Hazardous chromium levels found in dietary supplements; 195 adverse reactions confirmed
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ROCKVILLE, Md. - Hazardous amounts of chromium have been found in certain dietary supplements already associated with adverse events apparently linked to excess levels of selenium, the Food and Drug Administration reported May 1.
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Digoxin tablets recalled; double potency results in illnesses, injuries, maker says
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MORRISTOWN, N.J. - Digoxin tablets made by Actavis Totowa LLC for Mylan Pharmaceuticals Inc. and sold under the labels of Bertek and UDL are under a class 1 recall because they may contain twice the amount of active ingredient and have been associated with illnesses and injuries, Actavis announced April 25.
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Blood clotting factors
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Drug / Device: Blood clotting factors Defendant(s): Bayer Corp., Cutter Biological, Baxter Healthcare Corp. Hyland Div., Baxter International Inc., Immuno-U.S. Inc., Armour Pharmaceutical Co. Inc., Aventis Behring LLC, Aventis Inc., Alpha Therapeutic Corp.
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Ketek
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Drug / Device: Ketek Defendant(s): Sanofi-Aventis U.S. LLC, Sanofi-Aventis Worldwide Case name: Betty Johnson, et al. v. Sanofi-Aventis U.S., LLC., No. 08-611
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Ethicon surgical stapler
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Drug / Device: Ethicon surgical stapler Defendant(s): Ethicon End-Surgery Inc., 10 John Doe defendants
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Oxycontin
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Drug / Device: OxyContin Defendant(s): Purdue Frederick Co. Inc., Purdue Pharma LP, Michael Friedman, Howard R. Udell, Paul D. Goldenheim, M.D., James Drug Store Inc.
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Actimmune
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Drug / Device: Actimmune Defendant(s): Intermune Inc., W. Scott Harkonen, Genentech Inc. Case name: Deborah Jane Jarrett, et al. v. Intermune, Inc., et al., No. 08-2376
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Digitek digoxin
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Drug / Device: Digitek-brand digoxin Defendant(s): Actavis Group hf; Actavis Totowa LLC, f/k/a Amide Pharmaceutical Inc.; Actavis Inc.; Actavis Elizabeth LLC; Actavis US; Mylan Inc.; Mylan Pharmaceuticals Inc.; Mylan Laboratories Inc.; Mylan Bertek Pharmaceuticals Inc.; UDL Laboratories Inc.
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Digitek digoxin
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Drug / Device: Digitek-brand digoxin Defendant(s): Actavis Group, Actavis Totowa LLC, Mylan Pharmaceuticals Inc., Mylan Bertek Pharmaceuticals Inc., UDL Laboratories Inc.
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Heparin
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Drug / Device: Heparin Defendant(s): Baxter Healthcare Corp.; Baxter International Inc.; Wyeth subsidiary Illinois Corp., f/k/a Scientific Protein Laboratories
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News from the lexisnexis torts law center
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[Editor's Note: The following items of interest appeared recently on the LexisNexis Torts Law Center. Devoted to products liability and toxic tort litigation and industry news, the Torts Law Center is where you can connect with other professionals to discuss the hottest issues. Become a regular contributor. Visit the center on the open Web for products liability and toxic tort-related headlines, discussion, expert commentary and more at: http://law.lexisnexis.com/practiceareas/torts]
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Medtronic signs consent decree to comply with regulations for making aeds
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SEATTLE - Medtronic Inc. on April 25 signed a consent decree of permanent injunction agreeing to use current good manufacturing practices in the manufacture of Physio-Control Inc. Lifepak automatic external defibrillators (United States of America v. Medtronic, Inc., et al., No. 08-cv-649, W.D. Wash.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Oxycontin prosecutor stepping down may 16
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ROANOKE, Va. - The U.S. attorney who criminally prosecuted OxyContin maker Purdue Pharma and three executives will resign May 16.
