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Life Sciences
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March 27, 2013
Merck Atty's Letter Ruled Harmless In Whistleblower's Suit
A Pennsylvania federal judge Friday tossed defamation claims levied at Merck & Co. Inc. and an in-house lawyer by a former employee of a Merck contractor, finding that a statement by the attorney had caused no harm.
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March 27, 2013
Walgreen, Insurer End Avastin Eye Injury Coverage Suit
A Florida federal judge on Tuesday dismissed a lawsuit by Western Heritage Insurance Co. alleging it doesn't have to defend Walgreen Co. and others in eye injury lawsuits related to Genentech Inc.'s cancer drug Avastin, after the parties reached a settlement.
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March 27, 2013
Doc Gets 6 Years, To Pay $4.5M For Fen-Phen Settlement Fraud
A doctor convicted in Pennsylvania federal court of scamming money out of a massive Wyeth Pharmaceuticals Inc. class-action settlement fund set up to compensate users of fen-phen diet drugs was sentenced to six years in prison Tuesday.
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March 26, 2013
Human Genome, GSK Dodge Lupus-Drug Suicide Suit
A Maryland federal judge on Tuesday dismissed a consolidated securities class action accusing Human Genome Sciences Inc. and GlaxoSmithKline PLC of concealing suicide risks associated with lupus drug Benlysta, saying the plaintiffs had failed to show the companies purposefully hid reported suicides from investors.
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March 26, 2013
Pfizer Wins Promotion Contract Row In Pa. Appeals Court
A Pennsylvania appeals court found Monday that Pfizer Inc. is entitled to an extension in a multiple sclerosis drug promotion agreement it inked with EMD Serono Inc., saying the agreement is valid even though the drug's U.S. Food and Drug Administration approval fell through.
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March 25, 2013
Chinese Vitamin Cos. To Pay $23M To Settle Price-Fixing Plot
Weisheng Pharmaceutical Company Ltd. and its parent, China Pharmaceutical Group Ltd., agreed to pay $22.5 million and comply with any injunction issued against any co-defendant to settle price-fixing claims for vitamin C after dropping out of a class-action trial in New York federal court that walloped their co-defendants with a $54.1 million penalty.
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March 25, 2013
Okla. Device Ruling Puts Other Products In Crosshairs
The Oklahoma Supreme Court recently held that a medical device maker can be found negligent for a plaintiff's injury under state law simply for violating federal regulations, a groundbreaking decision that attorneys said Monday could be interpreted to apply to any federally regulated product, including food and cars.
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March 25, 2013
Plaintiffs Attys Say Sky's Not Falling After CAFA Ruling
Plaintiffs' attorneys see no reason to weep over the U.S. Supreme Court's recent ruling that individuals who bring class actions can't cap damages to dodge federal jurisdiction, telling Law360 that the decision trumpeted by the defense bar over the past week isn't actually a game changer.
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March 25, 2013
NJ Panel Refuses To Revive Fosamax 'Jaw Death' Suit
A New Jersey appeals court on Monday refused to revive the case of a woman who claimed Merck Sharp & Dohme Corp.'s osteoporosis drug Fosamax caused her to develop osteonecrosis of the jaw after a tooth extraction, rejecting her argument that the trial judge had wrongly excluded evidence.
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March 25, 2013
Lasik For Farsightedness Not Illegal Experiment: 9th Circ.
The Ninth Circuit on Monday ruled that Nidek Co. Ltd. and several doctors didn't break the law when they used Nidek's surgical eye laser for Lasik procedures to correct farsightedness, ruling that the procedures don't constitute prohibited medical experiments even though they haven't been approved by the U.S. Food and Drug Administration.
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March 25, 2013
Judge Stands By Decision Preempting DC Defamation Law
A Washington federal judge ruled Friday that the District of Columbia hadn't properly challenged his decision that federal law preempted a local law blocking frivolous defamation suits, reached in a 3M Co. suit over intimidation tied to a derailed medical testing device.
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March 25, 2013
Watson Can't Skirt Shire's Colitis Drug Patent Suit
A Florida federal judge on Thursday declined to rule outright that Irish drugmaker Shire Development LLC’s patent for its ulcerative colitis drug Lialda was invalid, rejecting an attempt by Watson Pharmaceuticals Inc. to have the court clear the way for its generic version of the drug.
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March 25, 2013
Actavis, AstraZeneca Settle Crestor Generic Suit
Actavis Inc. and Egis Pharmaceuticals PLC have reached an agreement with AstraZeneca UK Ltd. and Shionogi & Co. Ltd. to end Delaware patent litigation over a planned generic version of blockbuster cholesterol-reducing drug Crestor, the companies announced Monday.
