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A case from Douglas County, Nebraska, caught our eye this week for a couple of reasons. It’s a great Daubert order in an Accutane case in Nebraska state court.  In addition to that, this blogger’s mother grew up on a farm in Douglas County, Nebraska.  It was a lovely 80-acre parcel terraced into a gentle slope leading down to the Platte River.  The Platte River is a shallow meandering river—a mile wide at the mouth and six inches deep, as some Nebraskans like to say—and it flows from west to east, eventually emptying into the Missouri River, and then on to the great Mississippi.  It forms the western boundary of Douglas County.

The Platte River is no use as a commercial waterway, but because of the gradual slope of the Platte River Valley, it has been a highway into the Rocky Mountains for hundreds of years. Traders established trails through the Valley, followed by wagon trains carrying settlors and ultimately surveyors for the Trans-Continental Railroad.  When the Trans-Continental Railroad was built, the government’s policy toward public lands was one of disposition.  The government therefore divided parcels along the railroad’s route into 160-acre tracts and gave every other parcel to the railroad companies, with the government keeping the rest for sale to other private landowners.  This checkerboard land ownership pattern persists to this day.  We have not done the research, but we would wager a bushel of corn that some grantee around the turn of the twentieth century split his 160-acre grant in half and sold it to our great grandfather—resulting in our lovely 80-acre farm in Douglas County.

The Douglas County judge who decided Freeman v. Hoffman La Roche, Inc., No. CI 10-9312802, 2017 WL 385440 (Dist. Ct. Neb. Jan. 23, 2017), may or may not live within view of the Platte River, but she produced an extraordinarily exacting Daubert order that came to the correct result—the exclusion of causation opinion because the expert had not applied a reliable methodology.  The plaintiff alleged that her Accutane use resulted in Crohn’s disease, which the defendants contested.

The battle came down to experts, and it is clear that this case is not the first rodeo for these experts or the lawyers. The plaintiff’s causation expert was Dr. David Sachar, who has been a plaintiffs’ expert for 15 years.  He offered the opinion that Accutane caused the plaintiff’s Crohn’s disease, but he did not follow any accepted scientific method.  Instead, he purported to rely on “lines of evidence” to draw his conclusions.

What are “lines of evidence”? Well, it’s not all that clear to us, but the expert identified nine categories of information:  (1) Animal studies; (2) class effect; (3) biological plausibility; (4) dose relationship; (5) clinical studies; (6) adverse event and challenge/de-challenge/re-challenge reports; (7) the defendants’ internal documents; (8) published medical literature; and (9) epidemiological studies. Id. at *8.  This list looks good on its face, but it does not disclose a scientific method, let alone application of a scientific method to draw a valid conclusion. Put another way, this expert was probably able to produce a nice long report—assuming that expert reports are required and/or permitted under Nebraska procedure.  But a long-winded report is not necessarily good science.

Continue Reading Nebraska Daubert Order Finds Expert a Mile Wide at the Mouth, But Only Six Inches Deep

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 failure-to-warn claim by asserting that he or she would not have consented to the procedure if his or her doctor had told her about some risk.  Plaintiffs often assert these positions.  Neither is true.  And the magistrate judge’s report and recommendation granting summary judgment in Tomaselli v. Zimmer Inc., No. 14-CV-04474, 2017 U.S. Dist. LEXIS 9874 (S.D.N.Y. Jan. 20, 2017), does a really nifty job explaining why.

In Tomaselli, the plaintiff was treated with a hip repair device—a Greater Trochanter Reattachment device, or GTR.  A GTR is not like the ball-and-socket total hip replacement devices that have generated so much litigation and with which so many of our readers are familiar.  A GTR consists of a plate and two 1.8 millimeter cables that are surgically implanted to reinforce the top of a patient’s femur—the trochanter—in the event of a fracture. Id. at **1-2.

