The U.S. Food and Drug Administration on Tuesday updated safety information for a video tube made by Pentax Medical, warning cracks and gaps in the device can lead to an increased risk of infection.
Pharmaceutical giant Eli Lilly and Co. has agreed to buy migraine treatment developer CoLucid Pharmaceuticals Inc. for roughly $960 million, the companies said Wednesday, in a deal guided by legal advisers Weil Gotshal & Manges LLP and Faegre Baker Daniels.
A lawyer for Bio-Rad Laboratories Inc.’s ex-general counsel told a California federal jury during opening arguments in his retaliation suit Tuesday that the company fired him for blowing the whistle on its Foreign Corrupt Practices Act compliance in China, while Bio-Rad countered that he was an ill-tempered lawyer terminated for incompetence.
McKesson Corp. has agreed to pay a record $150 million penalty to settle U.S. Department of Justice allegations that the pharmaceutical drug distribution giant violated the Controlled Substances Act by filling millions of orders for drugs, including highly addictive opioids, without sufficient anti-abuse safeguards, the department announced Tuesday.
A stem cell therapy provider accused of wrongfully marketing and selling stem cell treatments to patients nationwide told a California federal judge Monday to scrap the proposed fraud class action, calling it nothing more than a “fishing expedition.”
The U.S. Food and Drug Administration’s long-awaited guidance on biosimilar interchangeability contains lots of flexible language that means the coveted designation could be much more attainable for some products than others, experts say. Here are three takeaways from Tuesday’s draft guidance.
The Florida Department of Health on Tuesday published its initial proposed rule for a medical marijuana program, taking a step toward implementing the recently passed Amendment 2 but creating controversy by charting a course closer to existing law than the broader guidelines voters overwhelmingly passed in November.
Stryker Corp. has been slapped with a whistleblower lawsuit in New Jersey state court by a former specialist alleging that he was fired about a year ago for refusing to perform surgeries without supervision or the certification needed to conduct the procedures on his own.
Warner Chilcott PLC and other defendants in multidistrict litigation challenging alleged pay-for-delay settlements over contraceptive Loestrin moved Friday in Rhode Island federal court to force a group of buyers to give up information that may shed light on whether the drug is a market unto itself.
Allergan has agreed to pay a $15 million fine and admit wrongdoing for failing to disclose it was negotiating a potential acquisition and white knight offer with Actavis in efforts to escape a hostile takeover from Valeant and Pershing Square, the U.S. Securities and Exchange Commission said Tuesday.
Biogen Inc. on Tuesday agreed to pay $1.25 billion to Forward Pharma A/S so it can license all of the Danish company’s intellectual property, as the two companies continue to battle in U.S. and European courts over patents related to multiple sclerosis drugs.
Seven companies launched initial public offerings totaling $1.7 billion on Tuesday, led by an estimated $650 million IPO from private-equity-backed oil and gas explorer Jagged Peak Energy, joined by two manufacturers and a bevy of smaller biotechs in the year's first burst of deals.
The U.S. Food and Drug Administration's foreign drug inspection program is persistently understaffed despite overall improvements to the program in recent years, the U.S. Government Accountability Office said in a report released Tuesday.
After more than three years of litigation in the wake of the U.S. Supreme Court's landmark pay-for-delay ruling, 2016 saw a slew of appellate opinions over the scope of the antitrust scrutiny patent settlements can face. Here are the cases to watch in the year ahead.
Medical device manufacturer Zimmer Inc. shirked its responsibility to warn doctors who use its knee replacement products about their potential to fail in obese patients, a jury in Illinois federal court was told Tuesday at the start of trial for a lawsuit over the claim.
The U.S. Supreme Court on Tuesday denied an appeal by a Johnson & Johnson unit that had asked it to end a four-way circuit split over when an expert’s false testimony should justify a new trial in a case over the alleged infringement of a Rembrandt Vision contact lens patent.
