Tuesday, November 30, 2010

Maryland County Bans Caffine-Alcohol Drinks

MIAMI - OCTOBER 27:  Cans of Four Loko are see...Image by Getty Images via @daylifeHoward County is banning the sale of alcoholic beverages that contain caffeine, effective at the close of business on Wednesday, Dec. 1, County Executive Kenneth Ulman and Health Officer Peter Beilenson announced Tuesday.

 County Executive Kenneth Ulman and Health Officer Dr. Peter Beilenson announced Tuesday, Nov. 30.

The ban— which applies to products such as Four Loko, Joose and Moonshot— comes after the Food and Drug Administration warning issued Nov. 17 that adding caffeine to alcoholic beverages is not recognized as safe.

Lisa de Hernandez, spokeswoman for the county Health Department, said there are about 25 different caffeine-infused alcoholic beverages that are made by four or five different companies in the United States.

“These ‘drinks’ are marketed to young adults despite the fact that one container provides the alcohol equivalent of three beers — nobody could, or should, try to consume that type of drink. We are banning them now because they are tragedies waiting to happen,” County Executive Kenneth Ulman said in a statement announcing the ban.

Beilenson agreed, noting the public health concern posed by the drinks because of the caffeine and high alcohol content.

“This combination of ingredients decreases an individual’s awareness of their alcohol intake potentially leading to serious illness or death,” he said in a statement.

Michigan and Washington state recently banned the drinks, and other states reportedly are considering bans as well. The drinks also have been banned on several college campuses.

The Howard County Health Department plans to send out letters Dec. 1 formally notifying county liquor establishments of the ban.

“Generally speaking, the turnaround time (between issuing and enforcing a ban) is not this fast,” Hernandez said, but “it’s a dangerous drink.”

“Alcohol is a depressant and caffeine is a stimulant,” she added. “You don’t feel the effects with the caffeine in there as you normally would.”

The Health Department plans to conduct follow-up investigations to make sure retailers are complying with the ban, but it encourages any resident who witnesses a sale of a alcoholic beverage containing caffeine in the county after Dec. 1 to report the incident to askhealth@howardcountymd.gov.

The first offense would result in a $50 fine, the second a $100 fine and the third a $500 fine, Hernandez said.

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Monday, November 29, 2010

November 29, 2010 Darvocet Legal News (Georgia/Florida)

Here is background and historical information from the FDA about Darvocet and Darvon: 

Following receipt of a Citizen Petition requesting the withdrawal of propoxyphene-containing products from the United States market, FDA convened an Advisory Committee meeting on January 30, 2009. After presentations by FDA, the petitioner, and the company reviewing the efficacy and safety data from the propoxyphene drug applications, the literature and postmarketing safety databases, the committee voted by a narrow margin (14-to-12) against the continued marketing of propoxyphene products.

Those who voted for propoxyphene to remain on the market advised requiring improved labeling, particularly with warnings about use in elderly patients and about use with concomitant opioids or alcohol. Finally, there was general agreement that additional information about the cardiac effects of propoxyphene would be relevant in further weighing the risk and benefit. As a result, under new authorities given to FDA by the Food and Drug Administration Amendments Act (FDAAA), the agency required the drug manufacturer to conduct a thorough QT study to formally evaluate the effects of propoxyphene on cardiac electrophysiology. In order to determine a safe supratherapeutic dose to incorporate into the Thorough QT study, FDA required the drug manufacturer to first conduct a multiple-ascending dose (MAD) study.

The MAD study was a randomized, double-blind, placebo-controlled sequential multiple-ascending dose study of propoxyphene for 11 days. The study was conducted in healthy volunteers. The first cohort of study subjects was dosed with a total daily dose of 600 mg of propoxyphene (the maximum labeled dose) and the second cohort was dosed with a total daily dose of 900 mg. Additional doses were planned, however the study was placed on clinical hold due to safety concerns. Study subjects were monitored with telemetry and intermittent ECG recordings, comparable to the monitoring that would occur during a Thorough QT study.

The drug manufacturer has submitted to FDA the results from the 600 mg and 900 mg cohorts.
Significant QTc interval prolongations were observed with the propoxyphene 600 mg and 900 mg dose levels. With the 600 mg daily dose, at steady state on Treatment Day 11, the largest mean change of QTcF* (ΔΔQTcF) was 29.8 milliseconds (ms), which occurred 7 hours after the last dose; with the 900 mg dose the largest mean change was 38.2 ms, which occurred 2 hours after the last dose. It is recognized in the International Conference on Harmonisation (ICH) E14 Guideline1 that drugs that prolong the mean QT/QTc interval by >20 ms have a substantially increased likelihood of being proarrhythmic. In addition, a dose-dependent prolongation of PR and QRS intervals was observed in the study.

Because the elderly and patients with renal insufficiency have a reduction in the clearance of propoxyphene and its cardioactive metabolite, norpropoxyphene, through the kidneys, these populations can be especially susceptible to proarrhythmic effects of the drug.

FDA has concluded that the safety risks of propoxyphene outweigh its limited benefits2-6 for pain relief at recommended doses.
*QTcF is the QT interval corrected for heart rate using the Fridericia formula (cubic root – QTcF = QT/RR1/3).
  • Guidance for Industry – E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. October 2005.
  • Beaver WT. Mild analgesics. A review of their clinical pharmacology. II. Am J Med Sci. 1966;251:576-99 concl.
  • Lasagna L. The clinical evaluation of morphine and its substitutes as analgesics. Pharmacol Rev. 1964;16:47-83.
  • Collins SL, Edwards JE, Moore RA, McQuay HJ. Single dose dextropropoxyphene, alone and with paracetamol (acetaminophen), for postoperative pain. Cochrane Database Syst Rev. 2000;(2):CD001440.
  • Collins SL, Edwards JE, Moore RA, McQuay HJ. Single-dose dextropropoxyphene in post-operative pain: a quantitative systematic review. Eur J Clin Pharmacol. 1998;54:107-12.
  • Veterans Health Administration Pharmacy Benefits Management Strategic Healthcare Group and Medical Advisory Panel. Review of the Efficacy and Safety of Propoxyphene. March 2006.

Another Tylenol Recall

J and J has recalled 9.3 million bottles of Tylenol cold treatments because they don’t disclose the medicine’s alcohol content on the front label.

The recall affects three types of Tylenol Multi-Symptom liquid cold medicine sold in the U.S. by the McNeil Consumer Healthcare unit, J&J spokeswoman Bonnie Jacobs said today in a telephone interview. Flavoring agents that contain less than 1 percent alcohol are used in the formulations, and the alcohol content was listed on the package rather than the front of the bottle, according to a statement on J&J’s website.
“This is a wholesale and retail level recall and is not being undertaken on the basis of adverse events,” J&J said on the website. “No action is required by consumers or health-care providers and consumers can continue to use the product.”

Source here: http://www.bloomberg.com/news/2010-11-24/j-j-mcneil-unit-recalls-some-tylenol-cold-products-over-labeling-mistake.html?cmpid=yhoo

Saturday, November 27, 2010

Advanced Bionics Announces Voluntary Recall of the HiRes 90K

From the FDA: 

Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has notified the US Food & Drug Administration (FDA) that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.

AB is continuing to evaluate the root cause(s) of the problem and is working closely with the FDA to address their questions and concerns, and institute changes to the product to ensure that the HiRes 90K has the highest quality for patients who use the device. This voluntary action is being taken to ensure continued patient safety and product quality.  The risk of any significant adverse medical events appears to be remote at present.

