Proton Pump Inhibitor Litigation Conference Recap

NastLaw was pleased to be a part of the HarrisMartin Proton Pump Inhibitors – Kidney Injury Litigation conference on June 15th, 2016. Daniel Gallucci of NastLaw co-chaired the event along with Neil Overholtz of Aylstock, Witkin, Kreis & Overholtz, and Paul Pennock of Weitz & Luxenberg.

The conference was very well attended, showing a strong interest in the litigation from firms and attorneys nationwide.

The agenda included discussions on:

  • Basics of Proton Pumps
  • Proton Pump Inhibitors & Patent Law
  • Science of PPI Injuries
  • PPI Liability for Acute Interstitial Nephritis and Chronic Kidney Disease
  • Issues with generic versions of PPI drugs
  • Over the counter (OTC) cases
  • Status of PPI litigation
  • Potential jurisdictions and defendants
  • Case Screenings

Several key developments in the proton pump inhibitor litigation were discussed:

Kidney Injury Causation Case is Strong

As interest in the PPI litigation grows and more of the research is uncovered and dissected, the case for kidney injuries resulting from proton pump inhibitor use is growing stronger.

Studies are available dating back to the early 1990’s that show a link between PPIs and kidney injuries such as acute interstitial nephritis. There is a substantial body of evidence from medical studies conducted across the globe that link PPIs to a variety of kidney injuries including AIN and CKD.

Despite the numerous studies on the subject, the warning labels on PPI drugs do not reflect the danger for kidney injuries. It wasn’t until 2014 that AIN was mentioned on the label of prescription PPI drugs, but there is no mention of the risk for CKD, and the OTC versions of the drugs have even less information.

If the data from the studies is accurate, proton pump inhibitors could be responsible for causing a significant public health crisis in America.

Over the Counter Cases are Strong and Gaining Momentum

Much of the focus during the early stages of PPI litigation has been on the prescription versions of the drugs. However, the case for serious kidney injuries from OTC PPIs was discussed as very strong for several reasons including:

  • No Warnings or Caution from Doctors – When an OTC drug is purchased, it is up to consumers to fully assess the risk of the product and manage dosing and usage. OTC versions of PPI are purchased without essential advice from physicians, increasing the chance of long term use without fully understanding the risks.
  • Less Information on PPI Warning Labels – OTC PPI drugs contain much less safety and warning information than the prescription versions. The warning labels provide no mention of AIN or kidney injuries.

Over the counter cases can be more difficult to litigate because it is harder to prove usage without a prescription history. Proof of use can come from purchase receipts, medical records with paperwork completed by the patients, and oral testimony from credible parties.

Defendants Have Used Very Aggressive Marketing Tactics

Proton pump inhibitors are some of the most widely used drugs in history, and there is a reason for the millions of prescriptions and OTC purchases every year. The manufacturers of these drugs have used very aggressive marketing tactics promoting Prilosec, Nexium, and Prevacid.

Billions of dollars have been spent on media to increase top of mind awareness and recall of terms like “the purple pill” (Nexium). Premium shelf space in pharmacy isles has been purchased to promote the OTC versions of the drugs and discourage use of the generic equivalents.

On top of the heavy promotion for PPIs, manufacturers have done nothing to help educate consumers about safer, long terms options to manage heartburn and acid reflux. Other options include calcium tablets and H2 blockers that are proven to be much safer than PPIs.

Proton Pump Inhibitors May Be “Addictive”

Another topic discussed at the conference was the “addictive” effects of PPIs. Data is growing that shows that PPIs alter the production of acid in the stomach to the point that, after the PPI drug is stopped, the stomach produces too much acid causing more symptoms than were initially present. This can force the patient into a vicious cycle of dependence on the drug, leading to long term use and increasing the risk for kidney injury.

Thank you to HarrisMartin Publishing for providing another informative conference. NastLaw is committed to providing the latest information on the status of proton pump inhibitor litigation. Follow us to stay up to date on PPIs and other current litigation.