July 2014

Court: It’s Only Unconstitutional If You, Not We, Do It

By Bexis on July 31, 2014

A bit of a rant today.

We’ve just read Gibson v. American Cyanamid Co., ___ F.3d ___, 2014 WL 3643353 (7th Cir. July 24, 2014), and we have to say that it’s one of the most constitutionally arrogant decisions we’ve ever read. Stripped to its essentials, Gibson is the judicial branch thumbing its nose at the supposedly co-equal legislative branch and saying “we can do it but you can’t.”

Gibson involves one of these seemingly one-way legal doctrines that only protects plaintiffs, but for some reason never defendants, the concept of so-called “vested rights.” Here’s the back-story.

Thirty years ago, the Wisconsin Supreme Court, in a judicial exercise of social policymaking, decided to adopt a peculiar form of an already peculiar doctrine – market share liability. See Collins v. Eli Lilly Co., 342 N.W.2d 37 (1984). The court breached a hitherto (mostly) sacrosanct defense – product identification − that a defendant can’t be liable unless the plaintiff first proves that s/he actually used the defendant’s product. The reason was … well, the usual fuzzy-headed logic that the common law can change and we think it’s better that the plaintiff wins. Id. at 45 (we can change the common law), 49 (we’re gonna change the law and let the plaintiffs win because of “interests of justice and fundamental fairness”). Despite the fact that the product was off the market and plaintiffs had taken it many years earlier, the court in Collins had no compunction in extending this new theory of liability retroactively to defendants whose conduct had previously been protected by the product identification defense.

Collins, as most of our readers probably already know, was a DES case. DES was, for all intents and purposes, the world’s first generic drug. Its patent had expired, so anybody who wanted to go to the time and effort to do so (this was the pre-1962 FDA, before NDA requirements were made a lot tougher) could set up shop and make the drug. Scores of companies did, and “DES” became the reference of choice for most doctors and pharmacists. Given the peculiarly long latency period for the peculiar injury – suffered in utero − in DES cases, product identification was a mess. Collins decided to let the plaintiffs win anyway by shifting the burden of proof, contrary to decades (at least) of precedent.

At least in Collins there was a real product identification problem. In the next case (the one ultimately at issue in Gibson), a bunch of class action lawyers decided to gin up a product identification problem. They wanted to sue on behalf of everybody theoretically injured by lead paint, which had been off the market for a quite a while by the time suit was brought. Since causation was an individualized issue that could defeat aggregated litigation, they created an impossible ID problem by skipping over the manufacturers of lead paint (some of whom might have been identifiable in building maintenance records) and sued only the bulk suppliers of lead paint pigment.Continue Reading Court: It’s Only Unconstitutional If You, Not We, Do It

More Maya

By Stephen McConnell on July 30, 2014

The other day ESPN’s Sportscenter ran a teaser entitled “Less of Maya Moore.” WNBA player Maya Moore had what was for her a less than stellar night, but her teammates on the Minnesota Lynx picked up the slack and they won anyway. Maya Moore is a fantastically gifted basketball player with the resume to prove it. She has won team championships and MVP trophies on the collegiate and professional levels. A scientist has measured Moore’s reflexes to approximate those of a striking rattlesnake. Moore has also donned makeup to look like an old lady and, along with Kyrie Irving dressed up as Uncle Drew, scammed some recreational ballers on a neighborhood hoops court. The video is here.

Maya Moore is very, very good at what she does.

By contrast, the Maya litigation in our fair city is very, very bad. First, there was the trial here in the Philly Court of Common Pleas, where the plaintiff won a $10 million verdict when a jury found that the defendant failed to warn that over-the-counter Motrin could cause SJS/TEN (a rare but life-threatening disease that causes severe blistering and sloughing off of skin, together with serious damage to the mouth, eyes, throat and esophagus).Continue Reading More Maya

Lack of Specificity OK in Kentucky

By Michelle Yeary on July 29, 2014

When a decision says the Court finds much of the reasoning in Bausch, Stengel, and Hughes particularly persuasive, you don’t have to be the Amazing Kreskin to guess that we aren’t going to like the ruling. You just need to be a regular reader of this blog.

Unfortunately, that’s precisely what Waltenburg v. St. Jude Medical, Inc., 2014 U.S. Dist. LEXIS 98369 at *35, *56 (W.D. Ken. Jul. 18, 2014) does say. We’ll give the opinion some credit for a fairly thorough discussion of the relevant case law going both ways on preemption and TwIqbal – but it loses most of its appeal by landing at the wrong end of the spectrum.

