Archives: Product Liability

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FDA finalizes guidance on voluntary recalls, issues recommendations for industry

The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how firms in a distribution chain can prepare when conducting a voluntary recall. The guidance includes nonbinding recommendations and explicitly does not establish legally enforceable … Continue Reading

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist. The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  In-person … Continue Reading

Reed Smith Attorneys to Present AdvaMed Webinar on “Top 10 Product Liability Issues”

Michael Brown and Lisa Baird from our Life Sciences Health Industry Team will be presenting an hour-long AdvaMed Medical Technology Learning Institute webinar on “Top 10 Product Liability Issues” on July 20 at 1 p.m. ET. Product liability litigation is ever-evolving, and the plaintiffs’ bar is continually adapting its business model and litigation strategy against … Continue Reading

French Supreme Court Ruling Clarifies Liability For Defective Products

A February 25, 2016, decision by the French Supreme Court clarifies some conditions for the imposition of liability with respect to defective products in ways that may be surprising to those more accustomed to U.S. product liability law. In the case at hand, a patient was prescribed Mediator, an appetite suppressant, between 1998 and 2008. … Continue Reading

A Proposed End to “Amarin Pharm v. FDA” has FDA Agreeing to Abide by District Court’s Order

We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa. We’ve also been following the similar Pacira Pharm., Inc. v. FDA case, which … Continue Reading

Breaking News – High Wattage Reasoning – Arizona Adopts Learned Intermediary

This post was first published on the Drug and Device Law Blog. We’ve been following Watts v. Medicis Pharmaceutical Corp. ever since the Arizona Court of Appeals issued its bizarre ruling that the learned intermediary doctrine (“LID”), which has been adopted in almost every state, was somehow incompatible with the Uniform Contribution Among Tortfeasors Act … Continue Reading

UPDATE: Pacira Pharmaceutical Inc. v. FDA Lawsuit Settled

The Pacira Pharmaceutical Inc. v. FDA lawsuit has been a frequent topic of discussion on the blog, and now, in breaking news, the case has been settled.  Pacira will be receiving essentially everything it wanted in a “favorable resolution,” and the FDA is formally withdrawing its warning letter that attempted a retroactive reduction in the … Continue Reading

Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues

As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its prescription drug Vascepa, Pacira Pharmaceuticals filed a similar lawsuit regarding off-label promotion of its prescription drug Exparel. While we await the FDA’s response to Pacira’s motion for preliminary … Continue Reading

Change Coming to FDA’s “Intended Use” Regulations?

Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a proposed rule regarding tobacco published in the Federal Register on September 25, 2015. As the FDA explained, the changes … Continue Reading

Attention Out-of-State Plaintiffs: The Tour Ends Here. Next Stop, Home

Last year, the Supreme Court sent a resounding message regarding personal jurisdiction when it decided Daimler AG v. Bauman, 134 S.Ct. 746, 752 (2014).  Bauman announced a significantly more stringent standard for finding a corporation to be “essentially at home” in a foreign jurisdiction and, as a result, made personal jurisdiction harder to establish in … Continue Reading

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved label indications.  The Amarin Pharm v. FDA litigation has garnered a good deal of attention, and after Amarin and the FDA … Continue Reading

Proceed with Caution: Attorney-Client Privilege and Communications with Third-Party Consultants

In our modern economy, businesses regularly use all manner of third-party consultants for many different reasons, including cost, efficiency, and expertise.  Less regularly, communications between businesses and consultants are the subject of discovery motion practice in litigation.  Two recent decisions out of the Southern District of New York demonstrate why businesses that use third-party consultants … Continue Reading

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa—understandably has been big news, analyzed here  and  elsewhere. Some are asking whether the FDA will pursue appellate review of the decision.  An indication about … Continue Reading

Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues

In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement actions against it over speech regarding “off-label” uses of its prescription drug, Vascepa.  Although Vascepa is regulated as a drug, equivalent products … Continue Reading

New Jersey’s DTC Advertising Exception to the Learned Intermediary Doctrine

When the New Jersey Supreme Court ruled in Perez v. Wyeth Lab, Inc. that if pharmaceutical manufacturer directly markets to consumers, the learned intermediary doctrine does not apply, it was deemed a “revolutionary,” decision. However, since the ruling, every New Jersey court which has confronted this issue has found that the DTC exception did not … Continue Reading

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior  posts  looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  We provided links to amicus briefs by the Pharmaceutical Research and Manufacturers of America and the Washington … Continue Reading

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  As we noted, on June 8, 2015, … Continue Reading

FDA Sued By Drug Manufacturer Over Constitutional Right To Discuss Off-Label Uses

The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug- and device-approval processes. … Continue Reading

Texas Legislature Passes Two Bills Affecting Personal Injury And Wrongful Death Litigation

Two bills recently passed by the 84th Texas Legislature, HB 1692 and SB 735 have the potential to affect businesses at risk of personal injury and wrongful death litigation in Texas.  Intended to curb the practice of foreign plaintiffs filing claims in Texas courts for personal injuries occurring outside state borders, HB 1692 would change … Continue Reading

Proposed 21st Century Cures Act Addresses Off-Label Promotion Issues for Drugs and Devices

Over on the Health Industry Washington Watch blog, Reed Smith attorneys Katie Pawlitz and Jeremy Alexander highlight the proposed changes to the Sunshine Act contained within H.R. 6, the “21st Century Cures Act,” which (as previously reported on Life Sciences Legal Update) was approved by the House Energy and Commerce Committee last Thursday, May 21, … Continue Reading

Insurance Coverage Considerations for Alleged Mislabeling of Herbal and Dietary Supplements

In the wake of the New York Attorney General's recent enforcement actions against four major retailers who allegedly sold herbal supplements that did not contain labeled ingredients or contained ingredients not explicitly identified on the labels, companies throughout the supply chain should consider examining their insurance policies to see whether or not they are sufficiently covered in the event of an investigation, enforcement action and/or litigation. Types of insurance policies that may provide coverage for affected companies are commercial general liability (CGL), directors and officers liability (D&O), errors and omissions liability (E&O), and product recall.… Continue Reading

3D Printing Raises Novel Questions About Potential Product Liability

Over on the Drug & Device Law blog, Reed Smith partner Jim Beck (aka "Bexis") offers his thoughts on the possible product liability implications of printing 3D medical devices. Specifically, Jim examines the question of what party (or parties) would be held liable as the manufacturer in a product liability case involving 3D printing. There are uncertainties surrounding each of the three primary parties who may be considered for liability: the hospital that owns the 3D printer used to produce medical devices; the manufacturer of the 3D printer; or the designer of the software used by the 3D printer to create the products. Jim's post discusses the current issues around naming each of those parties as the manufacturer, and concludes that - at least for the time being - 3D printing presents an unusual situation in which it is feasible that no entity qualifies as a "manufacturer" under the Restatements for strict liability. Additional legal issues like this will likely emerge as 3D printing's popularity continues to increase.… Continue Reading
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