We have another guest post today, from Reed Smith‘s own Erica Yen. This one is about a recent, interesting decision concerning the interaction between the Health Insurance Portability and Accountability Act (“HIPAA”) and the common law – with a good result this time. As always, our guest bloggers are 100% responsible for their
This is from the non-Reed Smith side of the blog.
Looking back at our posts on innovator liability, it’s becoming more and more difficult to title them. According to the DDL blog, innovator liability has been rejected, abolished, denied, refused, disallowed. You get the idea. With the news from earlier this summer that the California Supreme Court is going to consider the issue – which will hopefully spell the demise of Conte – we may be nearing the end of the chapter on innovator liability. In the meantime, we’ll keep bringing you the wins as they stack up.
Today’s case was actually decided right around the time the California Supreme Court decided to take on the issue. Gillette v. Boehringer Ingelheim Pharm., Inc., 2016 WL 4217758 (Mag. D. Minn. Jun. 16, 2016). The decision didn’t come to our attention, however, until the magistrate’s report and recommendation was adopted last week. See 2016 WL 4203422 (D. Minn. Aug. 9, 2016).
The Gillette decision comes out of the Mirapex MDL and involves the application of Indiana law. Indiana products liability claims are governed by the Indiana Products Liability Act (“IPLA”) which provides a single cause of action subsuming all common law strict liability and negligence claims, as well as tort based warranty claims. Gillette, 2016 WL 4217758 at *3-4, *6. So, plaintiff in this case had one cause of action based on her allegations that her use of Mirapex caused her to gamble compulsively.
But was it Mirapex that plaintiff was taking at the time she suffered her injuries? According to her pharmacy records, plaintiff was prescribed Mirapex from 2001 until 2015. Id. at *1-2. It appears that from 2001 until April 2010, plaintiff’s pharmacy filled her prescriptions with brand name Mirapex. In April 2010, when her prescribing physician increased plaintiff’s dosage, her pharmacy began filling her Mirapex prescriptions with its generic equivalent – pramipexole dihydrochloride. Id. at *1. From April 2010 until late 2015, plaintiff received the generic version of the drug manufactured by a succession of four different generic drug manufacturers. Id. at *1-2.
The imminent retirement of David Letterman sent our mind back to all those grim law school days that foreclosed any smiles until after midnight, when Letterman’s velcro suit, random items heaved off a roof, and stupid pet tricks helped us forget the indignities of Torts class or the opacities of Justice Blackmun. Letterman was not shy about highlighting his Indiana upbringing. Come to think of it, Indiana has produced an astonishing amount of talent. The Jackson 5 hailed from Gary, Indiana. John Mellencamp is from Indiana. (That hardly matters to us, but since Eric Alexander insisted on a Mellencamp shout-out, we obliged.) Two all-time icons of cool – James Dean and Steve McQueen – strolled out of Indiana. Sports is another area where Indianans have excelled. There are more NBA players per capita from Indiana than any other state. Larry Bird and Oscar Robertson played high school basketball in Indiana, and they both belong on the hoops Mt. Rushmore. Robertson’s high school team lost to tiny Milan High in the 1954 Indiana single-class high school state basketball tournament. Milan went on to win the championship. That remarkable run was the basis for Hoosiers, possibly the greatest sports movie ever. With Rudy and Breaking Away, that means that Indiana is the setting for three of the top ten sports movies. If you want to add Knute Rockne, All-American to the list, giving Indiana four of the top ten, we would not argue. Indiana also knows how to host a big-time sports event. The recent NCAA Final Four in Indianapolis was masterfully run. More important, it vindicated our prediction at a recent DRI conference that Duke would prevail. The NFL combine is conducted at Lucas Oil Stadium. If you ever get the chance to do a grounds tour of the Indianapolis Speedway, take it. You can do a lap around the brickyard, following the treadmarks of Johnny Rutherford, Mario Andretti, and AJ Foyt. Our tour guide was positively bursting with pride over the Speedway’s heritage. He pointed out that the first left turn on the French LeMans race course is named Indianapolis. The first left turn (they are all left turns) on the Indy Speedway is named … turn one.
One of our law school buddies was from New York. He tried and tried to get a job with one of the big Wall Street firms for the summer after his first year, but could not get a foot (white-shoed or not) in the door. He ended up working in Indianapolis that summer, and promptly fell in love with it. Your correspondent had the same reaction the first week in law school upon encountering a certain someone eight rows down in Property class. She was from Indiana. All of which is to say that we love pretty much everything about Indiana. When the Indiana Governor showed up on the Sunday morning talk shows a couple of weeks ago trying to defend a controversial statute, he kept saying that people from Indiana are relentlessly friendly. You can debate whether that friendliness had anything to do with the merits or demerits of that statute, but that friendliness is a fact. The next Hoosier we meet who is unfriendly, unkind, or unfunny will be the first. Moreover, putting our lawyer hat on (finally!), we have always found Indiana laws, judges, jurors, lawyers, and, last but certainly not least, clients, to be smart and sensible.