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March 22, 2013
Pfizer Settles With EPA On $205M NJ Superfund Cleanup
A Pfizer Inc. subsidiary has agreed to cover oversight costs in the $205 million cleanup of contaminated soil and groundwater at the American Cyanamid Superfund site in Bridgewater Township, N.J., the U.S. Environmental Protection Agency said Thursday.
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March 22, 2013
Doc Testimony Over Discontinuing NuvaRing Axed From MDL
A Missouri judge on Friday rejected a doctor's testimony arguing the contraceptive NuvaRing should be pulled from the market, but refused to exclude future testimony to that effect in the sprawling product liability multidistrict litigation against a Merck & Co. Inc. subsidiary.
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March 22, 2013
DC Circ. Defers To FDA In Stem Cell Device Marketing Row
The D.C. Circuit on Friday backed the U.S. Food and Drug Administration’s denial of expedited marketing approval for two Cytori Therapeutics Inc. devices that harvest stem cells from fat tissue, saying the court is ill-equipped to second guess the agency’s scientific decisions.
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March 22, 2013
Nordion Settles Dr. Reddy's $80M Negligent Testing Suit
Medical equipment and research company Nordion Inc. said Thursday it has agreed to settle a lawsuit in New Jersey federal court in which Dr. Reddy’s Laboratories Inc. claimed poor testing conditions at a Nordion unit’s laboratories cost it more than $80 million in retesting and delayed and abandoned generic drug approvals.
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March 21, 2013
Ky. Disbars Stanley Chesley Over $200M Fen-Phen Settlement
The Kentucky Supreme Court on Thursday permanently disbarred prominent class action attorney Stanley Chesley over his involvement in an attorney fee scheme that garnered a small group of lawyers 49 percent of a $200 million fen-phen settlement.
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March 21, 2013
11th Circ. AndroGel Decision Bolsters FTC Pay-For-Delay Case
The Eleventh Circuit on Thursday refused a bid by an Abbott Laboratories subsidiary to seal a proprietary financial analysis for its AndroGel drug, a decision that allows the Federal Trade Commission to use the document in its U.S. Supreme Court challenge to so-called pay-for-delay settlements.
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March 21, 2013
Illumina Beats Life Tech DNA Patent Infringement Claims
Illumina Inc. has not infringed three patents related to DNA amplification technology licensed by a subsidiary of genetic testing company Life Technologies Corp., a California federal judge ruled Wednesday.
Expert Analysis
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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.
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Takeaways From FDA's 1st Waiver Decision
Recently, the U.S. Food and Drug Administration, for the first time, approved two generic drugs with a risk evaluation and mitigation strategies program that differed from the innovator company’s existing program. Going forward, the pharmaceutical industry should keep watch of future waiver decisions to elucidate the burden-versus-benefit analysis that the agency utilized in its decision, say attorneys with Morgan Lewis & Bockius LLP.
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EU Food Business Operators Still Have A Lot To Chew Over
While the new guidelines of the European Commission on food-related health claims offer some welcome clarifications, they do not resolve the existing ambiguities and potential for inconsistent enforcement by the European Union member states. Food business operators will therefore continue to face considerable uncertainty in the EU market, say attorneys with Sidley Austin LLP.
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More FDA Detention Slips For Food Cos.
Recently, the U.S. Food and Drug Administration issued two proposed rules on preventive controls and produce, spelling out its administrative authority to detain food. Nearly all food is now subject to being detained, regardless of whether it enters interstate commerce, and it's likely that the agency will further expand the bases for its detention authority, say attorneys with Crowell & Moring LLP.
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A Look At The Health Care M&A Horizon
Factors such as the Affordable Care Act’s payment reforms, downward pressure on costs, enhanced focus among payers on outcomes and quality, and expanded Medicaid roles will continue in 2013 to influence M&A activity across industry sectors, increase regulatory and compliance costs, and provide additional incentives to federal and state agencies to boost enforcement efforts, say attorneys with Skadden Arps Slate Meagher & Flom LLP.
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A New Trend In Health Care Fraud Settlements
For the first time, companies have been placed on probation, under the supervision of federal courts and the U.S. Department of Justice, as part of health care fraud settlements. Companies may be exposed to more significant criminal penalties when the terms of a corporate integrity agreement are imposed as conditions of probation, say Jack Cinquegrana and Consuelo Valenzuela Lickstein of Choate Hall & Stewart LLP.