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Aredia / Zometa MDL Judge Denies Summary Judgment In 10 Jaw Injury Casesemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
NASHVILLE, Tenn. - The judge in the Aredia/Zometa multidistrict litigation on Aug. 13 denied defendant Novartis Pharmaceuticals Corp. summary judgment on failure to warn and general causation in 10 cases but also denied the plaintiffs summary judgment barring evidence of alternative causes of their alleged injuries (In Re: Aredia and Zometa Products Liability Litigation, MDL Docket No. 1760, No. 06-1760, M.D. Tenn., Nashville Div.). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

MDL Judge In New York Dismisses Punitive Claim In 1st Fosamax Bellwether Trialemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
NEW YORK - A woman who sued Merck & Co. Inc. on claims that her use of the osteoarthritis drug Fosamax caused her jaw injury is not entitled to punitive damages, the federal judge overseeing the multidistrict litigation held Aug. 5; her trial is set to begin Aug. 11 (In re: Fosamax Products Liability Litigation, MDL Docket No. 1789, No. 1:06-MD-1789-JFK, Shirley Boles v. Merck & Co. Inc., No. 06-9455, S.D. N.Y.; 2009 U.S. Dist. LEXIS 68901; See 7/23/09, Page 25). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Bellwether Seroquel Plaintiff Dismisses Del. Appeal Of Causation Expert Exclusionemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
WILMINGTON, Del. - The plaintiff whose trial would have been the first in the nation involving Seroquel before summary judgment on Aug.7 voluntarily dismissed her appeal to the Delaware Supreme Court (Nina Scaife v. AstraZeneca LP, et al., No. 391,2009, Del. Sup.; See 6/18/09, Page 6). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Warranty, Enrichment Claims By Union Health Fund Dismissed In Seroquel MDLemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
ORLANDO, Fla. - The judge overseeing the Seroquel multidistrict litigation on July 20 dismissed the express warranty and unjust enrichment claims of a union health fund for failure to state a claim on which relief can be granted (Pennsylvania Employees Benefit Trust Fund v. AstraZeneca Pharmaceuticals LP, No. 09-5003, M.D. Fla., Orlando Div.). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Summary Judgment Denied In Zyprexa MDL Case; Learned Intermediary Outemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
BROOKLYN, NY - The New York federal judge overseeing the Zyprexa multidistrict litigation on July 28 denied summary judgment in a diabetes injury case, finding a likelihood that a jury might find that a "more complete warning" of the drug's risks would have resulted in closer monitoring of the plaintiff's health and the prevention or mitigation of the disease (In Re: Zyprexa Products Liability Litigation, MDL Docket No. 1596, No. 04-md-1596, Venica Pruett v. Eli Lilly & Company, No. 07-1931, E.D. N.Y.). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Learned Intermediary Defeats Diabetes Claim By Man In Zyprexa MDLemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
BROOKLYN, NY - Eli Lilly and Co. was granted summary judgment July 31 in a diabetes case after the judge in the Zyprexa multidistrict litigation found his claim barred by the learned intermediary doctrine (In Re: Zyprexa Products Liability Litigation, MDL Docket No. 1596, No. 04-md-1596, Yolanda Chavez, et al. v. Eli Lilly & Company, No. 06-2592, E.D. N.Y.; 2009 U.S. Dist. LEXIS 71064). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Testimony, Records Used To Determine Dead Doctor Would Have Prescribed Zyprexaemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
BROOKLYN, NY - Relying on survivor testimony and medical records, the judge in the Zyprexa multidistrict litigation on July 27 granted summary judgment in a diabetes death case, finding that a stronger warning would not have changed a deceased doctor's decision to prescribe the atypical antipsychotic drug to treat schizophrenia (In Re: Zyprexa Products Liability Litigation, MDL Docket No. 1596, No. 04-md-1596, Alice C. Carey, et al. v. Eli Lilly & Co., No. 06-2798, E.D. N.Y.; 2009 U.S. Dist. LEXIS 69864). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Risperdal Maker Wants Contingency Fee Firm Disqualified From State Suitemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
PHILADELPHIA - Ortho-McNeil-Janssen Pharmaceuticals Inc. says in an Aug. 10 brief to the Pennsylvania Supreme Court that a contingency fee contract with a plaintiffs law firm to prosecute a Risperdal off-label marketing suit on behalf of the Commonwealth of Pennsylvania is unconstitutional and the law firm should be disqualified (Commonwealth of Pennsylvania, et al. v. Janssen Pharmaceutica, Inc., No. 24 EAP 2009, Pa. Sup.; See 7/2/09, Page 20). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Bloomberg News Gets Access To Seroquel Sales Call Notes, Doctors' Prescribing Dataemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
ORLANDO, Fla. - Bloomberg News on Aug. 10 was granted access to redacted sales call notes of AstraZeneca representatives and to redacted Seroquel prescribing records of doctors in the Seroquel multidistrict litigation (In Re: Seroquel Products Liability Litigation, MDL Docket No. 1769, No. 06-md-1769, M.D. Fla., Orlando Div.; See 3/5/09, Page 9). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