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Friday, November 26, 2010

Friday Tech: Apps to be Thankful for in 2010

Android Phone HT03-A (NTT Docomo)Image by jetalone via Flickr
Since opening my own law offices a couple of years ago, the great equalizer has been technology. Each year my list of Resolutions is loaded with tech-centric proposed changes. In 2010, I've converted to an iPad for hearings, and now have an Android phone to replace the iPhone.  For those who read this blog, you know that I am a fan of  free tech. So, here is my list of tech apps for droid and the iPad I am especially happy to use for fun and for work:

1.Avast:  Avast is a free anti-virus program for computer users to protect their systems for adware, spyware and viruses floating around. Find it here: avast 

2.Pandora: I'm an (aging/creaky) athlete, and I run. A lot. This is the best thing since the iPod. A company that almost went under until the iPhone arrived (and the app for it), that is now doing well. http://www.pandora.com/

3.Dropbox: Dropbox is a Web-based file hosting service operated by Dropbox, Inc. which uses cloud computing to enable users to store and share files and folders. http://www.dropbox.com/  

4.isynchr: I have more than 10,000 songs in itunes, but when I bought my android HTC phone, figured that 'd have to carry two devices. Wrong. Isyncr is an add that syncs the Android phone with iTunes. The lite version is free, the full on is about two bucks.

5.Open Office: If you are starting your own office, or have simply had enough of the big boys' word/spreadsheet suites, this is for you. A multiplatform and multilingual office suite and an open-source project. Compatible with all other major office suites, free to download, and use.

6.Phones for the iPad: Skype, Line2, Whistlestop. Whistle brings free continental US calling to iPad over WiFi or 3G. Whistle works out of the box with the 4th Gen iPod Touch. Whistle provides free inbound calling to your Whistle number, notifying you of calls through Push notifications.

7.Simplenote: Simplenotehelps me keep notes, lists, ideas and more. The  notes automatically synchronize with a computer and devices. It's extremely easy to use. Free. http://itunes.apple.com/us/app/simplenote/id289429962?mt=8

8.Firefox: I'm thankful that Windows Explorer is not a part of my work or personal websurfing life. Free. If you don't know how to find and use this, you'd better.

9.Launchy: Launchy is a free open source application launcher for Windows and (as of version 2.1.1) Linux. It indexes shortcuts in the start menu, and files in specific folders w/o opening the start menu. http://www.launchy.net/ 

10.Goodreader: A superb PDF reader, it was one of the first file management apps for the iPad, and connects to a huge range of different servers and devices. From their site: Quick summary: super-robust PDF reader with advanced reading, annotating, markup and highlighting capabilities, excellent file manager, TXT file reader and editor, audio/video player, Safari-like viewer for MS Office and iWorks files.  http://www.goodiware.com/goodreader.html

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Wednesday, November 24, 2010

Bayer Settles Multivitamin Prostate Cancer Claim Litigation

Bayer has agreed to a $3.3 million settlement with 3 states "over the company's unsupported claim that One A Day Men's Health Formula multivitamins reduce the risk of prostate cancer," according to the Oregon Department of Justice, which filed a complaint along with the attorney generals of California and Illinois.

Bayer will be barred from claiming that its One A Day multivitamins might cure, treat, or prevent any disease, including cancer, unless the company "can back up such claims with competent and reliable scientific evidence," according to the CSPI.
The heart of the current controversy is related to qualified health claims about selenium, an ingredient in the One A Day Men's Health Formula multivitamin.

Read more here.  http://www.medscape.com/viewarticle/731707

Saturday, November 20, 2010

November 20, 2010: Darvocet Recall News

Trade Name: Doloxene - 100 mg - dextropropoxyp...Image via WikipediaSome background after this week's recall: 

The first propoxyphene products were approved based on safety only under the
1938 Food Drug & Cosmetic Act (FD&C Act), and they were Darvon (propoxyphene HCl 32 mg and
65 mg) and a Darvon-Compound (aspirin, caffeine combination) that was later withdrawn.

There were published reviews of medications. The authors made similar conclusions: In one, it was claimed that Propoxyphene, as a single-ingredient product, was a weak analgesic. It was claimed that Propoxyphene had no or little contribution to efficacy of reduction of acute pain.

Darvon was initially developed by Eli-Lilly and now marketed by two companies--Xanodyne Pharmaceuticals of Kentucky and Qualitest/Vintage Pharmaceuticals of Alabama--was first approved for use in the United States in 1957. Darvon is commonly combined with a dose of acetaminophen and marketed by Xanodyne under the name Darvocet. Both drugs are classified as narcotic pain relievers. Darvocet is one of the most commonly prescribed drugs in the US for treating patients with mild to moderate pain, with more than 20 million prescriptions written in 2007.
Dextropropoxyphene did carry a black box warning, stating:
Propoxyphene should be used with extreme caution, if at all, in patients who have a history of substance/drug/alcohol abuse, depression with suicidal tendency, or who already take medications that cause drowsiness (e.g., antidepressants, muscle relaxants, pain relievers, sedatives, tranquilizers). Fatalities have occurred in such patients when propoxyphene was misused.

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FDA: Watch our for the Fake Viagra

viagra is a commercial produced medicine conta...Image via Wikipedia (This is the real stuff, not the copycat stuff the FDA's warning you about this weekThe U.S. Food and Drug Administration says Vigor-25, a product marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used because it contains sildenafil, the active ingredient in the prescription drug Viagra.

The FDA has found many products marketed as dietary supplements for sexual enhancement during the past several years that can be harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients.  Sexual enhancement products promising rapid effects (e.g., claim to work in minutes to hours) or long-lasting effects (e.g., claim to last 24-72 hours) are likely to contain a contaminant.
The FDA advises consumers who have experienced any negative side effects from sexual enhancement

products to stop using such products and consult a health care professional and to safely discard the product. The FDA urges health care professionals and consumers to report adverse events or side effects from use of Vigor-25 to the FDA's MedWatch Adverse Event Reporting program.


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November 20, 2010: Darvon/Darvocet Recall Information and History

12/15/2006 - Pillz (DaRvOcEt) #4695a.jpgImage by amayzun via FlickrThe news is out, but what do people know about how the recall came to be?

The consumer interest group Public Citizen filed a federal lawsuit last year against the U.S. Food and Drug Administration (FDA) claiming that the agency violated the law by failing to act on a petition filed in 2006, which urged the removal of Darvocet, Darvon and generic propoxyphene drugs from the market because they have been associated with over 2,000 accidental deaths, are physically addictive and are no more effective than other safer painkillers.

Darvon and Darvocet contain the narcotic propoxyphene, which is also available as a generic. It has been more than three years since British health authorities cited hundreds of Darvon and Darvocet deaths as the reason they ordered the drug to be phased off of the market, and it has been more than two years since Public Citizen filed their petition urging the FDA to phase the drug out. However, the U.S. drug regulators have not yet taken any actions to protect consumers from the dangerous side effects, and it remains one of the most widely prescribed generic drugs, with approximately 22 million prescriptions in 2007.

The narcotic drug is addictive, yet it is a relatively weak painkiller, say opponents. Public Citizen indicates that it is no more effective at treating most kinds of pain than other safer alternatives, such as ibuprofen (the active ingredient in Advil) and acetaminophen (the active ingredient in Tylenol).