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Kugel mdl plaintiffs must produce tax forms, as they agreed to
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PROVIDENCE, R.I. - Objections by plaintiffs in the Kugel surgical patch multidistrict litigation about providing copies of their tax returns were rebuffed May 2 by a magistrate judge who said the plaintiffs had agreed to release them along with filing plaintiff fact sheets (PFS) (In Re: Kugel Mesh Hernia Patch Litigation, MDL Docket No. 1842, No. 07-1842, D. R.I.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Propulsid psc waives 6 percent mdl fee from past, future awards
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NEW ORLEANS - The Plaintiffs' Steering Committee (PSC) in the Propulsid multidistrict litigation has agreed to waive the 6 percent MDL assessment fee from awards made to plaintiffs, according to an April 28 order (In Re: Propulsid Products Liability Litigation, MDL Docket No. 1355, No. 00-md-1355, E.D. La.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Moistureloc mdl judge takes common benefit fund under advisement
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CHARLESTON, S.C. - The judge in the Bausch & Lomb contact lens solution multidistrict litigation on May 13 took under advisement a motion for a common benefit fund (In Re: Bausch & Lomb Contact Lens Solution Products Liability Litigation, MDL Docket No. 1785, No. 2:06-MN-77777-DCN, D. S.C., Charleston Div.).
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Bausch & lomb: too early for global mediation of contact solution cases
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CHARLESTON, S.C. - Bausch & Lomb said April 28 that it cannot consent to global mediation of its contact lens solution multidistrict litigation cases "without further information about plaintiffs' cases and input on the design of a resolution process" (In Re: Bausch & Lomb Contact Lens Solution Products Liability Litigation, MDL Docket No. 1785, No. 2:06-MN-77777-DCN, D. S.C., Charleston Div.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Plaintiffs attorneys apply for leadership appointments in trasylol mdl
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MIAMI - Plaintiff attorneys in the newly created Trasylol multidistrict litigation recently asked the court to make leadership appointments (In Re: Trasylol Products Liability Litigation, MDL Docket No. 1928, No. 08-md-1928, S.D. Fla.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Depo provera sales rep can't be joined to case
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MONTGOMERY, Ala. - An Alabama federal judge on March 3 denied a plaintiff's motion to join a nondiverse defendant to her Depo Provera complaint nine months after it was removed (April Worley v. Pfizer, Inc., et al., No. 06-916, M.D. Ala., Northern Div.; 2008 U.S. Dist. LEXIS 16009).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Seroquel plaintiffs say astrazeneca had duty to preserve database
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ORLANDO, Fla. - Plaintiffs in the Seroquel multidistrict litigation say defendant AstraZeneca Inc. had a duty to preserve its GEL database when one of the first cases was filed, not when the company was under government investigation (In Re: Seroquel Products Liability Litigation, MDL Docket No. 1769, No. 06-md-1769, M.D. Fla., Orlando Div.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Astrazeneca pulls subpoena of zyprexa mdl documents
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BROOKLYN, NY - AstraZeneca has withdrawn a subpoena seeking records from a settlement master for the Zyprexa multidistrict litigation (In Re: Zyprexa Products Liability Litigation, MDL Docket No. 1596, No. 04-md-1596, E.D. N.Y.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Pfizer can rebut fda alert; neurontin mdl judge seeks fda's input on suicidality
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BOSTON - The Neurontin multidistrict litigation judge on April 28 affirmed her decision to allow defendant Pfizer Inc. to serve an expert report rebutting a January Food and Drug Administration alert on suicidality and antiepileptic drugs and said she will ask the FDA for input on that "key finding" (In Re: Neurontin Marketing, Sales Practices, and Products Liability Litigation, MDL Docket No. 1629, No. 04-10981, D. Mass.; See 4/17/08, Page 19).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Neurontin defendants want nearly 400 plaintiffs dismissed for failure to certify claims
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BOSTON - The defendants in the Neurontin multidistrict litigation want the court to dismiss the claims of almost 400 plaintiffs because their attorney has repeatedly failed to certify that there are prescription and medical records to support the claim (In Re: Neurontin Marketing, Sales Practices, and Products Liability Litigation, MDL Docket No. 1629, No. 04-10981, D. Mass.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Neurontin plaintiffs say mdl court doesn't need independent expert panel
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BOSTON - Plaintiffs in the Neurontin multidistrict litigation on April 23 asked the court not to grant a defendant's motion for the appointment of a panel of independent experts to help the court rule on the admissibility of expert evidence (In Re: Neurontin Marketing, Sales Practices, and Products Liability Litigation, MDL Docket No. 1629, No. 04-10981, D. Mass.; See 4/17/08, Page 19).