IBD Causation Expert Again Excluded From Accutane MDLemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
TAMPA, Fla. - "Re-asserted" general causation testimony by plaintiff expert Dr. Ronald Fogel was excluded from the Accutane multidistrict litigation for a second time on Aug. 11 when a judge found that his opinion that the acne drug causes inflammatory bowel disease (IBD) still overreaches data on which it is based (In Re: Accutane Products Liability, MDL Docket No. 1626, No. 04-md-2523, M.D. Fla., Tampa Div.; See 3/5/09, Page 15). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Generic Accutane Case Remanded In Illinois; Doctor's Joinder Properemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
CHICAGO - An Illinois federal judge on Aug. 6 remanded an Accutane case to state court after finding that the plaintiff is a state resident and that two medical co-defendants are not fraudulently misjoined (Stephen Livingston v. Hoffman-La Roche Inc., et al., No. 09-2611, N.D. Ill., Eastern Div.; 2009 U.S. Dist. LEXIS 70242). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Panacryl MDL Judge Says He'll Certify National Class; Proposed Order Opposedemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
RALEIGH, N.C. - Johnson & Johnson on Aug. 9 objected to a proposed national class action order submitted by the plaintiffs in the Ethicon Panacryl suture multidistrict litigation, saying the proposed order goes beyond what the judge asked for in his July 22 oral order (In Re: Panacryl Sutures Products Liability Litigation, MDL Docket No. 1959, No. 08-MDL-01958, E.D. N.C., Western Div.; See 1/22/09, Page 18). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

