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Preview: LexisNexis® Mealey's™ Ephedra & PPA Legal News

LexisNexis® Mealey's™ Ephedra & PPA Legal News

Headline Ephedra & PPA Legal News from LexisNexis®


Proposed Stay Of Liquidation Plan Pending Appeal Rejected By Judge
SAN DIEGO - The bankruptcy judge overseeing the Metabolife International Inc. settlement on Dec. 12 denied a motion to stay liquidation pending appeal brought by a former putative class action representative whose claims were denied in two courts, stating that he has not shown a likelihood that he will succeed on his appeal or the likelihood that he will suffer injury if a stay is not granted (In re: MII Liquidation, Inc., et al., No. 05-06040-H11, S.D. Calif. Bkcy.; See December 2007, Page 4). Full story on

Judge: Plaintiff Failed To Prove PPA Ingestion In 72-Hour Window
NEW ORLEANS - A federal judge said in a Dec. 17 order that a plaintiff cannot prove that he ingested the defendant's PPA-containing cold medication within 72 hours preceding his stroke and, therefore, cannot prove causation (Alejandro Garcia, et al. v. SmithKline Beecham Corp., et al., No. 01-3424, E.D. La.; 2007 U.S. Dist. LEXIS 92267; See August 2007, Page 13). Full story on

PPA Seller Cannot Supplement District Court Record
MONROE, La. - The former seller of a PPA-containing cold remedy that was denied insurance indemnity coverage may not supplement the record in a personal injury case to state that it only provided design specifications for the product and that the manufacturer provided the formula, a federal judge ruled Nov. 30 (Robert Weaver v. CCA Industries, Inc., No. 01-2096, W.D. La.; CCA Industries, Inc. v. New York Marine and General Insurance Co. No. 07-30597, 5th Cir.; 2007 U.S. Dist. LEXIS 88113, See August 2007, Page 15.). Full story on

Oklahoma Supplement Distributor Files Bankruptcy After Breach Of Contract Decision
OKLAHOMA CITY - AMS Health Sciences, a distributor of natural supplements, recently filed a Chapter 11 bankruptcy petition, citing a November verdict and judgment against it related to its acquisition of Heartland Cup Inc. (In Re: AMS Health Sciences, No. 07-14678, N.D. Okla. Bkcy.). Full story on

FDA Warns Against Use Of ED Supplements
ROCKVILLE, Md. - The U.S. Food and Drug Administration is warning consumers to avoid a number of Chinese dietary supplements being marketed for erectile dysfunction (ED) because they contain undeclared active ingredients that are otherwise found in prescription ED drugs. Full story on

'Maximum Slim' Seller Warned About Marketing Claims
ROCKVILLE, Md. - The Food and Drug Administration recently informed Martin Nutraceuticals Inc. that its marketing for "Maximum Slim" and "Arthrizyme" products violates the Federal Food Drug and Cosmetic Act (21 U.S. Code Section 321[g][1]) because it suggests that the supplements can be used to cure, mitigate, treat or prevent disease. Full story on

Supreme Court To Hear Drug Preemption Arguments At Feb. 25 Session
WASHINGTON, D.C. - The U.S. Supreme Court will hear arguments in its first ever drug preemption case on Feb. 25, the court announced last month (Warner-Lambert Co., et al. v. Kimberly Kent, et al., No. 06-1498, U.S. Sup.) Full story on

United States: Drug Warning Claims 'Impliedly Preempted' But Asks High Court To Hold Off
WASHINGTON, D.C. - The U.S. solicitor general on Dec. 21 told the U.S. Supreme Court that failure-to-warn claims involving a drug are barred by implied preemption, but he urged the court not to take up the case until it issues preemption rulings in separate drug and device cases that are pending (Wyeth v. Diana Levine, No. 06-1249, U.S. Sup.). Full story on

