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<title>LexisNexis&#174; Mealey's&#8482; Emerging Drugs &amp; Devices Legal News</title>

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<description>Headline Emerging Drugs &amp; Devices Legal News from LexisNexis&#174;</description>

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<title>LexisNexis&#174; Headline Emerging Drugs &amp; Devices Legal News</title>

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<copyright>Copyright 2012</copyright>

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<title>Abbott To Pay $1.5B In Civil, Criminal Penalties For Depakote Off-Label Promotion</title>
<description>ABINGDON, Va. - Abbott Laboratories Inc. on May 7 pleaded guilty to one misdemeanor criminal charge and agreed to pay $1.5 billion in criminal fines, civil penalties and forfeiture for off-label marketing its anti-epilepsy drug Depakote despite knowing that it was not effective for those purposes (United States of America v. Abbott Laboratories, No. 1:12-cr-26, United States of America, ex rel. Meredith McCoyd v. Abbott Laboratories, et al., No. 1:07-cv-81, United States of America ex rel. Susan Mulcahy, et al., No. 1:08-cv-54, United States of America, ex rel. Tamara Dietzler v. Abbott Laboratories, No. 1:09-cv-51, United States of America ex rel. Thomas J. Spetter, Jr., No. 1:10-cv-6, W.D. Va.; See 11/3/11, Page 18). </description>
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<title>1st Circuit: $21M Design Defect Verdict For Generic Drug Injury Not Preempted</title>
<description>BOSTON - A panel of the First Circuit U.S. Court of Appeals on May 2 affirmed a $21 million generic drug injury verdict, finding that a 2011 Supreme Court ruling about generic drug injury claims does not preempt design defect claims (Karen L. Bartlett v. Mutual Pharmaceutical Company, Inc., et al., No. 10-2277, 1st Cir.; 2012 U.S. App. LEXIS 9050; See 1/20/11, Page 4). </description>
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<title>Generic Reglan Manufacturers Dismissed On Preemption In N.J. State Court</title>
<description>ATLANTIC CITY, N.J. - A New Jersey state court judge on May 4 said that claims against generic drug companies that make metoclopramide are preempted by U.S. Supreme Court precedent (In Re Reglan Litigation, No. 289, N.J. Super., Atlantic Co.). </description>
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<title>42 Attorneys General Back Senate Bill To Allow Generic Drug Label Changes</title>
<description>WASHINGTON, D.C. - Attorneys general from 42 states and territories on May 11 told two U.S. senators that they support their bill that would overturn the U.S. Supreme Court's generic drug preemption ruling in Pliva, Inc. v. Mensing (131 S. Ct. 2567 [2011]; See 7/7/11, Page 4). </description>
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<title>3rd Circuit Affirms Dismissal Of Third-Party Claims In Off-Label Drug Marketing</title>
<description>PHILADELPHIA - The Third Circuit U.S. Court of Appeals on May 16 affirmed dismissal of third-party payer (TPP) and consumer claims involving the off-label marketing of four Schering-Plough Corp. drugs, saying the plaintiffs failed to connect the company's conduct to their having paid for the drugs (In Re: Schering-Plough Corp. Intron/Temodar Consumer Class Action, No. 10-3046, and 10-3047, 3rd Cir.; See 6/17/2010, Page 26). </description>
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<title>Pennsylvania Judge Says Verdicts In 2 Prempro Cases Should Be Affirmed</title>
<description>PHILADELPHIA - A Pennsylvania state court trial judge on April 23 told a state appeals court that there was overwhelming evidence that Prempro did not cause two plaintiffs' breast cancer and that he properly denied judgment notwithstanding the verdict (JNOV) or a new trial (Sharon Buxton v. Wyeth Pharmaceuticals, et al., No. 00202, Frances Henry, et al. v. Wyeth Pharmaceuticals, et al., No. 00875, Pa. Comm. Pls., Philadelphia Co.; Sharon Buxton v. Wyeth Pharmaceuticals, et al., No. 3374 EDA 2010, Frances Henry, et al. v. Wyeth Pharmaceuticals, et al., No.3399 EDA 2010, Pa. Super.). </description>
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<title>Ill. Federal Judge Excludes Breast-Density Expert In Prempro Case</title>
<description>CHICAGO - An Illinois federal judge on May 7 disqualified a plaintiff expert in a Prempro case after finding that his theory of linking increases in breast density to the risk of breast cancer and in measuring breast density are not scientifically reliable (Jo Belle Baldonado v. Wyeth, et al., No. 04-4312, N.D. Ill., E. Div.; 2012 U.S. Dist. LEXIS 63476; See 5/3/12, Page 5). </description>
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<title>U.S. Supreme Court Won't Hear Petition By Vioxx MDL Pro Se Litigant</title>
<description>WASHINGTON, D.C. - The U.S. Supreme Court on May 14 declined to hear the appeal by a Vioxx plaintiff whose claim was dismissed by a multidistrict litigation court for failure to file an expert report showing that the recalled pain drug caused a family member's death (James D. Schneller, et al. v. Merck and Company, Incorporated, No. 11-1117, U.S. Sup.). </description>
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<title>Actiq User's Addiction Tolls Dental Injury Claim, Arizona Federal Judge Says</title>
<description>PHOENIX - An Arizona federal judge on May 4 said a plaintiff's claim that his addiction to Actiq brand fentanyl "lollipops" made him incompetent tolls his claim that the narcotic product caused severe dental problems (Nicolai Tavilla, et al. v. Cephalon, Inc., No. 2:11-270, D. Ariz.; 2012 U.S. Dist. LEXIS 61860). </description>