N.J. Vioxx Judge Denies Reconsideration Of Denial Of Consumer Classemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
ATLANTIC CITY, N.J. - New Jersey's Vioxx court on Aug. 13 denied reconsideration of a decision not to certify an individual consumer class, saying the plaintiffs asserted no new grounds (Elaine Kleinman v. Merck & Co. Inc., No. ATL-L-3954-04, Ronald Martin v. Merck & Co. Inc., No. ATL-L-24-05, N.J. Super., Atlantic Co.; See 4/2/09, Page 9). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Ohio RU486 Case Remanded After State Supreme High Ruling On Off-Label Restrictionemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
CINCINNATI - A temporary injunction against enforcement of Ohio's regulation of mifepristone (also known as RU486) is back in place of a permanent injunction after the Sixth Circuit U.S. Court of Appeals on Aug. 6 took action in the wake of a state Supreme Court ruling on regulation of off-label use of the drug in later-stage abortions (Planned Parenthood Southwest Ohio Region, et al. v. Ted Strickland, et al., Nos. 06-4422 and 06-4423, 6th Cir.; See 7/23/09, Page 10). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Johnson & Johnson Seeks W. Va. High Court Review Of $4.4 Million Civil Fineemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
CHARLESTON, W. Va. - Johnson & Johnson says in a July 30 appeal petition to the West Virginia Supreme Court of Appeals that a trial judge improperly used two Food and Drug Administration warning letters involving the marketing of Risperdal and Duragesic to find that the company violated state consumer laws and to levy a $4.4 million fine (Johnson & Johnson, et al. v. State of West Virginia, et al., No. n/a, W. Va. Sup. App.; See 3/19/09, Page 18). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Hip Implant Parallel Claim Fails To Adequately Plead To Escape Preemptionemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
GREENSBORO, N.C. - A Trident hip plaintiff failed to adequately plead a parallel claim under North Carolina state law that is not preempted by federal law, a federal magistrate judge ruled Aug. 5 in recommending that the court dismiss the claim (Donald A. Covert v. Stryker Corporation, et al., No. 08-447, M.D. N.C.; 2009 U.S. Dist. LEXIS 68962). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Zimmer Hip Judgment Affirmed By Calif. Appeals Court On Medical Malpractice Rulingemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
LOS ANGELES - A California appeals court panel on Aug. 5 affirmed judgment for Zimmer Holdings Inc. in a Sulzer hip case after affirming summary judgment on the plaintiff's companion medical malpractice claim (Valerie Knight v. Zimmer Holdings, Inc., et al., No. B204627, Calif. App., Div. 2; 2009 Cal. App. Unpub. LEXIS 6301; See 1/5/06, Page 28). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Bausch & Lomb Must Produce Plant Inspection In Simplus Solution Caseemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
LAFAYETTE, La. - Bausch & Lomb Inc. must provide a Simplus contact lens solution plaintiff with documents about an environmental inspection at the defendant's South Carolina production plant, a Louisiana federal judge ruled July 27 (Robert G. Vidrine, et al. v. Bausch & Lomb, Inc., No. 08-213, W.D. La.; 2009 U.S. Dist. LEXIS 70043). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Nigerians Tell High Court No Review Needed Of 2nd Circuit Trovan Rulingemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
WASHINGTON, D.C. - Attorneys for a group of Nigerian plaintiffs told the U.S. Supreme Court on Aug. 10 that there is no misapplication of high court case law involving a 1996 Trovan clinical trial and that the facts of the case are "discrete" ones (Pfizer Inc. v. Rabi Abdullahi, et al., No. 09-34, U.S. Sup.; See 8/6/09, Page 6). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Pfizer Wants Restraining Order Against It, Private Eye Vacated As Unnecessaryemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
BOSTON - Pfizer Inc. on Aug. 10 asked the Neurontin multidistrict litigation court to vacate a restraining order against it and a private investigator after a trial witness complained to the court about the investigator's conduct (In Re: Neurontin Marketing, Sales Practices, and Products Liability Litigation, MDL Docket No. 1629, No. 04-10981, D. Mass.; See 8/6/09, Page 10). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Indirect Purchaser Class Action Brought Against Manufacturer Of Mirapexemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
PHILADELPHIA - Indirect purchasers of Mirapex on Aug. 7 filed a class action complaint in federal court against its manufacturer, alleging that the manufacturer engaged in anti-competitive conduct to maintain its monopoly on the drug (John Carver v. Boehringer Ingelheim International GmbH, et al., No. n/a, E.D. Pa.). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

R.I. Kugel Patch Judge OKs 12% Common Benefit Fee, Will Allow Challengesemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
PROVIDENCE, R.I. - The judge overseeing Rhode Island's Kugel surgical mesh patch litigation on Aug. 11 approved a 12 percent common benefit fee over the objections of two attorneys but said the court will remain open to challenges as the litigation progresses (In Re: All Individual Kugel Mesh Cases, Master Docket No. PC-2008-9999, R.I. Super., Providence). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