Metabolife Liquidation Plan Proponents Oppose Stay Pending Appeal
SAN DIEGO - MII Liquidation (formerly Metabolife International Inc.) and its creditors and indemnitees oppose a motion brought by the lead plaintiff of a denied settlement class to stay the implementation of a bankruptcy settlement plan pending appeal, stating that the motion was untimely and that a stay would lead to "turmoil" and might jeopardize the resolution of the Metabolife personal injury and wrongful death cases (In re: MII Liquidation, Inc., et al., No. 05-06040-H11, S.D. Calif., Bkcy.; See Nov. 2007, Page 5). Full story on

Metabolife Founder Pleads Guilty To Lying To FDA; Faces 5 Years In Prison
SAN DIEGO - Michael J. Ellis, founder and former president of Metabolife International Inc., on Nov. 5 pleaded guilty in federal court to charges of making false statements to the U.S. Food and Drug Administration in 1999 about the safety of Metabolife's ephedra supplements (USA v. Metabolife, Inc., et al., No. 03 CR 1088-J, S.D. Calif.). Full story on

Summary Judgment Granted For Lack Of Evidentiary Support
BATON ROUGE, La. - A federal judge on Nov. 16 granted summary judgment for Bayer Corp. in a PPA case, stating that he reviewed the record and found that Bayer's argument that the plaintiff failed to provide case-specific expert testimony or expert reports supporting her claims had merit and that the motion was unopposed (Mildred Mitchell v. Bayer Corp., No. 07-CV-212, M.D. La.; See September 2007, Page 17). Full story on

No Evidentiary Support Filed In PPA Case
BATON ROUGE, La. - Because a plaintiff has failed to provide case-specific expert testimony of causation in his PPA case, summary judgment is appropriate, a federal judge ruled Oct. 2 (Greg Stagg v. Bayer Corp., et al., No. 05-1348-C-M2, M.D. La.). Full story on

Metabolife Case Dismissed For Failure To File Proof Of Claim
NEW YORK - Ephedra multidistrict litigation Judge Jed S. Rakoff on Nov. 6 granted a motion to dismiss a personal injury case against Metabolife International Inc. because the plaintiff failed to file a proof of claim in the bankruptcy proceedings (In Re: Ephedra Products Liability Litigation, 04 M.D. 1598 [JSR]; David H. Fox v. M.I.I. Liquidation, et al., No. 06-cv-6609). Full story on

BDI Denied Leave To File Summary Judgment Motion
NEW YORK - In his Nov. 2 status order, ephedra multidistrict litigation Judge Jed S. Rakoff confirmed a ruling by MDL Special Master James Niss, denying a defendant leave to file additional motions for summary judgment (In Re: Ephedra Products Liability Litigation, 04 M.D. 1598; Russell Wilburn v. N.V.E., Inc., No. 06 Civ. 13046, S.D. N.Y.; See September 2007, Page 6). Full story on

Judiciary Committee Airs 'Preemption By Regulation'
WASHINGTON, D.C. - Sen. Patrick Leahy, D-Vt., recently accused the Bush administration of abusing executive authority by attempting to impose federal preemption on legal claims through agency regulations. Full story on

Preemption Judgment Denied; Seroquel Plaintiff's Claims Include Extra-Label Promotion
ORLANDO, Fla. - The Seroquel multidistrict litigation court on Nov. 6 denied, at least for now, defendant AstraZeneca's motion for preemption on 11 plaintiffs' failure-to-warn claims, saying they include not just drug labels but also promotional activities of sales representatives with doctors (In Re: Seroquel Products Liability Litigation, MDL Docket No. 1769, No. 06-md-1769, M.D. Fla., Orlando Div.). Full story on

FDA's Fraud Finding In Study Means Claims Against Company Are Not Preempted, Court Says
PHILADELPHIA - A plaintiff's claims against a contract research organization are not preempted because the Food and Drug Administration found that the company engaged in fraudulent reporting of clinical study data, a Pennsylvania federal judge said Oct. 25 in denying summary judgment (Eileen Wawrzynek, et al. v. Statprobe, Inc., et al., No. 05-1342, E.D. Pa.). Full story on