The plaintiff later complained of hip pain, and imaging revealed that one of the cables broke. Id. at *5.  It is not clear whether the broken cable made any difference:  The cable stayed in place, and removing it would not have alleviated the pain. Id. The evidence also suggests that the pain was not substantial:  The plaintiff went for long periods of time between doctor’s appointments; she was able to exercise and engage in daily activities; and she testified that stretching and taking a few steps would relieve any pain. Id. at *6.  The plaintiff sued the device’s manufacturer and distributor anyway, alleging a variety of product liability claims.

The defendants moved for summary judgment under New York law, and the magistrate recommended granting their motion on every claim. The magistrate’s report and recommendation is particularly interesting on the two issues that we foreshadowed above—failure to warn and product defect.

Continue Reading Hip Case Breaks the Right Way in New York

We thought we understood statutes of limitations and choice-of-law rules in New Jersey.  Until yesterday.  That was when we read the New Jersey Supreme Court’s opinion in McCarrell v. Hoffmann-La Roche, Inc., No. 076524, 2017 WL 344449 (N.J. Jan. 24, 2017), which unhinged that state’s statute of limitations and choice-of-law jurisprudence from its own precedent and placed statutes of limitations in a special class without much explanation.  And the court did all of this for the stated purpose of preserving plaintiffs’ claims and not “discriminating” against an out-of-state plaintiff’s ability to sue a New Jersey company in New Jersey, after the suit would be barred in the plaintiff’s home state.

How did we get here? Well, this is a New Jersey Accutane case, which tells you that it was contentious, as most things seem to be in that multi-county proceeding.  Other than that, the facts in McCarrell are fairly typical—an out-of-state plaintiff (in this case a fellow from Alabama) who was prescribed a drug in his home state, used the drug in his home state, experienced alleged complications in his home state, and received medical treatment in his home state sued the drug’s manufacturer where the company is incorporated—in this case, New Jersey. McCarrell, at *3.

The rub in McCarrell was that the plaintiff’s claim was time barred under Alabama’s statute of limitations, but not under New Jersey’s statute of limitations, which includes a discovery rule.  The choice of law therefore determined the outcome, which led the parties to contest the issue hotly in the trial court, the intermediate appellate court, and eventually the New Jersey Supreme Court.

Each court applied different rules, which is why this case is so interesting and why the Supreme Court’s opinion is so odd. We have long understood that the choice of forum does not determine the applicable substantive law.  Sure, the forum’s procedural law applies, but the substantive law is determined by applying the forum state’s choice-of-law rules.

Continue Reading New Jersey Supreme Court Turns Back The Clock on Statute of Limitations

The FDA released its final Guidance on Postmarket Management of Cybersecurity in Medical Devices during the week between Christmas and New Year. You can link to a full copy here, and we gave you our detailed take on the draft Guidance here. You can also click here to see what our data privacy and security colleagues wrote about the final Guidance on Reed Smith’s Technology Law Dispatch, as they beat us to the presses.

The final Guidance resembles the draft, with a few refinements. We see two guiding principles in the final Guidance.  First, the final Guidance continues to follow a risk-based approach.  As we observed before, the FDA could not have taken a different tack.  Medical devices always present both benefits and risks, and the goal of regulators when it comes to cybersecurity is to assess and mitigate risks without overly compromising a device’s benefits.  Second, the FDA recognizes that managing medical device cybersecurity takes a village.  Or, in the Agency’s words, “FDA recognizes that medical device cybersecurity is a shared responsibility among stakeholders including health care facilities, patients, providers, and manufacturers of medical devices.”  Guidance, at 12.

The final Guidance therefore recommends the implementation of cybersecurity risk management programs.  Such  programs would include monitoring reported adverse events under current regulations.  The FDA also recommends incorporating elements consistent with the National Institute for Standards and Technology’s Framework for Improving Critical Infrastructure Cybersecurity.  Guidance, at 14.  We commented in our prior post that the FDA was combining familiar medical device elements with others borrowed from the cybersecurity world.  The citation to NIST’s Framework is a perfect example of the wedding between those two worlds.

