This past weekend, we paid a return visit to Cleveland, the home
of our best law school friend, who braved the (figurative) waters
of New Haven with us so many years ago. In deference to the Drug
and Device Law Traveling Companion, we visited the Pro Football
Hall of Fame. In contrast to the stunning rotunda of our beloved
Country Music Hall of Fame, the Football Hall stacks all of the
inductees' busts against a single wall – sort of a
warehouse of disembodied heads. We felt like we were in the parts
department of Dr. Frankenstein's laboratory. But we enjoyed the
visit and paid fond homage to the bust of Tommy McDonald. We also visited the Rock and
Roll Hall of Fame, which we had seen before and which we continue
to find both impressive and tons of fun. This time, we lingered at
the "One-Hit Wonders" display, commemorating so many
recording artists who disappeared after just a bit of noise, never
to be heard from again.
The plaintiff in today's case followed the same trajectory,
albeit after his apparently meritless case languished on an MDL
docket for eight years. In Wilhelm v. Pfizer, Inc. 2016
U.S. Dist. LEXIS 127269 (D. Nev. Sept. 19, 2016), the complaint was
originally filed in 2006 in the District of Nevada by fourteen
plaintiffs alleging that the defendant's product caused
suicidal ideations. The JPML transferred the case to the Neurontin
MDL after it was filed, and remanded it back to the transferor
court in July 2013 with three plaintiffs remaining. One month
later, the court permitted counsel for these plaintiffs to
withdraw. Two of the plaintiffs dropped out, leaving a single
plaintiff, proceeding pro se. In February 2014, the
defendant moved for summary judgment, arguing that the plaintiff
could not produce any expert evidence proving that the
defendant's product caused his injuries. The plaintiff filed
for Chapter 7 bankruptcy in June 2014. He never disclosed his
product liability lawsuit in the course of his bankruptcy
In January 2016, the court finally held a hearing on the
defendant's 2014 motion for summary judgment. After the
hearing, the plaintiff filed a motion for summary judgment
attaching a doctor's letter, dated after the January hearing on
the defendant's motion and "years after discovery closed
and the dispositive motion deadline had passed,"
Wilhelm, 2016 U. S. Dist. LEXIS 127269 at *11, stating
that the defendant's product caused the plaintiff's
As an initial matter, the court explained that expert testimony
is required under Montana law "when the issue presented is
sufficiently beyond the common experience of the trier of fact and
the expert testimony will assist the trier of fact in determining
the issue or understanding the evidence." Id. at *9
(citations omitted). Because the plaintiff's claims involved
"complex factual question[s] . . . [especially because the
plaintiff] was taking multiple medications over a long period of
time and appear[ed] to have a family history" of mental health
issues, the court held that expert testimony was required to
establish causation as to all of the plaintiff's claims.
Id. at *10. To the extent that the letter attached to the
plaintiff's motion constituted such expert testimony, the court
held "that Plaintiff's disclosure of [the doctor's]
report [was] untimely and highly prejudicial to the
Defendant." Because the plaintiff had not disclosed the
expert's identity and had had not provided the report to the
defendant, the defendant had "no subsequent opportunity to
offer its own expert testimony, conduct a deposition of [the
doctor], or otherwise meaningfully rebut Plaintiff's evidence
before it filed its motion for summary judgment, or in response to
Plaintiff's motion, given that discovery had long since
closed." Id. at *12. Because the plaintiff had not
adduced evidence creating a genuine issue of material fact as to
whether the defendant's product caused his injuries, the court
granted summary judgment in favor of the defendant.
As if this were not enough, the court also found that the
plaintiff was "estopped from pursuing the action further,
because of his failure to disclose [the] lawsuit in his bankruptcy
proceeding," explaining that, under the Federal Rules of
Bankruptcy and the cases construing them, "[f]ailure to list
an asset or interest on the bankruptcy schedules causes the debtor
to be judicially estopped from pursuing a claim to recover that
interest after discharge." Id. at *13 (citations
Doctors have the Hippocratic Oath – "First, do no
harm." For litigants, the analog goes something like,
"First, follow the Rules." Otherwise, like the plaintiff
in Wilhelm (and like rock music's one-hit wonders),
you may soon be little more than a memory.
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).