Making Profits Without Risk — Generic Drug Sellers Get a Free Ride

If I sell you a product and make a profit from selling that product; do I owe a duty to you for the reasonable safety of that product?

Most reasonable people would agree that a company should not be permitted to simply ignore the safety of products it profits from and be permitted to cause injuries or death without any recourse available to the harmed person.

As reported by the New York Times that is exactly what generic drug manufacturers are permitted to do because of a Supreme Court ruling, Pliva v Mensing.

The Supreme Court has ruled a generic drug company can sell and profit from the sale of generic drugs it “copies” from a brand name drug manufacturer. Unlike the brand name drug manufacturer, the generic drug company has no liability for injuries or death the drug they sell may cause.

The theory behind the law is found in legislation requiring generic manufacturers to use the same labeling materials and verbiage that was used by the brand name drug manufacturer. So, if the brand name manufacturer has hidden the risks of a drug, the generic manufacturer is free from any liability for failing to ensure that the drug is safe before they sell and profit from it.

The “immunity” of generic drug manufacturers is particularly striking since they have gone from holding 19% of the drug market in 1984 to 75% of all dispensed drugs today. And, quite often, when a generic of a drug has begun to be marketed, the brand name manufacturer completely discontinues its sale, and thus concern for, the drug.

In minority opinion in Pliva v Mensing, the justices set forth the irrational application of the principles applied by the majority of the court:

“As the majority itself admits, a drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic. If a consumer takes a brand-name drug, she can sue the manufacturer for inadequate warnings under our opinion in Wyeth. If, however, she takes a generic drug, as occurs 75 percent of the time, she now has no right to sue. The majority offers no reason to think—apart from its new articulation of the impossibility standard—that Congress would have intended such an arbitrary distinction. In some States, pharmacists must dispense generic drugs absent instruction to the contrary from a consumer’s physician. Even when consumers can request brand-name drugs, the price of the brand-name drug or the consumers’ insurance plans may make it impossible to do so. As a result, in many cases, consumers will have no ability to preserve their state-law right to recover for injuries caused by inadequate warnings.”

Patients taking the generic drug are left with no legal recourse for their injuries and future medical care. So, if drug manufacturers are permitted to walk away from the damages they cause, who pays? We do. Tax payers or health insurers will bear the burden for the continued care of these tragically hurt people.