA -- widely considered the world's gold standard -- to provide them with balanced information."
• Gerie Voss, director of regulatory affairs for the American Association for Justice:  "The final rule is going to give drug and device companies the ability to claim complete immunity for failing to warn about potentially hazardous side effects of prescription drugs and medical devices."

I presume there will be plenty of commentary from all sides forthcoming about this new FDA final rule and what it means in terms of drug and medical device safety as well as product liability lawsuits for injured patients.

Of course, I welcome your opinion on this issue.  Please feel free to submit a Comment to this post and let us know what you think.

Wyeth v. Levine Supreme Court Hearing On Federal Preemption Of Drug Injury Lawsuits

Various Parties Have Filed Briefs With Their Arguments About Whether Or Not An Injured Patient Should Be Able To File A Lawsuit Against The Drug Company

(Posted by Tom Lamb at DrugInjuryWatch.com)

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

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

As stated by Justice John Paul Stevens: 

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

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

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

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As some of you are aware by now, this fall the Supreme Court will hear oral arguments in the case Wyeth v. Levine (No. 06-1294). In the case, Wyeth is appealing a Vermont Supreme Court decision that upheld a $6.8 million jury award to Diana Levine after her use of the drug company's anti-nausea drug Phenergan (promethazine HCl) resulted in serious complications and, ultimately, amputation of her arm.

In essence, Levine's lawsuit against the drug company alleges that the drug had inadequate warnings, whereas the company is arguing that the FDA's authority to approve drug labeling preempts state laws governing product liability.

I have long agreed with the position that the 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.

Of course, there are various parties with opinions about how the Supreme Court should rule on the federal preemption issue presented by the Wyeth v. Levine case.  Several of those parties have submitted Amicus Curiae (so-called "friend of the court") briefs, some of which are in support of Wyeth (the "Petitioner"), while others are in support of Ms. Levine (the "Respondent"). 

The American Bar Association has compiled a list of hyperlinks for the Amicus briefs filed in connection with the Wyeth v. Levine case for those of your who want to get an in-depth view of both sides to this very important legal and public policy issue.

As always, we welcome your opinion about whether a patient injured by serious side effects of an FDA-approved prescription drug should be able to file a products liability lawsuit against the drug company.  Simply submit a Comment to this post to join the discussion about federal preemption and drug injury product liability lawsuits.

August 2008: Byetta Associated With Hemorrhagic Pancreatitis And Necrotizing Pancreatitis

FDA Has Learned Of Six Such Cases Since October 2007 "Dear Doctor" Letter About Acute Pancreatitis In Patients Taking Byetta

(Posted by Tom Lamb at DrugInjuryWatch.com)

On August 18, 2008 the FDA issued a MedWatch email alert regarding Byetta (exenatide) which informed us that the agency had received reports about six cases of hemorrhagic pancreatitis or necrotizing pancreatitis since October 2007.

As background, the FDA last updated us on the link between pancreatitis and Byetta five months ago, which we covered in a post titled "More Information About Reports Of Byetta Use Being Linked To Acute Pancreatitis":

The quarterly issue of the FDA's online Drug Safety Newsletter [DSN] which was published on March 18, 2008 includes an article about a postmarket safety review of Byetta (Exenatide) that associates this diabetes drug with acute pancreatitis.

As background, one may recall that in October 2007 the FDA issued an alert to doctors informing them that the agency had reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, which was approved by the FDA on April 28, 2005 to treat adults with type 2 diabetes.

Now, from the "Information for Healthcare Professionals" page for Byetta we get this update from the FDA:

[UPDATED 08/18/2008] Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

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Free Byetta Case Evaluation 

Strictly Confidential, No Obligation.

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For your convenience, we provide these additional resources:

• The January 2008 revised Byetta package insert, or label, for Byetta from Amylin Pharmaceuticals, Inc.; and,

• The October 2007 so-called "Dear Doctor" letter about Byetta from Amylin Pharmaceuticals, Inc. and Eli Lilly and Company.

The October 2007 Byetta Dear Doctor letter was reportedly updated on or about February 27, 2007, but we have been unable to find the revised document on the FDA web site or elsewhere .  If anyone can provide us with a link to that document, or a copy, we will share this with our readers.

Of course, if and when we see any Dear Doctor letter in connection this August 2008 FDA alert about Byetta and hemorrhagic pancreatitis or necrotizing pancreatitis, we will add it to this article.