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Neurontin suicide plaintiffs alleged indirect influence of doctors by defendants
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BOSTON - Plaintiffs in the Neurontin multidistrict litigation on April 21 told the judge that she should find that defendants Pfizer Inc. and Warner-Lambert Co. indirectly influenced doctors to prescribe the drug (In Re: Neurontin Marketing, Sales Practices, and Products Liability Litigation, MDL Docket No. 1629, No. 04-10981, D. Mass.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Old e-mail on laptop led to qui tam lawsuit involving raplon's risks
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NEWARK, N.J. - The chance reassignment of a used Organon Inc. laptop and discovery of an old e-mail led to the filing of a False Claims Act complaint alleging that Organon and successor Schering-Plough Inc. failed to disclose serious adverse event problems with their Raplon anesthesia drug (United States of America, ex rel. Jeffrey D. Feldstein, M.D. v. Organon, Inc., et al., No. 07-2690, D. N.J.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Medtronic recalls devices with contaminated heparin
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MINNEAPOLIS - Medtronic Inc. on May 7 announced a voluntary recall of selected medical devices featuring the Carmeda BioActive surface because heparin applied to the device might be contaminated.
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Congressional staff report: fake heparin 100 times cheaper than real ingredient
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WASHINGTON, D.C. - Counterfeit heparin costs about $20 per kilogram compared to $2,000 per kilogram for crude heparin, an April 29 congressional staff report says, fueling speculation that counterfeit product was deliberately added to increase profits for Chinese heparin "workshops" or consolidators who sell it to primary suppliers.
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Minor cannot re-litigate blood factor infection claim as an adult, judge rules
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CHICAGO - The judge in the blood factor multidistrict litigation court on April 29 dismissed a complaint on the basis of res judicata because the plaintiff's identical claim had been dismissed while he was a minor and there was no appeal (In Re: Factor VIII or IX Concentrate Blood Products Liability Litigation, MDL Docket No. 986, No. 93-7452; M.D., et al. v. Bayer Corp., et al., No. 04-8273, N.D. Ill., Eastern Div.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Taiwanese blood plaintiffs say bayer, baxter reneged on hiv infection contract payments
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CHICAGO - A group of Taiwanese plaintiffs on May 7 asked the blood factor multidistrict litigation judge to sever from the MDL their claims that defendants Bayer Corp. and Baxter Healthcare Inc. violated a contract to provide humanitarian aid to HIV-infected plaintiffs (In Re: Factor VIII or IX Concentrate Blood Products Products Liability Litigation, MDL Docket No. 986, No. 93-7452, N.D. Ill.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Roche tells 11th circuit accutane suicide warnings were adequate for doctor
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ATLANTA - Hoffman-La Roche Inc. on March 25 told the 11th Circuit U.S. Court of appeals that it should find that Roche adequately warned the doctor of a congressman's son about Accutane's suicide risk (Laurie A. Stupak v. Hoffman-La Roche Inc., No. 07-15980, 11th Cir.; See 3/6/08, Page 19).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
New jersey won't postpone next accutane ibd trials pending appeal outcome
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ATLANTIC CITY, N.J. - New Jersey's Accutane judge on May 12 denied a motion to postpone two upcoming bowel injury trials pending an appeal but did adjourn them to an as-yet undecided future date (Carey Todd Wagner v. Hoffman-La Roche Inc., No. ATL-L-3259-04, Emily Beard v. Hoffman-La Roche Inc., No. ATL-L-2645,N.J. Super., Atlantic Co.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Mirapex mdl judge denies summary judgment in 5 cases; facts in dispute
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MINNEAPOLIS - The Mirapex multidistrict litigation judge on May 2 denied summary judgment in five cases, saying "disputed issues of law and fact prevent the entry of summary judgment at this time" (In Re: Mirapex Products Liability Litigation, MDL Docket No. 1836, No. 07-md-1836, D. Minn.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
2 plaintiff experts struck from zimmer knee case; methodology lacking