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<title>Magistrate Judge Finds Privilege Log Entries Adequately Describe Documents</title>
<description>RALEIGH, N.C. - A federal magistrate judge in North Carolina on May 7 found that documents listed on a privilege log by a pain pump manufacturer adequately described why they are being withheld from production and are not subject to disclosure to a woman claiming that her use of the pump caused her to sustain injuries (Lissa M. Rohlik v. I-Flow Corporation, No. 10-CV-173-FL, E.D. N.C.; 2012 U.S. Dist. LEXIS 63713). </description>
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<title>N.J. State Judge Won't Reconsider Limitations Ruling In Zometa Jaw Injury Case</title>
<description>NEW BRUNSWICK, N.J. - A New Jersey judge overseeing the state's Aredia/Zometa mass tort litigation on May 11 denied reconsideration of her ruling applying Virginia's two-year statute of limitations to a plaintiff's claim that he developed osteonecrosis of the jaw (ONJ) after being injected with Zometa (In Re: Zometa/Aredia, No. 278, Charles Irby v. Novartis Pharmaceuticals Corp., No. MID-L-1815-08 MT, N.J. Super., Middlesex Co.; See 4/5/12, Page 13). </description>
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<title>MDL Sought For Federal Drug Co-Pay Subsidy Cases Filed By Union Insurers</title>
<description>WASHINGTON, D.C. - A union health benefit provider on April 12 asked a federal judicial panel to centralize seven Racketeer Influenced and Corrupt Organizations Act class actions by other union health plans against 10 drug companies that the plaintiffs say pay consumers to get their expensive brand-name drugs rather than less expensive generic drugs (In Re: Prescription Drug Co-Pay Subsidy Litigation, MDL Docket No. 2370, JPMDL; See 3/15/12, Page 24). </description>
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<title>N.J. State Court Cases About Propecia Side Effects Are Centralized; No Mass Tort</title>
<description>TRENTON, N.J. - More than 150 New Jersey state court lawsuits alleging male sexual dysfunction from the Propecia hair loss drug have been centralized by the state Supreme Court, although it declined to designate the litigation as a mass tort. </description>
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<title>8 Pradaxa Lawsuits Filed In Illinois Federal Court Alleging Internal Bleeding</title>
<description>EAST ST. LOUIS, Ill. - A woman who says she was hospitalized for 12 days when the blood thinner drug Pradaxa caused severe gastrointestinal bleeding on May 11 sued manufacturer Boehringer Ingelheim Pharmaceuticals Inc. in an Illinois federal court, one of eight such suits filed on the same day (Jacqueline Boston v. Boehringer Ingelheim Pharmaceuticals, Inc., et al., No. 3:12-cv-610, S.D. Ill., E. St. Louis Div.). </description>
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<title>Ethicon Surgical Stapler Case Settles Before May 21 Trial</title>
<description>CHARLESTON, W.Va. - Ethicon Endo-Surgery Inc. on May 8 settled a surgical stapler injury lawsuit ahead of a May 21 trial date, according to the court docket (Sandra Hershberger, et al. v. Ethicon Endo-Surgery Inc., et al., No. 10-cv-000837, S.D. W.Va.; See 8/18/11, Page 21). </description>
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<title>New York Federal Judge Suggests Federal Panel Close Zyprexa MDL</title>
<description>BROOKLYN - The New York federal judge overseeing the Zyprexa multidistrict litigation has suggested that no more cases be transferred into the docket and that the MDL be closed, according to a letter filed in the court on May 10 (In Re: Zyprexa Products Liability Litigation, MDL Docket No. 1596, No. 1:04-md-1596, E.D. N.Y.). </description>
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<title>Design Defect, Warning Claims Survive In Wright Hip Case, As Does Defense Expert</title>
<description>ATLANTA - A Georgia federal judge on May 11 denied summary judgment on design defect and failure-to-warn claims in a Wright Medical Technology Inc. ProFemur hip case but also denied the plaintiffs' motion to exclude a defense expert (Elie M. Mims, et al. v. Wright Medical Technology, Inc., No. 1:11-213, N.D. Ga., Atlanta Div.; 2012 U.S. Dist. LEXIS 66805). </description>
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<title>Federal Claims Judge Vacates Benefits Denial For Child With Neurological Injury</title>
<description>WASHINGTON, D.C. - A Federal Claims Court judge on April 18 vacated a vaccine special master's denial of benefits for an "off-table" neurological injury of a child from three childhood vaccines, finding that the special master committed arbitrary and capricious errors (Doug Paluck, et al. v. Secretary of Health and Human Services, No. 07-889V, Fed. Clms.). </description>
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<title>Gardasil Death Petitioner Failed To Show Need For Subpoena Mandamus, Judge Says</title>
<description>WASHINGTON, D.C. - A U.S. Federal Claims Court judge says a vaccine compensation petitioner who claims that Gardasil killed a family member failed to show why she needs to subpoena information from vaccine manufacture Merck &amp; Co. Inc., according to an order unsealed April 20 (Zenoria Phillips-Deloatch, et al. v. Secretary of Health and Human Services, No. 09-171V, Fed. Clms.). </description>
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<title>Co-Lead, Liaison Counsel Appointed By Judge In Wright Hip MDL</title>
