The legal community’s interest in Pradaxa has recently surged due to study results presented on May 4, 2012, at the Thrombosis and Hemostasis Summit of North America. Those results showed that complications requiring drug discontinuation occurred more frequently with the blood thinner dabigatran (Pradaxa) than with a much older blood thinner, warfarin (Coumadin).

In March 2012, just months before the study results were publicized, another event put Pradaxa in the media spotlight: The online edition of the Journal of Neurosurgery reported circumstances surrounding the death of an elderly male Pradaxa patient from a massive brain hemorrhage after a routine fall. Fox News picked up the story.

The report’s bottom line was essentially that clinical trials have shown that Pradaxa patients have a lower incidence of stroke than Coumadin patients and face a similar overall rate of brain hemorrhage, but there is not an effective reversal agent to neutralize either drug. In other words, Pradaxa patients and Coumadin patients face equal risk of hemorrhage, and there currently isn’t a way to get either drug out of a hemorrhaging patient’s system. Since the U.S. Food & Drug Administration approved Pradaxa, there have been post-marketing reports of serious bleeding in patients who took the drug; in December 2011, the FDA announced plans to look into whether Pradaxa bleeding injuries are more likely than clinical trials have suggested.

Pradaxa, a member of the the direct thrombin inhibitors class of drugs, is an anticoagulant (blood-thinning) medication. It is prescribed to prevent strokes and to treat serious blood clots. The drug’s side effects range from nausea to serious cases of dizziness, bleeding gums, and the coughing up of blood.

Soon after the FDA announced that it would be further investigating Pradaxa bleeding risks, researchers uncovered more evidence of the bleeding risks posed by the drug, and the media took notice, publishing stories about Pradaxa bleeding risks and Pradaxa victims.

Thanks to this publicity, Pradaxa victims have come to learn that they’re not alone, and many of them have gotten in touch with us, the Rottenstein Law Group, to assess whether they have a case against the manufacturers of Pradaxa.

We are now filing individual lawsuits on behalf of many of the patients who have reached out to us claiming they were hurt by Pradaxa.

Here’s timeline of events leading up to the Pradaxa lawsuits currently being filed:

October 2010
FDA approves Pradaxa capsules for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). Approval is based largely on a clinical trial conducted on 18,000 patients, some of whom were on Pradaxa and some of whom were on warfarin. In that trial, a similar number of patients in each group suffered major bleeding events.

October 2010 — August 2011
Approximately 1.1 million Pradaxa prescriptions are dispensed and approximately 371,000 patients receive Pradaxa prescriptions from U.S. outpatient retail pharmacies.

December 2011
FDA announces plans to look into the risk of bleeding events posed by Pradaxa. FDA spokesperson says the agency isn’t prepared to disclose how many reports of serious bleeding events have been received because “they’re still being reviewed,” according to the Jan. 2012 issue of The Hospitalist.

March 2012
Online edition of the Journal of Neurosurgery reports on an elderly male Pradaxa patient’s death, which was caused by a massive brain hemorrhage after a routine fall.

May 4, 2012
At a scientific symposium in Chicago, researchers present results of a study showing that complications requiring drug discontinuation occurred more frequently with Pradaxa than with warfarin (brand name: Coumadin), a much older blood thinner.

May 6, 2012
The study results that were presented at the Chicago symposium on May 4, 2012, are published on the prestigious heart news site the Heart.org.

The New England Journal of Medicine on Wednesday published the FDA’s “Bisphosphonates for Osteoporosis — Where Do We Go from Here?”—in which the authors preface, “The long-term safety and efficacy of bisphosphonate therapy for osteoporosis are important concerns for the Food and Drug Administration (FDA). In response to postmarketing reports of rare but serious adverse events associated with bisphosphonates, such as atypical femur fractures, osteonecrosis of the jaw, and esophageal cancer, the FDA performed a systematic review of long-term bisphosphonate efficacy.”

