One Year After The Hearing In Pliva v. Mensing, Some Momentum Builds For (Once Again) Allowing Drug Injury Lawsuits On All Prescription Medications, Generic As Well As Brand Name
UPDATE: Introduction of the “Patient Safety and Generic Labeling Improvement Act” legislation in late April 2012
The Senate bill, S. 2295, was introduced by the Chairman of the Judiciary Committee, Senator Patrick Leahy (D-VT) and is cosponsored by Senators Al Franken (D-MN), Jeff Bingaman (D-NM), Sheldon Whitehouse (D-RI), Sherrod Brown (D-OH), Christopher Coons (D-DE), Richard Blumenthal (D-CT), and Mark Begich (D-AK).
The companion House bill is H.R. 4384, introduced by Representatives Chris Van Hollen (D-MD) and Bruce Braley (D-IA).
These bills would permit manufacturers of generic drugs to provide additional warnings about their drugs in the same manner that the Food and Drug Administration (FDA) allows for brand name manufacturers.
The Pliva, Inc., et al. v. Mensing case was decided by the Supreme Court of the United States (SCOTUS) on June 23, 2011. Justice Clarence Thomas delivered the opinion of the Court, concluding that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state law claims (see, in particular, pages 4–14 and 17–20 of this Pliva v. Mensing SCOTUS opinion).
The bottom line is that the U.S. Supreme Court ruled in favor of the generic drug company and against the injured patient.
Justice Sonia Sotomayor, in her dissent opinion, did well in pointing out the apparent absurdity of this new Supreme Court ruling about generic drug company lawsuits:
As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: this outcome "makes little sense."
For background, you may also want to look at the Transcripts of Oral Arguments to U.S. Supreme Court on March 30, 2011.
A year after the oral arguments in the Pliva v. Mensing case, there are some positive and significant developments to report concerning drug safety as well as patients rights.
On March 9, 2012 the FDA deferred making a determination on a Citizen's Petition submitted by the consumer advocacy group Public Citizen in August 2011 which seeks to require the FDA to update its regulations to allow generic manufacturers to utilize the Changes Being Effected (CBE) process. This recent agency decision suggests that the FDA may be considering revisions to its regulations in order to address the Mensing decision by the U.S. Supreme Court.
A week earlier the American Association for Justice (AAJ) filed comments in support of the Public Citizen petition. In his March 2, 2012 letter to the FDA, AAJ President Gary M. Paul set forth the reasons why generic drug makers should be required to update their warning labels independent of brand name manufacturers.
On March 21, 2012 The New York Times ran this article, "Generic Drugs Prove Resistant to Damage Suits", which told us about the negative consequences that the Mensing decision has had on Debbie Schork, of Indiana, and Camille Baruch, of Maryland -- both of whom suffered serious side effects after using generic drugs, as opposed to brand name medications.
In the March 26, 2012 edition of the Washington Drug Letter (subscription required) there appeared this article, "Labeling Preemption for Generics Could Be Threatened in Appeals", which was summarized by the publisher as follows:
Generic-drug makers are seeing product liability cases thrown out left and right, with judges ruling they're not required to change labels to reflect new safety concerns until after the brand drugmaker changes its labeling. But they shouldn't rejoice just yet as a so-called reference listed drug (RLD) theory of liability could come to life in an appellate case, an attorney tells WDL.
And, finally, in the March 27, 2012 edition of the Drug Industry Daily (subscription required) there appeared this article, "Bill Allowing Generic Safety Labeling Changes Is Coming, Senator Says", which was summarized by the publisher as follows:
The generic-drug industry's freedom from liability for safety labeling issues could soon disappear if a key Democratic lawmaker has his way. Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) plans to introduce a bill that would permit generic manufacturers to proactively improve warning information in labeling even before the brand drugmaker does. The legislation could come as early as this week, Leahy said Monday.
Now, a year after the March 30, 2011 oral arguments in the Pliva v. Mensing case, it seems there may be some momentum building for taking the steps necessary to create a solution to the real and serious problems that were created by the Mensing ruling by the U.S. Supreme Court. Let's hope that this momentum continues, for the sake of drug safety and patients rights, both.
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