News & Analysis as of

Failure To Warn

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

Reversal of $48 Million Product Liability Verdict Required Due to Inconsistent Jury Findings on Failure to Warn Claims and...

In Trejo v. Johnson & Johnson, et al. (No. B238339, filed 6/30/2017), the California Second Appellate District held, among other things, that the jury’s finding that defendant was liable for negligent failure to warn was...more

Federal Court Rules Spearin Doctrine Contractor Immunity for Defects in Owner's Design Includes Contractor's Failure to Warn Owner...

by Pepper Hamilton LLP on

The legal doctrine of implied fitness of design warranty, recognized by the U.S. Supreme Court, provides that a contractor bound to build according to plans and specifications prepared by an owner will not be responsible for...more

Tenth Circuit Finds Citizen Petition Denial to be "Clear Evidence" of Conflict Preemption

A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more

Fourth Circuit Punts West Virginia Innovator Liability Issue

by Reed Smith on

We have two posts on innovator liability that we update on a consistent basis: our innovator liability scorecard, and our “Innovator Liability at 100” state-by-state collection of materials that we originally compiled when...more

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

Kentucky Trial Court follows U.S., not Kentucky, Supreme Court Precedent to Hold that Claims Against Investigational Device Were...

by Reed Smith on

It is quite unusual for a state trial court to depart from that state’s highest court precedent. But consider that old Hebrew National frankfurter advertising campaign: “We answer to a higher authority.” If the United...more

N.D. Alabama Issues Mixed Bag of Branded Preemption Rulings

by Reed Smith on

We like bright lines in the law. They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their affairs with some degree of predictability. Rear-end a car and you’re liable,...more

Fourth Circuit Excludes FDA Evidence in Transvaginal Mesh Products Liability Case

by Sands Anderson PC on

In the Southern District of West Virginia, Johnson & Johnson and its subsidiary, Ethicon, Inc., were sued for defective design and failure to warn for their transvaginal mesh TVT-O, in addition to a loss of consortium claim....more

Another Accutane Verdict Vacated in New Jersey

by Reed Smith on

No one can be all that happy with how the Accutane mass tort proceeding has played out in New Jersey. We have no involvement in that proceeding, but we have monitored it from afar, and it has been extraordinarily contentious....more

SDNY Rejects Innovator Liability

by Reed Smith on

May 10 is an important day in the history of the law. On this date, way back in 1893, the Supreme Court ruled that the tomato is a vegetable, not a fruit. The case was called Nix v. Hedden, 149 U.S. 304 (1893). The issue...more

Fifth Circuit Holds That Spearin-like Provision of Louisiana Civil Code Bars Negligent Failure to Warn Claim

by Pepper Hamilton LLP on

LaShip, LLC v. Hayward Baker, Inc., 2017 U.S. App. LEXIS 3694 (5th Cir. Mar. 1, 2017) - Beginning in 2007, LaShip, LLC (“LaShip”) undertook the construction of a large shipbuilding facility in Houma, Louisiana (the...more

The Cheese Runneth Over...Into Illinois

by Reed Smith on

Last September we expressed our curiosity over Wisconsin cheese curd and our distaste for an order from the Western District of Wisconsin rejecting implied preemption in an amiodarone case. As we explained then, the district...more

Smoke Screens & Side Shows

by Reed Smith on

We confess, we can’t think of any good reason for admitting evidence concerning product risks that the plaintiff in a particular case never actually encountered – yet plaintiffs try it with a straight face all the time. It’s...more

WDNY Holds that Tysabri Warnings are Adequate as Matter of Law and that Product Liability Claims are Preempted

by Reed Smith on

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn. Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff...more

Product Liability Update: April 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Prescription Drug Case Holds “Learned Intermediary” Rule Requiring Warnings Only To Prescribing Physician Applied Even Though Patient and Caregiver Were Physicians, But Experts’ Affidavits of...more

Medical Device Manufacturers’ Duty to Warn Expands

by Knobbe Martens on

The Washington State Supreme Court recently released its decision in Taylor v. Intuitive Surgical, Inc. where it held that Washington law requires medical device manufacturers to warn hospitals that purchase their products of...more

Potential Liability for Design Defect in Use of Button Cell Batteries

by Miles & Stockbridge P.C. on

A recent Report and Recommendation by a Magistrate Judge in the United States District Court for the Western District of Pennsylvania may serve as a warning to companies that manufacture and supply products containing button...more

Merck Fails to Obtain Summary Judgment on Preemption Defense – Third Circuit Rules “Impossibility Preemption” Presents a Question...

In re: Fosamax (Alendronate Sodium) Products Liability Litigation, Nos. 14-1900 et al. (3d Cir. March 22, 2017). In a precedential decision issued on March 22, 2017, the United States Court of Appeals for the Third...more

Warning: Lawyers May Be Hazardous To Your Health

by Reed Smith on

Most of the cases we defend involve claims of inadequate warnings. What makes a warning inadequate? Falsehood is the first thing that comes to mind. But the Pontius Pilate question of “What is truth?” continues to vex. We...more

Aviation Happenings - Winter 2016-2017 Part 2

Part 2 of the winter edition of the Aviation Group’s newsletter examines some of the most recent and relevant cases and developments in aviation law, including: - Supreme Court Affirms Presumption Against Preemption...more

Washington: Product Manufacturers Must Warn Hospitals; May Be Strictly Liable for Failure to Warn

by Cozen O'Connor on

In Washington, manufacturers of medical devices now have a duty to warn hospitals that purchase their devices. Additionally, product manufacturers of “unavoidably unsafe products” face strict liability for failure to warn...more

What The Intuitive Ruling Means For Medical Device Makers

by Morrison & Foerster LLP on

Last month, in Taylor v. Intuitive Surgical Inc., the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law — the duty to warn hospitals about potential risks their...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

by Reed Smith on

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

The Failure to Warn of Cannabinoid Hyperemesis Syndrome

by Cozen O'Connor on

As more states legalize marijuana for recreational use, the long-term effects of marijuana use —the good and the bad — will continue to have a significant effect on the law, and in particular, products liability law. Products...more

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