July 2015

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We have managed to pretty much avoid asbestos litigation.  Sure, we encounter decisions from asbestos cases that sometimes impact our own cases.
They even sometimes appear in our posts, but rarely as a focus.  We have been less successful in avoiding consolidation of drug and device cases for trial.  Some courts that tend to favor multi-plaintiff trials are informed by experience from asbestos litigation.  Plaintiff lawyers, informed by whatever past experience makes them think there is a route to bigger verdicts and bigger settlements, often favor consolidating cases for trial.  To us, the plaintiff preference seems driven by the prospect of a jury being more sympathetic to several plaintiff themes when there are multiple injured plaintiffs in front of them throughout trial, especially if having a sicker plaintiff in the mix will drive up damages for the rest.  Plus, notwithstanding limiting instructions, the breadth of liability evidence tends to expand with each plaintiff.  Meanwhile, courts seem to mostly consider their dockets, accepting as given that trying cases together will get the number of pending cases down faster than would trying cases individually.  We had a case sent our way on consolidation in asbestos litigation and, given a combination of a paucity of blogworthy cases, our interest in the subject, and an impending vacation, we decided to post on it.

From In re: New York City Asbestos Litig., No. 190411/13, 2015 N.Y. Misc. LEXIS 2634 (N.Y. Sup. Ct., N.Y. Cty., July 24, 2015), we learned that there is a pretty developed law governing whether to consolidate asbestos cases for trial.  Without really digging in, we would say that it is more developed and detailed than the law on consolidating drug or device cases for trial and offers some principles that might work fairly well for our cases.  NYCAL­—that is what we will call it—concerned whether to put together two plaintiffs in each of two trials based on six factors identified in Malcolm v. National Gypsum Co., 995 F.2d 346, 350-53 (2d Cir. 1993).  Not all the Malcolm factors will have a direct parallel to drug or device cases, but they are a good start:  1) common or similar worksite, 2) similar occupations, 3) same exposure period, 4) same disease, 5) living or dead plaintiffs, and 6) extent of overlap between defendants.  Beyond the enumerated factors, though, the court should consider both judicial economy and the “paramount concern for a fair and impartial trial.”  2015 N.Y. Misc. LEXIS 2634, *9 (citation omitted).  In a well-expressed quote from another asbestos case, “The systemic urge to aggregate litigation must not be allowed to trump our dedication to individual justice, and we must take care that each individual plaintiff s – and defendant’s – cause not be lost in the shadow of a towering mass litigation.”  Id. (citation omitted).Continue Reading Considering Consolidating Cases for Trial

Photo of Michelle Yeary

This post is from the non-Reed Smith side of the blog.

Is anyone else watching the CW’s “Penn & Teller: Fool Us”?  It is perfect summer TV – easy, funny and interesting.  Each week aspiring, talented magicians perform to try to fool Penn & Teller.  If at the end of the trick, the comedy-magic duo can’t figure out how the trick was performed, the magician gets to appear on Penn & Teller’s enormously popular Las Vegas show.  Recorded on your DVR so you can skip commercials, it’s 45 minutes of stage performances, most of which are quite good and entertaining.  And that’s where we like to see magic – on the stage.  Who isn’t intrigued when a torn up playing card turns up tucked into a magician’s wallet whole again?  Or when a dove appears where only an egg was before? Slight of hand, hidden compartments, mirrors, trap doors – all things designed to make an audience think they are seeing something more than they really are.

When magic is at work in legal opinions, we aren’t as enthusiastic.  Especially, where the result is the conjuring of a case out of thin air.  That is precisely what happened in Fields v. Eli Lilly and Co., slip op., Case No. 2:13-CV-35-WKW (M.D. Ala. Jul. 20, 2015).  Plaintiff alleged that because she ingested Prozac in 1996 during the first 8 months of pregnancy, her son was born with a congenital heart defect.  But she has NO proof of two of the most fundamental aspects of any prescription drug case – that she ingested the drug and that an alleged inadequate warning caused the injury.  We would have thought that a complete lack of evidence on two key elements is enough for summary judgment, but plaintiffs managed to pull a rabbit out of a hat.