According to a New York Times piece about the FDA report, “Although the concerns about the long-term safety of bone drugs are not new, the [FDA] performed its own systematic review of the effectiveness of bisphosphonates after years of use. The agency’s analysis, which found little if any benefit from the drugs after three to five years of use, may prompt doctors around the country to rethink how they prescribe them.”

Despite being the most popular osteoporosis treatment medication on the market, Fosamax has been linked to several serious side effects. In 2004, researchers found a causal connection between Fosamax and osteonecrosis of the jaw, a condition where the jawbone dies due to a lack of blood supply. More recently, people have suffered low-impact femur fractures after falling from standing height or less. Evidence is building that taking Fosamax or similar medications for the treatment of osteoporosis causes a dramatic increase in risk of this particular kind of rare fracture to the thigh bone.

The Rottenstein Law Group urges anyone whose friend or relative has been prescribed Fosamax or another osteoporosis drug to reach out to that person and recommend that he or she consult a physician immediately and then speak to a qualified personal injury lawyer.

Chief Judge Joseph Goodwin, who is presiding over the multi-district litigation (MDL) consolidating 600 cases against Bard for vaginal mesh injuries, set the Feb. 15 trial start date last week, according to an article on BloombergBusinessweek.

The MDL centralizes the Bard cases in the U.S. District Court for the Southern District of West Virginia, where Judge Goodwin presides over the pre-trial proceedings for all of them, but the cases will still be tried as separate actions. The cases all involve injuries allegedly sustained as a result of Bard’s vaginal mesh products, most of which bear brand names that include “Avaulta” or the prefix “Pevi-.”

Cases against three other vaginal mesh manufacturers have been similarly consolidated in the U.S. District Court for the Southern District of West Virginia, where their pre-trial proceedings are also presided over by Judge Goodwin: MDL No. 2325 consolidates cases involving American Medical Systems’s vaginal mesh products; MDL No. 2326 consolidates cases involving Boston Scientific Corp.’s vaginal mesh products; and MDL No. 2327 consolidates cases involving Ethicon Inc.’s vaginal mesh products.

As a law firm that is representing many of the claimants in the vaginal mesh MDLs, the Rottenstein Law Group eagerly anticipates the start of the MDL case against Bard tnow scheduled to commence on Feb. 15, 2013, as well as the commencement of the vaginal mesh MDL cases that have yet to be assigned start dates.

What Are Riata Defibrillator Leads?

St. Jude Medical’s Riata Defibrillator and Riata ST Silicone Endocardial Defibrillator Leads are used in “implantable cardioverter defibrillator” (ICD) and “cardiac resynchronization therapy defibrillator” (CRT-D) device implantation procedures. The leads connect to the defibrillators and monitor and regulate recipients’ heart rates by controlling the voltage the defibrillators deliver to recipients.

Riata Defibrillator Leads Might Cause Injury and Death

On November 28, 2011, St. Jude Medical sent a “Physician Advisory Letter” to doctors informing them that the conductors in Riata Defibrillator Leads and Riata ST Silicone Endocardial Leads could become “externalized” through abrasions in the wires’ silicone insulation. When this happens, the defibrillator might not deliver the electrical impulse the heart requires, or worse, it can deliver excessive voltage. Both events can cause injury, cardiac arrest, and death. The letter served as an update from a December 15, 2010 letter St. Jude Medical sent to physicians informing them that it was discontinuing sales of the two products for similar reasons.

Then, on December 15, 2011, the FDA classified the November Physician Advisory Letter as a voluntary Class I Riata Defibrillator Lead recall, the most serious kind of FDA recall. Although the recall has minimal practical impact because the product had been discontinued for a year, the FDA estimates 79,000 patients still have Riata and Riata ST leads inside of them.

According to a Minneapolis Star Tribune article, a study of 212 Riata and Riata ST Leads recipients showed that 15 percent of them had “insulation breaches,” which cause wire externalization and the accompanying side effects of inadequate or excessive voltage discharges. In April 2012, the New York Times cited research showing that defective Riata Defibrillator Leads played a role in 20 patients’ deaths.