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CHICAGO - Two plaintiffs experts were struck March 19 in a Zimmer knee case because their methodology failed to established when a plastic component oxidized and possibly failed (Wayne V. Jaske v. Zimmer, Inc., No. 03-2939, N.D. Ill., Eastern Div.; 2008 U.S. Dist. LEXIS 22434; See 8/7/03, Page 25).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Learned intermediary applies to medical devices case, connecticut judge rules
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NEW HAVEN, Conn. - A Connecticut judge on March 5 ruled that the learned intermediary defense should apply to prescription medical devices as well as prescription drugs (Robert Wegryn v. Smith & Nephew, Inc., No. CV075013243S, Conn. Super., New Haven Dist.; 2008 Conn. Super. LEXIS 587).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
Fda goes 1-2 in trial over custom-made orthopedic devices
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ORLANDO, Fla. - A Florida federal judge on April 30 found that Endotech did not violate Food and Drug Administration regulations because two of three orthopedic devices were exempt as custom-made; a knee device, however, was found to be adulterated (United States of America v. Endotech, Inc., et al., No. 06-cv-1281, M.D. Fla., Orlando Div.).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
$7.7m vioxx death verdict overturned on appeal by texas appeals court
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SAN ANTONIO - A Texas state appeals court on May 14 overturned a $7.75 million Vioxx verdict, saying plaintiffs had failed to show that the painkiller, and not 71-year-old Leonel Garza's existing risk factors, caused his heart attack and death in 2001 (Merck & Co., Inc. v. Felicia Garza, et al., No. 04-07-00234-CV, Texas App., 4th Dist.; See 1/4/07, Page 5).
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Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News - May 16, 2008 Category: Medical Law Source Type: info
The true final verdict of my malpractice trial
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A lawsuit left this physician with worries about his reputation, until a surprising patient visit took
place. 2007 Doctors' Writing Contest - Young Doctor Award (Source: Medical Economics - Malpractice)
Source: Medical Economics - Malpractice - May 16, 2008 Category: Medical Law Source Type: journals
Malpractice consult: your responsibility for patients in the ed
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Primary care physicians need to reduce risk when patients go to the emergency
department. (Source: Medical Economics - Malpractice)
Source: Medical Economics - Malpractice - May 16, 2008 Category: Medical Law Source Type: journals
Analysis of mitochondrial length heteroplasmy in monozygous and non-monozygous siblings
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Abstract The segregation of mitochondrial genomes and the inheritance of mitochondrial DNA are constant matters of debate. To obtain
more information about this issue and to answer the question whether or not it is possible to distinguish mitochondrial DNA
(mtDNA) samples from monozygous individuals by analysing heteroplasmic length variants, 290 monozygous and 121 dizygous twin
pairs and 34 sets of multiples were studied by RFLP and partly by direct sequencing. A factor D describing the respective pattern of length variants in a given sample was also calculated. The results show that monozygous
individuals ...
Source: International Journal of Legal Medicine - May 14, 2008 Category: Medical Law Tags: International Journal of Legal Medicine Source Type: journals
Age of initiation plays no role in hormone therapy stroke risk
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CHICAGO - The risk of stroke associated with the use of combination hormone replacement therapy increases regardless of the age of the woman when she starts using the drugs, a recent review of data from the Nurses' Health Study revealed.
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Source: LexisNexis® Mealey's™ Hormone Replacement Therapy Legal News - May 12, 2008 Category: Medical Law Source Type: info
Plaintiff says general litigation fund incapable of covering costs
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LITTLE ROCK, Ark. - Wyeth should be ordered to pay a woman $28,602.84 in costs, the plaintiff who won the most recent trial in the Prempro multidistrict litigation court says in a May 5 reply brief, because the general litigation fund established under Practice and Procedure Order No. 5 is incapable of reimbursing law firms for expert expenditures, especially when the defendants have not indicated that they are willing to do anything other than try every case to conclusion (In re: Prempro Products Liability Litigation, MDL No. 1507; Donna Scroggin v. Wyeth, et al., No. 04-CV-1169, E.D. Ark.; See March 2008, Page 13).