Let’s sum up all of the missing evidence. Plaintiff has no pharmacy records showing that a Prozac prescription was ever filled.  She alleges her pharmacy no longer has those records.  She has no financial records (bank statements, receipts, credit card statements) showing a purchase of Prozac. Id. at 9.  Presumably she also doesn’t have insurance records reflecting a Prozac prescription. She has no medical records that Prozac was ever prescribed.  Id. at 8.  There isn’t a single reference in any of her medical records that confirms that Prozac was ever prescribed to plaintiff.Continue Reading Plaintiffs Allowed To Make a Case Out of Thin Air

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While Bexis is on vacation, here is a guest post to take up some of the slack.  Our guest blogger today is Henry Pietrkowski, a partner in Reed Smith’s Chicago office.  This one’s a little different.  It’s about the impact of a 1991 federal statute prohibiting unrequested faxes, and how it could impact on pharmaceutical promotional activities that send faxed information to healthcare providers.  As always, our guest bloggers deserve all the credit, as well as any blame, for their posts.  Here goes.

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Scottish inventor Alexander Bain is credited with inventing the first fax machine in 1843 – an “Electric Printing Telegraph.”  By 1846, Bain was able to reproduce graphic signs in laboratory experiments by synchronizing the movement of two pendulums to transmit a message across a wire.  But
it was not until over a century later, in 1964, that the Xerox Corporation introduced the first commercialized version of the modern fax machine. From there, faxes became ubiquitous.  They provided a standardized method of communication used worldwide, and their validity as a method of transmission was adopted by the business world.  By the 1980s, faxes had become widely used as a form of marketing.  Why pay the cost of postage to send an advertisement when the advertiser could use the recipient’s own paper and toner to print it?

It was at this point that Congress stepped in by passing the Telephone Consumer Protection Act of 1991 (the “TCPA”). Among other alleged telemarketing abuses, the TCPA specifically prohibits the use of a “telephone facsimile machine, computer, or other device to send, to a telephone facsimile machine, an unsolicited advertisement.”  47 U.S.C. § 227(b)(1)(C).  To ensure that businesses took the Act seriously, Congress imposed a minimum statutory damage award of $500 per fax regardless of the sender’s intent, and up to $1,500 for a knowing or willful violation of the statute.  Id. at § 227(b)(3).  Senator Ernest Hollings, who sponsored the bill, expressed his hope that violations of this law could be enforced by aggrieved individuals in small claims court where counsel would not be needed.Continue Reading Guest Post – Just the Fax, Ma’am

Photo of Rachel B. Weil

We flew to Pittsburgh this week for depositions.   From Philadelphia, it takes only about 40 minutes in the air to get to Pittsburgh.  But there are only a few nonstops each day.  With no other options, we booked a nonstop flight scheduled for a 7:55 a.m. departure, coordinated plans with colleagues, clients and witnesses, and went to sleep with our overnight bag packed and waiting at the door.  All in order, right?  Until our phone rang at 3:30 a.m. bearing the robotic message, “Your flight has been canceled.”  No explanation.  We called back to find that we had been “protected” – re-booked – on the next available flight, a couple of hours later.  So far, so good.   (Well, not really, but as good as it gets at that point.)  But then we discovered that our colleague, scheduled to fly with us, was not “protected” on our flight, but had been bumped to a much later flight so he could continue to take advantage of the first class upgrade he had not requested in the first place.  Good times. The next day, our flight for home departed right on schedule.  We landed in Philadelphia, taxied to the gate, stood up, and remained standing in the aisle for the next 30 minutes, informed that the jetway would not move to the door of the plane and “a mechanic has been called.”  Twice in one trip, the airline stopped just short of getting it right.

Recently, defendant Mentor Corp, moving for partial summary judgment in the Mentor ObTape Transobturator Sling Products MDL, similarly found itself at the mercy of a Court that laid the groundwork for a correct decision then stopped just short of getting it right.  Twice.