More specifically, a cybersecurity risk management program would include:

  • Monitoring cybersecurity information sources for identification and detection of cybersecurity vulnerabilities and risk;
  • Maintaining robust software lifecycle processes;
  • Understanding, assessing and detecting presence and impact of a vulnerability;
  • Establishing and communicating processes for vulnerability intake and handling;
  • Using threat modeling to define clearly how to maintain safety and essential performance of a device by developing mitigations that protect, respond and recover from the cybersecurity risk;
  • Adopting a coordinated vulnerability disclosure policy and practice; and
  • Deploying mitigations that address cybersecurity risk early and prior to exploitation.

Continue Reading What You Need To Know About the FDA’s Guidance on Postmarket Cybersecurity

This is the second time in two years that we have written the Drug and Device Law Christmas blogpost. Last year, your dedicated blogger posted on Christmas Day a nice little piece on innovator liability that we are sure you all read while listening to Andy Williams, drinking egg nog, and roasting chestnuts on an open fire (note: If you would rather not light an open fire, a gas grill is a very capable substitute for roasting chestnuts, if that is your thing.) If you did not read our post last year, we forgive you.  And whether you read us regularly or just pop in from time to time to read about preemption, please accept our holiday greetings and our undying gratitude.  To all our readers, Happy Holidays from the DDLB!

Our gift to you on this Friday, December 23, 2016, is a blogpost discussing a topic on which we have not written a lot—alter ego personal jurisdiction.  That is when a court takes jurisdiction over a corporation based on the forum contacts of a corporate subsidiary.  We wrote about a district court rejecting alter ego jurisdiction here, but there is not much else discussing the subject in detail in the archive. That could be because successful examples of alter ego jurisdiction are exceedingly rare.  The most common scenario is where plaintiffs sue an alleged corporate wrongdoer and try to hale into court not only the alleged wrongdoer, but also its out-of-state corporate parent.  Their motivation is not a mystery:  Plaintiffs want more defendants, larger balance sheets, and deeper pockets to reach into.  And if the corporate parent has a recognizable “big” name, that’s all the better.

Unfortunately for plaintiffs and fortunately for the defense, this transparent ploy rarely works, and it did not work in a recent hip replacement case, Goldthrip v. Johnson & Johnson, No. 15-00651-KD-B, 2016 U.S. Dist. LEXIS 170801 (S.D. Ala. Dec. 8, 2016).  In Goldthrip, the plaintiffs sued not only the company that made and sold the hip implant, but also its corporate parent.  There were, however, two problems:  First, the plaintiffs sued in Alabama, but the parent corporation was a New Jersey company.  Second, the parent corporation neither made nor sold products; it was a holding company, as parent companies often tend to be. Id. at **2-4.

Continue Reading Alter Ego and Agency – A Different Spin on Jurisdiction

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 be a real gem.  The case is Mullins v. Ethicon, Inc., No. 2:12-cv-02952, 2016 WL 7197441 (S.D. W. Va. Dec. 9, 2016), and we recommend it to all of you.  We say that not only because the district court held that West Virginia law requires that each plaintiff must prove a feasible alternative design—which is the correct result—but also because the order is particularly well reasoned.

Not every state requires proof of a feasible alternative design, but it is nevertheless a basic product liability concept. It is a particularly good fit when dealing with products that always bear risks—such as implanted medical devices.  The Restatement (Third) of Torts, Product Liability § 2 is as good a place as any to start, as it bakes alternative design right into the definition of a design defect:  “A product . . . (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe.”  (emphasis added).

Take the obvious example of a machine with sharp spinning parts. The same machine with a protective guard may be a safer alternative design.  Or it might not.  The point is that the plaintiff has to prove it.  Take also the example we discussed in Bexis’ aptly named post “On Alternative Design.”  That case involved hernia mesh, not pelvic mesh, and the plaintiffs’ claims failed because, among other reasons, they had failed to prove that a mesh of a different design would have been any safer.  Consider hormone-based contraceptives.  Cholesterol drugs.  We could go on and on.  All these products bear known and unavoidable risks, and those risks should not be labeled “defects” and result in potential liability unless the plaintiff can prove an alternate design would feasibly mitigate them.  And, no, it is not sufficient to say that the feasible alternative is to use a different product or not use any product at all.  As we observed in the aforementioned post, that would convert strict liability into absolute liability.  As we asked in yet another post on this topic, are motorcycles defective because full-sized automobiles are generally safer?  You get the point.