<description>ATLANTA - A Georgia federal judge overseeing the Wright hip multidistrict litigation on May 3 named plaintiffs' co-lead and co-liaison counsel (In Re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation, MDL Docket No. 2329, No. 1:12-md-2329, N.D. Ga., Atlanta Div.; See 2/16/12, Page 14). </description>
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<title>2,600 Kugel Mesh Cases Said To Be Settled By MDL Court</title>
<description>PROVIDENCE, R.I. - About 2,600 Kugel mesh product injury cases have been settled, the Rhode Island multidistrict litigation court reported May 3, representing between 65 and 76 percent of the case reported inventory (In Re: Kugel Mesh Hernia Products Liability Litigation, MDL Docket No. 1842, No. 1:07-md-1842, D. R.I.). </description>
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<title>Cardinal Health Settles With DEA, Will Suspend Drug Shipments From Fla. Warehouse</title>
<description>DUBLIN, Ohio - Cardinal Health Inc. on May 15 said it has agreed to stop shipping controlled drugs from its Lakeland, Fla., distribution center in settlement of its lawsuits against the U.S. Justice Department and the Drug Enforcement Agency over an administrative order suspending the company's registration (Cardinal Health, Inc. v. Eric H. Holder, Jr., et al., No. 1:12-cv-185, D. D.C.; Cardinal Health, Inc. v. Eric H. Holder, Jr., et al., No. 12-5061, and Cardinal Health, Inc. v. Drug Enforcement Agency, No. 12-1126, D.C. Cir.; See 3/15/12, Page 23). </description>
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<title>New Jersey Appeals Court Says Drug Rep's Retaliation Claim Was Filed Too Late</title>
<description>TRENTON, N.J. - A New Jersey Superior Court Appellate Division panel on May 9 agreed that a Celgene Corp. sales manager's claim of retaliation under New Jersey law was barred by the statute of limitations and was not tolled by an almost identical lawsuit pending in a Texas state court (David Schmidt v. Celgene Corporation, et al., No. A-2685-10T2, N.J. Super., App. Div.). </description>
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<title>Judge Denies Judgment On Pleadings In Securities Suit Against Pfizer, Others</title>
<description>TRENTON, N.J. - A federal judge in New Jersey on May 14 denied defendants' motion for judgment on the pleadings in a securities fraud class action lawsuit against a drug maker and certain of its executive officers and directors for alleged federal securities law violations because the defendants' argument that investors were fully aware of all of the defendants' actions at some earlier date "misses the point" (Alaska Electrical Pension Fund, et al. v. Pharmacia Corp., et al., No. 03-1519, D. N.J.; 2012 U.S. Dist. LEXIS 67266). </description>
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<title>Judge Appoints Lead Plaintiff, Lead Counsel In K-V Securities Class Action</title>
<description>ST. LOUIS - A federal judge in Missouri on May 3 appointed a shareholder as lead plaintiff in a securities class action lawsuit against a drug maker and certain of its executive officers for alleged federal securities law violations in connection with the marketing of a maternity injection drug, ruling that the shareholder has met all statutory requirements for serving in the role as lead plaintiff (In re K-V Pharmaceutical Co. Securities Litigation, No. 11-1816, E.D. Mo.; 2012 U.S. Dist. LEXIS 62161). </description>
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<title>Sham Litigation Claims Against Wellbutrin XL Manufacturer, Distributor Fail</title>
<description>PHILADELPHIA - A federal judge in Pennsylvania on May 11 granted summary judgment to the producers and distributors of Wellbutrin XL on direct and indirect purchasers' claims that the defendants illegally conspired to prevent generic versions of the drug from entering the American market by filing sham patent infringement lawsuits and a citizen petition (In re: Wellbutrin XL Antitrust Litigation, Nos. 08-2431 [direct], 08-2431 [indirect], E.D. Pa.; 2012 U.S. Dist. LEXIS 66312; See 4/19/12, Page 29). </description>
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<title>CDC Joins FDA In Warning Of Fungal Eye Infections Linked To Compounded Dye</title>
<description>ATLANTA - The Centers for Disease Control and Prevention (CDC) on May 4 advised health care personnel to avoid using compounded products labeled as sterile that were produced by Franck's Compounding Lab in Ocala, Fla., following 33 cases of fungal eye infections associated with a dye made by the pharmacy. </description>
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<title>FDA: Cancer Patients Taking Revlimid Are At Risk Of Developing Other Cancers</title>
<description>ROCKVILLE, Md. - The Food and Drug Administration on May 7 said bone cancer patients taking Revlimid face an increased risk of developing other cancers such as acute myelogenous leukemia, myelodysplastic syndromes and Hodgkin lymphoma. </description>
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<title>Gilenya MS Drug Gets New FDA Heart Rate Warning, Monitoring Recommendation</title>
<description>ROCKVILLE, Md. - The Food and Drug Administration said May 14 that while it cannot definitively conclude that the multiple sclerosis drug Gilenya is related to any deaths in patients taking the drug, it is adding a contraindication to the drug label and is recommending that patients starting the drug be monitored on an hourly basis to look for heart problems. </description>
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<title>$4M In Compensatory Damages Awarded By Conn. Jury In Prempro Breast Cancer Trial</title>