655 Fosamax Lawsuits Have Been Filed Against Merck & Co. According To June 30, 2008 Update

Most Of These Product Liability Cases Allege Fosamax Caused Drug-Induced Osteonecrosis Of The Jaw (ONJ)

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to an August 14, 2008 "MERCK & CO: Faces 655 Product Liability Cases Over Fosamax Drug", published by Lloyds Corporate Litigation Reporter: 

Merck & Co., Inc., as of June 30, 2008, faced approximately 655 product liability cases involving Fosamax drug, including about 1,120 plaintiff groups, which had been filed and were pending against the Company in either federal or state court.

As background, a Fosamax multidistrict litigation (the Fosamax MDL) was created by the Judicial Panel on Multidistrict Litigation (JPML) in August 2006, and assigned to Judge John Keenan in the United States District Court for the Southern District of New York (SDNY).

By operation of the Fosamax MDL, Judge Keenan is presiding over the coordinated pre-trial proceedings for all Fosamax lawsuits that have been filed in the federal court system.

Additional Fosamax lawsuits have been filed against Merck in New Jersey state court, as well as other state court systems around the country.

To date, most of these product liability cases filed against Merck allege the drug company failed to warn sufficiently that its osteoporosis drug Fosamax can cause bisphosphonates-induced osteonecrosis of the jaw (ONJ).

As with the Vioxx litigation, Merck is vowing to fully defend itself in the Fosamax litigation.  According to the August 14 Lloyds Corporate Litigation Reporter article:

As of Dec. 31, 2007, the Company had a remaining reserve of approximately US$27 million solely for its future legal defense costs for the Fosamax Litigation. During the first quarter of 2008, the Company spent approximately US$7 million and added US$40 million to its reserve. In the second quarter, the Company spent approximately US$10 million.

As of June 30, 2008, the Company had a reserve of approximately US$50 million.

We will continue to monitor the Fosamax litigation for developments in the federal court MDL as well as the in the various state courts where Fosamax lawsuits have been filed.

Senators Kennedy And Leahy Introduce Legislation To Protect Patients From Dangerous And Defective Devices

August 2008 Senate Counterpart of HR 6381, Medical Device Safety Act 2008, Which Was Sponsored By Congressmen Waxman And Pallone

(Posted by Tom Lamb at DrugInjuryWatch.com)

In a June 27, 2008 article, "Newly Introduced Legislation Would Protect Legal Rights of Patients Harmed By Defective Medical Devices", we said that soon after the July 4th Congressional recess there would be a bill introduced by Senators Ted Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) which would essentially correspond to HR 6381, the Medical Device Safety Act of 2008, introduced on June 26, 2008 by Congressmen Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.).

On August 1, 2008 the the Senate counterpart of the Medical Device Safety Act of 2008 was introduced on the Senate floor by Senator Patrick Leahy. 

The August 12, 2008 edition of FDAnews Device Daily Bulletin published an online report, "Senators Introduce Their Version of Anti-Preemption Bill", which provides us with some context:

Following the Riegel decision, Kennedy, who chairs the Senate Health, Education, Labor and Pensions Committee, threatened to create legislation to override the court. He said Congress never intended for FDA approval to give immunity to manufacturers from liability for injuries caused by faulty devices.

"The FDA used to be the gold standard, but the agency has come under scrutiny recently. If manufacturers are putting faulty devices on the market, they must be held accountable to the patients who use them, the way Congress always intended. I will continue to fight for legislation like this that puts the health and safety of Americans ahead of manufacturers’ interests," Sen. Barbara Mikulski (D-Md.), a co-sponsor of the bill, said.

Both the House bill and the Senate bill are intended to ensure that injured patients are not prevented by the Food, Drug and Cosmetic Act (FDCA) from filing product liability lawsuits against medical device companies under state tort laws.

Not surprisingly, the device makers have come out against these bills.  As regards the legislation recently introduced by Senators Kennedy and Leahy, from the August 12 FDAnews Device Daily Bulletin report:

The device industry warns the bill would result in more lawsuits and ultimately higher healthcare costs. "If enacted, this legislation would create a patchwork approach to medical device approvals where state courts would effectively review and regulate medical devices," AdvaMed President and CEO Stephen Ubl said.

We welcome all points of view on this important federal preemption issue.  You can express your opinion, here, by submitting a Comment to this post.