Full...
Source: LexisNexis® Mealey's™ Hormone Replacement Therapy Legal News - May 12, 2008 Category: Medical Law Source Type: info
Prempro mdl judge applies michigan law, dismisses case
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LITTLE ROCK, Ark. - Claims asserted by a woman who resided in Michigan when she used hormone replacement therapy and was diagnosed with breast cancer are subject to Michigan's law that shields drug manufacturers from liability, the federal judge presiding over the Prempro multidistrict litigation found in awarding Novartis Pharmaceutical Corp. summary judgment (In re: Prempro Products Liability Litigation, MDL No. 1507; Judith Dean v. Wyeth, et al., No. 04-CV-1202, E.D. Ark.; 2008 U.S. Dist. LEXIS 29201).
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Source: LexisNexis® Mealey's™ Hormone Replacement Therapy Legal News - May 12, 2008 Category: Medical Law Source Type: info
Nuvaring contraceptive mdl sought for missouri court by 65 federal plaintiffs
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WASHINGTON, D.C. - Plaintiffs in 65 NuvaRing contraceptive device cases on April 22 moved for the creation of a multidistrict litigation (In Re: NuvaRing Litigation, MDL Docket No. not assigned, JPMDL).
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Source: LexisNexis® Mealey's™ Hormone Replacement Therapy Legal News - May 12, 2008 Category: Medical Law Source Type: info
Public citizen asks fda to withdraw ortho evra
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WASHINGTON, D.C. - Public health watchdog group Public Citizen on May 8 petitioned the Food and Drug Administration seeking the withdrawal of Ortho Evra in six months based on study data showing that women using the birth control patch are at a possible twofold increase in the risk of blood clots and exposed to dangerous levels of estrogen.
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Source: LexisNexis® Mealey's™ Hormone Replacement Therapy Legal News - May 12, 2008 Category: Medical Law Source Type: info
Judge denies request for summary judgment on specific causation
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NEW BRUNSWICK, N.J. - The New Jersey judge presiding over the state's hormone therapy mass tort on May 7 denied motions for summary judgment submitted by the makers of Premarin, Prempro and Provera on the ground that a couple failed to provide sufficient specific causation testimony to support their claims that the drugs caused the woman to develop breast cancer (In re: HRT Litigation, Case No. 266, N.J. Super., Middlesex Co.; Dora Bailey, et al. v. Wyeth, et al., No. MID-L-0999-06 MT; N.J. Super., Middlesex Co.; See April 2008, Page 18).
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Source: LexisNexis® Mealey's™ Hormone Replacement Therapy Legal News - May 12, 2008 Category: Medical Law Source Type: info
Prempro maker says no evidence supports punitive damages claim
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NEW BRUNSWICK, N.J. - A woman claiming that her use of hormone replacement therapy contributed to her development of cancer is not entitled to pursue punitive damages claims, Wyeth says in a May 5 motion, because there is no evidence showing that it withheld information from the Food and Drug Administration about the risk of breast cancer (In re: HRT Litigation, Case No. 266; Loretta Deboard v. Wyeth, et al., No. MID-L-1147-06 MT, N.J. Super., Middlesex Co.; See related stories in this issue).
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Source: LexisNexis® Mealey's™ Hormone Replacement Therapy Legal News - May 12, 2008 Category: Medical Law Source Type: info
Wyeth ordered to post $58 million bond; pay attorney fees
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RENO, Nev. - A Nevada judge on April 11 ordered Wyeth to post a $58 million bond while it appeals a jury's finding in favor of three woman who claimed that they developed breast cancer as a result of using Premarin and Prempro and ordered the company to pay $1.6 million in attorney fees after finding that the company's refusal to accept a settlement offer was in bad faith (Arlene Rowatt, et al. v. Wyeth, No. CV04-01699, Nev. Dist., Washoe Co.; See March 2008, Page 5).
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Source: LexisNexis® Mealey's™ Hormone Replacement Therapy Legal News - May 12, 2008 Category: Medical Law Source Type: info
Prempro maker says woman did not rely on advertising
