In Miller v. Ortho-McNeil Pharmaceutical, Inc., No. 3:11oe40008 (N.D. Ohio November 5, 2013), the United States District Court for the Northern District of Ohio, Western Division granted defendant pharmaceutical manufacturers’ combined motion for summary judgment, motion for judgment on the pleadings, and motion to dismiss. Writing for the Court, Judge David A. Katz found that the plaintiff’s claims were barred by the learned intermediary doctrine and the applicable statute of limitations. The plaintiff’s claim also set forth facts insufficient to state a plausible claim for relief under Fed. R. Civ. P. 12 (c). Interpreting Mississippi law, the Court, therefore, found multiple reasons for granting the defendants’ combined motions.
Sarah Miller (“Plaintiff”) received the Ortho Evra contraceptive patch from two (2) different providers over the span of two (2) years. The first provider, Certified Nurse Practitioner Donna Cobb, knew the potential side-effects associated with the Ortho Evra patch, including the elevated risk of blood clots. During Plaintiff’s examination in 2006, Ms. Cobb discussed various possible complications with Plaintiff that could result from Ortho Evra, including blood clots. Ultimately, Ms. Cobb believed the benefits of the contraceptive patch outweighed its risks, and she prescribed Ortho Evra to Plaintiff. Plaintiff saw the second provider, Certified Nurse Practitioner Traci Speights, in 2007 and 2008. Ms. Speights was aware that Ortho Evra could increase a patient’s risk for thrombotic disease and pulmonary embolism. Ms. Speights had learned of the patch’s potential side-effects from the FDA-approved package inserts accompanying Ortho Evra, a Dear Healthcare Professional Letter (DHCP), and pharmaceutical representatives. Ms. Speights reviewed the warnings with Plaintiff, and encouraged Plaintiff to re-read the labeling and handouts included with the packet when prescribing her the patch.
In April 2008, Plaintiff suffered a pulmonary embolism, and filed suit against the manufacturers and distributors of Ortho Evra (“Defendants”) in August 2011. Plaintiff’s case was one of many, which the Judicial Panel on Multidistrict Litigation assigned to the United States District Court for the North District of Ohio. Defendants filed a combined Motion to Dismiss, Motion for Judgment, and Motion to Dismiss.
The Court granted Defendants’ motions, finding that Plaintiff’s claims were barred for several reasons. First, the Court held that the FDA-approved package inserts and DHCP letter sufficiently satisfied the Learned Intermediary Doctrine, and adequately discharged Defendants’ duty to warn. In reaching its conclusion, the Court explained that the Learned Intermediary Doctrine recognizes that a manufacturer has a duty to warn physicians, not laymen. The Court rejected Plaintiff’s argument that the warnings provided were inadequate. The Court noted that, while the adequacy of a warning is typically an issue for the trier of fact, a warning may be adequate as a matter of law where the adverse effect suffered by the patient was one that the manufacturer specifically warned against. In this case, Plaintiff suffered pulmonary embolism, and both professionals were aware of these warnings, and even counseled Plaintiff about those warnings. Furthermore, Plaintiff failed to show any disputed issue of fact regarding causation because she did not show that a different warning would have changed the decision to prescribe Ortho Evra.
The Court also found that Plaintiff’s Complaint was insufficient to state a claim under Fed. R. Civ. P. 12 (c). Rather than offer facts that supported a plausible claim for relief, Plaintiff merely provided conclusory allegations. See Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007). Plaintiff also failed to bring her claim within Mississippi’s three (3) year statute of limitations. Plaintiff sustained her injury in April 2008, and filed suit in August 2011. The Court rejected Plaintiff’s argument that Mississippi recognizes the Discovery Rule, and ultimately held that her claim was barred.
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Submitted by: Marisa A. Trasatti & Wayne C. Heavener, Semmes, Bowen & Semmes (Baltimore, MD)
Whether you like it or not, most of the world will develop an opinion of you based on what they see on the internet – based on your firm’s website, your wall on Facebook, your posts on LinkedIn, your tweets or whatever else is out there on Google by or about you. Remember that you have an image and a brand and you can either build up that brand or tear it down based on what you put out there in the internet. Also, from time to time, Google yourself and see what others are saying. With so many attorney review sites popping up, investigate what your reputation is and always do what you can to improve your online reputation.
