United States: Brand Defendants Thwart Another Innovator Liability Claim

Last Updated: August 16 2016
Article by Michelle Yeary

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 (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.

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.

Plaintiff's complaint and her sworn discovery responses allege that plaintiff did not begin to exhibit signs of compulsive gambling until her prescription was increased in April 2010. Id. at *5. While plaintiff tried to alter her allegations in her sur-reply to the motion for summary judgment to include instances of gambling before 2010, the court rejected them both as self-serving and as insufficient evidence of "compulsive" gambling (they were isolated incidents). Id. So the court concluded that plaintiff's injuries could only even have been potentially caused by the medication she ingested after April 2010 – the generic version. Id.

Plaintiff, however, only sued the brand-name manufacturer of Mirapex. Meaning plaintiff's product liability claim could only survive if the court found that a brand manufacturer could be liable for injuries caused to a user of a generic equivalent. Like so many other federal courts to face this issue, the Mirapex MDL court did not have a decision directly on point from the relevant state's highest court, in this case Indiana. But, it did have other federal court and lower state court interpretations of Indiana law and no reason to quibble with any of them. Id.

The IPLA requires that the defendant must have "sold, leased, or otherwise put into the stream of commerce the product that caused the user or consumer's physical harm." Id. Certainly those aren't the facts here where defendants did none of those things. And the cases to have interpreted the IPLA in similar factual circumstances concluded that brand manufacturers owed no duty of care to users of the generic product. Id. The discussion of innovator liability is neither lengthy nor complicated. It stands on considerable precedent. It's like a reverse Jenga game. The tower is virtually solid with only a few small holes to fill. Now to see if California plugs one of those gaps.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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