News & Analysis as of

Negligence Medical Devices

Three Strikes And . . . You Get Another Chance?

by Reed Smith on

“Legal conclusions, though, are not entitled to the assumption of truth.” If that were the only point we could take away from Wright v. Howmedica Osteonics Corp., No. 5:17-cv-459, 2017 U.S. Dist. LEXIS 168785 (M.D. Fla. Oct....more

Eleventh Circuit Gets It Wrong on Preemption

by Reed Smith on

We have a point of view. Our readers understand that we represent folks on the right side of the v., and our posts tend to read cases and legal trends with a pro-defense bent, although you can rest assured that we put a lot...more

Eastern District of Wisconsin Grants Summary Judgment on Hip Component Manufacturer’s Negligence Claims But Denies Summary...

by Reed Smith on

Last week, like most weeks during the past year, we spent a lot of our time on airplanes. One of those trips fell on a day with “lots of weather.” All of our flights were delayed, although we were luckier than many. When we...more

Health Alert (Australia) 12 June 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 7 June 2017 - Al Muderis v Duncan (No 3) [2017] NSWSC 726 - DEFAMATION – assessment of damage – highly respected orthopaedic...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

The Responsible Corporate Officer Doctrine in the Wake of DeCoster

Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more

Summary of California Appellate Decisions - February 2016

INSURANCE; BAD FAITH; GENUINE DISPUTE DOCTRINE - Paslay v. State Farm General Insurance Co. (2016) 248 Cal.App.4th 639 203 Cal.Rptr.3d 785 - FACTS: State Farm issued a homeowners policy to Paslay, the...more

Alert: 2016 Round-Up: Key Decisions Affecting Connecticut Health Care Providers

by Pullman & Comley, LLC on

Connecticut state and federal courts faced a number of significant health care issues last year. We have summarized those cases that we think are particularly relevant to Connecticut hospitals, group practices and individual...more

Decision Limiting Duties regarding Automated External Defibrillators Does Not Shock The Conscience

by Reed Smith on

Ponder the following: A man attends an exercise class at a facility run by a local religious institution. Assume that he belonged to this facility, wanted to attend an exercise class because his fitness was less than...more

Health Alert (Australia) September 19, 2016

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: South Australia - 13 September 2016 - Dang Pharmacy P/L v Dang [2016] SADC 106 - This is a review of a decision by...more

11th Circuit Upholds Award of Summary Judgment in Mirena Lawsuit

In March 2014, Jenna Thurmond sued Bayer in the U.S. District Court for the Northern District of Georgia, alleging that her use of the Mirena contraception system caused her to develop pseudotumor cerebri. Her symptoms...more

Even with a Road Map, Only One Dubious Claim Navigates Preemption

by Reed Smith on

Here’s another guest post, this time from Reed Smith‘s Jaimee Farrer.  This post concerns PMA preemption, and a second opinion largely getting rid of a case that we blogged about before.  As always, Jaimee deserves all the...more

Mixed and Matched Hip Components Equal Express Preemption

by Reed Smith on

If a surgeon combines a PMA device with a 510k device, what does that do to federal preemption? We ask this question because one of the more fascinating aspects of the medical device world is modularity. We have heard of...more

It’s Just Too Much

by Reed Smith on

We’ve blogged before about the long-running appeal in the Polett v. Public Communications litigation. That’s the case where the plaintiff had knee implant surgery that was so successful she agreed to make a promotional video...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

W.D. Penn. Dismisses Most Claims in Hernia Mesh Case

by Reed Smith on

You’ve probably heard James Carville’s description of Pennsylvania as Pittsburgh on one end, Philadelphia on the other, and Alabama in-between. Let’s put aside that last bit, which manages simultaneously to insult both...more

Health Alert (Australia) May 23, 2016

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: South Australia - 19 May 2016 - Inquest into the deaths of Robert Campbell and Jeremy Todd...more

Plaintiff’s Claim that Manufacturer Improperly Trained Physician in use of Class III Medical Device Preempted by Federal Law

In Ashley Glennen v. Allergan, Inc., 2016 Cal. App. LEXIS 347, published April 29, 2016, the California Court of Appeal, First District, affirmed the trial court’s sustaining of a demurrer in a Lap-Band injury case on the...more

Texas Federal Court Says Device Manufacturer is Not a Health Care Provider, but Also Not a Seller

by Reed Smith on

Sometimes it takes us a while to catch on to things. This is more than a little embarrassing for a Jersey guy to admit, but while many of our high school classmates were devout Springsteen fans after his first two albums,...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

Think Mink, part 2: Florida Federal Court Slams Door on Parallel Claims

by Reed Smith on

Last November we blogged about "specialized" preemption issues in several cases, including Mink v. Smith & Nephew, Inc., 2015 WL 7356285 (S.D. Fla. Nov. 19, 1015). The plaintiff in Mink claimed physical injuries from a...more

Health Alert (Australia) - March 14, 2016

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales 10 March 2016 - Jener Daluz v John McMahon [2016] NSWSC 2021 - The second defendant, South...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

C.R. Bard Awarded Summary Judgement on Warning Claim in IVC Case

An inferior vena cava (IVC) filter is used to prevent life threatening pulmonary emboli. Once installed, the filter’s arms and legs open and anchors it to the walls of the IVC. The filter then catches blood clots that would...more

Heedless Heeding Presumptions – How New York Law Became a Morass

by Reed Smith on

Ever since this blog started, we’ve made plain that we have no use for the so-called “heeding presumption.” This presumption posits that, because under Restatement §402A, comment j, a defendant providing an adequate warning...more

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