<description>NEW HAVEN, Conn. - A Connecticut federal jury on April 18 awarded a plaintiff and her husband $4 million in compensatory damages after finding that the hormone replacement therapy drug Prempro caused the plaintiff's breast cancer (Margaret B. Fraser, et al. v. Wyeth, Inc., et al., No. 3:04-1373, D. Conn.; See 3/15/12, Page 6). </description>
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<title>Prempro Punitives Expert Can't Suggest Method, Must Explain Net Worth, Judge Says</title>
<description>CHICAGO - An Illinois federal judge on April 30 excluded a plaintiff expert's opinion that a jury should award up to $21.3 billion in punitive damages in a Prempro trial and ordered a hearing on how the expert arrived at his determination of defendant Wyeth's net worth (Jo Belle Baldonado v. Wyeth, et al., No. 04-4312, N.D. Ill., E. Div.; 2012 U.S. Dist. LEXIS 59512). </description>
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<title>U.S. Supreme Court Won't Review Vacating Of $26.1M Texas Vioxx Death Verdict</title>
<description>WASHINGTON, D.C. - The U.S. Supreme Court on April 23 denied a petition to review a state appeals court's vacating of a $26.1 million Vioxx award in the first Vioxx case to go to trial nationwide (Carol A. Ernst, et al. v. Merck &amp; Co., Inc., No. 11-1144, U.S. Sup.; See 65/18/09, Page 12). </description>
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<title>Merck Fined $321.6M For Off-Label Promotion Of Vioxx For Rheumatoid Arthritis</title>
<description>BOSTON - Massachusetts federal Judge Patti B. Saris on April 19 fined Merck, Sharp &amp; Dohme $321.6 million after the company pleaded guilty to off-label promotion of its since-withdrawn painkiller Vioxx (United States of America v. Merck, Sharp &amp; Dohme Corp., No. 1:11-cr-10384, D. Mass.; See 12/1/11, Page 4). </description>
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<title>Vioxx MDL Judge Enjoins Missouri Class To Prevent Double Recovery</title>
<description>NEW ORLEANS - The Louisiana federal judge overseeing the Vioxx multidistrict litigation on April 23 enjoined plaintiffs in a Missouri state court class action from offering evidence that does not exclude damages that were already paid by defendant Merck, Sharp &amp; Dohme in two global settlements in the MDL (In Re: Vioxx Products Liability Litigation, MDL Docket No. 1657, No. 2:05-md-1657, E.D. Pa.; 2012 U.S. Dist. LEXIS 56634). </description>
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<title>Lack Of Lone Pine Reports Can Mean Summary Judgment, Vioxx MDL Judge Rules</title>
<description>NEW ORLEANS - Plaintiffs who opted out of the Vioxx Master Settlement Agreement can be required to submit case-specific expert reports that link the drug to their injury or face summary judgment, the Louisiana federal judge overseeing the multidistrict litigation said in an April 23 order in two cases (In Re: Vioxx Products Liability Litigation, MDL Docket No. 1657, No. 2:05-md-1657, Rosie Escamilla v. Merck &amp; Co., No. 08-3573, and Melvin Cormier, et al. v. Merck &amp; Co., Inc., No. 05-4991, E.D. Pa.). </description>
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<title>1 Plaintiff Attorney Wins $67,556 Fee In Dispute With Vioxx Co-Counsel</title>
<description>NEW ORLEANS - The Louisiana federal judge overseeing the Vioxx multidistrict litigation on April 25 awarded $67,556 in disputed attorney fees to an Orlando, Fla., attorney along with a $4,229 refund given to the co-counsel with which she had the dispute (In Re: Vioxx Products Liability Litigation, MDL Docket No. 1657, No. 05-md-1657, Gene Weeks v. Merck &amp; Co., Inc., No. 05-4578, E.D. La.; 2012 U.S. Dist. LEXIS 57732). </description>
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<title>Merck Wins Defense Verdict In 2nd N.J. Fosamax Jaw Injury Trial</title>
<description>ATLANTIC CITY, N.J. - A New Jersey state court jury on April 18 found that the osteoporosis drug Fosamax did not cause a plaintiff's osteonecrosis of the jaw (ONJ) (Jo Ann Sessner v. Merck, Sharpe &amp; Dohme, Inc., No. ATL-L-3394-11-MT, N.J. Super., Atlantic Co.; See 4/19/12, Page 7). </description>
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<title>U.S. Supreme Court Won't Hear Arguments That Mensing Creates Brand-Name Liability</title>
<description>WASHINGTON, D.C. - The U.S. Supreme Court on April 30 said it will not hear arguments that because product liability claims against generic drug manufacturers are preempted by a 2011 high court ruling, manufacturers of the brand-name predecessor drugs are vicariously liable for not updating warning labels (Lala Smith, et al. v. Wyeth, Inc., et al., No. 11-1046, U.S. Sup.; See 10/6/11, Page 24). </description>
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<title>Oregon Federal Judge Rejects Preemption Challenges In Reglan / Metoclopramide Case</title>
<description>EUGENE, Ore. - An Oregon federal judge on April 24 granted summary judgment to most defendants on most claims in a Reglan/metoclopramide case, finding in part that the preemption of claims against generic drug makers does not overrule case law that lets brand-name drug makers off the hook (Betty Phelps, et al. v. Wyeth, Inc., et al., No. 6:09-6168, D. Ore.; 2012 U.S. Dist. LEXIS 57967). </description>
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<title>Drug Wholesaler McKesson Pays $190M To Settle False Claims Allegations Of Markups</title>
<description>NEWARK, N.J. - Drug wholesaler McKesson Corp. has agreed to pay more than $190 million to settle allegations that it reported inflated drug prices and caused federal health care programs to overpay for drugs, the U.S. Attorney's Office for the District of New Jersey reported April 26 (United States ex rel. David Morgan v. Express Scripts, Inc., et al., No. 05-1714, D. N.J.). </description>
