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Preview: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News

LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News

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California Supreme Court: Brand-Name Drug Maker Liable Even After Divestment
SAN FRANCISCO - In a 4-3 ruling, the California Supreme Court on Dec. 21 ruled that Novartis Pharmaceuticals Corp. can be liable for failing to include a warning about fetal brain injury in labels used by generic drug makers and that the liability can extend to six years after Novartis sold its rights to the drug (T.H., et al. v. Novartis Pharmaceuticals Corporation, No. S233898, Calif. Sup., 2017 Cal. LEXIS 9636).

Judge Tosses Punitive Damages Award In AndroGel Injury Suit, Orders New Trial
CHICAGO - The federal judge in Illinois presiding over lawsuits alleging that the use of testosterone replacement therapy (TRT) resulted in injuries on Dec. 22 vacated a jury's $150 million punitive damages award to a man and ordered a new trial on his claim for fraudulent misrepresentation after finding that the jury's verdict, which also found AbbVie Inc. and Abbott Laboratories Inc. (collectively, AbbVie) not liable for negligence and strict liability, was "logically incompatible" (In re: Testosterone Replacement Therapy Products Liability Coordination Pretrial Proceedings, MDL 2545, Case No. 14-1748, Jesse Mitchell v. AbbVie, No. 14 C 9178, N.D. Ill.).

Global Settlement Reached In Eli Lilly Axiron Testosterone Injury Cases, MDL Judge Says
CHICACO - Plaintiffs and Eli Lilly and Co. have reached a global settlement of Axiron testosterone replacement therapy cases, an Illinois federal multidistrict litigation judge said in a Dec. 21 case management order (In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, N.D. Ill., Eastern Div.).

Missouri High Court Vacates Order Denying Dismissal Of Nonresident Essure Claims
JEFFERSON CITY, Mo. - The Missouri Supreme Court on Dec. 19 said a trial court erred in denying Bayer Corp.'s motion to dismiss the claims of 85 out-of-state Essure plaintiffs (State ex rel. Bayer Corporation, et al. v. Honorable Joan L. Moriarty, No. SC96189, Mo. Sup., 2017 Mo. LEXIS 582).

Drug Company Pays $210M For Paying Kickbacks Through Patient Assistance Nonprofit
BOSTON - United Therapeutics Corp. has agreed to pay $210 million to the federal government to resolve allegations that it violated the False Claims Act by paying kickbacks to Medicare patients through a charitable patient assistance foundation, the U.S. Attorney's Office for the District of Massachusetts announced Dec. 20.

Boehringer Ingelheim Pays $13.5M To Settle States' Off-Label Drug Claims
NEW YORK - Drug manufacturer Boehringer Ingelheim Pharmaceuticals Inc. has agreed to pay all 50 states and the District of Columbia $13.5 million to resolve allegations that it engaged in deceptive and misleading marketing of four drugs, the New York attorney general announced Dec. 20 (People of the State of New York, et al. v. Boehringer Ingelheim Pharmaceuticals, Inc., No. 453287/2017, N.Y. Sup., New York Co.).

Judge Recommends Closure Of Zoloft Birth Defect Multidistrict Litigation
PHILADELPHIA - The Pennsylvania federal judge overseeing the Zoloft birth defect multidistrict litigation on Dec. 27 recommended that the MDL be closed since no cases remain after the exclusion of all plaintiff causation experts (In Re: Zoloft [Sertraline Hydrochloride] Products Liability Litigation, MDL Docket No. 2342, No. 12-md-2342, E.D. Pa.).

Judge Limits Engineering, Testing Testimony Of Plaintiffs' IVC Filter Experts
PHOENIX - A federal judge in Arizona overseeing litigation stemming from injuries and deaths caused by allegedly defective inferior vena cava (IVC) filters on Dec. 22 ruled that three plaintiffs' experts cannot testify about the engineering and testing of the products because they lack the proper qualifications (In re: Bard IVC Filters Products Liability Litigation, No. 15-02641, D. Ariz., 2017 U.S. Dist. LEXIS 211400).

New Jersey Weighs Creation Of Abilify Multicounty Litigation In Bergen County
TRENTON, N.J. - The New Jersey Supreme Court on Dec. 27 sought comments or objections to a joint plaintiff and defendant motion to classify 42 state Abilify cases as a multicounty litigation.

