The Third Circuit just confirmed what we all knew had to be true
in device litigation: pointing to the failure of another device in
another patient or to a supposedly better label for a different
device is not nearly enough to get to trial on design defect or
failure to warn claims. That's precisely what the Zimmer
hip-implant plaintiff tried in Kline v. Zimmer Holdings,
Inc., 2016 WL 5864886 (3d Cir. Oct. 7, 2016), and the Third
Circuit rejected it.
To support his design defect claim, the plaintiff submitted an
affidavit from his treating doctor discussing a different patient
who also had a failure of a Zimmer hip implant. But the occurrence
of two purported failures does not clear the way to trial. In fact,
the court only had to scratch the surface of the affidavit to see
its problems. The other patient's product was a different
Zimmer product. The circumstances of the other patient, the implant
and its failure were different. There was no evidence as to what
caused the other device's failure. And the other patient's
implant failed after the device had already been implanted
in plaintiff. These facts so solidly established the irrelevance of
the affidavit that the Third Circuit held it inadmissible. The
plaintiff also tried a host of design defect theories from his
experts that were just that—theories—but with, as the
Third Circuit held, no "record evidence showing any of these
design choices were unreasonable." It then upheld summary
judgment against plaintiff's design defect claims.
The Third Circuit was equally unimpressed with plaintiff's
failure-to-warn evidence. That evidence consisted of pointing to
another product's label, which included a contraindication for
patients at a certain weight or BMI, something that the label for
the Zimmer product did not have. But that was the extent of
plaintiff's evidence. He did not show that the other device was
similar to the Zimmer device. He did not show that the other
device's contraindication was reasonable or why. And he did not
show that the risk of fracture in the Zimmer device with patients
at such a weight or BMI was high enough to warrant a
contraindication. It seems that plaintiff thought that, like
pointing to another patient who experienced a failure of a
different device, pointing to a contraindication in a different
device's label would get him to trial. It did not. The Third
Circuit upheld summary judgment against plaintiff on his failure to
Not surprisingly, pointing to the mere existence of other
products' failures or labeling isn't nearly enough to prove
a plaintiff's claims. We all knew that. To the extent we had
any doubts, the Third Circuit just dispelled them.
This article is presented for informational purposes only
and is not intended to constitute legal advice.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k "substantially equivalence" medical device clearance as non-preemptive because it was supposedly "focused on equivalence, not safety"? Id. at 493.
The US Food and Drug Administration (FDA) related portions of the 21st Century Cares Act, found in title III, establish a streamlined process for the exemption of certain Class I and II devices from the premarket notification requirement and allow for the establishment of revised regulatory standards for accessories to high-risk devices.
Hospitals are commonly named as defendants in medical malpractice lawsuits for claims arising from alleged injuries within their walls, but what is their exposure to liability for claims that arise from alleged sexual assaults by staff on their premises?
Eric Fader was quoted in a November 9 article, "Incoming Trump Administration May Mean Less Funding for HIPAA Audits," in Bloomberg BNA's Health Care Fraud Report. Eric said that the incoming Trump administration may eventually be forced to reduce funding for some healthcare initiatives to pay for other priorities, such as large tax cuts and increased spending on the military.
Title III of the 21st Century Cures Act includes portions of the FDA Device Accountability Act of 2015, Promoting Biomedical Research and Public Health for Patients Act, and FDA and NIH Workforce Authorities Modernization Act.
A February 2 article in Bloomberg BNA's Privacy Law Watch and other publications, "Hospital Hit With $3.2M Penalty for Ongoing Health Data Security Lapses," reported that Children's Medical Center of Dallas received a $3.2 million civil money penalty after years of noncompliance with HIPAA rules and after failing to request a hearing on the penalty.
The 21st Century Cures Act includes portions of the Helping Families in Mental Health Crisis Reform Act of 2016, which was approved by the US House of Representatives in July 2016, but not advanced by the Senate.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).