Federal law does not allow generic pharma companies to deviate from brand formula.
In late March, the U.S. Supreme Court heard arguments in a case being watched closely by pharmaceutical companies and federal regulators. The case will require the Court to clarify the legal remedies available to patients who are injured because they took generic drugs.
Karen Bartlett suffered horrific injuries following a reaction to the generic form of a relatively mild prescription anti-inflammatory medication that her physician prescribed in December 2004 for shoulder pain. Her injuries included blindness, lung and esophageal damage, and a skin condition known as toxic epidermal necrolysis, requiring two months in a hospital burn unit and months more in a medically induced coma. Bartlett sued the manufacturer of the drug, alleging the product was defective.
After 14 days of trial, New Hampshire jury awarded her $21 million.
The drug manufacturer, Mutual Pharmaceutical Company, appealed, arguing that it could not have changed the drug’s design because federal law does not allow generic pharmaceutical companies to deviate from the brand-name drug being copied.
Bartlett’s case will fit into a developing line of judicial precedent defining the limits of generic drugmakers’ liability. In 2011, the Supreme Court held that generic drugmakers could not be sued for inadequate labels or warnings because such companies have no control over labeling, which is dictated by requirements imposed by the FDA on the generic drug’s brand-name counterpart.
In the Bartlett case, Mutual claims that the same principle should apply to Bartlett’s lawsuit because similar to labeling, the recipe for a generic drug is dictated by its brand-name equivalent.
If the Supreme Court sides with Bartlett, generic drug manufacturers express concern that the decisions of individual juries would outweigh the authority of the federal agencies charged with regulating the manufacture of medications. Patient advocacy groups contend that Bartlett’s case differs from the 2009 Supreme Court case limiting liability for the labeling of generic drugs because, although federal law may require a drug company to label its products a certain way, drug companies do not enjoy an absolute right to sell their products.
The outcome of Bartlett’s case could affect millions of people: Generic drugs now account for 80% of all prescriptions in the United States, and most states permit pharmacists to dispense a generic in place of a brand-name drug. Until the Supreme Court decides the latest case in this developing legal landscape, it remains uncertain whether injury-causing generic and brand-name drugs can give rise to the same liability in addition to the same potential side effects.
Alexander B. Reich is an associate in Calfee’s Litigation group. He can be reached at 216.622.8621 or at email@example.com.