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<title>Whistle-Blower Lawsuit Against Heart Catheter Maker Dismissed In Federal Court</title>
<description>BOSTON - A Massachusetts federal judge on May 1 dismissed without prejudice a False Claims Act lawsuit against the maker of an angioplasty catheter, finding that the relator did not provide details about false claims and about how he was allegedly retaliated against and fired in violation of federal law and state policy (United States of America, ex rel. David Provuncher v. AngioScore, Inc., No. 09-12176, D. Mass.; 2012 U.S. Dist. LEXIS 60390). </description>
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<title>Convictions Of 2 Kentucky Attorneys For Fen-Phen Fraud Affirmed By 6th Circuit</title>
<description>CINCINNATI - A Sixth Circuit U.S. Court of Appeals panel on May 1 affirmed the wire fraud convictions of two Kentucky fen-phen lawyers for conspiring to take excessive fees from a $200.4 million aggregate settlement (United States of America v. Shirley A. Cunningham, et al., Nos. 09-5987 and 09-5998, 6th Cir.; 2012 U.S. App. LEXIS 8786; See 8/20/09, Page 30). </description>
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<title>1st Circuit Panel Affirms $11.4M Lupron Cy Pres Order, But Criticizes Method</title>
<description>BOSTON - A First Circuit U.S. Court of Appeals panel on April 24 affirmed the cy pres distribution of $11.4 million leftover from a Lupron class settlement, but questioned the propriety of the parties leaving the details up to a district court judge (In Re: Lupron Marketing and Sales Practices Litigation, Audrey Rohn, et al. v. TAP Pharmaceutical Products, Inc., et al., Nos. 10-2494, 11-1329, 1st Cir.; 2012 U.S. App. LEXIS 8263; See 8/19/10, Page 27). </description>
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<title>Vitamin Class Plaintiffs Can Seek Discovery Of Profits, Expenses</title>
<description>SAN DIEGO - A California federal judge on April 30 allowed plaintiffs in a vitamin class action to conduct discovery into defendant Bayer Corp.'s profits and expenses to possibly determine "restitutionary disgorgement" of profits (David Johns, et al. v. Bayer Corporation, et al., No. 3:09-cv-1935, S.D. Calif.; 2012 U.S. Dist. LEXIS 60121). </description>
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<title>Accutane Defect Claim Out For Now In Pennsylvania Mass Tort Litigation</title>
<description>PHILADELPHIA - A Pennsylvania state court judge overseeing the state's Accutane/isotretinoin mass tort docket on April 13 granted manufacturer defendant Hoffman-La Roche Inc.'s motion to dismiss the plaintiffs' strict liability - defective design claim for lack of specificity with leave to file an amended complaint (In Re: Accutane/Isotretinoin Litigation, No. 11060111, Pa. Common Pls., Philadelphia Co.). </description>
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<title>Drug Insert Publisher Fails To Get Dismissed From Pa. Accutane Litigation</title>
<description>PHILADELPHIA - A Pennsylvania state court judge overseeing the Accutane/isotretinoin mass tort litigation on April 13 overruled the preliminary objections by a publisher of patient drug prescription inserts that has been named as a defendant (In Re: Accutane/Isotretinoin Litigation, No. 110601110, Pa. Comm. Pls., Philadelphia Co.). </description>
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<title>Darvon / Propoxyphene Preemption Appealed To 6th Circuit, MDL Judge Says</title>
<description>COVINGTON, Ky. - The issue of whether claims involving generic Darvon are preempted by federal law has been appealed to the Sixth Circuit U.S. Court of Appeals, the Kentucky judge overseeing the Darvocet/Darvon/propoxyphene multidistrict litigation said in an April 27 order (In Re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, MDL Docket No. 2226, No. 2:11-md-2226, E.D. Ky.; See 3/15/12, Page 8). </description>
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<title>Darvon MDL Judge Won't Certify Warnings Issue To 6 State Supreme Courts</title>
<description>COVINGTON, Ky. - The Kentucky federal judge overseeing the Darvocet, Darvon and propoxyphene litigation on April 24 denied a motion by plaintiffs to have six state supreme courts decide if a brand-name drug manufacturer can be held liable for misrepresenting drug information used by a physician to prescribe a generic version of the drug (In Re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, MDL Docket No. 2226, No. 2:11-md-2226, E.D. Ky., N. Div.). </description>
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<title>Louisiana Product Liability Law Can't Avoid Preemption In Nerve Stimulator Case</title>
<description>NEW ORLEANS - A Louisiana federal judge on April 23 said a plaintiff in a spinal nerve stimulator case has not shown that her claims under the Louisiana Product Liability Act (LPLA) parallel federal requirements and escape preemption (Melinda S. Hinkel, et al. v. St. Jude Medical, S.C., Inc., No. 11-1608, E.D. La.; 2012 U.S. Dist. LEXIS 56322). </description>
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<title>Par Pharmaceuticals, United States Optimistic On Settlement Of 2 Investigations</title>
<description>WASHINGTON, D.C. - The United States and Par Pharmaceuticals Inc. on May 1 told a District of Columbia federal judge that they are optimistic that ongoing negotiations will result in a global resolution of criminal and civil investigations into the drug company's marketing of the cancer drug Megace ES (Par Pharmaceuticals, Inc. v. United States of America, et al., No. 1:11-1820, D. D.C.; See 10/21/11, Page 14). </description>