Maryland Appellate Court Affirms Defendants’ Motion for Summary Judgment Properly Granted Where Plaintiff Failed to Produce Sufficient Circumstantial Evidence of Lead at Subject Property
In West v. Rochkind, 212 Md. App. 164 (2013), the Circuit Court for Baltimore City granted summary judgment in favor of Defendants, NBS, Inc., and Stanley Rochkind (hereinafter, collectively “Defendants”), who owned and operated a residential property, 1814 Lorman Street, from May 4, 1990, through June of 2001. The Plaintiff alleged that he sustained injury from having ingested lead paint while living with his grandparents at 1814 Lorman Street from his birth in 1989 through February 10, 1992. The case was necessarily based on circumstantial evidence because no lead paint tests were ever conducted on 1814 Lorman Street and the property had since been razed. Discovery revealed that Plaintiff either resided or spent substantial amounts of time at a variety of different residences during the first six (6) years of his life – 1814 Lorman Street, plus an additional three (3) other properties. The trial court ruled that Plaintiff had not made out a prima facie case of negligence against the Defendants. The trial court reasoned that, given Plaintiff’s uncertain residential history and the lack of any direct evidence that 1814 Lorman Street ever contained lead paint, Plaintiff could not point to 1814 Lorman Street as the source of his lead poisoning. The Court of Special Appeals agreed and affirmed the judgment of the circuit court.
In the appeal, the Court of Special Appeals looked to its prior decision in Dow v. L & R Properties, Inc., 144 Md. App. 67 (2002), on the issue of whether the Plaintiff had produced sufficient circumstantial evidence to create a genuine dispute of material fact as to whether the subject property contained lead, and thus, to defeat a Defendant’s Motion for Summary Judgment, even without direct proof of lead in the form of tests conducted at the property. The Court emphasized that under Dow, a lead paint plaintiff may establish a prima facie case of negligence based solely on circumstantial evidence. In this case, however, where there was no direct evidence that 1814 Lorman Street even contained lead paint, Plaintiff may only rely on that critical fact, as a necessary part of his circumstantial evidence, if he can show by the process of elimination that 1814 Lorman Street was the only possible cause for the critical effect of lead poisoning. The existence of lead paint at 1814 Lorman Street can only be inferred from the Plaintiff’s condition if lead paint at Lorman Street is shown to have been the only possible explanation for the Plaintiff’s condition. Put another way, even in the absence of direct proof, the presence of lead paint at a particular site can be inferred by the process of elimination, but only if there is: 1) the effect of lead poisoning in the plaintiff and 2) the fact that the site in question was the exclusive possible source of the plaintiff's lead paint exposure. Such was not the case here.
In this case, at best, the Plaintiff could show that he may have been exposed to lead at any or all of the three (3) or four (4) residences where he spent substantial time as a child. By definition, that does not trigger the process of elimination, and he thereby failed to establish the threshold premise that lead was even present in the paint at Lorman Street. Under those circumstances, whether he spent a significant amount of time or only a negligible amount of time or no time at all at Lorman Street was immaterial, because he failed to establish the necessary premise on which the ultimate conclusion of probable causation logically depended. Therefore, the trial court properly granted Defendant’s Motion for Summary Judgment.
Submitted by: Marisa A. Trasatti and Colleen K. O’Brien, Semmes, Bowen & Semmes, Baltimore, Maryland
The key to writing is grabbing the reader’s attention and not letting go. Wham! Right between the eyes. Once you have landed that first punch, do not let up. Make your point and stick to it. Wander from your message, confuse or obfuscate it, and you run the risk of losing the reader. Make every paragraph, every sentence, every word, every syllable count, pushing the reader to your conclusion, getting him to embrace it like it was his own. What follows are some tips on how to improve your writing, whether it is addressed to a judge, a client or opposing counsel.
1. Brainstorm. Before you write, take a pen and a piece of paper and brainstorm your ideas. At this stage, leave the computer off. Just you and a piece of paper, making lists, jotting down ideas, doodling perhaps, figuring out what you are going to write about. Put down whatever idea comes into your head, however foolish it may strike you. You can discard the foolish ideas later. Who knows. That foolish idea may not be so foolish after all.
2. Prepare an outline. After you have put your thoughts on paper, organize them in the form of an outline. Sort through your ideas, keeping some and discarding others. The outline will serve as a blueprint for your writing.
3. Read. When you are not writing, spend time reading. Read the paper, magazines, non-fiction books, fiction, anything you can get your hands on. As you read, study the writing. How does the writer start? How does he build on his lead? How does he conclude? What words does he use and how does he use them? It is by reading that you will most improve your writing skills. Everything you read can serve as a writing tutorial.
4. Know your audience. Remember, you are not writing for you, you are writing for your audience. Forget this and risk alienating and boring the reader. How you write a motion for a judge is different from how you write a letter to a client.
5. Serve the reader. Keep the reader’s needs in the forefront when you write and serve those needs to a fault. You write to inform the reader, to persuade him, and yes, to entertain him. Serve your selfish needs over the reader’s at the risk of losing the reader’s attention.
6. Bam! Hit the reader between the eyes. Hit the ground running with a strong start. You are not working up to a crescendo. You start at the crescendo. The first sentence or two must grab the reader’s attention. In those first sentences, you must let the reader know why he should keep reading. Remember, Alice was down the rabbit hole on page two or three.
