Products Liability, Science, Computers & Technology

Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

by Ellen Adler, James W. Huston, Joanna Simon | Morrison & Foerster LLP on 5/16/2013

Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

by Fuerst Ittleman David & Joseph, PL on 5/10/2013

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

Generic Drugs: A Closely Watched Case

by Phillips Law Offices on 5/8/2013

In 2005, Karen Bartlett visited her doctor complaining of shoulder pain. Her doctor prescribed Sulindac, a nonsteroidal anti-inflammatory drug used to relieve pain and address symptoms of arthritis. Ms. Bartlett was dispensed...more

Supreme Court Denies Certiorari in MAO’s Double Damages Case

by Edward Waller | Fowler White Boggs P.A. on 5/3/2013

On April 15, 2013, the United States Supreme Court denied a petition for certiorari brought by GlaxoSmithKline (“Glaxo”) seeking review of a Third Circuit decision in favor of Humana Medical Plan (“Humana”), as a Medicare...more

New Product Liability Class Action Highlights Uncertainties in Class Proceedings

by Luiz Bihari, Craig Lockwood | Osler, Hoskin & Harcourt LLP on 4/29/2013

On April 15, 2013, the Ontario Superior Court of Justice certified a product liability class action in respect of pharmaceutical products manufactured by Bayer Inc. In so doing, the Court’s reasoning highlighted the continued...more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

by Matthew A. Reed | Sedgwick LLP on 4/26/2013

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

Product Liability Update - April 2013

by Foley Hoag LLP on 4/23/2013

In This Issue: - United States Supreme Court Holds Class Certification Improper Absent Showing Plaintiffs’ Damages Can Be Measured on a Classwide Basis through Use of a Common Methodology that Is Consistent with...more

FDA Grapples with Social Media

by Audet & Partners, LLP on 4/18/2013

As businesses continue to capitalize on social media as an inexpensive and effective advertising tool, pharmaceutical companies are struggling to find ways to embrace this trend while abiding by FDA regulations, “…fear of...more

A Narrow Exception To The Mensing Preemption Defense

by Erin M. Bosman, Jeffrey M. David, James W. Huston, Julie Y. Park | Morrison & Foerster LLP on 4/8/2013

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

Breaking Down The Bartlett Oral Argument

by Erin M. Bosman, James W. Huston, Julie Y. Park, Joanna Simon | Morrison & Foerster LLP on 4/5/2013

The U.S. Supreme Court has heard oral argument in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

Howard v. Zimmer: Negligence Per Se Based on Violations of the FDCA—Blurring the Line Between Parallel Claims and Preemption

by Erin M. Bosman, James W. Huston, Joanna Simon | Morrison & Foerster LLP on 3/28/2013

Last week in Howard v. Zimmer, — P.3d —, 2013 WL 1130759 (Okla. 2013), the Oklahoma Supreme Court held that a plaintiff can assert a negligence per se claim against a medical device manufacturer based on the manufacturer’s...more

Driving on Both Sides of the Road: Supreme Court Hears Bartlett Oral Argument

by Erin M. Bosman, James W. Huston, Julie Y. Park, Joanna Simon | Morrison & Foerster LLP on 3/21/2013

The Supreme Court heard oral argument yesterday in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

"Complex Mass Tort Product Liability Alert: Supreme Court Hears Oral Argument Regarding Scope of Generic Drug Preemption"

by John Beisner, Sheila Birnbaum, Mark Cheffo, Steven Napolitano | Skadden, Arps, Slate, Meagher & Flom LLP on 3/19/2013

Today, the Supreme Court of the United States held oral argument in Mutual Pharmaceutical Co. v. Bartlett, a follow-up to its landmark ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which addressed federal...more

Mind the Gap: Sixth Circuit Finds Room for Suit Against Generic Manufacturers After Mensing

by Erin M. Bosman, Jeffrey M. David, James W. Huston, Julie Y. Park | Morrison & Foerster LLP on 3/15/2013

Yesterday, the Sixth Circuit issued its decision in Fulgenzi v. PLIVA, Inc., a case involving a state law claim for failure to warn against a generic drug manufacturer. Case No. 12-3504 (6th Cir. March 13, 2013). The court...more

Superior Court Affirms Dismissal of Paxil Birth Defect Case Lacking Proximate Causation

by Emily Hanlon | Schnader Harrison Segal & Lewis LLP on 3/12/2013

In its March 4, 2013 non-precedential decision in Pettit v. GlaxoSmithKline, LLC, No. 850 EDA 2012, the Pennsylvania Superior Court (applying Ohio law) affirmed an order of Philadelphia Court of Common Pleas Judge Sandra...more

Kentucky Attorney General’s Parens Patriae Suit Against Oxycontin Manufacturer Is Not a “Class Action” Under CAFA

by Mike Williams | Sedgwick LLP on 3/5/2013

The Second Circuit Court of Appeals ruled in Purdue Pharma L.P. v. Commonwealth of Kentucky, 2013 WL 85918, No. 11-4087—mv (2nd Cir. Jan. 9, 2013), that the Kentucky Attorney General’s parens patriae claim against Purdue...more

What Litigators Can Learn From Some of the Coolest Graphics in Construction

by Cogent Legal on 2/28/2013

The ability to make powerful, high-quality trial graphics was extremely limited by the software available in the early 1990s. I was reminded of how far we’ve come in the area of visualization and modeling when I recently had...more

Second Circuit Labels Expert’s Testimony a Sham in Pharmaceutical Products Liability Litigation

by Mark Spatz | Cohen & Gresser LLP on 2/7/2013

As a little kid, I did not have an immediate appreciation that my actions could get me into trouble, and so, without thought, I told the truth. My dad would ask, “Did you write your name on the wall?” I would respond,...more

“Food Fraud Database”: a New Tool to Protect Against Tainted Ingredients

by Natalie Baughman, Jonathan M. Cohen | Gilbert LLP on 2/1/2013

Last week, the U.S. Pharmacopeial Convention (“USP”), a scientific nonprofit that sets standards for food ingredients, medicines and dietary supplements enforceable by the Food and Drug Administration, released an updated...more

Ninth Circuit limits Medical Device Amendment preemption of post-PMA tort claims

by Gregory Wartman | Saul Ewing LLP on 1/30/2013

Medical Device Companies should be aware of a recent en banc ruling by the Court of Appeals for the Ninth Circuit that has the potential to increase litigation involving class III medical devices....more

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

by Erin M. Bosman, James W. Huston, Julie Y. Park | Morrison & Foerster LLP on 1/18/2013

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more

Uncertainty Regarding the Future Regulation of Compounding Pharmacies

by Fuerst Ittleman David & Joseph, PL on 1/14/2013

As we previously reported, the nationwide outbreak of fungal meningitis linked to contaminated injections produced by New England Compounding Center (“NECC”), a compounding pharmacy in Framingham, Massachusetts, prompted...more

FDA Announces Publication of Two Proposed Rules Implementing the Food Safety Modernization Act

by Nathan Beaver, Michael Flanagan | Foley & Lardner LLP on 1/8/2013

On Friday, January 4, 2013, FDA announced the pre-publication of two long-awaited proposed rules implementing parts of the Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011....more

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

by Frederick Ball, Rachael G. Pontikes | Duane Morris LLP on 1/7/2013

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

by Michael M. Gaba, Shannon Hartsfield Salimone | Holland & Knight LLP on 12/27/2012

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

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Products Liability › Science, Computers & Technology