Justia Drugs & Biotech Opinion Summaries

Articles Posted in Medical Malpractice
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Joas underwent knee replacement at a Wisconsin hospital and received a Zimmer NexGen Flex implant. Within a few years, he began experiencing pain in his new knee. X-rays confirmed that the implant had loosened and required a surgical fix. Joas brought multiple claims against Zimmer. His case was transferred to a multidistrict litigation, where it was treated as a bellwether case. Applying Wisconsin law, the presiding judge granted Zimmer summary judgment. The Seventh Circuit affirmed, declining to reinstate a single claim based on a theory of inadequate warning. The court predicted that the Wisconsin Supreme Court would follow the majority of states and adopt the “learned intermediary” doctrine, which holds that the manufacturer of a medical device has no duty to warn the patient as long as it provides adequate warnings to the physician. In addition, Joas has not identified any danger that Zimmer should have warned him about. Joas has no evidence to support causation. Joas did not select the NexGen Flex implant, so the information would not have caused him to change his behavior. His doctor selected the product, making his decision based on his own past experience, not on any marketing materials or information provided by Zimmer. View "Joas v. Zimmer, Inc." on Justia Law

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In 2001, BioEnterics obtained FDA approval for the Lap-Band, “designed to induce weight loss in severely obese patients by limiting food consumption" by creation of a small gastric pouch. The FDA indicated that the Lap-Band’s labeling must “specify the requirements that apply to the training of practitioners who may use the device” and required annual progress reports on a postapproval study. BioEnterics's brochure states that surgeons planning laparoscopic placement must have specific experience, participate in a training program authorized by BioEnterics, be observed by “qualified personnel” during their first placements, have the equipment and experience necessary to complete the procedure via laparotomy if required, and report on their personal experiences using the device. In 2003, plaintiff underwent a surgical procedure to implant a Lap-Band, which eventually eroded into her stomach and her liver; Lap-Band tubing became entangled with her small intestine. During surgery to remove the Lap-Band she suffered a massive hemorrhaging from her liver, causing her to experience profound hypotension and systemic shock, resulting in brain damage. More than nine years later, plaintiff filed suit. The court of appeal affirmed dismissal of her claim that the company failed to adequately train physicians in the use of the Lap-Band, as preempted by federal law. View "Glennen v. Allergan, Inc." on Justia Law

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Hardin suffered complete blindness and permanent, severe and painful scarring after she took Lamotrigine, the generic form of the medication Lamictal. Hardin sued the prescribing physician, the manufacturer, the store where she bought the prescription (Safeway), WKH, which produced the drug information pamphlet (monograph), and PDX, a software provider that distributes drug information to pharmacy customers. Unlike physician package inserts and patient medication guides, which are FDA-mandated, WKH monographs are not regulated or reviewed by the FDA, but are produced as part of a self-regulating action plan required under 110 Stat. 1593. The WKH monograph was the only information received by Hardin when she first filled her prescription for Lamictal. The abbreviated warning used by Safeway and provided to Hardin omitted the “Black Box” warning: “BEFORE USING THIS MEDICINE” that stated: “SERIOUS AND SOMETIMES FATAL RASHES HAVE OCCURRED RARELY WITH THE USE OF THIS MEDICINE. Hardin says that had she been provided this warning, she would not have taken the medication. WKH moved to strike Hardin’s claims against it under Code of Civil Procedure section 425.16, the “anti-SLAPP” (Strategic Lawsuit Against Public Participation ) statute.. The trial court ruled that WKH’s production of drug monographs was protected speech concerning a public issue or an issue of public interest and that Hardin had no probability of prevailing because she could not establish that WKH owed her any duty. The court denied PDX’s motion to strike, finding that the activity underlying PDX’s alleged liability was the reprogramming of its software to permit Safeway to give customers an abbreviated, five-section monograph that omitted warnings instead of the full eight-section version that included those warnings. The court of appeal affirmed. View "Hardin v. PDX, Inc." on Justia Law

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In the late 1990s, people who had taken the prescription diet-drug combination Fen-Phen began suing Wyeth, claiming that the drugs caused valvular heart disease. A 2000 settlement included creation of the Fen-Phen Settlement Trust to compensate class members who had sustained heart damage. Claims required medical evidence. Attorneys who represented certain claimants retained Tai, a board-certified Level 2-qualified cardiologist, to read tests and prepare reports. Tai read 12,000 tests and asserted that he was owed $2 million dollars for his services. Tai later acknowledged that in about 10% of the cases, he dictated reports consistent with the technicians’ reports despite knowing that the measurements were wrong, and that he had his technician and office manager review about 1,000 of the tests because he did not have enough time to do the work. A review of the forms Tai submitted found that, in a substantial number of cases, the measurements were clearly incorrect and were actually inconsistent with a human adult heart. Tai was convicted of mail and wire fraud, 18 U.S.C. 1341 and 1343, was sentenced to 72 months’ imprisonment, and was ordered to pay restitution of $4,579,663 and a fine of $15,000. The Third Circuit rejected arguments that the court erred by implicitly shifting the burden of proof in its “willful blindness” jury instruction and applying upward adjustments under the advisory Sentencing Guidelines for abuse of a position of trust and use of a special skill, but remanded for factual findings concerning whether Tai supervised a criminally culpable subordinate, as required for an aggravated role enhancement. View "United States v. Tai" on Justia Law

