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Life Sciences
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May 7, 2013
Alcon Urges Dismissal Of Drug Bottle Size Class Action
Alcon Laboratories Inc. on Monday asked an Illinois federal judge to dismiss a putative class action accusing it of forcing consumers to buy bottles containing more prescription medicine than needed for effective treatment, arguing the plaintiff has no legitimate claim under state law for the federally regulated drugs.
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May 7, 2013
Whistleblowers Say DaVita Abusing Doc Privilege In FCA Case
The relators in a False Claims Act suit accusing DaVita Inc. of creating waste to overbill Medicare told a Georgia federal court Monday that the dialysis service provider was abusing attorney-client privilege by labeling an excessive amount of communications as confidential.
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May 6, 2013
Plan B Ruling's Supporters Urge Judge To Reject Stay
Emergency contraception advocates asked a New York federal judge Monday to reject the Food and Drug Administration's challenge to an order that would force the FDA to allow the morning-after pill to be sold over the counter with no restrictions, ahead of a Tuesday hearing on the FDA's stay motion.
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May 6, 2013
Stryker, Smith & Nephew Sued Over Bone Plate Patent
Medical device makers Stryker Inc. and Smith & Nephew Inc. were hit with suits by rival AngleFix Tech LLC in Tennessee federal court Monday, accusing them of infringing a patent for a bone plate apparatus used in orthopedic surgery.
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May 6, 2013
CVS Stops Some Prescription Reminders, Citing HIPAA Update
CVS Pharmacy Inc. said Monday it will stop using data from patient prescription drug records to mail prescription refill notices to customers on behalf of pharmaceutical manufacturers, citing newly implemented privacy rules in the Health Insurance Portability and Accountability Act.
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May 6, 2013
Jury Finds Cellectis Patent Claims Against Rival Invalid
A federal jury in Delaware on Friday shot down Cellectis SA’s intellectual property suit against rival genetic engineering firm Precision Biosciences Inc., finding that Precision didn't literally infringe claims of a patent related to “DNA scissors” and that the patent claims asserted against Precision weren't valid.
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May 6, 2013
Biomet Accused Of Breaking Patent Deal
Private equity-owned medical device maker Biomet Inc. was hit with a suit in Texas federal court Friday, accusing it of failing to pay royalties due under a licensing agreement and misusing confidential information to infringe on several patents for devices used in bone and joint repair surgery.
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May 6, 2013
Humira Risks Were Known Before Abbott Letter, Doc Says
An Illinois jury heard Monday that the rheumatologist who prescribed AbbVie Inc. and Abbott Laboratories' Humira arthritis drug to the plaintiff's wife already knew about the medication's risk for serious fungal infections when she prescribed it, even though Abbott didn't send a related warning letter until the following year.
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May 6, 2013
Cancer Drug Kadcyla Must Be Called By Full Name, FDA Says
The U.S. Food and Drug Administration on Monday urged health care professionals and publications to use the full generic name of Genentech Inc.’s breast cancer treatment Kadcyla when referring to the drug, saying use of a truncated name could lead to harmful confusion with another treatment.
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May 6, 2013
Vitacost Beats Suit Over Pre-IPO Disclosures In 11th Circ.
The Eleventh Circuit on Monday upheld the dismissal of a securities class action alleging vitamin retailer Vitacost.com Inc. failed to disclose plans to shake up its profitable manufacturing division before a disastrous $132 million initial public offering, finding the investors couldn’t make their case that Vitacost withheld material information.
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May 3, 2013
Punitive Damage Claims Kept Alive In NuvaRing Bellwethers
A New Jersey state judge on Friday refused to strike down claims for punitive damages in nine bellwether cases over injuries allegedly caused by a Merck & Co. Inc. subsidiary's NuvaRing contraceptive, ruling that the laws of the individual states could allow the awards.
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May 3, 2013
Chum Of Ex-Orioles Player Dodges Insider Trading Charges
California federal prosecutors have dropped their federal insider trading indictment against a man accused with three others, including former Baltimore Orioles third baseman Doug DeCinces, of insider trading on information about Abbott Laboratories' takeover of a medical device company.
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May 3, 2013
Abbott Followed FDA Rules On Humira Updates, Jury Hears
At an Illinois trial over claims that AbbVie Inc. and Abbott Laboratories failed to adequately warn about blockbuster arthritis drug Humira's risks, a regulatory expert testified Friday that Abbott had acted appropriately after the U.S. Food and Drug Administration told it to update information regarding the drug's link to infections.
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May 3, 2013
Ex-Frontier Chemist Dodges Prison For Disclosing Recipes
A Utah federal judge has decided that a former Frontier Scientific Inc. chemist won't face any prison time for sending chemical recipes to India without company authorization, significantly paring a possible five-year prison sentence and more than $160,000 in fines.
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May 3, 2013
Illumina Fails To Shred Syntrix DNA Patent After $96M Verdict
A Washington federal judge on Friday affirmed the validity of a Syntrix Biosystems Inc. patent covering DNA technology that a jury previously found was infringed by competitor Illumina Inc. as part of a $96 million verdict, ruling a claim construction in Syntrix's patent was "sufficiently clear".
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May 3, 2013
Kilpatrick Lures Medical IP Vet Back From Industry Role
Kilpatrick Townsend & Stockton LLP has lured a medical device intellectual property expert back to the firm to serve as a partner in the firm’s Silicon Valley office after serving in several senior industry roles, it said Thursday.