10 Texas Phenytoin Cases Centralized In State MDLemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
AUSTIN, Texas - The Texas Multidistrict Litigation Panel on Aug. 5 transferred 10 personal injury cases involving Mylan Bertek Pharmaceuticals Inc.'s Phenytek brand phenytoin antiepileptic drug (In Re Phenytoin Litigation, No. 09-267, Texas MDL Panel). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Plaintiff Seeks Zicam MDL For Sales, Marketing Claimsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
WASHINGTON, D.C. - The Judicial Panel on Multidistrict Litigation on Aug. 14 announced it will hear arguments on Sept. 24 about the creation of a Zicam cold remedy sales and marketing MDL (In Re: Zicam Cold Remedy Marketing and Sales Practices Litigation, MDL Docket No. 2096, JPMDL). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

1st Circuit Reinstates 1 False Claims Act Count Involving Procritemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
BOSTON - A former sales representative for Ortho Biotech Products LP pleaded his False Claims Act allegations with sufficient particularity to reverse dismissal of his case involving kickbacks and the cancer drug Procrit, a panel of the First Circuit U.S. Court of Appeals ruled Aug. 12 (United States, ex rel. Mark Eugene Duxbury, et al. v. Ortho Biotech Products, L.P., No. 08-1409, 1st Cir.). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

FDA May Act Without Warning Under Enforcement Initiative Announced By Commissioneremail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
WASHINGTON, D.C. - The Food and Drug Administration's recent action against the makers of allegedly illegal body-building steroids was cited as an example of the agency's new enforcement initiative by Commissioner Dr. Margaret A. Hamburg in an Aug. 6 speech. Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Fen-Phen Lawyers Sentenced To Long Prison Terms For Defrauding Clients Of $94Memail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
COVINGTON, Ky. - The disbarred Kentucky attorneys convicted on charges that they defrauded former clients of as much as $94 million of a $200 million settlement over American Home Products' (AHP) diet drugs Pondimin and Redux were sentenced to lengthy prison terms by a federal judge on Aug. 17 (United States of America v. William J. Gallion, et al., No. 2:07-cr-39-WOB; E.D. Ky., Covington Div.; See 4/16/09, Page 22). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Serostim, Nutropin Seller Found Guilty Of Conspiracy To Violate FDA Regulationsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
MIAMI - A Florida federal jury on Aug. 7 found a man guilty of conspiracy to engage in unlicensed wholesale distribution of prescription drugs Serostim and Nutropin AQ (United States of America v. Arnesto Segredo, No. 07-20766, S.D. Fla.). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Insurer Must Cover Claims For Post-Operative Device Involved In Toe Amputationemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
TULSA, Okla. - An additional insured's "work" was not completed at the time of an underlying injury stemming from the use of a thermal heating, cooling and compression therapy device after surgery and, therefore, a policy's products-completed operations hazards exclusion does not preclude coverage, an Oklahoma federal judge held Aug. 6 (Orthopedic Resources Inc. v. Nautilus Insurance Co., No. 08-CV-732-CVE-TLW, N.D. Okla.; 2009 U.S. Dist. LEXIS 68970). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

FDA Warns About Deaths Linked To False Results From Blood Glucose Stripsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
ROCKVILLE, Md. - The Food and Drug Administration on Aug. 13 issued a public health notification about false blood glucose readings from GDH-PQQ test strips after 13 reports of deaths among diabetic patients. Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Doctors Warned Of Risk From CellCept In Organ Transplant Patientsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
ROCKVILLE, Md. - The Food and Drug Administration and Hoffman-La Roche Inc. on Aug. 14 told doctors that cases of pure red cell aplasia (PRCA) have been reported in patients treated with the company's CellCept organ transplant anti-rejection drug. Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Hospira Recalls Devices Because Of Shock, Fire Riskemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
ROCKVILLE, Md. - Hospira Inc. has recalled various medical devices because of defective alternating current (AC) power cords that can spark, char or start fires, the company and the Food and Drug Administration announced Aug. 17. Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Watson Fentanyl Patches Recalled Because Of Leaksemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
MORRISTOWN, N.J. - Watson Pharmaceuticals Inc. on Aug. 7 announced that it recalled one lot of its fentanyl pain patch because they may leak the narcotic ingredient onto patients' skin, causing an overdose. Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Barr Amphetamine Tablets Recalled; Oversized Pills Could Lead To Overdoseemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
POMONA, NY - Barr Laboratories Inc. on Aug. 14 voluntarily recalled of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single entity amphetamine product) because the affected lot may contain some tablets exceeding weight requirements, which may lead to super-potent tablets, the company and the Food and Drug Administration announced. Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