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Pauline and her doctors were aware of Pauline’s allergy to heparin, an anti-coagulant; she wore a medical bracelet listing her heparin allergy and her medical records noted the allergy. Her estate alleges that on several occasions, the hospital’s medical staff injected Pauline with heparin “in direct contradiction to her specific directive,” which proximately caused her death. The district court dismissed, for failure to comply with the notice and heightened pleading requirements of the Tennessee Medical Malpractice Act. The court concluded that under Tennessee law the injections were not “procedures” or “treatments” for the purposes of medical battery, but were only component parts of her treatment process, which did not require consent and could form the basis for medical malpractice but not medical battery. The Sixth Circuit reversed, holding that the complaint plausibly alleged medical battery, which is not subject to the Act. View "Shuler v. Garrett" on Justia Law

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Volkman, an M.D. and a Ph.D. in pharmacology from University of Chicago, was board-certified in emergency medicine and a “diplomat” of the American Academy of Pain Management. Following lawsuits, he had no malpractice insurance and no job. Hired by Tri-State, a cash-only clinic with 18-20 patients per day, he was paid $5,000 to $5,500 per week. After a few months, pharmacies refused to fill his prescriptions, citing improper dosing. Volkman opened a dispensary in the clinic. The Ohio Board of Pharmacy issued a license, although a Glock was found in the safe where the drugs were stored. Follow-up inspections disclosed poorly maintained dispensary logs; that no licensed physician or pharmacist oversaw the actual dispensing process; and lax security of the drug safe. Patients returned unmarked and intermixed medication. The dispensary did a heavy business in oxycodone. A federal investigation revealed a chaotic environment. Cup filled with urine were scattered on the floor. The clinic lacked essential equipment. Pills were strewn throughout the premises. Months later, the owners fired Volkman, so he opened his own shop. Twelve of Volkman’s patients died. Volkman and the Tri-State owners were charged with conspiring to unlawfully distribute a controlled substance, 21 U.S.C. 841(a)(1); maintaining a drug-involved premises, 21 U.S.C. 856(a)(1); unlawful distribution of a controlled substance leading to death, 21 U.S.C. 841(a)(1) and 841(b)(1)(C), and possession of a firearm in furtherance of a drug-trafficking crime, 18 U.S.C. 24(c)(1) and (2). The owners accepted plea agreements and testified against Volkman, leading to his conviction on most counts, and a sentence of four consecutive terms of life imprisonment. The Sixth Circuit affirmed. View "United States v. Volkman" on Justia Law

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In 2004, plaintiff had arthroscopic surgery to treat pain and instability in his shoulder joint. The doctor implanted a pain-pump catheter and, over the next two days, a Stryker pain pump delivered a regular dose of a local anesthetic, bupivicaine, to the joint. Plaintiff’s condition improved after surgery but worsened over time, and in 2008 he learned he no longer had any cartilage remaining in his shoulder, a condition called chondrolysis. He sued, alleging strict liability, negligence and breach of warranty. The district court concluded that Stryker could not reasonably have known about the risk of chondrolysis in 2004 and thus had no duty to warn of the risk and held that Plaintiff failed as a matter of law to prove causation. The Sixth Circuit affirmed. Plaintiff did not present any evidence that Stryker knew or should have known that the use was dangerous or that a warning on Stryker's pain pump would have caused the doctor not to use the device in his joint space. View "Rodriguez v. Stryker Corp." on Justia Law

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Flying from Cairo to New York, a flight attendant thought plaintiff looked ill and recruited a second-year medical resident to perform an examination. The resident thought that plaintiff was suffering an ischemic stroke or transient ischemic attack. The pilot made an emergency landing and, less than two hours later, plaintiff was treated at a hospital. The hospital did not administer an intravenous shot of tissue plasminogen activator (t-PA), a form of thrombolytic therapy that dissolves clots, but is not appropriate for all patients. His condition deteriorated, then stabilized, and he was transferred for care in New York. The district court held a "Daubert" hearing in plaintiff's malpractice claim and two experts gave vastly different opinions about whether failure to administer t-PA caused plaintiff's injuries. The court held that the standard for causation was "more likely than not" and that Maine had not adopted the "lost chance" doctrine, excluded plaintiff's expert, and granted summary judgment for defendants. The First Circuit affirmed, holding that plaintiff failed to show causation.View "Samaan v. St. Joseph Hosp." on Justia Law