The newest deal team to join Dechert LLP’s Hong Kong office clocked a busy first two weeks, with the team of former Cadwalader Wickersham & Taft LLP attorneys sealing five separate transactions.
The Seventh Circuit on Friday threw out one of the many cases alleging Bayer Corp.’s birth control pill Yasmin causes blood clots because the attorneys running the case admittedly did "mostly nothing" for a year and a half.
The U.S. Food and Drug Administration released final guidance Thursday outlining what factors it considers when evaluating applications from medical device makers who want to start testing in humans.
A Florida federal judge on Friday declined to sanction the husband of one of the Federal Trade Commission’s key witnesses in the agency’s false advertising suit against diet pill maker Roca Labs after the company said he failed to respond to a subpoena, concluding that reasonable efforts to comply were made.
Every year, statistics reveal very little change in the number of women and minorities in the ranks of partnership. So how do law firms change this painfully slow rate of progress? It takes more than adding a diversity policy or a women’s leadership program to the current law firm business model, says Lucia Chiocchio, co-chair of Cuddy & Feder LLP's telecommunications and land use, zoning & development groups.
While 2016 marked one of the least productive years in the history of Congress, the same cannot be said of health care enforcement and regulatory agencies. Perhaps motivated by the impending change in administration, these agencies promulgated a number of notable regulations in 2016, say attorneys at Mintz Levin Cohn Ferris Glovsky and Popeo PC.
Following the U.S. Supreme Court's decision in Halo last year, district courts have taken diverging approaches to the pleading requirements for willful infringement. Some courts set a relatively low bar, and others set a relatively high bar, say Natalie Hanlon Leh and Michael Silhasek of WilmerHale.
The U.S. Food and Drug Administration recently announced the public release of data on adverse events related to cosmetics and foods. The data include reported negative reactions or complaints related to products, and do not indicate a determination of fault by the FDA. But the release could still lead to an increase in litigation, say Joanne Hawana and Daniel Herling of Mintz Levin Cohn Ferris Glovsky and Popeo PC.
Our first article in this two-part series focused on the most significant event in trade secret law in many years — the passage of the federal Defend Trade Secrets Act. Now we leave the DTSA and highlight five other trade-secret trends that promise to shape future developments, say attorneys with Faegre Baker Daniels LLP.
Bad cases make bad law, but egregiously overreaching cases can make good law. In Wallis v. Brainerd Baptist Church, decided recently by the Tennessee Supreme Court, a dead man's estate sued the seller of a defibrillator that was available but not used on the decedent during his heart attack. Imposing liability in such circumstances would be bad public policy, says Eric Alexander of Reed Smith LLP.
After a full year in effect, the amended Federal Rule of Civil Procedure 37(e) has been tested in a variety of district courts. A sampling of these decisions reveals that courts seem to be adhering closely to the amended rule and ordering adverse inference instructions only where there was intent to deprive another party of access to relevant information, say Carrie Amezcua and Samantha Southall of Buchanan Ingersoll & Rooney PC.
In 2016, courts around the country heard cases involving a variety of False Claims Act and other enforcement-related matters. Going forward these case law developments are expected to have an impact on both the scope of FCA liability and the means by which FCA liability can be proven at trial, say attorneys at Mintz Levin Cohn Ferris Glovsky and Popeo PC.
To date, questions about how the Trump administration will impact the Federal Trade Commission have focused primarily on antitrust issues, but clues to how the new administration will affect consumer protection issues might be found by examining the record of former Commissioner Joshua Wright, whom Trump has named to lead the FTC transition efforts, say attorneys at Skadden Arps Slate Meagher & Flom LLP.
Many organizations are interested in finding electronic discovery partners who offer tantalizingly low prices for electronic discovery services. However, unforeseen gaps, lax security practices, ignorance of global practices and delayed deliverables can all add up to a surprisingly large final cost, says Michael Cousino of Epiq Systems.