Onglyza Heart Failure MDL On Tap For Jan. 25 Hearing Of Federal Judicial Panel
WASHINGTON, D.C. - The Judicial Panel on Multidistrict Litigation (JPMDL) on Dec. 15 said it will hear arguments Jan. 25 on the centralization of 42 federal lawsuits alleging heart failure from the diabetes drug Onglyza (In Re: Onglyza [Saxagliptin] Products Liability Litigation, MDL Docket No. 2809, JPMDL).

Defendants Now Want MDL For Sorin 3T Heater-Cooler Cases; Most Plaintiffs Oppose
WASHINGTON, D.C. - The Judicial Panel on Multidistrict Litigation (JPMDL) on Dec. 15 said it will hear arguments on Jan. 25 on a new petition to centralize lawsuits involving the Sorin 3T Heater-Cooler System, a motion filed this time by the defendants (In Re: Sorin 3T Heater-Cooler System Products Liability Litigation [No. II]), MDL Docket No. 2816, JPMDL).

$290M Settlement Reached In Related Valeant Insider Trading Suits
SANTA ANA, Calif. - Defendants in a pair of related securities class action lawsuits alleging an insider-trading and front-running scheme regarding pharmaceutical company Valeant Pharmaceuticals International Inc.'s attempt at a hostile takeover of Allergan Inc. will pay $290 million to settle the claims against them, according to a press release issued by Valeant on Dec. 29 (Anthony Basile, et al. v. Valeant Pharmaceuticals International Inc., et al., No. 14-2004, C.D. Calif., and Timber Hill LLC v. Pershing Square Capital Management, No. 17-4776, C.D. Calif.).

Preemption Summary Judgment Reversed By 9th Circuit In Incretin Mimetic MDL Appeal
SAN FRANCISCO - The Ninth Circuit U.S. Court of Appeals on Dec. 6 unsealed its Nov. 28 opinion reversing summary judgment in the incretin mimetic multidistrict litigation, saying the MDL judge misapplied a U.S. Supreme Court precedent, improperly blocked discovery, misinterpreted what constituted new evidence and improperly disqualified a plaintiff expert (In Re: Incretin-Based Therapies Products Liability Litigation, Jean Adams, et al. v. Merck Sharp & Dohme Corp., et al., No. 15-56997, 9th Cir., 2017 U.S. App. LEXIS 24674).

New Jersey State Court Jury Returns $15M Verdict In Ethicon Pelvic Mesh Trial
HACKENSACK, N.J. - A New Jersey state court jury on Dec. 14 awarded $15 million to a plaintiff and her husband in the state's second pelvic mesh trial (Elizabeth Hrymoc, et al. v. Ethicon, Inc., et al., No. L-13686-14, N.J. Super., Bergen Co.).

11th Circuit Says ObTape Claim May Not Be Time-Barred By Minnesota Law
ATLANTA - The 11th Circuit U.S. Court of Appeals on Nov. 16 reversed dismissal of a Mentor Corp. pelvic mesh case on the grounds of the statute of limitations, saying evidence can support that there was no causal connection between the plaintiff's injuries and the device until a doctor told her so in 2008 (Frances Alvarado v. Mentor Corporation, et al., No. 16-16000, 11th Cir., 2017 U.S. App. LEXIS 22999).

Illinois Appeals Court Reverses Forum Ruling In Pelvic Mesh Case
MOUNT VERNON, Ill. - An Illinois appeals panel on Dec. 8 reversed a trial court ruling denying a motion for forum non conveniens in a pelvic mesh case because a trial court order set no limit on when the defendant had to file a response and because the plaintiffs will not be prejudiced by having the plaintiffs refile the case in Maryland state court (Shawn McIver, et al. v. American Medical Systems, Inc., et al., No. 5-17-0011, Ill. App., 5th Dist., 2017 Ill. App. Unpub. LEXIS 2502).

Pennsylvania Appeals Court Affirms $29.6M Remitted Zimmer Knee Judgment
PHILADELPHIA - A Pennsylvania appeals court panel on Dec. 15 said a trial judge did not err when remitting a Zimmer Inc. knee verdict to $29.6 million and said it declined to substitute its judgment in place of the jury's (Margo Polett, et al. v. Public Communications, Inc., et al., No. 80 EDA 2017, Pa. Super., 2017 Pa. Super. Unpub. LEXIS 4603).

