New Haven, CT"Cipro (Ciprofloxacin) and Avelox are 'last resort' antibiotics to kill off very dangerous forms of bacteria but they have been marketed and advertised way beyond what is appropriate for patients' conditions," says Attorney Mike Stratton of Stratton Faxon. He adds that Bayer, the manufacturer of both drugs, has been "cagey" about Cipro and Avelox side effects, right up until both antibiotics got slapped with a black box warning.
Like Cipro, Avelox is in a class of drugs called fluoroquinolones; both are prescription antibiotics used to treat common respiratory infections including bacterial sinusitis, bronchitis, and pneumonia in adults. But they have both been used "off-label" and they also have adverse side effects in common.
"We have seen these drugs mainly associated with tendon ruptures all over the body," says Stratton, "but the most common injuries are Achilles heel, shoulder, hand and bicep tendon ruptures—these drugs are equal opportunity pursuers." He adds that Bayer has also issued a recent warning that there is also liver toxicity issues associated with these medications. Still, herbal ephedra can still be purchased in some outlets, and online.
Stratton says his firm first became involved with these drugs when one of their staff members took Avelox and suffered a tendon tear in her knee. "We looked at the package inserts, took a look at Public Citizen's information and then by word of mouth told lawyers we were interested in handling these cases," says Stratton.
In 2006, Public Citizen, a national, nonprofit consumer advocacy organization, asked Bayer to warn the public about the risk of tendon rupture associated with Cipro and other fluoroquinolone antibiotics, including Levaquin. "Prior to that time doctors were prescribing Cipro and Levaquin not knowing how toxic these drugs were," says Stratton. "The only warning regarding tendon ruptures was that you shouldn't do these drugs with steroids, which should have put these drugs on alert, but many doctors were indiscriminate and Bayer had this blockbuster drug that made millions of dollars.
"Bayer refused to respond in 2006 to Public Citizen and the FDA finally stepped in and did the right thing but they were atrociously slow, especially during the Bush years: the FDA budget was slashed and there was little pressure by the FDA on drug manufacturers."
Because of Stratton's experience with big pharma (such as breast implant litigation and then Celebrex/Vioxx litigation), he sees a similarity with these drugs regarding the slowness and delays in giving them the black box warning. "Merck knew they had a dangerous product with Vioxx for 5 years but they were making a ton of money—the same goes for Cipro," he says.
There is a lot of press about Levaquin, so if these fluoroquinolones are basically the same chemical structure, why doesn't the public know more about the dangers of Cipro and Avelox? Stratton says it's mainly because no public education or information has been issued by the FDA or Bayer or even the plaintiff's trial bar regarding these two drugs.
"The plaintiff's trial bar seems to be myopically focused on Levaquin as the drug targeted with litigation and people who have take Cipro or Avelox have been turned away by law firms who accept big pharma litigation," explains Stratton. "I think we have a huge underserved population of clients who haven't been told about Avelox and Cipro; as we began our marketing campaign, we found many people surprised that their tendon ruptures could be linked to these drugs.
"I have one particular client (Simjian v. Bayer), a mother of two who is a classic Avelox victim. She had chronic sinusitis and was prescribed Avelox for several months and then developed both rotator cuff tears in her shoulders; wrist tendon injuries; and impacted her Achilles tendon. Now she is completely disabled and can't lift anything. She is in constant pain, and looking at multiple surgeries to regain function. Her life has been dramatically altered.
"My client said her doctor had no idea of the drug's association to tendon tears and ruptures; it wasn't until the black box warning came out that they made the connection. She had no previous trauma or arthritic conditions, except taking the Avelox."
Cipro and Avelox Lawsuits
Many people have potential lawsuits, even though Stratton says that Bayer is soon going to lose their patent on Cipro and maybe Levaquin is a better target defendant, with a larger market share. He adds that lawsuits are targeting the "big gun" (Levaquin) but they are still leaving two baby elephants--Cipro and Avelox--in the room.
"A multi-district litigation (MDL) has been created in the federal court of Minnesota for Levaquin," says Stratton, "and after you get a critical mass of lawsuits nationwide the federal courts have a mechanism for consolidating to reduce the coherency and cost in litigation: one judge can manage the whole docket. This is when many lawyers are consolidated—which is called a mass tort. Everyone is represented but they are brought together as one litigation, such as Vioxx.
"We are at the filing stage with Cipro and Avelox. We filed a few cases here in Connecticut—there is no MDL. We are taking on Bayer because the centerpiece in my office is a big portrait of Don Quixote, I like to keep life interesting," Stratton says, laughing.
Stratton's firm was the only law firm in the country that didn't participate in the global settlement of Vioxx. Instead they are trying cases individually. "We are willing to take on more risk than other law firms but not without having thought about each case carefully," he points out.
Statute of Limitations
"The statute of limitations is state-dependant, but most states have a discovery-based statute," says Stratton, which means that the statute begins to run when you first find out that your injury was caused by ingestion of the drug.
"So when the black box warning came out in July 2008, that is when the clock started ticking for most people," explains Stratton. "For example, the maximum time here in Connecticut would be 3 years---up until July 2011 to file suit. If your doctor told you in April 2006 that there was a connection between your injury and the drug, it might be too late so time is of the essence and cases have to be researched first--they demand a more rigorous investigation."
Stratton's firm is now prepared to file these cases in Pennsylvania (the plan is to file in Bayer's home state) on behalf of clients nationally—everyone will still have their own lawyer. If people want to have their cases evaluated and seek compensation they should seek legal help as soon as possible.