We use cookies to give you the best online experience. By using our website you agree to our use of cookies in accordance with our cookie policy. Learn more here.Close Me
This post is from the non-Reed Smith side of the blog.
It's not a long decision – but there's still a lot
to it. Maybe that's because there wasn't a lot to
plaintiff's complaint. Regardless, Sharp v. St. Jude
Medical, S.C., Inc., 2019 WL 3821895 (N.D.GA Aug. 14, 2019)
makes some key defense rulings.
The case involves an implantable cardiac defibrillator
("ICD") that plaintiff alleges malfunctioned and did not
deliver the necessary shock when plaintiff's husband went into
cardiac arrest. Plaintiff alleges the reason for the failure was
friction between the insulation and the wires. Id. at *1.
Plaintiff brought claims for manufacturing defect, failure to warn,
and negligence per se. Defendant raised by both preemption and
TwIqbal grounds for dismissal.
In deciding the motion to dismiss, the court first held that
plaintiff cannot state a viable manufacturing defect claim premised
solely on allegations that the device malfunctioned. Id.
at *4. A malfunction is not the equivalent of a defect and the
latter cannot be inferred from the former. Plaintiff also tried to
rely on Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.
2010) to argue that she needed discovery of defendant's PMAs
before she could plead a parallel violation claim. But Georgia is
in the Eleventh Circuit where Wolicki-Gables v. Arrow
Int'l, Inc., 634 F.3d 1296 (11th Cir. 2011) controls which
requires the complaint "point to specific PMA requirement[s]
that have been violated and not wait for discovery on such
matters." Sharp at *4.
On failure to warn, the court starts by applying Georgia's
learned intermediary doctrine. So any duty to warn extended to
plaintiff's husband's physician. Id. at *5. In
this case, the court also applied the sophisticated user doctrine
which provides that a manufacturer need not warn a physician of
risks from prescription medical devices that are "generally
known" to physicians. Id. Having pointed to multiple
public sources of information concerning the ICD leads at issue,
the court was able to conclude that the risk was well-known in the
medical community which barred plaintiff's failure to warn
claim.
Turning to preemption, plaintiff appears to allege different
causes for the failure of the ICD but doesn't link them to any
specific PMA requirement that was allegedly violated. Id.
at *7. Without a causal connection between the ICD implanted in
plaintiff's husband and a PMA violation, plaintiff's claim
is preempted. The court didn't even have to go that far on
failure to warn, agreeing with defendant that "Plaintiff's
claim that Defendants should have provided additional or different
warnings is preempted, no matter how the arguments are
construed." Id. Failure to warn premised on a failure
to file a report with the FDA is the equivalent of
"fraud-on-the-FDA" and therefore preempted. Id.
The fact that the product was recalled does not change the
preemption analysis. Id. And to the extent plaintiff tried
to bring a claim for failure to provide adverse event reports
directly to patients and physicians – that would be a state
duty that exceeds federal requirements and is likewise preempted.
Id. at *8.
Finally, plaintiff's negligence per se claim is impliedly
preempted as an attempt at private FDCA enforcement.
Id.
Sometimes good things do come in small packages. We'll take
a short, sweet, and solid defense win any day.
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.
In this putative class action, banquet server and bartender Lauren O'Grady alleged that her employer's practice of automatically imposing a 21 percent "service charge"
Under the wage orders issued by California's Industrial Welfare Commission (IWC), "[a]ll working employees shall be provided with suitable seats when the nature of the work reasonably permits...
Employers began to rethink how they obtain authorization and retrieve background and credit checks for new employees after the Ninth Circuit's decision in Gilberg v. California Check Cashing
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
US Disputes: Can You Avoid A Court Battle? (Video)
