Manufacturers Pharmaceutical Industry

News & Analysis as of

Opportunities for Increased Drug Sales to the VA

Pharmaceutical manufacturers that produce drugs in non-designated countries under the Trade Agreements Act (TAA) may now have an opportunity to increase their sales to the United States government. The Department of Veterans...more

Trimming Some Fat From Statin Litigation With Daubert and Preemption

In the mythical days of product liability yore, a big drug litigation was spurred by a notable event—like a study describing a new risk appearing in a major journal, a significant labeling change because of new or greater...more

Massachusetts Enacts First-in-Country Opioid Take Back Law

On March 14, 2016, Governor Charlie Baker of Massachusetts signed a bill entitled “An Act Relative to Substance Use, Treatment, Education and Prevention.” This legislation contains multiple provisions designed to control...more

Are Drug Prices Really Too High?

Those working in the pharmaceutical space are used to hearing complaints about the high costs of drugs, and patents often are blamed for allowing pharmaceutical companies to charge “too much” for their products. But are drug...more

Benesch’s 2nd Annual 3D Printing Seminar (A Summary Repeat)

Several hundred business leaders, engineers, attorneys and academics gathered last week for an annual symposium on 3D Printing hosted by Benesch, Friedlander, Coplan & Aronoff. The ability to form physical objects from...more

Follow the Data: FDA Addresses cGMPs for Data Integrity Issues in Draft Guidance

The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies. In recent years, issues involving the integrity of and controls around manufacturing data...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose

In third party payor litigation over prescription medical products, we have often marveled at the causation arguments that plaintiffs have offered and the willingness of some courts to accept collective proof over what really...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

CMS Delays Enforcement of Medicaid AMP Rules for 5i Drugs until July 1, 2016

CMS has announced that it is delaying until July 1, 2016 enforcement of new rules regarding the determination of the average manufacturer price (AMP) for inhalation, infusion, instilled, implanted or injectable drugs (“5i...more

FDA Biosimilars Guidance Not Conducive To Preemption

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...more

Some Good Georgian Res Judicata

Usually, when res judicata comes up in our cases, we are trying to fend it off. Luckily, non-mutual offensive res judicata is rarely recognized, so plaintiffs usually fail when trying to preclude the drug or device...more

Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory

We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard...more

Controlled Substances Act Regulation Legislation Approved by Senate

The Senate recently approved an amended version of S. 483, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. The bill, which was approved on March 17, 2016, would clarify the standards an applicant to...more

Another Outlier From California On Innovator Liability

We have closely followed the development (or perhaps more accurately, stagnation) of so-called “innovator liability.” It started with the wrongly reasoned and wrongly decided opinion from the California Court of Appeal in...more

MDL Decision Debunking the Pendent Jurisdiction Fallacy Post-Bauman

Spring seems to be finally here in the mid-Atlantic region and we could think of nothing better to usher in spring than some personal jurisdiction and procedural wrangling. Every year, we see new cases with multiple...more

The Renaissance of the Learned Intermediary Rule

Our recent “breaking news” post on West Virginia’s statutory restoration of the learned intermediary rule started us thinking about how every state now has pro-learned intermediary precedent. That’s a big change even from...more

Ninth Circuit Holds that Therapist was Fraudulently Joined

If Sunday night’s Academy Awards show has propelled you towards your nearest movie theater to catch up on the nominated flicks and winners, put The Revenant on the top of your list if you have not already seen it. Most of...more

Breaking News - West Virginia Statute Adopts Learned Intermediary Rule

The West Virginia legislature has passed, and the governor signed, S.B. 15, adopting the learned intermediary rule on February 26, 2016. ...more

New FDA Draft Guidance On Medical Devices Would Notify Public Of Risk Before Analysis Or Confirmation

On December 31, 2015, the FDA released a draft policy which would alter how and, more significantly, when the public is notified of a potential risk associated with a medical device that has already been approved for the...more

Health Law Alert: Pharmacies and Prescription Drug Dispensers...Are You Ready for The March 1, 2016 DSCSA Compliance Deadline?

In order to improve drug security throughout the supply chain, and to facilitate drug recalls and to address drug importation, diversion, and counterfeiting, Congress passed the Drug Supply Chain Security Act (the "DSCSA")....more

Remembering Scalia, Remembering Riegel

For the second time in a week we are considering a former professor at our law school, though this occasion swims in sorrow. Before he became a Justice on the Supreme Court, before he became a Judge on the DC Circuit, Antonin...more

Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

It is not often that we get the opportunity to discuss an opinion from a panel of judges including two former professors from our law school. Diane Wood is the Chief Judge of the 7th Circuit and taught us Civil Procedure at...more

Competition/antitrust law

Focus on the US - Cartel enforcement activity and stiffer criminal penalties against price fixing - The Department of Justice (DOJ) continues to investigate and seek criminal charges against worldwide cartels. This...more

Injunctive Relief Claims Lead to Defense Opportunities

It’s not all that common, but every now and then our opponents feel their oats and seek injunctive relief – usually against the continued marketing of an FDA-approved product. A state-law plaintiff seeking such injunctive...more

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