Why would any defendant not want to be in Indiana?
Well, litigation takes on a life of its own. All sorts of variables are in play as to where one would want a litigation to take place. Sometimes we argue about whether a court can exercise personal jurisdiction over our client. With the recent Bauman decision, that argument has renewed vigor. Sometimes we argue forum non conveniens – a term that means exactly what it sounds like, that a particular court is not sufficiently convenient for the parties. We’ve been on different sides of the forum non conveniens issue, sometimes arguing that the trial should be where our client is located, and sometimes arguing that the trial should be where the alleged injury took place. The latter is probably slightly more common, but we cheerfully admit to our flexibility. For that reason, we are usually careful in making pronouncements on forum non conveniens decisions, because we never know which side of the issue we will be on in any particular case. In the recent case of Depuy Orthopaedics v. Brown, 2015 Ind. LEXIS 319 (Indiana Supreme Court April 24, 2015), the defendants argued that their home jurisdiction of Indiana was less convenient than courts where the plaintiffs lived, in Virginia and Mississippi. The trial court disagreed with the defendants, but the Court of Appeals reversed and ordered the cases to be sent south. The Indiana Supreme Court then got the last word, and its word favored the plaintiffs and affirmed the trial court’s original decision keeping the case in Indiana.
On Friday, we posted about a Florida court that allowed negligence claims against a pharmacy that did nothing more than fill prescriptions as they were written (Oleckna). As you can imagine, we had some reservations about the ruling. Well, those reservations were driven home when we happened upon another recent pharmacy liability case, this one in Indiana – Kadambi v. Express Scripts, 2015 U.S. Dist. LEXIS 13607 (N.D. Ind. Feb. 5, 2015).
If we call Oleckna a “damned if you don’t” case, then Kadambi is the example of “damned if you do.” Which leaves the question – what is a pharmacy to do?
Plaintiffs in Kadambi are an endocrinologist, Dr. Kadambi, and 8 of his patients for whom he prescribed human growth hormone (HIGH). While plaintiffs allege that the prescriptions were medically necessary, the defendant pharmacies refused to fill HIGH prescriptions from Dr. Kadambi because they believe the prescriptions might violate federal law making it a “crime to knowingly distribute HIGH” for improper purposes. Id. at *3. Defendants alleged that they had a good faith belief that Dr. Kadambi was prescribing HIGH for non-medically acceptable reasons and/or that he was affiliated with organizations that advocate
off-label use of HIGH. Id. at *4.
Plaintiffs advanced essentially two causes of action against the pharmacies – violation of Indiana’s statute governing pharmacies and defamation. While the court dismissed the statutory claim, it allowed the defamation action. We’ll go through the court’s ruling, but our real interest lies in the fact that both Kadambi and Oleckna are moving forward.
As one of our other bloggers have recently revealed, Bexis recently went on vacation for two weeks. He was diligent, however, and pre-wrote two posts (not time sensitive) that appeared in his absence. As for the co-blogger’s quip about Bexis’ “active, muscular vacations” well, in this instance that’s probably right. For most of Bexis’ two-week absence, he was rafting through the Grand Canyon.
With Bexis otherwise occupied, the blog’s other denizens did an admirable job of keeping up with current developments in case law, but nonetheless items piled up in Bexis’ inbox awaiting his return. Most of them weren’t even judicial opinions. It’s time to empty that inbox.
Perhaps the most important development was the approval, on May 29, by the full Federal Judicial Conference’s Standing Committee on Rules of Practice and Procedure, of the discovery-related rules changes that we’ve been covering on the blog. Bexis has been heavily involved in this effort through the Lawyers for Civil Justice (“LCJ”), and LCJ sent him notice of the approval. We’d pass it along, except it includes internal LCJ business as well. So we’ll just hit the highlights.
First, there were no changes to the language of the proposed amendments themselves, which we have previously discussed. The only changes from the version published in the subcommittee’s agenda book were: (1) a new sentence in Note for Rule 26(b)(1) encouraging computer search technology (that is to say, predictive coding), and (2) modifying the Note for Rule 37(e) concerning the role of prejudice in subsection (e)(2). Thus, the main benefits of the amendments from our perspective remain:
- enshrinement of proportionality in Rule 26(b)(1);
- curtailment of the capacious “reasonably calculated” standard for the scope of discovery in the same subsection;
- Explicit rejection of the negligence-based standard for ediscovery sanctions in Residential Funding Corp. v. DeGeorge Financial Corp., 306 F.3d 99 (2d Cir. 2002), and thus by necessary implication of other precedent in that circuit following that standard (this means you, Zubulake); and
- Requiring a finding of specific “intent to deprive another party of the information’s use in the litigation,” under Rule 37(e)(2) before any federal jury can be instructed on evidentiary presumptions from loss of electronic information.