“A large portion of the deaths from propoxyphene occurred because the drug is converted into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, resulting in cardiac depression,” said Public Citizen in a statement released February 28, 2006 when they originally filed their petition. “Adverse cardiac events associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a decreased ability of the heart to contract properly.”

According to data from the Federal Drug Abuse Warning Network, deaths related to Darvocet, Darvon and other generic propoxyphene drugs account for over 5% of all drug-related deaths between 1987 and 200
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November Avandia News

Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, released a committee report based on a two year inquiry of the diabetes drug Avandia. The senators also asked the Food and Drug Administration to describe what steps the agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007.

The committee report quotes the senators as saying, “As senior members of the United States Senate and Chairman and Ranking Member of the Committee on Finance (Committee), we have a duty under the Constitution to conduct oversight into the actions of executive branch agencies, including the Food and Drug Administration (FDA). In this capacity, we must ensure that FDA properly fulfill their mission to advance the public’s welfare, safeguard the nation’s drug supply, and protect patients participating in clinical trials.”

Will the FDA seek a withdrawal of Avandia? Stay tuned

Friday, November 19, 2010

Darvon and Darvocet/Propoxyphene News November 19, 2010

The FDA  has asked that propoxyphene, (brand names Darvon and Darvocet, Xanodyne Pharmaceuticals) be removed from the US market. The decision will also affect generic manufacturers and the makers of propoxyphene-containing products.

The FDA has told medical professionals to stop prescribing propoxyphene. Patients who are taking the stated medications should not sinply stop taking it, ut should contact their doctor soon as possible to discuss switching to another pain-management therapy.

Propoxyphene is an opioid typically used to treat mild to moderate pain. It was first approved by the FDA in 1957. It is sold by prescription under various names alone or in combination with acetaminophen. Since 1978, the FDA has received two requests to remove propoxyphene from the market.

In January 2009, an FDA advisory committee voted 14 to 12 against the continued marketing of propoxyphene products. At that time, the committee called for additional information about the drug's cardiac effects.

Talk to us if you believe that you or a loved one was injured because of this medication. The call is confidential and free.

Call us anytime, including after 5 PM and on weekends

Reusable Shopping Bags and Possible Lead Contamination?

Australian Green BagImage via Wikipedia The recent report by a newspaper in Tampa, Fl. has caused retailers and the Food and Drug Administration (FDA) to investigate the lead levels of reusable shopping bags.

Tests showed some Publix reusable bags had lead levels that exceed federal limits for paint and exceeded rules coming soon for children's toys. Though the bags comply with other limits, Publix, in a cautionary move, asked its bag suppliers to lower lead content in bags. That decision came after officials were told the results of tests.

Read more here at the source: http://www2.tbo.com/content/2010/nov/14/140842/lead-taints-reusable-bags/news-metro/

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Wednesday, November 17, 2010

Iqbal/Twombly Applies to All Civil Cases in Federal Court, Including State Law Claims Removed to Federal Court

Boston ScientificImage via Wikipedia

So says the TN USDCT, in an opinion released last week. 




BOSTON SCIENTIFIC, et al., Defendants.

No. 3:10-CV-178.
United States District Court, E.D. Tennessee, Knoxville Division.
November 4, 2010.


THOMAS W. PHILLIPS, District Judge.
This matter is before the Court on Defendants' Motion to Dismiss [Doc. 8]. On June 4, 2010, Defendants filed a Motion to Dismiss pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. Defendants argue that Plaintiff's claims—all based in products liability—do not satisfy the federal pleading requirements, as modified in Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, ___ U.S. ___, 129 S.Ct. 1937 (2009).
On October 19, 2010, Plaintiff responded in opposition, arguing that: (1) federal pleading requirements do not apply to state law claims removed to federal court; and (2) in any event, Plaintiff satisfied the federal pleading requirements, as modified by Twombly. [Plaintiff's Response to Defendants' Motion to Dismiss, Doc. 13]. On October 28, 2010, Defendants filed a Reply in support of their Motion to Dismiss. [Doc. 15].
Based upon the following, Defendants' Motion to Dismiss [Doc. 8] is GRANTED, whereby Plaintiff's complaint is DISMISSED. While Plaintiff's complaint is dismissed, Plaintiff has 30 days from entry of this Memorandum and Order to file an amended complaint. If Plaintiff fails to file an amended complaint within this time period, or if the amended complaint fails to satisfy the federal pleading requirements, judgment shall be entered in favor of the Defendants.


As an initial matter, the Court notes that it has jurisdiction pursuant to 28 U.S.C. §§ 1332, 1441. The following facts are taken mostly from Plaintiff's complaint, and will be assumed as true for purposes of the 12(b)(6) motion. See, e.g., DIRECTV, Inc. v. Treesh, 487 F.3d 471, 476 (6th Cir. 2007) (in ruling upon motions to dismiss under Rule 12(b)(6), a court must "construe the complaint in the light most favorable to the plaintiff, accept its allegations as true, and draw all reasonable inferences in favor of the plaintiff").
On March 16, 2010, Plaintiff filed a product liability action against defendants Boston Scientific Corporation[1], Advanced Bionics[2], Scott Stewart, and John Does 1-5. [Plaintiff's Complaint, Doc. 1-1]. The complaint was filed in the Circuit Court for Knox County. [Id.]. On April 23, 2010, Defendants removed the case to federal court on the basis of diversity jurisdiction, 28 U.S.C. §§1331, 1441. [Defendants' Notice of Removal, Doc. 1].
In her complaint, Plaintiff alleges that she suffered injuries[3] after having a medical device implanted. [Plaintiff's Complaint, Doc. 1-1, ¶ IX, at 6]. In June 2007, at Fort Sanders Regional Medical Center in Knoxville, Tennessee, Plaintiff had a spinal cord simulation system device implanted. [Id.]. This device, the "Implantable Pulse Generator Advanced Bionics Precision SCS, Model number IPG SC-1110" (hereafter, the "Device"), is used to treat back pain. [Id.]. On October 6, 2007, a recall was issued for the model that Plaintiff had implanted. [Notice of Recall, Doc. 1-1 at 12-15]. According to Boston Scientific, only 8 patients out of 12,700 reported problems with the Device. [Field Safety Notice, Doc. 1-1 at 17]. On March 20, 2009, after "much pain and intense suffering and massive infection," Plaintiff had the Device removed.[4] [Plaintiff's Complaint, Doc. 1-1, ¶ IX, at 7].
Plaintiff has filed product liability claims against Boston Scientific and Advanced Bionics, the corporations which allegedly "designed, manufactured, assembled, distributed and sold" the Device. [Id. ¶ V, at 4]. In addition, Plaintiff has sued Scott Stewart, a field sales representative for Boston Scientific, who allegedly "maintained, sold, serviced, controlled, installed and removed" the Device. [Id. ¶ VI, at 5]. Plaintiff has also sued "John Does 1-5," several unidentified defendants [Id.].
Plaintiff has sued Defendants under several theories, including negligence, reckless misconduct, malice, fraud and oppression, and strict liability "in manufacturing, designing, assembling distributing maintaining, repairing, servicing, selling and installation"of the Device," and in "failing to include warnings as to its dangerous propensities and handling characteristics." [Id. ¶X.1, at 7]. While Plaintiff has not clearly identified her causes of action, it appears that she has sued Defendants under theories of defective design, defective manufacturing, and "failure to warn," among others.
On June 4, 2010, Defendants moved to dismiss pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. Defendants argue that Plaintiff failed to satisfy the federal pleading requirements, as modified in Twombly, 550 U.S. 544, and Iqbal, 129 S.Ct. 1937. On October 19, 2010, Plaintiff responded in opposition. [Plaintiff's Response to Defendants' Motion to Dismiss, Doc. 13]. On October 28, 2010, Defendants filed a Reply in support of their Motion to Dismiss [Doc. 16]. The matter is now ripe for adjudication.