RLG’s Riata Defibrillator Leads Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Riata Defibrillator Leads lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Riata Defibrillator Leads lawsuit on your behalf if necessary. RLG will also keep you up to date on any Riata Defibrillator Leads class action lawsuits, FDA Riata Defibrillator Leads warnings, and additional Riata Defibrillator Leads FDA recall announcements. If you received Riata Defibrillator Leads with your defibrillator and believe they harmed you, contact RLG today.

The FDA would use those numbers “to search large databases of records that could include veterans’ and other hospitals, as well as large insurance companies,” the WSJ article states. “That could potentially allow the agency to know more precisely the rate at which a device is failing, and which patients have devices prone to malfunctions.” Congress first approved the FDA’s plan to create UDIs in 2007, according to an April 19, 2012, article on FierceHealthIT.com, “but FDA’s UDI proposal has been stalled at the Office of Management and Budget (OMB) since July 2011.” A bipartisan group of four senators recently introduced legislation that includes a UDI provision establishing a December 31, 2012, deadline for promulgating the UDI regulations.

The Rottenstein Law Group supports legislative initiatives that, like the aforementioned bill, increase the FDA’s power to protect patients that receive medical device implants.

Published on April 24, 2012, in the online journal Frontiers in Evolutionary Psychology, the paper is titled Primum no nocere: evolutionary analysis of whether antidepressants do more harm than good. According to an article on MedicalXpress.com, the paper’s conclusions are based on its authors’ analysis of  “previous patient studies into the effects of anti-depressants.”

The paper’s authors report having “had difficulty finding strong evidence of [antidepressants’] beneficial effects.” But, their paper states, they did find significant evidence of antidepressants’ negative impact on bodily processes that rely on seratonin, an “evolutionarily ancient biochemical” that antidepressants increase in the brain, where seratonin regulates mood. As a result of antidepressants’ negative effect on these processes, antidepressants can cause digestive problems, atypical sperm development, abnormal bleeding, stroke and premature death, the paper’s authors wrote.

Since the authors’ “review shows that antidepressants have adverse effects on every major system regulated by serotonin,” and since their review also found little credible scientific evidence to support assertions that antidepressants benefit their users, the paper concludes: “The weight of current evidence suggests that, in general, antidepressants are neither safe nor effective; they appear to do more harm than good.”

As an advocate of patients who have been injured or killed as a result of having taken the antidepressant Zoloft, the Rottenstein Law Group hopes the medical community, as suggested by the paper’s authors: (1) explains to patients that the symptom-reducing effects of antidepressants are modest for all but the most serious depressives, (2) exercises significantly greater caution in the prescription of antidepressants, and (3) conducts significantly more research into the overall functioning of antidepressants.

Almost two years after DePuy recalled its ASR devices, the first lawsuits against the manufacturer have been scheduled for trial. Two ASR lawsuits will proceed before juries in Nevada and Maryland state courts on December 3, 2012, and in January 2013, respectively. Each case involves three recipients of DePuy ASR hip replacements.

The Nevada and Maryland plaintiffs fought against DePuy to keep their cases out of federal court and the ASR multidistrict litigation (MDL) proceeding because they believed that process would take too long. MDL consolidates the pretrial proceedings of a large group of cases with common facts, legal issues, and parties. The DePuy ASR MDL is being administered in the United States District Court for the Northern District of Ohio before Judge David A. Katz. Judge Katz recently requested that the parties discuss bellwether trial selection protocols and submit proposals to the court on April 27, 2012. An open court conference will be held on May 1. It is unknown when the first bellwether trial will begin.

The article, which ran on April 18, 2012, chronicles the history of St. Jude Medical’s “Riata,” a wire—or lead—that connects a defibrillator to a patient’s heart. The product was recalled, but not before approximately 128,000 patients worldwide had already been implanted with it.

Now, a recently released study by an outside researcher, Dr. Robert Hauser of Minneapolis, indicates that short-circuits and other failures of the Riata might have played a role in some 20 patient deaths. Dr. Robert Hauser’s report also points to “a separate and potentially more serious problem,” according to the Times article: “the likelihood that the Riata’s insulation could wear away, short-circuiting the device.”

