News & Analysis as of

Design Defects Medical Devices

3D Printed Medical Implants: Should Laws and Regulations Be Revolutionized to Address This Revolutionary Customized Technology?

by Wilson Elser on

Previously on this blog, Wilson Elser attorneys have written several posts about 3D printing technology and the law. We have predicted that this new technology has the potential to change the landscape of product liability...more

EDNY Rejects Successor Liability in Hip Implant Case

by Reed Smith on

Happy birthday, Christopher Plummer. The great Canadian actor turns 88 today, and seems as vibrant as ever. What a marvelous career Plummer has had. He is a preeminent Shakespearean actor. We saw him play Iago to James...more

Unavoidably Unsafe PMA Medical Devices

by Reed Smith on

When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...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

Summary Judgment for Concentric Medical on Design Defect and Warnings Claims Related to Fracture of Merci Retriever Device

by Reed Smith on

When last we wrote, we were about to embark on a journey to Budapest and Vienna to visit the Drug and Device Law Rock Climber. We mentioned that we were thrilled to hold tickets to see the Lipizzaner stallions perform at the...more

No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, and Shutts Down Utts

by Reed Smith on

Late last year we happily blogged about Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), chiefly because it held that design defect claims against a branded prescription drug...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

Hip Case Breaks the Right Way in New York

by Reed Smith on

A recent case in the Southern District of New York debunks two myths that we see all the time. Myth number one: A medical device is defective if it fails. Myth number two: A plaintiff can prove causation on a...more

A Gem on Alternative Design from a Pelvic Mesh MDL

by Reed Smith on

We don’t write a lot on the various pelvic mesh MDLs in West Virginia because we are so heavily involved in two of them. But the MDL court entered an order last week on design defect and alternative design that we consider to...more

What are experts saying about Stryker Accolade V40?

Stryker Accolade V40 LFIT Hip Implant Dissociation - Over the past few years, various orthopedic surgeons around the country and their patients have faced a catastrophic failure of Stryker’s Accolade and V40 LFIT hip...more

Are Stryker V40 Femoral Heads (CoCr) Defective?

Stryker V40 Femoral Heads (CoCr) Associated With Spontaneous and Catastrophic Head-Neck Dissociation - Stryker may face yet another crisis associated with their total hip replacement medical devices – and this time it...more

Australia Concerned About Stryker Made LFIT Femoral Heads

On September 27, 2016, the Department of Health Therapeutic Goods Administration (the Australian equivalent of the Food & Drug Administration) issued a hazard alert relating to LFIT Anatomic CoCr V40 femoral heads...more

California Federal Court Dismisses Inferior Complaint

by Reed Smith on

Inferior vena cava filters resemble what we used to call “daddy long legs.” You know what we mean: the spider-like creatures with small centers, from which long, bent legs emanate in all directions. That is sort of what IVC...more

The Difference Between Manufacturing and Design Defects

by Reed Smith on

Some plaintiffs seem to think that if they allege any problems about anything in the manufacturing process of a prescription medical product, then it falls under the rubric of “manufacturing defect.” They’re wrong, of course....more

Product Liability Verdicts in Arizona

by Snell & Wilmer on

Product liability cases show a strong defense trend in Arizona. Since 2011, Arizona juries have given twelve defense verdicts and three plaintiff’s verdicts. Here are all of the Arizona product liability verdicts over the...more

Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

by Reed Smith on

According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning: - By even greater force of logic; even more so it follows. We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567...more

Comment K Case by Case – Falling Out of Favor?

by Reed Smith on

When we examined Restatement (Second) of Torts §402A, comment k (1965), in our 2011 research post “Comment K, Some of the Way,” we remarked about how it said “a lot of things,” including: (1) that one can’t design away...more

Guest Post - Design Defect Preemption - It’s as Simple as One, Two, Three

by Reed Smith on

Courts are starting to “get” the design defect preemption argument. That makes sense because the argument is simple. Any major changes in the design of a drug or a medical device require the prior approval or permission of...more

New Jersey Mesh Summary Judgment Hat Trick

by Reed Smith on

We’re pleased to report that good things continue to happen in Atlantic County product liability proceedings following recent judicial turnover. On February 19, 2016, the Reed Smith Bard/Davol defense team scored a hat trick...more

Preemption And Causation Do Away With Contraception Lawsuit

by Reed Smith on

With Spring Training well underway, we took notice of the solid base hit delivered last month by the Northern District of California in La Paz v. Bayer Healthcare LLC, No. C 15-03995, 2016 U.S. Dist. LEXIS 13058 (N.D. Cal....more

Power Morcellator Cases Transferred to Kansas

Power morcellators are electric surgical devices used to cut tissue has been used in recent years as an alternative to traditional, abdominal surgical hysterectomies, laparotomies and myomectomies. In April 2014, the...more

Mentor Case Time Barred

In 2004, North Carolina resident Melanie Cole was implanted with Mentor’s OB Tape, which is a sling device that is used to treat urinary incontinence. Three weeks after the surgery, Ms. Cole visited her surgeon and...more

Res Ipsa Loquitur, Ipse Dixit, And A Non-Retained Expert

by Reed Smith on

As a defendant manufacturer in a drug or device product liability case, it is one of the last things you want to see. The key treating physician concludes that your product was to blame for the plaintiff’s problems and...more

“May the Odds Be Ever in Your Favor” – The Ten Best Prescription Drug/Medical Device Decisions of 2015

by Reed Smith on

The iconic Hunger Games line, “may the odds be ever in your favor” pretty much sums up how we feel about our top ten best decisions of 2015. These are results that put the “happy” in Happy New Year – which we wish all our...more

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