7. Just say it. Be direct. If what you have to say is important enough to reduce to writing, just say it. Do not mince words, do not hem or haw. Be bold, blurt the words out and keep moving.
8. Get to your point. Right away, let the reader know the point of your writing. If the reader has to read three pages of your six page motion to figure out what you are trying to say, then you have failed as a writer.
9. Stick to the point. Once you make your point, stick to it. Do not wander off the path. Digressions distract.
10. Support your point. If you make assertions, support them. Why does your position make sense? Why should the reader agree with you? Use facts, anecdotes, examples, cases, whatever you need to bolster your position.
Title: Negligence Claims against Pharmacy found to Fall within California’s One-Year Statute of Limitations for Professional Negligence
In Manion v. Vintage Pharmaceuticals, LLC, No. C-13-2996 (N.D. Cal. Oct. 16, 2013), the United States District Court for the Northern District of California found that plaintiffs’ claims against defendant pharmacies for failure to notify plaintiffs of a recall on an allegedly defective drug fell within California’s one-year statute of limitations for professional negligence. The Court determined that pharmacies provide professional services for which they are licensed when notifying customers of drug recalls. The Court granted defendant pharmacies’ Motion to Dismiss, but granted plaintiffs leave to amend their Complaint.
This case arises out of an unintended pregnancy that was allegedly the result of defective packaging. Ashley Manion and Brian Dodd (“Plaintiffs”) had a daughter together on June 3, 2012, which was the result of an unplanned pregnancy. Prior to her daughter’s birth, Ms. Manion purchased the birth control pill Tri-Previfem from a CVS Pharmacy in Napa, California in July and August 2011. In September 26, 2011, CVS notified Ms. Manion of a recall for Tri-Previfem pills. On May 23, 2013, Plaintiffs brought suit against several pharmaceutical manufacturers and distributors, including CVS Pharmacy, Inc. and Longs Drug Stores of California LLC (collectively, “CVS”). In their Complaint, Plaintiffs allege that the Tri-Previfem they purchased was packaged incorrectly, such that there was a mismatch between the actual sequence of the pills and the sequence indicated by the package. As a result, Ms. Manion allegedly took placebo pills when she should have been taking active pills. Plaintiffs filed suit in the Superior Court of the State of California for the County of Napa, and CVS removed the case to federal court on June 28, 2013.
Plaintiffs only cause of action against CVS was for negligence. In particular, Plaintiffs alleged that CVS breached its duty to notify their customers of the recall on Tri-Previfem by waiting until September 26, 2011 to notify Plaintiffs. CVS filed a Motion to Dismiss under Fed. R. Civ. P. 12(b)(6), arguing that Plaintiffs’ claim was barred by the applicable statute of limitations. CVS claimed that Plaintiffs’ cause of action was barred under Cal. Civ. Code § 340.5, which states that “the time for the commencement of action shall be . . . one year after the plaintiff discovers, or through the use of reasonable diligence should have discovered” claims of an injury arising from “professional negligence” by a “health care provider.” In opposition, Plaintiffs argue that Civ. Code § 340.5 does not apply, but rather that California’s general two-year limitations period for injuries caused by negligence should apply. See Cal. Civ. Code § 335.1.
The Court granted CVS’s Motion to Dismiss the Plaintiffs’ Complaint, with leave to amend. As a preliminary matter, the Court recognized that CVS is a “health care provider” within the meaning of Civ. Code § 340.5 because its pharmacists are licensed under Cal. Bus. & Prof. Code §§ 4110 and 4018. Rejecting Plaintiffs’ argument that their claims constituted ordinary rather than professional negligence, the Court held that CVS rendered professional services not only when it dispensed the allegedly defective pill, but also in providing notice to customers of the drug’s recall. The Court determined that Plaintiffs’ injury, for the purposes of Civ. Code § 340.5, was the conception, rather than the birth, of Plaintiffs’ child. The limitations period began to run when Ms. Manion either actually discovered, or through the use of reasonable diligence, should have discovered, that she was pregnant. The Court permitted Plaintiffs leave to amend their Complaint, in order to plead additional facts showing when and how Plaintiffs discovered Ms. Manion’s “surprise” pregnancy. This permitted Plaintiffs an opportunity to plead facts that would effectively toll the one-year period under Civ. Code § 340.5 until the time Ms. Manion knew, or should have known, that she was pregnant.