Since Dr. Hauser’s study was based on reports of possible Riata-related deaths that St. Jude had filed with the FDA itself, his findings have called into question St. Jude Medical’s failure to notify doctors early on about the Riata’s underlying insulation problem. Although the company had been receiving reports of the device wearing through its insulation since 2010, St. Jude Medical did not send an alert warning doctors about the exposed wires until late 2011.

“It was not supposed to be this way,” the authors of the Times piece point out, referring to the safeguards that major defibrillator makers including St. Jude Medical adopted after it was discovered in 2005 that another major maker of heart defibrillators, Guidant, had not warned doctors about a potentially fatal flaw in its products. The safeguards those device makers adopted provided that they would “quickly investigate malfunctions in their products and alert doctors to potential problems,” according to the Times. “The key to preventing a repeat episode, specialists say, was for manufacturers to scrutinize every death to see if it pointed to an underlying flaw that could kill or injure other patients.”

As an advocate of patients who have been injured or killed as a result of faulty medical implants, the Rottenstein Law Group hopes the publicity surrounding St. Jude Medical’s missteps will prompt other device manufacturers to scrutinize reports of deaths that may be related to their devices as early as possible so that they can discover the devices’ underlying problems before the devices injure or kill more patients.

In a press release dated April 18, Merck & Co., Inc, manufacturer of the embattled osteoporosis drug Fosamax, announced that “a state court jury in New Jersey found in [Merck’s] favor in the Sessner v. Merck case, rejecting the claims of a woman who blamed her jaw-related problems on her FOSAMAX use.”

“We believe the evidence showed the company acted properly, and that [Fosamax] did not cause the plaintiff’s dental and jaw problems,” said outside counsel for Merck, according to the release.

Judge Carol E. Higbee of the Superior Court for Atlantic County, N.J., presided over the trial (Docket No. ATL-L-3394-11-MT), the sixth Fosamax case to go to trial. Merck has won five of the six trials. Four trials were conducted as part of the federal multidistrict litigation proceedings before Judge John F. Keenan in the U.S. District Court for the Southern District of New York.

Despite being the most popular osteoporosis treatment medication on the market, Fosamax has been linked to several serious side effects. In 2004, researchers found a causal connection between Fosamax and osteonecrosis of the jaw, a condition where the jawbone dies due to a lack of blood supply. More recently, people have suffered low-impact femur fractures after falling from standing height or less. Evidence is building that taking Fosamax or similar medications for the treatment of osteoporosis causes a dramatic increase in risk of this particular kind of rare fracture to the thigh bone.

The Rottenstein Law Group urges anyone whose friend or relative has been prescribed Fosamax or another osteoporosis drug to reach out to that person and recommend that he or she consult a physician immediately and then speak to a qualified personal injury lawyer.

“Propecia labels will now include warnings for libido disorders, ejaculation disorders, and orgasm disorders that continued for men even months after stopping the drug,” according to CBS News. “Proscar’s label will include a ‘decreased libido’ warning that continues after drug discontinuation. Both drugs’ labels will also include a new description of reported cases of male infertility and poor semen quality that improved after patients stopped taking the drug.”

By including these disclosures, the new labels will forewarn potential Propecia and Proscar patients about the full extent of those drugs’ potential negative side effects—news that the Rottenstein Law Group has long been publicizing.

Get answers to these questions …from a lawyer and mother who’s been there.

What are SSRIs, and which medicines fall
into the SSRI category of drugs?

Are some SSRIs considered more dangerous
for unborn children than others?

What adverse effects might the children of moms who took SSRIs
when they were pregnant suffer?

Is your baby safe if you took SSRIs prior to pregnancy?

Can a woman take SSRIs during her first trimester? Should she?

What options are available to a woman who believes her child might
have suffered adverse effects as a result of her having taken SSRIs
while she was pregnant?