STRATTICE™ biologic mesh is made with pig tissue as opposed to synthetic material. Litigations are located in New Jersey State Court[i] and the District of New Jersey, informally consolidated before the Honorable Brian Martinotti.[ii]
The Honorable John C. Porto, who manages the New Jersey State litigation in Atlantic County, has set a “Science Day”[iii] on May 18, 2023. Science days are when plaintiffs and defendants can educate the judge about a drug or medical device. These can occur over one or more days. Sometimes the judge requests live testimony of doctors and experts.
These are often considered informal as none of what is being said is considered to be under oath nor is it considered to be evidence. Judges simply request that the scientific information is presented objectively.
What will be presented on Science Day?
Judge Porto has specifically asked for[iv]:
- a background on hernias; a background on the treatment of hernias, including surgical repair;
- other types of mesh utilized to repair hernias; the injuries alleged in this litigation;
- the design of STRATTICE™ Reconstructive Tissue Matrix;
- clinical and non-clinical studies and outcomes regarding STRATTICE™ Reconstructive Tissue Matrix;
- medical literature regarding the use of STRATTICE™ Reconstructive Tissue Matrix;
What will the Plaintiffs focus on at Science Day?
The plaintiffs have made multiple allegations in the litigation that STRATTICE™ mesh has a higher failure rate, infection rate and more complications than popular synthetic meshes. This data is found in various clinical and non-clinical studies – which are done on a purely scientific basis and not in any way for litigation purposes.
Another area of focus will be on the product itself. What are the risks of the mesh? What risks were known to Lifecell? What risks were shared (or not shared) with the FDA and surgeons? What warnings (or lack thereof) were shared with patients?
The judge also wants to know about the use of the product. Was it marketed for certain conditions, such as infection, COPD, obesity, pregnancy and other unique conditions? And, if so, was it successful for these difficult health conditions?
Does Science Day decide who wins the case and what settlement the amounts will be?
No, Science Day is an informal teaching day for the judge. However, the judge becomes educated about what product defects are being alleged. This helps the judge know what type of test trials should be done, also known as bellwether trials. This involves what the typical injuries are to plaintiffs.
For this litigation, one could expect there to be significant verdicts for failed meshes, extra surgeries, infections, scarring, internal organ complications and permanent pain. The seriousness of the injuries will also be considered for test trials.