The federal government said the Federal Circuit got it wrong when it concluded that biosimilar makers can’t give a 180-day notice of sales to rivals until a product is approved, telling the U.S. Supreme Court the ruling inserted a limit that didn’t exist in the law.
An Illinois federal judge on Thursday tossed a wrongful death suit brought by siblings who claimed their mother’s death from sepsis was caused by an allegedly defective C.R. Bard hernia patch, finding that one expert’s opinion wasn’t reliable and that they hadn’t shown another was qualified.
Shareholders in medical aesthetics company Cynosure Inc. filed suit in Massachusetts federal court Friday to halt the company’s proposed $1.44 billion sale to Hologic Inc., saying they don’t have enough information to ensure the cash purchase is a good deal.
The U.S. Department of Agriculture’s animal health department must have been channeling George Orwell’s "1984" when deciding to pull down records of inspection reports and enforcement actions in animal welfare cases, according to a California federal suit Thursday aimed at getting the data back online.
The Patent Trial and Appeal Board on Thursday invalidated two patents for the Anacor Pharmaceuticals Inc. toenail fungus treatment Kerydin, delivering a victory to the Coalition for Affordable Drugs, an organization started by hedge fund manager Kyle Bass.
A New York federal judge held Friday that U.S. Specialty Insurance Co. doesn't have to cover Catalent Inc.'s claim for more than $10 million in losses due to a five-month suspension of softgel capsule manufacturing at its facility in France, finding that no covered loss occurred within the terms of the pharmaceutical company's policy.
The use of complex algorithms to sort through massive amounts of health data to improve medical care, or "black-box medicine," could expose providers to a new world of malpractice claims, experts say, and doctors may decline to adopt the technology without legal protections.
Medtronic Inc. has been slapped with a lawsuit in New Jersey state court by a woman alleging that a company representative did not properly consult a doctor on the insertion of a device to treat urological issues, saying she was forced to undergo surgery to fix the improper placement.
Squire Patton Boggs LLP has brought in a health care and life sciences partner from the federal government, Lando & Anastasi LLP has hired three new patent agents and Barnes & Thornburg LLP has added a health care partner from Krieg DeVault LLP.
A cancer survivor suing Johnson & Johnson over the alleged role of its talcum powder in her disease told a Missouri jury Thursday that she has been “shocked” over the past few days to learn key details about the tumor she had removed in 2013, like the stage it had reached and the fact that it could return.
Bio-Rad Laboratories Inc. on Thursday agreed to pay $3.5 million in attorneys’ fees and costs to the team that represented former general counsel Sanford Wadler in his $8 million jury win in a retaliation suit arising from whistleblowing on potential Foreign Corrupt Practices Act violations.
A New York federal judge dismissed without prejudice on Thursday a breach of contract suit brought by startup investment company Microbanc Inc. against medical device maker InspireMD Inc., finding that InspireMD never agreed in writing to pay Microbanc a finder's fee for a $24 million investment.
Officers and directors at Spectrum Pharmaceuticals Inc. were hit with a shareholder derivative action in Delaware federal court on Thursday alleging they harmed investors and the company with a new drug application for a bladder cancer treatment drug filed in defiance of U.S. Food and Drug Administration advice.
A shareholder alleging generic-drug maker Impax Laboratories Inc. failed to disclose to investors a federal investigation over possibly collusive market activity has dropped his proposed class action in New Jersey federal court because a similar action is pending in California.
Guaranteed Returns on Wednesday urged a Pennsylvania federal court to tell a jury that puffery or sales talk is not fraud, in the midst of a trial alleging that the company — which helps the government and providers return expired drugs — stole $116 million worth of refunds from pharmaceutical manufacturers.
A Delaware Chancery Court judge has appointed Andrews & Springer LLC and Gainey McKenna & Egleston to represent CytRx Corp. investors in a derivative action accusing the biopharmaceutical company’s board of sanctioning a brazen stock-pumping scheme, calling their complaint “superior” to another in the consolidated suit.