DaVita Pharmacy To Pay $63.7M To Settle Allegations Of False Claims, Kickbacks
DALLAS - Nationwide pharmacy DaVita Rx LLC has agreed to pay $63.7 million to resolve federal false claims and kickback allegations that it billed federal health care programs for drugs it never shipped and for taking kickbacks in the form of patient assistance programs, the U.S. attorney for the Northern District of Texas announced Dec. 14 (United States of America, ex rel. Patsy Gallian, et al. v. DaVita Rx, LLC, et al., No. 3:16-cv-943, N.D. Texas).

Medtronic Pays $12M To 5 States For Deceptive Marketing Of Infuse Bone Graft
BOSTON - Medtronic Inc. has agreed to pay $12 million to five states to resolve allegations that it engaged in deceptive marketing of the company's Infuse bone graft, according to a consent judgment entered Dec. 13 in the Suffolk County, Mass., Superior Court (Commonwealth of Massachusetts v. Medtronic Sofamor Danek, Inc., et al., No. 17-4030D, Mass. Super., Suffolk Co.).

New Jersey Supreme Court To Weigh Reinstatement Of Accutane Experts, Cases
TRENTON, N.J. - The New Jersey Supreme Court on Dec. 5 granted petitions and cross-petitions to appeal a state appellate court's reversal of expert exclusions in the state's Accutane multicounty litigation and the reinstatement of 2,076 dismissed cases (In Re: Accutane Litigation, C-388 September Term 2017, C-329 September Term 2017 and C-390 September Term 2017, N.J. Sup.).

2,353 Claims Received By NECC Tort Trustee, $149.4M Paid Out
BOSTON - The tort trustee for the fungal meningitis settlement on Dec. 18 told a Massachusetts federal court that her office has received 2,353 claims and has paid out $149.4 million of the $200 million settlement (In Re: New England Compounding Pharmacy, Inc. Products Liability Litigation, MDL Docket No. 2419, No. 13-md-2419, D. Mass.).

Pennsylvania Supreme Court Won't Hear Appeal Of Zoloft Expert's Exclusion
PHILADELPHIA - The Pennsylvania Supreme Court on Dec. 13 denied a petition to review a Zoloft birth defect case that was dismissed when the plaintiffs' causation expert was excluded by the trial court (Robert and Katherine Porter, et al. v. SmithKline Beecham Corporation, et al., No. 257 EAL 2017, Pa. Sup., Eastern Dist., 2017 Pa. LEXIS 3661).

New Trial Denied in 3rd Xarelto MDL Bellwether Case After Defense Verdict
NEW ORLEANS - The judge overseeing the Xarelto multidistrict litigation on Dec. 14 denied a motion for a new trial by the plaintiff in the third bellwether trial, finding, among other things, that the plaintiff's "newly discovered evidence" is actually cumulative of previously known and admitted evidence (In Re: Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, E.D. La., 2017 U.S. Dist. LEXIS 205422).

With Last 2 Cases Gone, Pradaxa MDL Judge Again Recommends Termination
EAST ST. LOUIS, Ill. - With the last two pending cases now closed, the Illinois federal judge overseeing the Pradaxa multidistrict litigation on Dec. 11 again recommended that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL (In Re: Pradaxa [Dabigatran Etexilate] Products Liability Litigation, MDL Docket No. 2385, No. 12-md-2385, S.D. Ill.).

Fen-Phen MDL Quietly Closed After 20 Years
PHILADELPHIA - After nearly 20 years of existence, the diet drug multidistrict litigation, also known as the fen-phen MDL, was quietly closed Oct. 27 (In Re: Diet Drugs [Phentermine/Fenfluramine/Dexfenfluramine] Products Liability Litigation, MDL Docket No. 1203, No. 2:11-md-1203, E.D. Pa.).

Testim Bellwether Plaintiff: Off-Label Evidence Probative, New Trial Sought
CHICAGO - A plaintiff who lost his testosterone replacement therapy case on Dec. 14 asked an Illinois federal court for a new trial, arguing that the court erred by excluding evidence the plaintiff says shows that defendant Auxilium Pharmaceuticals LLC pushed off-label sales of the drug Testim to get more sales and profits (In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Steve Holtsclaw v. Auxilium Pharmaceuticals, LLC, et al., No. 15-3941, N.D. Ill.).

