Opposing parties held a science day in Fluoroquinolone Products Liability Litigation on Jan. 17, one of the penultimate steps before a comprehensive settlement is reached in 713 actions against Bayer, Johnson & Johnson and its Janssen subsidiary.
Chief US District Judge John R. Tunheim in Minnesota, who is supervising MDL 2642, viewed Powerpoint presentations by the parties’ scientists, explaining the connection between the powerful fluoroquinolone antibacterial drugs (FLQs) — Cipro, Avelox and Levaquin — and peripheral neuropathy.
The nerve condition is irreversible and its symptoms include pain, burning, tingling, numbness, weakness, alterations of sensation affecting musculoskeletal, neuropsychiatric, sensory (e.g., vision or hearing), skin, and cardiovascular systems.
Admission of Liability
The MDL has steadily grown since it was created on August 17, 2015, when there were only 20 actions. An admission of liability by the defendants and other indications show that the cases are in the process of being settled. At the December 1, 2016 status conference, the parties asked the court to delay setting dates for bellwether trials so that they could seek a settlement.
FLQs are broad-spectrum synthetic antibacterial agents marketed and sold in oral tablet, IV solution, and ophthalmic solution, used to treat lung, sinus, skin, and urinary tract infections caused by certain germs called bacteria.
“The are trying to establish anything to mitigate damages,” said mass tort expert consultant John Ray. “I expect see a settlement based on a value based on the type of injury, mitigated by any any co-morbidity.”
- Both the J&J and Bayer defendants have publicly acknowledged that FLQs can cause neuropathy. At the FDA’s joint advisory committee meeting in November 2015, Dr. Susan Nicholson, Vice-President of safety, surveillance, and risk management for the Johnson & Johnson, testified for all the defendants. She agreed that FLQs cause tendon ruptures, severe arrhythmia, and neuropathy.
- The FDA issued a safety announcement on May 12, 2016, advising that “the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.” The FDA instructed that patients with these conditions should not be treated with a fluoroquinolone if alternative treatment options are available.
- In an unusual expansion of liability, courts in California, Alabama, Illinois and Vermont have ruled that the brand-name manufacturers owe a duty of care to patients who took a generic version of an FLQ.
“The defendants know they’re going to pay,” Ray said. “It’s a question of how much they’ll pay and how much they can get out of paying. They are giving individual cases more scrutiny.”
Illustrating this point, the plaintiff’s fact sheet, which is used instead of interrogatories, is double the usual length at 42 pages. It betrays that the defense strategy is to pick off cases one-by-one with fraud, statute of limitations and alternative cause defenses. It probes plaintiffs with questions in granular detail, including what Facebook groups a plaintiff belongs to. For example:
- Have you every used a computer to look for information on the internet about any fluoroquinolone drugs?
- Have you ever read or posted any weblogs (blogs), social networking sites (such as Facebook or LinkedIn), or message boards regarding any fluoroquinolone drugs.
- Do you belong to any fluoroquinolone-related information or support groups, either online or elsewhere? (e.g. Floxie Hope; Facebook’s “Fluoroquinolone Antibiotic Toxicity Community;” Facebook’s “Fluoroquinolone Wall of Pain;” The Tropical Penguin Health Forum, etc.)
- Please indicate whether your parents, siblings, children or grandparents have ever experienced to been diagnosed with peripheral neuropathy?
- Were you ever given any written [or verbal] instructions, warnings or other information about any fluoroquinolone?”
- Have you ever filed a lawsuit or made a claim relating to any bodily injury?
- Have you been convicted of, or pled guilty to, a felony or a crime of fraud or dishonesty within the past ten years?
- Have you ever been diagnosed with any of the following 47 conditions — starting with alcoholism to vascular disease.
- Have you had any communications with your health care providers, orally or in writing, about whether your condition is related to your use of fluoroquinolones?
The case proceeds when the next status conference is held on February 21, 2017, at 2:00 p.m.