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<title>11th Circuit Upholds Reverse Payment Settlement Against FTC Challenge</title>
<description>ATLANTA - Reverse payment settlements between the holder of a drug patent and generic manufacturers of the drug did not constitute an unfair restraint on trade in violation of Section 5(a) of the Federal Trade Commission Act, the 11th Circuit U.S. Court of Appeals ruled April 25 in affirming the dismissal of the Federal Trade Commission's antitrust lawsuit (Federal Trade Commission v. Watson Pharmaceuticals, Inc., et al., No. 10-12729, 11th Cir.; 2012 U.S. App. LEXIS 8377). </description>
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<title>Thoratec LVAD Device Under Class 1 Recall</title>
<description>ROCKVILLE, Md. - Thoratec Corp. on Feb. 23 initiated a class 1 recall of its HeartMate II Left Ventricular Assist System - known as a left-ventricular assist device, or LVAD - because a component may detach and result in reduced blood flow or damage to another component, the Food and Drug Administration announced April 4. </description>
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<title>Arkansas Judge Orders J&amp;J Unit To Pay $1.2B Penalty For Risperdal Marketing</title>
<description>LITTLE ROCK, Ark. - An Arkansas state court judge on April 11 assessed a $1.2 billion penalty against the Ortho-McNeil-Janssen Pharmaceuticals Inc. subsidiary of Johnson &amp; Johnson for thousands of violations of state trade practices and Medicaid fraud laws, sources told Mealey Publications (State of Arkansas v. Ortho-McNeil-Janssen Pharmaceuticals Inc., No. CV07-14345, Ark. Cir., Pulaski Co.). </description>
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<title>Mo. Federal Jury Awards $225,000 In Split Verdict In Aredia/Zometa Jaw Case</title>
<description>JEFFERSON CITY, Mo. - A Missouri federal jury on April 6 found that Novartis Pharmaceuticals Corp. negligently failed to warn a cancer patient that bone drugs Aredia and Zometa can cause bisphosphonate-related osteonecrosis of the jaw (BRONJ), but also found that Novartis was not liable for strict liability failure to warn (Christine Winter v. Novartis Pharmaceuticals Corporation, No. 06-4049, W.D. Mo.). </description>
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<title>Leap Day May Have Had Role In Zometa Appeal Being Dismissed As Untimely</title>
<description>ST. LOUIS - Leap day may have played a role in a federal appeals court's April 11 dismissal of an Zometa defense verdict as untimely (John E. Brodie, et al. v. Novartis Pharmaceuticals Corporation, No. 12-1547, 8th Cir.; See 2/16/12, Page 4). </description>
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<title>Closing Arguments Under Way In 2nd N.J. Fosamax Trial Alleging Jaw Bone Injury</title>
<description>ATLANTIC CITY, N.J. - Closing arguments began April 17 in New Jersey's second state court Fosamax jaw injury trial (Jo Ann Sessner v. Merck, Sharpe &amp; Dohme, Inc., No. ATL-L-3394-11-MT, N.J. Super., Atlantic Co.; See 3/1/12, Page 16). </description>
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<title>Drug Pump Claims Preempted Expressly, Implicitly, 9th Circuit Panel Majority Says</title>
<description>SAN FRANCISCO - In a 2-1 ruling, a panel of the Ninth Circuit U.S. Court of Appeals said April 16 that claims that a Medtronic drug pump and spine catheter caused a plaintiff to become a paraplegic are preempted explicitly and implicitly by federal medical device law and by U.S. Supreme Court case law (Richard Stengel, et al. v. Medtronic Incorporated, No. 10-17755, 9th Cir.; 2012 U.S. App. LEXIS 7556; See 12/2/10, Page 14). </description>
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<title>U.S. Supreme Court Won't Review Denial Of Discovery Rule In Vaccine Cases</title>
<description>WASHINGTON, D.C. - The U.S. Supreme Court on April 16 said it will not review a federal appeals court ruling that denied creating a discovery rule for vaccine injury claims (Melissa Cloer v. Kathleen Sebelius, Secretary of Health and Human Services, No. 11-832, U.S. Sup.). </description>
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<title>Divided Federal Circuit Says Untimely Vaccine Act Claimants Can Seek Fees</title>
<description>WASHINGTON, D.C. - The Federal Circuit U.S. Court of Appeals on April 11 ruled 7-6 that vaccine injury petitioners who filed untimely claims can request attorney fees and costs (Melissa Cloer, M.D. v. Secretary of Health and Human Services, No. 09-5052, Fed. Cir.). </description>
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<title>U.S. High Court Won't Review Learned Intermediary Ruling In Cultured Cells Case</title>
<description>WASHINGTON, D.C. - The U.S. Supreme Court on April 16 denied review of rulings that a plaintiff's claim involving cultured knee cartilage cells is barred by Florida's learned intermediary doctrine (Denise Rounds v. Genzyme Corp., No. 11-971, U.S. Sup.; See 9/15/11, Page 14). </description>
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<title>N.J. Supreme Court Won't Hear Hoffman-La Roche's Appeal About Accutane Warnings</title>
<description>TRENTON, N.J. - The New Jersey Supreme Court on April 9 denied Hoffman-La Roche Inc.'s attempt to get the court to find that post-2002 warnings on the Accutane label preclude a plaintiff's failure-to-warn claim (Priya Chaitanya Tanna v. Hoffman-La Roche Inc., et al., No. 1181 September Term 2001 070344, N.Y. Sup.; See 1/5/12, Page 4). </description>