The case involves an implantable cardioverter defibrillator (ICD). Plaintiff alleges that certain of the wires (or leads) have eroded causing the ICD to inappropriately administer electrical shocks to plaintiff. Id. at *1-3. The ICD is a Class III, PMA medical device. Defendant moved to dismiss the complaint based on preemption and TwIqbal.Continue Reading Lack of Specificity OK in Kentucky

Privacy of Medical Information: Still No Harm, Still No Foul

By Steven Boranian on July 28, 2014

We expanded our practice into data privacy and security out of practical necessity. Expectations surrounding privacy of personal information are evolving, and the laws that regulate data privacy change every day, generally to expand protection for private information. Another thing that has changed is that we used to say that drug companies and medical device…

Guest Post – Another Third Party Payor Case Is Shown The Door

By Bexis on July 25, 2014

Today we have this guest post from Reed Smith‘s Andrew Stillufsen about a recent defense win in a third party payer (or is it”payor”?) case here in the Eastern District of Pennsylvania. We hope you find it as interesting as we did. As usual all credit and/or blame belong to the guest poster.

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Travelers Indemnity Co. v. Cephalon, Inc., is a third party payor case where plaintiffs – workers compensation insurers – claimed that they were injured by paying for prescriptions for defendant drug company’s pain medications which were written as a result of its alleged off-label marketing of the drug. 2014 U.S. Dist. Lexis 95075 (E.D. Pa. July 14, 2014). SPOILER ALERT: as with similar cases, even after extensive discovery and an amended complaint, plaintiffs still failed to allege facts sufficient to establish standing or to support any of their fraud claims. Motion to dismiss granted.

Before the court could address plaintiffs’ substantive claims, it first had to determine whether the allegations were sufficient to establish standing. To establish standing, the plaintiff must show that they suffered a cognizable injury. Id. at *16-18. “The contours of the injury-in-fact requirement, while not precisely defined, are very generous, requiring only that the claimant allege some specific, identifiable trifle of injury.” Id. at *17. (citations and internal quotations omitted). Under the now-familiar TwIqbal analysis, plaintiffs failed to allege sufficient facts to show even a mere “trifle.”

In this case, plaintiffs essentially alleged two theories of injury. First, they claimed they were injured because “they did not get what they paid for,” as plaintiffs paid for drugs that were not safe or effective due to defendant’s alleged fraudulent off-label marketing. Second, but for the alleged off-label marketing, plaintiffs claimed they were injured when they paid for more expensive drugs when less-expensive drugs were available. Id. at *18-19.Continue Reading Guest Post – Another Third Party Payor Case Is Shown The Door

Testing the Limits of Prescription Drug Preemption

By Steven Boranian on July 24, 2014

Just how far can a state go in regulating prescription drugs? The simple answer is that states can go nowhere and that FDA is king in this field under the FDCA and the Supremacy Clause. But we all know that it is not that simple. We are reminded every day when we come to work that states regulate prescription drugs by allowing state-law tort lawsuits, although federal preemption is a mighty shield where it applies. We are also aware that states regulate the practice of medicine, as well as regulating the pharmacies that dispense prescription drugs on doctors’ orders.

So before we blithely tell our various state regulators to stand down and keep their hands off, let’s take a more nuanced view, including revisiting what is going on in Massachusetts over the narcotic pain medication Zohydro. As we have previously said, Zohydro ER is an extended release version of hydrocodone, but it is the only hydrocodone analgesic on the market whose sole active ingredient is hydrocodone. Others contain acetaminophen, and removing that component mitigates the risk of liver damage for which acetaminophen is well known.

After the FDA approved Zohydro in December 2013, the state of Massachusetts and others tried to prohibit its use because of concerns over abuse. In Massachusetts, the state issued an emergency order banning the prescription, ordering, dispensing, and administration of Zohydro—essentially a state-law order taking an FDA-approved drug off the market. On April 15, 2014, the District of Massachusetts enjoined the law as an obstacle to the purposes and objectives of Congress. In other words, it was a textbook example of implied conflict preemption, and the only solution was for the state requirement to give way, which is what the district court held in granting a preliminary injunction. Zogenix, Inc. v. Patrick, No. 14-11689-RWZ, 2014 WL 1454696 (D. Mass. Apr. 15, 2014). Our post on that decision is here.

Continue Reading Testing the Limits of Prescription Drug Preemption

Court Dismisses Balderdash Solodyn Complaint

By Stephen McConnell on July 23, 2014

The genius who devised the theory of evolution. The statesman who defended Western Civilization against the Nazis. The man who freed a subcontinent via the majesty of nonviolent resistance. The greatest basketball player of all time. The composer of Shaft. The Pope’s favorite saint. Our national emblem.