We start June with a fabulous two-fer: yes, that is two cases discussed in the same post. But wait, there’s more. The two cases each discuss civil RICO claims against drug companies and state law claims. For an unknown, but surely exorbitant, cost to the defendants, the courts, and maybe even the third party payors…
This post is from the non-Reed Smith side of the blog.
As we pointed out earlier this week, we are typically more interested in defense victories on this blog. But every once and a while, we find cases that go the other way that we believe merit a mention. Sometimes that is because the decision is too significant to ignore.
Sometimes it is because of the court that renders the decision. Sometimes – like yesterday and today – it is because we want to remind our readers of issues that while not common, are nonetheless real. Unfortunate issues that crop up from time to time. Yesterday, that was about a loss on fraudulent joinder involving claims against a sales representative. As we mentioned then, more often than not – defendants win that issue.
Today’s case continues the sales representative theme. A couple of years ago, we posted a cumulative piece on cases dealing with sales representatives who are present in the operating room. It isn’t something that we come across very often and from our review, the decisions are split (largely based on the particular facts) as to whether the actions of a sales representative create a cause of action against the device manufacturer. The issue, boiled down to basics, is whether the sales rep got too involved in the actual treatment of the patient or use of equipment during surgery. It was on that basis that the plaintiff in Medtronic, Inc. v. Malander, 2013 Ind. App. LEXIS 499 (Ind. Ct. App. Oct. 11, 2013) brought a negligence claim against the manufacturer of her husband’s defibrillator. The defibrillator, a Class III PMA medical device, was implanted in 1997 and upgraded in 2004. In 2006, plaintiff’s husband began experiencing a problem with the device known as V-V intervals. Id. at *3.
During another upgrade surgery, one of defendant’s “clinical specialists” was present to assist with testing the device. The test revealed no problems. During the procedure, plaintiff’s surgeon also called defendant’s “technical services department” requesting information on V-V intervals and lead failures. Id. at *4. Defendant’s technicians responded: “Don’t worry about that; it doesn’t mean anything . . . I don’t think that’s a problem . . .” Id. The surgeon did not replace the device. Plaintiff’s husband died a month later, following more episodes of V-V intervals. Plaintiff’s claims against the defendant included design defect, failure to warn, failure to recall, and failure to recommend removal during the 2006 surgery. Id. at *5.
The Indiana Court of Appeals recently issued an opinion applying the section of Indiana’s Product Liability Act (IPLA) that, under certain circumstances, creates a rebuttable presumption against a finding of defect or negligence in product liability actions. See Gresser v. Dow Chem. Co., 2013 Ind. App. LEXIS 204 (Ind. Ct. App. Apr. 30, 2013). …
Indiana now has its first appellate decision concerning MDA preemption. McGookin v. Guidant Corp., ___ N.E.2d ___, No. 71A04-1001-CT-101, …
We see so many cases alleging “illegal” promotion of off-label use that when we find one where the plaintiffs don’t make that sort of allegation, it makes us sit up and take notice. That’s the case with Meharg v. I-Flow Corp., No. 1:08-cv-184-WTL-TAB, slip op. (S.D. Ind. March 1, 2010). It’s a pain pump case – the allegations being that these pumps, which are used after shoulder surgery, continuously “infused” various types of anesthetics intended to (evidently successfully) reduce post surgical pain, but that the continuous exposure (or anything else a creative expert might come up with to blame on defendants) caused long-term deterioration (“chondrolysis”) of shoulder cartilage.
The pumps (which are FDA approved) are machines, and of course machines don’t care what you put in them – they’ll infuse it. Thus, the most interesting aspect of pain pump cases we’d seen prior to Meharg had to do with product identification. That is, plaintiffs have been trying to sue various drug companies without even being able to allege the the defendant’s drug was actually used. That’s a no-no, and it’s produced some favorable decisions reaffirming the rule that a plaintiff can only sue the manufacturer of a product s/he actually used. Timmons v. Linvatec Corp., ___ F.R.D. ___, 2010 WL 476661, at *3-4 (C.D. Cal. Feb. 9, 2010); Haskins v. Zimmer Holdings Inc., 2010 WL 342552, at *2 (D. Vt. Jan. 29, 2010); Gilmore v. DJO Inc., 663 F. Supp.2d 856, 860-61 (D. Ariz. 2009); Combs v. Stryker Corp., 2009 WL 4929110, at *2-3 (E.D. Cal. Dec. 14, 2009); Dittman v. DJO, LLC, 2009 WL 3246128, at *3 (D. Colo. Oct. 5, 2009); Sherman v. Stryker Corp., 2009 WL 2241664 at *5 (C.D. Cal. March 30, 2009). These pain pump cases are yet another reason why we like Twombly/Iqbal.
We expect that the pain pump litigation will continue producing decisions on weird points, because the plaintiffs will be suing the wrong defendants, the manufacturers of the drugs used in the pumps, over injuries that were caused, not so much by the drugs, but by how the drugs were continuously infused by the pumps – if there’s any causation at all, that is. In fact, we can almost guarantee it.