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<title>Illinois Federal Judge Won't Aggregate 3 Plavix Cases For CAFA Removal</title>
<description>EAST ST. LOUIS, Ill. - An Illinois federal judge on April 13 refused to aggregate three Plavix multiplaintiff lawsuits in order to justify removal under the Class Action Fairness Act (CAFA) as a "mass action" (Richard Davidson, et al. v. Bristol-Myers Squibb Company, et al., No. 12-58, 2012 U.S. Dist. LEXIS 52429; Thomas Boyer, et al. v. Bristol-Myers Squibb Company, et al., No. 12-61, 2012 U.S. Dist. LEXIS 52430; Kenneth Anglin, et al. v. Bristol-Myers Squibb Company, et al., No. 12-60, S.D. Ill.). </description>
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<title>Judge In Attorney General Plavix Case Recuses Self, Although It Isn't Mandated</title>
<description>LAFAYETTE, La. - A Louisiana federal judge on April 5 recused himself from a state attorney general lawsuit involving the marketing of Plavix, saying that but for a lack of opposition from the plaintiffs, he did not need to (James Buddy Caldwerll v. Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership, et al., No. 12-443, W.D. La., Lafayette Div.; 2012 U.S. Dist. LEXIS 48649). </description>
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<link>http://www.lexis.com/research/xlink?canceldest=form&amp;keyenum=25271&amp;keytnum=0&amp;searchtype=get&amp;search=17-8%20Mealey%27s%20Emerg.%20Drugs%20Devices%2012%20(2012)&amp;view=full&amp;ORIGINATION_CODE=00144 target=_blank</link>
<title>Darvon MDL Judge Wants To Apply Preemption Ruling To All Generic Manufacturers</title>
<description>COVINGTON, Ky. - The Kentucky federal judge overseeing the Darvocet/Darvon/propoxyphene multidistrict litigation on April 10 said he will find all claims involving generic drug manufacturers preempted unless the plaintiffs show cause why those defendants should not be dismissed (In Re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, MDL Docket No. 2226, No. 2:11-md-2226, E.D. Ky., N. Div.). </description>
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<link>http://www.lexis.com/research/xlink?canceldest=form&amp;keyenum=25271&amp;keytnum=0&amp;searchtype=get&amp;search=17-8%20Mealey%27s%20Emerg.%20Drugs%20Devices%2013%20(2012)&amp;view=full&amp;ORIGINATION_CODE=00144 target=_blank</link>
<title>Darvocet MDL Judge: Plaintiffs Can't Hold Parent Liable For Subsidiaries' Drugs</title>
<description>COVINGTON, Ky. - The Kentucky federal judge overseeing the Darvocet/Darvon/propoxyphene multidistrict litigation on April 4 dismissed with prejudice the claims of nine plaintiffs, finding that they could not assert claims that Endo Pharmaceuticals Holdings Inc. and Endo Pharmaceuticals Inc. are liable for drugs made by newly acquired subsidiaries (In Re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, MDL Docket No. 2226, No. 2:11-md-2226, E.D. Ky., N. Div.). </description>
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<title>Zoloft Birth Defects MDL Created, Assigned To Eastern District Of Pennsylvania</title>
<description>WASHINGTON, D.C. - More than 92 federal lawsuits alleging birth defects caused by the antidepressant Zoloft and its generic version sertraline were centralized April 17 before Judge Cynthia M. Rufe in the U.S. District Court for the Eastern District of Pennsylvania by the Judicial Panel on Multidistrict Litigation (In Re: Zoloft [Sertraline Hydrochloride] Products Liability Litigation, MDL Docket No. 2342, JPMDL; See 2/16/12, Page 11). </description>
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<title>Propecia MDL Sent To Eastern District Of N.Y.; Plaintiffs Allege Dysfunction</title>
<description>WASHINGTON, D.C. - Sixteen federal lawsuits alleging persistent sexual dysfunction allegedly caused by the hair loss treatment drug Propecia were centralized April 16 before Judge John Gleeson of the U.S. District Court for the Eastern District of New York by the federal Judicial Panel on Multidistrict Litigation (JPMDL) (In Re: Propecia (Finesteride) Product Liability Litigation, MDL Docket No. 2331, JPMDL; See 1/19/12, Page 13). </description>
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<title>Propecia, Proscar Labels To Warn Of Sexual Side Effects Even After Discontinuance</title>
<description>ROCKVILLE, Md. - The Food and Drug Administration on April 11 said it has revised the labels for Propecia and Proscar brand finasteride to warn of reports of libido, ejaculation and orgasm disorders, male infertility and/or poor semen quality even after the drugs are discontinued. </description>
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<title>Fen-Phen Judge Dismisses Fraud Claims Brought By Diet Clinic Operators</title>
<description>PHILADELPHIA - Claims by California diet clinic operators that they were defrauded under the state's unfair competition law (UCL) by American Home Products' marketing of the since-withdrawn diet drugs Pondimin and Redux were dismissed April 9 by the fen-phen multidistrict litigation judge (In re: Diet Drugs (phentermine/fenfluramine/dexfenfluramine) Products Liability Litigation, MDL NO. 1203, Geoffrey Drew, M.D., et al. v. American Home Products Inc., No. 00-21044, E.D. Pa.; 2012 U.S. Dist. LEXIS 49319). </description>
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<title>6th Circuit Affirms Rescission Of Policy In Legal Malpractice Coverage Suit</title>