Under Rule 8(a)(2) of the Federal Rules of Civil Procedure, a complaint must contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). In 2007, the Supreme Court modified the pleading standard in the context of antitrust cases. Twombly, 550 U.S. at 570. Notably, the Supreme Court held that in order to survive a 12(b)(6) motion to dismiss—which attacks the sufficiency of a complaint—the plaintiff must "state a claim to relief that is plausible on its face." Id. (emphasis added). In 2009, the Supreme Court extended the Twombly (or plausibility) standard to all federal civil cases. Iqbal, 129 S.Ct. at 1953.
Under the new standard, a claim is facially plausible if the plaintiff "pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. at 1949 (citing Twombly, 550 U.S. at 556). While this is not akin to a "probability requirement," the plaintiff must show "more than a sheer possibility that a defendant has acted unlawfully." Id. (citing Twombly, 550 U.S. at 556). This "requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555 (citations and quotation marks omitted). In other words, a plaintiff must "plead factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 129 S.Ct. at 1949. A plaintiff falls short if he pleads facts "merely consistent with a defendant's liability" or if the alleged facts do not "permit the court to infer more than the mere possibility of misconduct . . ." Id.
In ruling upon motions to dismiss under Rule 12(b)(6), a court must "construe the complaint in the light most favorable to the plaintiff, accept its allegations as true, and draw all reasonable inferences in favor of the plaintiff." DIRECTV, 487 F.3d at 476. However, the court "need not accept as true legal conclusions or unwarranted factual inferences." Id. (quoting Gregory v. Shelby Cnty., 220 F.3d 433, 446 (6th Cir. 2000)). See also Iqbal, 129 S.Ct. at 1949 ("[T]he tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.") (citing Twombly, 550 U.S. at 555). Ultimately, this determination-whether a plaintiff's claim is "plausible"—is a "context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Iqbal, 129 S.Ct. at 1950 (citations omitted).


A. Twombly Applies to All Civil Cases in Federal Court, Including State Law Claims Removed to Federal Court

As an initial matter, Plaintiff argues that the Court should look to Tennessee law for pleading requirements. [Plaintiff's Response to Defendants' Motion to Dismiss, Doc. 13 at 4]. In other words, Plaintiff wants the Court to apply Tennessee law—instead of Twombly—in ruling upon the 12(b)(6) motion. [Id.]. According to Plaintiff, the Court "should follow state law pleading requirements since this is a claim based upon state law . . ." [Id.].
Plaintiff's argument is without merit. It does not matter whether Plaintiff's claims are based upon state law or federal law: all claims, once removed to federal court, are subject to federal pleading requirements. In Iqbal,. the Supreme Court held that Twombly's plausibility standard applies to all civil cases in federal court. 129 S.Ct. at 1953. In Iqbal, the respondents argued that the plausibility standard should be limited to antitrust cases, as in Twombly. Id. The Supreme Court rejected this argument, holding that the plausibility standard applies to all civil cases in federal court:
Though Twombly determined the sufficiency of a complaint sounding in antitrust, the decision was based on our interpretation and application of Rule 8. That Rule in turn governs the pleading standard in all civil actions and proceedings in the United States district courts.
Id. (emphasis added) (citations and quotations omitted). See also Minger v. Green, 239 F.3d 793, 799-801 (6th Cir. 2001) (applying federal pleading rules in a case based upon diversity jurisdiction); Wilkey v. Hull, 366 F. App'x 634, 637 (6th Cir. 2010) (applying Twombly pleading standard in a diversity case to determine whether the plaintiff alleged sufficient facts to support state law claims); Foust v. Stryker Corp., No. 2:10-cv-00005, 2010 WL 2572179, at *2 (S.D. Ohio Jun. 22, 2010) (applying Twombly pleading standard to a complaint alleging product liability claims under Ohio law).
Although the complaint was filed in state court, it was eventually removed to federal court. As a result, the complaint is subject to federal pleading requirements, which includes Rule 8(a)(2) of the Federal Rules of Civil Procedure. See Granny Goose Foods, Inc. v. Brotherhood of Teamsters & Auto Truck Drivers Local No. 70 of Alameda Cnty., 415 U.S. 423, 438 (1974) ("The Federal Rules of Civil Procedure, like other provisions of federal law, govern the mode of proceedings in federal court after removal.") (emphasis added); Fed R. Civ. P. 81(c) ("These rules apply to civil actions removed to the United States district courts from the state courts and govern procedure after removal.") (emphasis added). In Twombly, 550 U.S. at 550, and Iqbal, 129 S.Ct. at 1953, the Supreme Court modified Rule 8(a)(2) by incorporating a "plausibility" standard. Accordingly, the Court must determine whether Plaintiff has "state[d] a claim to relief that is plausible on its face." Twombly, 550 U.S. at 570 (emphasis added).