Hi-Tech Challenge To FDA Ephedra Rule Denied In District Court
PITTSBURGH - A federal judge ruled Oct. 15 that the U.S. Food and Drug Administration did not act in an arbitrary and capricious manner in enacting the 2004 Final Rule on ephedra and that it acted properly in seizing five unlabeled boxes of ephedra products from a fitness products company in Pennsylvania (United States of America v. 5 Unlabeled Boxes and Hi-Tech Pharmaceuticals, Inc. v. Andrew C. Von Eschenbach, M.D., et al., No. 2:06-cv-00027-NBF, W.D. Pa.). Full story on

Westfall Class Wants Metabolife Liquidation Stayed Pending Appeal
SAN DIEGO - Willard Westfall, the representative of a dismissed putative Metabolife class action, is moving for a stay of the implementation of the joint plan of liquidation for the Metabolife bankruptcy pending his appeal of the approval, arguing that the plan contains impermissible releases (In Re: MII Liquidation, Inc., No. 05-6040-H11, S.D. Calif. Bkcy.; See October 2007, Page 6). Full story on

MuscleTech Wants 24 Ephedra MDL Cases Dismissed
NEW YORK - MuscleTech Research and Development Inc. on Nov. 5 in the ephedra multidistrict litigation moved to dismiss 24 individual ephedra cases that were settled as the result of mediation in the company's bankruptcy proceedings (In Re: Ephedra Products Liability Litigation, 04 MDL 1598 [JSR]; In Re: MuscleTech Research and Development, Inc., No. 06 Civ. 538 [JSR]; In Re: RSM Richter, Inc. v. Sharon Aguilar, No. 06 Civ. 539 [JSR], S.D. N.Y.; See January 2007, Page 13). Full story on

Judge Approves Common Fund Assessment Reallocation
NEW YORK - The ephedra multidistrict litigation judge on Oct. 17 granted a motion by the plaintiffs to change the common benefit fee for each gross settlement to allocate 1 percent to expenses and 5 percent to attorney fees (In Re: Ephedra Products Liability Litigation, 04 M.D. 1598 [JSR], S.D. N.Y.; See October 2007, Page 8). Full story on

Cap On Travel Expenses Raised For Ephedra MDL Plaintiff Attorneys
NEW YORK - The cap on reimbursable expenses for Plaintiffs' Coordinating Counsel (PCC) members of the ephedra multidistrict litigation traveling in major cities was modified in an Oct. 17 order to $400 a day for hotel and meals (In Re: Ephedra Products Liability Litigation, 04 M.D. 1598, S.D. N.Y.; See October 2007, Page 11). Full story on

Case Dismissed For Lack Of Substitute Plaintiff
NEW YORK - The ephedra multidistrict litigation judge on Oct. 17 granted an unopposed motion by Metabolife to dismiss a case because 90 days have passed since a suggestion of death was filed and no plaintiff has been substituted (In Re: Ephedra Products Liability Litigation, 04 M.D. 1598 [JSR]; Robert Hutchinson v. Metabolife International, Inc., et al., No. 1:06-cv-04478-JSR, S.D. N.Y.). Full story on

FDA Committees Vote To Ban OTC Cold Remedies For Children Under 6
SILVER SPRING, Md. - Two U.S. Food and Drug Administration advisory committees voted Oct. 19 to ban over-the-counter (OTC) cold remedies for children under the age of 6. Full story on

FDA Seizes $71,000 In Dietary Supplements It Says Were Misbranded
WASHINGTON, D.C. - The Food and Drug Administration on Oct. 9 ordered that U.S. marshals seize $71,000 in dietary supplements that the agency said were being improperly promoted as treatments for serious diseases. Full story on

FDA Requests Recall Of 'All Natural' Erectile Dysfunction Formulations
WASHINGTON, D.C. - The U.S. Food and Drug Administration said in a Nov. 2 press release that it has requested that America True Man Health Inc. recall its "all natural" erectile dysfunction products because they contain potentially dangerous ingredients. Full story on