Saturday, November 20, 2010

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. 

http://scholar.google.com/scholar_case?case=14595711359472781380&hl=en&as_sdt=2&as_vis=1&oi=scholarr

 

 

SALLIE MANESS, Plaintiff,
v.
BOSTON SCIENTIFIC, et al., Defendants.

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

MEMORANDUM AND ORDER

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.

I. BACKGROUND

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.

II. STANDARD OF REVIEW

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).

III. ANALYSIS

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.
Id.
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.

IV. CONCLUSION

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.
IT IS SO ORDERED.
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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
• “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.”
DHEA
• “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.
Sincerely,
 /S/
Barbara J. Cassens
Director
San Francisco District

FDA issues warnings to marketers of unapproved ‘chelation’ products

The FDA has warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products.
 
The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions. Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy.
 
The drug products involved have not been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug, and Cosmetic Act (FFDCA). Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care.
 
In addition, there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood.  Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death.  
 
“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.”
 
The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks and should be performed only under medical supervision.
 
The FDA has noted an increase in “chelation therapy” products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths.
 
Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy.
 
"FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness.” said Dara A. Corrigan, associate commissioner for Regulatory Affairs.
 
Under the FFDCA, companies that market products that claim to prevent, diagnose, treat or cure diseases must file an application with the FDA and provide data that demonstrate their products’ safety and effectiveness.
 
The companies must take prompt action to correct the legal violations cited in the warnings letters or face possible legal action, including seizure and injunction. The FDA issued warning letters to the following companies:
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Wednesday, November 03, 2010

Purple Glove Syndrome

An advisory committee of the Food and Drug Administration will consider whether IV phenytoin, marketed as Dilantin, should be relabled or even suspended because of the threat of Purple Glove Syndrome.




PGS is a rare condition first noted in the 1980s, when patients who received IV Dilantin were developing painful, swollen hands that turned a deep shade of violet. Some 43 cases of PGS have been documented, according to the FDA. However, it's very likely the disorder is under reported.

The condition is often caused when the toxic drug doesn’t go directly into a vein, but instead seeps into the underlying tissue of the hand. Often, the damage is permanent.

Another drug, fosphenytoin, marketed under the brand name Cerebyx, appears to control seizures as well as phenytoin, but without the same risk of PGS. Both drugs have similar risks of other side effects.

Source: http://bodyodd.msnbc.msn.com/_news/2010/11/03/5398283-purple-glove-syndrome-leads-fda-panel-to-review-drug

FDA tests confirm Listeria at Texas food plant

CeleryImage via WikipediaTests conducted by the FDA have found Listeria monocytogenes bacteria at a San Antonio Texas Fresh Cut Produce food processing plant after state health officials linked four deaths to contaminated celery from the facility.

A recall was issued on October 20, 2010 citing packages of chopped celery from the facility that had been sold to hospitals, restaurants and schools since January. Although the Fresh Cut Produce products were not sold directly to the public, investigators said they had linked tainted celery to at least six cases of listeriosis.

The listeria bacterium can cause severe illness, with symptoms that include fever, muscle aches, diarrhea and vomiting. Symptoms can occur up to 70 days after exposure. The disease affects primarily older people, pregnant women, newborns and people with weakened immune systems.

Link:http://www.examiner.com/fda-in-national/fda-tests-confirm-listeria-at-texas-food-plant





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Tuesday, November 02, 2010

A Disgraceful/Dangerous Stat: FDA fails to inspect 2,390 Foreign Drug Factories

Logo of the United States Government Accountab...Image via WikipediaThe General Accountability Office has just released a report that the FDA miserably failed to follow through on suggestion to inspect manufacturing facilities outside the USA. The folks at the GAO writes that there is an  “urgent need” to better protect public health.

Some stats from the GAO: In the FDA completed 424 foreign inspections. That more than the 324 inspections conducted in 2008. Also in 2009, 1,015 domestic inspections were completed. That is less than half of all USA run facilities. The GAO report says that equals one inspection every two and half years. Is that acceptable?

There were 3,765 facilities in the FDA databases, but 2,394 may never had been inspected. Is that acceptable?

Find the report here (PDF). Most damning conclusion? The GAO wrote: " Among other things, we determined that, because of inaccurate information in FDA’s databases, the agency did not know how many foreign drug establishments were subject to inspection."




 


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Monday, November 01, 2010

Merck: $950 Million Fine to US Regarding Vioxx

RofecoxibImage via Wikipedia
Merck booked a $950 million reserve in the third quarter to cover an anticipated resolution of a government investigation of the company's former pain drug Vioxx.

Merck, Whitehouse Station, N.J., withdrew Vioxx from the market in 2004 after it was linked to a higher risk of heart attacks and strokes. The company previously settled thousands of personal-injury lawsuits filed by Vioxx users and their families for about $4.85 billion.

The latest matter stems from a Justice Department probe of Merck's research, marketing and selling activities surrounding Vioxx. Merck previously disclosed the government was conducting a criminal investigation of the matter.

The U.S. Attorney's Office in Boston last year sent Merck a letter identifying the company as the target of a grand jury investigation regarding Vioxx.

"The company's discussions with the government are ongoing," said Merck spokesman Ron Rogers


Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201010290807dowjonesdjonline000408%20&title=merck-books-950-million-reserve-to-settle-us-vioxx-probe#ixzz144IpwqIb
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