In the original Hunger Games movie, while Katniss and Rue are plotting to blow up the Careers’ food stash, Katniss remarks that “destroying things is much easier than making them.” That’s how we feel about our bottom ten worst prescription drug and medical device decisions of 2015. It’s so much easier to destroy life-saving and health-enhancing prescription medical products through litigation than to create them. New prescription medical products have added much of the decade-plus increase in life expectancy since 1950 (from 68.2 to almost 79 years in 2013). But the United States still trails dozens of countries that don’t tolerate the kind of litigation that we allow here – despite spending more than anyone on healthcare. Is it mere coincidence? We can’t say, but we doubt that litigation ever increases life expectancy.
It’s easier to denigrate products than to create them, as the cases that follow demonstrate. Hold your collective noses because here we go again. What follows is our annual list of the ten worst court decisions of the year (2015) arising from prescription medical product liability litigation – often with reasoning worthy of tracker jacker venom. These blood-pressure-raising decisions did nothing for our life expectancy, and even less to encourage development of new products that could help others. We can’t justify these rulings, except to say that sometimes the rats win the rat race, and the goose that laid the golden egg gets cooked. Before we dampen holiday spirits too much, remember that next week we get to celebrate the best, instead of bemoaning the worst.
But for now, let the bemoaning begin:
- Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015). The worst thing about this case isn’t that it affirms a $63 million (over $100 million with interest) verdict, so you know it’s pretty bad. It’s another SJS/TENS case in which the horrific nature of the injuries all too often overcomes a jury’s common sense. For this reason, such cases should engender heightened judicial scrutiny, but in Reckis the opposite happened. Doing the most potential damage, long term, was the court’s ruling on preemption, an issue that has now been appealed to the Supreme Court. The court converted the Levine (2009 -1) “clear evidence” test from what the Supreme Court said – “that the FDA would have” rejected a warning change − to an unprecedented “FDA actually did reject” the change when proposed by the defendant standard. To do so, Reckis presumed that the FDA would violate its statutory mandate, and be more likely to approve a label change submitted by a manufacturer (the defendant) than the same label change submitted via citizen’s petition, although the substantive standards are completely identical. The court offered no support for this total speculation. The actual Levine standard is bad enough; this one is essentially impossible to meet and only if the defendant ignores the regulatory scheme. That’s not all. The court allowed causation based solely on the testimony of a witness-for-hire pharmacologist who had never treated an SJS/TENS patient. Since nobody knows what causes SJS/TENS, and plaintiffs have laid the condition at the doorstep of literally dozens of drugs in litigation, the court allowed an unqualified and inexperienced witness to offer a novel causation opinion where numerous, real physicians who had actually treated this condition were unwilling to tread. Oh, and it appears to be the largest PI verdict ever allowed on appeal in Massachusetts history. We lambasted Reckis here and then discussed the defense cert. petition to the Supreme Court here.
- Boston Scientific Medizintechnik GmbH v. AOK Sachsen-Anhalt – Die Gesundheitskasse, 613CJ0503 (CJEU 4th Ch. March 5, 2015). This is the first time that any decision from outside the United States has ever appeared on our year-end best/worst lists. This dangerous medical device decision by the equivalent of the supreme court of Europe fully warrants the exception. From now on, anybody recalling a product (the case goes beyond medical devices) in Europe must be very careful in wording the recall notice or else will run the risk of large damages for every device of the type involved. Plaintiffs (here, third-party payers) no longer have to prove that the particular device alleged to cause injury even had the defect that prompted the recall. Throughout the European Union, under its consumer expectation standard a maker of a product having life-threatening risks essentially becomes an insurer. “In view of the life-threatening risk presented by a defective device, the patient may, in principle, reasonably expect the implanted device to have a failure rate of close to zero.” Got that? Zero. Furthermore, actual warnings don’t defeat this deemed “expectation.” And we thought communism was dead in Europe. We brought our readers the bad news from across the Pond here.
- State v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 777 S.E.2d 176 (S.C. 2015). Just about every place else – Pennsylvania, Louisiana, Arkansas, Alabama, West Virginia − where state attorney generals (or more likely no-bid, contingent fee lawyers purporting to exercise state power on their behalf) have sought (and sometimes obtained) huge verdicts through endless multiplication of statutory penalties, state appellate courts have stepped in to restore sanity. Not so in South Carolina. As we lamented here, after the South Carolina Supreme Court got through with the aptly sounding acronym SCUTPA, the defendant was...