<description>CINCINNATI - The Sixth Circuit U.S. Court of Appeals on April 13 affirmed a district court's ruling that an insurer was entitled to rescind a fen-phen lawyer's professional liability insurance policy because the insured made material misrepresentations and omissions on the policy application, further finding that a May 20, 2010, Kentucky Supreme Court order disbarring the insured from practicing law further bars coverage under the policy's dishonesty exclusion clause (Continental Casualty Co. v. Law Offices of Melbourne Mills Jr. PLLC, et al., Nos. 10-5813 and 10-5814, 6th Cir.; 2012 U.S. App. LEXIS 7445). </description>
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<title>Avandia MDL Judge Insists On Specific Causation, Denies Remand, Sets November Trial</title>
<description>PHILADELPHIA - The Pennsylvania federal judge overseeing the Avandia multidistrict litigation on April 4 denied attempts by several nonsettling plaintiffs for relief from providing expert causation opinions and for remand of their cases and scheduled five cases for trial Nov. 12 (In Re: Avandia Marketing, Sales Practices and Products Liability Litigation, MDL Docket No. 1871, No. 2:07-md-1871, E.D. Pa.). </description>
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<title>Avandia MDL Judge Remands Utah, Louisiana Cases; No Federal Question Found</title>
<description>PHILADELPHIA - The Pennsylvania federal judge overseeing the Avandia multidistrict litigation on April 4 remanded lawsuits by the states of Utah and Louisiana to state court after finding that there is no substantial federal issue (In Re: Avandia Marketing, Sales Practices and Products Liability Litigation, MDL Docket No. 1871, No. 07-md-1871, Mark Shurtleff, ex rel. The State of Utah v. GlaxoSmithKline, LLC, et al., No. 11-2915, and State of Louisiana v. GlaxoSmithKline, LLC, No. 11-3521, E.D. Pa.; 2012 U.S. Dist. LEXIS 48319). </description>
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<title>Actos MDL Judge Appoints Sidley Austin Attorney As Defense Lead Counsel</title>
<description>LAFAYETTE, La. - The Louisiana federal judge overseeing the Actos multidistrict litigation on April 12 appointed Sara J. Gourley of Sidley Austin in Chicago defense lead counsel (In Re: Actos (Pioglitazone) Products Liability Litigation, MDL Docket Nol. 2299, No. 6:11-md-2299, W.D. La., Lafayette Div.; See 3/15/12, Page 19). </description>
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<title>GlaxoSmithKline Pays $2.6M To Settle Drug Pricing Suit By Idaho Attorney General</title>
<description>BOISE, Idaho - GlaxoSmithKline PLC (GSK) has agreed to pay $2.6 million to settle a lawsuit by Idaho that accused the drug maker of reporting inflated drug prices paid for by the state Medicaid program, according to a settlement agreement announced April 17 by the state Attorney General's Office (State of Idaho v. Aventis Pharmaceuticals Inc., et al., No. CVOC 07-10318, Idaho Dist., Ada Co.). </description>
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<title>Plaintiff, Defense Leadership Appointed In 3 New Pelvic Mesh MDLs</title>
<description>CHARLESTON, W.Va. - A West Virginia federal judge overseeing three newly created multidistrict litigations involving vaginal slings on April 17 appointed plaintiffs and defense leadership, including naming the same lead plaintiffs and Plaintiffs' Executive Committee for all three dockets (In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, MDL Docket No. 2325, No. 1:12-md-2325, In Re: Boston Scientific Corp. Pelvic Repair Systems Products Liability Litigation, MDL Docket No. 2326, and In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, S.D. W.Va., Charleston Div.; See 2/16/12, Page 13). </description>
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<title>Ariz. Federal Judge Allows Plaintiff Expert's Method To Set Defendants' Net Worth</title>
<description>PHOENIX - A plaintiff who claims that she developed breast cancer from long-term use of Premarin and Provera can have an expert present his own testimony about the defendants' net worth, but the expert can't suggest an amount to the jury, an Arizona federal judge ruled April 5 (Catherine Johnson v. Wyeth LLC, et al., No. 10-2690, D. Ariz.; 2010 U.S. Dist. LEXIS 48149). </description>
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<title>Ex-Orthofix VP Pleads Guilty To Paying Kickback For Bone Growth Stimulators</title>
<description>BOSTON - A Massachusetts federal judge on April 9 accepted the guilty plea of a former vice president for Orthofix Holdings Inc. to paying kickbacks to a doctor in exchange for exclusively prescribing the company's bone growth stimulators (United States of America v. Thomas P. Guerrieri, No. 1:12-cr-10061, D. Mass.). </description>
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<title>Certification Of Indirect Purchaser Class In Wellbutrin XL Antitrust Case Stands</title>
<description>PHILADELPHIA - A federal judge in Pennsylvania on April 9 refused to reconsider her order granting certification of a class of indirect purchasers who are suing the producers and distributors of Wellbutrin XL for illegally conspiring to prevent generic versions of the drug from entering the American market (In re: Wellbutrin XL Antitrust Litigation, No. 08-2431 [indirect], E.D. Pa.; See August 2011; See 8/18/11, Page 25). </description>
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<title>Drospirenone Birth Control Drugs Get New Blood Clot Risks Added After FDA Review</title>
<description>ROCKVILLE, Md. - Birth control pills containing drospirenone may be associated with a higher risk of blood clots than other progestin-containing oral contraceptives, and the new risk information will be added to the labels of 10 products, the Food and Drug Administration said April 10 in a drug safety alert after concluding a review of epidemiological studies. </description>
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