Generic drug makers escape legal liability under landmark Mensing case decision

For people hurt by bad drugs, the process for seeking recovery and damages are pretty straightforward: hire an attorney, sue the “Big Pharma” company responsible for making the bad drug (often in a class-action with thousands of similarly injured individuals), settle outside of court or hope for a huge jury verdict with punitive damages, and wait for the check, minus the one-third cut for attorney’s fees. While the actual litigation process can be quite a bit more complex than that simplistic view, most mass-tort Plaintiffs were at least secure in knowing that they could pursue their case against a big, deep-pocketed target in the pharmaceutical company that made the drug, whoever that company was. Now, under the Supreme Court’s holding in a case known to the mass tort bar simply as Mensing, plaintiffs find that their options for recovery from harm from a bad drug depend largely on whether that drug was a name-brand or a generic.

You see, under Mensing, a generic manufacturer of a specific drug can avoid liability, while the original brand-name manufacturer of the drug could not. Mensing states, in a nutshell, that generic manufacturers of drugs cannot be held responsible for a faulty “design” of a drug, because they merely copied the chemical composition of a drug designed by the original developers of the drugs, the Merck’s and Johnson & Johson-types of big pharmaceutical companies. Because the generic manufacturer merely “copied” someone else’s product that had its patent protection expire, the theory goes that they had nothing to do with the design or development of a faulty drug that later caused injury to patients. Generics don’t “design” at all, they merely make exact copies, so they avoid liability that the original designer cannot.

The other main approach plaintiff’s attorneys use to attack a bad drug is under a concept of failure to warn: that although the drug may be effective in treating whatever health condition it is prescribed for, it also comes with many unwanted and potentially dangerous side effects. Anyone who has listened to the long list of “side effect disclaimers” at the end of the latest miracle drug commercial showing smiling happy users is familiar with this concept. It’s also the reason every prescription you get comes with a “tiny-print” list of all the potential side effects you should be aware of. These are the drug manufacturer’s attempts to “warn” users upfront, to avoid potential legal issues later from people who claim they were unaware of the risks, but were informed of them upfront by the maker.

The “failure to warn” approach is also rendered ineffective against generics under Mensing though, but for a different reason. The FDA approval of generic medications requires not only that they be chemically-identical to the original drug, but that their instructions and warnings be identical too, otherwise they risk substantial legal action against them from the FDA or state consumer protection bureaucracies. So, even if a generic manufacturer wanted to add additional warnings to a drug because of side effects they became aware of and wanted to inform consumers about, they are prohibited from making any changes to the labeling or literature unless the original drug’s wording has been updated first. Thus, since the generics are forbidden from using any warnings that aren’t already approved for the original drug, it makes sense that the courts would say they couldn’t then be held liable for failing to warn consumers.

Although it sounds counter-intuitive, the same drug causing the same injury could be completely safe from legal liability, depending purely on which brand name is on it. For consumers who are taking a presumably less-expensive version of a drug, and one that has been on the market for some period of time, their chances of a legal recovery are slim or non-existent because of which version they picked up at the pharmacy. While this make strike some people as grossly unfair to bar recovery for legitimately harmed consumers just because their particular pill is the generic version, for now this case dramatically changes the litigation environment for plaintiff’s seeking to recover for their injuries from taking dangerous drugs.

Barry Sommers

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