Submitted by: Marisa A. Trasatti & Wayne C. Heavener, Semmes, Bowen & Semmes (Baltimore, MD)
Continuing the presentation of the Ten Commandments of Leadership for Lawyers--Why It Counts---a paper prepared by me and Connie Lewis Lensing of FedEx. The first five commandments were that training will create better lawyers, better people, a better ethics/professionalism environment, more business, and a better environment for your law firm. Here is the sixth commandment:
6. You will improve the visibility of your firm. Of course, it is important for lawyers to be effective leaders in the law firm and in their practice of law. However, law firms should encourage their lawyers to get involved in things beyond the law firm. They can become leaders in other legal organizations and associations—like DRI, IADC, FDCC or Lawyers for Civil Justice. That will improve the visibility of the individual lawyer and, derivatively, his or her law firm. You will learn things. You will be involved in an important network beyond the law firm, which expands your horizons and referral base. And you will have some fun. Getting involved actively in legal organizations exposes a lawyer to a host of new referring lawyers and potential clients, and impressing those other people in that environment will say a lot about you and your law firm.
Get in the habit of reading the local business paper each day. Generally these papers highlight what is going on in the legal community. You can follow what your peers are doing, keep up with business and legal trends and add to your general knowledge for cocktail hour conversation. In Miami, read the Daily Business Review and the Florida Bar News to see what colleagues are doing. If you notice an old friend or colleague move to another firm, go in-house or win a major victory, consider sending her a handwritten note congratulating her. It’s a good way to keep in touch.
Title: Expert testimony that Mold causes neurocognitive and musculoskeletal injuries inadmissible in Maryland Courts.
Plaintiffs, employees for the Baltimore Washington Conference of the United Methodist Church, filed workers’ compensation claims for physical injuries, including “neurocognitive and musculoskeletal symptoms, as a result of exposure to mold in the Baltimore Washington Conference’s office.” Plaintiffs offered the testimony of Dr. Ritchie Shoemaker, a family physician and self-professed expert on mold, on the issue of causation. Montgomery Mutual, the Defendant, moved to exclude Dr. Shoemaker’s testimony on the basis that it was not generally accepted by the medical and scientific community and, therefore, inadmissible under the standard set by Frye-Reed. The trial Court denied the motion, without holding a Frye-Reed hearing, and judgment was entered against Defendant after a trial on the merits in which Dr. Shoemaker’s testimony was critical.
InMontgomery Mut. Ins. Co. v. Chesson, 399 Md. 314, 318, 923 A.2d 939, 941 (2007) (“Chesson I”), the Court of Appeals ordered that the case be remanded for the purpose of conducting the Chesson I hearing. The trial court conducted the Frye-Reed hearing on Dr. Shoemaker’s methodology and theory of causation, and held that “Dr. Shoemaker’s ‘Repetitive Exposure Protocol’ was a differential diagnosis, which itself was ‘reliable’ and ‘properly performed,’ bringing it within general acceptance of the relevant scientific community.” Defendant appealed the holding. The Court of Special Appeals overturned the ruling, and the Court of Appeals granted certiorari.
The Court began with an overview of Maryland’s Frye-Reed standard for the admissibility of testimony presenting “novel” questions of science. The standard’s test requires, in part, that the proffered theory be generally accepted by the scientific community. “A trial judge also cannot admit expert testimony based on scientific methodology without consideration of whether the analysis itself is flawed and posits an ‘analytical gap.’”
The Court then reviewed the Frye-Reed hearing testimony of both Dr. Shoemaker, and the defense’s expert, Dr. Hung Cheung, who was qualified as an expert in internal medicine, occupational medicine, environmental medicine, toxicology, and indoor air quality. Dr. Shoemaker testified regarding his “Repetitive Exposure Protocol” – the differential diagnosis process that he developed, which supported his theory. Dr. Shoemaker noted that prior to 2005 his process and theory were controversial, but claimed that after 2005, they gained acceptance in the relevant scientific community. Conversely, Dr. Cheung testified that the medical literature clearly showed that Dr. Shoemaker’s process and theory were never generally accepted, and that the process contained critical analytical gaps. Specifically, Dr. Shoemaker’s process failed to take into account the level of mold exposure in diagnosing and treating mold-related health problems, which was necessary “as part of a careful environmental and medical history.”
The Court further noted that numerous other jurisdictions had excluded Dr. Shoemaker’s testimony, including the District Court for the District of Columbia, Virginia, Florida, and Alabama. The Court then held that “Dr. Shoemaker’s technique, which reflects a dearth of scientific methodology, as well as his causal theory, therefore, are not shown to be generally accepted in the relevant scientific community.” The Court affirmed the judgment of the Court of Special Appeals reversing the trial Court’s holding, effectively vacating the original judgments rendered in Plaintiffs’ favor.
Submitted by: Marisa A. Trasatti and Gregory S. Emrick, Semmes, Bowen & Semmes, Baltimore, Maryland
When preparing for your client’s deposition, spend time drafting what you expect to be the other side’s cross-examination. Think through the questions they’ll ask, the lines of questioning they’ll pursue, the potential traps they’ll try to set. This will help you focus on the tough questions you expect to be asked of your client and you can better prepare her on how to respond to them.