Plaintiff had been implanted with an ObTape transobturator sling in 2004 to address her stress urinary incontinence.  It was apparently undisputed that plaintiff “did not speak with anyone from Mentor or see any brochures, videos, product inserts, or other materials from Mentor before the procedure.”  In re Mentor Corp. Obtape Transobturator Sling Prods. Liab. Litig., 2015 U.S. Dist. LEXIS 93001 at *5 (M.D. Ga. July 17, 2015).  Plaintiff was happy with her implant until 2010, when she “began experiencing pain in her thighs.”  Id.  Initially, plaintiff was diagnosed with a groin strain; however, after several months of worsening symptoms, she was diagnosed with an abscess caused by erosion of the ObTape. She underwent excision surgery during which as much of the ObTape as possible was removed.  Id. at *6-7.Continue Reading Almost, but Not Quite: No Summary Judgment for Mentor on Two of Plaintiff’s ObTape Claims

Photo of Stephen McConnell

Is there a tougher federal district judge than Stephen Wilson in Los Angeles?  By “tougher,” we do not mean in the usual sense when applied to judges: handing out long criminal sentences – though that certainly does apply to Judge Wilson.   No, we mean in the sense of not suffering fools gladly.  (To borrow a phrase from the movie Rounders, if you are in court for a case for more than a few minutes and you cannot spot the fool, odds are that it is you.)  Judge Wilson, like Judge Rakoff in SDNY or Judge Posner on the 7th Circuit or Judge Kozinski on the 9th Circuit, has a sharp mind and sharp pen (or keyboard).  If he thinks your theory is wrong, he will say so.  If he thinks you are dumb, he will say so.  Sometimes Judge Wilson can come across as a wee bit impatient. When we were a prosecutor in C.D. Cal. (as Judge Wilson had been several years before us), Judge Wilson was the first judge we encountered who imposed strict time limits during trial.  If he decided that a witness examination had gone on long enough, he would halt the examination on the spot.  We remember a guilty plea in front of Judge Wilson that took place the day before trial was scheduled.  Guilty pleas can be messy affairs.  Some people, no matter how overwhelming the evidence, have a hard time admitting that they did the crime.  And yet, such admission is an essential part of the guilty plea.  Often, the defendant stumbles over the admission.  It can take some goading, some reassuring whispers from defense counsel, and simply some time before the defendant can bring him or herself to utter the magic words.  In our case, the defendant hemmed and hawed a little too much.  Judge Wilson said that there was not enough there for a valid guilty plea, he rejected it, ordered the parties to show up the next day for jury selection, and then called the next case.  It seemed to happen in an instant.  There was panic.  We had already told our witnesses that the case would plead out and that they did not need to come to the federal courthouse the next day.  For all we knew, our case agent was already well outside the jurisdiction, on a protection detail or going undercover.  On the other side of the ledger, the defendant knew what the result at trial would be, and wanted at least to get a couple of points off the sentencing guidelines for acceptance of responsibility.  Somehow the defendant and his lawyer got their act together and returned to court near the end of the day and performed the requisite guilty plea allocution, and all was right with the world.   Judge Wilson’s demonstration of impatience had worked.
Continue Reading Cymbalta Class Certification Denied Again

Photo of Steven Boranian

Federal preemption in the drug and medical device world is a game of categories.  Express preemption versus implied.  Conflict preemption versus field preemption.  Drugs versus devices, generic versus branded, premarket approved versus not.  These categories make a difference, and if you can place your controversy into the correct boxes, you can usually determine how to analyze whether federal law preempts state-law claims.  Sometimes you can even predict the result, or at least predict what the correct result should be.  We say “should” because there is discretion involved, and also some ambiguity in the applicable law. Moreover, preemption is like hockey: Many Americans can discuss it with some familiarity, but a much smaller number have studied all the nuances of the game.

From time to time a preemption order thinks outside the box, and that is what happened in Williams v. Zimmer US, Inc., No. 5:14-cv-468, 2015 U.S. Dist. LEXIS 91238 (E.D.N.C. July 14, 2015).  The case involved a bizarre situation where a surgeon took a medical device home, and “in his own garage, [he] used nonmedical tools purchased from a home improvement store to bend a 5.5 mm chrome rod into a ‘U’ shape.” Id. at *4.  Facts like these make us scratch our heads, but putting the weird facts aside, the device was cleared through the 510k premarket notification process.  As our readers know, under Lohr and Riegel, there generally is no express preemption under the Medical Device Amendments for 510k-cleared devices, so our knee-jerk reaction when a 510k device is involved is to put that case into a “no preemption” box.