Continue Reading A Gem on Alternative Design from a Pelvic Mesh MDL

It took us a long time to understand how off-label promotion of prescription drugs had anything to do with the False Claims Act, and we’re still not so sure that the two are a fit. The FCA penalizes anyone who presents, or causes to be presented, to the federal government “a false or fraudulent claim for payment or approval.”  31 U.S.C. § 3729(a)(1).  Easy, right?  As we explained just last month in this quick primer on the FCA, Congress enacted the FCA after the Civil War to curb abuses in government procurement.  That part we get.  If you sell the Army 1,000 horses and send them a bill for 2,000 horses, that’s a false claim.

We’re writing about this today because the First Circuit issued an opinion last month that comes to the correct result and also illustrates how FCA claims are alleged in connection with off-label promotion—and how they fail. In Lawton v. Takeda Pharmaceuticals Co., No. 16-1382, 2016 U.S. App. LEXIS 20943 (11th Cir. Nov. 22, 2016), a patent lawyer filed a qui tam action against the manufacturer of a prescription diabetes medication.  He did not actually use the medication, nor did he buy or sell it.  So what did he allege?  He alleged that the manufacturer engaged in an elaborate scheme to promote the drug for un-approved uses—off-label promotion—and that the manufacturer thereby induced medical providers to make allegedly false claims for reimbursement to Medicare and Medicaid. Id. at **4-7.

It’s a two-step process. The manufacturer did not itself make a false claim, but rather engaged in alleged conduct that induced someone else to make a claim, whether the claimant knew it was false or not.  The problem for the plaintiff (or more accurately, the “relator”) is that he alleged neither falseness nor a claim.  We call that a double whammy.  Or maybe it’s a double fault.

Continue Reading This Is How A False Claims Act Case Works—And Fails

As we hurtle into the holiday season, we are reminded that good things often come in small packages. That certainly was the case in a one-and-a-half-page opinion that the Ninth Circuit filed last week in a prescription antidepressant case.  The case is Plumlee v. Pfizer, Inc., No. 14-16924, 2016 WL 6610223 (9th Cir. No. 9, 2016), and the lesson was that the statute of limitations can be a powerful thing.

The facts are pretty simple: The plaintiff alleged that she stopped taking Zoloft in June 2008 because she believed it was ineffective “contrary to [the manufacturer’s] representations.”  But she did not file her class action lawsuit until more than four years later. Id. at *1.  That sounds to us as though the plaintiff filed after the expiration of any applicable statute of limitations, and it sounded that way to the district court too, leading to an order dismissing the case.

The Ninth Circuit affirmed, holding that California’s discovery rule did not extend the plaintiff’s time to sue. The core holding is as follows:

Under the discovery rule, [Plaintiff’s] failure to allege any facts that she exercised reasonable diligence between June 2008 and May 2012, or that she was unable to discovery the factual basis for her claims between June 2008 and May 2012 despite exercising reasonable diligence, constitutes a sufficient basis for affirming the district court’s dismissal with prejudice . . . .”

Id.  This may seem like a routine result at first blush, but let’s unpack this a little bit.  First, we find it interesting that the district court dismissed the plaintiff’s complaint under Rule 12(b)(6).  We do not often see courts ruling on statutes of limitations on the pleadings, although there is no reason why discovery should be necessary when the defense is evident on the face of the complaint.  Here, the plaintiff alleged that she believed the product was ineffective in June 2008 despite “representations to the contrary.” Id.  In other words, she suspected wrongdoing, which caused her claim to accrue under any application of the discovery rule.  From that point, the clock was ticking.