2nd Circuit Vacates Drug Importation Conviction For Advice-Of-Counsel Defense
NEW YORK - The Second Circuit U.S. Court of Appeals on Dec. 13 vacated the conviction of a drug wholesaler for illegally importing drugs and medical devices because the trial court improperly limited his advice-of-counsel defense (United States of America v. William Scully, et al., No. 16-3073-cr, 2nd Cir., 2017 U.S. App. LEXIS 25124).

Investor Group Named Lead Plaintiff In Drug Company's Stock Drop Suit
SAN FRANCISCO - An investor group is the most appropriate candidate for lead plaintiff because it has the largest financial stake in the litigation and meets all other statutory requirements to serve in the role, a federal judge in California ruled Dec. 8 in appointing the investor group as lead plaintiff (Inchen Huang v. Depomed Inc., et al., No. 17-4830, N.D. Calif., 2017 U.S. Dist. LEXIS 202580).

Magistrate Judge Won't Dismiss Amended Complaint In Generic Lovenox Antitrust Case
NASHVILLE, Tenn. - A Tennessee federal magistrate judge on Dec. 14 allowed two plaintiffs to file an amended complaint against two drug companies for alleged antitrust violations for their distribution of enoxaparin, a generic version of the anticoagulant Lovenox (The Hospital Authority of Metropolitan Government of Nashville and Davidson County, Tennessee, et al. v. Momenta Pharmaceuticals, Inc., et al., No. 15-1100, M.D. Tenn., Nashville Div., 2017 U.S. Dist. LEXIS 205747).

6 Plaintiffs Awarded $247M In 4th DePuy Pinnacle Hip MDL Bellwether Trial
DALLAS - A Texas federal jury on Nov. 16 awarded six plaintiffs $247.49 million in the fourth multidistrict litigation bellwether trial involving the DePuy Orthopaedics Inc. Pinnacle hip (In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, MDL Docket No. 11-md-02244, Ramon Alicea, et al. v. DePuy Orthopaedics., Inc., et al., No. 15-03489, Uriel Barzel v. DePuy Orthopaedics, Inc., et al., No. 16-1245, Karen Kirschner v. DePuy Orthopaedics, Inc., et al., No. 16-1526, Hazel Miura v. DePuy Orthopaedics, Inc., et al., No. 13-4119, Michael A. Stevens v. DePuy Orthopaedics, Inc., et al., No. 14-1776, Eugene Stevens Jr. v. DePuy Orthopaedics, et al., No. 14-2341, N.D. Texas).

Zimmer Gets 3 Of 4 Claims Dismissed In Hip Defect Case
NEW YORK - A New York federal judge on Nov. 29 dismissed four of five claims in a Zimmer metal-on-metal hip case (Joseph Shaw v. Zimmer, Inc., et al., No. 17-2119, S.D. N.Y., 2017 U.S. Dist. LEXIS 196014).

Only Negligence Claim Survives Dismissal In Zimmer Hip Case
BROOKLYN, N.Y. - A New York federal judge on Nov. 27 dismissed all but a negligence claim in a Zimmer Inc. metal-on-metal hip case (James Viania v. Zimmer, Inc., et al., No. 17-1641, E.D. N.Y., 2017 U.S. Dist. LEXIS 195183).

Pennsylvania Jury Awards $27.8M In State's 1st Xarelto Trial
PHILADELPHIA - A Pennsylvania state court jury on Dec. 5 awarded an Indiana woman and her husband $27.8 million for injuries allegedly caused by the anticoagulant drug Xarelto, a source told Mealey Publications (Lynn Hartman, et al. v. Janssen Pharmaceuticals, Inc., et al., No. 160503416, Pa. Comm. Pls., Philadelphia Co.).

Delaware State Court Eliquis Plaintiffs Fail To Escape MDL Utts Dismissal
NEW YORK - The New York federal judge overseeing the Eliquis multidistrict litigation on Nov. 29 dismissed with prejudice 24 new complaints that she said failed to escape her previous preemption rulings (In Re: Eliquis [Apixaban] Products Liability Litigation, MDL Docket No. 17-md-2745, S.D. N.Y., 2017 U.S. Dist. LEXIS 196320).

Jury Finds For Defense In 1st Testim Bellwether Trial In Testosterone MDL
CHICAGO - Jurors in the first testosterone replacement therapy multidistrict bellwether trial involving Testim on Nov. 16 found in favor of defendant Auxilium Pharmaceuticals LLC (In Re: Testosterone Replacement Therapy Litigation, MDL Docket No. 2545, Steve Holtsclaw v. Auxilium Pharmaceuticals LLC, et al., No. 15-3941, N.D. Ill.).

