OIG Issues Rare Special Fraud Alert Targeting Pharmaceutical and Medical Device Speaker Programs

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on fraud and abuse risks “associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies.” The OIG generally defines speaker programs as company-sponsored events at which a physician or other health care professional (HCP) “makes a speech or presentation to other HCPs about a drug or device product or a disease state” on behalf of a manufacturer.…
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FDA Approves First COVID-19 Drug: Veklury

The Food and Drug Administration (FDA) approved the first drug for the treatment of COVID-19. The antiviral drug Veklury (remdesivir), manufactured by Gilead Sciences Inc., is approved for use in hospitalized adult and pediatric patients 12 years of age and older. Veklury was previously issued as an emergency use authorization (EUA) in May 2020 following the National Institutes of Health’s clinical trial, which showed promising results in battling COVID-19. Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial…
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From One to Five: A “Snapshot” Look at the Breakthrough in the Scheduling System for Cannabis Based Medication

Medical use? Recreational Use? Federal vs. State? These are many of the common questions and concerns your average patient has with respect to cannabis today and the answer isn’t quite as clear as we would like it to be; however, there is a linguistic trend steering towards the term “medicated” to replace, the pejorative, “high” for cannabis users seeking medical relief. Notwithstanding, this re-branding and imaging of cannabis, the basis for much of this confusion is the Controlled Substances Act. As a refresher, cannabis is…
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Issues Abound in Cannabis Cultivation – What Can We Expect

When cannabis began its march towards legalization, both medically and recreationally, there were many mistakes made by state agencies issuing licenses for cultivation, manufacturing and dispensing. This was the result of self-imposed deadlines, no clear path how to go about deciding who “wins” a license and who does not and various legal hurdles concerning everything from zoning to security for facilities. And as always, let’s not forget the Federal Government’s continued ban on cannabis as a Schedule I substance. Many believe other countries throughout the…
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Superior Court of Pennsylvania Issues Ruling Addressing Multiple Issues in Pharmaceutical Case

In an opinion filed January 8, 2018, Pennsylvania’s intermediate appellate court addressed multiple issues arising after a plaintiff’s verdict in a case from the In Re: Risperdal Litigation. The issues the court addressed are discussed below. Initially, the court, citing Frye, reiterated that in Pennsylvania, a party wishing to introduce novel scientific evidence must demonstrate that the relevant scientific community has reached general acceptance of the principles and methodology employed by the expert witness to testify regarding his conclusions. However, the conclusions themselves…
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Third Defense Verdict in Xarelto Litigation

On Friday, August 18, 2017, a federal jury in Mississippi rendered a defense verdict in favor of Janssen Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc. in a bellwether trial involving the prescription blood thinner Xarelto. The plaintiff alleged Xarelto caused gastrointestinal bleeding resulting in her hospitalization. Federal District Court Judge Eldon E. Fallon presided over the case. Notwithstanding the claims and evidence presented by the plaintiff, a jury returned what is now the third straight defense verdict for Janssen and Bayer in several bellwether trials…
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The FTC has its Eyes on Biotech for Antitrust Enforcement

On July 27, 2017, representatives of the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) gave coordinated testimony to Congress that ought to raise alarm bells for pharmaceutical companies. Scott Gottlieb, Commissioner of the FDA, and Markus Meier, Acting Director of the Bureau of Competition at the FTC, both testified before the House Judiciary Committee’s Subcommittee on Regulatory Reform Commercial and Antitrust Law. Their statements announced a renewed coordination between the respective agencies with a goal to increase competition in the pharmaceuticals market…
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New Jersey, (Mass Actions) & You — Still Perfect Together?

Earlier this month, we wrote about a choice-of-law decision from the New Jersey Supreme Court that we believe will invite more out-of-state plaintiffs to forum-shop and file suit in New Jersey. This prospect of increased “litigation tourism” brought to mind the old New Jersey tourism slogan “New Jersey and You – Perfect Together.” It also brought to mind that New Jersey’s state-law version of an MDL — the New Jersey Multicounty Litigation program — remains a favorite vehicle for plaintiffs and their lawyers to pursue…
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Pharma Opioid Suits Casting a Wider Net

Under both federal and state law, it is unlawful to advertise if the advertisement tends to mislead or deceive. States have enacted consumer protection laws to enforce and regulate such deceptive practices. In New York, under General Business Law §349, deceptive acts or practices in the conduct of any business, trade, or commerce, or in the furnishing of any service in the state, is declared unlawful. Over the years, the Federal Trade Commission has prosecuted many businesses accused of engaging in false and deceptive advertising.…
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Developments in Depakote Litigation as Illinois Federal Jury Returns $15 Million Verdict

In the sixth case to go to trial over Depakote, a drug used to treat seizures and bipolar disorder, a federal jury in the Southern District of Illinois returned a $15 million verdict earlier this month. Earlier trials in federal courts in Ohio and Illinois resulted in defense verdicts, but a state jury in Missouri previously awarded $38 million to a group of 25 plaintiffs. This most recent trial addressed the claims of one of the lead plaintiffs in a mass action numbering over 600…
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