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May 3, 2013
11th Circ. Denies Cert. Appeal In $867M Astellas Antitrust Suit
The 11th Circuit refused Thursday to let a Florida hospital appeal in hopes of winning certification of an $867 million antitrust class action accusing Astellas Pharma Inc. of improperly requiring use of its Adenoscan drug with patented cardiac tests, but the provider intends to soldier on alone.
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May 3, 2013
K-V Pharma Will Pursue Investors' Alternative Ch. 11 Plan
K-V Pharmaceutical Co. on Friday indicated that it is ready to ditch its proposed Chapter 11 plan for an alternative plan offered by a group of investors that could provide general unsecured creditors five times as much recovery as the current plan would.
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May 3, 2013
FDA Stings Gilead For Manufacturing Violations
Gilead Sciences Inc. disclosed Thursday that U.S. Food and Drug Administration inspectors have formally notified the company of manufacturing problems at a California plant, apparently leading the agency to reject the company’s bid for expanded use of certain ingredients in its HIV medicine Stribild.
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May 6, 2013
CORRECTED: Judge Pads Stryker's $4.5M Interest Award In Knee Suit
A federal judge on Friday padded Stryker Corp.’s $4.5 million prejudgment interest award by $75,000 in the company’s suit against XL Insurance America Inc. seeking coverage for litigation over its allegedly defective artificial knee. (Correction: A previous version of this article said the judge reduced the interest award from $4.5 million to $75,000. The error has been corrected.)
Expert Analysis
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What You Should Know About PPACA Reporting Rules
The Centers for Medicare & Medicaid Services recently published new rules on manufacturers' reporting requirements under the Physician Payment Sunshine Act. The act provides unique reporting requirements for those making payments related to clinical and preclinical research, and manufacturers may want to analyze their relationships to prepare for the data collection start date, say attorneys with Duane Morris LLP.
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And Now A Word From The Panel ...
One of the most fascinating facets of watching the Judicial Panel on Multidistrict Litigation is trying to guess not simply whether an MDL will be created, but where it will be located. Take, for example, In re Mirena IUD Products Liability and Marketing Litigation, slated to be heard at the March 21 hearing, says Alan Rothman of Kaye Scholer LLP.
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Current Trends In FDA's Good Manufacturing Enforcement
An analysis of recent warning letters and inspectional observation data reveals that most products that the U.S. Food and Drug Administration alleges are "adulterated" actually work as intended, and most warning letters are not reactions to product failures. Rather, the bulk of the warnings reflect the FDA’s increasing focus on the processes and procedures intended to prevent defects, says Jonathan Berman of Jones Day.
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What Litigators Must Know About Va.’s 'Rocket Docket'
Do not be lulled into a false sense of complacency by the formality, civility and, in some cases, old-fashioned Southern charm of the U.S. District Court for the Eastern District of Virginia. Cases usually move with lightning speed, handled by efficient, polite, but no-nonsense jurists and courtroom deputies. There are many traps for the unwary, say Robert Tata and Wendy McGraw of Hunton & Williams LLP.
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Reading Tea Leaves After Amgen
The fascinating aspect of the U.S. Supreme Court ruling in Amgen Inc. v. Connecticut Retirement Plans and Trust Fund is that four of the justices questioned the continued vitality of the “fraud-on-the-market” presumption, recognized in the 1988 case Basic Inc. v. Levinson, without which securities fraud class actions cannot proceed, say Paul Bork and Matthew Baltay of Foley Hoag LLP.
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How FDA Differs From CMS In Clinical Lab Test Oversight
Since the U.S. Food and Drug Administration has expressed interest in regulating diagnostic tests used in providing personalized medicine clinical care, stakeholders have weighed in on whether the agency should expand its jurisdiction, resulting in significant differences of opinion — especially when the outcome of a test impacts pharmacological intervention, says Antoinette Konski of Foley & Lardner LLP.
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The Outer Limits Of Expert Testimony Gatekeeping
The Delaware Supreme Court is set to hear oral argument in Tumlinson v. Advanced Micro Devices Inc., one of 25 cases in which employees of AMD have alleged that their work in "clean rooms" exposed them to chemicals that resulted in their children's birth defects. This case demonstrates the key gatekeeper role courts must play in admitting expert testimony based on epidemiological studies, say attorneys with Gibson Dunn & Crutcher LLP.
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Remember To Pay Attention To Antitrust Standing Issues
The importance of the Third Circuit's opinion in Ethypharm SA France v. Abbott Laboratories lies not just in the court’s affirmation of the multifactor test typically used to analyze antitrust standing, but in the court’s analysis of how the regulatory framework in the pharmaceutical industry plays a role in analyzing the antitrust standing of participants in that industry, say attorneys with Pepper Hamilton LLP.
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A Bitter Loss For POM Signals More FTC Scrutiny
Recently, the Federal Trade Commission released its much-anticipated decision in In the Matter of POM Wonderful LLC, upholding that POM Wonderful deceptively advertised its products. While it is likely that POM will file an appeal of the commission's decision, the opinion sends a strong signal that the FTC may begin requiring a heightened standard of substantiation for marketers, say attorneys with Crowell & Moring LLP.
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Getting The Wrinkles Out Of Anti-Aging Products
Lately, the cosmetics industry — particularly with respect to anti-aging products — has been a popular target for both the U.S. Food and Drug Administration and plaintiffs. Since the cosmetics industry may remain a target for some time, there are steps that companies should take to help avoid FDA warning letters and prepare for the possibility of class action litigation, says Isabella Lacayo of Weil Gotshal & Manges LLP.