Risperdal Gynecomastia Cases Barred By Michigan Shield Law, Pennsylvania Panel Says
PHILADELPHIA - A Pennsylvania state appeals panel on Nov. 28 affirmed the dismissal of 13 Risperdal gynecomastia cases, agreeing with a trial judge that the plaintiffs' claims are preempted by Michigan's drug shield law and that the plaintiffs could not prove that the fraud exception applied to their claims (In Re: Risperdal Litigation, MA.J.L., et al v. Janssen Pharmaceuticals Inc., et al., No. 55 EDA 2015, et al., Pa. Super., 2017 Pa. Super. LEXIS 965).

U.S. Supreme Court Asks Solicitor General To Weigh In On Fosamax Preemption
WASHINGTON, D.C. - The U.S. Supreme Court on Dec. 4 invited the U.S. solicitor general to express the views of the United States on whether there is "clear and convincing evidence" that the Food and Drug Administration would have rejected a stronger warning about femur fractures from the osteoporosis drug Fosamax (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup.).

About 180 Federal Opioid Cases Centralized In MDL Assigned To Ohio Court, Judge
WASHINGTON, D.C. - A federal judicial panel on Dec. 5 centralized almost 180 federal lawsuits against opioid manufacturers and distributers by cities, counties and state before U.S. Judge Dan A. Polster of the Northern District of Ohio (In Re: National Prescription Opiate Litigation, MDL Docket No. 2804, JPMDL).

Washington Supreme Court Won't Be Asked To Rule On City's Opioid Suit
SEATTLE - A Washington federal judge on Nov. 30 denied a motion by opioid maker Purdue Pharma LP to certify to the state Supreme Court its challenge of a city's use of the municipal cost-recovery rule for costs that the defendant says are not a cognizable tort injury (City of Everett v. Purdue Pharma L.P., et al., No. 17-209, W.D. Wash., Seattle Div.).

Opioid False Claims Lawsuit Voluntarily Dismissed By Relator; U.S. Motion Still Sealed
SYRACUSE, N.Y. - A whistleblower on Nov. 30 was allowed by a New York federal court to voluntarily dismiss without prejudice her five-month-old federal False Claims Act lawsuit against six large opioid manufacturers in light of a federal government investigation, according to a court order (State of New York, ex rel. Laurie Khanzadian v. Purdue Pharma, Inc., et al., No. 17-742, N.D. N.Y., 2017 U.S. Dist. LEXIS 197239).

Plaintiffs Denied New Trial In Depakote Birth Defect Case
CLEVELAND - An Ohio federal judge on Nov. 22 denied a plaintiffs' motion for a new trial in a Depakote birth defect case that ended in a defense verdict (Kevin Hutchens, et al. v. Abbott Laboratories, Inc., et al., No. 14-176, N.D. Ohio, Eastern Div., 2017 U.S. Dist. LEXIS 193494).

U.S. High Court Won't Review Whether Bellwether Trials Of IVC Cases Trigger CAFA
WASHINGTON, D.C. - The U.S. Supreme Court on Nov. 27 declined to review lower court rulings that the consolidation of inferior vena cava (IVC) filter cases for individual bellwether trials does not convert the cases into a mass action under the Class Action Fairness Act (CAFA), (Cordis Corporation v. Jerry Dunson, et al., No. 17-257, U.S. Sup.).

9th Circuit Denies Try By Ex-InterMune CEO To Revisit Expert Witness Issue
SAN FRANCISCO - Former InterMune Inc. CEO W. Scott Harkonen, M.D., on Dec. 4 lost another attempt to vacate his 2009 wire fraud conviction when the Ninth Circuit U.S. Court of Appeals said he and his trial counsel voluntarily decided not to present testimony by their own biostatistician and pulmonologist and there was no ineffective counsel (United States of America v. W. Scott Harkonen, M.D., No. 15-16844, 9th Cir., 2017 U.S. App. LEXIS 24475).

2nd New Jersey Ethicon Pelvic Mesh Trial Gets Under Way Nov. 27
HACKENSACK, N.J. - The second Ethicon pelvic mesh case to go to trial in New Jersey state court got under way on Nov. 27 (Elizabeth Hrymoc, et al. v. Ethicon, Inc., et al., No. L-13686-14, N.J. Super., Bergen Co.).