Alaris Infusion Pumps Recalled; 5 Problems May Cause Over-, Under-Treatmentemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
ROCKVILLE, Md. - Alaris System infusion pumps made by Cardinal Health have been recalled because of five problems that could lead to serious injury or death, the Food and Drug Administration announced Aug. 5. Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 22, 2009 Category: Medical Law Source Type: info

$41.5 Million Proposed Settlement Announced In Vytorin / Zetia Litigationemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
NEWARK, N.J. - On Aug. 5, the parties in the federal Vytorin/Zetia multidistrict litigation announced that they had reached a proposed settlement of all claims except personal injury claims for a total of $41.5 million (In Re: Vytorin/Zetia Marketing, Sales Practices and Products Liability Litigation, No. 08-cv-00285, MDL No. 1938, D. N.J.). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

Nigerian State Claims Over 1996 Trovan Clinical Trial Settled By Pfizer For $75Memail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
NEW YORK - Pfizer Inc. on July 30 announced a $75 million settlement with the Kano state government in Nigeria to settle civil and criminal claims related to the 1996 Trovan antibiotic clinical trial conducted in that country. Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

High Court Review Sought For Nigerian Trovan Claims Under Alien Tort Statuteemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
WASHINGTON, D.C. - Pfizer Inc. on July 8 asked the U.S. Supreme Court to review a federal appeals court ruling in a case involving the Trovan Nigerian clinical trial, saying the high court needs to resolve a split on the applicability of the Alien Tort Statue (ATS) (Pfizer Inc. v. Rabi Abdullahi, et al., No. 09-34, U.S. Sup.; See 7/23/09, Page 18). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

Eli Lilly, West Virginia Settle Zyprexa Off-Label Claimsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
BROOKLYN, NY - West Virginia and Eli Lilly and Co. have settled the state's Zyprexa Medicaid and consumer fraud claims, Lilly's counsel told the multidistrict litigation court on July 27 (In Re: Zyprexa Products Liability Litigation, MDL Docket No. 1596, No. 04-md-1596; State of West Virginia, et al. v. Eli Lilly and Company, No. 06-5826, E.D. N.Y.). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

Zyprexa MDL Plaintiff Appeals Summary Judgment On Lack Of Causationemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
BROOKLYN, NY - A Zyprexa plaintiff whose case was twice dismissed by the multidistrict litigation court filed an appeal on July 29 with the Second Circuit U.S. Court of Appeals (In Re: Zyprexa Products Liability Litigation, MDL Docket No. 1596, No. 04-md-1596, Estate of Donna L. Smith v. Eli Lilly & Company, No. 05-5305, E.D. N.Y.; See 6/4/09, Page 4). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

Seroquel Defense Cost AstraZeneca $593M, Depleting Liability Insuranceemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
WILMINGTON, Del. - AstraZeneca said July 30 that it has spend about $593 million defending itself in litigation involving its Seroquel antipsychotic drug and has depleted its insurance coverage. Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

1st Neurontin Trial Ends After Benefactor Creates $50,000 Trust Fundemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
BOSTON - The first Neurontin suicide case to go to trial ended abruptly on July 29 when an anonymous plaintiff lawyer from the courtroom gallery offered to put $50,000 into a trust account for the decedent's 10-year-old daughter if the estate would dismiss the case (In Re: Neurontin Marketing, Sales Practices, and Products Liability Litigation, MDL Docket No. 1629, No. 04-10981, Ronald J. Bulger, Sr., et al. v. Pfizer, Inc., et al., No. 07-11426, D. Mass.; See 7/23/09, Page 20). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