B. Plaintiff's Complaint Does Not Satisfy Twombly's Pleading Requirements

1. Introduction

Defendants argue that Plaintiff's complaint does not satisfy Twombly because it does not "plead sufficient factual allegations concerning how the product was purportedly defective, and how the purported defect caused her alleged injury." [Defendants' Reply in Support of their Motion to Dismiss, Doc. 15 at 3]. In response, Plaintiff argues that her complaint satisfies Twombly because it put Defendants "on notice that this it [sic] is a products liability case, that the Defendants[s] are the maker of a defective product, and that this defective product had to be removed from the Plaintiff's body." [Plaintiff's Response in Opposition to Defendants' Motion to Dismiss, Doc. 14 at 3]. Having reviewed Plaintiff's complaint, the Court finds that it fails to allege sufficient facts to support a product liability action.
While Plaintiff has filed several claims against Defendants, each is covered by the Tennessee Product Liability Act of 1978 ("TPLA"), T.C.A. §§ 29-28-101 et seq.[5] See Higgs v. Gen. Motors Corp., 655 F. Supp. 22, 23 (E.D. Tenn. 1985) ("Indeed, it makes no difference whether the complaint is couched in terms of negligence, strict liability or breach of warranty, it has generally been held in the State of Tennessee that in order for a plaintiff to recover under any theory of product liability, the plaintiff must establish that the product was defective and unreasonably dangerous at the time the product left the control of the manufacturer."). Regardless of Plaintiff's theory of recovery—which includes strict liability, defective design, defective manufacturing, failure to warn—Plaintiff must allege facts for the Court to infer that the Device was "defective" or "unreasonably dangerous" at the time it left the control of the manufacturer. See King v. Danek Med., Inc., 37 S.W.3d 429, 435 (Tenn. Ct. App. 2000) ("Unless the product was in a defective condition or unreasonably dangerous when it left the control of [the manufacturer], there is no liability pursuant to [the TPLA]"); T.C.A § 29-28-105(a) ("A manufacturer or seller of a product shall not be liable for any injury to person or property caused by the product unless the product is determined to be in a defective condition or unreasonably dangerous at the time it left the control of the manufacturer or seller.") (emphasis added). At this stage in the proceeding, Plaintiff must allege facts for the Court to infer that: "(1) the product was defective and/or unreasonably dangerous, (2) the defect existed at the time the product left the manufacturer's control, and (3) the plaintiff's injury was proximately caused by the defective product." Sigler v. Am. Honda Motor Co., 532 F.3d 469, 483 (6th Cir. 2008) (citing King, 37 S.W.3d at 435). Under the TPLA, a product is "defective" if it is a "product that renders it unsafe for normal or anticipate handling and consumption." T.C.A. § 29-28-102(2). In addition, a product is "unreasonably dangerous" if it is "dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics, or that the product because of its dangerous condition would not be put on the market by a reasonably prudent manufacturer or seller assuming that he knew of its dangerous condition." T.C.A. § 29-28-102(8).
In Tennessee, there are two tests for determining whether a product is unreasonably dangerous. See T.C.A. § 29-28-102(8). Under the "consumer expectation test," this "requires a showing that the product's performance was below reasonable minimum safety expectations of the ordinary consumer having ordinary, `common' knowledge as to its characteristics." Jackson v. Gen. Motors Corp., 60 S.W.3d 800, 806 (Tenn. 2001). Under the "prudent-manufacturer test," the Court "imputes knowledge of the dangerous condition to the manufacturer, and then asks whether, given that knowledge, a prudent manufacturer would market the product. As the Tennessee Supreme Court has articulated, `[t]he consumer expectation test is, by definition, buyer oriented; the prudent manufacturer test, seller oriented.'" Johnson v. Manitowoc Boom Trucks, Inc., 484 F.3d 426, 428-29 (6th Cir. 2007) (citations omitted). Only sellers and manufacturers may be held liable under the TPLA.[6] See T.C.A. § 29-28-102(4), (7).
In all product liability actions, "[a] plaintiff must show that there was something wrong with the product, and trace the plaintiff's injury to the specific defect." King, 37 S.W.3d at 435 (citations omitted). See also Browder v. Pettigrew, 541 S.W.2d 402, 404 (Tenn. 1976) (holding that in order to establish a defective design claim, the plaintiff must "trace the injury to some specific error in construction or design of the [product]" and that "in a products liability action in which recovery is sought under the theory of negligence, the plaintiff must establish the existence of a defect in the product just as he does in an action where recovery is sought under the strict liability theory or for breach of warranty, either express or implied.") (citations omitted). At this stage in the proceedings, Plaintiff must allege facts for the Court to infer that the Device was defective, and that Plaintiff's injuries were caused by the condition of the Device. In this case, Plaintiff has failed to do both.

2. Plaintiff Failed to Allege Sufficient Facts for the Court to Infer that the Device Was Defective or Unreasonably Dangerous

The fact that Plaintiff allegedly suffered an injury from the Device does not show that the Device was defective. See King, 37 S.W.3d at 435 ("[i]n a product liability claim, the fact that a plaintiff is injured is not proof of a defect in the product") (citing Whaley v. Rheem Mfg. Co., 900 S.W.2d 296, 299 (Tenn. Ct. App. 1995); King, 37 S.W. 3d at 435 (recognizing that "the failure or malfunction of the device, without more, will not make the defendant liable") (citing Harwell v. Am. Med. Sys., Inc., 803 F. Supp. 1287, 1298 (M.D. Tenn. 1992)); Allen v. Am. Med. Sys., Inc., 1989 WL 105626 (Tenn. Ct. App. Sept. 15, 1989) (declining to find liability based upon the fact that the device did not function). Even assuming that the Device injured Plaintiff, that is not enough to show that the Device was defective or unreasonably dangerous—an element necessary for each of Plaintiff's claims. Instead of alleging facts for the Court to infer that the Device was defective or unreasonably dangerous, Plaintiff asserts conclusory allegations. For example, Plaintiff alleges that the "defective medical device [the Device] was not fit for the purpose intended and was defective and therefore caused the plaintiff harm." [Plaintiff's Complaint, Doc. 1-1, ¶ IV, at 6].
The facts of the present case are similar to Frey v. Novartis Pharm. Corp, 642 F. Supp. 2d 787 (S.D. Ohio 2009). In Frey, the plaintiff filed a product liability action in state court against the manufacturer of an anti-seizure medication. Id. at 790. The plaintiff alleged that she suffered health complications after ingesting the medication. Id. The plaintiff sued the manufacturer under theories of defective design and manufacturing (under Ohio law). Id. In support of her claims, the plaintiff alleged the following:
Defendants failed to design, manufacture, test, and control the quality of [the anti-seizure medication] such that when it left the control of the Defendant, it deviated in a material way from the design specification, formula or performance standards of the manufacturer, or from otherwise identical units manufactured to the same design specifications, formula or performance standards.
As a direct and proximate result of the defect in manufacture or construction by Defendants, Plaintiff [] suffered the injuries [] and damages set forth herein.
The defendant manufacturer removed the action to federal court, and then moved to dismiss under Rule 12(b)(6). Id. In particular, the defendant argued that the complaint failed to satisfy Twombly's pleading requirements. In response, the plaintiff argued that she could not "particularly allege that the scientific makeup of the drug is defective for a specific reason without conducting discovery, which requirement would exceed Twombly's plausibility standard." Id. at 792. The district court dismissed the defective design and manufacturing claims, finding that the complaint failed to satisfy Twombly:
Plaintiffs' first cause of action for strict liability for defect in the manufacture [and design] of [the anti-seizure medication] . . . must be dismissed pursuant to Rule 12(b)(6) for failure to state a plausible claim for relief. Plaintiffs have done nothing more than provide a formulaic recitation of the elements of a claim under the statute. They have failed to allege any facts that would permit the Court to conclude that a manufacturing defect [or design defect] occurred and that the defect was the proximate cause of [the Plaintiffs'] alleged injuries. Plaintiffs' allegations in this regard fall far short of the sufficiency standard set forth in Twombly.
Id. at 795.
Like the plaintiff in Frey, Plaintiff in the present case asserts legal conclusions about the nature of the Device. For example, Plaintiff alleges that Defendants "failed to warn" others of the "dangerous propensities and handling characteristics" of the Device. [Plaintiff's Complaint, Doc. 1-1, ¶ X.1, at 7]. However, Plaintiff does not allege any facts for the Court to infer that the Device was unreasonably dangerous. To plead a "failure to warn" claim[7], Plaintiff must allege facts for the Court to infer that the Device was "unreasonably dangerous" within the meaning of T.C.A. § 29-28-102(8). See Evridge v. Am. Honda Motor Co., 685 S.W.2d 632, 636 (Tenn. 1985) (defining an adequate warning-which is a defense to a "failure to warn" claim—as "one calculated to bring home to a reasonably prudent user of the product the nature and the extent of the danger involved in using the product") (emphasis added). Regardless of the theory of recovery—whether it be breach of warranty, negligence, defective design-Plaintiff must allege facts for the Court to infer that the Device was defective or unreasonably dangerous. See, e.g., Friedman v. Intervet Inc., No. 3:09CV2945, 2010 WL 2817257, at *3, 4 (S.D. Ohio Jul. 16, 2010) (denying a defendant manufacturer's motion to dismiss a product liability action because "[u]nlike Frey, in this case, plaintiff alleges specific problems with the product [a veterinary pharmaceutical used to treat diabetes in animals]; namely, that test results showed the product was out of specification with regard to its primary compound, and that this was a deviation from the product's intended characteristics" and that "[p]laintiff's allegations-detailing the product's problem . . . are more than sufficient to nudge [] [his] claims across the line from conceivable to plausible") (emphasis added) (quotations and citation omitted). Like the plaintiff in Frey, Plaintiff failed to satisfy Twombly's plausibility standard because she did not allege facts for the Court to infer that the Device was defective or unreasonably dangerous.