Continue Reading Don’t Underestimate the Statute of Limitations

We never heard the term “slack fill” before we started writing for this blog, but it seems to be getting a lot of attention lately. We enjoyed a podcast from NPR’s Planet Money the other day discussing slack fill in black pepper containers, and we blogged on the FDA’s regulation of slack fill a little more than a year ago.  We have to admit, the words are fun to say.  “Slack fill.”  They snap off your tongue with a certain percussive elegance.  Sort of like “Severus Snape.”  Or “Coco Crisp,” who is an actual person, a switch-hitting outfielder currently vying for a World Series crown with the Cleveland Indians.  (Coco Crisp, whose given name is Covelli Crisp, broke into the big leagues with the Indians in 2002, and he returned to Cleveland just a few months ago after spending six-and-a-half seasons leading off for our beloved Oakland Athletics.  His change from the white cleats to black is a big loss for Oakland and, if the Indians beat the Cubs, a bigger win for Coco.  But we digress.)

For those who missed our prior post on slack fill, the term refers to empty space, like the extra air in a bag of chips. The variant “nonfunctional slack fill” refers to pointless empty space.  It’s just there, serving no purpose, just like a recent slack fill class action that recently met its demise in the Eastern District of New York, Fermin v. Pfizer, Inc., No. 15-cv-2133, 2016 U.S. Dist. LEXIS 144851 (E.D.N.Y. Oct. 18, 2016).  In Fermin, the plaintiffs’ alleged that they were “tricked” into purchasing ibuprofen because the containers were too big. Id. at *1.  Never mind that the labels prominently and accurately stated exactly what was in the bottles, down to the number of pills.  These plaintiffs alleged that the “excessive empty space” in the packaging misled them into purchasing the product, and they purported to represent a class of purchasers under the consumer laws of multiple states. Id.

Continue Reading “Slack Fill” Class Action Is Empty Space

The Telephone Consumer Protection Act (“TCPA”) potentially touches just about every kind of business, including the business of selling prescription drugs. That is what the Northern District of California grappled with (correctly) in Jackson v. Safeway, Inc., No. 15-cv-04419, 2016 U.S. Dist. LEXIS 140763 (N.D. Cal. Oct. 11, 2016).  In Jackson, the plaintiff received a telephone reminder from her pharmacy that she was due for an annual flu shot, which prompted her to go in the next day to receive her shot. Id. at **5-6.  Of course, what do you do after you receive disease-preventing medical treatment?  You file a class action lawsuit dissing the pharmacy for bothering to call.  What is the old saying about no good deed?

For the uninitiated, the TCPA is the federal statute passed in the early 1990s that regulates “telemarketing.” We place that word in quotes for two separate reasons.  First, we use quotes to demarcate a term of art—the FCC uses the term “telemarketing” to define significant obligations under the Act.  Second, we use quotes to indicate irony (picture us making the familiar “air quotes” gesture as you read this post).  Although Congress passed the TCPA to cut down on intrusive “telemarketing” calls, many say that the FCC’s regulations do not target “telemarketers” narrowly enough.  That makes other businesses who are reaching out to their customers (like our pharmacy) potential targets for abusive litigation.  The stakes are high.  The statute imposes penalties of up to $1,500 per violation, and in a society where telephones increasingly serve as our windows to commerce and human relations, those penalties can multiple to large numbers quickly.

A particular target for critics of the regulations is a 2012 FCC order that could have, for example, strengthened an exception for calls made within existing business relationships. But the 2012 order instead abolished that exception, among other provisions.  A follow-up order issued in 2015 clarified matters, but that also fell short of expectations for many.  One example is the FCC’s definition of an “automated telephone dialing system,” which some say is now broad enough to include our iPhones.  We are not so sure, but the ambiguity in the rules is most unwelcome.  (You can read Reed Smith’s alert on the 2015 order here.)

We are writing about this here because the district court in Jackson invoked two TCPA exceptions that apply to healthcare:  (1) The “exigent healthcare treatment exception,” which creates a safe harbor for “exigent” calls that have a “healthcare treatment purpose” and “are not charged to the calling party”; and (2) the “telemarketing health care exception,” which permits automated calls that deliver “health care” messages from HIPAA covered entities and their business associates.

Continue Reading TCPA Health Care Exceptions Properly Applied In California