But don’t forget about implied preemption, which is where  this district judge went with this case. Our do-it-yourself doctor used his Home Depot version of the device to treat a patient, who later sued alleging injuries.  But she couched her complaint entirely in terms of violations of the FDCA.

That had two dramatic consequences.  First, the defendants removed the case to federal court, and the district court ruled that it had subject matter jurisdiction because the case arose under federal law, i.e., the court had federal question jurisdiction.  Id. at **6-7.  This is exceptional because the vast majority of drug and medical device cases in federal court are there under diversity jurisdiction, even though the industry is subject to intense federal regulation.  An opinion finding federal question jurisdiction in a medical device case is a welcome development, and this plaintiff seems to have pleaded straight into it.Continue Reading Inside the Implied Conflict Preemption Box

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We are pleased to report that the proposed ABA Resolution 105 – first blogged about here – has been withdrawn and will not be an issue at the House of Delegates session at the upcoming ABA meeting.  The originators chose to withdraw it in the face of opposition from “several ABA entities and individual leaders…

Photo of Stephen McConnell

Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975).  Happy birthday also to Albert Brooks, writer/director/star of Modern Romance (1981), Lost in America (1985), Defending Your Life (1991), and a gaggle of other comedies.  Brooks also did fine work as an actor in several non-comedies, such as Taxi Driver (1976), Broadcast News (1987), and Drive (2011).  But for our money, his best performance is in Out of Sight (1998), where Brooks played a Michael Milken-esque financier-turned-prison-inmate.  By the way, Brooks’ birth name was Albert Einstein.  Brooks changed his name for obvious reasons.  He cracked that the great physicist had changed his name to Albert Einstein simply to sound smart.  Finally, happy birthday to Don Henley of The Eagles.  Henley sang and co-wrote “Hotel California” (1977), an allegory about SoCal showbiz excess.  The best line in the song is “We are all just prisoners here of our own device.”

Does that trio of birthdays suggest a theme?  Indeed, it does:  drugs and prisoners.  Today’s case is Flowers v. Eli Lilly & Co., 2015 U.S. Dist. LEXIS (D. Nevada July 10, 2015), in which a pro se plaintiff prisoner claimed that Zyprexa gave him diabetes.  The plaintiff had been prescribed Zyprexa at the beginning of his incarceration in 1997, went off it in 2003, and then back on it in 2009, continuing up through the filing of the lawsuit in 2014.  The plaintiff was diagnosed with diabetes in November 2012.  After learning of the diagnosis, the plaintiff requested that he be taken off Zyprexa.  The request was denied.  Remember, the plaintiff was a prisoner.  Patient choice seldom matters from a legal point of view in these cases (because of the learned intermediary doctrine, discussed below), but in this case it really, really does not matter. Zyprexa is an antipsychotic drug that can be used to treat very serious conditions such as schizophrenia and bipolar disorder.  The court’s opinion does not tell us why the prison wanted the plaintiff to be on an antipsychotic, but odds are there was a very good reason.Continue Reading Little Reprieve for Prisoner Zyprexa Suit

Photo of Michelle Yeary

If you are a parent, you’ve probably thought (more than once) that you speak a language your children do not understand.  After all, when you say “put your shoes away” or “stop hitting your sister” or the more recent addition of “no iPads at dinner” – you believe these to be simple, easily understood directions.  But when you’ve said them 5 times in the span of one hour, you start to question your own command of the language.  What is it that is not getting through?  What don’t they understand?  You look for acknowledgement from your significant other that he/she understands you.  While you take comfort in knowing that other adults comprehend, they are on your team already.  You don’t need to convince your own side.  But how do you finally drive it home to them.