3. Plaintiff Failed to Allege Sufficient Facts for the Court to Infer a Causal Connection Between the Device's Condition and Her Alleged Injuries

Plaintiff's complaint fails for a second reason: she did not allege facts for the Court to infer that the condition of the Device—based upon an alleged design or manufacturing defect—caused her alleged injuries. As Tennessee courts make clear, it is not enough that Plaintiff suffered injuries from using (or in this case, having implanted) a product. See, e.g., Browder, 541 S.W.2d at 404 (holding that in order to establish a product liability claim, the plaintiff must "trace the injury to some specific error in construction or design of the [product]"). While Plaintiff alleges that the Device caused her pain, she does not allege facts regarding how an alleged defect—whether it be in design or manufacturing—caused her injuries. The relevant question is not whether the Device caused her pain; the issue is whether the alleged defective design or manufacturing of the Device caused her pain. See id. Plaintiff has not alleged any facts regarding this issue.
On a final note, the Court finds Plaintiff's allegations regarding a recall insufficient to support her product liability claims. While a Notice of Recall [Doc. 1-1, at 12-15] was issued in February 2008[8], Plaintiff alleges that she was not informed until much later. [Plaintiff's Complaint, Doc. 1-1, ¶ X.2, at 8]. In particular, Plaintiff alleges that "the defective device remained in the plaintiffs' [sic] person causing pain and injury for a period of more than sixteen months after the recall of this defective device, which was unknown and never at anytime published to the plaintiff. Plaintiff believes and avers that the facts and circumstances which lead to the recall of this defective device and that they were known to the defendants at the time, or shortly thereafter, its installment into the plaintiffs' body." [Id.]. In support of her product liability claims, Plaintiff attached the Notice of Recall to her complaint. [Doc. 1-1, at 12-15]
In ruling upon a Rule 12(b)(6) motion to dismiss, courts consider the complaint as well as "documents incorporated into the complaint by reference, and matters of which a court may take judicial notice." Bowers v. Wynne, 615 F.3d 455, 470 (6th Cir. 2010) (emphasis added) (quoting Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322 (2007)). See also Bassett v. NCAA, 528 F.3d 426, 430 (6th Cir. 2008) ("When a court is presented with a Rule 12(b)(6) motion, it may consider the Complaint and any exhibits attached thereto . . . so long as they are referred to in the Complaint and are central to the claims contained therein.") (citation omitted). Because the complaint expressly mentions the recall, and because it is central to Plaintiff's product liability claims, the Notice of Recall [Doc. 1-1 at 12-15] will be incorporated by reference. The Notice of Recall, which was issued on February 27, 2008, states that the Device was recalled for the following reason:
Incorrect Data-Corruption of internal memory component results in an inability for the physician to reprogram the IPG [Implantable Pulse Generator, the type of device that Plaintiff had implanted] with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of `10h0' or `00h0' through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informational purposes. . . .
[Id. at 14]. In addition, Boston Scientific issued a Field Safety Notice[9] on October 24, 2007, stating the following:
This condition does not affect routine IPG functionality. The IPG delivers the same therapy as it would without the error, and the Remote Control continues to allow the full range of simulation parameter adjustment. The IPG, however, will cease logging of some data that could be used for informational purposes.
[Field Safety Notice, Doc. 1-1 at 16]. The Field Safety Notice states that only "8 patients out of over 12,7000 implanted IPGs (0.063%)" suffered from the recall problem. [Id. at 17].
While Plaintiff attached the Notice of Recall [Doc. 1-1 at 12-15] and Field Safety Notice [Doc. 1-1 at 16-17] to her complaint, she failed to allege facts for the Court to infer a connection between the recall, the condition of the Device, and her alleged injuries. Notably, Plaintiff does not allege that the Device malfunctioned, or that the Device suffered from the recall problem. Moreover, it does not appear that the recall was even motivated by a safety concern. As Defendants explain, the recall "was related to a software issue in the device's remote control memory, which would result in an error code being displayed on the remote control screen." [Defendants' Memorandum of Law in Support of their Motion to Dismiss, Doc. 9 at 3]. In sum, Plaintiff failed to allege facts regarding: (1) whether the recall was based upon injuries to other persons, or a concern about future injuries; (2) whether the Device suffered from the recall problem; and (3) assuming that the Device suffered from the recall problem, whether such condition caused her alleged injuries.


As the Supreme Court stated in Iqbal, "[a] pleading that offers `labels and conclusions' or `a formulaic recitation of the elements of a cause of action will not do.'" Iqbal, 129 S.Ct. at 1949 (quoting Twombly, 550 U.S. at 555). Plaintiff's complaint fails for two reasons. First, Plaintiff failed to allege facts for the Court to infer that the Device was defective or unreasonably dangerous. Second, Plaintiff failed to allege facts for the Court to infer that the product's condition caused Plaintiff's alleged injuries.
Based upon the foregoing, Defendants' Motion to Dismiss [Doc 8] is GRANTED, whereby Plaintiff's complaint is DISMISSED. However, Plaintiff is granted 30 days from entry of this Memorandum and Order to file an amended complaint. If Plaintiff fails to file an amended complaint within this time period, or if the amended complaint fails to satisfy federal pleading requirements, judgment shall be entered in favor of the Defendants.
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France: Diabetes drug linked to 500 deaths?

The now-banned diabetes and weight loss drug Mediator may have been linked to the deaths of about 500 people in the 33 years it was on the market.

France's health products safety agency has advised those who used the drug from 2006 to 2009 to see their doctor to check for possible heart valve problems.

The agency said Tuesday that about 5 million people used Mediator — the brand name for benfluorex in France — from 1976 until it was pulled off the market in 2009.

The European Medicines Agency said last year that it decided to remove benfluorex from the market because it had little effect on diabetes and might lead to a dangerous thickening of heart valves.

Benfluorex, used especially to treat weight problems among diabetics, underwent various tests over time, but it was only in 2006 that a confirmed case of heart valve problems related to its use was reported, the health safety agency said.

Source:  http://news.yahoo.com/s/ap/20101116/ap_on_he_me/eu_france_diabetes_pill

Tuesday, November 16, 2010

So long to caffeinated alcoholic beverages? FDA will ban them, one senator says

MIAMI - OCTOBER 27:  Cans of Four Loko are see...Image by Getty Images via @daylife
From the LA Times:

Caffeinated alcoholic drinks that have been making college kids sick on campuses in several states may not be around much longer -- if news report of their proposed demise are correct.

Sen. Charles Schumer (D-N.Y.), who has supported such a ban, reports Tuesday on his website that the Food and Drug Administration plans to ban caffeinated alcoholic drinks like Four Loko and Joose as an "unsafe food additive to alcoholic beverages.

