Two medical device companies are facing multi-million dollar lawsuits over claims filed by injured patients. One company is defending itself against allegations that it implanted pacemakers unnecessarily; the other is accused of injuring patients by selling pain pumps for off-label uses. Medical device lawyers at Pintas & Mullins Law Firm detail these two cases.
In addition to the injury lawsuits, both companies are also facing charges by their insurance companies. The insurers claim they were tricked into providing coverage for the injury lawsuits. The pain pump seller recently settled with its insurer for $10 million, while the complaints against the pacemaker company are pending.
The pacemaker lawsuits are against Biotronik Inc., for conspiring with a doctor in New Mexico to implant pacemakers unnecessarily. The first suit, filed in November 2010, resulted in a $65 million judgement against the company, which was eventually reduced to $28 million. The second lawsuit is still ongoing.
Plaintiffs accuse Biotronik and a doctor in New Mexico, Demosthenes Klonis, of intentionally implanting pacemakers in patients who did not need them in a scheme to increase the number of Biotronik devices in patients. Patients obviously suffered immense harm from this intentional wrongdoing.
In December 2014 Biotronik informed its two insurance companies of the lawsuits against it, requesting coverage for the legal costs. The insurance companies filed a complaint, saying they owed no coverage or duty to Biotronik since the policy specifically states that they will not cover any claims resulting from intentional injuries.
The insurers state that Biotronik’s conduct was intentionally harmful, and that the injuries suffered by plaintiffs were expected or intended by Biotronik. They also argue that it took Biotronik four years to notify them of the suits, so the claims should also be time-barred.
Biotronik is facing two other injury lawsuits due to its pacemakers; the company also recently agreed to pay nearly $5 million to settle allegations that it paid kickbacks to doctors as incentives to use its medical devices.
The medical device distributor DJO Global is also snared in court over its poor business practices. The company is facing lawsuits for selling pain pumps for off-label uses, resulting in injuries to patients. The first suit was filed in 2006 by a patient who accused DJO of marketing the pumps, which distribute anesthetics through a catheter, for uses not approved by the FDA. Specifically, for use in shoulder or knee joints after an operation.
Three years after the first pain pump injury lawsuit was filed, DJO applied for a $10 million excess coverage policy from the insurance company Ironshore, stating that the personal injury lawsuits it was facing only involved defective product claims. Ironshore argued that, had it known DJO was actually accused of intentionally injuring patients, it never would have provided coverage.
Ironshore’s complaint also alleged that DJO failed to disclose that it was being accused of marketing the pain pumps for non-FDA-approved use in shoulder and knee joints. Ironshore and DJO recently agreed to an undisclosed settlement, in which Ironshore agreed to drop the charges.
In 2012, several pain pump manufacturers, including DJO, were hit with
a False Claims Act lawsuit for marketing the devices off-label. The other
accused companies were Stryker, I-Flow, and Orthofix International. The
orthopedic surgeon who filed the complaint
said the use of pain pumps in joints caused a “startling number”
of shoulder complications among patients.
The shoulder condition is called post-arthroscopic glenohumeral chondrolysis, which often causes repeated medical and surgical treatments. The complaint alleges that Stryker and the others made false representations to doctors and patients that their products could be used inside joints and that this was approved by the FDA.
This false marketing resulted in millions of dollars wrongly paid by Medicare and Medicaid for these uses, in addition to the immense pain and suffering to patients.
If you or someone you love was seriously injured by a dangerous or defective medical device, contact our firm immediately. Our team of medical device lawyers has 30 years of experience fighting on behalf of patients and their families. We provide free legal consultations to potential clients nationwide.