Zometa was substantial factor in woman’s development of osteonecrosis of the jaw, expert says in lawsuit

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by Jim Orr

Zometa is a bisphosphonate, a class of drug commonly used to reduce or eliminate the possibility of skeletal-related degeneration and injuries to which cancer patients are particularly susceptible. Over the course of her treatment for breast cancer, Linda Messick developed osteoporosis. She was treated with Zometa.

Messick began to have dental problems. She saw two oral specialists who discovered osteonecrosis near three of her teeth. Both doctors treated her under the assumption it was bisphosphonate-related osteonecrosis of the jaw (“BRONJ”).

The root “osteo” means bone and “necrosis” means death. Osteonecrosis of the jaw, commonly called ONJ, occurs when the jaw bone is exposed and begins to starve from a lack of blood. The bone begins to weaken and die, which usually causes pain.

A BRONJ diagnosis is considered appropriate for patients with (1) current or previous treatment with bisphosphonates, (2) exposed bone in the maxillofacial region that has lasted for more than eight weeks, and (3) no history of radiation therapy to the jaw. Although ONJ may be caused by many factors, BRONJ does have unique features: it lasts more than eight weeks and is not related to radiation therapy. Messick’s ONJ healed about three years after diagnosis.

Messick files a lawsuit against Novartis

Messick and her husband brought suit against Novartis for strict products liability, negligent manufacture, negligent failure to warn, breach of express and implied warranty, arguing that her BRONJ was caused by Zometa. For pre-trial purposes, the case was made part of multi-district litigation proceedings regarding Zometa in the Middle District of Tennessee, MDL No. 1760.

As we have reported, Novartis has faced considerable litigation regarding Zometa. For instance, the Eighth Circuit Court of Appeals recently affirmed a jury verdict for Ruth Baldwin against Novartis for damages due to osteonecrosis of the jaw after taking Aredia and Zometa.

Similarly, last year a New York jury found Novartis liable for $450,000 in compensatory damages and $10 million in punitive damages to a woman who took the drug Zometa and suffered from osteonecrosis of the jaw.

The court’s role as “gatekeeper” of expert testimony

Federal Rule of Evidence 702 governs expert witness testimony. Among other requirements, expert testimony needs to be based on sufficient facts or data and the product of reliable principles and method. Expert testimony must be both relevant and reliable.

The district court is to act as a “gatekeeper” to exclude junk science that does not meet Rule 702’s reliability standards. The Supreme Court has provided a non-exclusive and flexible list of factors that a court may consider when determining the reliability of expert testimony, including:

  1. whether a theory or technique can be tested
  2. whether it has been subjected to peer review and publication
  3. the known or potential error rate of the theory or technique
  4. whether the theory or technique enjoys general acceptance within the relevant scientific community

To support her claims, Ms. Messick offered testimony by Dr. Richard Jackson, an oral surgeon who is a specialist in osteonecrosis of the jaw. While the action was pending in Multi–District Litigation proceedings, Novartis filed a motion to exclude the testimony of Dr. Jackson.

After the case was remanded and transferred, the district court granted the motion to exclude and granted summary judgment in favor of Novartis. The district court excluded Dr. Jackson’s testimony as irrelevant because of its view that his “differential diagnosis only determines that Ms. Messick’s ONJ is related to her bisphosphonate use, and he admits that a diagnosis of BRONJ does not mean that bisphosphonates caused her ONJ.”

The court of appeals rules Messick’s expert should be allowed to testify

The Ninth Circuit Court of Appeals has now reversed. In Messick v. Novartis Pharmaceuticals Corp., — F.3d —-, 2014 WL 1328182 (9th Cir. 2014), the Ninth Circuit held that district should have allowed the expert testimony of Dr. Jackson regarding the causal link between Messick’s bisphosphonate treatment and later development of BRONJ. The court of appeals ruled that Dr. Jackson should be allowed to testify regarding his opinion that a patient without cancer or exposure to radiation in the mouth area would not normally develop ONJ lasting for years.

According to the Ninth Circuit, the district court applied too high a relevancy bar:

While Dr. Jackson never explicitly stated that Messick’s bisphosphonate use caused her BRONJ, he did say it was at least a substantial factor in her development of BRONJ. Specifically, Dr. Jackson equated Messick’s use of bisphosphonates leading to BRONJ with the oxygen necessary to start a fire. Although one might imagine more targeted testimony, Dr. Jackson’s testimony indicates that Messick’s bisphosphonate use was a substantial factor in her development of BRONJ, so his testimony is relevant.

Dr. Jackson relied on his own extensive clinical experience as the basis for his differential diagnosis, as well as his examination of Messick’s records, treatment, and history. He also relied on the AAOMS definition of BRONJ in reaching his diagnosis and causation conclusions. The Ninth Circuit determined these sources formed an appropriate scientific basis for his opinions, and the district court abused its discretion in concluding otherwise.

A doctor using a differential diagnosis grounded in significant clinical experience and examination of medical records and literature can certainly aid the trier of fact and cannot be considered to be offering “junk science ” Dr. Jackson’s testimony should be admitted as relevant and reliable.

Id.

Because the district court’s summary judgment in favor of Novartis had been based entirely on the decision to exclude Dr. Jackson’s testimony, the Ninth Circuit also reversed the summary judgment. The case was remanded to district court and will proceed toward trial.

HO&P Fighting for Drug Safety

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