Defect Claims Out In Trileptal Case Alleging Multiple Organ Failureemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
CINCINNATI - A plaintiff in a Trileptal organ injury complaint failed to adequately plead design and manufacturing defect, and manufacturer Novartis Pharmaceuticals Corp. cannot be sued as a supplier, an Ohio federal judge ruled July 9 (Amanda Frey, et al. v. Novartis Pharmaceuticals Corporation, et al., No. 07-317, S.D. Ohio, W. Div.; See 5/9/07, Page 21). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

3rd Circuit Affirms Summary Judgment In Immunoglobulin Clot Caseemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
PHILADELPHIA - A New Jersey federal judge correctly granted summary judgment in an intravenous immunoglobulin (IVIG) case for lack of expert witness testimony on the inadequacy of warnings about blood clots, a panel of the Third Circuit U.S. Court of Appeals ruled July 24 in a per curiam ruling (Colleen Mary Grobelny, et al. v. Baxter Healthcare Corporation, et al., No. 08-3475, 3rd Cir.; 2009 U.S. App. LEXIS 16418; See 6/5/08, Page 22). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

Most Experts Allowed In Fosamax MDLemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
NEW YORK - Fourteen of 15 experts for the plaintiffs and the defense in the Fosamax multidistrict litigation will be allowed to testify, a New York federal judge ruled July 27 (In Re: Fosamax Products Liability Litigation, MDL Docket No. 1789, No. 06-md-1789, S.D. N.Y.; 2009 U.S. Dist. LEXIS 64661; See 7/2/09, Page 31). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

Fosamax MDL Court Quashes Subpoena Of Doctor In FDA Drug Safety Studyemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
NEW YORK - A magistrate judge in the Fosamax multidistrict litigation on Aug. 4 quashed a plaintiffs' subpoena of a National Academy of Sciences member, saying that there is no need for his testimony and that allowing it could have a chilling effect on scientific research (In Re: Fosamax Products Liability Litigation, MDL Docket No. 1789, No. 06-md-1789, S.D. N.Y.). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

N.J. Fosamax Dismissal Sought Under Michigan Drug Shield Lawemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
ATLANTIC CITY, N.J. - Merck & Co. Inc. on July 24 asked New Jersey's bisphosphonate court to apply Michigan state law and dismiss a Fosamax claim as preempted by the state's drug shield law (Mary Ellen Roedel v. Merck & Co. Inc., et al., No. L-451-09-MT, N.J. Super., Atlantic Co.). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

Manufacturing Defect Deemed Admissible Parallel Claim In Aneurysm Stent Caseemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
SACRAMENTO, Calif. - A plaintiff's manufacturing defect claim parallels federal premarket approval (PMA) requirements in an abdominal aortic aneurysm stent case and survives preemption, a California federal judge ruled July 9 (Marlene Prudhel, et al. v. Endologix, Inc., et al., No. 09-661, E.D. Calif.; 2009 U.S. Dist. LEXIS 64402). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

MRI Device Reclassification Doesn't Change PMA Status Or Evade Preemptionemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
WHITE PLAINS, NY - Reclassification of a magnetic resonance imaging (MRI) device from Class III to Class II by the Food and Drug Administration does not mean that the device was not approved through the premarket approval (PMA) process and that claims involving it are preempted, a New York state trial court ruled July 6 (John Colombini, et al. v. Westchester County Health Care Corporation, et al., No. 11101/2002, N.Y. Sup., Westchester Co.; 2009 N.Y. Misc. LEXIS 1907). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info

Pain Pump Claims Preempted; Salesman Not Liable For Doctor's 'Off-Label' Useemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
TAMPA, Fla. - A Florida federal judge on July 22 granted summary judgment in a pain pump case, finding that claims against the manufacturer are preempted and that there is no evidence that a sales representative who was in the operating room and allegedly took an explanted component was liable for off-label use of the device (Linda Wolicki-Gables, et al. v. Arrow International, Inc., et al., No. 08-151, M.D. Fla., Tampa Div.; 2009 U.S. Dist. LEXIS 65614; See 4/16/09, Page 18). Full story on lexis.com
Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - August 8, 2009 Category: Medical Law Source Type: info