How about when them are the plaintiffs?  How many different courts, over how many years, in how many different ways can say the same thing – Pennsylvania does not recognize strict liability for prescription medical products.  We are quickly approaching 20 years since Hahn v. Richter, 673 A.2d 888 (PA 1996) banned strict liability for prescription drugs and the extension of that ban to medical devices has been on solid footing for at least the last 10 years as well. But because the Pennsylvania Supreme Court has yet to explicitly state that the reasoning and ruling of Hahn applies equally to medical devices, plaintiffs keep filing strict liability device claims in Pennsylvania courts. And, appropriately, the courts keep shredding them.

Last week saw two such decisions from the Eastern and Western Districts of Pennsylvania.  One case involved a spinal implant – Wilson v. Synthes USA Prods., LLC, 2015 U.S. Dist. LEXIS 92347 (E.D. Pa. Jul. 15, 2015).  The other involved a hip implant – Cogswell v. Wright Medical Tech., Inc., 2015 U.S. Dist. LEXIS 92461 (W.D. Pa. Jul. 16, 2015).  In both, plaintiffs tried to argue that Pennsylvania’s ban on strict liability did not apply to medical devices.  In Wilson, plaintiff focused on the idea that medical devices could be “altered” to be more safe.  Wilson at *7.  The court was unpersuaded, finding instead that both drugs and devices are “unreasonably dangerous, but should not be subjected to strict liability because they benefit certain members of society.”  Id. Plaintiff in Cogswell tried a similar argument contending that medical devices are different because the risks could have been avoided.  Cogswell at *5.  Again, the court was unpersuaded.

The Cogswell plaintiff, however, took the argument further.  First, he tried to argue that prescription products are only covered by comment k (the basis for the strict liability ban in Pennsylvania) if certain caveats are met.  Those caveats were not recognized by the Pennsylvania Supreme Court and therefore, weren’t recognized by the district court either.  Id. at *6.  Next, he attempted to distinguish a strict liability manufacturing defect claim as permissible, arguing that Hahn only applied to failure to warn.  Not a new argument, but also not one that the court was willing to entertain.  “Had the Pennsylvania Supreme Court intended an exception to the strict liability rule, it presumably would have articulated one.”  Id. at *8.Continue Reading NO PRESCRIPTION MEDICAL PRODUCT STRICT LIABILITY IN PENNSYLVANIA

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The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much.  We’re gluttons for punishment, however, and this time we were rewarded.  We found a couple of recent law review articles that we think were actually worth the effort.

The first of these comes from our quest for enlightenment regarding 3D printing – which is already making an impact in the medical device market.  Aside from our own prior thoughts, we had not come across anything that we considered a serious analysis of the product liability possibilities when the user (or someone else farther along in the supply chain) also becomes the manufacturer of the product.  That changed with Heidi Nielson, “Manufacturing Consumer Protection for 3-D Printed Products, 57 Ariz.L. Rev. 609 (2015).  This article notes the various ways in which 3D printed products can reach the consumer:  (1) They could be manufactured and sold in the traditional way, with the consumer ordering a 3D printed product from a manufacturer or retailer; (2) a “hobbyist” (casual seller) sells a 3D printed product of his/her own design to a consumer (again, relatively traditional, but raising “deep pocket” concerns); (3) the consumer buys/downloads open source software and produces the product from the consumer’s own 3D printer; (4) the consumer, using acquired software, scans an existing product, creates his/her own printable file and then reprints the product from his/her own 3D printer (which could become typical for replacement parts).  Article, 57 Ariz. L. Rev. at 614-15.  This list already shows some serious thought.

The section on “Liability for Defective 3-D Printed Product” continues with the kind of discussion we’ve been hoping for.  In the first variant, it’s pretty traditional, except to the extent that a seller of 3D printed products claims to sell 3D printing “services” instead of products.  Such sellers “may attempt to contract out of liability for defects and instead hold CAD-file designers responsible.”  Id. at 616.  The article states that “independent designers of products are generally not held strictly liable for defects in their designs, but may be liable for negligence in their designs.”  Id. (citing law review article).  The casual seller problem is also noted.  Id. The bottom line (according to the article) is that small-scale sellers of 3D printed products would be subject to negligence, and larger-scale sellers subject to strict liability.  Id.Continue Reading A Couple of Law Review Articles We Actually Like

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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