Read more here: http://www.latimes.com/health/boostershots/la-heb-caffeinated-alcohol-drinks-ban-20101116,0,3776751.story
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New Federal Rules Information, Rule 26

West face of the United States Supreme Court b...Image via WikipediaOn December 1, 2010, regardless of the filing date, all cases in Federal Court are subject to a revision of the Rule 26 of the Federal Rules of Civil Procedure as it relates to expert witness reports.   No longer will Rule 26 require full discovery of draft expert reports and broad disclosure of any communications between an expert and his attorney client.
Instead, those communications will are considered work-product.  The revision of this rule will prohibit discovery of draft expert reports and limit discovery of attorney-expert communications.  However, this rule does not affect discovery of the expert's opinions and of the facts or data used to support them.
The rule was approved by the U.S. Judicial Conference in September 2009. The Supreme Court approved the change to the rule in April of 2010 and submitted it to Congress. By law, if Congress takes no action to reject, modify or defer the proposed rule, it takes effect on Dec. 1.  John K. Rabiej, an attorney advisor on court rules to the Judicial Conference, confirmed publicly that Congress has taken no action and that the rule will in-fact take effect on Dec. 1.
The rule expressly provides that the work-product protection applies to "protect drafts of any report or disclosure required under Rule 26(a), regardless of the form in which the draft is recorded."
The rule also applies work-product protection to communications between experts and the counsel who retain them. The rule maintains three exceptions to this protection:
Communications pertaining to the expert's compensation
Facts or data that the attorney provided and the expert considered in forming opinions
Assumptions that the attorney provided and that the expert relied on
The Judicial Conference proposed the new rule in order to address problems created by the 1993 revisions to Rule 26. Courts interpreted the rule to allow discovery of all communications between counsel and expert witnesses and all draft expert reports. That resulted in "significant practical problems," the conference said in its report to the Supreme Court.
"Lawyers and experts take elaborate steps to avoid creating any discoverable record and at the same time take elaborate steps to attempt to discover the other side’s drafts and communications," the report said.
"The artificial and wasteful discovery-avoidance practices include lawyers hiring two sets of experts – one for consultation, to do the work and develop the opinions, and one to provide the testimony – to avoid creating a discoverable record of the collaborative interaction with the experts."
The change to Rule 26 received broad support from trial lawyers and bar organizations, perceiving it as a long-overdue step towards reducing the cost and contentiousness of litigation. At hearings conducted by the Advisory Committee on Civil Rules on the changes to Rule 26 and Rule 56, some 90 witnesses presented testimony.
Amending the rule would enable litigants to avoid the kind of "artificial behavior" that is now all-too common, he suggested. No longer would lawyers and experts feel compelled to avoid written communications and no longer would well-funded litigants hire two sets of experts, one to consult in case development and the other to testify.
"The proposed amendments provide protection to attorney-expert communications that allows the attorney and the expert to communicate freely with each other without having to engage in time-consuming and wasteful measures to avoid the creation of a draft report," said John H. Martin, a past-president of the Defense Research Institute and a partner with Thompson & Knight in Dallas.
"This allows the attorney to learn about the scientific or technical aspects of the case from the expert so that legal arguments not based on sound scientific methodology can be discarded, and the issues to be presented at trial can be narrowed," Martin added. "At the same time, it allows the attorney to speak freely with the expert, many of whom are not fulltime professional expert witnesses, and to engage in an ethical preparation of the witness to present opinion testimony."
It appears that the new rule extends the work-product protection to not just the expert, but also to the expert's employees. The official committee note that accompanies the proposed rule explains that its protection is intended to include communications "between the party's attorney and assistants of the expert witnesses."
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Monday, November 15, 2010

MMSEA Reporting Deadline for Liability Settlements Extended

Centers for Medicare and Medicaid Services (Me...Image via Wikipedia
On November 9th, the Centers for Medicare and Medicaid Services ("CMS") posted an alert (the "Alert") on its website extending, once again, the trigger and reporting dates for most liability settlements. The Alert also extends the dollar thresholds for reporting by one year.
Extension for Reporting:
Liability insurance (including self-insurance) total payment obligations to claimant ("TPOC") 1 must be reported if the settlement date is on or after October 1, 2011 (rather than October 1, 2010 as required by Version 3.1 of the User Guide 2).   The reporting must be no later than the designated submission window in the first quarter of 2012.
The reporting requirements for cases that include on-going recurring medicals ("ORM") have not changed; therefore, there are no reporting changes for workers' compensation, liability settlements that include ORM, or no-fault cases. These cases must be reported no later than the designated submission window during the first quarter of 2011.
The Alert states that if the reporting entity wishes to report liability (including self-insurance) TPOC settlements prior to the first quarter of 2012 they are allowed to do that.  The reporting entity must report during their assigned quarterly submission window. 
Extension of Current Dollar Thresholds:
The Alert provides for the interim dollar reporting thresholds, as provided in Section 11.4 of Version 3.1 of the User Guide, to be extended by one year.  The dollar amounts have not changed.  The thresholds for exemption from reporting are summarized as:
  • Settlement date prior to January 1, 2013 and amount is $5,000 or less
  • Settlement date during 2013 and amount is $2,000 or less
  • Settlement date during 2014 and amount is $600 or less
How does this affect you?
This Alert provides an additional twelve months for CMS and the reporting entities to prepare for the mandatory reporting of liability claims.  This deferral does not, however, change the need for all parties to ensure that Medicare's interests are being protected for past and future medical expenses. Actions items to ensure verification, resolution, and reporting include the following:
  • Proper release language is incorporated in settlement documents to protect all parties
  • Processes are in place to ensure compliance
  • Train for the who, what, when and why of compliance
  • Query open claims to determine Medicare beneficiary status
  • Begin reporting cases to guarantee that the processes are in place well before the mandatory reporting date   
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Congressional Panel wants FDA to Answer Questions about

Coat of Arms of the Commonwealth of Puerto RicoImage via WikipediaOn November8, 2010 The Committee on Oversuight and Government Reform sent to the FDA a letter that possibly suggests that business as usual may change. From the letter written by Edolphus Towns:

The safety of children's over-the-counter (OTC) pharmaceutical products is of
paramount importance to the American people. During the Committee's follow-up
hearing on the recall of infant, children, and adult OTC products by McNeil Consumer
Healthcare, LLC (McNeil), a number of bipartisan questions were raised regarding the
involvement of the U.S. Food and Drug Administration (FDA) district office in Puerto
Rico.  Through documents produced to the Committee, there are still unanswered
questions regarding the silent recall and the actions of FDA Puerto Rico's employees

Congressman Towns went right after the FDA:  "It appears that FDA's Puerto Rico district office may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the
island." That, in my view is the understatement of the century, not just for P.R. but for the FDA's oversight of all facilities.

He goes on to write: GlaxoSmithKline sold 20 drugs with questionable safety that were made at a huge plant
in PUelio Rico that for years was rife with contamination.'

The FDA was given until 11/17/2010 to produced numerous documents. In my humble opinion, heads must roll. The public is grossly unprotected by an ineffective, toothless FDA that is underfunded and hopelessly understaffed. I've come to the conclusion that in my lifetime, nothing will change.

Quis custodiet ipsos custodes? 

 Plato asked that very question - who will guard the guards? It seems that the US government cannot yet answer that question for the American people.