Ex-Valeant Pharmaceuticals International Inc. executive Gary Tanner and former Philidor Rx Services LLC CEO Andrew Davenport on Thursday in Manhattan federal court denied charges that they participated in a $40 million merger fraud and kickback scheme.
Law360 is pleased to announce the formation of its 2017 Life Sciences editorial advisory board.
Braeburn Pharmaceuticals Inc., a commercial-stage biotech company developing a drug to treat opioid addiction, formally pulled an estimated $150 million initial public offering Wednesday, saying public markets are currently unattractive, echoing a common concern among life science issuers.
A Nevada woman claimed Wednesday she suffered high blood pressure, an eye injury and other side effects from Merck & Co.’s Zostavax shingles vaccine in what appears to be the first suit over the inoculation in Philadelphia’s Court of Common Pleas.
Presidential adviser Kellyanne Conway's TV appearances provide some examples of what lawyers should and shouldn't do when speaking to the media, says Michelle Samuels, a vice president of public relations at Jaffe.
We all recognize that cutting or copying text from earlier works and pasting it into new documents saves attorneys time. However, with this increase in speed comes an increased risk of making, or not catching, errors, says Robert Lang of D’Amato & Lynch LLP.
Because the Affordable Care Act was upheld by the U.S. Supreme Court as a tax law, its repeal would entail a $1.1 trillion tax revenue loss over 10 years. Based on the direction that the Republicans take in crafting their replacement bill and what portions of the ACA will be repealed, individuals and corporations could be looking at drastic tax changes, say Michael White and Eddie Geraghty of M. White & Associates LLC.
Detractors of litigation funding have strained to characterize a recent decision from a California federal court as significant headway in their crusade against the litigation funding industry. However, in truth, this is a victory for both the industry and those in need of capital to bring meritorious claims against wrongdoers in an often prohibitively expensive legal system, say Matthew Harrison and Priya G. Pai of Bentham IMF.
A lesson for practitioners from the Federal Circuit's recent decision in Shire v. Watson is to use the Markush style of claim drafting with caution, such as only when truly necessary, for example, to avoid prior art, say attorneys with Finnegan Henderson Farabow Garrett & Dunner LLP.
Consumers harmed by medical devices often find themselves wronged but without relief, thanks to federal preemption. But President Donald Trump’s regulatory rollback could backfire against device manufacturers — and confer an unexpected benefit on plaintiffs — by weakening the U.S. Food and Drug Administration's oversight process and thus fortifying plaintiffs' state claims against federal preemption, says Benjamin Lajoie of Bailey & Glasser LLP.
Not surprisingly, many different views emerged at this year's J.P. Morgan Healthcare Conference on the future state of the Affordable Care Act and what it would mean for investors. After a long and seemingly endless cycle of election analysis, we’re happy to report some deal trends and predictions of our own, say attorneys with McGuireWoods LLP.
Can jurors grasp the role of genetics in personal injury claims alleged to arise from exposure to specific chemicals? A recent asbestos trial featured a discussion of the plaintiff's genetic mutations as a factor in her mesothelioma. Trial lawyers should be thinking about how juries understand cancer, genetics and disease causation, say David Schwartz of Innovative Science Solutions and Kirk Hartley of LSP Group LLC.
The Delaware Supreme Court's recent decision in Volcano Stockholders Litigation is consistent with the Delaware courts’ continued expansive interpretation of the seminal Corwin v. KKR Financial decision, which has resulted in a strong trend of early dismissal of post-closing damages actions challenging noncontroller M&A, say attorneys with Fried Frank Harris Shriver & Jacobson LLP.
The European Union's General Data Protection Regulation will considerably increase the sanctions and penalties that can be imposed on organizations that breach its requirements. The implications for organizations operating in the life sciences and health care sectors are likely to be particularly far-reaching, say attorneys with Ropes & Gray LLP.