What do these heroes have in common?

Today’s case is Dimieri v. Medicis Pharm. Corp., 2014 U.S. Dist. LEXIS 95409 (M.D. Fla. July 14, 2014). Dimieri ingested Solodyn for the treatment of acne. He discontinued use of Solodyn after experiencing “numbing pain in the crown of his head” and noticing alleged hair loss. He alleged that Solodyn was making him bald. That, apparently, ranks as an injury. He brought a complaint against the defendant for failure to warn, strict liability, breach of warranties, misrepresentation, negligence, and fraud.Continue Reading Court Dismisses Balderdash Solodyn Complaint

No Duty for Sales Representatives in the Operating Room

By Michelle Yeary on July 22, 2014

If anyone is still shocked that medical device manufacturers’ sales representatives are present during surgery – don’t be. It’s a common practice. If you don’t believe us, see our posts here and here. Surgeons believe manufacturers’ representatives have an important role to play in making sure the surgical instruments and the surgical team are fully prepared. That means that reps are in the OR to stay.

With that comes the very real possibility of sales representatives being sued by plaintiffs who believe something went wrong during surgery or the possibility of manufacturers being sued for the alleged acts/omissions of their representatives during surgery. Our earlier posts cover both situations and today we’ve stumbled upon another example of the latter — McCartney v. U.S., No. 2:13-CV-1118 TS, slip op. (D. Utah Jul. 16, 2014). Plaintiff underwent multiple surgeries involving implantation of defendant’s spinal cord stimulator. One or more of defendant’s representatives was present during plaintiff’s surgeries. McCartney, slip op. at 1-2. During one of the procedures, one of these reps called the plaintiff’s wife to ask about the location of the plaintiff’s pain. Plaintiff’s wife didn’t know which leg was afflicted. Id. at 2.

Plaintiff brought two negligence claims against the manufacturer based on its representatives being present during his surgery. The first claim is premised on an alleged general duty of care owed by manufacturers to ensure that their devices are properly implanted. Id. at 4. In support, plaintiff alleged that the manufacturer’s representatives “instructed” his surgeon as to how to implant the stimulator (an act) and failed to ensure that the device was properly implanted (an omission). Id. at 6. The difference between an act and an omission was critical to the court’s decision on whether there was a duty. “Acts of misfeasance typically carry a duty of care while nonfeasance generally implicates a duty only in cases of special legal relationships.” Id.Continue Reading No Duty for Sales Representatives in the Operating Room

The Next Best Thing to Removal

By Bexis on July 22, 2014

Okay, so you’d really like to remove that case that the other side filed in one of the notorious litigation tourist traps, but. . . . The insignificant in-state – that is to say, nondiverse – defendant was held not to be fraudulently joined, so your case was remanded to state court. What next?

Defense lawyers shouldn’t give up. We’ve written before about Bauman and the new personal jurisdiction arguments it may provide.

But other, less novel approaches also exist. How about forum non conveniens?

That’s the lesson of the recent California trial court decision in In re Accutane Drug Cases, 2014 WL 3579826, slip op. (Cal. Super. L.A. Co. July 21, 2014), obtained courtesy of Brian Ziska at Shook Hardy.

The defendant in Accutane was the same boat as a lot of defendants in California litigation. Plaintiffs from all over the country, literally from New York to Washington state, joined a factually insignificant in-state drug distributor (McKesson Corp.) for the purpose of defeating diversity jurisdiction, and for that reason alone. We’ve blogged about this fact pattern before, and it’s undoubtedly duplicated in dozens of fraudulent joinder/remand cases from California.Continue Reading The Next Best Thing to Removal

Preemption Made Easy

By John Sullivan on July 21, 2014

The reason that the court’s decision in Wagner v. Pfizer, 2014 U.S. Dist. LEXIS 94281 (W. D. Wisc. July 11, 2014), is useful is not because it dismisses state-law claims against generic manufacturers on the basis of preemption and other defenses we like. It certainly does those things, and that’s good. But we see decisions like that almost every week. What Wagner does, however, is add to the quality of those decisions, not just their quantify. Its opinion is clear and unhesitating. It takes on Mensing and Bartlett preemption and the non-existence of failure-to-update claims in barely more than three crisp pages. And, along the way, it provides uncomplicated and convincing passages that all of us can use in our future briefing.
Continue Reading Preemption Made Easy

Drug & Device Law