Access To Justice

A federal judge has ruled that FDA approval of a generic drug does not inoculate generic drug makers against lawsuits, according to a report in the Legal Intelligencer. U.S. District Judge Berle M. Schiller based his ruling upon the U.S. Supreme Court’s landmark Wyeth v. Levine preemption decision, which says that federal regulatory approval of a drug does not shield the maker from liability under state law.

In his decision regarding In re Budeprion XL Marketing & Sales Litigation, Schiller declined to dismiss a suit in which the plaintiffs alleged they experienced side effects after changing from brand-name antidepressant Wellbutrin to bupropion, a generic version, according to the Legal Intelligencer. The suit claimed that makers Teva Pharmaceuticals and Impax Laboratories failed to warn the plaintiffs about differences between the generic version, called Budeprion, and Wellbutrin.  The Legal Intelligencer reported that lawyers for the manufacturers had argued that the suit be dismissed because of the FDA determination that the generic products were the “bioequivalent” of the brand-name and thus just as safe and effective.

It’s week two of the new decade and we still haven’t figured out whether it’s “two thousand and ten” or “twenty-ten”.  That’s the bad news.  The good news is that the “decade in review” news pieces that inevitably focus on celebrity deaths, scandals, and divorces have already started to fade.

While such retrospectives often do little more than rehash old news, Joanne Doroshow, the Executive Director of the Center for Justice and Democracy, did have a great piece in the Huffington Post looking back on a decade of major civil justice triumphs.  The piece is here.

Doroshow cites three in particular that are worth calling out.

•    First she talks about the Supreme Court decision in Wyeth vs. Levine, which overturned a previous decision holding that companies could not be sued in state court for killing or injuring someone just because their product was regulated by the federal government (in Wyeth’s case, by the FDA).  Wyeth was landmark because it essentially rolled back the Bush administration’s misguided attempts to use the doctrine of preemption to protect corporations from being sued for negligence.

•    Second, she points out that despite its best efforts, the Bush administration was unable in its eight years in office to cap damages in medical malpractice cases.  Despite a hue and cry from the right, and having Bill Frist (a doctor and health care executive) as the Senate Republican Leader, Bush was unable to roll back people’s right to sue and collect compensation.

•    Finally, squeaking in just below the wire was a huge setback for so-called “forced arbitration” provisions that came in 2009.  These provisions essentially require people to go to arbitration instead of suing and, surprise surprise, the corporation that is negligent is usually the one who gets to pick the arbitrator.   I’ve written about forced arbitration before.  It was a particular favorite of the credit card companies, until both the National Arbitration Forum and American Arbitration Association said they would no longer do credit card collection disputes. Then, a class action lawsuit against big banks led to a number of them agreeing to drop these clauses altogether.

All three of these are important victories for the basic notion that people who are hurt should be compensated for their injuries.  Let’s see what the twenty tens bring.