July 2008 Journal Article: Bextra And Vioxx Increase Risk Of Cerebrovascular Events, Or Strokes

Study Published In Stroke Shows Risk Not Increased With Celebrex Nor With Other Medications In NSAIDs Class Of Drugs

(Posted by Tom Lamb at DrugInjuryWatch.com)

An article in the July 2008 edition of the medical journal Stroke reports that the COX-2 inhibitors Bextra (valdecoxib) and Vioxx (rofecoxib) significantly increase the risk of cerebrovascular events, commonly referred to as strokes, whereas another COX-2 drug, Celebrex (celecoxib), apparently does not.

The July 2008 Stroke article, "Nonaspirin NSAIDs, Cyclooxygenase 2 Inhibitors, and the Risk for Stroke", reports on a study of 336,906 patients, with these details taken from its Abstract:

Methods — Retrospective cohort study among Tennessee Medicaid enrollees aged 50 to 84 years between January 1, 1999 and December 31, 2004. Noninstitutionalized persons with continuous enrollment in Medicaid and no stroke or other serious medical illness in the year before cohort entry were included. The 7 most common NSAIDs were examined: celecoxib, rofecoxib, valdecoxib, ibuprofen, naproxen, diclofenac, and indomethacin. Nonuse of NSAIDs was the reference group. Because new use is less susceptible to bias, we conducted a similar analysis confined to new users. The outcome was hospitalization for an incident cerebrovascular event: ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage.

An August 7, 2008 Reuters article, "Vioxx, Bextra linked to increased stroke risk: study", provides some commentary from the lead researcher and summarizes the conclusion of this COX-2 and NSAIDs stroke-risk study:

Vioxx and Bextra were withdrawn from the market "because they increase the risk of cardiovascular events," lead researcher Dr. Christianne Roumie noted in comments to Reuters Health. Her team wanted to determine whether these so-called "COX-2" inhibitors and traditional nonsteroidal anti-inflammatory drugs (NSAIDs) drugs such as naproxen or ibuprofen can also increase the risk of stroke....

"This study suggests that rofecoxib and valdecoxib were associated with higher stoke risk than other NSAIDs," Roumie said in the interview.

"Because of this and other studies, their withdrawal from the market is appropriate and these medications should not be re-introduced, especially since safer alternatives are available," she explained.

"Since all NSAIDs, including coxibs, can raise blood pressure and increase the risk of gastrointestinal bleeding, we believe that caution is warranted, especially with long-term use of these medicines."

As many of you are aware, Vioxx was pulled from the U.S. market in September 2004, and Bextra met a similar fate in April 2005.

More Serious Side Effect Warnings And Recalls Predicted Due To Current FDA Approval System

August 2008 ASA Meeting: Sociologist Donald Light Presents His Paper, "Institutional Foundations of the Vioxx Disaster"

(Posted by Tom Lamb at DrugInjuryWatch.com)

On August 3, 2008, at the American Sociological Association (ASA) annual meeting in Boston, Donald W. Light, PhD, MS, presented the paper, "Institutional Foundations of the Vioxx Disaster", in which this sociologist identified eight institutional foundations for likely future serious side-effect problems with some new prescription drugs approved by the FDA.

Dr. Light is a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey.

According to an August 5, 2008 ScienceDaily online article, "Toxic Drugs, Toxic System: Sociologist Predicts Drug Disasters", Dr. Light's paper and presentation included these contentions:

• "Drug disasters are literally built into the current system of drug testing and approvals in the United States."

• "Recent changes in the system have only increased the proportion of new drugs with serious risks."

• "Speed-up reviews for safety have more than tripled the number of 'black box warnings' of side effects or withdrawals after drugs are on the market."

In more detail, from the August 5 ScienceDaily article:

According to Light, rather than using current approved drugs as benchmarks of efficacy, the existing testing system evaluates the effectiveness of new drugs based on their effects compared to placebos. Systematic reviews indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the U.S. Food and Drug Administration (FDA), including black box warnings, adverse reaction warnings, or even withdrawal of the drug.

Based on this system, Light asserts that new drugs are twice as likely to harm patients as to provide them with benefits superior to existing drugs.

The current FDA drug approval picture depicted by Dr. Light certainly seems to me yet another compelling reason why any application of the federal preemption doctrine to prohibit product liability lawsuits involving prescription drugs is bad public policy.

What do you think: Should injured patients be prohibited from filing product liability lawsuits against pharmaceutical companies?