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Friday, November 12, 2010

November Fosamax Lawsuit News: Raising Questions for Doctors, and Juries

In a civil case now pending New York, a woman is suing Merck, the maker of Fosamax. She claims that that Fosamax had caused such debilitating jawbone deterioration that the Plaintiff has now  required five major operations, including a lengthy surgery to replace her broken jaw with bone from her left arm.

Merck has defended itself, arguing  that the plaintiff took other prescriptions — like steroids to treat rheumatoid arthritis — that weakened her immune system, leading to her jaw infection and healing problems.

The NY Times article is a good one discussing the elements of this next trial,  and you can read the rest right here: http://www.nytimes.com/2010/11/11/health/11bone.html?_r=1&hp

Monday, November 08, 2010

November 2010 Georgia Reglan News

The U.S. Solicitor General has asked the U.S. Supreme Court to reject an appeal by pharmaceutical companies in a generic Reglan lawsuit, in a case known as the Mensing decison.

The manufacturers of the generic Reglan, metoclopramide, are seeking a reversal of an appellate court decision that holds them liable for failing to warn patients about the risk of tardive dyskinesia, a rare movement disorder linked to the drug. The Supreme Court asked the U.S. Solicitor General for an opinion on the accountability of generic Reglan manufacturers.

The Solicitor General supported the appellate court ruling in an amicus brief that had been filed a week ago.  “The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted,” the brief said. “A generic manufacturer can (and indeed, must) inform the FDA of new information about the risks that may require a change in the labeling of its drug.”

Thursday, November 04, 2010

FDA Receives Complaints Associated With the Use of Brazilian Blowout

Logo for the United States Occupational Safety...Image via WikipediaTheFDA has recently received a number of inquiries from consumers and salon professionals concerning the safety of “Brazilian Blowout” and similar “professional use only” hair care products. The following information is intended to answer questions people may have on this subject.
Has FDA received reports of problems related to these products?

FDA has been notified by some state and local organizations of reports from salons about problems associated with the use of Brazilian Blowout, a product used to straighten hair. Complaints include eye irritation, breathing problems, and headaches. State and local organizations with authority over the operation of salons are currently investigating these reports. FDA has recently received some adverse event reports on
Brazilian Blowout from salon personnel or consumers. These reports included symptoms similar to those in the reports received by state and local organizations, as well as symptoms such as rashes and fainting.

What is FDA’s role in regulating these products?
Although FDA does not have authority over the operation of salons, we do have certain authority over hair straighteners and similar cosmetic products. To learn more, please see "FDA Authority Over Cosmetics."

Who regulates salon safety?
Workplace safety in general, including air quality issues, is regulated by the Occupational Safety and Health Administration (OSHA). Salons are generally subject to state and local authorities as well, which may specify safety practices such as assuring proper ventilation.

What is FDA doing?
FDA is working with state and local organizations, as well as OSHA, to determine whether the products or ingredients would be likely to cause health problems under the intended conditions of use. The composition of the products and the labeling, including use instructions and any warning statements, will be factors in this determination. One safety issue we’ll be evaluating is whether formaldehyde may be released into the air after the product is applied to the hair and heated.

Link: http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm228898.htm
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Chelation Products Warning Letter from FDA to Dr. Rhonda Henry

From the FDA site,  a follow up to my prior post. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm229243.htm

October 12, 2010
Dr. Rhonda Henry
247 La Costa Ave.
Dayton, NV 89403
Dear Dr. Rhonda Henry:                                                                                 
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the internet address www.drhenry.com in July 2010 and has determined that the products, “Pure Heart,” “Melatonin,” “Flaxseed Meal,” “DHEA” and “Cardio Chelate (H-870)” are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].
The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  The marketing of the products with these claims violates the Act.
Examples of some of the claims observed on your website include:
On a webpage at the Dr. Rhonda’s Health Store entitled, “Lose Weight Permanently By Eating”:
Pure Heart
• “[T]here is a completely safe … therapy that can prevent and even reverse heart disease”
•  “The results showed a superior clinical improvement in the Pure Heart group including:
o Decrease of LDL cholesterol
o Increase of HDL cholesterol
o Moderate to Dramatic decrease in angina
o Increase in total blood flow through previously occluded vessels
o Improvement in feeling of depression
o Recovery of myocardial function in previous ischemic and necrotic areas
o Reduction in tachycardia upon stress exercise”
• “The ingredients in Pure Heart appear to be capable of partially or completely reducing ischemia.”
•  “Pure Heart was created to help prevent the changes in the blood vessels which result in heart disease.”
• “Melatonin boosts the immune system reducing the likelihood and severity of infectious diseases, it is a super antioxidant that protects cells from free radical damage, slows the growth of tumors, regulates blood pressure, wards off heart disease, prevents cancer....helps control Parkinson’s Disease, stops or delays the formation of cataracts….”
Flaxseed Meal
• “The dynamic health benefits [of Flaxseed Meal] include: lowered blood pressure … and anti-cancer benefits.”
• “Research has found DHEA to have significant anti-obesity ... anti-cancer effects.”
• [L]ow DHEA levels correlate to increased risk of cancer, heart disease, osteoporosis, obesity, diabetes …”
• “Scientific research has linked increased levels of DHEA with reduced risk of most degenerative diseases ….”
Cardio Chelate (H-870)
• “Oral Chelation Formula Removes Plaque that Clogs and Hardens Arteries.”
• “Ayurvedic Herbs Work on the Cause of Heart Disease.”
• “This balanced herbal formula displays the following properties:
o “Pushkarmul and kut have beta blocking like activity.”
o “Arjuna has antihypertensive calcium channel blocker activity.”
o “Gugul has hypolipidemic and antithrombic properties.”
o “Shankhpushpi, arjuna and jalneem are … antihypertensive.”
o “Kut has antidiabetic properties.”
o “Gugul decreases obesity … ”
• “[B]romelain, an enzyme from pineapple, and Papain … cleanse the arteries.”
• “These enzymes break down fibrin, inhibit clotting and promote normal healing of surface lesions.”
Your website also contains disease claims in the form of personal testimonials. The following are excerpted from a webpage entitled “Dr. Rhonda Henry’s Health Test”:
•  “Recently, an excruciatingly painful arthritis flare up in my knees …. Dr. Rhonda heard of my pain, she came in like an angel, bearing a bag of supplements ….  Within 24 hours, my condition turned around.  The inflammation left, the mobility increased.”
• “8 years ago, I was a very sick person.  I had battled colitis, diverticulitis, Epstein-Barr virus and low blood sugar.  I spent thousands of dollars on tests and doctor bills trying to find an end to all my health problems.  I picked up parasites in the Yucatan Peninsula …. I was down 93 pounds, couldn’t digest food, and was weak
• and dizzy all the time … I now eat and digest my food, lift weights 3 times a week, and have energy to spare.”
The claims quoted above are supplemented by the metatags used to bring consumers   to your website through Internet searches.  The metatags include “diabetes”, “arthritis”, “depression”, “menopause”, “peri-menopause”, “Candida”, “digestive disorders”, “osteoporosis”, and “infections”.
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].  New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)].  FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The above violations are not meant to be an inclusive list of deficiencies in your products and their labeling.  It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence.  Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur.  Include any documentation necessary to show that correction has been achieved.  If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Juliane K. Jung-Lau, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502.  If you have any questions regarding any issues in this letter, please contact Ms. Jung-Lau at 510-337-6793.
Barbara J. Cassens
San Francisco District