Mentor Asks Judicial Panel To End ObTape Pelvic Mesh MDL After Zero Cases Remain
COLUMBUS, Ga. - One of the oldest active pelvic mesh multidistrict litigations has no more cases, and the MDL should be closed, defendant Mentor Worldwide LLC told the U.S. District Court for the Middle District of Georgia on Dec. 4 (In Re: Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 08-md-2004, M.D. Ga.).

Teva Urges Justices To Overturn 9th Circuit Ruling On Admissibility Of Experts
WASHINGTON, D.C. - The Ninth Circuit U.S. Court of Appeals' reversal of summary judgment for a drugmaker on a claim that its immunosuppressant drugs caused a young man's death from cancer should be reviewed by the U.S. Supreme Court because the appeals court overstepped its bounds in reversing the exclusion of expert causation testimony, the drug company argues in a Nov. 20 petition for a writ of certiorari (Teva Pharmaceuticals USA, Inc. v. Stephen Wendell, et ux., No. 17-747, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4571).

Parties Ask 9th Circuit To Unseal Nov. 28 Ruling In Incretin Mimetics MDL Case
SAN FRANCISCO - Defendants and plaintiffs on Dec. 1 and Nov. 30 urged the Ninth Circuit U.S. Court of Appeals to unseal its Nov. 28 order in their appeal of the dismissal of claims involving incretin mimetic diabetes drugs (Jean Adams, et al. v. Merck Sharpe & Dohme Corp., et al., No. 15-56997, 9th Cir.).

Cherokee Nation's Actos 'Lien' Transferred From MDL To Oklahoma Federal Court
LAFAYETTE, La. - Although she said she has "grave doubts" about whether the Cherokee Nation has a substantive claim to a third-party lien in the Actos settlement, the Louisiana judge overseeing the multidistrict litigation on Nov. 28 issued a final ruling that the court lacks venue and granted a motion by defendant Takeda Pharmaceuticals USA Inc. to transfer the case to a federal court in Oklahoma where the tribe and its allegedly injured members are located (In Re: Actos [Pioglitazone] Products Liability Litigation, MDL No. 2299, No. 11-md-2299, Cherokee Nation v. Takeda Pharmaceuticals U S A Inc et al., No. 15-1485, W.D. La., 2017 U.S. Dist. LEXIS 196577).

Diabetic Test Strip Class Action Transferred, Joins Insulin Class Actions
SEATTLE - A federal lawsuit alleging collusion between pharmacy benefit managers (PBMs) and diabetic test strip manufacturers was transferred Nov. 28 from a Washington federal court to a New Jersey federal court to join other lawsuits alleging collusion between PBMs and insulin makers (Jeanine Prescott, et al. v. CVS Health Corporation, et al., No. 17-803, W.D. Wash., 2017 U.S. Dist. LEXIS 195188).

Medtronic Insulin Pump Case Dismissed As Preempted, But Plaintiff Can Refile
CAMDEN, N.J. - A New Jersey federal judge on Nov. 30 said that a plaintiff's claims involving an allegedly defective Medtronic Inc. insulin pump are preempted but that in light of the seriousness of the plaintiff's alleged injuries, the plaintiff can file an amended complaint to assert claims that will parallel federal regulations (Kevin Hart v. Medtronic, Inc., et al., No. 16-5404, D. N.J.).

OIG Rescinds Approval Of Drug Patient Assistance Program For Privacy Breaches
WASHINGTON, D.C. - The Office of Inspector General (OIG) on Nov. 28 rescinded a 2006 advisory opinion for the drug patient assistance program Caring Voice Coalition Inc. after determining that the program provided patient-specific data to one or more supporting drug companies, according to an OIG letter and a company statement.

Philippines FDA Orders Sanofi Pasteur To Pull New Dengue Fever Vaccine
MUNTINLUPA, Philippines - The Philippines Food and Drug Administration on Dec. 4 ordered Sanofi Pasteur Inc. to suspend the sale and distribution of its Dengvaxia dengue fever vaccine in the wake of a post-marketing clinical study indicating that the vaccine poses a potential risk to patients who have not previously been infected by the virus.

Public Citizen Petitions FDA To Remove Benicar Blood Pressure Drug From Market
WASHINGTON, D.C. - Advocacy group Public Citizen on Nov. 15 petitioned the Food and Drug Administration to immediately require the removal of Benicar from the market because it says the blood pressure drug "has unique serious risks but no unique benefit."